Drug Register (December 2025)
This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.
| S/N | NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | MANUFACTURING SITE | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|---|
| 1 | NDA/MAL/HHP/10019 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOMYN TABLETS | CHARAK PHARMA PRIVATE LIMITED, JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER | 3/7/22 |
| 2 | NDA/MAL/HHP/10020 | KALBE INTERNATIONAL PTE LTD | ABACUS PHARMA (AFRICA) LIMITED | WOOD'S PEPPERMINT LOZENGES (ORIGINAL FLAVOUR) | PT.KALBE FARMA TBK - JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- | INDONESIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | I. 1*15*6LOZENGE SACHET | 3/10/22 0:00 |
| 3 | NDA/MAL/HHP/10021 | KALBE INTERNATIONAL PTE LTD | ABACUS PHARMA (AFRICA) LIMITED | WOOD'S PEPPERMINT LOZENGES(CHERRY FLAVOUR) | PT.KALBE FARMA TBK - JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- | INDONESIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | I. 1*15*6LOZENGE SACHET | |
| 4 | NDA/MAL/HHP/10500 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL NATURA SYRUP | THE MADRAS PHARMACEUTICALS.., NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 12/2/22 |
| 5 | NDA/MAL/HHP/11013 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | DEEP RUBY BALM | 1. ARIHANT REMEDIES BLOCK NO. 444, ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP, CHANGODAR - 382213 AHMEDABAD, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL BALMS | I. 1*1*10G BOTTLE | 10/13/23 0:00 |
| 6 | NDA/MAL/HHP/11501 | ZYDUS LIFESCIENCES LTD. | ABACUS PHARMA (AFRICA) LIMITED | SIMBA PAIN BALM | N/A | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 ML CONTAINER | 7/3/24 |
| 7 | NDA/MAL/HHP/11502 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | REVITAL | SOFTESULE PRIVATE LIMITED, PLOT O. 86-A, L.B.S MARG, MULUND (W) MUMBAI 400080 - INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X30.0 CAPSULE BOTTLE | 8/20/24 |
| 8 | NDA/MAL/HHP/11503 | LDD BIOSCIENCE PVT. LTD. | DELMAW ENTERPRISES LIMITED | MENSORALPLUS TABLETS | LDD BIOSCIENCE PVT. LTD. PLOT NO. 71, SECTOR 8, IMT MANESAR, GURUGRAM, HARYANA 122051 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 12/18/24 |
| 9 | NDA/MAL/HHP/11504 | LDD BIOSCIENCE PVT. LTD. | DELMAW ENTERPRISES LIMITED | PROSTORITE TABLETS | LDD BIOSCIENCE PVT. LTD. PLOT NO. 71, SECTOR 8, IMT MANESAR, GURUGRAM, HARYANA 122051 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 12/18/24 |
| 10 | NDA/MAL/HHP/11505 | LDD BIOSCIENCE PVT. LTD. | DELMAW ENTERPRISES LIMITED | ALPHA POWER M TABLETS | LDD BIOSCIENCE PVT. LTD. PLOT NO. 71, SECTOR 8, IMT MANESAR, GURUGRAM, HARYANA 122051 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 12/18/24 |
| 11 | NDA/MAL/HHP/11506 | LDD BIOSCIENCE PVT. LTD. | DELMAW ENTERPRISES LIMITED | STONOKID TABLET | LDD BIOSCIENCE PVT. LTD. PLOT NO. 71, SECTOR 8, IMT MANESAR, GURUGRAM, HARYANA 122051 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 12/22/22 |
| 12 | NDA/MAL/HHP/11507 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ROYAL PHARMA 2011 LIMITED | GOFEN BALM | 1. ARYA VAIDYA SALA, KOTTAKKAL. NO 82-P3, KIADB INDUSTRIAL AREA NANJANGUD KARNATAKA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL BALMS | 1*25G TUBE | 7/15/22 |
| 13 | NDA/MAL/HHP/11508 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ROYAL PHARMA 2011 LIMITED | GOFEN SPRAY | 1. ARYA VAIDYA SALA, KOTTAKKAL. NO 82-P3, KIADB INDUSTRIAL AREA NANJANGUD KARNATAKA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1*60ML CANNISTER | 7/15/22 |
| 14 | NDA/MAL/HHP/11510 | MARTIN DOW MARKER LTD | HEALTHCARE LTD. | WINTOGENO BALM | MARTIN DOW MARKER LIMITED, 7, JAIL ROAD, QUETTA - PAKISTAN | PAKISTAN | TOPICAL EXTERNAL EMULSIONS | I. 1*150G TUBE | |
| 15 | NDA/MAL/HHP/11511 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ROYAL PHARMA 2011 LIMITED | GINSOMIN EVE | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY SOFT GELATIN CAPSULE | 1*3*10 CAPSULE BLISTER | 9/30/24 |
| 16 | NDA/MAL/HHP/3115 | CINCINNATI CHILDREN€™S HOSPITAL | SHURIK LTD | RHINO BALM | MEHTA UNANI PHARMACY & CO LTD, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER | 7/1/01 |
| 17 | NDA/MAL/HHP/5500 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | APTIZOOOM SYRUP | CHARAK PHARMA PRIVATE LIMITED, JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA| CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 7/1/00 |
| 18 | NDA/MAL/HHP/5502 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | GASEX | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*100TABLET CONTAINER II. 1*25TABLET CONTAINER | 7/1/00 |
| 19 | NDA/MAL/HHP/5508 | ABACUS PHARMA (A) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMRUTANJAN DRAGON BALM | AMRUTANJAN HEALTH CARE LIMITED - PLOT NO. 37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK, CHENGALPATTU DISTRICT, INDIA | INDIA | TOPICAL EXTERNAL OTHER OINTMENTS | I. 1*9G CONTAINER | 7/1/04 |
| 20 | NDA/MAL/HHP/5517 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | MENTAT | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*50TABLET CONTAINER | 7/1/04 |
| 21 | NDA/MAL/HHP/5518 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | PENODEX OINTMENT | MEHTA UNANI PHARMACY & CO LTD, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G CONTAINER | 7/1/07 |
| 22 | NDA/MAL/HHP/5519 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | APDYL-H, HERBAL COUGH SYRUP | AJANTA PHARMA LTD - , 31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD| SAVERA PHARMACEUTICALS PVT LTD -, H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 7/1/04 |
| 23 | NDA/MAL/HHP/5520 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | PILEX | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*25TABLET CONTAINER II. 1*1*100TABLET CONTAINER | 7/1/01 |
| 24 | NDA/MAL/HHP/5527 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | KOFLET | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*100ML BOTTLE | 7/1/00 |
| 25 | NDA/MAL/HHP/5528 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | AQUAREST | 288,SIDCO ESTATE, AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X765.0 MG SACHET | 7/1/09 |
| 26 | NDA/MAL/HHP/5529 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | LIV.52 | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*1*100ML BOTTLE II. 1*200ML BOTTLE | 7/1/00 |
| 27 | NDA/MAL/HHP/5530 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | LIV.52 TABLETS | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*100TABLET BOTTLE II. 1*1*25TABLET BOTTLE | 7/1/00 |
| 28 | NDA/MAL/HHP/5531 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | RUMALAYA | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*30G TUBE | 7/1/00 |
| 29 | NDA/MAL/HHP/5532 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | ATMANANTHAN COLD RUB | META UNANI PHARMACY & CO PVT, G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI | INDIA | NASAL TOPICAL LIQUID INHALATIONS | 1.0X12.0X1.0 G ROD | 7/1/09 |
| 30 | NDA/MAL/HHP/5536 | ABACUS (A) PHARMA LTD | JEET PHARMACEUTICALS LIMITED | MENTHO PLUS PAIN BALM | EMAMI LTD, EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI | INDIA | NASAL TOPICAL OINTMENTS | 1.0X24.0X3.5 ML VIAL,1.0X1.2 G JAR,1.0X4.0 G JAR,1.0X9.0 G JAR,1.0X30.0 G JAR,1.0X1.2 ML VIAL,1.0X4.0 ML VIAL,1.0X9.0 ML VIAL,1.0X30.0 ML BOTTLE | 7/1/04 |
| 31 | NDA/MAL/HHP/5538 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | SEPTILIN | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*100TABLET CONTAINER | 7/1/00 |
| 32 | NDA/MAL/HHP/5546 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | PAEDRITONE SYRUP | CHARAK PHARMA PVT LTD,, EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 7/1/15 |
| 33 | NDA/MAL/HHP/5549 | HIMALAYA DRUG COMPANY | EUROPA HEALTHCARE (U) LTD | BONISAN LIQUID | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | I. 1*1*120ML BOTTLE | 7/1/00 |
| 34 | NDA/MAL/HHP/5550 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | GUM TONE GEL | CHARAK PHARMA PVT LTD,, EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X50.0 G TUBE | 7/1/15 |
| 35 | NDA/MAL/HHP/5557 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | NEW BETA GRIPE WATER | SYDLER REMEDIES PRIVATE LIMITED C-7-8 (2) MIDC BHOSARI, PUNE ? 411026, MAHARASHTRA| BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100 | INDIA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1*120ML BOTTLE 1*100ML BOTTLE | 7/1/14 |
| 36 | NDA/MAL/HHP/5559 | CINCINNATI CHILDREN€™S HOSPITAL | SHURIK LTD | STAR SKIN OINTMENT | MEHTA UNANI PHARMACY & CO LTD, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X12.0 G TUBE | 7/1/01 |
| 37 | NDA/MAL/HHP/5563 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | CYSTONE | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*100TABLET CONTAINER | 7/1/01 |
| 38 | NDA/MAL/HHP/5570 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | SITCOM | PANACEA BIOTEC PHARMA LIMITED, MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 7/1/13 |
| 39 | NDA/MAL/HHP/5572 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | VIGOMAX FORTE | CHARAK PHARMA PVT LTD, JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER | 7/1/11 |
| 40 | NDA/MAL/HHP/5574 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NEW PINKOO GRIPE WATER | AJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 7/1/09 |
| 41 | NDA/MAL/HHP/5583 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | EVECARE | 1. HIMALAYA WELLNESS COMPANY (FORMERLY KNOWN AS THE HIMALAYA DRUG COMPANY) MAKALI, BENGALURU, KARNATAKA, INDIA, PIN CODE: 562162 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*30CAPSULE CONTAINER | 7/1/01 |
| 42 | NDA/MAL/HHP/5587 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | MANOLL SYRUP | CHARAK PHARMA PVT LTD, JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA| CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X250.0 MG BOTTLE | 7/1/16 |
| 43 | NDA/MAL/HHP/5588 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | KOFOL (HONEY LEMON FLAVOUR) | CHARAK PHARMA PVT LTD,, EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X6.0 LOZENGE BLISTER | 7/1/14 |
| 44 | NDA/MAL/HHP/5620 | UNIQUE PHARMACEUTICAL LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF COLD RUB | 1. UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J. B. CHEMICALS & PHARMACEUTICALS LIMITED) PLOT NO. 4, PHASE IV, GIDC, INDUSTRIAL AREA, PANOLI - 394 116, DIST: BHARUCH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*20G CONTAINER | 7/1/09 |
| 45 | NDA/MAL/HHP/5623 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/1/05 |
| 46 | NDA/MAL/HHP/5629 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/1/05 |
| 47 | NDA/MAL/HHP/5630 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH REMEDY | UNIQUE PHARMACEUTICAL LABORATORIES -, PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI€”394 116,INDIA. | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 7/1/00 |
| 48 | NDA/MAL/HHP/5631 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES(LEMON) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/1/14 |
| 49 | NDA/MAL/HHP/6848 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | KOFOL (MINT) | LEAMARK HEALTHCARE PVT LTD, SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X3.0X4.0 LOZENGE BLISTER,1.0X2.0X6.0 LOZENGE BLISTER | 7/1/16 |
| 50 | NDA/MAL/HHP/7929 | WOCKHARD LTD | KAMCARE PHARMA LIMITED | MANIX HERBAL CAPSULES | TIRUPATI LIFESCIENCES, NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 7/1/15 |
| 51 | NDA/MAL/HHP/7934 | STAR PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SENSUR RUBEFACIENT | SYDLER REMEDIES, PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA| | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 7/1/15 |
| 52 | NDA/MAL/HHP/7937 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | SENSUR OIL | GLENMARK PHARMACEUTICAL LIMITED, 61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X10.0 ML VIAL | 7/1/15 |
| 53 | NDA/MAL/HHP/7940 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SENSUR LOTION | SYDLER REMEDIES, PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA| | INDIA | TOPICAL EXTERNAL OTHER CREAMS | 1.0X50.0 ML BOTTLE | 7/1/15 |
| 54 | NDA/MAL/HHP/7942 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGICA FORT | DHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA), NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 7/1/16 |
| 55 | NDA/MAL/HHP/7947 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES(HONEY LEMON) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/1/14 |
| 56 | NDA/MAL/HHP/7949 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH (SUGAR FREE) | UNIQUE PHARMACEUTICAL LABORATORIES -, PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI€”394 116,INDIA. | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE CONTAINER | 7/1/16 |
| 57 | NDA/MAL/HHP/7950 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES(RASPBERRY) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/1/14 |
| 58 | NDA/MAL/HHP/7954 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES(PINEAPPLE) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/1/14 |
| 59 | NDA/MAL/HHP/7956 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL (SUGAR FREE) | UNIQUE PHARMACEUTICAL LABORATORIES. , SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 7/1/15 |
| 60 | NDA/MAL/HHP/8215 | AMRUTANJAN HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | AMRUTANJAN DRAGON BACK PAIN ROLL-ON | AMRUTANJAN HEALTH CARE LIMITED - , PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X50.0 ML CONTAINER | 7/1/04 |
| 61 | NDA/MAL/HHP/8220 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NOCOLIC | AJANTA PHARMA LTD - , 31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 7/1/17 |
| 62 | NDA/MAL/HHP/8379 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | M2 TONE TABLET | CHARAK PHARMA PRIVATE LIMITED, JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 9/20/17 |
| 63 | NDA/MAL/HHP/8505 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOMYN SYRUP | CHARAK PHARMA PVT LTD, INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011| CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE | 2/2/18 |
| 64 | NDA/MAL/HHP/8506 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | ALKA 5 SYRUP | CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 2/2/18 |
| 65 | NDA/MAL/HHP/8508 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | KOFOL SF SYRUP | CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA| CHARAK PHARMA PVT LTD, INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 2/2/18 |
| 66 | NDA/MAL/HHP/8509 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EVANOVA CAPSULE | CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER | 11/29/17 |
| 67 | NDA/MAL/HHP/8510 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS COUGH SYRUP | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 3/6/18 |
| 68 | NDA/MAL/HHP/8548 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICAL LTD | PEPSOL | ARTURA PHARMACEUTICALS PRIVATE LIMITED - NO. 1505, PORTIA ROAD SRI CITY SEZ, SATYAVEDU MANDAL, CHITTOOR DIST-517 588, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | I. 1*3*10CAPSULE BLISTER | 10/24/17 |
| 69 | NDA/MAL/HHP/8552 | AMRUTANJAN HEALTHCARE LIMITE | ABACUS PHARMA (AFRICA) LIMITED | AMRUTANJAN DRAGON BALM | AMRUTANJAN HEALTH CARE LIMITED , PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK, KANCHEEPURAM, DIST. €“ 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X10.0 ML TUBE | 11/24/17 |
| 70 | NDA/MAL/HHP/8556 | MANKIND PHARMA LTD. | TATA UGANDA LIMITED | UNIORTHO-500 | TIRUPATI LIFESCIENCES, NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 11/10/17 |
| 71 | NDA/MAL/HHP/9093 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | COFTA EXTRA SYRUP | BETA HEALTHCARE INTERNATIONAL LTD , PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 3/22/19 |
| 72 | NDA/MAL/HHP/9179 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | ADDYZOA CAPSULES | CHARAK PHARMA PVT. LTD,, PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER | 1/29/20 |
| 73 | NDA/MAL/HHP/9254 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF HERBAL COUGH LOZENGES-STRAWBERRY FLAVOUR | UNIQUE PHARMACEUTICAL LABORATORIES ;, SURVEY NO. 101/2 & 102/1, DAMAN INDUSTRIAL ESTATE, KAPAIYA, DAMAN 396210 | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE STRIP | 7/18/20 |
| 74 | NDA/MAL/HHP/9332 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGICA IVY SYRUP | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 8/31/20 |
| 75 | NDA/MAL/HHP/9333 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGICA MOUTH SPRAY | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X10.0 ML BOTTLE | 8/31/20 |
| 76 | NDA/MAL/HHP/9342 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | LOZETS- ORANGE | 1. PRINCE SUPPLICO PHARMA PVT LTD. PLOT 90/A, CHITRA GUJARAT INDUSTRIAL DEVELOPMENT CORPORATION, BHAVNAGAR, GUJARAT 364004, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL TOPICAL LOZENGES | I. 1*2*12LOZENGE BLISTER | 11/5/20 |
| 77 | NDA/MAL/HHP/9343 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | LOZETS-WARM GINGER | 1. PRINCE SUPPLICO PHARMA PVT LTD. PLOT 90/A, CHITRA GUJARAT INDUSTRIAL DEVELOPMENT CORPORATION, BHAVNAGAR, GUJARAT 364004, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL TOPICAL LOZENGES | I. 1*2*12LOZENGE BLISTER | 11/5/20 |
| 78 | NDA/MAL/HHP/9344 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | LOZETS- COOL MINT | 1. PRINCE SUPPLICO PHARMA PVT LTD. PLOT 90/A, CHITRA GUJARAT INDUSTRIAL DEVELOPMENT CORPORATION, BHAVNAGAR, GUJARAT 364004, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL TOPICAL LOZENGES | I. 1*2*12LOZENGE BLISTER | 11/5/20 |
| 79 | NDA/MAL/HHP/9489 | KALBE INTERNATIONAL PTE LTD | ABACUS PHARMA (AFRICA) LIMITED | WOOD'S HERBAL COUGH SYRUP | PT.KALBE FARMA TBK - JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- | INDONESIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*60ML BOTTLE | 2/9/21 0:00 |
| 80 | NDA/MAL/HHP/9711 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | GINSOMIN | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/7/21 |
| NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | MANUFACTURER | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|
| NDA/MAL/VHP/8117 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | SOOTHING OIL | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | UNKNOWN OILS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 7/1/2016 |
| S/N | NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | GENERIC NAME OF DRUG | STRENGTH OF DRUG | MANUFACTURING SITE | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NDA/MAL/HDP/0002 | ABACUS PARENTERAL DRUGS LIMITED. | ABACUS PARENTERAL DRUGS LIMITED | X-SONE-N | DEXAMETHASONE+NEOMYCIN | 0.1W/V+ 0.35W/V | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2011 |
| 2 | NDA/MAL/HDP/0006 | HOVID BHD | BARIKI EXIM PHARMA LTD | DIAMIDE | GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE | 5MG + 500MG | HOVID BERHAD,, LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X12.0 TABLET BLISTER | 01/07/2014 |
| 3 | NDA/MAL/HDP/0007 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROCIP SYRUP | CYPROHEPTADINE HYDROCHLORIDE | 2MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2013 |
| 4 | NDA/MAL/HDP/0012 | HOVID BHD | BARIKI EXIM PHARMA LTD | PENGESIC SR | TRAMADOL HYDROCHLORIDE SR | 100MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 5 | NDA/MAL/HDP/0013 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | IMPLANON NXT | ETONOGESTREL | 68MG | N.V. ORGANON, KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND | NETHERLANDS | PARENTERAL RETARD IMPLANTS | 1X1 IMPLANT AMPOULE, 1X68 MG IMPLANT | 01/07/2015 |
| 6 | NDA/MAL/HDP/0014 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | MONTELAIR 10MG TABLET | MONTELUKAST | 10MG | HOVID BERHAD (CHEMOR SITE)-, LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 7 | NDA/MAL/HDP/0016 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CODIMEX-CT TABLETS | CETIRIZINE DIHYDROCHLORIDE | 10MG | REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 8 | NDA/MAL/HDP/0017 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | S-HYDRO | HYDROCORTISONE | 100MG | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X7.5 ML VIAL, 1.0X50.0X100.0 MG VIAL | 01/07/2011 |
| 9 | NDA/MAL/HDP/0022 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | QUININE SULPHATE | QUININE SULPHATE | 300MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2009 |
| 10 | NDA/MAL/HDP/0024 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMPICLOXA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 11 | NDA/MAL/HDP/0030 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | TRADMIN | TRAMADOL HYDROCHLORIDE | 50MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE | 01/07/2015 |
| 12 | NDA/MAL/HDP/0031 | MANKIND PHARM LTD | TATA UGANDA LIMITED | CEFTATIME-SB 1.5 | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | MANKIND PHARMA LTD-, VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL | 01/07/2015 |
| 13 | NDA/MAL/HDP/0041 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RECIM | CIMETIDINE | 200MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 14 | NDA/MAL/HDP/0045 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL CAPLETS | PARACETAMOL | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 15 | NDA/MAL/HDP/0048 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AURASERT 50 | SERTRALINE HYDROCHLORIDE | 50 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*2*14TABLET BLISTER | 01/07/2008 |
| 16 | NDA/MAL/HDP/0049 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AURASERT 100 | SERTRALINE HYDROCHLORIDE | 100 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 01/07/2008 |
| 17 | NDA/MAL/HDP/0052 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DISPERCAM | PIROXICAM | 0.5%W/V | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/2014 |
| 18 | NDA/MAL/HDP/0054 | GOOD DAY PHARMACY LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | FUNGOAL | CLOTRIMAZOLE | 1%W/W | KREMOINT PHARMA PVT LTD--, B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2013 |
| 19 | NDA/MAL/HDP/0056 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR QPS | DICLOFENAC | 4%W/V | TROIKAA PHARMACEUTICALS LTD, THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA| TROIKAA PHARMACEUTICALS LTD, BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE | INDIA | TOPICAL EXTERNAL SPRAYS WITHOUT GAS | 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 01/07/2015 |
| 20 | NDA/MAL/HDP/0060 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML) | FOLLITROPIN ALFA | 22 µG/0,5 ML | MERCK SERONO S.A , SUCCURSALE D'AUBONNE, ZONE INDUSTRIELLE DE L'OURIETTAZ, 1170 AUBONNE, SWITZERLAND| MERCK SERONO SPA (BARI), VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | ITALY| SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION | 01/07/2015 |
| 21 | NDA/MAL/HDP/0063 | HETERO LABS LTD | AIVEEN (U) LIMITED | ABACAVIR SULPHATE + LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 600MG + 300MG | HETERO LABS LTD. UNIT (V), 439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2015 |
| 22 | NDA/MAL/HDP/0064 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 450 IU/ IE 0,75 ML (33 µG) | FOLLITROPIN ALFA | 33µG/ 0.7ML | MERCK SERONO S.A. (MSA) , 1170 SUCCURSALE D€™AUBONNE ZONE INDUSTRIELLE DE L€™OURIETTAZ, SWITZERLAND| MERCK SERONO SPA (BARI), VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | SWITZERLAND | PARENTERAL ORDINARY CARTRIDGES | 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION | 01/07/2015 |
| 23 | NDA/MAL/HDP/0065 | HOVID BHD | BARIKI EXIM PHARMA LTD | ALENDRONATE 70MG | ALENDRONATE SODIUM | 70MG | HOVID BHD, LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMOR | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2015 |
| 24 | NDA/MAL/HDP/0069 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | LIPITOR | ATORVASTATIN | 10MG | PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER | 01/07/1999 |
| 25 | NDA/MAL/HDP/0070 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | LIPITOR | ATORVASTATIN | 20MG | PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/1999 |
| 26 | NDA/MAL/HDP/0071 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SUMAFIX 100 | SUMATRIPTAN SUCCINATE | 100MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*5*4TABLET BLISTER | 01/07/2014 |
| 27 | NDA/MAL/HDP/0075 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | SYNRIAM | ARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE | 150 MG + 750 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED , INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2014 |
| 28 | NDA/MAL/HDP/0077 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | X-SONE | DEXAMETHASONE SODIUM PHOSPHATE | 0.1 % W/V | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2015 |
| 29 | NDA/MAL/HDP/0079 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | REVOKE 72 | LEVONORGESTREL | 750MCG | MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2014 |
| 30 | NDA/MAL/HDP/0083 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | ZINNIA-F | LEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE | 150MCG + 30MCG + 75MG | MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER | 01/07/2014 |
| 31 | NDA/MAL/HDP/0088 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | D-LYTE CO-PACK | ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC | 2.7MG+0.52MG+0.58MG+0.30MG+20MG PER 200ML,6.75MG+1.30MG+1.45MG+0.75MG+20MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG+20MG PER 1000ML SACHET | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES | 4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS | 01/07/2015 |
| 32 | NDA/MAL/HDP/0097 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | SAFELEVO 750 | LEVOFLOXACIN | 750MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 33 | NDA/MAL/HDP/0098 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | ATOREM 10 | ATORVASTATIN | 10MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 34 | NDA/MAL/HDP/0101 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTETRA CAPSULES | TETRACYCLINE HYDROCHLORIDE | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/1998 |
| 35 | NDA/MAL/HDP/0102 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | SILMELT 100 | SILDENAFIL CITRATE | 100MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X2.0 TABLET BLISTER | 01/07/2014 |
| 36 | NDA/MAL/HDP/0103 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | ATOREM 20 | ATORVASTATIN | 20MG | MSN LABORATORIES LTD, PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 37 | NDA/MAL/HDP/0104 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | SILMELT 50 | SILDENAFIL CITRATE | 50MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X2.0 TABLET BLISTER | 01/07/2014 |
| 38 | NDA/MAL/HDP/0105 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOSPRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 39 | NDA/MAL/HDP/0110 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI 40 | TELMISARTAN | 40MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 40 | NDA/MAL/HDP/0111 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI 80 | TELMISARTAN | 80MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 41 | NDA/MAL/HDP/0112 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 5MG/160MG | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | NOVARTIS PHARMA STEIN AGH-4332 STEIN SCHAFFAUSERTRASSE | | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2007 |
| 42 | NDA/MAL/HDP/0119 | DAWA LIMITED | SUPER MEDIC LTD | DACOLD | CAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE | 30MG+4MG+400MG+30MG | DAWA LIMITED , BABA DOGO RWARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 43 | NDA/MAL/HDP/0121 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | PEDZINC | ZINC SULPHATE | 20 MG | 1. BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100, KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY SOLUBLE TABLETS | I. 1*10TABLET BLISTER | 2015-07-01 00:00:00 |
| 44 | NDA/MAL/HDP/0124 | DAWA LIMITED | SUPER MEDIC LTD | AMPECIN | AMPICILLIN TRIHYDRATE | 125MG/5ML | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| 45 | NDA/MAL/HDP/0125 | DAWA LIMITED | SUPER MEDIC LTD | SULPHUR OINTMENT | SULPHUR | 10%W/W | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 01/07/2013 |
| 46 | NDA/MAL/HDP/0130 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TRIGAN -D | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | 1. CADILA PHARMACEUTICALS LIMITED 1389, TRASAD ROAD, DHOLKA-382225, DIST. AHMEDABAD, GUJARAT STATE - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*2ML AMPOULE II. 1*2ML VIAL | 01/07/2015 |
| 47 | NDA/MAL/HDP/0135 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | HEMOVIT SYRUP | IRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC | 200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MG | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| 48 | NDA/MAL/HDP/0139 | DAWA LIMITED- | SUPER MEDIC LTD | MOXAFORTE | FLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE | 250MG + 250MG | DAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 49 | NDA/MAL/HDP/0142 | PFIZER LABORATORIES | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PREVENAR 13 | PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED) | 2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,19A,19F,23F,AND 4.4MCG FOR SEROTYPE 6B | PFIZER MANUFACTURING BELGIUM NV - RIJKSWEG 12, 2870 PUURS - BELGIUM | UNITED STATES| BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X0.5 ML VIAL (1 DOSE) | 01/07/2011 |
| 50 | NDA/MAL/HDP/0157 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RECODIN | CODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE | 10MG + 4MG /5ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| 51 | NDA/MAL/HDP/0160 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | TIZIGESIC | TIZANIDINE HYDROCHLORIDE | 2MG | UNICHEM LABORATORIES LIMITED, C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 52 | NDA/MAL/HDP/0161 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TRAMAREN | TRAMADOL HYDROCHLORIDE | 50MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 53 | NDA/MAL/HDP/0162 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COSYP-D LINCTUS | DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE | 10MG +4MG /5ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| 54 | NDA/MAL/HDP/0163 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PHENAREN | PROMETHAZINE HYDROCHLORIDE | 5MG/5ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2015 |
| 55 | NDA/MAL/HDP/0164 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENPRESS | PROPRANOLOL | 40MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 56 | NDA/MAL/HDP/0165 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TOLANZ 5 | OLANZAPINE ORODISPERSIBLE TABLETS | 5MG | TORRENT PHARMACEUTICALS LTD .,, AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 57 | NDA/MAL/HDP/0166 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | X-PEL | MEBENDAZOLE | 100MG/5ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2015 |
| 58 | NDA/MAL/HDP/0167 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TOLANZ 10 | OLANZAPINE ORODISPERSIBLE TABLETS | 10MG | TORRENT PHARMACEUTICALS LTD .,, AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 59 | NDA/MAL/HDP/0168 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | FEBUDAY | FEBUXOSTAT | 80MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 60 | NDA/MAL/HDP/0175 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | XARELTO 10MG | RIVAROXABAN | 10MG | BAYER HEALTHCARE AG,, D-51368, LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2009 |
| 61 | NDA/MAL/HDP/0177 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ILET B2 | GLIMEPIRIDE | 2MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 62 | NDA/MAL/HDP/0178 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP DAYTIME AND NIGHT TIME CAPSULE | DAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHEDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE) | DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG) | REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X8.0 CAPSULE BLISTER | 01/07/2013 |
| 63 | NDA/MAL/HDP/0180 | REGAL PHARMACEUTICALS LIMITED | SONATEC MOUTHWASH | CETYLPYRIDINIUM CHLORIDE | 0.05%W/V | 1. REGAL PHARMACEUTICALS LIMITED PLOT NO. 7978/18, OFF BABA DOGO ROAD, RUARAKA - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1*200ML BOTTLE, 1*170ML BOTTLE | 01/07/1997 | |
| 64 | NDA/MAL/HDP/0182 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | FEBUDAY 40 | FEBUXOSTAT | 40MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 65 | NDA/MAL/HDP/0186 | WIDE SPECTRUM ENTERPRISES (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BBC SPRAY | BENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE | 1.5%W/V+0.15%W/V+0.0413%W/V | AMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X25.0 ML BOTTLE | 01/07/2014 |
| 66 | NDA/MAL/HDP/0187 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KAPRON TABLET | TRANEXAMIC ACID | 500 MG | AMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2014 |
| 67 | NDA/MAL/HDP/0191 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CLEDOMOX 228.5 | AMOXICILLIN + CLAVULANATE | 200 MG + 28.5 MG | MEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2013 |
| 68 | NDA/MAL/HDP/0193 | MEDOPHARM, INDIA | VITACARE LIMITED | CLEDOMOX 625 | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | MEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET STRIP | 01/07/2013 |
| 69 | NDA/MAL/HDP/0196 | QUALITY CHEMICAL INDUSTRIES LIMITED(QCIL) | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LAMIVUDINE AND ZIDOVUDINE TABLETS | LAMIVUDINE/ZIDOVUDINE | 150MG/300MG | QUALITY CHEMICAL INDUSTRIES LIMITED. , PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2013 |
| 70 | NDA/MAL/HDP/0203 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | SERETIDE EVOHALER 250 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG + 250MCG | GLAXO WELLCOME, PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2015 |
| 71 | NDA/MAL/HDP/0209 | HETERO LABS LTD | AIVEEN (U) LIMITED | ABACAVIR SULPHATE ORAL SOLUTION | ABACAVIR SULPHATE | 20MG/ML | HETERO LABS PRIVATE LIMITED UNIT III, SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X240.0 ML BOTTLE | 01/07/2013 |
| 72 | NDA/MAL/HDP/0210 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | HEPATICUM | SILYMARIN | 140MG | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 73 | NDA/MAL/HDP/0212 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | HEPATICUM | SILYMARIN | 1G/100ML | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE | 01/07/2012 |
| 74 | NDA/MAL/HDP/0220 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ZENOCET-10 | CETIRIZINE | 10MG | LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 07/01/2013 |
| 75 | NDA/MAL/HDP/0221 | DAWA LIMITED | SUPER MEDIC LTD | AMPICLO-DAWA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | DAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 76 | NDA/MAL/HDP/0222 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | AVIR-200 | ACYCLOVIR | 200MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.| LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 77 | NDA/MAL/HDP/0230 | STRIDES PHARMA SCIENCE LIMITED | DELMAW ENTERPRISES LIMITED | COMBIART | ARTHEMETHER + LUMEFANTRINE | 20MG +120MG | STRIDES PHARMA SCIENCE LIMITED (STRIDES SHASUN), KRS GARDENS, PLOT 36/7 SURAGAJKKANAHALLI, INDLAWADI CROSS, ANKAL TALUK, BANGALORE SOUTH - 562106, INDIA| UNIVERSAL CORPORATION LIMITED, PLOT NO 13777, PO BOX 1748-00902 KIKUYU CLUB RD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER | 01/07/2013 |
| 78 | NDA/MAL/HDP/0232 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | BRANTA | LOSARTAN POTASSIUM + AMLODIPINE BESILATE | 50MG + 5MG | TORRENT PHARMACEUTICALS LTD .,, AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 79 | NDA/MAL/HDP/0233 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | CEFIMED 400 | CEFIXIME TRIHYDRATE | 400MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C, 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER | 01/07/2014 |
| 80 | NDA/MAL/HDP/0234 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | CEFIMED 200 | CEFIXIME TRIHYDRATE | 200MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 81 | NDA/MAL/HDP/0235 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AXETINE 500 | CEFUROXIME AXETIL | 500MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2014 |
| 82 | NDA/MAL/HDP/0239 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | KOMEFAN 140 | ARTEMETHER + LUMEFANTRINE | 20 MG+ 120 MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X3.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER | 01/07/2014 |
| 83 | NDA/MAL/HDP/0245 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EUGLIM 4 | GLIMEPIRIDE | 4MG | ZYDUS LIFESCIENCES LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 84 | NDA/MAL/HDP/0250 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DIKON | DICLOFENAC | 1%W/W | LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER | 01/07/2013 |
| 85 | NDA/MAL/HDP/0252 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VAST-40 | ATORVASTATIN | 40MG | LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 86 | NDA/MAL/HDP/0254 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 5 | BISOPROLOL HEMIFUMARATE | 5MG | WINTHROP PHARMACEUTICALS(PTY) LTD,, 315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)|MERCK KGAA, 250 FRANKFRUTER STRASSE 250-64293 DARMSTADT| | SOUTH AFRICA|GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 87 | NDA/MAL/HDP/0256 | HETERO LABS LTD | REDDYS PHARMA LIMITED | CAPETERO 500 | CAPECITABINE | 500MG | HETERO LABS (UNIT VI), INDIA, APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET CONTAINER | 01/07/2015 |
| 88 | NDA/MAL/HDP/0266 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | BENZATHINE PENICILLIN INJECTION | BENZATHINE PENICILLIN | 2.400.000 IU | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON | 01/07/2001 |
| 89 | NDA/MAL/HDP/0269 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMISTAT-8 | ONDANSETRON | 8MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 90 | NDA/MAL/HDP/0270 | HETERO LABS LTD | REDDYS PHARMA LIMITED | LEVIN 500MG | LEVOFLOXACIN HEMIHYDRATE | 500MG | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 91 | NDA/MAL/HDP/0271 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | BETT | TETANUS VACCNE ADSORBED | 40 I.U | BIOLOGICAL E LTD, PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES) | 01/07/2015 |
| 92 | NDA/MAL/HDP/0275 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | ZENTEL | ALBENDAZOLE | 400MG | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED, 39 HAWKINS AVENUE, EPPING INDUSTRIA 1, 7460, CAPE TOWN, SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2011 |
| 93 | NDA/MAL/HDP/0276 | MICRO LABS LTD | LABOREX UGANDA LIMITED | MELANOV 80 | GLICLAZIDE | 80MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 94 | NDA/MAL/HDP/0278 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CHLORPROMAZINE TABLETS B.P 100MG | CHLORPROMAZINE HYDROCHLORIDE | 100MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 95 | NDA/MAL/HDP/0283 | DAWA LIMITED | SUPER MEDIC LTD | AMPICLO-DAWA | AMPICILLIN + CLOXACILLIN | 125 MG + 125 MG | DAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 96 | NDA/MAL/HDP/0290 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | NATOA | MEBENDAZOLE | 100MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 97 | NDA/MAL/HDP/0293 | HETERO LABS LTD | AIVEEN (U) LIMITED | DARUNAVIR | DARUNAVIR | 600MG | HETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2014 |
| 98 | NDA/MAL/HDP/0296 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PRAZITEL TABLETS | PRAZIQUANTEL | 600MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 99 | NDA/MAL/HDP/0298 | SAKAR HEALTH CARE PVT .LTD | MEDINOVATION ENTERPRISES LTD | SEFIXI-50 DRY SYRUP | CEFIXIME | 50MG | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 01/07/2013 |
| 100 | NDA/MAL/HDP/0300 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | AB-DOX-100 | DOXYCYCLINE | 100MG | JIANGSU PENGYAO PHARMACEUTICALS CO. LTD, NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA| | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 101 | NDA/MAL/HDP/0301 | HETERO LABS LTD | REDDYS PHARMA LIMITED | MONAST 10 | MONTELUKAST SODIUM | 10MG | HETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 102 | NDA/MAL/HDP/0302 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CINAMET-400 | CIMETIDINE | 400 | JIANGSU PENGYAO PHARMACEUTICALS CO. LTD , NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 103 | NDA/MAL/HDP/0303 | HETERO LABS LTD | AIVEEN (U) LIMITED | ABACAVIR SULPHATE | ABACAVIR SULPHATE | 300MG | HETERO DRUGS LTD, UNIT III , 22-110, IDA, JEEDIMETLA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2014 |
| 104 | NDA/MAL/HDP/0306 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | FULVIN | GRISEOFULVIN | 500 MG | JIANGSU PENGYAO PHARMACEUTICALS CO. LTD, NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 105 | NDA/MAL/HDP/0311 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | FENTANYL | FENTANYL CITRATE | 50MCG/ML | MARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2013 |
| 106 | NDA/MAL/HDP/0312 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXISPA ORAL SOLUTION 125 | CLOXACILLIN | 125MG/5ML | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 107 | NDA/MAL/HDP/0314 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | SUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTION | SUXAMETHONIUM CHLORIDE | 50MG/ML | MARTINDALE PHARMA , BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2013 |
| 108 | NDA/MAL/HDP/0318 | DAWA LIMITED | SUPER MEDIC LTD | SABULIN | SALBUTAMOL | 4MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 109 | NDA/MAL/HDP/0320 | DAWA LIMITED | SUPER MEDIC LTD | DAZOLE | CLOTRIMAZOLE | 1%W/W | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2013 |
| 110 | NDA/MAL/HDP/0322 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-5 | NEBIVOLOL HCL | 5MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 111 | NDA/MAL/HDP/0326 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | OSTEBON | CALCIUM + COLECALCIFEROL | 250MG + 125 IU | ARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2014 |
| 112 | NDA/MAL/HDP/0333 | KOPRAN LIMITED | TATA UGANDA LIMITED | CLAVAMYN-625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500MG +125MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2014 |
| 113 | NDA/MAL/HDP/0335 | GOOD DAY PHARMACY LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NEOMYCIN SULPHATE CREAM USP | NEOMYCIN SULPHATE CREAM USP | 0.5%WW | KREMOINT PHARMA PVT LTD, B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 01/07/2013 |
| 114 | NDA/MAL/HDP/0337 | IND-SWIFT | PLANET PHARMACEUTICALS UGANDA LTD | SWAZI *500 | AZITHROMYCIN | 500MG | IND SWIFT LTD, GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER, 1.0X10.0X1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 115 | NDA/MAL/HDP/0339 | IND-SWIFT | PLANET PHARMACEUTICALS UGANDA LTD | SWAZI *250 | AZITHROMYCIN | 250MG | IND SWIFT LTD, GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0 TABLET BLISTER, 1.010.0X1.0X6.0 TABLET BLISTER | 01/07/2014 |
| 116 | NDA/MAL/HDP/0341 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | TELSWIFT- H 40 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | IND SWIFT LTD, GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 117 | NDA/MAL/HDP/0342 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | TELSWIFT- H 80 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | IND SWIFT LTD, GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 118 | NDA/MAL/HDP/0348 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | XBETA | BETAMETHASONE SODIUM PHOSPHATE | 0.1%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2015 |
| 119 | NDA/MAL/HDP/0349 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | CLAXY 1.2 G | COAMOXICLAV | 1.2G | SWISS PARENTERALS LIMITED UNIT II, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA| | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL | 01/07/2013 |
| 120 | NDA/MAL/HDP/0350 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CETRIREN | CETIRIZINE HYDROCHLORIDE | 10MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 121 | NDA/MAL/HDP/0354 | KOPRAN LIMITED | TATA UGANDA LIMITED | LEVOKOP | LEVOFLOXACIN | 500MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 122 | NDA/MAL/HDP/0355 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LTD | BICO VITA | THIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE | 10MG + 0.1MG + 1MG + 10MG | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2015 |
| 123 | NDA/MAL/HDP/0356 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | LEVO DENK 50O | LEVOFLOXACIN HEMIHYDRATE | 500MG | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBH, HILDERBRAND, STR 12-37081, GOTTINGEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 124 | NDA/MAL/HDP/0360 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 20MG | ESOMEPRAZOLE | 20MG | ASTRA ZENECA AB, SODERTALJE, GARTUNAYEGEN, SODERTALJE | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON | 01/07/2001 |
| 125 | NDA/MAL/HDP/0362 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | BUPI | BUPIVACAINE | 5 MG/ML | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2015 |
| 126 | NDA/MAL/HDP/0366 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | AGYCIN 500 | AZITHROMYCIN | 500MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2014 |
| 127 | NDA/MAL/HDP/0370 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-H | NEBIVOLOL + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 128 | NDA/MAL/HDP/0376 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-D | AMLODIPINE + HYDROCHLOROTHIAZIDE | 2.5 MG + 12.5 MG | EMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 129 | NDA/MAL/HDP/0377 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | DUINUM | CLOMIFENE | 50MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 130 | NDA/MAL/HDP/0386 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-80 | ENOXAPARIN SODIUM | 80MG/ 0.8ML | EMCURE PHARMACEUTICALS LTD , PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 01/07/2014 |
| 131 | NDA/MAL/HDP/0388 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AZUCLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 132 | NDA/MAL/HDP/0389 | PT SANBE FARMA | ONCOPHARM (U) LTD | SANMOL INFUSION IV | PARACETAMOL | 1000MG/100ML | PT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 133 | NDA/MAL/HDP/0394 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | DOXYLEB | DOXYCYCLINE | 100MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 134 | NDA/MAL/HDP/0397 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-LT | AMLODIPINE + LOSARTAN POTASSIUM | 2.5 MG + 50 MG | EMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 135 | NDA/MAL/HDP/0401 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | MONTUS L | LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | FOURRTS (INDIA) LABORATORIES (PVT) LTD, FOURRTS AVENUE, VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2015 |
| 136 | NDA/MAL/HDP/0403 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | SUPRIDOL | TRAMADOL HYDROCHLORIDE | 50MG/ML | NEON LABORATORIES LTD -, PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 01/07/2013 |
| 137 | NDA/MAL/HDP/0405 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | CHEMLET | LETROZOLE | 2.5MG | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 138 | NDA/MAL/HDP/0406 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | EVATOCIN | OXYTOCIN | 10 I.U./ ML | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 01/07/2015 |
| 139 | NDA/MAL/HDP/0407 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | NEOROF | PROPOFOL | 1%W/V | NEON LABORATORIES LTD -, PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2013 |
| 140 | NDA/MAL/HDP/0408 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | ALGIC - P | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 141 | NDA/MAL/HDP/0409 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | TYDE-S* | CHLORAMPHENICOL SODIUM SUCCINATE | 1G/VIAL | NEON LABORATORIES LTD -, PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2013 |
| 142 | NDA/MAL/HDP/0410 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LDNIL 20 | ROSUVASTATIN CALCIUM | 20MG | MSN LABORATORIES LTD, PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 143 | NDA/MAL/HDP/0411 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | JADELLE SINE | LEVONORGESTREL | 150MG | BAYER OY, PANSIONATE 47 20210 TURKU FINLAND | FINLAND | PARENTERAL RETARD IMPLANTS | 1.0X10.0X1.0X2.0X75.0 MG IMPLANT | 01/07/2003 |
| 144 | NDA/MAL/HDP/0413 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | XSPAS | HYOSCINE BUTYLBROMIDE | 20MG/ML | NEON LABORATORIES LTD -, PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 01/07/2013 |
| 145 | NDA/MAL/HDP/0415 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | RELEX | DIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL | 14.03MG+138MG+57.03MG+0.90MG | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 146 | NDA/MAL/HDP/0421 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | PREGASAFE 150 | PREGABALIN | 150MG | MSN LABORATORIES LTD, PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 147 | NDA/MAL/HDP/0422 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PARAFLAM | IBUPROFEN + PARACETAMOL | 100MG + 162.5MG /5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| 148 | NDA/MAL/HDP/0423 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRAM | TRAMADOL | 50MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 149 | NDA/MAL/HDP/0424 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CHLORPROMAZINE TABLETS B.P 25MG | CHLORPROMAZINE | 25MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 150 | NDA/MAL/HDP/0427 | MICRO LABS LTD | LABOREX UGANDA LIMITED | AMLOZAAR -H | LOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE | 50MG + 5MG + 12.5MG | MICRO LABS LTD .., 57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 151 | NDA/MAL/HDP/0428 | MICRO LABS LTD | LABOREX UGANDA LIMITED | MICROMOX-400 | MOXIFLOXACIN | 400MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X5.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 152 | NDA/MAL/HDP/0429 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FLEXON MR | IBUPROFEN + PARACETAMOL + CHLORZOXAZONE | 400MG + 325MG + 250MG | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 153 | NDA/MAL/HDP/0430 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO ACECLO PLUS | ACECLOFENAC+PARACETAMOL | 100MG+500MG | ARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X15.0X10.0 TABLET BLISTER, 1.0X2.0X15.0 TABLET BLISTER | 01/07/2013 |
| 154 | NDA/MAL/HDP/0432 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | K MAC ORAL SOLUTION | POTASSIUM CITRATE + MAGNESIUM CITRATE | 22MG + 7.5MG | FOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| 155 | NDA/MAL/HDP/0433 | PT SAMBE FARMA | ONCOPHARM (U) LTD | PROANES MCT/LCT | PROPOFOL | 1%W/V | PT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X5.0X20.0 ML AMPOULE | 01/07/2014 |
| 156 | NDA/MAL/HDP/0434 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | PROHIBIN | GASTRO-RESISTANT OMEPRAZOLE CAPSULES BP 20 | 20 MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP | 01/07/2010 |
| 157 | NDA/MAL/HDP/0441 | AGIO PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | AGISEC | SECNIDAZOLE | 1 G | 1. AGIO PHARMACEUTICALS LIMITED T-81, 82, M.I.D.C., BHOSARI, PUNE 411026, MAHARASHTRA STATE - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2TABLET BLISTER | 01/07/2015 |
| 158 | NDA/MAL/HDP/0447 | PT SANBE FARMA | ONCOPHARM (U) LTD | SANEXON®125 | METHYLPREDNISOLONE SODIUM SUCCINATE | 125MG/VIAL | PT SANBE FARMA UNIT 3., JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNG | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI | 01/07/2014 |
| 159 | NDA/MAL/HDP/0449 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMINOGUARD GRANULES | CYANOCOBALAMIN | 5MCG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY GRANULES | 1.0X10.0X5.0 G SACHET | 01/07/2013 |
| 160 | NDA/MAL/HDP/0451 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANEXON®500 | METHYLPREDNISOLONE SODIUM SUCCINATE | 500 MG/VIAL | PT. SANBE FARMA (UNIT 3) JI. INDUSTRI CIMAREME NO. 8, DESA CIMAREME, KECAMATAN NGAMPRAH, KABUPATEN BANDUNG BARAT - INDONESIA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI*500MG VIAL | 01/07/2014 |
| 161 | NDA/MAL/HDP/0453 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMINOGUARD LIQUID | AMINO ACIDS + MULTIVITAMINS | MULTI INGREDIENTS | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| 162 | NDA/MAL/HDP/0454 | PT SANBE FARMA | ONCOPHARM (U) LTD | LEVOCIN INFUSION | LEVOFLOXACIN HEMIHYDRATE | 500 MG | PT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 163 | NDA/MAL/HDP/0456 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LIMITED | METROLEB | METRONIDAZOLE | 125MG/5ML | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 164 | NDA/MAL/HDP/0460 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 7.5MG/ML | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X15.0 ML BOTTLE | 01/07/2009 |
| 165 | NDA/MAL/HDP/0463 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TOPHEN | PHENYTOIN | 100MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 166 | NDA/MAL/HDP/0467 | DAWA PHARMACEUTICALS LIMITED | SUPER MEDIC LTD | CURAMOL PLUS | PARACETAMOL/CAFFEINE | 500MG/60MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 50.0X2.0 TABLET STRIP | 01/07/1997 |
| 167 | NDA/MAL/HDP/0470 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVOMIX 30 FLEXPEN | INSULIN ASPART | 100I.U/ML | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL| NOVO NORDISK A/S , NOVO ALLE DK-2880 BAGSVAERD| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE | DENMARK | PARENTERAL ORDINARY DRY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| 168 | NDA/MAL/HDP/0471 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVORAPID FLEXPEN | INSULIN ASPART | 100 I.U/ML | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE| NOVO NORDISK A/S , NOVO ALLE DK-2880 BAGSVAERD | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| 169 | NDA/MAL/HDP/0472 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | BCG VACCINE (FREEZE DRIED) | BCG VACCINE(FREEZE DRIED) | 1.33*100000 C.F.U/0.1ML | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL, 1.0X0.5 ML VIAL | 01/07/2015 |
| 170 | NDA/MAL/HDP/0475 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | TINI-500 | TINIDAZOLE | 500MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X25.0X4.0 TABLET BLISTER | 01/07/2015 |
| 171 | NDA/MAL/HDP/0477 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMISTAT-4 | ONDANSETRON | 4MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 172 | NDA/MAL/HDP/0482 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LIMITED | AZILEB-500 | AZITHROMYCIN | 500MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X3.0 TABLET BLISTER | 01/07/2014 |
| 173 | NDA/MAL/HDP/0489 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | CEBAY-200 DT | CEFIXIME | 200MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 174 | NDA/MAL/HDP/0491 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCHLOR EYE DROPS | CHLORAMPHENICOL | 0.5% W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/2013 |
| 175 | NDA/MAL/HDP/0493 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PRASUSAFE 10 | PRASUGREL | 10MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 176 | NDA/MAL/HDP/0496 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | MYPRODOL | PARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE | 250MG + 200MG + 10MG | ADCOCK INGRAM LIMITED , 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 177 | NDA/MAL/HDP/0497 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | KEMOXYL DRY SUSPENSION | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 178 | NDA/MAL/HDP/0502 | STEDMAN PHARMACEUTICALS LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ GARGLE | IODINATED POVIDONE | 2%W/V | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| 179 | NDA/MAL/HDP/0507 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FILDILOL 12.5 | CARVEDILOL | 12.5 MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 180 | NDA/MAL/HDP/0509 | FOURRTS (INDIA) LABORATORIES (PVT) LTD | DELMAW ENTERPRISES LIMITED | FILDILOL 25 | CARVEDILOL | 25MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 181 | NDA/MAL/HDP/0510 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | LIZOLID-600 | LINEZOLID | 600MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET STRIP | 01/07/2004 |
| 182 | NDA/MAL/HDP/0512 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 10 | ATORVASTATIN CALCIUM | 10MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 183 | NDA/MAL/HDP/0515 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 20 | ATORVASTATIN | 20MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 184 | NDA/MAL/HDP/0518 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CYCLOREN | ACICLOVIR | 200MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2014 |
| 185 | NDA/MAL/HDP/0520 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 40 | ATORVASTATIN CALCIUM | 40MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 186 | NDA/MAL/HDP/0526 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | AMILEB- 25 | AMITRIPTYLINE | 25MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 187 | NDA/MAL/HDP/0538 | MICRO LABS LTD | LABOREX UGANDA LIMITED | XONADINE 180 | FEXOFENADINE HYDROCHLORIDE | 180 MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 188 | NDA/MAL/HDP/0540 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | HYDRICORT | HYDROCORTISONE SODIUM SUCCINATE | 100MG | LINCOLN PHARMACEUTICALS LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X100.0 MG VIAL, 1.0X10.0X100.0 MG VIAL, | 01/07/2014 |
| 189 | NDA/MAL/HDP/0541 | MICRO LABS LTD | LABOREX UGANDA LIMITED | XONADINE 120 | FEXOFENADINE HYDROCHLORIDE | 120MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 190 | NDA/MAL/HDP/0542 | DAWA LIMITED | SUPER MEDIC LTD | PHENBITAL | PHENOBARBITAL | 30MG | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 191 | NDA/MAL/HDP/0543 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLIMERYL 2 | GLIMEPIRIDE | 2MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 192 | NDA/MAL/HDP/0544 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 193 | NDA/MAL/HDP/0547 | NAARI LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | MISO-KARE | MISOPROSTOL | 200MCG | NAARI PHARMA PRIVATE LIMITED, PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER | 01/07/2013 |
| 194 | NDA/MAL/HDP/0548 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNICAST | MONTELUKAST | 5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-, P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY | JORDAN | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 195 | NDA/MAL/HDP/0550 | DAWA LIMITED | SUPER MEDIC LTD | DA-ZEPAM | DIAZEPAM | 5MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2014 |
| 196 | NDA/MAL/HDP/0553 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | EQUIRAB | RABIES ANTISERUM | 1000IU/ 5ML | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL (5 DOSE VIAL) | 01/07/2013 |
| 197 | NDA/MAL/HDP/0555 | HOVID BHD | BARIKI EXIM PHARMA LTD | CARZEPIN | CARBAMAZEPINE | 200MG | HOVID BHD, LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 198 | NDA/MAL/HDP/0558 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABGENTA EYE DROPS | GENTAMICIN SULPHATE | 0.3% W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML VIAL | 01/07/2014 |
| 199 | NDA/MAL/HDP/0559 | HOVID BHD | MEDICAL ACCESS (UGANDA) LIMITED | DIABETMIN RETARD | METFORMIN HYDROCHLORIDE | 850MG | HOVID BHD, LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 200 | NDA/MAL/HDP/0563 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | EZO 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | IND-SWIFT-LTD,, GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 201 | NDA/MAL/HDP/0568 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FLUOXIREN | FLUOXETINE | 20MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 202 | NDA/MAL/HDP/0570 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | TETGLOB 250 I.U | HUMAN TETANUS IMMUNOGLOBULIN | 250IU | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X1.0X2.0 ML VIAL (1 DOSE VIAL) | 01/07/2013 |
| 203 | NDA/MAL/HDP/0571 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL KAOPEC | LIGHT KAOLIN + PECTIN (CITRUS) | 1G + 20MG/5ML | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE | 01/07/2015 |
| 204 | NDA/MAL/HDP/0572 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | AZARGA | BRINZOLAMIDE + TIMOLOL | 10MG/ML + 5MG/ML | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 01/07/2010 |
| 205 | NDA/MAL/HDP/0573 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (A) LTD. | AXCEL PARACETAMOL-250 | PARACETAMOL | 250MG/5ML | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2014 |
| 206 | NDA/MAL/HDP/0576 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | DUODART | DUTASTERIDE + TAMSULOSIN | 0.5MG + 0.4MG | CATALENT GERMANY SCHONDORF GMBH , STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER | 01/07/2015 |
| 207 | NDA/MAL/HDP/0580 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUCAP | MULTINGREDIENT | MULTINGREDIENT | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 208 | NDA/MAL/HDP/0582 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ACECLO SERA | ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE | 100MG + 500MG + 15MG | ARISTO PHARMACEUTICALS PVT LTD, VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 209 | NDA/MAL/HDP/0584 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRIGLIMIPREX 1 | GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE | 1MG+15MG+500MG | ARISTO PHARMACEUTICALS PVT LTD--, VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 210 | NDA/MAL/HDP/0585 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DOMPERON | DOMPERIDONE | 1MG/ML | CADILA PHARMACEUTICALS LTD., 1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2013 |
| 211 | NDA/MAL/HDP/0586 | CADILA PHARMACEUTICALS LIMITED | AAFIYA (A) LIMITED | ONSETT | ONDANSETRON | 2MG/ML | CADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE | 01/07/2013 |
| 212 | NDA/MAL/HDP/0587 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CADIGREL | CLOPIDOGREL | 75MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 213 | NDA/MAL/HDP/0589 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRIGLIMIPREX 2 | GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE | 2MG+15MG+500MG | ARISTO PHARMACEUTICALS PVT LTD--, VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 214 | NDA/MAL/HDP/0593 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PANTOP-D | PANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES | 20MG+10MG | ARISTO PHARMACEUTICALS PVT LTD ., MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP | 01/07/2014 |
| 215 | NDA/MAL/HDP/0595 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ORNOF | ORNIDAZOLE + OFLOXACIN | 500MG + 200MG | ARISTO PHARMACEUTICALS PVT LTD--, VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 216 | NDA/MAL/HDP/0596 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-H | TELMISARTAN/HYDROCHLOROTHIAZIDE | 40MG/12.5MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2011 |
| 217 | NDA/MAL/HDP/0599 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | GRAMOCEF-O-400 | CEFIXIME | 400MG | MICROLABS LIMITED, PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 218 | NDA/MAL/HDP/0600 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | CARVEDI-DENK 6.25 | CARVEDILOL | 6.25MG | ARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 219 | NDA/MAL/HDP/0605 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | CARVEDI-DENK 25 | CARVEDILOL | 25MG | ARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 220 | NDA/MAL/HDP/0609 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | CLOPI-DENK 75 | CLOPIDOGREL BESYLATE | 75MG | ARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 221 | NDA/MAL/HDP/0610 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | PYLOR KIT | LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE | 30MG + 250MG + 500MG | LINCOLN PHARMACEUTICALS LTD ., 10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) | 01/07/2016 |
| 222 | NDA/MAL/HDP/0614 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 125MG/5ML + 31.25MG/5ML | SMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1998 |
| 223 | NDA/MAL/HDP/0615 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | VALSAR 80 | VALSARTAN | 80MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2015 |
| 224 | NDA/MAL/HDP/0618 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | VALSAR 160 | VALSARTAN | 160 MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 2015-07-01 00:00:00 |
| 225 | NDA/MAL/HDP/0619 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D10 | GLUCOSE | 10%W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2013 |
| 226 | NDA/MAL/HDP/0623 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | GELCID | MAGNESIUM SULPHATE | 50%W/V | LINCOLN PHARMACEUTICALS LTD-, 11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK,1.0X5.0 ML AMPOULE IN BLISTER PACK, 1.0X10.0 ML AMPOULE IN BLISTER PACK | 01/07/2015 |
| 227 | NDA/MAL/HDP/0626 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CARDIPAC-10 | AMLODIPINE BESILATE | 10MG | KPI INDUSTRIES (1996) LTD, PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 228 | NDA/MAL/HDP/0627 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AMOXIKID | AMOXICILLIN TRIHYDRATE | 125MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD, PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 229 | NDA/MAL/HDP/0633 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CIPROCIN | CIPROFLOXACIN | 0.3%W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2013 |
| 230 | NDA/MAL/HDP/0635 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-AMIN | AMINOPHYLLINE | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| 231 | NDA/MAL/HDP/0636 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | REVOKE-1.5 | LEVONORGESTREL | 1.5MG | MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213| MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2014 |
| 232 | NDA/MAL/HDP/0637 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | ZUDICORT | FUSIDIC ACID + BETAMETHASONE VALERATE | 20MG + 1MG/G | NABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2014 |
| 233 | NDA/MAL/HDP/0638 | PHARMACIE BETHEL | ABACUS PARENTERAL DRUGS LIMITED | ABLOL-5 EYE DROPS | TIMOLOL MALEATE | 0.5% W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2013 |
| 234 | NDA/MAL/HDP/0639 | NEM LABORATORIES (PVT) LTD | RENE PHARMACY LTD | RHEUMATIC CREAM | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 235 | NDA/MAL/HDP/0645 | KUNMING PHARMACEUTICALS CORP | SUPER PHARMACEUTICALS LIMITED | COMETHER | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | 1. KPC PHARMACEUTICALS, INC. QIGONGLI, WEST SUBURB, KUNMING CITY, YUNNAN PROVINCE CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | ORAL SOLID ORDINARY TABLETS | I. 1*3*8TABLET BLISTER | 01/07/2015 |
| 236 | NDA/MAL/HDP/0652 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS | VILDAGLIPTIN | 50MG | NOVARTIS PHARMA STEIN AG, SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2009 |
| 237 | NDA/MAL/HDP/0654 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN / METFORMIN | 50MG/500MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2013 |
| 238 | NDA/MAL/HDP/0657 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN / METFORMIN | 50MG / 850MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 01/07/2013 |
| 239 | NDA/MAL/HDP/0658 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN/ METFORMIN | 50MG/1000MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 01/07/2013 |
| 240 | NDA/MAL/HDP/0665 | HETERO LABS LTD | REDDYS PHARMA LIMITED | IRBIS 150 | IRBESARTAN | 150MG | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 241 | NDA/MAL/HDP/0666 | HETERO LABS LTD | REDDYS PHARMA LIMITED | IRBIS-H 300 | IRBESARTAN | 300MG | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 242 | NDA/MAL/HDP/0667 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (A) LTD. | AXEL MICONAZOLE | MICONAZOLE NITRATE | 2%W/W | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/2013 |
| 243 | NDA/MAL/HDP/0668 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELI 40 | TELMISARTAN | 40MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 244 | NDA/MAL/HDP/0669 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (A) LTD. | AXEL FUNGICORT CREAM | MICONAZOLE NITRATE + HYDROCORTISONE | 2% W/W + 1% W/W | KOTRA PHARMA SDN BDN, 1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/2013 |
| 245 | NDA/MAL/HDP/0670 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FLUNAZ-200 | FLUCONAZOLE | 200MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER,10.0X4.0 CAPSULE STRIP | 01/07/2014 |
| 246 | NDA/MAL/HDP/0674 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODAPS-100 | DAPSONE | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2013 |
| 247 | NDA/MAL/HDP/0675 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL METRONIDAZOLE 400 | METRONIDAZOLE | 400MG | KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| KOTRA PHARMA, BHD 1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 248 | NDA/MAL/HDP/0677 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DOPAMET | METHYLDOPA | 250MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 249 | NDA/MAL/HDP/0678 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL HYDROCORTISONE CREAM | HYDROCORTISONE | 1%W/W | KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/2014 |
| 250 | NDA/MAL/HDP/0679 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | MEFENA-250 CAPSULES | MEFENAMIC ACID | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 251 | NDA/MAL/HDP/0681 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ELAXIM 40 | TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR) | 40MG/VIAL | GENNOVA BIOPHARMACEUTICALS LIMITED, BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI | 01/07/2013 |
| 252 | NDA/MAL/HDP/0685 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SOMAZINA | CITICOLINE | 1000MG | FERRER INTERNATIONAL, S.A., C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | PARENTERAL RETARD I M AMPOULES | 1.0X5.0X4.0 ML AMPOULE | 01/07/2015 |
| 253 | NDA/MAL/HDP/0687 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SOMAZINA | CITICOLINE | 1000MG | FERRER INTERNATIONAL, S.A., C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X6.0X10.0 ML SACHET | 01/07/2015 |
| 254 | NDA/MAL/HDP/0688 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | HBB | HYOSCINE BUTYLBROMIDE | 10MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 255 | NDA/MAL/HDP/0689 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGONAL | NALIDIXIC ACID | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 256 | NDA/MAL/HDP/0690 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | HEALTHEASE CREAM | BECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL | 0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/W | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2014 |
| 257 | NDA/MAL/HDP/0692 | DAWA LIMITED | SUPER MEDIC LTD | DAWACLOX -250 | CLOXACILLIN SODIUM | 250MG | DAWA LIMITED , BABA DOGO RWARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2015 |
| 258 | NDA/MAL/HDP/0693 | DAWA LIMITED | SUPER MEDIC LTD | MOXACIL -250 | AMOXYCILLIN TRIHYDRATE | 250MG | DAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2014 |
| 259 | NDA/MAL/HDP/0694 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DT ZINC-20 TABLETS | ZINC SULPHATE | 20MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON | 01/07/2013 |
| 260 | NDA/MAL/HDP/0696 | HETERO LABS LTD | AIVEEN (U) LIMITED | RITONAVIR | RITONAVIR | 100MG | HETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2014 |
| 261 | NDA/MAL/HDP/0700 | ZYDUS LIFESCIENCES LTD. | ABACUS PHARMA (AFRICA) LIMITED | VAXIRAB N | INACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN) | >2.5 I.U | ZYDUS LIFESCIENCES LIMITED, SURVEY NO. 417, 419 & 420, SARKHEJ - BAVLA NATIONAL HIGHWAY NO. 8A, VILLAGE - MORAIYA, TALUKA - SANAND, DIST. AHMEDABAD - 382 210, GUJARAT STATE - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL) | 01/07/2015 |
| 262 | NDA/MAL/HDP/0702 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEPTOCIN | STREPTOMYCIN SULPHATE | 1GM | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 01/07/2014 |
| 263 | NDA/MAL/HDP/0703 | GOOD DAY PHARMACY LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | DICLODAY GEL | DICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL | 11.6MG + 30MG + 100MG + 50MG | KREMOINT PHARMA PVT LTD--, B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2013 |
| 264 | NDA/MAL/HDP/0704 | HETERO LABS LTD UNIT IX | REDDYS PHARMA LIMITED | M-FLOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER | 01/07/2013 |
| 265 | NDA/MAL/HDP/0705 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ACICLOVIR | ACICLOVIR | 5%W/W | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2011 |
| 266 | NDA/MAL/HDP/0706 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 5 | ROSUVASTATIN | 5MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 267 | NDA/MAL/HDP/0710 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 20 | ROSUVASTATIN | 20MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 268 | NDA/MAL/HDP/0712 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | ZENTEL | ALBENDAZOLE | 100MG/5ML | ASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSE, INDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOE | GERMANY | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE | 01/07/1997 |
| 269 | NDA/MAL/HDP/0713 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 20 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 20MG | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN | | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2015 |
| 270 | NDA/MAL/HDP/0715 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40MG | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN | | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2015 |
| 271 | NDA/MAL/HDP/0718 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | GLYMET-2 | GLIMEPIRIDE+METFORMIN HYDROCHLORIDE | 2MG + 500MG | LINCOLN PHARMACEUTICALS L.T.D, TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER | 01/07/2014 |
| 272 | NDA/MAL/HDP/0720 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | JUSDEE 400 DROPS | COLECALCIFEROL | 400 I.U/ML | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE | 01/07/2013 |
| 273 | NDA/MAL/HDP/0721 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ARH-A | ARTEMETHER | 80MG/ML | LINCOLN PHARMACEUTICAL LTD TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE | 01/07/2014 |
| 274 | NDA/MAL/HDP/0722 | FDC LTD | AIVEEN (U) LIMITED | IOTIM 0.5% | TIMOLOL MALEATE | 0.5% W/V | FDC LIMITED , B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ €“ AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2014 |
| 275 | NDA/MAL/HDP/0726 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | T DOL RAPID | TRAMADOL HYDROCHLORIDE | 50MG | TROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2014 |
| 276 | NDA/MAL/HDP/0727 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | STOMACH FIT SYRUP | BISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL | 140MG+9MG+0.15MG+0.2/5ML | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X225.0 ML BOTTLE | 01/07/2013 |
| 277 | NDA/MAL/HDP/0733 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYNAC | ACECLOFENAC | 100MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 278 | NDA/MAL/HDP/0734 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | OMMED -20 | OMEPRAZOLE | 20MG | MEDICO REMEDIES PVT LIMITED, 8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA| | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2015 |
| 279 | NDA/MAL/HDP/0736 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MABRON 50 | TRAMADOL HYDROCHLORIDE | 50MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 280 | NDA/MAL/HDP/0740 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | COTRIM | CO-TRIMOXAZOLE | 960MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 281 | NDA/MAL/HDP/0741 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOCIPRIN | CIPROFLOXACIN | 500MG | MEDOCHEMIE LTD (FACTORY AZ), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 282 | NDA/MAL/HDP/0742 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | BROT | METFORMIN HYDROCHLORIDE | 500MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 283 | NDA/MAL/HDP/0745 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELI 80 | TELMISARTAN | 80MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 284 | NDA/MAL/HDP/0746 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | DTS-Z KIT | TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSE | TABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75G | COSMOS LIMITED, KENYA, RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 285 | NDA/MAL/HDP/0748 | BAYER PHARMA | SURGIPHARM (U) LIMITED | XARELTO 15MG | RIVAROXABAN | 15MG | BAYER PHARMA AG 51368 LEVERKUSEN, BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/2013 |
| 286 | NDA/MAL/HDP/0750 | BAYER PHARMA | SURGIPHARM (U) LIMITED | XARELTO 20MG | RIVAROXABAN | 20MG | BAYER PHARMA AG 51368 LEVERKUSEN, BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/2013 |
| 287 | NDA/MAL/HDP/0751 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN | ACECLOFENAC | 100MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 288 | NDA/MAL/HDP/0754 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TORAS DENK 10 | TORASEMIDE | 10MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 289 | NDA/MAL/HDP/0757 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLFREE 150 | TOLPERISONE | 150MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 290 | NDA/MAL/HDP/0759 | MICRO LABS LTD | LABOREX UGANDA LIMITED | COTRIMOXAZOLE | COTRIMOXAZOLE | 960MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 291 | NDA/MAL/HDP/0764 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORVADIL 5 | AMLODIPINE | 5MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2011 |
| 292 | NDA/MAL/HDP/0765 | SHANGHAI DAHUA PHARMACEUTICAL CO., LTD. | UNITED HEALTHCARE DISTRIBUTORS LTD | LEVOPLANT | LEVONORGESTREL | 75MG | SHANGHAI DAHUA PHARMACEUTICAL CO. LTD, CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI | CHINA | PARENTERAL RETARD IMPLANTS | 1.0X10.0X2.0 ROD IMPLANT | 01/07/2010 |
| 293 | NDA/MAL/HDP/0772 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PREGABALIN MEGA 150 | PREGABALIN | 150MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 294 | NDA/MAL/HDP/0774 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NODON | NEBIVOLOL HYDROCHLORIDE | 10 MG | CADILA PHARMACEUTICALS LTD 1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*1*10TABLET BLISTER | 01/07/2012 |
| 295 | NDA/MAL/HDP/0776 | FREDUN PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | FREMOL TABLETS | PARACETAMOL TABLETS | 500MG | FREDUN PHARMACEUTICALS LTD, 14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1999 |
| 296 | NDA/MAL/HDP/0780 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ATORVA TABLETS | ATORVASTATIN | 10MG | BETA HEALTHCARE INTERNATIONAL LTD , PLOT NO. LR 209/6554, MOGADISHU ROAD INDUSTRIAL AREA, NAIROBI KENYA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2001 |
| 297 | NDA/MAL/HDP/0781 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRICOLD | PARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE | 500MG/10MG/30MG/2MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER | 01/07/2013 |
| 298 | NDA/MAL/HDP/0786 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DERMA 1 | GRISEOFULVIN | 500 MG | 1. TRIVENI FORMULATIONS LIMITED PLOT NOS: 52, 53, 54, 62, 63, 64, ALEAP INDUSTRIAL ESTATE, SURAMPALLI VILLAGE, GANNAVARAM MANDAL, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 01/07/2013 |
| 299 | NDA/MAL/HDP/0794 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | AMYGYDEX | TOBRAMYCIN/DEXAMETHASONE | 3MG+1MG/ML | REMINGTON PHARMACEUTICALS (PVT) LTD, 18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2014 |
| 300 | NDA/MAL/HDP/0795 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPEN-250 | PHENOXYMETHYL PENICILLIN POTASSIUM | 250MG | MILAN LABORATORIES (INDIA) PVT LTD ., PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 301 | NDA/MAL/HDP/0796 | HETERO LABS LTD | REDDYS PHARMA LIMITED | AMLOSIN 5 | AMLODIPINE BESILATE | 5MG | HETERO DRUGS LTD. -VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, TEHSIL NALAGARH, DIST. SOLAN, HIMACHAL PRADESH PIN: 173 205 | HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | HETERO LABS LIMITED (UNIT I)-VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE 173205 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 302 | NDA/MAL/HDP/0798 | HETERO LABS LTD | REDDYS PHARMA LIMITED | AMLOSIN 10 | AMLODIPINE BESILATE | 10MG | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 303 | NDA/MAL/HDP/0802 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE HCT 5MG/ 160MG/12.5MG | AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 5MG+ 160MG+ 12.5MG | NOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2015 |
| 304 | NDA/MAL/HDP/0811 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN -SR | ACECLOFENAC | 200MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 305 | NDA/MAL/HDP/0816 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 2 | GLIMEPIRIDE | 2MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 306 | NDA/MAL/HDP/0821 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 3 | GLIMEPIRIDE | 3MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 307 | NDA/MAL/HDP/0822 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXCIN-500 | CLOXACILLIN SODIUM | 500MG | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL | 01/07/2014 |
| 308 | NDA/MAL/HDP/0824 | I CARE PHARMA LIMITED | VITACARE LTD | CLOXACILLIN | CLOXACILLIN | 250MG | MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2013 |
| 309 | NDA/MAL/HDP/0826 | I CARE PHARMA LIMITED | VITACARE LTD | AMOXYCILLIN | AMOXYCILLIN | 250MG | MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | | AMN LIFE SCIENCE PVT LTD-67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2013 |
| 310 | NDA/MAL/HDP/0830 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 25 MCG | LEVOTHYROXINE SODIUM | 25 MCG | MERCK KGAA - , FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER | 01/07/2015 |
| 311 | NDA/MAL/HDP/0831 | I CARE PHARMA LIMITED | VITACARE LTD | AMPICILLIN CAPSULES | AMPICILLIN | 250MG | MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | AMN LIFE SCIENCE PVT LTD, 67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2013 |
| 312 | NDA/MAL/HDP/0832 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 100MCG | LEVOTHYROXINE | 100MCG | MERCK KGAA - , FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER | 01/07/2015 |
| 313 | NDA/MAL/HDP/0834 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMI-6 | DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE | 10MG + 10MG | LINCOLN PHARMACEUTICALS LIMITED., TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 314 | NDA/MAL/HDP/0835 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBIS | BISACODYL | 5MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2013 |
| 315 | NDA/MAL/HDP/0836 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CALBONE-500 | CALCIUM CARBONATE + COLECALCIFEROL | 1250MG + 250 I.U | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| 316 | NDA/MAL/HDP/0842 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | SAC | SECNIDAZOLE | 1000MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X2.0 TABLET BLISTER | 01/07/2013 |
| 317 | NDA/MAL/HDP/0845 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | OLEVO-500 | LEVOFLOXACIN | 500 MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 318 | NDA/MAL/HDP/0850 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LCT KIT | LANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE | 30MG + 250MG + 500MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) | 01/07/2012 |
| 319 | NDA/MAL/HDP/0853 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | BRUSTAN GEL | IBUPROFEN + LEVOMENTHOL | 5% W/W+ 3%W/W | SUN PHARMACEUTICALS LIMITED - KHASRA NO. 1335-1340 NEAR EPIP-1, VILLAGE - BHATOLIKALAN, BADDI, DISTRICT -SOLAN, HIMACHAL PRADESH 173205 - INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X50.0 G CONTAINER | 01/07/2012 |
| 320 | NDA/MAL/HDP/0854 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | IBICAR-50 | BECLOMETASONE | 50MCG PER ACTUATION | 1. GLENMARK PHARMACEUTICAL LIMITED (UNIT-III) VILLAGE: KISHNPURA, BADDI - NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | I. 1*200METERED DOSE CANNISTER | 01/07/2013 |
| 321 | NDA/MAL/HDP/0855 | HETERO LABS LTD | REDDYS PHARMA LIMITED | LAZINE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 322 | NDA/MAL/HDP/0857 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID-V6 VAGINAL TABLETS | CLOTRIMAZOLE | 100MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP | 01/07/2000 |
| 323 | NDA/MAL/HDP/0864 | HETERO LABS LTD UNIT IX | REDDYS PHARMA LIMITED | PANTIN-40 | PANTOPRAZOLE SODIUM | 40 MG | HETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 324 | NDA/MAL/HDP/0866 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | LIZOLID | LINEZOLID | 2MG/ML | AMANTA HEALTHCARE LIMITED, PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| 325 | NDA/MAL/HDP/0868 | SAKAR HEALTH CARE PVT .LTD | GITTOES PHARMACEUTICALS LIMITED | VARMIKA-500 | AMIKACIN SULFATE | 500 MG | 1. SAKAR HEALTHCARE LIMITED BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VIL: CHANGODAR, DIST; AHMEDABAD-382213, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*2*5*2ML AMPOULE | 01/07/2013 |
| 326 | NDA/MAL/HDP/0869 | SAKAR HEALTH CARE PVT .LTD | MEDINOVATION ENTERPRISES LTD | LARTRM | ARTEMETHER | 80MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | | INDIA | | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2013 |
| 327 | NDA/MAL/HDP/0870 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROY-K | PHYTOMENADIONE | 10MG/ML | TROIKAA PHARMACEUTICALS LIMITED, THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2010 |
| 328 | NDA/MAL/HDP/0871 | SAKAR HEALTH CARE PVT .LTD | MEDINOVATION ENTERPRISES LTD | DEXA | DEXAMETHASONE SODIUM | 4MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 2.0X6.0X2.0 ML VIAL | 01/07/2013 |
| 329 | NDA/MAL/HDP/0873 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | OXYTOCIN INJECTION | OXYTOCIN | 10I.U/ML | SAKAR HEALTH CARE PVT LTD10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | LABORATE PHARMACEUTICALS INDIA LIMITED - UNIT II, 31, RAJBAN ROAD, NAIWALA, PAONTA SAHIB, DISTT. SIRMOUR, HIMACHAL PRADESH - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2009 |
| 330 | NDA/MAL/HDP/0874 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | LEBASMA-4 | SALBUTAMOL | 4MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 331 | NDA/MAL/HDP/0877 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | ANTAGIT DS GEL MINT FLAVOUR | DRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 400MG + 400MG + 50MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X170.0 ML BOTTLE | 01/07/2007 |
| 332 | NDA/MAL/HDP/0879 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | TRIBEES FORTE FILM COATED TABLETS | THIAMINE + PYRIDOXINE + CYANOCOBALAMIN | 200MG + 50MG +1000MCG | COSMOS LIMITED, KENYA, RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2012 |
| 333 | NDA/MAL/HDP/0882 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOVANCE 500MG/2.5MG | METFORMIN + GLIBENCLAMIDE | 500MG + 2.5MG | MERCK SANTE S.A.S, CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER | 01/07/2012 |
| 334 | NDA/MAL/HDP/0883 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOVANCE 500MG/5MG | METFORMIN + GLIBENCLAMIDE | 500MG + 5MG | MERCK SANTE S.A.S, CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER | 01/07/2012 |
| 335 | NDA/MAL/HDP/0889 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DNS | SODIUM CHLORIDE + GLUCOSE | 0.9%W/V + 5% W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2012 |
| 336 | NDA/MAL/HDP/0894 | HETERO LABS LTD | REDDYS PHARMA LIMITED | GIAGRA 100 | SILDENAFIL CITRATE | 100MG | HETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER | 01/07/2014 |
| 337 | NDA/MAL/HDP/0895 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYORTH | SODIUM HYALURONATE | 10MG/1ML | VIRCHOW BIOTECH PVT, LTD, SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0 ML PRE- FILLED SYRINGE | 01/07/2015 |
| 338 | NDA/MAL/HDP/0897 | VIRCHOW HEALTHCARE PVT LTD | LEGIT MEDEQ 2007 LIMITED | DEBRIDACE | PAPAIN + UREA | 521700UNITS+100MG/G | VIRCHOW BIOTECH PVT, , SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/2015 |
| 339 | NDA/MAL/HDP/0898 | HETERO LABS LTD | REDDYS PHARMA LIMITED | LOSAGEN 50 | LOSARTAN POTASSIUM | 50MG | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 340 | NDA/MAL/HDP/0899 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | VIRIAXONE | CEFTRIAXONE | 1G | INJECTCARE PARENTERALS PVT. LTD., PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML VIAL WFI | 01/07/2013 |
| 341 | NDA/MAL/HDP/0902 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPINE SR | NIFEDIPINE | 20MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 342 | NDA/MAL/HDP/0906 | VIRCHOW HEALTHCARE PVT LTD | LEGIT MEDEQ 2007 LIMITED | IONSIL | SILVER NITRATE | 0.2%W/W | VIRCHOW BIOTECH PVT, , SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2015 |
| 343 | NDA/MAL/HDP/0911 | VIRCHOW LABORATORIES LIMITED | SURGIPHARM (U) LIMITED | HEALACE | RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B | 100MCG/G | VIRCHOW BIOTECH PVT, LTD, SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2015 |
| 344 | NDA/MAL/HDP/0914 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | OSTEOTIDE | TERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION | 250MCG/ML | VIRCHOW BIOTECH PRIVATE LIMITED, SURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN | 01/07/2015 |
| 345 | NDA/MAL/HDP/0926 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | BACTOCLAV-375 | AMOXICILLIN +CLAVULANATE POTASSIUM | 250MG + 125MG | MICRO LABS LIMITED., PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP | 01/07/2004 |
| 346 | NDA/MAL/HDP/0928 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | INSTACLOP 75 | CLOPIDOGREL | 75MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 347 | NDA/MAL/HDP/0934 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT 4 | MONTELUKAST | 4MG | ZYDUS LIFESCIENCES LTD SARKHEJBAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210 | INDIA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 348 | NDA/MAL/HDP/0938 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | ESOMEGA 20MG | ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS | 20MG | FEROZSONS LABORATORIES LTD, AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 01/07/2013 |
| 349 | NDA/MAL/HDP/0940 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | ESOMEGA 40MG | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | FEROZSONS LABORATORIES LTD - AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | I. 1*2*7CAPSULE BLISTER | 01/07/2013 |
| 350 | NDA/MAL/HDP/0941 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA | AZITHROMYCIN | 200MG/5ML | AJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 01/07/2013 |
| 351 | NDA/MAL/HDP/0948 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | LORHISTINA SYRUP 5MG/5ML | LORATADINE | 5MG/5ML | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE | 01/07/2013 |
| 352 | NDA/MAL/HDP/0951 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | NORAD | STERILE NORADRENALINE CONCENTRATE | 2MG/2ML | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY S C AMPOULES | 1.0X5.0X2.0 ML AMPOULE | 01/07/2013 |
| 353 | NDA/MAL/HDP/0952 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | EFECTAL | CEFTRIAXONE | 1G | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2013 |
| 354 | NDA/MAL/HDP/0953 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | CIZCAN | CISPLATIN | 10MG/10ML | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 01/07/2013 |
| 355 | NDA/MAL/HDP/0954 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | ANAWIN | BUPIVACAINE | 50MG/20ML | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL RETARD OTHER VIALS | 1.0X20.0 ML VIAL | 01/07/2013 |
| 356 | NDA/MAL/HDP/0957 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | LYRED SYRUP | VITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC | 2500 IU + 10 IU + 50MG + 35MCG + 3MG | TORQUE PHARMACEUTICALS PVT LTD, ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2012 |
| 357 | NDA/MAL/HDP/0959 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN DISPERSIBLE 20/120 | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER | 01/07/2013 |
| 358 | NDA/MAL/HDP/0969 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-2.5 | AMLODIPINE BESILATE | 2.5MG | EMCURE PHARMACEUTICALS LTD , LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 359 | NDA/MAL/HDP/0981 | HOVID BHD | BARIKI EXIM PHARMA LTD | CLOFENAC SR TABLETS | DICLOFENAC SODIUM | 100MG | HOVID BERHAD (CHEMOR SITE)-, LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 360 | NDA/MAL/HDP/0988 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CADITOR 20 | ATORVASTATIN | 20MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 361 | NDA/MAL/HDP/0990 | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | FUSIDERM CREAM | FUSIDIC ACID | 2 %W/W | 1. EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES 176 EL-SADAT ST. (FROM MANSOURIA STREAM) KAFR EL-GABAL, PYRAMIDS GIZA, EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 01/07/2013 |
| 362 | NDA/MAL/HDP/0995 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCOMOL | PARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE | 250MG + 5MG + 10MG + 2MG | LINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 363 | NDA/MAL/HDP/0999 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | THIOEVA | THIOTIC ACID | 600MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2014 |
| 364 | NDA/MAL/HDP/1000 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROYCURIUM | ATRACURIUM | 10MG/ML | TROIKAA PHARMACEUTICALS LIMITED, THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE | 01/07/2012 |
| 365 | NDA/MAL/HDP/1001 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | THIOEVA | THIOTIC ACID | 300MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 366 | NDA/MAL/HDP/10032 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ACICRO-200 | ACICLOVIR | 200.0 MG | 1. M/S SYNOKEM PHARMACEUTICALS LIMITED PLOT NO. 35-36, SECTOR-6A, IIE, SIDCUL, RANIPUR, DISTT. HARIDWAR, UTTARAKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 06/07/2022 |
| 367 | NDA/MAL/HDP/10033 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | EMCAR | CARBAMAZEPINE | 200 MG | MEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER | 14/07/2022 |
| 368 | NDA/MAL/HDP/10036 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOL | PARACETAMOL | 500 MG | MEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER | 14/07/2022 |
| 369 | NDA/MAL/HDP/10037 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BORINI-K | LANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN | 30 MG + 500 MG + 250 MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET STRIP | 14/07/2022 |
| 370 | NDA/MAL/HDP/10038 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CLEDOMOX 312.5 MG/5 ML | AMOXILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 312.5 MG/5 ML | MEDOPHARM PVT LIMITED, NO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML CONTAINER | 14/07/2022 |
| 371 | NDA/MAL/HDP/10040 | NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | CARBAMAZEPINE TABLETS USP 200 MG | CARBAMAZEPINE | 200 MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 372 | NDA/MAL/HDP/10041 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | PUMPINOX | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20MG | PHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X14.0 TABLET CONTAINER | 06/07/2022 |
| 373 | NDA/MAL/HDP/10045 | SURGE LABORATORIES (PVT.) LTD. | HEALTHCARE LTD. | SURGITEC | CEFOTAXIME SODIUM | 1 G/VIAL | SURGE LABORATORIES (PVT) LTD.,,-10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*5ML, WFI IN A CLEAR GLASS AMPOULE | 19/07/2022 |
| 374 | NDA/MAL/HDP/10047 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | ARCELIA CHLORAMPHENICOL SODIUM SUCCINATE FOR INJECTION USP 1000 MG | CHLORAMPHENICOL SODIUM SUCCINATE | 1000 MG/VIAL | SANJAR PHARMACEUTICALS LIMITED, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL | 06/07/2022 |
| 375 | NDA/MAL/HDP/10050 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL) ROTASIIL LIQUID | LIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT [G1, G2, G3, G4 AND G9] | ?105.6 FFU / SEROTYPE PER DOSE (2 ML) | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X2.0 ML VIAL, 1.0X50.0X2.0 ML VIAL | 19/07/2022 |
| 376 | NDA/MAL/HDP/10052 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 5000 IU | CHOLECALCIFEROL | 5,000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X30.0 CAPSULE CONTAINER | 19/07/2022 |
| 377 | NDA/MAL/HDP/10055 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FIMABUTE-400 | CEFIXIME TRIHYDRATE | 400MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 19/07/2022 |
| 378 | NDA/MAL/HDP/10056 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | AVARIN | SIMETHICONE+ ALVERINE CITRATE | 300 MG + 60 MG | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0X1.0X10.0 CAPSULE BLISTER | 19/07/2022 |
| 379 | NDA/MAL/HDP/10057 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | ZIMLOX 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 06/07/2022 |
| 380 | NDA/MAL/HDP/1006 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRIPRIDE-2 | GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN | 2MG+15MG+500MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 381 | NDA/MAL/HDP/10060 | EMCURE PHARMACEUTICALS LTD - | HARLEYS UGANDA LIMITED | VIROPIL | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | EMCURE PHARMACEUTICALS LIMITED, PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 19/07/2022 |
| 382 | NDA/MAL/HDP/10061 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | INSTACLOP PLUS | CLOPIDOGREL + ASPIRIN | 75 MG + 75 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 19/07/2022 |
| 383 | NDA/MAL/HDP/10063 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | CARDIONE 25 | SPIRONOLACTONE | 25MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/07/2022 |
| 384 | NDA/MAL/HDP/10064 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROSUVAT 20 | ROSUVASTATIN CALCIUM | 20.0 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/07/2022 |
| 385 | NDA/MAL/HDP/10065 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/ 300 MG/ 300 MG | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 600 MG + 300 MG + 300 MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X90.0 TABLET BOTTLE,1.0X30.0 TABLET BOTTLE | 19/07/2022 |
| 386 | NDA/MAL/HDP/10066 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | FEMPRO | LETROZOLE | 2.5MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/07/2022 |
| 387 | NDA/MAL/HDP/10069 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | OPELAN ODT 5 | OLANZAPINE | 5 MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 14/07/2022 |
| 388 | NDA/MAL/HDP/1007 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZINCOS DISPERSIBLE TABLETS 20MG | ZINC SULPHATE | 20MG | COSMOS LIMITED, KENYA, RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 389 | NDA/MAL/HDP/10070 | ZIM LABORATORIES LTD | ESCORTS PHARMACEUTICALS LTD - WILSON ROAD | TELCARD H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 390 | NDA/MAL/HDP/10071 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICAL LTD | FENAPAR | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | ARTURA PHARMACEUTICALS PRIVATE LIMITED - NO. 1505, PORTIA ROAD SRI CITY SEZ, SATYAVEDU MANDAL, CHITTOOR DIST-517 588, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/07/2022 |
| 391 | NDA/MAL/HDP/10072 | EMCURE PHARMACEUTICALS LTD - | HARLEYS UGANDA LIMITED | INBEC | ABACAVIR SULPHATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 600 MG + 50 MG + 300 MG | EMCURE PHARMACEUTICALS LIMITED, PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 14/07/2022 |
| 392 | NDA/MAL/HDP/10074 | TAURUS CHEMICALS (P) LTD. | HEALTHCARE LTD. | MAGACID SUSPENSION | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | (215 MG + 80 MG + 25 MG)/5ML | AL FAZAL PHARMA INDUSTRIES (PVT) LTD, PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X120.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 14/07/2022 |
| 393 | NDA/MAL/HDP/10083 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | MORCET | ESCITALOPRAM OXALATE | 20 MG | SEARLE PAKISTAN LTD.., F-319, S.I.T.E., OPP. KESC POWER STATION, KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 14/07/2022 |
| 394 | NDA/MAL/HDP/10086 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | NEOMICLAV-DS | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | (200 MG + 28.5 MG)/5 ML | CHIROS PHARMA, VILLAGE LOHARON, P.O. GHATTI, DISTT. - SOLAN, HIMACHAL PRADESH - INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE, 1.0X1.0X100.0 ML BOTTLE | 14/07/2022 |
| 395 | NDA/MAL/HDP/1009 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BUPITROY 0.5% | BUPIVACAINE | 5MG/ML | TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2012 |
| 396 | NDA/MAL/HDP/10091 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | PG-150 | PREGABALIN | 150 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 14/07/2022 |
| 397 | NDA/MAL/HDP/10093 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MUCOSIL BR | SALBUTAMOL + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN + MENTHOL | 2.0 MG + 4.0 MG + 100 MG + 1.0 MG | RAVIAN LIFE SCIENCE PVT LTD, PLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 18/07/2022 |
| 398 | NDA/MAL/HDP/10100 | HETERO LABS LTD | REDDYS PHARMA LIMITED | PANTIN | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40 MG/VIAL | ASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL | 18/07/2022 |
| 399 | NDA/MAL/HDP/10101 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | VILDARIL 50 | VILDAGLIPTIN | 50 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/07/2022 |
| 400 | NDA/MAL/HDP/10104 | IND-SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELSWIFT 40 | TELMISARTAN | 40 MG | IND-SWIFT LIMITED /, VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJAB | INDIA | TABLETS (COATED | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 401 | NDA/MAL/HDP/10105 | IND-SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELSWIFT 80 | TELMISARTAN | 80 MG | IND-SWIFT LIMITED /, VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJAB | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 06/07/2022 |
| 402 | NDA/MAL/HDP/10112 | KESAR PHARMA | METRO PHARMACEUTICALS LIMITED | KESKETO | KETOCONAZOLE | 2 % W/W | KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 14/07/2022 |
| 403 | NDA/MAL/HDP/10114 | QUALITY CHEMICAL INDUSTRIES LIMITED(QCIL) | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300/300 MG | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300 MG + 300 MG | QUALITY CHEMICAL INDUSTRIES LIMITED. , PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 06/07/2022 |
| 404 | NDA/MAL/HDP/10117 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VENOSMIL | HIDROSMIN | 200 MG | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 06/07/2022 |
| 405 | NDA/MAL/HDP/1012 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | LOX 2% | LIDOCAINE | 2% W/V | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL | 01/07/2013 |
| 406 | NDA/MAL/HDP/10129 | HETERO LABS LTD | AIVEEN (U) LIMITED | DARUNAVIR AND RITONAVIR TABLETS 400 MG/50 MG | DARUNAVIR ETHANOLATE + RITONAVIR | 400 MG + 50 MG | HETERO LABS PRIVATE LIMITED UNIT III, SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 18/07/2022 |
| 407 | NDA/MAL/HDP/1013 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | THIOSOL | THIOPENTAL SODIUM | 500MG | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 ML VIAL | 01/07/2013 |
| 408 | NDA/MAL/HDP/1014 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | TIDAZOL TABLETS | TINIDAZOLE | 500MG | ELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X4.0 TABLET BLISTER | 01/07/2015 |
| 409 | NDA/MAL/HDP/10140 | UNICHEM LABORATORIES LIMITEDˆŠ | EUROPA HEALTHCARE (U) LTD | ALDROL 5 | DONEPEZIL HYDROCHLORIDE | 5MG | UNICHEM LABORATORIES BADI-UNIT II, VILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 410 | NDA/MAL/HDP/10141 | UNICHEM LABORATORIES LIMITEDˆŠ | EUROPA HEALTHCARE (U) LTD | ALDROL 10 | DONEPEZIL HYDROCHLORIDE | 10MG | UNICHEM LABORATORIES BADI-UNIT II, VILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 411 | NDA/MAL/HDP/10146 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | UMBILICA GEL | CHLORHEXIDINE GLUCONATE | 4%W/W | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | PAKISTAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X10.0 G TUBE | 18/07/2022 |
| 412 | NDA/MAL/HDP/10148 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RALEF 60 | ETORICOXIB | 60MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 18/07/2022 |
| 413 | NDA/MAL/HDP/10149 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RALEF 90 | ETORICOXIB | 90MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 18/07/2022 |
| 414 | NDA/MAL/HDP/10150 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RALEF 120 | ETORICOXIB | 120MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 18/07/2022 |
| 415 | NDA/MAL/HDP/10151 | S KANT HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | FUNGARIN | MICONAZOLE | 2%W/W | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 06/07/2022 |
| 416 | NDA/MAL/HDP/10164 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ASPIRIN TABLETS | ACETYLSALICYCLIC ACID | 300MG | ELYS CHEMICAL INDUSTRIES LIMITED,, OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X200.0 TABLET TIN,1.0X1000.0 TABLET TIN | 02/09/2022 |
| 417 | NDA/MAL/HDP/10168 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | LYFE | ORAL REHYDRATION SALT | N/A | ELYS CHEMICAL INDUSTRIES LIMITED,, OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X14.0 G SACHET,1.0X28.0 G SACHET | 02/09/2022 |
| 418 | NDA/MAL/HDP/10169 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ORODAR | SULFADOXINE+PYRIMETHAMINE | 500MG+25MG | ELYS CHEMICAL INDUSTRIES LIMITED,, OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 02/09/2022 |
| 419 | NDA/MAL/HDP/1017 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYCLOX | AMPICILLIN/CLOXACILLIN | 125MG/125MG | ELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| 420 | NDA/MAL/HDP/10172 | SURGE LABORATORIES (PVT.) LTD. | HEALTHCARE LTD. | SURGICOMB INJECTION 2G | CEFOPRAZONE SODIUM + SULBACTUM SODIUM | (1G + 1G)/VIAL | SURGE LABORATORIES (PVT) LTD.,,-10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X2.0 G VIAL + 10ML WFI CLEAR GLASS AMPOULE | 09/09/2022 |
| 421 | NDA/MAL/HDP/1018 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM CHLOR | CHLORAMPHENICOL | 250MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER | 01/07/1997 |
| 422 | NDA/MAL/HDP/10182 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | CYCLOSERINE 250 MG | CYCLOSERINE | 250 MG | MYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 09/09/2022 |
| 423 | NDA/MAL/HDP/10183 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | TEXAKIND | TRANEXAMIC ACID | 500MG/5ML | MANKIND PHARMA LIMITED, UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X4.0X5.0 ML AMPOULE | 09/09/2022 |
| 424 | NDA/MAL/HDP/10184 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ROFAST 20 | ROSUVASTATIN CALCIUM | 20MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 425 | NDA/MAL/HDP/10185 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TURBOVAS-10 | ROSUVASTATIN CALCIUM | 10MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 426 | NDA/MAL/HDP/10186 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | AARLOFLOX OZ | OFLOXACIN + ORNIDAZOLE | 200 MG + 500 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 427 | NDA/MAL/HDP/10187 | PINNACLE LIFE SCIENCE PVT LTD. | METRO PHARMACEUTICALS LIMITED | AARCET 5 | CETIRIZINE HYDROCHLORIDE | 5 MG | 1. PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 09/09/2022 |
| 428 | NDA/MAL/HDP/10188 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | AARLEFLOX 750 | LEVOFLOXACIN HEMIHYDRATE | 750 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 429 | NDA/MAL/HDP/10189 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ETRICOX 120 | ETORICOXIB | 120 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 430 | NDA/MAL/HDP/10191 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | VALSAR HT 160/25 | VALSARTAN + HYDROCHLORTHIAZIDE | 160MG + 25MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 431 | NDA/MAL/HDP/10192 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUTAXIM 1 GM | CEFOTAXIME SODIUM | 1 G/ VIAL | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)| ZEISS PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL RETARD DRY VIALS | 1.0X1.0X1.0 G VIAL | 09/09/2022 |
| 432 | NDA/MAL/HDP/10193 | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC PLUS | HYDROCHLOROTHIAZIDE + IRBESARTAN | 12.5 MG + 300 MG | 1. UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 433 | NDA/MAL/HDP/10194 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BETOLINA | BUPIVACAINE HYDROCHLORIDE | 0.5%W/V | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X20.0 ML VIAL | 03/10/2022 |
| 434 | NDA/MAL/HDP/10197 | CENTURION LABORATORIES PVT. LTD. | BIOGEN PHARMA LIMITED | LEVOZINE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5 MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 435 | NDA/MAL/HDP/10199 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | GOFEN 200 | IBUPROFEN | 200 MG | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X6.0X1.0X1.0X10.0 CAPSULE BLISTER | 09/09/2022 |
| 436 | NDA/MAL/HDP/1020 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PA-12 | PARACETAMOL SUSTAINED RELEASE | 1000MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID RETARD LAYERED TABLETS | 1.0X10.0X1.0X12.0 TABLET BLISTER | 01/07/2012 |
| 437 | NDA/MAL/HDP/10201 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ETRICOX 60 | ETORICOXIB | 60 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 438 | NDA/MAL/HDP/10208 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KENZOPRAZOL | ESOMEPRAZOLE SODIUM | 40MG PER VIAL | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X40.0 MG VIAL | 03/10/2022 |
| 439 | NDA/MAL/HDP/10209 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRAMAPA FORT 75MG/650MG | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 75 MG + 650 MG | FERRER INTERNATIONAL, S.A, C/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| 440 | NDA/MAL/HDP/10210 | FDC LTD | AIVEEN (U) LIMITED | IOPROST EYE DROPS | LATANOPROST | 0.005%W/V | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC LIQUIDS | 1.0X2.5 ML BOTTLE | 29/09/2022 |
| 441 | NDA/MAL/HDP/10212 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | SPASNIL P | MEFENAMIC ACID + PARACETAMOL | 500 MG + 325 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 442 | NDA/MAL/HDP/10214 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ILAXTEN 20 MG TABLETS | BILASTINE | 20MG | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL-VIA CAMPO DI PILE 67100 L'AQUILA (AQ) | | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 09/09/2022 |
| 443 | NDA/MAL/HDP/10218 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | COMIT-100 | SILDENAFIL CITRATE | 100 MG | BLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER, 1.0X10.0X1.0X4.0 TABLET BLISTER | 09/09/2022 |
| 444 | NDA/MAL/HDP/1022 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - | UNITED HEALTHCARE DISTRIBUTORS LTD | CONVENTIN | GABAPENTIN | 300MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 445 | NDA/MAL/HDP/10224 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ITRO-100 | ITRACONAZOLE | 100 MG | 1. M/S SYNOKEM PHARMACEUTICALS LIMITED PLOT NO. 35-36, SECTOR-6A, IIE, SIDCUL, RANIPUR, DISTT. HARIDWAR, UTTARAKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 09/09/2022 |
| 446 | NDA/MAL/HDP/10228 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | SEPTOPRIM 960 | TRIMETHOPRIM + SULFAMETHOXAZOLE | 160 MG + 800 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT|CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 447 | NDA/MAL/HDP/1023 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | ZINNIA P | LEVONORGESTREL + ETHINYLESTRADIOL | 150MCG + 30MCG | MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER | 01/07/2013 |
| 448 | NDA/MAL/HDP/10230 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | MBEN | MEBENDAZOLE | 100 MG/5 ML | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT|CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA| | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X30.0 ML BOTTLE | 09/09/2022 |
| 449 | NDA/MAL/HDP/10232 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | TOPGYL | METRONIDAZOLE BENZOATE | 125 MG/5 ML | CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| 450 | NDA/MAL/HDP/10234 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | TERBINAFORCE 250 | TERBINAFINEHYDROCHLORIDE | 250 MG | MANKIND PHARMA LIMITED, UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 451 | NDA/MAL/HDP/10235 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | LOFNAC GEL | LINSEED OIL + DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + MENTHOL | 3.00%W/W + 1.16% W/W + 10.00%W/W + 5.00%W/W | KREMOINT PHARMA PVT LTD PLANT II, B-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST) DIST. THANE 421506 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 09/09/2022 |
| 452 | NDA/MAL/HDP/10239 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | ZITMYC | AZITHROMYCIN | 500MG | CSPC OUYI PHARMACEUTICAL CO. LTD., WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 09/09/2022 |
| 453 | NDA/MAL/HDP/10241 | SK AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT FORTE | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*6TABLET BLISTER | 09/09/2022 |
| 454 | NDA/MAL/HDP/10242 | EMCURE PHARMACEUTICALS LTD - | HARLEYS UGANDA LIMITED | INSTGRA | DOLUTEGRAVIR SODIUM | 50MG | EMCURE PHARMACEUTICALS LIMITED, PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 09/09/2022 |
| 455 | NDA/MAL/HDP/10246 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLENDES | DESLORATADINE | 5MG | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 456 | NDA/MAL/HDP/10249 | FDC LTD | AIVEEN (U) LIMITED | IOPROST €“ T | LATANOPROST + TIMOLOL MALEATE | (50 MCG + 5 MG)/ML | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML BOTTLE | 09/09/2022 |
| 457 | NDA/MAL/HDP/10251 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CITADONE | BETAMETHASONE | 0.6 MG/5 ML | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| 458 | NDA/MAL/HDP/10255 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | HOTGRA 100 | SILDENAFIL CITRATE | 100MG | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C., JEJURI DIST PUNE 412303, MAHARASHTRA,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*4TABLET BLISTER | 09/09/2022 |
| 459 | NDA/MAL/HDP/10256 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | HOTGRA 50 | SILDENAFIL CITRATE | 50MG | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C., JEJURI DIST PUNE 412303, MAHARASHTRA,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*4TABLET BLISTER | 09/09/2022 |
| 460 | NDA/MAL/HDP/10257 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FENTEX® | PHENYTOIN | 250MG/5ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X10.0X5.0 ML VIAL | 19/09/2022 |
| 461 | NDA/MAL/HDP/10258 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY PLUS 5/160 25 MG | AMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE | 5 MG + 160 MG + 25 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 462 | NDA/MAL/HDP/10259 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY PLUS 10/160 12.5 MG | AMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE | 10 MG + 160 MG + 12.5 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 463 | NDA/MAL/HDP/10260 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | OPELAN ODT 10 | OLANZAPINE | 10MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 464 | NDA/MAL/HDP/10261 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | NTCLOT-C75 | CLOPIDOGREL BILSULFATE | 75 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT| CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA| | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 09/09/2022 |
| 465 | NDA/MAL/HDP/10263 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | WORMAID ORAL SUSPENSION | ALBENDAZOLE | 200 MG/5ML | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT| CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA| | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE | 09/09/2022 |
| 466 | NDA/MAL/HDP/10265 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | MYVORCON 200 MG | VORICONAZOLE | 200 MG | MYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X15.0 TABLET BLISTER | 09/09/2022 |
| 467 | NDA/MAL/HDP/10267 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PROTOZOX-500 | NITAZOXANIDE | 500 MG | SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1*1*10 TABLET BLISTER | 09/09/2022 |
| 468 | NDA/MAL/HDP/10268 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | WORMAID TABLET | ALBENDAZOLE | 400 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT|CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 09/09/2022 |
| 469 | NDA/MAL/HDP/10270 | GLENMARK PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MALAGLEN | ATOVAQUONE + PROGUANIL HYDROCHLORIDE | 250 MG + 100 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*12TABLET BLISTER | 09/09/2022 |
| 470 | NDA/MAL/HDP/10272 | WOCKHARDT LTD | KAMCARE PHARMA LIMITED | POWERCEF S | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1.5 GM /VIAL | ZEISS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL + 1.0X1.0X10ML AMPOULE OF WFI | 09/09/2022 |
| 471 | NDA/MAL/HDP/10280 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | ZENOXIM 500 | CEFUROXIME AXETIL | 500 MG | INDCHEMIE HEALTH SPECIALITIES PVT. LTD, VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 472 | NDA/MAL/HDP/10282 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | MUPIWAYS | MUPIROCIN | 2.0 W/W | NEXT WAVE, RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 09/09/2022 |
| 473 | NDA/MAL/HDP/10283 | DAWA LIMITED- | SUPER MEDIC LTD | DAZOLE | CLOTRIMAZOLE | 100MG | DAWA LIMITED, PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY BLISTER | 09/09/2022 |
| 474 | NDA/MAL/HDP/10287 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | VILDA DENK 50 MG | VILDAGLIPTIN | 50 MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 09/09/2022 |
| 475 | NDA/MAL/HDP/10290 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | PHENYTOIN TABLETS BP 100 MG | PHENYTOIN SODIUM | 100 MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 476 | NDA/MAL/HDP/10292 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SPASMOTRIT | DICYCLOVERINE HYDROCHLORIDE + PARACETAMOL | 20 MG + 500 MG | 1. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 09/09/2022 |
| 477 | NDA/MAL/HDP/10293 | BIOLOGICAL E. LIMITED | GITTOES PHARMACEUTICALS LIMITED | TYPHOID CONJUGATE VACCINE (MONOVALENT) | TYPHOID VI POLYSACCHARIDE CONJUGATED TO 16.7 µG - 100 µG OF CRM197 | 25 µG /(0.5 ML)DOSE | BIOLOGICAL E. LIMITED , PLOT NO. 1, BIOTECH PARK, PHASE-II, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, TELENGANA STATE, 500078 - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X48.0X5.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL | 25/07/2024 |
| 478 | NDA/MAL/HDP/10294 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALTCIP | CIPROFLOXACIN | 200MG | ALTHEA PHARMA PRIVATE LIMITED, WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| 479 | NDA/MAL/HDP/10296 | LUPIN LIMITED- | AIVEEN (U) LIMITED | RIFAMPIN, ISONIAZID, PYRAZINAMIDE, ETHAMBUTOL HYDROCHLORIDE TABLETS USP150/75/400/275MG | RIFAMPIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE | 150MG + 75MG + 400MG + 275MG | LUPIN LTD, A-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X14.0 TABLET BLISTER | 09/09/2022 |
| 480 | NDA/MAL/HDP/10297 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 1000 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 875 MG + 125 MG | MEDICEF PHARMA, NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 481 | NDA/MAL/HDP/10298 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | COXZOTA 90 | ETORICOXIB | 90 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 482 | NDA/MAL/HDP/10299 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | MEDICEF PHARMA, NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| 483 | NDA/MAL/HDP/1030 | LABORATORIOS SALVAT SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MALACUR | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG + 320MG | CIRON DRUGS PHARMACEUTICALS PRIVATE LTD,, 35-37, 43-45, CFC-B DEWAN UDYOG NAGAR, ALIYALI, DIST - PALGHAR 401 404, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER | 01/07/2014 |
| 484 | NDA/MAL/HDP/10300 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 375 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 250 MG + 125 MG | MEDICEF PHARMA, NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| 485 | NDA/MAL/HDP/10302 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYOTRAM-P 37.5/325 | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 486 | NDA/MAL/HDP/10303 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DAPZIN-5 | DAPAGLIFLOZIN | 5 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER, | 09/09/2022 |
| 487 | NDA/MAL/HDP/10304 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DAPZIN-10 | DAPAGLIFLOZIN | 10 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 488 | NDA/MAL/HDP/10305 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SPASCOLIC | DICYCLOVERINE HYDROCHLORIDE + MEFENAMIC ACID | 10 MG + 250 MG | SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1*1*10 TABLET BLISTER | 09/09/2022 |
| 489 | NDA/MAL/HDP/10306 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | OMEZOLE | OMEPRAZOLE SODIUM | 40 MG | SWISS PARENTERALS LIMITED (UNIT-1), 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL + 1.0X1.0X10.0ML AMPOULE OF WFI | 09/09/2022 |
| 490 | NDA/MAL/HDP/10307 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | DESLOZED-5 | DESLORATADINE | 5 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 491 | NDA/MAL/HDP/1031 | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | MOXIFLOX | MOXIFLOXACIN HYDROCHLORIDE | 400 MG | 1. EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES 176 EL-SADAT ST. (FROM MANSOURIA STREAM) KAFR EL-GABAL, PYRAMIDS GIZA, EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY TABLETS | I. 1*1*5TABLET BLISTER | 01/07/2013 |
| 492 | NDA/MAL/HDP/10310 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ZINRO INFUSION | ORNIDAZOLE | 500MG/100ML | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGA | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| 493 | NDA/MAL/HDP/10311 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | LOPINAVIR AND RITONAVIR TABLETS USP | LOPINAVIR + RITONAVIR | 200MG + 50MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET BOTTLE | 09/09/2022 |
| 494 | NDA/MAL/HDP/10312 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | DICLOTRIX | DICLOFENAC DIETHYLAMINE + VIRGIN LINSEED OIL + METHYL SALICYLATE + MENTHOL | 1.0%W/W + 3.0%W/W + 10.0%W/W + 5.0%W/W | NANZ MED SCIENCE PHARMA PVT. LTD, RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X20.0 G TUBE | 09/09/2022 |
| 495 | NDA/MAL/HDP/10313 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | LOPINAVIR AND RITONAVIR TABLETS USP | LOPINAVIR + RITONAVIR | 100MG + 25MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 09/09/2022 |
| 496 | NDA/MAL/HDP/10314 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | AFRICURE PHARMACEUTICALS U LIMITED | SPIRONOLACTONE TABLETS BP 25 MG | SPIRONOLACTONE | 25MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 497 | NDA/MAL/HDP/10317 | Y.S.P. INDUSTRIES (M) SDN. BHD. | ROYAL PHARMA 2011 LIMITED | VOREN SUPPOSITORY 100 MG | DICLOFENAC SODIUM | 100 MG | 1. Y.S.P INDUSTRIES (M) SDN BHD LOT 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN PERINDUSTRIAAN BANDAR BARU BANGI, 43000 KAJANG, SELANGO MALAYSIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. Y.S.P INDUSTRIES (M) SDN BHD LOT 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN PERINDUSTRIAAN BANDAR BARU BANGI, 43000 KAJANG, SELANGO MALAYSIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MALAYSIA | RECTAL SYSTEMIC SUPPOSITORIES | I. 1*2*5SUPPOSITORY STRIP | 2022-09-09 00:00:00 |
| 498 | NDA/MAL/HDP/10318 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS 40 | TELMISARTAN | 40 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 499 | NDA/MAL/HDP/10319 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS 80 | TELMISARTAN | 80 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 500 | NDA/MAL/HDP/10322 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ORAFLOX | LEVOFLOXACIN HEMIHYDRATE | 500MG | CACHET PHARMACEUTICAL PVT LTD., VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 501 | NDA/MAL/HDP/10323 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XELTIN | TOFACITINIB CITRATE | 5MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 502 | NDA/MAL/HDP/10324 | APEX LABORATORIES PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | ZINCOVIT TABLETS | VITAMIN A (AS ACETATE) + VITAMIN D3 (CHOLECALCIFEROL) + VITAMIN E (AS DL-TOCOPHERYL ACETATE) + THIAMINE NITRATE + RIBOFLAVIN + PYRIDOXINE HYDROCHLORIDE + CYANOCOBALAMIN + NICOTINAMIDE + CALCIUM PANTOTHENATE + ASCORBIC ACID + MAGNESIUM OXIDE + MANGANESE SU | 5000IU + 400IU + 15MG +10MG + 10MG + 2MG + 7.5MCG + 50MG + 10MG + 75 MG + 30MG + 2.8MG + 2MG + 63MG +70MCG | APEX LABORATORIES PRIVATE LIMITED- PLANT 1, B-23, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, KANCHEEPURAM DISTRICT 603 110 | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 09/09/2022 |
| 503 | NDA/MAL/HDP/1033 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYNAMOGEN | GLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE | 3MG +1G | FAES FARMA, S.A , MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X20.0X10.0 ML SACHET | 01/07/2015 |
| 504 | NDA/MAL/HDP/10335 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PRIDOCAINE | LIDOCAINE + PRILOCAINE | 2.5 %W/W + 2.5 %W/W | 1. GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, PLOT 40, 18 STREET, 16TH OCTOBER CITY, GIZA 12581 EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT. | EGYPT | TOPICAL EXTERNAL CREAMS | I. 1*1*15G TUBE | 09/09/2022 |
| 505 | NDA/MAL/HDP/10336 | BIOLOGICAL E. LIMITED | GITTOES PHARMACEUTICALS LIMITED | MEASLES AND RUBELLA VACCINE (LIVE) (ATTENUATED, FREEZE DRIED) | MEASLES VIRUS (CAM-70 STRAIN) + RUBELLA VIRUS (WISTAR RA 27/3 STRAIN) | (? 1000 CCID50 + ? 1000 CCID50)/0.5 ML( DOSE) | BIOLOGICAL E. LIMITED , PLOT NO. 1, BIOTECH PARK, PHASE-II, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, TELENGANA STATE, 500078 - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X5.0 DOSE VIAL + 1*50*2.5ML AMPOULE OF NACL, 1.0X50.0X10.0 DOSE VIAL + 1*50*5ML AMPOULE OF NACL | 09/09/2022 |
| 506 | NDA/MAL/HDP/10340 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KERELLA | BETAMETHASONE DIPROPIONATE + SALICYLIC ACID | 0.5 MG/G + 220 MG/G | 1. GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, PLOT 40, 18 STREET, 16TH OCTOBER CITY, GIZA 12581 EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | TOPICAL EXTERNAL LOTIONS | I. 1*1*30ML BOTTLE | 09/09/2022 |
| 507 | NDA/MAL/HDP/10343 | DAWA LIMITED- | SUPER MEDIC LTD | KENAZOLE | KETOCONAZOLE | 2%W/W | DAWA LIMITED, PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 09/09/2022 |
| 508 | NDA/MAL/HDP/10349 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC | ARTEMETHER + LUMEFANTRINE | 80MG + 480MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER,30.0X6.0 TABLET BLISTER | 09/09/2022 |
| 509 | NDA/MAL/HDP/10352 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROYALTRIM 80 MG + 400 MG | TRIMETHOPRIM + SULFAMETHOXAZOLE | 80 MG + 400 MG | SYNOKEM PHARMACEUTICALS LIMITED-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) |LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 510 | NDA/MAL/HDP/10353 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | PAINAID | PARACETAMOL + IBUPROFEN + CAFFEINE | 400 MG + 325 MG + 40 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT|CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA| | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 09/09/2022 |
| 511 | NDA/MAL/HDP/10355 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RIVATAS 15 | RIVAROXABAN | 15 MG | INTAS PHARMACEUTICALS LTD.-PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 512 | NDA/MAL/HDP/10356 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | RIVATAS 20 | RIVAROXABAN | 20 MG | INTAS PHARMACEUTICALS LTD - PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*0TABLET BLISTER | 2022-09-09 00:00:00 |
| 513 | NDA/MAL/HDP/10358 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | VOLDIC - K | DICLOFENAC POTASSIUM | 50MG | PHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| 514 | NDA/MAL/HDP/10361 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | AFRICURE PHARMACEUTICALS U LIMITED | AFRICAL | CALCIUM LACTATE | 300 MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 515 | NDA/MAL/HDP/10365 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | MYLTEGA DT | DOLUTEGRAVIR SODIUM | 10MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X90.0 TABLET BOTTLE | 09/09/2022 |
| 516 | NDA/MAL/HDP/10367 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | SUVITRA €“ 750 | LEVETIRACETAM | 750MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 517 | NDA/MAL/HDP/10369 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | SITAPRIL 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 518 | NDA/MAL/HDP/10370 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | SITAPRIL 100 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 100MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 519 | NDA/MAL/HDP/10372 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IPOPRIN 2 | POMALIDOMIDE | 2MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X21.0 CAPSULE BOTTLE | 09/09/2022 |
| 520 | NDA/MAL/HDP/10373 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IPOPRIN 4 | POMALIDOMIDE | 4MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X21.0 CAPSULE BOTTLE | 09/09/2022 |
| 521 | NDA/MAL/HDP/10375 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | AFRI-FLU | PARACETAMOL + CAFFEINE + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE | 500 MG + 15 MG + 5 MG + 2 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*50*4TABLET BLISTER | 09/09/2022 |
| 522 | NDA/MAL/HDP/10377 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AROXICAM 15 | MELOXICAM | 15MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 09/09/2022 |
| 523 | NDA/MAL/HDP/10382 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | PINN-TRYPTILLIN | AMITRIPTYLINE HYDROCHLORIDE | 25MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 524 | NDA/MAL/HDP/10384 | SANJAR PHARMA LLP. | MOTI PHARMA (UGANDA) LIMITED | MOFENAC | DICLOFENAC SODIUM | 75MG/3ML | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X3.0 ML AMPOULE | 09/09/2022 |
| 525 | NDA/MAL/HDP/10388 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | DEXOMETH-N CREAM | NEOMYCIN SULPHATE + DEXAMETHASONE SODIUM PHOSPHATE | (5MG + 1MG)/ G | 1. AL-FAZAL PHARMA INDUSTRIES AL-FAZAL PHARMA INDUSTRIES (PVT) LTD. 16KM SHEIKHUPURA ROAD LAHORE PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | TOPICAL EXTERNAL CREAMS | I. 1*1*15G TUBE | 09/09/2022 |
| 526 | NDA/MAL/HDP/10390 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN DT 40/240 | ARTEMETHER + LUMEFANTRINE | 40MG + 240MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 09/09/2022 |
| 527 | NDA/MAL/HDP/10391 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | HYDROXYUREA 100MG | HYDROXYCARBAMIDE | 100MG | SIEGFRIED BARBERA, S.L.-RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA, SPAIN. | HAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG | | SPAIN| GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE,1.0X1.0X120.0 TABLET BOTTLE,1.0X200.0 TABLET BOTTLE | 09/09/2022 |
| 528 | NDA/MAL/HDP/10392 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | HYDROXYUREA 1000MG | HYDROXYCARBAMIDE | 1000MG | SIEGFRIED BARBERA, S.L.-RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA, SPAIN. | HAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG | | SPAIN| GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 09/09/2022 |
| 529 | NDA/MAL/HDP/1041 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN | RECOMBINANT HUMAN ERYTHROPOIETIN | 4000 I.U/1ML | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL | 01/07/2013 |
| 530 | NDA/MAL/HDP/10418 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA CT 100 | SILDENAFIL CITRATE | 100 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 08/02/2023 |
| 531 | NDA/MAL/HDP/10419 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | SITAPRIL M 50/1000 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 532 | NDA/MAL/HDP/1042 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS-H 80/12.5 | TELMISARTAN +HYDROCHLOROTHIAZIDE | 80MG +12.5 MG | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 533 | NDA/MAL/HDP/10420 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | SITAPRIL M 50/500 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 534 | NDA/MAL/HDP/10423 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | MALAKANT DISPERSIBLE JUNIOR | SULFADOXINE + PYRIMETHAMINE | 250MG + 12.5MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X25.0X3.0 TABLET BLISTER | 08/02/2023 |
| 535 | NDA/MAL/HDP/10424 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | MALAKANT DISPERSIBLE | SULFADOXINE + PYRIMETHAMINE | 500MG + 25MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X25.0X3.0 TABLET BLISTER | 08/02/2023 |
| 536 | NDA/MAL/HDP/10426 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SUPAGREL 90 | TICAGRELOR | 90 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 537 | NDA/MAL/HDP/10427 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CELMAC 400 | CELECOXIB | 40 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 538 | NDA/MAL/HDP/10428 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMOXI-DENK 1000 | AMOXICILLIN TRIHYDRATE | 1000 MG | PENCEF PHARMA GMBH, BREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| 539 | NDA/MAL/HDP/10429 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMOXI-DENK 500 | AMOXICILLIN TRIHYDRATE | 500 MG | PENCEF PHARMA GMBH, BREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 08/02/2023 |
| 540 | NDA/MAL/HDP/10432 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | VAMOCIN 500 | VANCOMYCIN HYDROCHLORIDE | 500MG | GUFIC BIOSCIENCES LIMITED (UNIT 2), SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X500.0 MG VIAL | 08/02/2023 |
| 541 | NDA/MAL/HDP/10436 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | PETHIDINE HYDROCHLORIDE INJECTION | PETHIDINE HYDROCHLORIDE | 50 MG/ML | YICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED-NO. 19, DALIAN ROAD, YICHANG DEVELOPING ZONE, YICHANG, HUBEI, CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 10/02/2023 |
| 542 | NDA/MAL/HDP/1044 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ANGINET 80MG | VALSARTAN | 80MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 543 | NDA/MAL/HDP/10440 | BIOMATRIX HEALTHCARE PRIVATE LIMITED. | MEDIWORLD PHARMA AFRICA LTD | PHENIREX | CHLORPHENAMINE MALEATE | 4 MG | CENTURION LABORATORIES PRIVATE LIMITED P-2, BIO-TECH PARK, MANJUSAR, TAL: SAVALI, VADADORA -391775, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1*10*10 TABLET BLISTER | 08/02/2023 |
| 544 | NDA/MAL/HDP/10441 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PREDNOVA 5 | PREDNISOLONE | 5MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| 545 | NDA/MAL/HDP/10442 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECARB | CARBAMAZEPINE | 200MG | CENTURION LABORATORIES PVT LTD, PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| 546 | NDA/MAL/HDP/10443 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | FUNGIDERM | CLOTRIMAZOLE | 1 % W/W | NANZ MED SCIENCE PHARMA PVT. LTD, RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 08/02/2023 |
| 547 | NDA/MAL/HDP/10446 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ZITHROPLUS 500 | AZITHROMYCIN DIHYDRATE | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X1.0X3.0 TABLET BLISTER | 08/02/2023 |
| 548 | NDA/MAL/HDP/10447 | PT SANBE FARMA | ONCOPHARM (U) LTD | TRADOSIK | TRAMADOL HYDROCHLORIDE | 50 MG/ML | PT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3), JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIA | INDONESIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X1.0X5.0X2.0 ML AMPOULE | 08/02/2023 |
| 549 | NDA/MAL/HDP/10449 | PT SANBE FARMA | SHREEJI PHARMACEUTICALS LIMITED | POLIDEMISIN | NEOMYCIN SULFATE + POLIMYXYN B SULFATE + DEXAMETHASONE | (3.5 MG + 6000 IU + 1 MG)ML | PT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3), JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIA | INDONESIA | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML BOTTLE | 08/02/2023 |
| 550 | NDA/MAL/HDP/10450 | PT SANBE FARMA | SHREEJI PHARMACEUTICALS LIMITED | MEFINAL 500 | MEFENAMIC ACID | 500 MG | PT CAPRIFARMINDO LABORATORIES ,, JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIA | INDONESIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 08/02/2023 |
| 551 | NDA/MAL/HDP/10451 | GUANGZHOU WONDFO BIOTECH CO. LTD | METRO PHARMACEUTICALS LIMITED | WAXFREE | SODIUM BICARBONATE | 5%W/V | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | NASAL TOPICAL LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 08/02/2023 |
| 552 | NDA/MAL/HDP/10452 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | OPTIPRED | PREDNISOLONE ACETATE | 1.0% W/V | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML BOTTLE | 08/02/2023 |
| 553 | NDA/MAL/HDP/10456 | UNIMED TECHNOLOGIES CO., LTD | OMAB UGANDA LIMITED | ENOXAMED 4000 IU ANTI-XA /0.4 ML | ENOXAPARIN SODIUM | 4000 IU ANTI-XA /0.4 ML (EQUIVALENT TO 40 MG PER 0.4 ML) | UNIMED LABORATORIES, P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 08/02/2023 |
| 554 | NDA/MAL/HDP/10457 | UNIMED TECHNOLOGIES CO., LTD | OMAB UGANDA LIMITED | ENOXAMED 6000 IU ANTI-XA /0.6 ML | ENOXAPARIN SODIUM | 6000 IU ANTI-XA /0.6 ML (EQUIVALENT TO 60 MG PER 0.6 ML) | UNIMED LABORATORIES, P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 08/02/2023 |
| 555 | NDA/MAL/HDP/10458 | UNIMED TECHNOLOGIES CO., LTD | OMAB UGANDA LIMITED | ENOXAMED 8000 IU ANTI-XA /0.8 ML | ENOXAPARIN SODIUM | 8000 IU ANTI-XA /0.8 ML (EQUIVALENT TO 80 MG PER 0.8 ML) | UNIMED LABORATORIES, P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 08/02/2023 |
| 556 | NDA/MAL/HDP/10460 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | AERIALLERG 5MG | DESLORATIDINE | 5 MG | PHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 557 | NDA/MAL/HDP/10461 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | AERIALLERG 0.5MG/ML | DESLORATIDINE | 0.5MG/ML | PHARMA INTERNATIONAL CO. LTD , AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X125.0 ML BOTTLE | 08/02/2023 |
| 558 | NDA/MAL/HDP/10462 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TOR - LOOP 10 | ANHYDROUS TORASEMIDE | 10MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 08/02/2023 |
| 559 | NDA/MAL/HDP/10463 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DISFOR | METHOCARBAMOL | 500 MG | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 08/02/2023 |
| 560 | NDA/MAL/HDP/10464 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN 4 FLU TABLETS | DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE | 12.5MG + 500MG + 22.5MG | JOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWN| | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X12.0 TABLET BLISTER | 08/02/2023 |
| 561 | NDA/MAL/HDP/1047 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EXOFEN 180MG | FEXOFENADINE | 180MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X15.0 TABLET BLISTER | 01/07/2013 |
| 562 | NDA/MAL/HDP/10474 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | POLYMOL EXTRA | CAFFEINE + PARACETAMOL | 30 MG + 500 MG | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 08/02/2023 |
| 563 | NDA/MAL/HDP/10475 | MARCYRL PHARMACEUTICAL INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | EVASTINE | EBASTINE | 10 MG | 1. MARCYRL PHARMACEUTICALS INDUSTRIES EL-OBOUR CITY, THE WEST EXTENSION BLOCK 20005 - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*10TABLET BLISTER | 08/02/2023 |
| 564 | NDA/MAL/HDP/10483 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | PATIZRA | RANIBIZUMAB | 10 MG/ML | NOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONS, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1.0X1.0X0.23 ML VIAL | 08/02/2023 |
| 565 | NDA/MAL/HDP/1049 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVATE | BETAMETHASONE VALERATE | 0.1%W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/2013 |
| 566 | NDA/MAL/HDP/10491 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | APRETUDE 30 MG | CABOTEGRAVIR | 30 MG | GLAXO WELLCOME S.A, AVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAIN | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 08/02/2023 |
| 567 | NDA/MAL/HDP/10496 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | IRIS SYRUP | DESLORATADINE | 0.5 MG/ML | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY, AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 08/02/2023 |
| 568 | NDA/MAL/HDP/1050 | INTAS PHARMACEUTICALS LIMITED | ZEE PHARMACEUTICALS LIMITED | AMTAS-10 | AMLODIPINE | 10MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)| INTAS PHARMACEUTICALS LTD, PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 569 | NDA/MAL/HDP/10502 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VORIOLE 200 | VORICONAZOLE | 200 MG | 1. MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 08/02/2023 |
| 570 | NDA/MAL/HDP/10503 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | HI-ALFA SR 10 | ALFUZOSIN HYDROCHLORIDE | 10MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 08/02/2023 |
| 571 | NDA/MAL/HDP/10504 | INFUGEN PHARMA PVT LTD | TATA UGANDA LIMITED | INFUROXIM 1.5 G | CEFUROXIME SODIUM | 1.5 G | 1. ZEISS PHARMACEUTICALS PRIVATE LIMITED PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*2G VIAL | 08/02/2023 |
| 572 | NDA/MAL/HDP/10505 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | OPTOR EYE DROPS | KETOROLAC TROMETHAMINE | 0.5%W/V | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGA | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 08/02/2023 |
| 573 | NDA/MAL/HDP/10508 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FIMABUTE-100 | CEFIXIME TRIHYDRATE | 100MG/5ML | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 08/02/2023 |
| 574 | NDA/MAL/HDP/10509 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | PANTRO INJECTION | PANTOPRAZOLE SODIUM | 40MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL + (1*1*10ML OF SODIUM CHLORIDE SOLUTION IN CLEAR GLASS AMPOULE) | 08/02/2023 |
| 575 | NDA/MAL/HDP/10510 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | NEUROZIM 75 | PREGABALIN | 75MG | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 576 | NDA/MAL/HDP/10512 | CENTURION LABORATORIES PVT. LTD. | BIOGEN PHARMA LIMITED | FINADOL ULTRA | CAFFEINE + PARACETAMOL | 30 MG + 500 MG | 1. CENTURION LABORATORIES PRIVATE LIMITED P-2, BIO-TECH PARK, MANJUSAR, TAL: SAVALI, VADADORA -391775 ? INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 08/02/2023 |
| 577 | NDA/MAL/HDP/10513 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EXITINE 0.5MG/5ML | FLUMAZENIL | 0.5MG/5ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X5.0 ML VIAL | 10/02/2023 |
| 578 | NDA/MAL/HDP/10514 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICAL LTD | ORITA-100 | SILDENAFIL CITRATE | 100 MG | ARTURA PHARMACEUTICALS PRIVATE LIMITED - NO. 1505, PORTIA ROAD SRI CITY SEZ, SATYAVEDU MANDAL, CHITTOOR DIST-517 588, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*4TABLET BLISTER | 08/02/2023 |
| 579 | NDA/MAL/HDP/10517 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRULEXIN-250 | CEFALEXIN MONOHYDRATE | 250MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 580 | NDA/MAL/HDP/10519 | PT SANBE FARMA | SHREEJI PHARMACEUTICALS LIMITED | PLASMINEX | TRANEXAMIC ACID | 500MG | PT SANBE FARMA UNIT 1, JALAN INDUSTRI I NO. 9 RT. 01 RW.08, KELURAHAN UTAMA, KECAMATAN CIMAHI SELATAN, KOTA CIMAHI 40553 - INDONESIA | INDONESIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 08/02/2023 |
| 581 | NDA/MAL/HDP/1052 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | MICLOGEN | MICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE | 2.0%W/W+0.05%W/W+0.1W/W | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| 582 | NDA/MAL/HDP/10522 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | CEFRIM 500 | CEFUROXIME AXETIL | 500 MG | 1. ZIM LABORATORIES LIMITED B-21/22, MIDC AREA, KALMESHWAR - 441501, DIST. NAGPUR, MAHARASHTRA STATE €“ INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 08/02/2023 |
| 583 | NDA/MAL/HDP/10523 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | SYNRIAM DT | ARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE | 37.5 MG + 187.5 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED , INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X3.0 TABLET BLISTER | 08/02/2023 |
| 584 | NDA/MAL/HDP/10525 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA 50 | PREGABALIN | 50MG | PHARMATHEN INTERNATIONAL S.A-INDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECE | | GREECE | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X7.0 CAPSULE BLISTER | 08/02/2023 |
| 585 | NDA/MAL/HDP/10526 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA 75 | PREGABALIN | 75MG | PHARMATHEN INTERNATIONAL S.A-INDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECE | | GREECE | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X7.0 CAPSULE BLISTER | 08/02/2023 |
| 586 | NDA/MAL/HDP/10527 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | PRELYNCA 150 MG | PREGABALIN | 150MG | PHARMATHEN INTERNATIONAL S.A-INDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECE | | GREECE | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 08/02/2023 |
| 587 | NDA/MAL/HDP/10528 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | EZIUM 20 MG | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 08/02/2023 |
| 588 | NDA/MAL/HDP/10529 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | EZIUM 40 MG | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 08/02/2023 |
| 589 | NDA/MAL/HDP/10530 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | COXZOTA 120 | ETORICOXIB | 120MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 590 | NDA/MAL/HDP/10531 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | ENO CALCIUM ANTACID TABLETS | CALCIUM CARBONATE | 500MG | GLAXOSMITHKLINE LIMITED, LIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI| | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 08/02/2023 |
| 591 | NDA/MAL/HDP/10535 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGINOVAG | DEQUALINIUM CHLORIDE + TYROTHRICIN + ? -GLYCYRRHETINIC ACID (ENOXOLONE) + HYDROCORTISONE ACETATE + LIDOCAINE HYDROCHLORIDE | (100MG + 400MG + 60MG + 60MG+100MG) PER 100 ML | FERRER INTERNATIONAL, S.A, C/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X10.0 ML BOTTLE | 08/02/2023 |
| 592 | NDA/MAL/HDP/10539 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZOTAMET-850 | METFORMIN HYDROCHLORIDE | 850MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| 593 | NDA/MAL/HDP/1054 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-250 | AZITHROMYCIN | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER | 01/07/2011 |
| 594 | NDA/MAL/HDP/10540 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | ATAZANAVIR AND RITONAVIR TABLETS | ATAZANAVIR SULFATE + RITONAVIR | 300MG + 100MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 08/02/2023 |
| 595 | NDA/MAL/HDP/10545 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | BRAMOL | PARACETAMOL | 10MG/ML | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML VIAL | 08/02/2023 |
| 596 | NDA/MAL/HDP/10546 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | OXOFERIN | TETRACHLORODECAOXIDE | 138.0 X 10^6 PMOL/100ML | BROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | | PAKISTAN | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X50.0 ML BOTTLE | 08/02/2023 |
| 597 | NDA/MAL/HDP/10547 | PROFARMA SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | HALOPERIDOL SOLUTION FOR INJECTION 5MG/ML | HALOPERIDOL | 5MG/ML | PROFARMA SH.A-MYSLYM KETA,TIRANA | | ALBANIA | | PARENTERAL ORDINARY VIALS | 1.0X2.0X5.0X1.0 ML VIAL | 08/02/2023 |
| 598 | NDA/MAL/HDP/10550 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AZADUAL 100 | AZACITIDINE | 100MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0X100.0 MG VIAL | 08/02/2023 |
| 599 | NDA/MAL/HDP/10551 | ARCELIA LIFESCIENCES LIMITED | MOTI PHARMA (UGANDA) LIMITED | ADRENLIN | ADRENALINE ACID TARTRATE | 1MG | SANJAR PHARMA LLP, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1X1X10X1 MG AMPOULE | 08/02/2023 |
| 600 | NDA/MAL/HDP/10556 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | PIADIN | POVIDONE IODINE | 5.0 W/W | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 08/02/2023 |
| 601 | NDA/MAL/HDP/10557 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | LOFNAC-50 | DICLOFENAC SODIUM | 50MG | BLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| 602 | NDA/MAL/HDP/1056 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVATE-N OINTMENT | BETAMETHASONE + NEOMYCIN | 0.1%W/W + 0.5% W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 01/07/2013 |
| 603 | NDA/MAL/HDP/10564 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | ISONIAZID/PYRIDOXINE HYDROCHLORIDE/SULFAMETH OXAZOLE TRIMETHOPRIM TABLETS 300 MG/25 MG/800 MG/160 MG | ISONIAZID + PYRIDOXINE HYDROCHLORIDE + SULFAMETHOXAZOLE + TRIMETHOPRIM | 300 MG + 25 MG + 800 MG + 160 MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BOTTLE | 08/02/2023 |
| 604 | NDA/MAL/HDP/10567 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CELMAC 200 | CELECOXIB | 200MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 605 | NDA/MAL/HDP/10568 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | AMADAY PL 5/4 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 5 MG + 4 MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 606 | NDA/MAL/HDP/10569 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | AMADAY PL 5/8 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 5MG + 8MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 607 | NDA/MAL/HDP/10570 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | AMADAY PL 10/4 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 10 MG + 4 MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 608 | NDA/MAL/HDP/10571 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | AMADAY PL 10/8 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 10MG + 8MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 609 | NDA/MAL/HDP/10572 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | NAT-B FORTE | THIAMINE MONONITRATE (VITAMIN B1) + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) + METHYLCOBALAMIN (VITAMIN B12) + FOLIC ACID + D-ALPHA-TOCOPHEROL ACETATE + VITAMIN A + VITAMIN D3 + COPPER SULPHATE ANHYDROUS + CHROMIUM PICOLINATE + ZINC AMINO ACID CHELATE | 100 MG + 200 MG + 500 MCG + 200 MCG + 200 IU + 5000 IU + 400 IU + 1.0 MG + 0.20 MG + 15.0 MG | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 610 | NDA/MAL/HDP/10573 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DABIFIB 110 | DABIGATRAN ETEXILATE | 110MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 611 | NDA/MAL/HDP/10574 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DABIFIB 150 | DABIGATRAN ETEXILATE | 150MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| 612 | NDA/MAL/HDP/10576 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | QUITIDE 100 | QUETIAPINE FUMARATE | 100 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 08/02/2023 |
| 613 | NDA/MAL/HDP/10578 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | OCORTIN | HYDROCORTISONE | 1%W/W | KREMOINT PHARMA PVT LTD. , B-8, ADDITIONAL AMBERNATH M.I.D.C, OPP. ANAND NAGIAR POLICE CHECK POST, AMBERNATH (E), DIST. THANE. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 08/02/2023 |
| 614 | NDA/MAL/HDP/10579 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | BENZYL BENZOATE APPLICATION BP | BENZYL BENZOATE | 25%W/V | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE | 08/02/2023 |
| 615 | NDA/MAL/HDP/10589 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | PILECA-EZ | ATORVASTATIN + EZETIMIBE | 10 MG + 10 MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 616 | NDA/MAL/HDP/10590 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | ULCEREST 20 | ESOMEPRAZOLE MAGNESIUM | 20MG | MYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 15/02/2023 |
| 617 | NDA/MAL/HDP/10591 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | ULCEREST 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | MYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 15/02/2023 |
| 618 | NDA/MAL/HDP/10592 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | ASCARD-75 | ASPIRIN | 75MG | ATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | | PAKISTAN | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 619 | NDA/MAL/HDP/10598 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | MIXIF | CEFIXIME TRIHYDRATE | 400MG | DAR AL DAWA, NA€™UR €“ PRINCE HASHEM BIN AL-HUSSEIN STREET P.O. BOX 9364 AMMAN 11191 JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0 CAPSULE BLISTER | 21/03/2023 |
| 620 | NDA/MAL/HDP/10601 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VORIOLE 50 | VORICONAZOLE | 50 MG | 1. MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 2023-02-15 00:00:00 |
| 621 | NDA/MAL/HDP/10605 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | HALOPAC | HALOPERIDOL | 5MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| 622 | NDA/MAL/HDP/10607 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | DOLAC | KETOROLAC TROMETHAMINE | 10 MG | CADILA PHARMACEUTICALS LTD, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDABAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP | 15/02/2023 |
| 623 | NDA/MAL/HDP/10608 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | QOSMET 500/50 | METFORMIN HYDROCHLORIDE + SITAGLIPTIN PHOSPHATE MONOHYDRATE | 500 MG + 50 MG | 1. WILSHIRE LABS (PVT) LTD 124/1, QUAID-E-AZAM INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*5TABLET BLISTER | 15/02/2023 |
| 624 | NDA/MAL/HDP/10609 | ORANE | AIVEEN (U) LIMITED | OCUDOR | DORZOLAMIDE HYDROCHLORIDE | 2%W/V | FDC LIMITED-WALUJ., PLOT B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 (DIST AURANGABAD) | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| 625 | NDA/MAL/HDP/1061 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BISACODYL TABLETS | BISACODYL | 5MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 626 | NDA/MAL/HDP/10611 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | NEWSTAR 160/10 MG | VALSARTAN + AMLODIPINE BESYLATE | 160 MG + 10 MG | PHARMA INTERNATIONAL CO. LTD -AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 15/02/2023 |
| 627 | NDA/MAL/HDP/10612 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | NEWSTAR 160/5 MG | VALSARTAN + AMLODIPINE BESYLATE | 160 MG + 5 MG | PHARMA INTERNATIONAL CO. LTD -AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 15/02/2023 |
| 628 | NDA/MAL/HDP/10613 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ZINAXIME 500 | CEFUROXIME AXETIL | 500MG | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 06/03/2023 |
| 629 | NDA/MAL/HDP/10614 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | AVIRAX | ACICLOVIR | 5% W/W | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 06/03/2023 |
| 630 | NDA/MAL/HDP/10615 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LEVOZIN 5 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| 631 | NDA/MAL/HDP/10616 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | GLYSIT 5 | DAPAGLIFLOZIN | 5MG | COSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| 632 | NDA/MAL/HDP/10617 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | GLYSIT 10 | DAPAGLIFLOZIN | 10MG | COSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| 633 | NDA/MAL/HDP/10618 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF 150 I.U | RECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH) | 150 I.U/1ML | BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE | 15/02/2023 |
| 634 | NDA/MAL/HDP/10619 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | DEXIREN | DEXKETOPROFEN TROMETAMOL | 50MG/2ML | IDOL LLAC DOLUM A.S-DAVUTPASA CADDESI. CEBE ALI BEY SOK. NO. 20 34010/ DAVUTPASA - TOPKAPI / ISTANBUL | | TURKEY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X6.0X2.0 ML AMPOULE | 15/02/2023 |
| 635 | NDA/MAL/HDP/1062 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | VANCONEX-CP | VANCOMYCIN | 500MG | VENUS REMEDIES LIMITED, UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI BADDI (HP) 173205 INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2013 |
| 636 | NDA/MAL/HDP/10621 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PENIREN | PHENOXYMETHYLPENICILLIN POTASSIUM | 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| 637 | NDA/MAL/HDP/10623 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | STERIREN | CHLORHEXIDINE GLUCONATE | 5% W/V | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X5.0 L CONTAINER | 15/02/2023 |
| 638 | NDA/MAL/HDP/10624 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MIBZO | BORTEZOMIB | 3.5 MG/VIAL | MSN LABORATORIES PRIVATE LIMITED, FORMULATIONS DIVISION, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*3.5MG VIAL | 15/02/2023 |
| 639 | NDA/MAL/HDP/10625 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | ESOGRESS 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | STANFORD LABORATORIES PRIVATE LIMITED (A SUBSIDIARY COMPANY OF LA RENON HEALTHCARE PRIVATE LIMITED), 8, INDUSTRIAL AREA, MEHATPUR - 174315, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 640 | NDA/MAL/HDP/10630 | INNOVA CAPTAB LTD. | TATA UGANDA LIMITED | INFIXIME 400 | CEFIXIME TRIHYDRATE | 400MG | INNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| 641 | NDA/MAL/HDP/10631 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | RYALTRIS | MOMETASONE FUROATE + OLOPATADINE HYDROCHLORIDE | 25 µG + 665 µG | 1. GLENMARK PHARMACEUTICAL LIMITED (UNIT-III) VILLAGE: KISHNPURA, BADDI - NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | NASAL SYSTEMIC UNIT DOSE AEROSOLS | I. 1*1*240METERED DOSE BOTTLE | 15/02/2023 |
| 642 | NDA/MAL/HDP/10634 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROFLU-CARE | CAFFEINE + PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE | 30 MG + 500 MG + 10 MG + 2 MG | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*6TABLET BLISTER II. 1*50*4TABLET BLISTER | 15/02/2023 |
| 643 | NDA/MAL/HDP/10636 | UNICHEM LABORATORIES LIMITEDˆŠ | EUROPA HEALTHCARE (U) LTD | UNIPROEX ER 250 | DIVALPROEX SODIUM | 250MG | UNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 644 | NDA/MAL/HDP/10640 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DISTEM | METHOCARBAMOL + PARACETAMOL | 380 MG + 300 MG | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 15/02/2023 |
| 645 | NDA/MAL/HDP/10645 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VINKAMINE | VANCOMYCIN HYDROCHLORIDE | 500MG | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X500.0 MG VIAL | 06/03/2023 |
| 646 | NDA/MAL/HDP/10646 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ENZYSTAL P | PANCREAS POWDER | EQUIVALENT TO AMYLASE ACTIVITY 4200 PH. EUR UNITS, LIPASE ACTIVITY 3500 PH. EUR UNITS AND PROTEASE ACTIVITY 250 PH. EUR UNITS | TORRENT PHARMACEUTICALS LTD , VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI €“ 173205, DIST: SOLAN, HIMACHAL PRADESH, | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| 647 | NDA/MAL/HDP/1065 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SLIPIZEM-5 | DIAZEPAM | 5MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| 648 | NDA/MAL/HDP/10650 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | MEROPENEM FOR INJECTION USP | MEROPENEM TRIHYDRATE | 1G | CSPC OUYI PHARMACEUTICAL CO. LTD., WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 15/02/2023 |
| 649 | NDA/MAL/HDP/10651 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BROZELIN | AMBROXOL HYDROCHLORIDE + SALBUTAMOL + GUAIPHENESIN + MENTHOL | (30 MG + 2 MG + 50 MG + 1 MG)/5 ML | THE MADRAS PHARMACEUTICALS.., NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 06/03/2023 |
| 650 | NDA/MAL/HDP/10652 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | Z-OFLOX 200 | OFLOXACIN | 200MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| 651 | NDA/MAL/HDP/10653 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | COXZOTA-60 | ETORICOXIB | 60MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 652 | NDA/MAL/HDP/10654 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION | SODIUM LACTATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE | 0.320%W/V + 0.600%W/V + 0.040%W/V + 0.027%W/V | ALTHEA PHARMA PRIVATE LIMITED, WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 15/02/2023 |
| 653 | NDA/MAL/HDP/10655 | HETERO LABS LTD | AIVEEN (U) LIMITED | TENOFOVIR ALAFENAMIDE TABLETS | TENOFOVIR ALAFENAMIDE HEMIFUMARATE | 25MG | HETERO LABS LIMITED (UNIT V), SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 15/02/2023 |
| 654 | NDA/MAL/HDP/10658 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATORKEY 40 | ATORVASTATIN CALCIUM TRIHYDRATE | 40 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 15/02/2023 |
| 655 | NDA/MAL/HDP/10660 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | AZITOZ-250 | AZITHROMYCIN DIHYDRATE | 250MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 15/02/2023 |
| 656 | NDA/MAL/HDP/10661 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | LIVOTA-750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| 657 | NDA/MAL/HDP/10662 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | TOMOZA | MOSAPRIDE CITRATE DIHYDRATE | 5MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 658 | NDA/MAL/HDP/10663 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRAMAPA 37.5 MG/325 MG | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5 MG/325 MG | FERRER INTERNATIONAL, S.A, C/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| 659 | NDA/MAL/HDP/10664 | FDC LTD | AIVEEN (U) LIMITED | OCUDORT-T | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | (20 MG + 5 MG)/ML | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| 660 | NDA/MAL/HDP/10665 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CIATUFF 10 | TADALAFIL | 10 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*4TABLET BLISTER | 15/02/2023 |
| 661 | NDA/MAL/HDP/10666 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | VANCOLIN-500 | VANCOMYCIN HYDROCHLORIDE | 500 MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL | 15/02/2023 |
| 662 | NDA/MAL/HDP/10668 | LUPIN LIMITED | AIVEEN (U) LIMITED | DOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMERATE 50MG/300MG/300MG | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | LUPIN LIMITED NAGPUR, PLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 15/02/2023 |
| 663 | NDA/MAL/HDP/1067 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | IBUPARA | IBUPROFEN+PARACETAMOL | 200MG+ 250MG/10ML | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 664 | NDA/MAL/HDP/10672 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | NORSALINE-D | SODIUM CHLORIDE + ANHYDROUS GLUCOSE | 0.9%W/V & 5%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED-SURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 | | INDIA | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1.0X500.0 ML BAG | 15/02/2023 |
| 665 | NDA/MAL/HDP/10675 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | JENTIN 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50 MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 15/02/2023 |
| 666 | NDA/MAL/HDP/10676 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | JENTIN 100 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 100 MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 21/03/2023 |
| 667 | NDA/MAL/HDP/10677 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOCRIPTINE 2.5 MG | BROMOCRIPTINE MESILATE | 2.5 MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 668 | NDA/MAL/HDP/10679 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | PG-75 | PREGABALIN | 75 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 15/02/2023 |
| 669 | NDA/MAL/HDP/10681 | BIODEAL LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | PODOSAL OINTMENT | SALICYLIC ACID + PODOPYLLUM RESIN | 25 %W/W + 20 %W/W | 1. BIODEAL LABORATORIES LIMITED PLOT NO. 123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O. BOX 32040-00600, NAIROBI, KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | TOPICAL EXTERNAL OINTMENTS | I. 1*1*10G TUBE | 15/02/2023 |
| 670 | NDA/MAL/HDP/10686 | HETERO LABS LTD | REDDYS PHARMA LIMITED | CELOFEN 200 | CELECOXIB | 200MG | HETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| 671 | NDA/MAL/HDP/10689 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | LOSARZED-100 | LOSARTAN POTASSIUM | 100 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 672 | NDA/MAL/HDP/1069 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | K-ONE INJECTION | PHYTOMENADIONE | 10MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X1.0 ML AMPOULE | 01/07/2014 |
| 673 | NDA/MAL/HDP/10691 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROGLOPENTIN 400 MG | GABAPENTIN | 400 MG | 1. GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, PLOT 40, 18 STREET, 16TH OCTOBER CITY, GIZA 12581 EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 15/02/2023 |
| 674 | NDA/MAL/HDP/10692 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROGLOPENTIN 300 MG | GABAPENTIN | 300 MG | 1. GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, PLOT 40, 18 STREET, 16TH OCTOBER CITY, GIZA 12581 EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 15/02/2023 |
| 675 | NDA/MAL/HDP/10693 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | GEN DEX EYE DROPS | DEXAMETHASONE SODIUM PHOSPHATE + GENTAMICIN SULFATE | 0.1 %W/V + 0.3 %W/V | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML BOTTLE | 2023-02-15 00:00:00 |
| 676 | NDA/MAL/HDP/10694 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | OTYCULF 500 MG | FLUCYTOSINE | 500MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X100.0 TABLET BOTTLE | 15/02/2023 |
| 677 | NDA/MAL/HDP/10697 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | ASPORELIX | CETRORELIX ACETATE | 0.25MG | BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY I V VIALS | 1.0X0.25 MG VIAL + 1*1ML GLASS AMPOULE OF WFI | 15/02/2023 |
| 678 | NDA/MAL/HDP/10703 | ARCELIA LIFE SCIENCES LTD | MOTI PHARMA (UGANDA) LIMITED | TOPSUNATE | ARTESUNATE | 60 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*60MG VIAL | 15/02/2023 |
| 679 | NDA/MAL/HDP/10704 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EMEFILM-4 | ONDANSETRON HYDROCHLORIDE | 4 MG | SHILPA THERAPEUTICS PVT. LIMITED, PLOT NO. 118, PHASE-III, IDA, CHERLAPALLY, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500016, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X5.0 SACHET CARTON | 21/03/2023 |
| 680 | NDA/MAL/HDP/1071 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-ANGINET 160/25MG | HYDROCHLOROTHIAZIDE + VALSARTAN | 25 MG + 160 MG | 1. UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET STRIP | 01/07/2013 |
| 681 | NDA/MAL/HDP/10714 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | DICLOTRIX PLUS | DICLOFENAC SODIUM + PARACETAMOL | 50MG + 500MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| 682 | NDA/MAL/HDP/10715 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | VILDARIL M 50/500 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 500MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 683 | NDA/MAL/HDP/10716 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | VILDARIL M 50/850 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 850 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 684 | NDA/MAL/HDP/10717 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | VILDARIL M 50/1000 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 685 | NDA/MAL/HDP/10719 | HETERO LABS LTD | REDDYS PHARMA LIMITED | GOAB 5 | SOLIFENACIN SUCCINATE | 5 MG | M/S. ANNORA PHARMA PRIVATE LIMITED-SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 686 | NDA/MAL/HDP/1072 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CO-ANGINET 80/12.5MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD ., 57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 687 | NDA/MAL/HDP/10720 | HETERO LABS LTD | REDDYS PHARMA LIMITED | GOAB 10 | SOLIFENACIN SUCCINATE | 10MG | M/S. ANNORA PHARMA PRIVATE LIMITED-SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 688 | NDA/MAL/HDP/10725 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | BESICOR 2.5 | BISOPROLOL FUMARATE | 2.5MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 689 | NDA/MAL/HDP/10726 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | BESICOR 5 | BISOPROLOL FUMARATE | 5MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 690 | NDA/MAL/HDP/10727 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | BESICOR 10 | BISOPROLOL FUMARATE | 10MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 691 | NDA/MAL/HDP/10729 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BRISCORIL | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | (1MG + 2MG + 50MG ) PER 5ML | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 15/02/2023 |
| 692 | NDA/MAL/HDP/10730 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICHLOR 25 | CHLORTHALIDONE | 25MG | UNICHEM LABORATORIES LIMITED-C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 693 | NDA/MAL/HDP/10731 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICHLOR 50 | CHLORTHALIDONE | 50 MG | UNICHEM LABORATORIES LIMITED-C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 694 | NDA/MAL/HDP/10735 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | CIPLADON PLUS | CAFFEINE + CODEINE PHOSPHATE + DOXYLAMINE SUCCINATE + PARACETAMOL | 30 MG + 10 MG + 5 MG + 450 MG | 1. QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7, RING ROAD, LUZIRA INDUSTRIAL PARK, P.O. BOX 34871, KAMPALA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY TABLETS | I. 1*2*10TABLET BLISTER II. 1*4*10TABLET BLISTER | 15/02/2023 |
| 695 | NDA/MAL/HDP/10736 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNIPROEX ER 500 | DIVALPROEX SODIUM | 500MG | UNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER (ALU-ALU BLISTER),1.0X3.0X10.0 TABLET BLISTER (ACLAR €“ PVC BLISTER) | 15/02/2023 |
| 696 | NDA/MAL/HDP/10737 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | ABACAVIR 600 MG AND LAMIVUDINE 300 MG FILM COATED TABLETS | ABACAVIR SULFATE + LAMIVUDINE | 600MG + 300MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 15/02/2023 |
| 697 | NDA/MAL/HDP/10738 | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD | TATA UGANDA LIMITED | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS | DOLUTEGRAVIR + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD, 1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE, 1.0X1.0X90.0 TABLET BOTTLE | 15/02/2023 |
| 698 | NDA/MAL/HDP/10744 | ZYDUS LIFESCEINCES IMITED | ABACUS PHARMA (AFRICA) LIMITED | TAZILIN | PIPERACILLIN + TAZOBACTAM | 4 G + 0.5 G | ZYDUS HEALTHCARE LIMITED, DAMAN - UNIT 1, SURVEY NO. 48, RINGANWADA VILLAGE, DAMAN (U.T)-396210 - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL | 15/02/2023 |
| 699 | NDA/MAL/HDP/10747 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 400 MG/300 MG/300 MG | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400 MG + 300 MG + 300 MG | HETERO LABS LIMITED (UNIT V), SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 15/02/2023 |
| 700 | NDA/MAL/HDP/10749 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | TENOFOVIR ALAFENAMIDE TABLETS 25 MG | TENOFOVIR ALAFENAMIDE FUMARATE | 25MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 15/02/2023 |
| 701 | NDA/MAL/HDP/10750 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN PLUS | PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE | 500 MG + 15 MG + 10 MG + 2 MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| 702 | NDA/MAL/HDP/10751 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | TYKODAS 50 | DASATINIB | 50 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 703 | NDA/MAL/HDP/10752 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | TYKODAS 70 | DASATINIB | 70 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 704 | NDA/MAL/HDP/10753 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | HISTALIN 8 | BETAHISTINE DIHYDROCHLORIDE | 8 MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 705 | NDA/MAL/HDP/10754 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | HISTALIN 16 | BETAHISTINE DIHYDROCHLORIDE | 16 MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 706 | NDA/MAL/HDP/1076 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | UNICAST 4MG | MONTELUKAST SODIUM | 4MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 707 | NDA/MAL/HDP/10762 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LINEZOLID TABLETS 600 MG | LINEZOLID | 600 MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| 708 | NDA/MAL/HDP/10764 | HOVID BHD | BARIKI EXIM PHARMA LTD | CLOPIVID | CLOPIDOGREL HYDROGEN SULPHATE | 75MG | HOVID BERHAD,, LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 709 | NDA/MAL/HDP/10765 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HEXGABALIN 75 | PREGABALIN | 75 MG | 1. GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, PLOT 40, 18 STREET, 16TH OCTOBER CITY, GIZA 12581 EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 15/02/2023 |
| 710 | NDA/MAL/HDP/10768 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | NEBUNTA 5 | NEBIVOLOL HYDROCHLORIDE | 5 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 711 | NDA/MAL/HDP/10769 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN-500 | AMOXICILLIN TRIHYDRATE | 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 15/02/2023 |
| 712 | NDA/MAL/HDP/10772 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | QOSMET 1000/50 | METFORMIN HYDROCHLORIDE + SITAGLIPTIN PHOSPHATE MONOHYDRATE | 1000 MG + 50 MG | 1. WILSHIRE LABS (PVT) LTD 124/1, QUAID-E-AZAM INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*5TABLET BLISTER | 15/02/2023 |
| 713 | NDA/MAL/HDP/10773 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. | HEALTHCARE LTD. | GESIDOL | TRAMADOL HYDROCHLORIDE | 50 MG | AL FAZAL PHARMA INDUSTRIES (PVT) LTD - PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | I. 1*1*10CAPSULE BLISTER | 15/02/2023 |
| 714 | NDA/MAL/HDP/10776 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | LEEFLOX | LEVOFLOXACIN HEMIHYDRATE | 0.5%W/V | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1), PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| 715 | NDA/MAL/HDP/10777 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | GLUCOTIM 0.5% | TIMOLOL MALEATE | 0.5%W/V | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1), PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 19/04/2023 |
| 716 | NDA/MAL/HDP/1078 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT INFUSION | LEVOFLOXACIN HEMIHYDRATE | 500MG | AHLCON PARENTERALS (INDIA) LTD, SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 717 | NDA/MAL/HDP/10788 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | DIULACTONE 25 MG | SPIRONOLACTONE | 25MG | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 03/05/2023 |
| 718 | NDA/MAL/HDP/1079 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOG-QUININE SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| 719 | NDA/MAL/HDP/10790 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | DIULACTONE 100 MG | SPIRONOLACTONE | 100MG | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| 720 | NDA/MAL/HDP/10791 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | VAPTOR 20MG | ROSUVASTATIN | 20MG | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| 721 | NDA/MAL/HDP/10793 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | NUBIN INJECTION 10MG/ML | NALBUPHINE HYDROCHLORIDE | 10MG/1ML | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 03/05/2023 |
| 722 | NDA/MAL/HDP/10794 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | MORCET 10 MG | ESCITALOPRAM OXALATE | 10MG | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 03/05/2023 |
| 723 | NDA/MAL/HDP/10797 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | APREZO | APREMILAST | 10MG TABLETS CO-PACKED WITH 20MG TABLETS AND 30MG TABLETS | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 19*30MG TABLETS],1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 47*30MG TABLETS] | 25/05/2023 |
| 724 | NDA/MAL/HDP/10798 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 325 MG | STEDMAN PHARMACEUTICALS PVT LTD , C-4 SIDCO PHARMACEUTICAL COMPLEX ALATHUR THIRUPORUR 603 110 TAMILNADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET BLISTER | 25/05/2023 |
| 725 | NDA/MAL/HDP/10799 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | GEFITINIB 250MG TABLETS | GEFITINIB | 250MG | CIPLA LIMITED, GOA (UNIT X)-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147, L-147/1 TO L-147/3, L-138 AND L-147/A, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE, GOA. PIN: 403722 | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| 726 | NDA/MAL/HDP/10801 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS (900 IU + 450 IU)/1.44ML | FOLLITROPIN ALFA + LUTROPIN ALFA | (900 IU + 450 IU)/1.44ML | MERCK SERONO S.P.A,., VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BA | ITALY | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0X1.44 ML PREFILLED PEN + 14 INJECTION NEEDLES | 03/05/2023 |
| 727 | NDA/MAL/HDP/10802 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS (300 IU + 150 IU)/1.44ML | FOLLITROPIN ALFA + LUTROPIN ALFA | (300 IU + 150 IU)/1.44ML | MERCK SERONO S.P.A,., VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BA | ITALY | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0X1.44 ML PREFILLED PEN + 5 INJECTION NEEDLES | 03/05/2023 |
| 728 | NDA/MAL/HDP/10803 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS (450 IU + 225 IU)/0.72 ML | FOLLITROPIN ALFA + LUTROPIN ALFA | (450 IU + 225 IU)/0.72ML | MERCK SERONO S.P.A,., VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BA | ITALY | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0X0.72 ML PREFILLED PEN | 03/05/2023 |
| 729 | NDA/MAL/HDP/10804 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | COLIMEX TABLETS | DICYCLOVERINE HYDROCHLORIDE + PARACETAMOL | 20MG + 500MG | WALLACE PHARMACEUTICALS PVT LTD, BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 26/05/2023 |
| 730 | NDA/MAL/HDP/10805 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BISODAC-HF 5 | BISOPROLOL FUMARATE | 5 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 03/05/2023 |
| 731 | NDA/MAL/HDP/10806 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | LOSARZED-50 | LOSARTAN POTASSIUM | 50MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| 732 | NDA/MAL/HDP/10807 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN PLUS | PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | (250MG + 10MG + 2MG + 5MG) PER 5ML | LINCOLN PHARMACEUTICALS LTD .,., 10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 03/05/2023 |
| 733 | NDA/MAL/HDP/10808 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ROSUNA-10 | ROSUVASTATIN CALCIUM | ROSUNA-10 | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| 734 | NDA/MAL/HDP/10810 | BRAWN LABORATORIES LIMITED | TATA UGANDA LIMITED | BUCLAPOXIME 200 | CEFPODOXIME PROXETIL | 200 MG | 1. BRAWN LABORATORIES LIMITED 13, N.I.T., INDUSTRIAL AREA, FARIDABAD - 12001, HARYANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 03/05/2023 |
| 735 | NDA/MAL/HDP/10811 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | LAMOTRIX 50MG | LAMOTRIGINE | 50 MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| 736 | NDA/MAL/HDP/10812 | MICRO LABS LTD | LABOREX UGANDA LIMITED | URYSOREN-5 | SOLIFENACIN SUCCINATE | 5 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| 737 | NDA/MAL/HDP/10813 | MICRO LABS LTD | LABOREX UGANDA LIMITED | URYSOREN-10 | SOLIFENACIN SUCCINATE | 10 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| 738 | NDA/MAL/HDP/10814 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CAVIT SUSPENSION | MAGNESIUM HYDROXIDE + CALCIUM PHOSPHATE + ELEMENTAL PHOSPHOROUS IN CALCIUM PHOSPHATE + VITAMIN D3 + ZINC GLUCONATE | 75 MG + 300 MG + 150 MG + 200 IU + 4 MG | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*150ML BOTTLE | 03/05/2023 |
| 739 | NDA/MAL/HDP/10816 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AMITRYP-25 | AMITRIPTYLINE HYDROCHLORINE | 25 MG | LINCOLN PHARMACEUTICALS LTD .,., 10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 03/05/2023 |
| 740 | NDA/MAL/HDP/10817 | M/S HETERO LABS LIMITED | REDDYS PHARMA LIMITED | CELOFEN 100 | CELECOXIB | 100 MG | HETERO LABS LIMITED (UNIT III)-VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 | HETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 03/05/2023 |
| 741 | NDA/MAL/HDP/10818 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LINFLOX | OFLOXACIN | 0.3 % W/V | LINCOLN PHARMACEUTICALS LTD .,., 10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARAT | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 03/05/2023 |
| 742 | NDA/MAL/HDP/10819 | LABORATORIO ALDO-UNION, S.L | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NASOALDO | MOMETASONE FUROATE | 50 µG/NASALSPRAY | 1. LABORATORIO ALDO-UNION, S.L CALLE BARONESA DE MALDA 73, 08950 ESPLUGUES DE LLOBREGAT (BARCELONA) - SPAIN SPAIN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SPAIN | NASAL SYSTEMIC UNIT DOSE AEROSOLS | I. 1*20ML BOTTLE | 03/05/2023 |
| 743 | NDA/MAL/HDP/1082 | DAWA LIMITED | SUPER MEDIC LTD | DACOF PAEDIATRIC | DIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL | 75MG + 28.5MG + 0.55MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 744 | NDA/MAL/HDP/10820 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OLOPAT EYE DROPS | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD ., N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 03/05/2023 |
| 745 | NDA/MAL/HDP/10822 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 228.5 | AMOXICILLIN TRIHYDRATE + CLAVULANIC ACID | (200MG + 28.5 MG) PER 5ML | MEDICEF PHARMA, NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 03/05/2023 |
| 746 | NDA/MAL/HDP/10823 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VACODIL 12.5 | CARVEDILOL | 12.5 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 03/05/2023 |
| 747 | NDA/MAL/HDP/10824 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLANGEM OD 5 | OLANZAPINE | 5 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISINTEGRATING TABLETS | I. 1*4*7TABLET BLISTER | 03/05/2023 |
| 748 | NDA/MAL/HDP/10825 | NOVARTIS OVERSEAS INVESTMENT | SURGIPHARM (U) LIMITED | UPERIO 50MG | SACUBITRIL + VALSARTAN | 24.3MG + 25.7MG | NOVARTIS FARMA S.P.A., NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY| NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC, YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | ITALY|TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 03/05/2023 |
| 749 | NDA/MAL/HDP/10826 | NOVARTIS OVERSEAS INVESTMENT | SURGIPHARM (U) LIMITED | UPERIO 100MG | SACUBITRIL + VALSARTAN | 48.6MG +51.4MG | NOVARTIS FARMA S.P.A., NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY| NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC, YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | ITALY| TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 03/05/2023 |
| 750 | NDA/MAL/HDP/10827 | NOVARTIS OVERSEAS INVESTMENT | SURGIPHARM (U) LIMITED | UPERIO 200MG | SACUBITRIL + VALSARTAN | 97.2MG + 102.8MG | NOVARTIS FARMA S.P.A., NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY| NOVARTIS SAGLIK GIDA VE TARIM URUNLERI SAN. VE TIC A.S. - TURKEY. | ITALY|TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 03/05/2023 |
| 751 | NDA/MAL/HDP/10831 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | LASTAVIN 80 | VALSARTAN | 80 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| 752 | NDA/MAL/HDP/10832 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | LASTAVIN 160 | VALSARTAN | 160MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/06/2023 |
| 753 | NDA/MAL/HDP/10833 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | MOLNAFLU | MOLNUPIRAVIR | 200MG | AUROBINDO PHARMA LIMITED, UNIT - XV, PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021| AUROBINDO PHARMA LIMITED UNIT 3, PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X40.0 CAPSULE BOTTLE | 06/06/2023 |
| 754 | NDA/MAL/HDP/10837 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF 300I.U | FOLLITROPIN | 1*1*300 I.U, PRE-FILLED SYRINGE | BHARAT SERUMS AND VACCINES LTD,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST) 421501 | | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X300.0 I.U PRE- FILLED SYRINGE | 06/06/2023 |
| 755 | NDA/MAL/HDP/10838 | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD | TATA UGANDA LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR SODIUM | 50MG | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD, 1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 03/05/2023 |
| 756 | NDA/MAL/HDP/10839 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | ZEEDERM | ZINC OXIDE | 15%W/W | STEDMAN PHARMACEUTICALS PVT. LTD., C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 06/06/2023 |
| 757 | NDA/MAL/HDP/1084 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENIRAMINE MALEATE | 4MG | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 758 | NDA/MAL/HDP/10840 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ THROAT SPRAY | POVIDONE IODINE | 0.45%W/V | STEDMAN PHARMACEUTICALS PVT. LTD., C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X50.0 ML CONTAINER | 06/06/2023 |
| 759 | NDA/MAL/HDP/10841 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DUTABIT PLUS 0.5/0.4 | DUTASTERIDE + TAMSULOSIN HYDROCHLORIDE | 0.5 MG + 0.4 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULE | 1.0X3.0X10.0 CAPSULE BLISTER | 03/05/2023 |
| 760 | NDA/MAL/HDP/10845 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TURBOVAS-20 | ROSUVASTATIN CALCIUM | 20MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/05/2023 |
| 761 | NDA/MAL/HDP/10846 | ZIM LABORATORIES LTD- | REDDYS PHARMA LIMITED | CEFRAZ SUSPENSION | CEFIXIME | 100MG/5ML | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE (AMBER PET BOTTLE) | 25/05/2023 |
| 762 | NDA/MAL/HDP/10847 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | BUDESMA | BUDESONIDE | 200 µG/ACTUATION | 1. GLENMARK PHARMACEUTICAL LIMITED (UNIT-III) VILLAGE: KISHNPURA, BADDI - NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | I. 1*200METERED DOSE CANNISTER | 03/05/2023 |
| 763 | NDA/MAL/HDP/10848 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | MEFENA FORTE-500 | MEFENAMIC ACID | 500MG | AGOG PHARMA LIMITED .-PLOT 33, SECTOR II THE VASAI TALUKA INDUSTIRAL COOP ESTE LTD GAURAIPADA, VASAI (E) DIST. THANE-401208 | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 03/05/2023 |
| 764 | NDA/MAL/HDP/10851 | DEVA HOLDING A.S- | SHREEJI PHARMACEUTICALS LIMITED | LOSAPRES PLUS 50 MG / 12.5 MG | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50 MG + 12.5 MG | DEVA HOLDING A.S (CERKEZKOY PRODUCTION SITE), CERKEZKOY ORGANIZE SANAYI BOLGESI. KARAAGAC MAH. ATATURK CAD. NO: 32 59510 KAPAKLI/TEKIRDAG/TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 03/05/2023 |
| 765 | NDA/MAL/HDP/10852 | INFUGEN PHARMA PVT. | TATA UGANDA LIMITED | INTRAM | TRAMADOL HYDROCHLORIDE | 50MG | FREDUN PHARMACEUTICALS LTD, 14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 03/05/2023 |
| 766 | NDA/MAL/HDP/10853 | SAVA HEALTHCARE LIMITED - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUTIAIR-S 250 | SALMETEROL + FLUTICASONE PROPIONATE | (50 MCG + 250 MCG)/CAPSULE | SAVA HEALTHCARE LIMITED., PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | LUNG ADMINISTRATION INHALER CAPSULES | 1.0X30.0X1.0X250.0 MU CAPSULE, 1.0X30.0X1.0X250.0 MCG CAPSULE | 03/05/2023 |
| 767 | NDA/MAL/HDP/10856 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KEPAM 500MG/5ML | LEVETIRACETAM | 500MG/5ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X10.0X5.0 ML VIAL (CLEAR GLASS VIAL) | 03/05/2023 |
| 768 | NDA/MAL/HDP/1086 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | SYNOGEN TABLETS | DIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE | 50MG +250MG + 750MG | NEM LABORATORIES LIMITED, 133 KRISHNA IND. ESTATE, VASAI (E), THANE €“ 401 210, MAHARASHTRA €“ INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 769 | NDA/MAL/HDP/10860 | ASPIRO PHARMA LIMITED | AIVEEN (U) LIMITED | YESOM 40 | ESOMEPRAZOLE SODIUM | 40 MG | 1. M/S ASPIRO PHARMA LIMITED PLOT NO. 23, SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA (VILLAGE), MARKOOK MANDAL, SIDDIPET DI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*5ML VIAL | 03/05/2023 |
| 770 | NDA/MAL/HDP/10875 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BLACIDEC 5 | SOLIFENACIN SUCCINATE | 5 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| 771 | NDA/MAL/HDP/10876 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BLACIDEC 10 | SOLIFENACIN SUCCINATE | 10MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| 772 | NDA/MAL/HDP/10877 | SEGURA PHARMA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RABEGUARD IV | RABEPRAZOLE SODIUM | 20 MG/VIAL | RATNATRIS PHARMACEUTICALS PRIVATE LIMITED - SURVEY NO. 416, AT. - INDRAD, TA. - KADI, DIST. - MEHSANA, PIN. 382715 GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 MG VIAL + 1*10 ML WATER FOR INJECTION IN LDPE CONTAINER | 05/09/2023 |
| 773 | NDA/MAL/HDP/10878 | LUPIN LIMITED- | AIVEEN (U) LIMITED | LINEZOID 600 MG TABLETS | LINEZOLID | 600MG | LUPIN LTD, 198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| 774 | NDA/MAL/HDP/10879 | LUPIN LIMITED- | AIVEEN (U) LIMITED | ISONIAZID TABLETS 300MG | ISONIAZID | 300MG | LUPIN LIMITED , A-28/1 MIDC CHIKALTHANA AURANGABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| 775 | NDA/MAL/HDP/10882 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF 1200 IU | RECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH) | 1200IU/VIAL (MULTIDOSE) | BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY DRY AMPOULES | 1.0X1.0 AMPOULE AMPOULE 1 PREFILLED SYRINGE OF DILUENT + 15 DISPOSABLE SYRINGES] | 17/08/2023 |
| 776 | NDA/MAL/HDP/10883 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SYNTREXA | DAPAGLIFLOZIN PROPANEDIOL | 10MG | CIPLA LIMITED, PLOT NOS. L-139, S-103 & M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA, 403 722 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 17/08/2023 |
| 777 | NDA/MAL/HDP/10885 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | NEBIMAC 10 | NEBIVOLOL HYDROCHLORIDE | 10MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK €“N1), BLOCK N1, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, HIMACHAL PRADESH -174101, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 17/08/2023 |
| 778 | NDA/MAL/HDP/10887 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | OMLINK | OMEPRAZOLE | 40 MG/VIAL | LINCOLN PHARMACEUTICALS LIMITED-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X10.0 ML VIAL + 1*10ML WATER FOR INJECTION IN LDPE AMPOULE | 17/08/2023 |
| 779 | NDA/MAL/HDP/10890 | M/S HETERO LABS LIMITED | REDDYS PHARMA LIMITED | ZIQUANTA | PRAZIQUANTEL | 600MG | HETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 17/08/2023 |
| 780 | NDA/MAL/HDP/10891 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | BINAFIN | TERBINAFINE HYDROCHLORIDE | 1%W/W | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 17/08/2023 |
| 781 | NDA/MAL/HDP/10894 | REYOUNG PHARMACEUTICAL CO LTD | BIOGEN PHARMA LIMITED | FRUSOGEN | FUROSEMIDE | 20MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 17/08/2023 |
| 782 | NDA/MAL/HDP/10896 | REYOUNG PHARMACEUTICAL CO LTD | BIOGEN PHARMA LIMITED | AMPIGEN | AMPICILLIN SODIUM + CLOXACILLIN SODIUM | (250MG + 250MG)VIAL | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X0.5 G VIAL | 17/08/2023 |
| 783 | NDA/MAL/HDP/10900 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TRAMADOL DENK | TRAMADOL HYDROCHLORIDE | 100MG/2 ML | SOLUPHARM GMBH , INDUSTRIESTRASSE 3, 34212 MELSUNGEN | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE | 17/08/2023 |
| 784 | NDA/MAL/HDP/10905 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | VERQUVO 2.5 MG TABLET | VERICIGUAT | 2.5MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER | 28/08/2023 |
| 785 | NDA/MAL/HDP/10906 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | VERQUVO 5MG TABLET | VERICIGUAT | 5MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER | 28/08/2023 |
| 786 | NDA/MAL/HDP/10907 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | VERQUVO 10 MG TABLET | VERICIGUAT | 10MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER | 28/08/2023 |
| 787 | NDA/MAL/HDP/10918 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | ESUPRONE | ESOMEPRAZOLE SODIUM | 40 MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL + 1*10 ML, SODIUM CHLORIDE IN LDPE PACK | 17/08/2023 |
| 788 | NDA/MAL/HDP/10922 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LABCLAV 1G TABLETS | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 875MG + 125MG | LABORATORY & ALLIED LTD -PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| 789 | NDA/MAL/HDP/10924 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | METOPRIX 10 | METOCLOPRAMIDE | 10 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| 790 | NDA/MAL/HDP/10926 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACELEVO 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| 791 | NDA/MAL/HDP/10927 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACELEVO 750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| 792 | NDA/MAL/HDP/10928 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | FIX-A | CEFIXIME TRIHYDRATE | 100MG/5ML | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X75.0 ML BOTTLE | 17/08/2023 |
| 793 | NDA/MAL/HDP/10931 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNIDROL 10 | ALFUZOSIN HYDROCHLORIDE | 10 MG | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| 794 | NDA/MAL/HDP/10933 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 20 MG + 160 MG | BLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X2.0X3.0 TABLET BLISTER, 1.0X10.0X2.0X3.0 TABLET BLISTER, 1.0X10.0X1.0X3.0 TABLET BLISTER | 17/08/2023 |
| 795 | NDA/MAL/HDP/10934 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | ALERCON | OLOPATADINE HYDROCHLORIDE | 1 MG/ML | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 17/08/2023 |
| 796 | NDA/MAL/HDP/10935 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | SUPERPIME 1G IM/IV INJECTION | CEFEPIME HYDROCHLORIDE | 1 G/VIAL | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 17/08/2023 |
| 797 | NDA/MAL/HDP/10936 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | TEARLIN-0.5 % | CARMELLOSE SODIUM | 0.5% W/V | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 17/08/2023 |
| 798 | NDA/MAL/HDP/10937 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | TEARLIN-1 % | CARMELLOSE SODIUM | 1.0% W/V | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 17/08/2023 |
| 799 | NDA/MAL/HDP/1094 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-100 | CEFIXIME | 100MG/5ML | MICRO LABS LTD-, NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 800 | NDA/MAL/HDP/10940 | BRAWN LABORATORIES LTD | PLANET PHARMACEUTICALS UGANDA LTD | MASTIC-LC | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10MG + 5MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| 801 | NDA/MAL/HDP/10941 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | ENCORATE CHRONO 200 | SODIUM VALPROATE + VALPROIC ACID | 133.2 MG + 58 MG | SUN PHARMA LABORATORIES LIMITED, 6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 17/08/2023 |
| 802 | NDA/MAL/HDP/10948 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | FLUCOLD | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE | 500 MG + 10 MG + 2 MG | WALLACE PHARMACEUTICALS PVT LTD, BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| 803 | NDA/MAL/HDP/10949 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | CLAMOXIN-375 TABLETS | AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE | 250MG + 125 MG | MEDOPHARM PVT LIMITED, NO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 17/08/2023 |
| 804 | NDA/MAL/HDP/1095 | MICRO LABS LTD | LABOREX UGANDA LIMITED | EROSTINE-20 | EBASTINE | 20MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2012 |
| 805 | NDA/MAL/HDP/10950 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | DICORATE ER 500 | DIVALPROEX SODIUM | 500 MG | SUN PHARMA LABORATORIES LIMITED, 6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIA | INDIA | ORAL SOLID RETARD COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 17/08/2023 |
| 806 | NDA/MAL/HDP/10951 | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC PLUS | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300 MG + 25 MG | 1. UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 17/08/2023 |
| 807 | NDA/MAL/HDP/10953 | KOPRAN LIMITED | TATA UGANDA LIMITED | LOKIT HP | CLARITHROMYCIN + TINIDAZOLE + OMEPRAZOLE | 250 MG + 500 MG + 20 MG | KOPRAN LIMITED, VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY COMBINATION PACK COATED TABLETS | 1.0X7.0X1.0X1.0X6.0 TABLET STRIP (EACH STRIP CONTAINS 2 TABLETS OF CLARITHROMYCIN + 2 TABLETS OF TINIDAZOLE + 2 CAPSULES OF OMEPRAZOLE) | 17/08/2023 |
| 808 | NDA/MAL/HDP/1096 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ARTEMETHER | ARTEMETHER | 80 MG/ML | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*8*1ML AMPOULE III. 1*6*1ML AMPOULE | 05/07/2014 |
| 809 | NDA/MAL/HDP/10960 | AXA PARENTERALS LTD | VITACARE LIMITED | AXADEX D5 | GLUCOSE ANHYDROUS | 5% W/V | AXA PARENTERALS LTD, KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 17/08/2023 |
| 810 | NDA/MAL/HDP/10962 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | DARUNAVIR/RITONAVIR TABLETS 400 MG/50 MG | DARUNAVIR ETHANOLATE + RITONAVIR | 400 MG + 50 MG | MYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 17/08/2023 |
| 811 | NDA/MAL/HDP/10964 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AZIREN | AZITHROMYCIN DIHYDRATE | 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 17/08/2023 |
| 812 | NDA/MAL/HDP/10965 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | MPHETAS-500 | MYCOPHENOLATE MOFETIL | 500MG | INTAS PHARMACEUTICALS LTD .., PLOT NO. 457-458 VILL MATODA BAVLA ROAD TA SANAND DIST AHMEDABAD PIN-382 210 GUJARART STATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| 813 | NDA/MAL/HDP/10969 | FDC LTD | AIVEEN (U) LIMITED | VITCOFOL | FERROUS FUMARATE + FOLIC ACID + CYANOCOBALAMIN | (100MG + 0.5MG + 5MCG)/5ML | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 17/08/2023 |
| 814 | NDA/MAL/HDP/10973 | SWISS PARENTERALS LTD. | SHREEJI PHARMACEUTICALS LIMITED | ADRENALINE INJECTION BP 1MG/ML 1ML | ADRENALINE ACID TARTRATE | 1MG/ML | SWISS PARENTERALS LIMITED (UNIT-1), 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 17/08/2023 |
| 815 | NDA/MAL/HDP/10975 | VERVE HUMAN CARE LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | BUPIVER-H | BUPIVACAINE HYDROCHLORIDE | 5 MG/ML | 1. VERVE HUMAN CARE LABORATORIES PLOT NO. 15-A, PHARMA CITY, SELAQUI, DEHRADUN - 248011 (UTTARAKHAND), INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*5*4ML AMPOULE | 17/08/2023 |
| 816 | NDA/MAL/HDP/10977 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | FIRIALTA® | FINERENONE | 10MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 28/08/2023 |
| 817 | NDA/MAL/HDP/10979 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | FIRIALTA® | FINERENONE | 20MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 28/08/2023 |
| 818 | NDA/MAL/HDP/10980 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEFENEC PLUS | MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE | 250 MG + 20 MG | RAVIAN LIFE SCIENCE PVT. LIMITED, PLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHAND | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| 819 | NDA/MAL/HDP/10985 | APEX LABORATORIES PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | ZINCOVIT DROPS | VITAMIN A (AS PALMITATE) + RRR -ALPHA-TOCOPHERYL ACETATE + COLECALCIFEROL + THIAMINE HYDROCHLORIDE + RIBOFLAVIN SODIUM PHOSPHATE + PYRIDOXINE HYDROCHLORIDE + ASCORBIC ACID + DEXPANTHENOL + NICOTINAMIDE + ZINC SULFATE HEPTAHYDRATE + LYSINE HYDROCHLORIDE | (2500.00 IU + 2.50 MG + 200.00 IU + 1.00 MG + 1.00 MG + 0.50 MG + 40.00 MG + 1.00 MG + 10.00 MG + 13.30 MG + 10.00 MG)ML | APEX LABORATORIES PRIVATE LIMITED (PLANT III), 510 KUNNAM VILLAGE AND POST, THENNERI (VIA) SRIPERUMBUDUR TK KANCHEEPRURAM DISTRICT, PIN CODE: 631 604, TAMIL NADU | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X1.0X5.0 ML BOTTLE (AMBER GLASS BOTTLE) | 17/08/2023 |
| 820 | NDA/MAL/HDP/10986 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | JENTIN MET | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 17/08/2023 |
| 821 | NDA/MAL/HDP/10987 | LUPIN LIMITED- | AIVEEN (U) LIMITED | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG AND 300 MG | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300 MG + 300 MG | LUPIN LTD, PLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 17/08/2023 |
| 822 | NDA/MAL/HDP/10989 | M/S HETERO LABS LIMITED | REDDYS PHARMA LIMITED | BINFIN 5 | FINASTERIDE | 5MG | HETERO LABS LIMITED (UNIT III)...-22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 17/08/2023 |
| 823 | NDA/MAL/HDP/1099 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | MOMATE F CREAM | FUSIDIC ACID+MOMETASONE FUROATE | 2.1%W/W + 0.1W/W | GLENMARK PHARMACEUTICALS LTD UNIT II., UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2012 |
| 824 | NDA/MAL/HDP/10990 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BISODAC-HF 10 | BISOPROLOL FUMARATE | 10 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 17/08/2023 |
| 825 | NDA/MAL/HDP/10991 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | IXAROLA 10 FILM-COATED TABLETS | RIVAROXABAN | 10MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 28/08/2023 |
| 826 | NDA/MAL/HDP/10992 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | IXAROLA 20 FILM-COATED TABLETS | RIVAROXABAN | 20MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 28/08/2023 |
| 827 | NDA/MAL/HDP/10993 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | IXAROLA 15 FILM-COATED TABLETS | RIVAROXABAN | 15MG | BAYER PHARMA AG, 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 28/08/2023 |
| 828 | NDA/MAL/HDP/10998 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | MOCIN | MOXIFLOXACIN HYDROCHLORIDE | 400MG/100ML | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGA | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 17/08/2023 |
| 829 | NDA/MAL/HDP/1100 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIR SKIN CREAM | ACICLOVIR | 5% W/W | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X5.0 G TUBE | 01/07/2013 |
| 830 | NDA/MAL/HDP/11002 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | MICONA VAGINAL CREAM | MICONAZOLE NITRATE | 2%W/W | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 2), PLOT NO 39-41TIVIM INDUSTRIAL ESTATE, KARASWADA - MAPUSA, GOA-403526 | INDIA | VAGINAL CREAMS | 1.0X1.0X40.0 G TUBE | 29/08/2023 |
| 831 | NDA/MAL/HDP/11004 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | FAST 125 | PARACETAMOL | 125MG | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 17/08/2023 |
| 832 | NDA/MAL/HDP/11008 | ZYDUS LIFESCIENCES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FORAIR 250 INHALER | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG/ACTUATION+ 250MCG/ ACTUATION | ZYDUS LIFESCIENCES LIMITED, SURVEY NO. 417, 419 & 420, SARKHEJ - BAVLA NATIONAL HIGHWAY NO. 8A, VILLAGE - MORAIYA, TALUKA - SANAND, DIST. AHMEDABAD - 382 210, GUJARAT STATE - INDIA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1X120 METERED DOSE CANNISTER, | 25/08/2023 |
| 833 | NDA/MAL/HDP/11009 | ZYDUS LIFESCIENCES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FORAIR 125 | SALMETEROL/ FLUTICASONE PROPIONATE | 25MCG/ 125MCG PER ACTUATION | ZYDUS LIFESCIENCES LIMITED, SURVEY NO. 417, 419 & 420, SARKHEJ - BAVLA NATIONAL HIGHWAY NO. 8A, VILLAGE - MORAIYA, TALUKA - SANAND, DIST. AHMEDABAD - 382 210, GUJARAT STATE - INDIA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1X1 CANNISTER CARTON, | 25/08/2023 |
| 834 | NDA/MAL/HDP/11022 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CEFIXIME QUIX DISPERSIBLE TABLETS 200MG | CEFIXIME TRIHYDRATE | 200 MG | 1. M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*1*10TABLET BLISTER II. 1*10*10TABLET BLISTER | 13/12/2023 |
| 835 | NDA/MAL/HDP/11024 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LTD | CLONAPIN-2 | CLONAZEPAM | 2 MG | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 836 | NDA/MAL/HDP/11025 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | DYGYL | METRONIDAZOLE BENZOATE | 125MG/5ML | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 12/13/2023 |
| 837 | NDA/MAL/HDP/11026 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LTD | TELMISIN | TELMISARTAN | 40 MG | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 838 | NDA/MAL/HDP/11028 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | APLENE 50 | PREGABALIN | 50MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 839 | NDA/MAL/HDP/11029 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | APLENE 75 | PREGABALIN | 75MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 840 | NDA/MAL/HDP/1103 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIN CREAM | NEOMYCIN SULFATE | 0.5 %W/W | 1. AGOG PHARMA LIMITED PLOT NO. 33, SECTOR - II, THE VASAI TALUKA INDL. CO-OP. ESTATE LIMITED, GAURAIPADA, VASAI ‚¬ DIST - INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 01/07/2014 |
| 841 | NDA/MAL/HDP/11030 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | APLENE 150 | PREGABALIN | 150MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 842 | NDA/MAL/HDP/11031 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | NIZACARD 500 | RANOLAZINE | 500 MG | 1. M/S HETERO LABS LIMITED, UNIT III SURVEY NO.:51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA JEEDIMETLA, HYDERABAD DISTRICT, 500055, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID RETARD TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 843 | NDA/MAL/HDP/11033 | KESAR PHARMA | JEET PHARMACEUTICALS LIMITED | FLUPLEX | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE ANHYDROUS | 500MG + 10MG + 2MG + 30MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET STRIP | 12/13/2023 |
| 844 | NDA/MAL/HDP/11036 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | DROCELIA | DROTAVERINE HYDROCHLORIDE | 40 MG/2ML | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*5*2ML AMPOULE | 13/12/2023 |
| 845 | NDA/MAL/HDP/11038 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DELOHIST 5 | DESLORATADINE | 5 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 846 | NDA/MAL/HDP/1104 | HOVID BHD | BARIKI EXIM PHARMA LTD | LIPIDUCE 10 | ATORVASTATIN CALCIUM | 10MG | 1. HOVID BERHAD LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR, 31200 CHEMOR - MALAYSIA MALAYSIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MALAYSIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*3TABLET BLISTER | 04/07/2014 |
| 847 | NDA/MAL/HDP/11041 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | ROMYCIN | AZITHROMYCIN DIHYDRATE | 500 MG | 1. M/S NABIQASIM INDUSTRIES PRIVATE LIMITED 17/24, KORANGI INDUSTRIAL AREA, KORANGI, KARACHI - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*3TABLET BLISTER | 13/12/2023 |
| 848 | NDA/MAL/HDP/11043 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | DIAZAC 5 | DAPAGLIFLOZIN | 5MG | 1. AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 849 | NDA/MAL/HDP/11044 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | DIAZAC 10 | DAPAGLIFLOZIN | 10MG | 1. AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 850 | NDA/MAL/HDP/11045 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MYELOPAST 25 | LENALIDOMIDE | 25MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X21.0 CAPSULE CONTAINER | 12/13/2023 |
| 851 | NDA/MAL/HDP/11046 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MYELOPAST 10 | LENALIDOMIDE | 10MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X28.0 CAPSULE CONTAINER | 12/13/2023 |
| 852 | NDA/MAL/HDP/11047 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | MURAXAL -10 | ALFUZOSIN HYDROCHLORIDE | 10 MG | 1. MICRO LABS LIMITED NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126, TAMIL NADU - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID RETARD TABLETS | I. 1*1*10TABLET BLISTER | 13/12/2023 |
| 853 | NDA/MAL/HDP/11048 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | APRETUDE 600 MG | CABOTEGRAVIR | 200 MG/ML | 1. GLAXO OPERATIONS UK LIMITED HARMIRE ROAD, BARNARD CASTLE, DURHAM, DL 12 DT UNITED KINGDOM ENGLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UNITED KINGDOM | PARENTERAL ORDINARY VIALS | I. 1*1*3ML VIAL II. 1*25*3ML VIAL III. 1*5*3ML VIAL | 13/12/2023 |
| 854 | NDA/MAL/HDP/11050 | SURGE LABORATORIES (PVT) LTD, | HEALTHCARE LTD. | SERGIFEX 1G | CEFTRIAXONE SODIUM | 1 G | 1. SURGE LABORATORIES PRIVATE LIMITED 10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | I. 1*1G VIAL | 13/12/2023 |
| 855 | NDA/MAL/HDP/11051 | SURGE LABORATORIES (PVT) LTD, | HEALTHCARE LTD. | SERGIFEX 2G | CEFTRIAXONE SODIUM | 2 G | 1. SURGE LABORATORIES PRIVATE LIMITED 10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | I. 1*2G VIAL | 13/12/2023 |
| 856 | NDA/MAL/HDP/11052 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ACESON-SP | ACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE | 100 MG + 325 MG + 15 MG | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 13/12/2023 |
| 857 | NDA/MAL/HDP/11053 | ABACUS PARENTERAL DRUGS LIMITED (APDL) | ABACUS PARENTERAL DRUGS LIMITED | OLODINE | OLOPATADINE HYDROCHLORIDE | 0.1 %W/V | 1. ABACUS PARENTERAL DRUGS LIMITED (APDL) BLOCK 191, PLOT NO.114, KINGA MUKONO, P.O. BOX 31376, KAMPALA UGANDA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML CONTAINER | 13/12/2023 |
| 858 | NDA/MAL/HDP/11054 | ABACUS PARENTERAL DRUGS LIMITED (APDL) | ABACUS PARENTERAL DRUGS LIMITED | TORA | TOBRAMYCIN SULFATE | 0.3 %W/V | 1. ABACUS PARENTERAL DRUGS LIMITED (APDL) BLOCK 191, PLOT NO.114, KINGA MUKONO, P.O. BOX 31376, KAMPALA UGANDA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML CONTAINER | 13/12/2023 |
| 859 | NDA/MAL/HDP/11055 | ABACUS PARENTERAL DRUGS LIMITED (APDL) | ABACUS PARENTERAL DRUGS LIMITED | TORA-D | TOBRAMYCIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.3 %W/V + 0.1 %W/V | 1. ABACUS PARENTERAL DRUGS LIMITED (APDL) BLOCK 191, PLOT NO.114, KINGA MUKONO, P.O. BOX 31376, KAMPALA UGANDA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | OPHTHALMIC DROPS | I. 1*1*5ML CONTAINER | 13/12/2023 |
| 860 | NDA/MAL/HDP/11056 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | VOLDIC ® 1% EMULGEL | DICLOFENAC DIETHYLAMINE | 1%W/W | PHARMA INTERNATIONAL COMPANY ,., AL-QASTAL AREA, AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA, 11941, AMMAN - JORDAN | JORDAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 12/13/2023 |
| 861 | NDA/MAL/HDP/1106 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS | DIACEREIN | DIACEREIN | 50MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER, 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 862 | NDA/MAL/HDP/11063 | PHARMA BAVARIA INTERNACIONAL(PBI) PORTUGUAL | GOODMAN INTERNATIONAL LTD | COMBOFUSIV | PARACETAMOL + IBUPROFEN | 10MG/ML + 3MG/ML | S.M. FARMACEUTICI S.R.L, ZONA INDUSTRIALE, 85050 TITO (PZ) | ITALY | PARENTERAL ORDINARY VIALS | 1.0X10.0X100.0 ML VIAL | 12/13/2023 |
| 863 | NDA/MAL/HDP/11065 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | AROX | MOXIFLOXACIN HYDROCHLORIDE | 0.5 %W/V | 1. JAMJOOM PHARMACEUTICALS COMPANY PLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SAUDI ARABIA | OPHTHALMIC DROPS | I. 1*1*5ML BOTTLE | 13/12/2023 |
| 864 | NDA/MAL/HDP/11066 | MACARTHYS LABORATORIES T/A MARTINDALE PHARMA | LABOREX UGANDA LIMITED | COLISTIMETHATE SODIUM 1 MIU | COLISTIMETHATE SODIUM | 1 MIU/VIAL | 1. ALTAN PHARMACEUTICALS S.A. AVDA. DE LA CONSTITUCION 198 - 199, POLIGONO INDUSTRIAL MONTE BOYAL, CASARRUBIOS DE MONTE, 45950 TOL SPAIN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SPAIN | PARENTERAL ORDINARY DRY VIALS | I. 1*10*1MU VIAL | 13/12/2023 |
| 865 | NDA/MAL/HDP/11067 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVAUR 250 | LEVETIRACETAM | 250MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 866 | NDA/MAL/HDP/11068 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVAUR 500 | LEVETIRACETAM | 500MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 867 | NDA/MAL/HDP/11069 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVAUR 1000 | LEVETIRACETAM | 1000MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 868 | NDA/MAL/HDP/1107 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | HEPATITIS B VACCINE(RDNA) (PAEDIATRIC)) | HEPATITIS B VACCINE (RDNA) | 10 µG/0.5ML | 1. SERUM INSTITUTE OF INDAI PVT. LTD. (SIIPL) 212/2 HADAPSAR PUNE 411028 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY I M VIALS | I. 1*10*0.5 ML VIAL II. 1*25*5ML VIAL | 01/07/2005 |
| 869 | NDA/MAL/HDP/11070 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JITRIT-5 | TOFACITINIB CITRATE | 5 MG | 1. MICRO LABS LIMITED NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126, TAMIL NADU - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*4*15TABLET BLISTER | 13/12/2023 |
| 870 | NDA/MAL/HDP/11073 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PARACO-DENK 500/30 | PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE | 500 MG + 30 MG | 1. BENE-ARZNEIMITTEL GMBH HERTERTICHSTR. 1-3, 81479 MUNCHEN - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | GERMANY | ORAL SOLID ORDINARY TABLETS | I. 1*2*10TABLET BLISTER | 13/12/2023 |
| 871 | NDA/MAL/HDP/11076 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELPMENT CO., LTD | TRIDEM PHARMA UGANDA LIMITED | G-COSPE® | PYRIMETHAMINE | 25 MG | 1. GUILIN PHARMACEUTICAL COMPANY LIMITED NO. 43, QILIDIAN ROAD, GUILIN 541004, GUANGXI P.R. OF CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | ORAL SOLID ORDINARY TABLETS | I. 1*100*3TABLET BLISTER II. 1*50*3TABLET BLISTER | 13/12/2023 |
| 872 | NDA/MAL/HDP/11079 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | MIRAFOLIC | FOLIC ACID | 5MG | MEDOPHARM, NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 02/02/2024 |
| 873 | NDA/MAL/HDP/11081 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUROXIM | CEFUROXIME SODIUM | 750MG | ZEISS PHARMACEUTICALS PRIVATE LIMITED, PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X750.0 MG VIAL | 02/02/2024 |
| 874 | NDA/MAL/HDP/11082 | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC PLUS | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150 MG + 12.5 MG | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY, AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 875 | NDA/MAL/HDP/11084 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | INVEL FORTE L | METRONIDAZOLE + MICONAZOLE NITRATE + LIDOCAINE | 750 MG + 200 MG + 100 MG | BLISS GVS PHARMA LTD, PLOT NO. 11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI, PALGHAR, MAHARASHTRA 401404, INDIA | INDIA | VAGINAL SUPPOSITORIES | 1.0X2.0X7.0 SUPPOSITORY STRIP | 02/02/2024 |
| 876 | NDA/MAL/HDP/11085 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMITINO INJECTION | ONDANSETRON HYDROCHLORIDE | 4MG/2ML | SAKAR HEALTHCARE PVT LTD, BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULE | 02/02/2024 |
| 877 | NDA/MAL/HDP/1109 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENAMINE MALEATE | 2 MG/5ML | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL LIQUID ORDINARY SYRUPS | I. 1*60ML BOTTLE | 01/07/2014 |
| 878 | NDA/MAL/HDP/11093 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XERATEC | IRON SUCROSE | 100MG | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X5.0 ML VIAL | 02/02/2024 |
| 879 | NDA/MAL/HDP/11094 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FETNAL 500 | CEFUROXIME AXETIL | 500MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 02/02/2024 |
| 880 | NDA/MAL/HDP/11098 | VERVE HUMAN CARE LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | ADEVER | ADRENALINE ACID TARTRATE | 1MG/ML | VERVE HUMAN CARE LABORATORIES, PLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 02/02/2024 |
| 881 | NDA/MAL/HDP/11102 | ENCORE HEALTHCARE PVT. LTD. | REDDYS PHARMA LIMITED | ONTADEX 50MG | TRAMADOL HYDROCHLORIDE | 50MG | ENCORE HEALTHCARE PVT LTD, D-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 02/02/2024 |
| 882 | NDA/MAL/HDP/11103 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LOXIBS 50 | LOSARTAN POTASSIUM | 50MG | CACHET PHARMACEUTICAL PVT LTD., VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 883 | NDA/MAL/HDP/11104 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ROSUCACH 10 | ROSUVASTATIN CALCIUM | 10MG | CACHET PHARMACEUTICAL PVT LTD., VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 884 | NDA/MAL/HDP/11105 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. | HEALTHCARE LTD. | TELOSIN | TAMSULOSIN HYDROCHLORIDE | 0.4MG | AL FAZAL PHARMA INDUSTRIES (PVT) LTD, PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 02/02/2024 |
| 885 | NDA/MAL/HDP/11112 | HOVID BHD | BARIKI EXIM PHARMA LTD | BETASONE | BETAMETHASONE VALERATE | 0.1%W/W | HOVID BERHAD (IPOH SITE), 121, JALAN TUNKU ABDUL RAHMAN 30010 IPOH PERAK | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 02/02/2024 |
| 886 | NDA/MAL/HDP/11113 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ATRONA-20 | ATORVASTATIN CALCIUM | 20MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 887 | NDA/MAL/HDP/11114 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA(A) LTD | APTIN M 50/500 F/C TABLET | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 888 | NDA/MAL/HDP/11115 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA(A) LTD | SITOMET 50/500 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 889 | NDA/MAL/HDP/11116 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA(A) LTD | SITOMET 50/1000 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 890 | NDA/MAL/HDP/11117 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | FAST 250 SUPPOSITORY | PARACETAMOL | 250MG | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 02/02/2024 |
| 891 | NDA/MAL/HDP/11118 | LUPIN LIMITED- | AIVEEN (U) LIMITED | MOXIFLOXACIN | MOXIFLOXACIN HYDROCHLORIDE | 400 MG | LUPIN LIMITED, UNIT-2, PLOT NO. M-2 & M-2-A, SPECIAL ECONOMIC ZONE, PHASE II, MISC. ZONE, APPAREL PARK, DIST. DHAR - M.P. PITHAMPUR, 454775, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/02/2024 |
| 892 | NDA/MAL/HDP/1113 | MACK BROWN PHARMACEUTICALS PRIVATE LIMITED | SHURIK LTD | ALCID-YELLOW | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETICONE | 400 MG + 400 MG + 50 MG | 1. TORQUE PHARMACEUTICALS PRIVATE LIMITED - UNIT 1 (DAPPAR) ISSAPUR VILLAGE, POST: DAPPAR, MOHALI DISTRICT, PUNJAB 140506 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*160ML BOTTLE II. 1*400ML BOTTLE | 1997-07-01 00:00:00 |
| 893 | NDA/MAL/HDP/11131 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | DABIFIB 75 | DABIGATRAN ETEXILATE | 75 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 894 | NDA/MAL/HDP/11132 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | SELTAVIR 30 | OSELTAMIVIR PHOSPHATE | 30MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 895 | NDA/MAL/HDP/11133 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | SELTAVIR 45 | OSELTAMIVIR PHOSPHATE | 45MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 896 | NDA/MAL/HDP/11134 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | SELTAVIR 75 | OSELTAMIVIR PHOSPHATE | 75 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| 897 | NDA/MAL/HDP/11136 | KESAR PHARMA | ABACUS PHARMA (AFRICA) LIMITED | WOMTRA TABLETS | ALBENDAZOLE | 400 MG | 1. KESAR PHARMA PRIVATE LIMITED PLOT SURVEY NO. 50/2, VILLAGE BILESHWARPURA, PO. CHHATRAL - 382729, TAL: KALOL, DIST. GANDHINAGAR, G INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | I. 1*1*1TABLET BLISTER | 13/12/2023 |
| 898 | NDA/MAL/HDP/11137 | HETERO LABS LIMITED | AIVEEN (U) LIMITED | DARUNIVIR AND RITONIVIR TABLETS | DARUNAVIR ETHANOLATE + RITONAVIR | 800 MG + 100 MG | 1. M/S HETERO LABS LIMITED, UNIT III SURVEY NO.:51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA JEEDIMETLA, HYDERABAD DISTRICT, 500055, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*180TABLET CONTAINER II. 1*60TABLET CONTAINER | 13/12/2023 |
| 899 | NDA/MAL/HDP/11139 | LAURUS LABS LIMITED | BEYOND LOGISTICS LTD | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS | EMTRICITABINE | 200 MG | 1. LAURUS LABS LIMITED (UNIT II) PLOT NO. 19, 20 & 21, WESTERN SECTOR, APSEZ, GURAJAPALEM VILLAGE, RAMBILLI MANDAL, ANAKAPALLI DISTRI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*30TABLET BOTTLE II. 1*90TABLET BOTTLE | 13/12/2023 |
| 900 | NDA/MAL/HDP/1114 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TRANGEL ULTRA | DICLOFENAC + MENTHOL + METHYL SALICYLATE | 10 MG + 60 MG + 80 MG | 1. NEM LABORATORIES PRIVATE LIMITED 133 KRISHNA INDUSTRIES ESTATE, VASAI , PALGHAR - 401210, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAM | I. 1*20G CONTAINER | 01/07/2012 |
| 901 | NDA/MAL/HDP/11142 | PSYCHOTROPICS INDIA LTD- | BIOGEN PHARMA LIMITED | CEFTRIONE-1 | CEFTRIAXONE SODIUM | 1G/VIAL | REYOUNG PHARMACEUTICAL COMPANY LIMITED-NUMBER 1, RUIYANG ROAD, YIYUAN COUNTY, SHANGDONG, PROVINCE P.R, CHINA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 12/13/2023 |
| 902 | NDA/MAL/HDP/11144 | QUALITY CHEMICAL INDUSTRIES LIMITED | QUALITY CHEMICAL INDUSTRIES LIMITED | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400 MG + 300 MG + 300 MG | 1. QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7, RING ROAD, LUZIRA INDUSTRIAL PARK, P.O. BOX 34871, KAMPALA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*30TABLET BOTTLE II. 1*90TABLET BOTTLE | 13/12/2023 |
| 903 | NDA/MAL/HDP/11147 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | MEMTIN 10 | MEMANTINE HYDROCHLORIDE | 10 MG | 1. UNICHEM LABORATORIES LIMITED (UNIT II) VILLAGE BHATAULI KALAN, THE BADDI, DISTT. SOLAN, HIMACHAL PRADESH - 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 904 | NDA/MAL/HDP/11148 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | CONAZ CREAM | KETOCONAZOLE | 2 %W/W | ATCO LABORATORIES LIMITED B-18, S.I.T.E, KARACHI - 75700 | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1*1*10G TUBE | 01/02/2024 |
| 905 | NDA/MAL/HDP/1115 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | CALYZID | CALCIUM CARBONATE + L-LYSINE MONOHYDROCHLORIDE + ZINC GLUCONATE + VITAMIN D3 | 250 MG + 50 MG + 5 MG + 125 IU | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*200ML BOTTLE | 01/07/2013 |
| 906 | NDA/MAL/HDP/11150 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | LABCLAV 625MG TABLETS | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | LABORATORY & ALLIED LTD , PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| 907 | NDA/MAL/HDP/11153 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAFARIV 15 | RIVAROXABAN | 15 MG | 1. MYLAN LABORATORIES LIMITED PLOT NO. H-12 AND H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD, 431136, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 13/12/2023 |
| 908 | NDA/MAL/HDP/11154 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAFARIV 20 | RIVAROXABAN | 20 MG | 1. MYLAN LABORATORIES LIMITED PLOT NO. H-12 AND H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD, 431136, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 13/12/2023 |
| 909 | NDA/MAL/HDP/11157 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | DOVATO 50MG/300MG | DOLUTEGRAVIR + LAMIVUDINE | 50 MG + 300 MG | GLAXOSMITHKLINE, LLC, 1011 NORTH ARENDELL AVENUE ZEBULON, NORTH CAROLINA 27597 | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 02/02/2024 |
| 910 | NDA/MAL/HDP/11159 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | TIBAN 20 | TENEGLIPTIN HYDROBROMIDE HYDRATE | 20MG | AJANTA PHARMA LIMITED, B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD MAHARASHTRA STATE INDIA 431 128 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 911 | NDA/MAL/HDP/11160 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ROSUNA-5 | ROSUVASTATIN CALCIUM | 5MG | ZOTA HEATHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 912 | NDA/MAL/HDP/11162 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | TATA UGANDA LIMITED | RABZOL | RABEPRAZOLE SODIUM | 20MG | NAPROD LIFE SCIENCES PVT. LTD, G-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 MG VIAL + 1*5ML LDPE BOTTLE OF WATER FOR INJECTION | 02/02/2024 |
| 913 | NDA/MAL/HDP/11167 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAGULANT 2.5 | APIXABAN | 2.5 MG | 1. MYLAN LABORATORIES LIMITED PLOT NO. H-12 AND H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD, 431136, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 13/12/2023 |
| 914 | NDA/MAL/HDP/11168 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAGULANT 5 | APIXABAN | 5 MG | 1. MYLAN LABORATORIES LIMITED PLOT NO. H-12 AND H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD, 431136, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 13/12/2023 |
| 915 | NDA/MAL/HDP/1117 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TETRACYCLINE EYE OINTMENT USP 1% | TETRACYCLINE HYDROCHLORIDE | 1 %W/W | 1. NEM LABORATORIES PRIVATE LIMITED 133 KRISHNA INDUSTRIES ESTATE, VASAI , PALGHAR - 401210, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC OINTMENTS | I. 1*20*4G TUBE | 01/07/2013 |
| 916 | NDA/MAL/HDP/1118 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ELAXIM 52.5 | TENECTEPLASE | 52.5 MG | 1. GENNOVA BIOPHARMACEUTICALS LIMITED BLOCK 1, PLOT P1 & P2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE ? 411057, MAHARASHTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY I V VIALS | I. 1*53MG VIAL | 01/07/2013 |
| 917 | NDA/MAL/HDP/11183 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | LURATA 80 | LURASIDONE HYDROCHLORIDE | 80MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| 918 | NDA/MAL/HDP/11184 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LURATA 40 | LURASIDONE HYDROCHLORIDE | 40 MG | 1. MSN LABORATORIES PRIVATE LIMITED MSN LABORATORIES PRIVATE LIMITED, FORMULATIONS DIVISION, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 13/12/2023 |
| 919 | NDA/MAL/HDP/11189 | BIOMATRIX HEALTHCARE PRIVATE LIMITED. | MEDIWORLD PHARMA AFRICA LTD | CLEOBACT 150 | CLINDAMYCIN HYDROCHLORIDE | 150 MG | 1. BIOMATRIX HEALTHCARE PRIVATE LIMITED SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD ? 382 220, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | I. 1*10*10CAPSULE BLISTER | 13/12/2023 |
| 920 | NDA/MAL/HDP/11191 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | FUNGIDERM | CLOTRIMAZOLE + ZINC OXIDE + DIMETHICONE | 1% W/W + 1.75% W/W + 2.50% W/W | NANZ MED SCIENCE PHARMA PVT. LTD, RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL DUSTING POWDERS | 1.0X50.0 G BOTTLE | 12/13/2023 |
| 921 | NDA/MAL/HDP/11192 | BIOMATRIX HEALTHCARE PRIVATE LIMITED. | MEDIWORLD PHARMA AFRICA LTD | ERINOCIN 250 | ERYTHROMYCIN STEARATE | 250 MG | 1. BIOMATRIX HEALTHCARE PRIVATE LIMITED SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD ? 382 220, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 13/12/2023 |
| 922 | NDA/MAL/HDP/11193 | UNOSOURCE PHARMA LIMITED | MEDVIN PHARMA LIMITED | WELGRA 100 | SILDENAFIL CITRATE | 100 MG | 1. AKUMS DRUGS & PHARMACEUTICALS LIMITED 19, 20, 21, SEC. 6A, IIE, SIDCUL, RANIPUR, HARIDWAR - 249403, UTTARAKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*3TABLET BLISTER | 13/12/2023 |
| 923 | NDA/MAL/HDP/11194 | UNOSOURCE PHARMA LIMITED | MEDVIN PHARMA LIMITED | UNOKETRO | KETOROLAC TROMETHAMINE | 30 MG/ML | 1. AKUMS DRUGS AND PHARMACEUTICALS LIMITED 2, 3, 4 & 5, SEC. 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR 249403, UTTARAKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*10*1ML AMPOULE | 13/12/2023 |
| 924 | NDA/MAL/HDP/11195 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | WINOP 60 | KETOROLAC TROMETHAMINE | 60 MG/2ML | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | PARENTERAL ORDINARY AMPOULES | I. 1*1*5*1ML AMPOULE II. 1*1*5*2ML AMPOULE III. 1*1*2ML AMPOULE | 13/12/2023 |
| 925 | NDA/MAL/HDP/11196 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | PERMIN | PERMETHRIN | 5 %W/W | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | TOPICAL EXTERNAL CREAMS | I. 1*1*30G TUBE | 13/12/2023 |
| 926 | NDA/MAL/HDP/11198 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | GENTAMICIN SULPHATE | GENTAMICIN SULFATE | 80 MG/2ML | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. LABORATE PHARMACEUTICALS INDIA LIMITED UNIT II, 31, RAJBAN ROAD, NAIWALA, PAONTA SAHIB, DISTT. SIRMOUR, HIMACHAL PRADESH INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY VIALS | I. 1*1*2ML VIAL | 13/12/2023 |
| 927 | NDA/MAL/HDP/11205 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | 20M | MANNITOL | 20 %W/V | 1. OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED SURVEY NO.: 199 TO 201 & 208 TO 210, VILLAGE: VASANA - CHACHARWADI, TAL - SANAND, DIST. AHMEDABAD - 382213, GUJARAT STATE INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | I. 1*1*500ML BOTTLE | 13/12/2023 |
| 928 | NDA/MAL/HDP/1122 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCHLOR EAR DROPS | CHLORAMPHENICOL | 5%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OTIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2013 |
| 929 | NDA/MAL/HDP/11230 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | CYVAC | R21 MALARIA VACCINE (RECOMBINANT, ADJUVANTED) | 5µG OF MALARIA ANTIGEN & 50µG OF MATRIX-M1 PER DOSE OF 0.5ML | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X0.5 ML VIAL (1 DOSE), 1.0X50.0X1.0 ML VIAL (2 DOSE) | 22/03/2024 |
| 930 | NDA/MAL/HDP/11233 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | AMCARDIA-10 | AMLODIPINE BESYLATE | 10 MG | UNIQUE PHARMACEUTICAL LABS LIMITED. ., PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| 931 | NDA/MAL/HDP/11234 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | MOXILEB €“ 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | LEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| 932 | NDA/MAL/HDP/11237 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | PERILIN | METOCLOPRAMIDE HYDROCHLORIDE | 10MG/2ML | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 22/03/2024 |
| 933 | NDA/MAL/HDP/11238 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | DESLORA-5 | DESLORATADINE | 5MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| 934 | NDA/MAL/HDP/11240 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | NOSIL 0.05% | XYLOMETAZOLINE | 0.05%W/V | LINCOLN PHARMACEUTICAL LIMITED 11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | NASAL TOPICAL DROPS | 1.0X1.0X10.0 ML BOTTLE | 22/03/2024 |
| 935 | NDA/MAL/HDP/11242 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | SITAP 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| 936 | NDA/MAL/HDP/11244 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | ESOPRALIN | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| 937 | NDA/MAL/HDP/11245 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | VALPIN-200 | SODIUM VALPROATE | 200MG | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 22/03/2024 |
| 938 | NDA/MAL/HDP/11247 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | IBUN | IBUPROFEN | 100MG/5ML | LINCOLN PHARMACEUTICALS LTD .11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 22/03/2024 |
| 939 | NDA/MAL/HDP/11248 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | VIDAGLIN | VILDAGLIPTIN | 50 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| 940 | NDA/MAL/HDP/11249 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | ARH-L | ARTEMETHER + LUMEFANTRINE | (180 MG + 1080 MG)/ 60ML | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 22/03/2024 |
| 941 | NDA/MAL/HDP/11250 | OCHOA LABORATORIES | SUPER MEDIC LTD | DOBESIL H | CALCIUM DOBESILATE MONOHYDRATE + LIDOCAINE HYDROCHLORIDE + HYDROCORTISONE ACETATE + ZINC OXIDE | 0.5 % W/W + 3.0 %W/W + 0.25 % W/W + 5.0 % W/W | AUROCHEM LABORATORIES (I) PVT LTD, 8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 22/03/2024 |
| 942 | NDA/MAL/HDP/11251 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | THROMBAN 5 | APIXABAN | 5 MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 16/03/2024 |
| 943 | NDA/MAL/HDP/11252 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | TELMICLAR HTZ 40/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40 MG + 12.5 MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 16/03/2024 |
| 944 | NDA/MAL/HDP/11254 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ORIXO 400 | OFLOXACIN | 400MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| 945 | NDA/MAL/HDP/11255 | MANKIND PHARM LTD | TATA UGANDA LIMITED | MAHACEF-200 | CEFIXIME TRIHYDRATE | 200 MG | COPMED PHARMACEUTICALS PVT LTD-UNIT II. ,, PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/03/2024 |
| 946 | NDA/MAL/HDP/11256 | BRAWN LABORATORIES LTD | TATA UGANDA LIMITED | MOXIBRU | MOXIFLOXACIN | 0.5% W/V | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 22/03/2024 |
| 947 | NDA/MAL/HDP/11257 | BRAWN LABORATORIES LTD | TATA UGANDA LIMITED | BRUCOXIA-90 | ETORICOXIB | 90MG | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| 948 | NDA/MAL/HDP/11258 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | ADERAN HTZ 16/12.5 | CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE | 16 MG + 12.5 MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 16/03/2024 |
| 949 | NDA/MAL/HDP/11260 | MANKIND PHARM LTD | TATA UGANDA LIMITED | MAHACEF-100 | CEFIXIME TRIHYDRATE | 100 MG | COPMED PHARMACEUTICALS PVT LTD-UNIT II. ,, PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/03/2024 |
| 950 | NDA/MAL/HDP/11261 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | COLIHENZ | CITICOLINE SODIUM | 500MG | STANFORD LABORATORIES PRIVATE LIMITED (A SUBSIDIARY COMPANY OF LA RENON HEALTHCARE PRIVATE LIMITED), 8, INDUSTRIAL AREA, MEHATPUR - 174315, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 16/03/2024 |
| 951 | NDA/MAL/HDP/11264 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | FLAIROF | ROFLUMILAST | 250MCG | HETERO LABS LIMITED (UNIT III)..., 22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X15.0 TABLET BLISTER | 16/03/2024 |
| 952 | NDA/MAL/HDP/11266 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | IZ 500 | AZITHROMYCIN DIHYDRATE | 500MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 16/03/2024 |
| 953 | NDA/MAL/HDP/11267 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHMAX-200 | CEFIXIME TRIHYDRATE | 200 MG | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)| | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| 954 | NDA/MAL/HDP/11268 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PARACO-DENK 1000/60 | PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE | 1000 MG + 60 MG | BENE-ARZNEIMITTEL GMBH, HERTERTICHSTR. 1-3, 81479 MUNCHEN - GERMANY | GERMANY | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 16/03/2024 |
| 955 | NDA/MAL/HDP/1127 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | CLARION TABLETS 500MG | CLARITHROMYCIN | 500MG | FEROZSONS LABORATORIES LTD | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10TABLET BLISTER | |
| 956 | NDA/MAL/HDP/11271 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR SODIUM 50 MG, EMTRICITABINE 200 MG AND TENOFOVIRAL AFENAMIDE 25 MG | DOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 50 MG + 200 MG + 25 MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 16/03/2024 |
| 957 | NDA/MAL/HDP/11272 | APEX LABORATORIES PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | ZINCOFER LIQUID | FERRIC AMMONIUM CITRATE USP + NICOTINAMIDE BP + PYRIDOXINE HYDROCHLORIDE BP + CYANOCOBALAMIN BP + ZINC SULFATE HEPTAHYDRATE BP|FERRIC AMMONIUM CITRATE USP + NICOTINAMIDE BP + PYRIDOXINE HYDROCHLORIDE BP + CYANOCOBALAMIN BP + ZINC SULFATE HEPTAHYDRATE BP | (225 MG + 50 MG + 1.5 MG + 7.5 MCG + 44.4 MG) PER 15ML|(225 MG + 50 MG + 1.5 MG + 7.5 MCG + 44.4 MG) PER 5ML | APEX LABORATORIES PRIVATE LIMITED (PLANT III)510 KUNNAM VILLAGE AND POST, THENNERI (VIA) SRIPERUMBUDUR TK KANCHEEPRURAM DISTRICT, PIN CODE: 631 604, TAMIL NADU | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X200.0 ML BOTTLE | 22/03/2024 |
| 958 | NDA/MAL/HDP/11273 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE TABLETS | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 600 MG + 50 MG + 300 MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 16/03/2024 |
| 959 | NDA/MAL/HDP/11279 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | SILOTRIF 8 | SILODOSIN | 8MG | MSN LABORATORIES LTD. , PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 16/03/2024 |
| 960 | NDA/MAL/HDP/1128 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BTC KIT | FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE | 150MG + 1G + 1G | LINCOLN PHARMACEUTICALS L.T.D, TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY COMBINATION PACK TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2013 |
| 961 | NDA/MAL/HDP/11280 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUGENTA EYE/EAR DROPS | GENTAMICIN SULFATE | 0.3%W/V | BRAWN LABORATORIES LTD ., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE | 16/03/2024 |
| 962 | NDA/MAL/HDP/11283 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | VAPTOR 10MG | ROSUVASTATIN CALCIUM | 10MG | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| 963 | NDA/MAL/HDP/11287 | LABORATÓRIOS BASI | ONCOPHARM (U) LTD | MIDAZOLAM BASI | MIDAZOLAM | 15 MG/3 ML | LABORATORIOS BASI - INDUSTRIA FARMACEUTICA, PARQUE INDUSTRIAL MANUEL LOURENCO FERREIRA, LOTES 8, 15 E 16, 3450-232 MORTAGUA - PORTUGAL | PORTUGAL | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X3.0 ML AMPOULE | 22/03/2024 |
| 964 | NDA/MAL/HDP/11288 | MICRO LABS LIMITED | PHARMA VILLE LIMITED | PARACETAMOL BP 500MG TABLET | PARACETAMOL | 500MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| 965 | NDA/MAL/HDP/11289 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ADCCLENA 5 | LENALIDOMIDE | 5MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BLISTER | 16/03/2024 |
| 966 | NDA/MAL/HDP/11290 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ADCCLENA 10 | LENALIDOMIDE | 10MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BLISTER | 16/03/2024 |
| 967 | NDA/MAL/HDP/11291 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ADCCLENA 15 | LENALIDOMIDE | 15MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BLISTER | 16/03/2024 |
| 968 | NDA/MAL/HDP/11292 | HEALTHCARE PHARMACEUTICALS LTD | MIDAS CARE (U) LIMITED | CANDINIL | FLUCONAZOLE | 50 MG/5ML | HEALTHCARE PHARMACEUTICAL LIMITEDGAZARIAPARA, RAJENDRAPUR, GAZIPUR 1703 - BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X35.0 ML BOTTLE | 16/03/2024 |
| 969 | NDA/MAL/HDP/11293 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOFECON 500 | MYCOPHENOLATE MOFETIL | 500MG | CONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 22/03/2024 |
| 970 | NDA/MAL/HDP/11294 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOFECON C-250 | MYCOPHENOLATE MOFETIL | 250 MG | CONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER | 22/03/2024 |
| 971 | NDA/MAL/HDP/11295 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYGLI- 100 | SITAGLIPTIN | 100MG | BAFNA PHARMACEUTICALS LIMITED, UNIT II 147 MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI, CHENNAI, IN 600052, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| 972 | NDA/MAL/HDP/11296 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYGLI-50 | SITAGLIPTIN | 50MG | BAFNA PHARMACEUTICALS LIMITED, UNIT II 147 MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI, CHENNAI, IN 600052, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| 973 | NDA/MAL/HDP/11299 | LABORATÓRIOS VITÓRIA, S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRAUSAN | CITICOLINE SODIUM | 100MG/ML | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X50.0 ML BOTTLE | 22/03/2024 |
| 974 | NDA/MAL/HDP/1130 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KLARO-500 | CLARITHROMYCIN TABLETS | 500MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2012 |
| 975 | NDA/MAL/HDP/1131 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | XAVOR 50 | LOSARTAN | 50MG | FEROZSONS LABORATORIES LTD, AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 976 | NDA/MAL/HDP/1132 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | M-CALZ | CALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL | 1000MG+100MG+4MG+200.I.U | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2012 |
| 977 | NDA/MAL/HDP/11330 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | PREGASAFE M 75 | PREGABALIN + METHYLCOBALAMIN | 75 MG + 750 MCG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 24/05/2024 |
| 978 | NDA/MAL/HDP/11331 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | ALMOTAN 12.5 | ALMOTRIPTAN MALATE | 12.5 MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X1.0 TABLET BLISTER | 22/05/2024 |
| 979 | NDA/MAL/HDP/11336 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | TOLSIN 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/05/2024 |
| 980 | NDA/MAL/HDP/1134 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | XAVOR DIU | LOSARTAN + HYDROCHLORTHIAZIDE | 50MG + 12.5MG | FEROZSONS LABORATORIES LTD - AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 01/07/2013 |
| 981 | NDA/MAL/HDP/11344 | WOCKHARDT LTD | KAMCARE PHARMA LIMITED | ZEDEX COLD | ACETAMINOPHEN + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE | 325 MG + 10 MG + 5 MG | SOFTGEL HEALTHCARE PRIVATE LIMITED, 20/1, VANDALUR - KELAMBAKKAM ROAD, PUDUPAKKAM VILLAGE, KANCHEEPURAM DISTRICT, TAMIL NADU - 603 103 - INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/06/2024 |
| 982 | NDA/MAL/HDP/11346 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TORSINEX-10 | TORSEMIDE | 10MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 983 | NDA/MAL/HDP/11347 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | REDCEPHIN SL | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1000 MG + 500 MG | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 ML VIAL | 01/06/2024 |
| 984 | NDA/MAL/HDP/11348 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | OTRINAL | XYLOMETAZOLINE HYDROCHLORIDE | 0.1%W/V | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGA | UGANDA | NASAL TOPICAL DROPS | 1.0X1.0X10.0 ML VIAL | 01/06/2024 |
| 985 | NDA/MAL/HDP/11350 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | KLOVINAL | METRONIDAZOLE + CLOTRIMAZOLE + LACTOBACILLUS SPORES | 500 MG + 100 MG + 150 MILLIONS | BLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY STRIP | 01/06/2024 |
| 986 | NDA/MAL/HDP/11351 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | LOTEL | LOTEPREDNOL ETABONATE | 0.5%W/W | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | OPHTHALMIC GELS/SOLS | 1.0X1.0X5.0 ML BOTTLE | 22/05/2024 |
| 987 | NDA/MAL/HDP/11352 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | BRINZOX | BRINZOLAMIDE | 1.0% W/V | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML BOTTLE | 22/05/2024 |
| 988 | NDA/MAL/HDP/11353 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | BETOACT | BEPOTASTINE BESILATE | 1.5% W/V | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 22/05/2024 |
| 989 | NDA/MAL/HDP/11357 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DOVPRELA | PRETOMANID | 200MG | MYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X26.0 TABLET CONTAINER | 24/05/2024 |
| 990 | NDA/MAL/HDP/11358 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | EVAFACT | DIENOGEST | 2MG | NAARI PHARMA PRIVATE LIMITED, PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 24/05/2024 |
| 991 | NDA/MAL/HDP/11359 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | HALOPER-5 | HALOPERIDOL | 5MG | M/S SCOTT-EDIL PHARMACIA LTD , 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/05/2024 |
| 992 | NDA/MAL/HDP/1136 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOSCAB APPLICATION | BENZYL BENZOATE | 25%W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL EMULSIONS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2013 |
| 993 | NDA/MAL/HDP/11360 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | HALOPER-10 | HALOPERIDOL | 10MG | SCOTT-EDIL PHARMACIA LTD. 56, EPIP, PHASE-I, JHARMAJRI, BADDI 173 205, (HP), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/05/2024 |
| 994 | NDA/MAL/HDP/11361 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ETORIB 90 | ETORICOXIB | 90MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/05/2024 |
| 995 | NDA/MAL/HDP/11362 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ETORIB 120 | ETORICOXIB | 120MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/05/2024 |
| 996 | NDA/MAL/HDP/11363 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ETORIB 60 | ETORICOXIB | 60MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/05/2024 |
| 997 | NDA/MAL/HDP/11371 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | PAGENAX 120 MG/ML | BROLUCIZUMAB | 120 MG/ML | NOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONS, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLAND| | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL + 1*1 FILTER NEEDLE | 22/05/2024 |
| 998 | NDA/MAL/HDP/11376 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNIFEN 10 | BACLOFEN | 10 MG | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/05/2024 |
| 999 | NDA/MAL/HDP/11378 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNIFEN 20 | BACLOFEN | 20MG | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/05/2024 |
| 1000 | NDA/MAL/HDP/1138 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CALAMINE | CALAMINE | 15%W/W | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2013 |
| 1001 | NDA/MAL/HDP/11383 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | METAPIR 100 | TOPIRAMATE | 100MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1002 | NDA/MAL/HDP/11386 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | METAPIR - 50 | TOPIRAMATE | 50MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1003 | NDA/MAL/HDP/11389 | OMNICALS PHARMA PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | OMIZINC 20 | ZINC SULFATE MONOHYDRATE | 20MG | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER | 22/05/2024 |
| 1004 | NDA/MAL/HDP/1139 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVATE | BETAMETHASONE | 0.1%W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2012 |
| 1005 | NDA/MAL/HDP/11390 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPHONEX | AMPHOTERICIN B | 50MG | BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X50.0 MG VIAL | 01/06/2024 |
| 1006 | NDA/MAL/HDP/11392 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | TELMICLAR 80 | TELMISARTAN | 80MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1007 | NDA/MAL/HDP/11396 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ESMOLOC 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1008 | NDA/MAL/HDP/11398 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | ROSUCHOL -10 | ROSUVASTATIN | 10MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1009 | NDA/MAL/HDP/11399 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DOLOGAN DENK | PARACETAMOL + IBUPROFEN + CAFFEINE | 250 MG + 200 MG + 50 MG | ARTESAN PHARMA GMBH & CO. KG, WENDLANDSTR.1, 29439, LUCHOW | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 24/05/2024 |
| 1010 | NDA/MAL/HDP/1140 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVATE-N | BETAMETHASONE+NEOMYCIN SULPHATE | 0.1%W/W+0.5%W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| 1011 | NDA/MAL/HDP/11400 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | CLARZIM 500 | CLARITHROMYCIN | 500MG | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1012 | NDA/MAL/HDP/11404 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | LASTAVIN AM 5/160 | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1013 | NDA/MAL/HDP/11406 | MEDICAL UNION PHARMACEUTICALS. | KARURI PHARMACEUTICALS LTD. | INSULINAGYPT 70/30 100 IU/ML INJECTION 10 ML | INSULIN HUMAN (RECOMBINANT DNA ORIGIN) | 100 IU/ML (70% ISOPHANE INSULINE + 30% REGUILAR INSULIN) | MEDICAL UNION PHARMACEUTICALS, 6TH OCTOBER SITE, 2ND INDUSTRIAL ZONE, PLOT NO. 1, STREET NO. 22, GIZA GOVERNORATE - EGYPT | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL | 21/06/2024 |
| 1014 | NDA/MAL/HDP/11407 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ITRAPINN | ITRACONALE | 100 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X4.0 CAPSULE BLISTER | 01/06/2024 |
| 1015 | NDA/MAL/HDP/11408 | MEDOCHEMIE LTD. | LABOREX UGANDA LIMITED | CELMANTIN 20 | ROSUVASTATIN CALCIUM | 20MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1016 | NDA/MAL/HDP/11409 | ZOTA HEALTHCARE LTD. | REDDYS PHARMA LIMITED | ATRONA-10 | ATORVASTATIN CALCIUM | 10MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1017 | NDA/MAL/HDP/11412 | LG CHEM, LTD. | MM PARTNERS LOGISTICS LIMITED | EUPOLIO | INACTIVATED POLIOVIRUS TYPE 1 (SABIN STRAIN) + INACTIVATED POLIOVIRUS TYPE 2 (SABIN STRAIN) + INACTIVATED POLIOVIRUS TYPE 3 (SABIN STRAIN) | 5 D-ANTIGEN UNITS + 8 D-ANTIGEN UNITS + 16 D-ANTIGEN UNITS | LG LIFE SCIENCES LTD., YONGJE-DONG IKSA-51, JEONBUK-DO 570350 | NORTH KOREA | PARENTERAL ORDINARY VIALS | 1.0X10.0X2.5 ML VIAL,1.0X10.0X0.5 ML VIAL | 24/05/2024 |
| 1018 | NDA/MAL/HDP/11413 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN DISPERSIBLE 40/320 | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40 MG + 320 MG | BLISS GVS PHARMA LTD,, PLOT 10, SURVEY NO. 38/1, DEWAN UDYONG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE - INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 24/05/2024 |
| 1019 | NDA/MAL/HDP/11416 | BIODEAL LABORATORIES LTD PLOT NO.123 | ABACUS PHARMA (AFRICA) LIMITED | PODOSAL PAINT | PODOPHYLLUM RESIN | 20%W/V | BIODEAL LABOARATORIES LTD, 123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBI | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X10.0 ML VIAL | 12/06/2024 |
| 1020 | NDA/MAL/HDP/11418 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | ACORA | TICAGRELOR | 90 MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/05/2024 |
| 1021 | NDA/MAL/HDP/11419 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | APTIN | VILDAGLIPTIN | 50MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/05/2024 |
| 1022 | NDA/MAL/HDP/1142 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CANDIZOL | CLOTRIMAZOLE | 1%W/W | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE, 1.0X15.0 G TUBE, 1.0X10.0 G TUBE | 01/07/2013 |
| 1023 | NDA/MAL/HDP/11420 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | ADERAN HTZ 8/12.5 | CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE | 8 MG + 12.5 MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1024 | NDA/MAL/HDP/11421 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUSUNATE | ARTESUNATE | 60 MG /VIAL | SANJAR PHARMACEUTICALS LIMITED, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL + 5ML CLEAR GLASS AMPOULE OF 0.9%W/V SODIUM CHLORIDE INJECTION BP + 1ML CLEAR GLASS AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION | 22/05/2024 |
| 1025 | NDA/MAL/HDP/11422 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | CLEOBACT 300 | CLINDAMYCIN HYDROCHLORIDE | 300 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 22/05/2024 |
| 1026 | NDA/MAL/HDP/11423 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | SKLOBETA | CLOBETASOL PROPIONATE | 0.05% W/W | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/06/2024 |
| 1027 | NDA/MAL/HDP/11424 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | ROTASIL - LIQUID | LIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT STRATIN [G1, G2, G3, G4 AND G9] | ? 10^5.6 FFU /SEROTYPE PER DOSE (2.0 ML) | SERUM INSTITUTE OF INDIA LTD ., PLOT NO. 212/2 HADAPSAR, OFF SOLI POONAWALLA ROAD, PUNE 411028 - INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X50.0X4.0 ML VIAL | 22/05/2024 |
| 1028 | NDA/MAL/HDP/11425 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | SACUVAN 24/26 | SACUBITRIL + VALSARTAN | 24 MG + 26 MG | HETERO LABS LIMITED (UNIT III)..., 22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1029 | NDA/MAL/HDP/11426 | GLAXOSMITHKLINE BIOLOGICALS S.A. | UNITED HEALTHCARE DISTRIBUTORS LTD | MOSQUIRIX | RTS,S (PLASMODIUM FALCIPARUM AND HEPATITIS B ANTIGEN ) | 25 MICROGRAMS OF RTS,S/DOSE (0.5 ML) | GLAXOSMITHKLINE BIOLOGICALS S.A, PARC DE LA NOIRE EPINE, AVENUE FLEMING 20-1300 WAVRE - BELGIUM| GLAXOSMITHKLINE BIOLOGICALS, 637 RUE DES AULMOIS, 59230 SAINT-AMAND-LES-EAUX | BELGIUM | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X2.0 DOSE VIAL + 1*50*1ML GLASS VIAL OF DILUENT | 24/05/2024 |
| 1030 | NDA/MAL/HDP/11427 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE TABLETS 600MG/50MG/300MG | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 600MG + 50MG + 300MG | HETERO LABS LIMITED (UNIT V), SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/06/2024 |
| 1031 | NDA/MAL/HDP/11428 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | SACUVAN 49/51 | SACUBITRIL + VALSARTAN | 49 MG + 51 MG | HETERO LABS LIMITED (UNIT III)..., 22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1032 | NDA/MAL/HDP/11429 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | GLINSIP 25 | SITAGLIPTIN PHOSPHATE | 25MG | M/S. ANNORA PHARMA PRIVATE LIMITED, SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE €“ 502313, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 01/06/2024 |
| 1033 | NDA/MAL/HDP/1143 | LINCOLN P'CALS LTD | METRO PHARMACEUTICALS LIMITED | LOSA-H | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1034 | NDA/MAL/HDP/11430 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | GLINSIP 50 | SITAGLIPTIN PHOSPHATE | 50 MG | M/S. ANNORA PHARMA PRIVATE LIMITED, SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE €“ 502313, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 01/06/2024 |
| 1035 | NDA/MAL/HDP/11432 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHMONT-LC TABLET | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 5 MG + 10 MG | CACHET PHARMACEUTICALS PVT LTD ., VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1036 | NDA/MAL/HDP/11434 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHMONT-LC SYRUP | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | (2.5 MG + 4 MG )/5 ML | CACHET PHARMACEUTICALS PVT LTD ., VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 01/06/2024 |
| 1037 | NDA/MAL/HDP/11439 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZOTAMET 500 | METFORMIN HYDROCHLORIDE | 500MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1038 | NDA/MAL/HDP/11440 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | URYDOS-4 | SILODOSIN | 4 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 01/06/2024 |
| 1039 | NDA/MAL/HDP/11441 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | URYDOS-8 | SILODOSIN | 8 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 01/06/2024 |
| 1040 | NDA/MAL/HDP/11445 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | DICLOTRIX | DICLOFENAC SODIUM | 50 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1041 | NDA/MAL/HDP/11446 | INJECTCARE PARENTERALS PVT. LTD | REDDYS PHARMA LIMITED | FORCIL | BENZYL PENICILLIN SODIUM | 1,000,000 UNITS (600MG) PER VIAL | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X600.0 MG VIAL | 01/06/2024 |
| 1042 | NDA/MAL/HDP/11447 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | SITAP 100 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 100MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED 7, HAJEEGONG ROAD, GODNYL, NARAYANGANJ ? 1400, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/05/2024 |
| 1043 | NDA/MAL/HDP/11449 | PT SANBE FARMA | ONCOPHARM (U) LTD | PUMPISEL | PANTOPRAZOLE SODIUM | 40 MG/VIAL | PT SANBE FARMA UNIT 3., JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNG | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL | 01/06/2024 |
| 1044 | NDA/MAL/HDP/11450 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | DICORATE ER 250 | DIVALPROEX SODIUM | 250MG | SUN PHARMA LABORATORIES LIMITED, 6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1045 | NDA/MAL/HDP/11451 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | PREGASAFE ER 82.5 | PREGABALIN | 82.5 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1046 | NDA/MAL/HDP/11453 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | PREGASAFE ER 165 | PREGABALIN | 165 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1047 | NDA/MAL/HDP/11454 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | HARTEZE 10 | RIVAROXABAN | 10MG | COSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 31/05/2024 |
| 1048 | NDA/MAL/HDP/11455 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | HARTEZE 15 | RIVAROXABAN | 15MG | COSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 31/05/2024 |
| 1049 | NDA/MAL/HDP/11456 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | HARTEZE 20 | RIVAROXABAN | 20MG | COSMOS LTD.., RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 31/05/2024 |
| 1050 | NDA/MAL/HDP/11457 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ROXPINN 20 | RIVAROXABAN | 20 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1051 | NDA/MAL/HDP/11458 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | PIXAB 5 | APIXABAN | 5 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1052 | NDA/MAL/HDP/11461 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | LOPAGYL | LOPERAMIDE HYDROCHLORIDE | 2MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED, SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/06/2024 |
| 1053 | NDA/MAL/HDP/11462 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | LINEZOD | LINEZOLID | 600 MG | LINCOLN PHARMACEUTICAL LIMITED , TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1054 | NDA/MAL/HDP/11463 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | MAJEROL | CARBAMAZEPINE | 200 MG | LINCOLN PHARMACEUTICAL LIMITED , TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1055 | NDA/MAL/HDP/11464 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHMAX- DS | CEFIXIME TRIHYDRATE | 100MG/5ML | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)| | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0ML BOTTLE, 1.0X1.0X100.0ML BOTTLE | 01/06/2024 |
| 1056 | NDA/MAL/HDP/11465 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ROXPINN 10 | RIVAROXABAN | 10 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1057 | NDA/MAL/HDP/11466 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LYSOFLAM | PARACETAMOL + DICLOFENAC POTASSIUM + SERRATIOPEPTIDASE | 500 MG + 50 MG + 15 MG | CACHET PHARMACEUTICALS PVT LTD ., VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1058 | NDA/MAL/HDP/11468 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | NAT D 5000 IU | CHOLECALCIFEROL | 5000 IU | MEGA LIFESCIENCES PUBLIC CO. LTD, PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X30.0 CAPSULE CONTAINER,1.0X60.0 CAPSULE CONTAINER | 01/06/2024 |
| 1059 | NDA/MAL/HDP/11469 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | AZILEB-200 | AZITHROMYCIN DIHYDRATE | 200MG/5ML | LEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X15.0 ML BOTTLE | 31/07/2024 |
| 1060 | NDA/MAL/HDP/11472 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | KIKVERM | MEBENDAZOLE | 100MG/5ML | LEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X30.0 ML BOTTLE | 30/07/2024 |
| 1061 | NDA/MAL/HDP/11473 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | COROLOR | TICAGRELOR | 90 MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1062 | NDA/MAL/HDP/11474 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | ALWO | ALBENDAZOLE | 100MG/5ML | LEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X20.0 ML BOTTLE | 23/07/2024 |
| 1063 | NDA/MAL/HDP/11476 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS -H-80/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80 MG + 12.5 MG | AUROBINDO PHARMA LTD, UNIT VII, SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1064 | NDA/MAL/HDP/11478 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS -H-40/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40 MG + 12.5 MG | AUROBINDO PHARMA LTD, UNIT VII, SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1065 | NDA/MAL/HDP/11481 | INTAS PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | RISPITAS 1 | RISPERIDONE | 1MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1066 | NDA/MAL/HDP/11485 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MAGMEN 625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/06/2024 |
| 1067 | NDA/MAL/HDP/11491 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | OMESCOT | OMEPRAZOLE SODIUM | 40 MG/VIAL | M/S SCOTT-EDIL PHARMACIA LTD , 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL (10 ML AMBER GLASS VIAL) + 1*10 ML AMPOULE, WFI IN LDPE BOTTLE | 01/06/2024 |
| 1068 | NDA/MAL/HDP/11494 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | HYOSCINE BUTYLBROMIDE 20 MG/ML | HYOSCINE BUTYLBROMIDE | 20 MG/ML | M/S SCOTT-EDIL PHARMACIA LTD , 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0X1.0 ML AMPOULE | 01/06/2024 |
| 1069 | NDA/MAL/HDP/11496 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | PHYLLINE | AMINOPHYLLINE | 250MG/10ML | SWISS PARENTERALS LIMITED (UNIT-1), 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X10.0ML AMPOULE, 1.0X1.0X10.0X10.0ML AMPOULE, | 22/05/2024 |
| 1070 | NDA/MAL/HDP/11499 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | ARMENATE-60 | ARTESUNATE | 60MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL 0.5ML VIALOF 5.0%W/V SODIUM CARBONATE + 2.5ML VIAL OF 0.9%W/V SODIUM CHLORIDE | 05/06/2024 |
| 1071 | NDA/MAL/HDP/11504 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ABMIST | HYPROMELLOSE | 0.7% W/V | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGA | UGANDA | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 25/09/2024 |
| 1072 | NDA/MAL/HDP/11505 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROYMIDATE MCT | ETOMIDATE | 2 MG/ML | TROIKAA PHARMACEUTICALS LIMITED,,, C-1, SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARAKHAND | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL | 25/09/2024 |
| 1073 | NDA/MAL/HDP/11508 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | SUPYRA DISPERSIBLE JUNIOR 262.5/75 CO-BLISTER PACK | AMODIAQUINE HYDROCHLORIDE + (SULFADOXINE + PYRIMETHAMINE) | 75 MG + (250 MG + 12.5 MG) | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X50.0X4.0 TABLET BLISTER | 25/09/2024 |
| 1074 | NDA/MAL/HDP/11509 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | SUPYRA DISPERSIBLE JUNIOR 525/150 CO-BLISTER PACK | AMODIAQUINE HYDROCHLORIDE + (SULFADOXINE + PYRIMETHAMINE) | 150 MG + (500 MG + 25 MG) | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X50.0X4.0 TABLET BLISTER | 25/09/2024 |
| 1075 | NDA/MAL/HDP/11510 | LUPIN LIMITED- | AIVEEN (U) LIMITED | BEDAQUILINE TABLETS 100 MG | BEDAQUILINE FUMARATE | 100 MG | LUPIN LTD, A-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X188.0 TABLET CONTAINER, 1.0X1.0X24.0 TABLET CONTAINER, 1.0X1.0X10.0 TABLET STRIP, 1.0X4.0X12.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1076 | NDA/MAL/HDP/11511 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | FLUCONA-DENK 100 | FLUCONAZOLE | 100MG | DENK PHARMA GMBH & CO. KG, GOLLSTR. 1, 84529, TITTMONING | GERMANY | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 25/09/2024 |
| 1077 | NDA/MAL/HDP/11512 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | FLUCONA-DENK 150 | FLUCONAZOLE | 150MG | DENK PHARMA GMBH & CO. KG, GOLLSTR. 1, 84529, TITTMONING | GERMANY | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 25/09/2024 |
| 1078 | NDA/MAL/HDP/11513 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DOLO-DENK GEL | ETOFENAMATE | 100 MG/G | C.P.M. CONTRACTPHARMA GMBH & COMPANY KG, FRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM | GERMANY | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE, 1.0X1.0X50.0 G TUBE | 25/09/2024 |
| 1079 | NDA/MAL/HDP/11521 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ENVUTEG | LAMIVUDINE + TENOFOVIR ALAFENAMIDE FUMARATE + DOLUTEGRAVIR SODIUM | 300 MG + 25 MG + 50 MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 25/09/2024 |
| 1080 | NDA/MAL/HDP/11524 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | KAVIDEZA DISTAB | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 60 MG + 5 MG + 30 MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X180.0 TABLET CONTAINER | 25/09/2024 |
| 1081 | NDA/MAL/HDP/11527 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | KADCYLA 100 MG | TRASTUZUMAB EMTANSINE | 100 MG/VIAL | F. HOFFMANN - LA ROCHE KAISERAUGST, WURMISWEG CH-4303 BASEL | SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X15.0 ML VIAL | 25/09/2024 |
| 1082 | NDA/MAL/HDP/11529 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | PHESGO 600/600 | PERTUZUMAB + TRASTUZUMAB | 600 MG + 600 MG | F. HOFFMANN - LA ROCHE KAISERAUGST, WURMISWEG CH-4303 BASEL | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1.0X1.0X15.0 ML VIAL | 25/09/2024 |
| 1083 | NDA/MAL/HDP/11530 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | PHESGO 1200/600 | PERTUZUMAB + TRASTUZUMAB | 1200 MG + 600 MG | F. HOFFMANN - LA ROCHE KAISERAUGST, WURMISWEG CH-4303 BASEL | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1.0X1.0X15.0 ML VIAL | 25/09/2024 |
| 1084 | NDA/MAL/HDP/11531 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | TECENTRIQ | ATEZOLIZUMAB | 1200 MG/20 ML | F. HOFFMANN - LA ROCHE KAISERAUGST, WURMISWEG CH-4303 BASEL | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL | 25/09/2024 |
| 1085 | NDA/MAL/HDP/11532 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | TECENTRIQ 840MG | ATEZOLIZUMAB | 840MG/14ML | F. HOFFMANN - LA ROCHE KAISERAUGST, WURMISWEG CH-4303 BASEL | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1.0X1.0X15.0 ML VIAL | 25/09/2024 |
| 1086 | NDA/MAL/HDP/11538 | FAES FARMA S.A | HIDROFEROL | CALCIFEDIOL MONOHYDRATE | 0.266 MG | 1. FAES FARMA, S.A. C/ MAXIMO AGUIRRE, 14 48940 LEIOA (VIZCAYA) - SPAIN. SPAIN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SPAIN | ORAL SOLID ORDINARY SOFT GELATIN CAPSULE | I. 1*5CAPSULE BLISTER | 25/09/2024 | |
| 1087 | NDA/MAL/HDP/1154 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | BACQURE | IMIPENEM + CILASTATIN | 500MG + 500MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 ML VIAL | 01/07/2012 |
| 1088 | NDA/MAL/HDP/11542 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NUGREL-A PLUS | CLOPIDOGREL BISULFATE + ASPIRIN | 75 MG + 100 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY PELLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1089 | NDA/MAL/HDP/11549 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | BONAIR HFA INHALER | SALBUTAMOL SULPHATE | 100MCG/ACTUATION | MIDAS CARE PHARMACEUTICALS PVT LTD., B-16 MIDC, WALUJ AURANGABAD 431136, MAHARASHTRA, INDIA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X1.0X200.0 METERED DOSE CANNISTER | 25/09/2024 |
| 1090 | NDA/MAL/HDP/1155 | TRIVENI FORMULATIONS LIMITED | SUPER MEDIC LTD | DOXYCYCLINE | DOXYCYCLINE | 100 | TRIVENI FORMULATION LTD-PLOT NO.52,53,54,63,62,64, ALEAP INDUSTRIAL ESTATE SURAMPALI, AP-INDIA – 521212 | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2012 |
| 1091 | NDA/MAL/HDP/11551 | FDC LTD | AIVEEN (U) LIMITED | IOBRIM | BRIMONIDINE TARTRATE | 0.2%W/V | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 25/09/2024 |
| 1092 | NDA/MAL/HDP/11552 | MILAN LABORATORIES (INDIA) PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | BETRIM FORTE | SULFAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | MILAN LABORATORIES (INDIA) PVT LTD ., PLOT NOS. 35, 36, 63, 64, 65, 67 & 87 JAWAHAR CO-OP. INDUSTRIAL ESTATE LIMITED. KAMOTHE, PANVEL (NAVI MUMBAI) DISTRICT RAIGAD, 410209 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER | 25/09/2024 |
| 1093 | NDA/MAL/HDP/11553 | BHARAT SERUMS & VACCINES LTD. | GITTOES PHARMACEUTICALS LIMITED | GAMMA- I.V. 5.0 G | IMMUNOGLOBULIN G | 0.05 G/ML | BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML VIAL | 25/09/2024 |
| 1094 | NDA/MAL/HDP/11555 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | ORNI-BKRS | ORNIDAZOLE | 500 MG | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 25/09/2024 |
| 1095 | NDA/MAL/HDP/11559 | THE SEARLE COMPANY LIMITED | HEALTHCARE LTD. | SPIROMIDE-40 TABLETS | SPIRONOLACTONE + FUROSEMIDE | 50 MG + 40 MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1096 | NDA/MAL/HDP/11560 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-AM | TELMISARTAN + AMLODIPINE BESILATE | 40 MG + 5 MG | MICRO LABS LIMITED, HOSUR, NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1097 | NDA/MAL/HDP/11561 | MEDOCHEMIE LTD. | LABOREX UGANDA LIMITED | CELMANTIN 10 MG | ROSUVASTATIN CALCIUM | 10MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1098 | NDA/MAL/HDP/11564 | ATABAY KIMYA SANAYI VE TICARET | PRINCESS GROUP LIMITED | PAROL | PARACETAMOL | 500 MG | ATABAY ILAC FABRIKASI A.S, ACIBADEM KOFTUNCU SOKAK NO. 1 KADIKOY 34718, ISTANBUL | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1099 | NDA/MAL/HDP/11565 | ATABAY KIMYA SANAYI VE TICARET | PISTON MEDICAL LIMITED | ENOX 4000 ANTI-XA IU/0.4ML | ENOXAPARIN SODIUM | 4000 ANTI-XA IU/0.4ML | ATABAY ILAC FABRIKASI A.S, ACIBADEM KOFTUNCU SOKAK NO. 1 KADIKOY 34718, ISTANBUL | TURKEY | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X0.4 ML PRE- FILLED SYRINGE | 25/09/2024 |
| 1100 | NDA/MAL/HDP/11566 | ATABAY KIMYA SANAYI VE TICARET | PISTON MEDICAL LIMITED | HEDNAVIR 0.5 MG | ENTECAVIR MONOHYDRATE | 0.5 MG | ATABAY ILAC FABRIKASI A.S, ACIBADEM KOFTUNCU SOKAK NO. 1 KADIKOY 34718, ISTANBUL | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 25/09/2024 |
| 1101 | NDA/MAL/HDP/11567 | ATABAY KIMYA SANAYI VE TICARET | PISTON MEDICAL LIMITED | HEDNAVIR 1 MG | ENTECAVIR MONOHYDRATE | 1 MG | ATABAY ILAC FABRIKASI A.S, ACIBADEM KOFTUNCU SOKAK NO. 1 KADIKOY 34718, ISTANBUL | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 25/09/2024 |
| 1102 | NDA/MAL/HDP/11568 | ATABAY KIMYA SANAYI VE TICARET | PISTON MEDICAL LIMITED | ENOX 6000 ANTI-XA IU/0.6ML | ENOXAPARIN SODIUM | 6000 ANTI-XA IU/0.6ML | ATABAY ILAC FABRIKASI A.S, ACIBADEM KOFTUNCU SOKAK NO. 1 KADIKOY 34718, ISTANBUL | TURKEY | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.6 ML PRE- FILLED SYRINGE | 25/09/2024 |
| 1103 | NDA/MAL/HDP/11573 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EASCOF D | DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE | (10 MG + 5 MG + 2 MG)/5 ML | CACHET PHARMACEUTICAL PVT LTD., VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 25/09/2024 |
| 1104 | NDA/MAL/HDP/11574 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | GLUCOSE INTRAVENOUS INFUSION BP 5 % W/V | ANHYDROUS GLUCOSE | 5.0%W/V | ALTHEA PHARMA PRIVATE LIMITED-WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X500.0 ML BOTTLE | 25/09/2024 |
| 1105 | NDA/MAL/HDP/11575 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALT-FLUCAN 2MG/ML | FLUCONAZOLE + SODIUM CHLORIDE | (200 MG + 900 MG)/100 ML | ALTHEA PHARMA PRIVATE LIMITED, WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X2.0X14.0 TABLET BLISTER | 25/09/2024 |
| 1106 | NDA/MAL/HDP/11576 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | LIDOCAINE INJECTION BP 1%W/V | LIDOCAINE HYDROCHLORIDE | 1.0 % W/V | ALTHEA PHARMA PRIVATE LIMITED, WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X10.0X5.0 ML VIAL | 25/09/2024 |
| 1107 | NDA/MAL/HDP/11577 | MSN PHARMACHEM PRIVITE LIMITED | AIVEEN (U) LIMITED | BREATHEZY 10 | MONTELUKAST | 10MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION-PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1108 | NDA/MAL/HDP/11578 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | TAPACID | PANTOPRAZOLE SODIUM | 40 MG/ML | MSN LABORATORIES (PVT) LTD - FORMULATIONS DIVISION - PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X10.0 ML VIAL | |
| 1109 | NDA/MAL/HDP/1158 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRAMADOL | TRAMADOL | 50MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2012 |
| 1110 | NDA/MAL/HDP/11582 | FAROMED LIFESCIENCES LLP | ABACUS PHARMA (AFRICA) LIMITED | ECOSPRIN PLUS | ASPIRIN + CLOPIDOGREL BISULFATE | 75 MG + 75 MG | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1111 | NDA/MAL/HDP/11584 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | FOSFOMAX | FOSFOMYCIN TROMETAMOL | 3G/SACHET | NEUTEC ILAC SAN. TIC. A.S.-1. OSB. 1. YOL NO: 3 VE 2. YOL, NO:2, ARIFIYE, SAKARYA/TURKEY | | TURKEY | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0X3.0 G SACHET | 25/09/2024 |
| 1112 | NDA/MAL/HDP/11588 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | CARVILIN-6.25 | CARVEDILOL | 6.25 MG | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/09/2024 |
| 1113 | NDA/MAL/HDP/11589 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | CARVILIN 12.5 | CARVEDILOL | 12.5 MG | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/09/2024 |
| 1114 | NDA/MAL/HDP/11590 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XATIZA | CABAZITAXEL | 40MG/ML | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X60.0 MG VIAL + 1*5.67 ML OF 13% W/W ETHANOL IN WATER FOR INJECTION (DILUENT) | 25/09/2024 |
| 1115 | NDA/MAL/HDP/11591 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SUPAGREL 60 | TICAGRELOR | 60 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1116 | NDA/MAL/HDP/11594 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | BORTETRUST 3.5 | BORTEZOMIB | 3.5 MG/VIAL | PANACEA BIOTEC PHARMA LIMITED-MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH, 173205 - INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X3.5 MG VIAL | 25/09/2024 |
| 1117 | NDA/MAL/HDP/11599 | KESAR PHARMA | ABACUS PHARMA (AFRICA) LIMITED | KESLEVO | LEVOFLOXACIN HEMIHYDRATE | 750 MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1118 | NDA/MAL/HDP/11601 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ORIXO 200 | OFLOXACIN | 200 MG | AJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1119 | NDA/MAL/HDP/11602 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ROSUCHOL-20 | ROSUVASTATIN CALCIUM | 20MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1120 | NDA/MAL/HDP/11605 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | ARCELIA IRON SUCROSE INJECTION BP | ELEMENTAL IRON | 20 MG/ML | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0ML AMPOULE | 25/09/2024 |
| 1121 | NDA/MAL/HDP/11606 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ACTINAC ER 200 | ACECLOFENAC | 200 MG | AJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1122 | NDA/MAL/HDP/11607 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | FEBURIC 40 | FEBUXOSTAT | 40 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1123 | NDA/MAL/HDP/11612 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | WOXHEAL | DIPEROXOCHLORIC ACID | 1.16 MG/ML BEFORE RECONSTITUTION 0.29 MG/ML AFTER RECONSTITUTION | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)-PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | | INDIA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X7.5 ML CONTAINER + 1*22.5 ML, SODIUM CHLORIDE PACKED IN HDPE CONTAINER CO-PACKED WITH GAUZE | 25/09/2024 |
| 1124 | NDA/MAL/HDP/11614 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ACTIVATED CHARCOAL-300 | ACTIVATED CHARCOAL | 300 MG | M/S SCOTT-EDIL PHARMACIA LTD , 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1125 | NDA/MAL/HDP/11616 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | TOFF-DC | DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 10 MG + 2 MG + 5 MG | PANACEA BIOTEC PHARMA LIMITED-MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH, 173205 - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1126 | NDA/MAL/HDP/11620 | SUN PHARMACEUTICAL INDUSTRIES LTD | STAR PHARMACEUTICALS LTD | PYLOBACT NEO 2 | AMOXICILLIN TRIHYDRATE + LEVOFLOXACIN HEMIHYDRATE + ESOMEPRAZOLE MAGNESIUM | 1000 MG + 500 MG + 20 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED -INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER | 25/09/2024 |
| 1127 | NDA/MAL/HDP/11622 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TACROCORD 1 | TACROLIMUS | 1 MG | CONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER | 25/09/2024 |
| 1128 | NDA/MAL/HDP/11623 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TACROCORD 5 | TACROLIMUS | 5 MG | CONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER | 25/09/2024 |
| 1129 | NDA/MAL/HDP/11624 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TACROCORD 0.5 | TACROLIMUS | 0.5MG | CONCORD BIOTECH LIMITED, 297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER | 25/09/2024 |
| 1130 | NDA/MAL/HDP/11625 | INDASI LIFESCIENCE PVT. LTD | SHREEJI PHARMACEUTICALS LIMITED | INDART 30 PLUS | ARTESUNATE | 30 MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 0.5 ML OF 5.0 %W/V SODIUM BICARBONATE VIAL + 2.5 ML OF 0.9% W/V SODIUM CHLORIDE VIAL | 25/09/2024 |
| 1131 | NDA/MAL/HDP/11627 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | PRECIDEX | DEXMEDETOMIDINE HYDROCHLORIDE | 100 MCG/ML | BROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | | PAKISTAN | | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X1.0X2.0X2.0 ML AMPOULE | 25/09/2024 |
| 1132 | NDA/MAL/HDP/11628 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | CANESTEN THRUSH | CLOTRIMAZOLE | 500 MG | BERLIMED S.A ., POLIGONO INDUSTRIAL SANTA ROSA CALLE FRANCISO ALONSO 7, 28806 ALCALA DE HENARES (MADRID) | SPAIN | VAGINAL CAPSULES | 1.0X1.0X1.0 CAPSULE BLISTER | 25/09/2024 |
| 1133 | NDA/MAL/HDP/1163 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | FRUSEMIDE | FUROSEMIDE | 40MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1134 | NDA/MAL/HDP/11633 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VERTIKIND-8 | BETAHISTINE DIHYDROCHLORIDE | 8 MG | MANKIND PHARMA LIMITED, UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1135 | NDA/MAL/HDP/11634 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VERTIKIND-16 | BETAHISTINE DIHYDROCHLORIDE | 16 MG | MANKIND PHARMA LIMITED, UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1136 | NDA/MAL/HDP/11639 | LINCOLN PHARMACEUTICALS LTD. | METRO PHARMACEUTICALS LIMITED | NEVOSPRIN | NEOMYCIN SULFATE + POLYMYXIN B + SULFATE BACITRACIN ZINC | (5 MG + 5000 UNITS + 400 UNITS)/G | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 25/09/2024 |
| 1137 | NDA/MAL/HDP/1164 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | PIROXICAM | PIROXICAM | 20MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 1138 | NDA/MAL/HDP/11651 | M/S SCOTT-EDIL PHARMACIA LIMITED | ROYAL PHARMA 2011 LIMITED | GENTASCOT | GENTAMICIN SULFATE | 0.3%W/V | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC LIQUIDS | I. 1*1*10ML BOTTLE | |
| 1139 | NDA/MAL/HDP/11652 | BIOGEN PHARMA LIMITED | BIOGEN PHARMA LIMITED | MONOPIL-SB 1.5G | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | (1G+ 500 MG)/VIAL | REYOUNG PHARMACEUTICAL COMPANY LIMITED-NUMBER 1, RUIYANG ROAD, YIYUAN COUNTY, SHANGDONG, PROVINCE P.R, CHINA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL | 25/09/2024 |
| 1140 | NDA/MAL/HDP/11654 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | MICROGYNON ED NO PIL | LEVONORGESTREL + ETHINYLESTRADIOL | 150 MCG +30 MCG | BAYER WEIMER GMBH UND CO.KG, DOEBEREINERSTRASSE 20 D-99427 WEIMER,| BAYER AG, BERLIN, MULLERSTRABE 178, 13353 BERLIN - GERMANY | GERMANY | ORAL SOLID ORDINARY COATED TABLETS | 1.0X3.0X28.0 TABLET BLISTER | 25/09/2024 |
| 1141 | NDA/MAL/HDP/11657 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | PEPSTONE | ESOMEPRAZOLE SODIUM | 40MG/VIAL | GLAND PHARMA LIMITED ;, RANGA REDDY DISTRICT, HYDERABAD, ANDHRA PRADESH | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X40.0 MG VIAL | 25/09/2024 |
| 1142 | NDA/MAL/HDP/1166 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | DOLZERO | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | PANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1143 | NDA/MAL/HDP/11661 | AJANTA PHARMA LIMTED | ASTRA PHARMA (U) LIMITED | TELMICLAR 40 | TELMISARTAN | 40MG | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1144 | NDA/MAL/HDP/11663 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | PIXAB 2.5 | APIXABAN | 2.5MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1145 | NDA/MAL/HDP/11666 | ASTRAZENECA (UK) LTD | MACNAUGHTON LIMITED | FASLODEX 250MG | FULVESTRANT | 250 MG/5 ML | ASTRAZENECA UK OPERATIONS., CHARTER WAY, SILK ROAD BUSINESS PARK, MACCLESFIELD CHESSHIRE,SK10 2 NA | UNITED KINGDOM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X5.0 ML PRE- FILLED SYRINGE | 25/09/2024 |
| 1146 | NDA/MAL/HDP/11668 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CLOXAVID-125 | CLOXACILLIN SODIUM | 125MG/5ML | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED, HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 25/09/2024 |
| 1147 | NDA/MAL/HDP/1167 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | METOCLOPRAMIDE INJECTION | METOCLOPRAMIDE | 5MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD ., N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| 1148 | NDA/MAL/HDP/11671 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | FLOZIP- 5 | DAPAGLIFLOZIN | 5 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1149 | NDA/MAL/HDP/11672 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | FLOZIP-10 | DAPAGLIFLOZIN | 10MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1150 | NDA/MAL/HDP/11676 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | MOCIN-D | MOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE | 0.5%W/V + 0.1%W/V | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191, KINGA | UGANDA | OTIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 25/09/2024 |
| 1151 | NDA/MAL/HDP/11677 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | ZEROCIN | AZITHROMYCIN DIHYDRATE | 500MG | LABORATORY AND ALLIED LTD .., PLOT 209/10349, OFF MOMBASA ROAD | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 25/09/2024 |
| 1152 | NDA/MAL/HDP/11678 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | BRONCIPRO | CIPROFLOXACIN HYDROCHLORIDE | 0.3 %W/V | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 25/09/2024 |
| 1153 | NDA/MAL/HDP/1168 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CORT CREAM | HYDROCORTISONE | 1%W/W | DAWA LTD , BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| 1154 | NDA/MAL/HDP/11683 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | ATAZANAVIR AND RITONAVIR TABLETS | ATAZANAVIR SULFATE + RITONAVIR | 300 MG + 100 MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER, 1.0X90.0 TABLET CONTAINER | 25/09/2024 |
| 1155 | NDA/MAL/HDP/11686 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR ALAFENAMIDE | 50 MG + 300 MG + 25 MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER, 1.0X90.0 TABLET CONTAINER, 1.0X120.0 TABLET CONTAINER | 25/09/2024 |
| 1156 | NDA/MAL/HDP/1169 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | NEBI 5 | NEBIVOLOL HYDROCHLORIDE | 5MG | ARISTO PHARMACEUTCALS PVT LTD, PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1157 | NDA/MAL/HDP/11690 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SEFOZOL | CEFAZOLIN SODIUM | 1 G/VIAL | SWISS PARENTERALS LTD, UNIT- II, PLOT NO. 402,412-414 KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, DIST: AHMEDABAD | INDIA | PARENTERAL RETARD DRY VIALS | 1.0X1.0X1.0 G VIAL | 25/09/2024 |
| 1158 | NDA/MAL/HDP/11693 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | DAPIFLOZIN 10 | DAPAGLIFOZIN | 10MG | INVENTIA HEALTHCARE LIMITED, F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1159 | NDA/MAL/HDP/11694 | KOPRAN LIMITED | TATA UGANDA LIMITED | LORATIN | LORATADINE | 10MG | KOPRAN LIMITED, VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 25/09/2024 |
| 1160 | NDA/MAL/HDP/11695 | HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LTD.) | TATA UGANDA LIMITED | ABHAY-TOX | TETANUS TOXOID | ? 40 IU (5 TO 25 LF)/0.5ML | HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LTD), RAKSHAPURAM, GACHIBOWLI, HYDERABAD - 500 032, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X0.5 ML VIAL | 25/09/2024 |
| 1161 | NDA/MAL/HDP/11697 | INDASI LIFESCIENCE PVT. LTD | SHREEJI PHARMACEUTICALS LIMITED | BICORTISONE-100 | HYDROCORTISONE SODIUM SUCCINATE | 100MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X100.0 MG VIAL, 1.0X50.0X100.0 MG VIAL, 1.0X1.0X100.0 MG VIAL | 25/09/2024 |
| 1162 | NDA/MAL/HDP/11698 | INDASI LIFESCIENCE PVT. LTD | SHREEJI PHARMACEUTICALS LIMITED | BITOPRAZ | PANTOPRAZOLE | 40MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL | 25/09/2024 |
| 1163 | NDA/MAL/HDP/11701 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | CLARIFIC | CLARITHROMYCIN | 500MG/VIAL | GUFIC BIOSCIENCES LIMITED (UNIT 2), SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X500.0 MG VIAL | 25/09/2024 |
| 1164 | NDA/MAL/HDP/11713 | GLOBELA PHARMA PVT. LTD | SHREEJI PHARMACEUTICALS LIMITED | GLOMYCIN 250 | ERYTHROMYCIN STEARATE | 250 MG | GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER, 1.0X10.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1165 | NDA/MAL/HDP/11714 | ABARIS HEALTHCARE PVT. LTD. | ROYAL PHARMA 2011 LIMITED | 10D | GLUCOSE ANHYDROUS | 10 %W/V | ABARIS HEALTHCARE PRIVATE LIMITED PLOT NO. 1407 - 1411, VILLAGE RAJPUR, TALUKA: KADI, DIST: MEHSANA, GUJARAT - 382 740, INDIA | | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 18/12/2024 |
| 1166 | NDA/MAL/HDP/11715 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ANTHEL 10 ML | ALBENDAZOLE | 200 MG/5 ML | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*10ML BOTTLE | 18/12/2024 |
| 1167 | NDA/MAL/HDP/11718 | BAROQUE PHARMACEUTICALS PVT LTD | JEET PHARMACEUTICALS LIMITED | BARODEX P | PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 500 MG + 15 MG + 2 MG + 10 MG | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 18/12/2024 |
| 1168 | NDA/MAL/HDP/11719 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | BURN NIL | SILVER SULFADIAZINE | 1 %W/W | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 18/12/2024 |
| 1169 | NDA/MAL/HDP/1172 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 20MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD ., N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X25.0X20.0 ML VIAL, 1.0X25.0X30.0 ML VIAL | 01/07/2010 |
| 1170 | NDA/MAL/HDP/11720 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B. CHEMICALS & PHARMACEUTICALS LTD.) | PLANET PHARMACEUTICALS UGANDA LTD | CARBAMAZEPINE EXTENDED RELEASE TABLETS USP 200 MG | CARBAMAZEPINE | 200 MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J. B. CHEMICALS AND PHARMACEUTICALS LIMITED) PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIA | | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1171 | NDA/MAL/HDP/11721 | ARCELIA LIFE SCIENCES LTD | NOVOMED HEALTHCARE LIMITED | CEFTRARC-S | CEFTRIAXONE SODIUM+SULBACTAM SODIUM | 1 G+0.5 G | REYOUNG PHARMACEUTICAL COMPANY LIMITED NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P.R. CHINA | | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL | 18/12/2024 |
| 1172 | NDA/MAL/HDP/11722 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CLOXVID 250 | CLOXACILLIN SODIUM | 250 MG/5ML | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 18/12/2024 |
| 1173 | NDA/MAL/HDP/11723 | ACULIFE HEALTHCARE PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | D5RL | DEXTROSE MONOHYDRATE + SODIUM LACTATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE | (5.5 G + 0.31 G + 0.6 G + 0.03 G + 0.02 G)/100ML | ACULIFE HEALTHCARE PRIVATE LIMITED VILLAGE: SACHANA, TALUKA: VIRAMGAM, DISTRICT: AHMEDABAD - 382150, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1000.0 ML BOTTLE | 18/12/2024 |
| 1174 | NDA/MAL/HDP/11724 | GRIFFON BIOMETRIX PVT. LTD | JEET PHARMACEUTICALS LIMITED | RENODERM CREAM | BETAMETHASONE DIPROPIONATE+CLOTRIMAZOLE+GENTAMICIN SULFATE | 0.05% W/W + 1.0% W/W + 0.1% W/W | KESAR PHARMA PRIVATE LIMITED PLOT SURVEY NO. 50/2, VILLAGE BILESHWARPURA, PO. CHHATRAL - 382729, TAL: KALOL, DIST. GANDHINAGAR, G | | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE, 1.0X1.0X30.0 G TUBE | 18/12/2024 |
| 1175 | NDA/MAL/HDP/11725 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | DIOSTAR -PLUS ® 160/12.5MG | HYDROCHLOROTHIAZIDE+VALSARTAN | 12.5 MG+160 MG | PHARMA INTERNATIONAL COMPANY AL-QASTAL AREA, AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA, 11941, AMMAN - JORDAN | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1176 | NDA/MAL/HDP/11726 | NURASYL LIFESCIENCES PVT LTD | VITACARE LIMITED | EPISYL | ADRENALINE ACID TARTRATE | 1 MG/ML | 1. FARBE FIRMA PLOT NO. 1508, NR. ATIQUE BAKERY, GIDC ANKLESHWAR - 393002, GUJARAT INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*10*1ML AMPOULE | 18/12/2024 |
| 1177 | NDA/MAL/HDP/11727 | SYNOKEM PHARMACEUTICALS LIMITED | BIOGEN PHARMA LIMITED | ESOGEN | ESOMEPRAZOLE MAGNESIUM | 40 MG | M/S SYNOKEM PHARMACEUTICALS LIMITED PLOT NO. 35-36, SECTOR-6A, IIE, SIDCUL, RANIPUR, DISTT. HARIDWAR, UTTARAKHAND - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 18/12/2024 |
| 1178 | NDA/MAL/HDP/11728 | VIPRO LIFESCIENCE | VEERAM HEALTHCARE (U) LIMITED | FEPANIL 650 MG | PARACETAMOL | 650 MG | KESAR PHARMA PRIVATE LIMITED PLOT SURVEY NO. 50/2, VILLAGE BILESHWARPURA, PO. CHHATRAL - 382729, TAL: KALOL, DIST. GANDHINAGAR, G | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1179 | NDA/MAL/HDP/11729 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FIBGAL 145 | FENOFIBRATE | 145 MG | AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY | | NULL | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1180 | NDA/MAL/HDP/11730 | MACLEODS PHARMACEUTICAL LTD | VITACARE LIMITED | FLUCYTOSINE 500MG TABLETS | FLUCYTOSINE | 500 MG | MACLEODS PHARMACEUTICALS LIMITED - UNIT XI PLOT NO. M50-M-54A, INDORE SPECIAL ECONOMIC ZONE, PHASE II, PITHAMPUR, MADHYA PRADESH - 454774. | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 18/12/2024 |
| 1181 | NDA/MAL/HDP/11731 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | AIRZ-F | GLYCOPYRRONIUM + FORMOTEROL FUMARATE | 12.5 MCG + 12 MCG | 1. GLENMARK PHARMACEUTICALS LIMITED VILLAGE - KISHANPURA, BADDI NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | LUNG ADMINISTRATION INHALER CAPSULES | I. 1*1*30CAPSULE BOTTLE II. 1*2*30CAPSULE BOTTLE | 18/12/2024 |
| 1182 | NDA/MAL/HDP/11732 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELPMENT CO., LTD | TRIDEM PHARMA UGANDA LIMITED | GNOPAR 60 MG/0.6 ML | ENOXAPARIN SODIUM | 40 MG/0.4 ML | 1. GLAND PHARMA LIMITED SY. NO. 143-148, 150 & 151 NEAR GANDIMAISAMMA CROSS ROADS, D.P. PALLY DUNDIGAL POST, DUNDIGAL GANDIMAISAMMA MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500 043, TELANGANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | I. 1*2*0.6ML PREFILLED SYRINGE | 18/12/2024 |
| 1183 | NDA/MAL/HDP/11733 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELPMENT CO., LTD | TRIDEM PHARMA UGANDA LIMITED | GNOPAR 40 MG/0.4 ML | ENOXAPARIN SODIUM | 60 MG/0.6 ML | 1. GLAND PHARMA LIMITED SY. NO. 143-148, 150 & 151 NEAR GANDIMAISAMMA CROSS ROADS, D.P. PALLY DUNDIGAL POST, DUNDIGAL GANDIMAISAMMA MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500 043, TELANGANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | I. 1*2*0.4ML PREFILLED SYRINGE | 18/12/2024 |
| 1184 | NDA/MAL/HDP/11734 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP 100 MG | HYDROCORTISONE SODIUM SUCCINATE | 100 MG/VIAL | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*10*100MG VIAL | 18/12/2024 |
| 1185 | NDA/MAL/HDP/11735 | RUSAN PHARMA LTD | NORVIK ENTERPRISES LIMITED | HYOSCINE BUTYL BROMIDE | HYOSCINE BUTYLBROMIDE | 20 MG/ML | RUSAN PHARMA LIMITED KHSRA NO. 122 M, CENTRAL HOPE TOWN, SELAQUI, DISTRICT:- DEHRADUN - 248197, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 18/12/2024 |
| 1186 | NDA/MAL/HDP/11736 | WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. | MIS GOODMAN INTERNATIONAL LIMITED | LIMENDA-L | METRONIDAZOLE + MICONAZOLE NITRATE + LIDOCAINE | 750 MG + 200 MG + 100 MG | WORLD MEDICINE ILAC SAN VE TIC A.S. 15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO. 50 K:4 WM PLAZA, GUNESLI-BAGCILAR/ISTANBUL - TURKEY | | TURKEY | VAGINAL SUPPOSITORIES | 1.0X1.0X7.0 SUPPOSITORY STRIP | 18/12/2024 |
| 1187 | NDA/MAL/HDP/11737 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | LASTAVIN AM 10/160 | AMLODIPINE BESILATE+VALSARTAN | 10 MG + 160 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1188 | NDA/MAL/HDP/11738 | DKT HEALTHCARE INTERNATIONAL UGANDA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | LYDIA CONTRACEPTIVE INJECTION | MEDROXYPROGESTERONE ACETATE | 150 MG/ML | MONTAGE LABORATORIES PRIVATE LIMITED (UNIT II) DHANDHA, IDAR ROAD, HIMATNAGAR. GUJARAT, 383001, INDIA | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X25.0X1.0 ML VIAL | 18/12/2024 |
| 1189 | NDA/MAL/HDP/11739 | SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD. | ROYAL PHARMA 2011 LIMITED | MAGMEN 1 G | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 875 MG + 125 MG | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1190 | NDA/MAL/HDP/11740 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEGABA 75 | PREGABALIN | 75 MG | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED PLANT 2: 515/1, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKAN 1028 | | THAILANDA | ORAL SOLID ORDINARY CAPSULES | 1X3X10 CAPSULE BLISTER | 18/12/2024 |
| 1191 | NDA/MAL/HDP/11741 | KESAR PHARMA PRIVATE LIMITED | JEET PHARMACEUTICALS LIMITED | MINTOGEST | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 250 MG/ 5ML + 250 MG/ 5ML + 50 MG / 5ML | 1. KESAR PHARMA PRIVATE LIMITED PLOT SURVEY NO. 50/2, VILLAGE BILESHWARPURA, PO. CHHATRAL - 382729, TAL: KALOL, DIST. GANDHINAGAR, G INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*200ML BOTTLE | 18/12/2024 |
| 1192 | NDA/MAL/HDP/11742 | OMNICALS PHARMA (PVT.) LTD | METRO PHARMACEUTICALS LIMITED | OMCAROS 10 | ROSUVASTATIN CALCIUM | 10 MG | 1. THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1193 | NDA/MAL/HDP/11743 | OMNICALS PHARMA (PVT.) LTD | METRO PHARMACEUTICALS LIMITED | OMCAROS 20 | ROSUVASTATIN CALCIUM | 20 MG | 1. THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1194 | NDA/MAL/HDP/11744 | UNICHEM LABORATORIES LIMITED | EUROPA HEALTHCARE (U) LTD | ROSUVASTATIN-UNICHEM 20 | ROSUVASTATIN CALCIUM | 20 MG | UNICHEM LABORATORIES LIMITED (UNIT II) VILLAGE BHATAULI KALAN, THE BADDI, DISTT. SOLAN, HIMACHAL PRADESH - 173205, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1195 | NDA/MAL/HDP/11745 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | ROZVAST 10 | ROSUVASTATIN CALCIUM | 10 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1196 | NDA/MAL/HDP/11746 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | ROZVAST 20 | ROSUVASTATIN CALCIUM | 20 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1197 | NDA/MAL/HDP/11747 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | SPASCOT | DROTAVERINE HYDROCHLORIDE | 20 MG/ML | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE | 18/12/2024 |
| 1198 | NDA/MAL/HDP/11748 | MICRO LABS LTD | LABOREX UGANDA LIMITED | SULFADOXINE & PYRIMETHAMINE | PYRIMETHAMINE+SULFADOXINE | 25 MG+500 MG | MICRO LABS LIMITED NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126, TAMIL NADU - INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0TABLET CONTAINER | 18/12/2024 |
| 1199 | NDA/MAL/HDP/11749 | SYNOKEM PHARMACEUTICALS LIMITED | BIOGEN PHARMA LIMITED | TRANSGEN | TRANEXAMIC ACID | 500 MG | M/S SYNOKEM PHARMACEUTICALS LIMITED PLOT NO. 35-36, SECTOR-6A, IIE, SIDCUL, RANIPUR, DISTT. HARIDWAR, UTTARAKHAND - INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1200 | NDA/MAL/HDP/11750 | BIOMATRIX HEALTHCARE PVT LTD. | MEDIWORLD PHARMA AFRICA LTD | WHITFIELD'S OINTMENT | BENZOIC ACID+SALICYLIC ACID | 6 %W/W+3 %W/W | NANZ MED SCIENCE PHARMA PRIVATE LIMITED RAMPUR GHAT, PAONTA SAHIB, DISTT. SIRMOUR - 173025, H.P. - INDIA | | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 18/12/2024 |
| 1201 | NDA/MAL/HDP/11751 | TENTH OF RAMADAN FOR PHARMACEUTICAL INDUSTRIES AND DIAGNOSTIC REAGENTS (RAMEDA) | GAMA PHARMACEUTICALS (U) LIMITED | ORDESCA 2.5 MG SYRUP | DESLORATADINE | 2.5 MG/5ML | THE TENTH OF RAMADAN FOR PHARMACEUTICAL INDUSTRIES AND DIAGNOSTIC REAGENTS (RAMEDA), SECOND INDUSTRIAL ZONE, PLOT NO. 5 SIX OF OCTOBER CITY, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 18/12/2024 |
| 1202 | NDA/MAL/HDP/11752 | SQUARE PHARMACEUTICALS LTD. | GAMA PHARMACEUTICALS (U) LIMITED | FLACOL | SIMETHICONE | 67 MG/ML | SQUARE PHARMACEUTICALS LIMITED SQUARE ROAD, SALGARIA, PABNA, 6600 - BANGLADESH | | BANGLADESH | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X15.0 ML BOTTLE | 18/12/2024 |
| 1203 | NDA/MAL/HDP/11753 | SQUARE PHARMACEUTICALS LIMITED | GAMA PHARMACEUTICALS (U) LIMITED | MAXPIME | CEFEPIME HYDROCHLORIDE | 1 G | SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT, KALIAKOIR, GAZIPUR - BANGLADESH | | BANGLADESH | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL+ 1.0*10.0 ML, LDPE CONTAINER OF WFI | 18/12/2024 |
| 1204 | NDA/MAL/HDP/11754 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DUO-DP | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40 MG + 320 MG | 1. AGOG PHARMA LIMITED PLOT NO. 33, SECTOR - II, THE VASAI TALUKA INDL. CO-OP. ESTATE LIMITED, GAURAI PADA, VASAI DIST - THANE INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*9TABLET BLISTER | 18/12/2024 |
| 1205 | NDA/MAL/HDP/11755 | WOCKHARDT LIMITED | KAMCARE PHARMA LIMITED | POWERCEF – T 1125 MG | CEFTRIAXONE SODIUM+TAZOBACTAM SODIUM | 1000 MG+125 MG | M/S ZEISS PHARMACEUTICALS PVT. LTD. 72, EXPORT PROMOTION INDUSTRIAL PARK, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN (HP) | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1125.0 MG VIAL | 18/12/2024 |
| 1206 | NDA/MAL/HDP/11756 | HOSPICE AFRICA UGANDA | HOSPICE AFRICA UGANDA LIMITED | ORAL MORPHINE SOLUTION | MORPHINE SULFATE | 5 MG/5ML | HOSPICE AFRICA (UGANDA) PRODUCTION UNIT PLOT 130 MAKINDYE ROAD, P.O BOX 7757 KAMPALA | | UGANDA | ORAL LIQUID ORDINARY LIQUID | 1.0X500.0 ML BOTTLE | 18/12/2024 |
| 1207 | NDA/MAL/HDP/11757 | BRAWN LABORATORIES LTD. | GOOD DAY PHARMACY LIMITED | BRUZOLIN | XYLOMETAZOLINE HYDROCHLORIDE | 0.1 %W/V | BRAWN LABORATORIES LIMITED 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIA | INDIA | NASAL TOPICAL DROPS | 1.0X1.0X15.0 ML BOTTLE | 18/12/2024 |
| 1208 | NDA/MAL/HDP/11758 | MARCYRL PHARMACEUTICAL INDUSTRIES | PREMIUM MEDICAL SERVICES LIMITED | BIOGEST 200MG | PROGESTERONE | 200 MG | MARCYRL PHARMACEUTICAL INDUSTRIES 2 PART NO 8-BLOCK 13033-1 INDUSTRIAL ZONE -EL OBOUR CITY EGYPT | | EGYPT | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X3.0X5.0 PESSARY STRIP | 18/12/2024 |
| 1209 | NDA/MAL/HDP/11759 | MARCYRL PHARMACEUTICAL INDUSTRIES | PREMIUM MEDICAL SERVICES LIMITED | BIOGEST 400 MG | PROGESTERONE | 400 MG | MARCYRL PHARMACEUTICAL INDUSTRIES 2 PART NO 8- BLOCK 13033-1 INDUSTRIAL ZONE-EL OBOUR CITY-CAIRO-EGYPT | | EGYPT | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X3.0X5.0 PESSARY STRIP | 18/12/2024 |
| 1210 | NDA/MAL/HDP/1176 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FUNGISAFE | TERBINAFINE HYDROCHLORIDE | 1%W/W | AMOUN PHARMACEUTICAL CO. S.A.E, 1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| 1211 | NDA/MAL/HDP/11760 | MARCYRL PHARMACEUTICAL INDUSTRIES | PREMIUM MEDICAL SERVICES LIMITED | BIOGEST 100 MG /2 ML | PROGESTERONE | 100 MG/2ML | MARCYRL PHARMACEUTICAL INDUSTRIES 2 PART NO 8- BLOCK 13033-1 INDUSTRIAL ZONE-EL OBOUR CITY-CAIRO-EGYPT | | EGYPT | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X2.0ML AMPOULE, 1.0X2.0X5.0X2.0 ML AMPOULE | 18/12/2024 |
| 1212 | NDA/MAL/HDP/11761 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ROSUCACH 20 | ROSUVASTATIN CALCIUM | 20 MG | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1213 | NDA/MAL/HDP/11762 | THE MADRAS PHARMACEUTICALS | MALIX PHARMA (U) LIMITED | ZEECET | CETIRIZINE HYDROCHLORIDE | 5 MG/5ML | THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA | | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0.X60.0 ML BOTTLE | 18/12/2024 |
| 1214 | NDA/MAL/HDP/11763 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | SPEGRA | DOLUTEGRAVIR SODIUM+EMTRICITABINE+TENOFOVIR ALAFENAMIDE | 50 MG + 200 MG + 25 MG | EMCURE PHARMACEUTICALS LIMITED (ORAL SOLID DIVISION & STERILE PRODUCT DIVISION) PLOT NO. P1 & P2, I.T.B.T., PHASE-II, PARK, M.I.D.C., HINJAWADI, PUNE - 411057, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 18/12/2024 |
| 1215 | NDA/MAL/HDP/11764 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LOXIBS H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1216 | NDA/MAL/HDP/11765 | PINNACLE LIFE SCIENCE PVT. LTD. | ABACUS PHARMA (AFRICA) LIMITED | ESOCID 20 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101, INDIA | | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1217 | NDA/MAL/HDP/11766 | HONG KONG VILUCK PHARMA LIMITED | BHL HEALTHCARE LIMITED | KINHEAL | KETOCONAZOLE + CLOBETASOL PROPIONATE + NEOMYCIN SULFATE | (10 MG + 0.25 MG + 5000 IU)/G | JIANGSU CHENPAI BOND PHARMACEUTICAL CO., LIMITED NO. 555, BEIJING EAST ROAD, HAIMEN, JIANGSU PROVINCE, CHINA | | CHINA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 18/12/2024 |
| 1218 | NDA/MAL/HDP/11767 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ROSUNA-20 | ROSUVASTATIN CALCIUM | 20 MG | ZOTA HEALTHCARE LIMITED PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT- 394230 GUJARA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1219 | NDA/MAL/HDP/11768 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZEDGRA 100 | SILDENAFIL CITRATE | 100 MG | ZOTA HEALTHCARE LIMITED PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT- 394230 GUJARA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 18/12/2024 |
| 1220 | NDA/MAL/HDP/11769 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ATRONA-40 | ATORVASTATIN CALCIUM | 40 MG | ZOTA HEALTHCARE LIMITED PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT- 394230 GUJARA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1221 | NDA/MAL/HDP/11770 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | RESCUWAVE | SALBUTAMOL SULFATE | 100 MCG /ACTUATION | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. B-25 MIDC, SHENDRA, AURANGABAD 431154, MAHARASHTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | I. 1*1*200METERED DOSE CANNISTER | 18/12/2024 |
| 1222 | NDA/MAL/HDP/11771 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | THROMBAN 2. 5 | APIXABAN | 2.5 MG | ZYDUS LIFESCIENCES KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1223 | NDA/MAL/HDP/11772 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PAINFORCE | IBUPROFEN | 100 MG/5ML | BIOMATRIX HEALTHCARE PRIVATE LIMITED SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD ? 382 220, | | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 18/12/2024 |
| 1224 | NDA/MAL/HDP/11774 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LYSOFLAM GEL | LINSEED OIL + DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + MENTHOL | 3.0% W/W + 1.16%W/W + 12.0% W/W + 5.5% W/W | 1. INDCHEMIE HEALTH SPECIALITIES PRIVATE LIMITED VILLAGE - THANA, BADDI, DISTT. SOLAN (H.P) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | I. 1*1*30G TUBE | 18/12/2024 |
| 1225 | NDA/MAL/HDP/11776 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LIMITED | PARIN-E | ENOXAPARIN SODIUM | 60 MG/0.6ML | VENUS REMEDIES LIMITED UNIT-II, HILL TOP INDUSTRIAL ESTATE, JHARMAJRI, EPIP PHASE - I (EXTENSION), BHATOLI KALAN, BADDI, HIMACHAL PRADESH (173205) INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.6 ML PREFILLED SYRINGE | 18/12/2024 |
| 1226 | NDA/MAL/HDP/11777 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LTD | FEXOLEB-180 | FEXOFENADINE HYDROCHLORIDE | 180 MG+180 MG | LEBEN LABORATORIES PRIVATE LIMITED PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA-444 104 (MS). - INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1227 | NDA/MAL/HDP/11778 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LTD | FEXOLEB ORAL SUSPENSION | FEXOFENADINE HYDROCHLORIDE | 30 MG/5ML+30 MG/5ML | LEBEN LABORATORIES PRIVATE LIMITED PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA-444 104 (MS). - INDIA | | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0ML BOTTLE | 18/12/2024 |
| 1228 | NDA/MAL/HDP/11779 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LTD | REGURG | METOCLOPRAMIDE HYDROCHLORIDE | 10 MG+10 MG | LEBEN LABORATORIES PRIVATE LIMITED PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA-444 104 (MS). - INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 18/12/2024 |
| 1229 | NDA/MAL/HDP/1178 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | TENOFOVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | HETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| 1230 | NDA/MAL/HDP/11780 | BIOGEN PHARMA LTD. | BIOGEN PHARMA LIMITED | ARTEGEN 30 | ARTESUNATE | 30 MG | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X30.0 MG VIAL+ 1.0 ML OF 5.0 %W/V SODIUM BICARBONATE AMPOULE + 5.0 ML OF 0.9% W/V SODIUM CHLORIDE AMPOULE | 18/12/2024 |
| 1231 | NDA/MAL/HDP/11781 | VIRCHOW HEALTHCARE PVT. LTD. | SURGIPHARM (U) LIMITED | V-IMMUNE | HUMAN NORMAL IMMUNOGLOBULIN | 50 G/L | VIRCHOW BIOTECH PRIVATE LIMITED SURVEY NO. 172 PART, GAGILLAPUR (V), DUNDIGAL GANDIMAISAMMA (M), MEDCHAL-MALKAJGIRI (D), TELENGANA (STATE)-500 043 | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 18/12/2024 |
| 1232 | NDA/MAL/HDP/11782 | DELMAW ENTERPRISES LTD | DELMAW ENTERPRISES LIMITED | DELCER | OMEPRAZOLE SODIUM | 40 MG | LINCOLN PHARMACEUTICAL LTD TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL | 18/12/2024 |
| 1233 | NDA/MAL/HDP/11783 | BIOGEN PHARMA LTD | BIOGEN PHARMA LIMITED | DEXAGEN | DEXAMETHASONE SODIUM PHOSPHATE | 4 MG/ML | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0*2.0 ML, CLEAR GLASS VAIL | 18/12/2024 |
| 1234 | NDA/MAL/HDP/11785 | BAROQUE PHARMACEUTICALS PRIVATE LIMITED | JEET PHARMACEUTICALS LIMITED | BENICLAV 625 | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 500 MG+125 MG | BAROQUE PHARMACEUTICALS PRIVATE LIMITED 192/2 & 3, 190/1 AND 202/9, AT. SOKHADA - 388620, TA.: KHAMBHAT DIST. ANAND, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0TABLET BLISTER | 18/12/2024 |
| 1235 | NDA/MAL/HDP/11786 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | BISCOT-10 | BISOPROLOL FUMARATE | 10 MG | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0TABLET BLISTER, 1X3X10TABLET BLISTER | 18/12/2024 |
| 1236 | NDA/MAL/HDP/11787 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | BISCOT-5 | BISOPROLOL FUMARATE | 5 MG | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0TABLET BLISTER, 1X3X10TABLET BLISTER | 18/12/2024 |
| 1237 | NDA/MAL/HDP/11788 | UNIVERSAL CORPORATION LIMITED | DELMAW ENTERPRISES LIMITED | CHX | CHLORHEXIDINE GLUCONATE | 0.2 %W/V | UNIVERSAL CORPORATION LIMITED CLUB ROAD, PAST POST OFFICE, PLOT NO. 13777, P.O. BOX 1748-00902, KIKUYU TOWN - KENYA | KENYA | ORAL TOPICAL LIQUIDS | 1.0X1.0X200.0ML BOTTLE | 18/12/2024 |
| 1238 | NDA/MAL/HDP/11789 | DAWA LIMITED | SUPER MEDIC LTD | DAPAFLO -10MG TABLETS | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 10 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1239 | NDA/MAL/HDP/1179 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | OVITRELLE | CHORIOGONADOTROPIN ALFA | 250MCG/0.5ML | MERCK SERONO S.P.A, VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY| MERCK SERONO SA, 1170 AUBONNE(SWITZERLAND) | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON | 01/07/2015 |
| 1240 | NDA/MAL/HDP/11790 | DAWA LIMITED | SUPER MEDIC LTD | DAPAFLO -5MG TABLETS | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 5 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1241 | NDA/MAL/HDP/11791 | DAWA LIMITED | SUPER MEDIC LTD | DAPAFLO M 5/1000 MG | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE + METFORMIN HYDROCHLORIDE | 5 MG + 1000 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1242 | NDA/MAL/HDP/11792 | DAWA LIMITED | SUPER MEDIC LTD | DAPAFLO M 500 TABLETS | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE + METFORMIN HYDROCHLORIDE | 5 MG + 500 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1243 | NDA/MAL/HDP/11793 | LUPIN LIMITED | AIVEEN (U) LIMITED | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE TABLETS 50MG/ 300MG/ 25MG | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR ALAFENAMIDE FUMARATE | 50 MG + 300 MG + 25 MG | 1. LUPIN LIMITED NAGPUR PLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*30TABLET CONTAINER II. 1*90TABLET CONTAINER | 18/12/2024 |
| 1244 | NDA/MAL/HDP/11794 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | EMFANEF | EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE + EFAVIRENZ | 200 MG + 25 MG + 400 MG | 1. MYLAN LABORATORIES LIMITED PLOT NO. 11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR - 454775, DIST.- DHAR, MADHYA PRADESH INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*30TABLET CONTAINER | 18/12/2024 |
| 1245 | NDA/MAL/HDP/11795 | AJANTA PHARMA LIMITED. | ASTRA PHARMA (U) LIMITED | EMPADIL M 12.5/500 | EMPAGLIFLOZIN+METFORMIN HYDROCHLORIDE | 12.5 MG+500 MG | AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0TABLET BLISTER | 18/12/2024 |
| 1246 | NDA/MAL/HDP/11796 | AJANTA PHARMA LIMITED. | ASTRA PHARMA (U) LIMITED | EMPADIL M 5/1000 | EMPAGLIFLOZIN+METFORMIN HYDROCHLORIDE | 1000 MG+5 MG | AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0TABLET BLISTER | 18/12/2024 |
| 1247 | NDA/MAL/HDP/11797 | AJANTA PHARMA LIMITED. | ASTRA PHARMA (U) LIMITED | EMPADIL M 5/500 | EMPAGLIFLOZIN+METFORMIN HYDROCHLORIDE | 5 MG+500 MG | AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0TABLET BLISTER | 18/12/2024 |
| 1248 | NDA/MAL/HDP/11798 | DAWA LIMITED | SUPER MEDIC LTD | EMPAFLO M 12.5/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 12.5 MG + 1000 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1249 | NDA/MAL/HDP/11799 | DAWA LIMITED | SUPER MEDIC LTD | EMPAFLO M 12.5/500 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 12.5 MG + 500 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1250 | NDA/MAL/HDP/11800 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | GLIPINN M 50/1000 | METFORMIN HYDROCHLORIDE+SITAGLIPTIN PHOSPHATE MONOHYDRATE | 1000 MG+50 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0TABLET BLISTER | 18/12/2024 |
| 1251 | NDA/MAL/HDP/11801 | PINNACLE LIFE SCIENCE PVT LTD. | METRO PHARMACEUTICALS LIMITED | GLIPINN M 50/850 | METFORMIN HYDROCHLORIDE+SITAGLIPTIN PHOSPHATE MONOHYDRATE | 850 MG+50MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0TABLET BLISTER | 18/12/2024 |
| 1252 | NDA/MAL/HDP/11802 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | GYNO V6 | CLOTRIMAZOLE | 100 MG | 1. AKRITI PHARMACEUTICAL PRIVATE LIMITED D-10 AND D-11, M.I.D.C. JEJURI - NIRA ROAD, JEJURI. TALUKA: PURANDAR, DIST. PUNE, 412 303, MAHARASHTRA STATE INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | VAGINAL TABLETS | I. 1*1*6TABLET BLISTER | 18/12/2024 |
| 1253 | NDA/MAL/HDP/11805 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. (EIPICO0 | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NOSTAMINE EYE/NOSE DROPS | CHLORPHENAMINE MALEATE+NAPHAZOLINE HYDROCHLORIDE | 0.5 MG/ML+0.5 MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. (EIPICO) 10TH RAMADHAN CITY INDUSTRIAL AREA-B1 | EGYPT | OPHTHALMIC LIQUIDS | 1.0X1.0X15.0ML CONTAINER | 18/12/2024 |
| 1254 | NDA/MAL/HDP/11806 | MEDOHOUSE | NUGEN PHARMACEUTICALS UGANDA LIMITED | NUDOPA | METHYLDOPA | 250 MG | MEDOPHARM NO. 34-B, INDUSTRIAL AREA, MALUR - 563 160, KARNATAKA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0TABLET BLISTER | 18/12/2024 |
| 1255 | NDA/MAL/HDP/11807 | GLAXOSMITHKLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL EXTRA SOLUBLE | CAFFEINE+PARACETAMOL | 65 MG+500 MG | GLAXOSMITHKLINE DUNGARVAN LIMITED, DUNGARVAN, CO. WATERFORD | IRELAND | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X6.0X4.0TABLET STRIP | 18/12/2024 |
| 1256 | NDA/MAL/HDP/11808 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | SULPHATRIM | SULFAMETHOXAZOLE+TRIMETHOPRIM | 40 MG/5ML+200 MG/5ML | LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0ML BOTTLE | 18/12/2024 |
| 1257 | NDA/MAL/HDP/11809 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICALS LIMITED | SURGIVID | METHYL SALICYLATE | 0.5 %W/V | MAVID PHARMACEUTICALS INDUSTRIES LIMITED PLOT 490 BIRONGO OFF KIGO ROAD, ENTEBBE MUNYONYO EXPRESS HIGHWAY, WAKISO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0ML BOTTLE | 18/12/2024 |
| 1258 | NDA/MAL/HDP/11810 | NOBEL LLAC SAN. VE TIC. A.S | DELMAW ENTERPRISES LIMITED | VESIFIX 5 MG | SOLIFENACIN SUCCINATE | 5 MG | NOBEL LLAC SAN. VE TIC. A.S ESKI AKCAKOCA CADDESI NO: 299 SANCAKLAR MAHALLESI 81100 DUZCE | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0TABLET BLISTER | 18/12/2024 |
| 1259 | NDA/MAL/HDP/11811 | DAWA LIMITED | SUPER MEDIC LTD | VIGLIPTIN 50MG | VILDAGLIPTIN | 50 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 18/12/2024 |
| 1260 | NDA/MAL/HDP/11812 | FINA HEALTHCARE PRIVATE LIMITED | PHARMA VILLE LIMITED | WELLFINA | IBUPROFEN | 400 MG | CENTURION LABORATORIES PRIVATE LIMITED P-2, BIO-TECH PARK, MANJUSAR, TAL: SAVALI, VADADORA -391775 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0TABLET BLISTER | 18/12/2024 |
| 1261 | NDA/MAL/HDP/11813 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZALASTIN | AZELASTINE HYDROCHLORIDE | 1 MG/ML | AMMAN PHARMACEUTICAL INDUSTRIES KING ABDULLAH II IND. ESTATE - SAHAB - AMMAN | JORDAN | NASAL TOPICAL METERED DOSE AEROSOLS | 1.0X1.0X10.0ML BOTTLE | 18/12/2024 |
| 1262 | NDA/MAL/HDP/11814 | C & D PHARMA | KAMCARE PHARMA LIMITED | ZICOSUN 120MG | ARTESUNATE | 120 MG | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X120.0MG VIAL | 18/12/2024 |
| 1263 | NDA/MAL/HDP/11815 | C & D PHARMA | KAMCARE PHARMA LIMITED | ZICOSUN 60 | ARTESUNATE | 60 MG | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0MG VIAL | 18/12/2024 |
| 1264 | NDA/MAL/HDP/11816 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NOPYLO KIT | AMOXICILLIN TRIHYDRATE + CLARITHROMYCIN + OMEPRAZOLE | 500 MG + 500 MG + 20 MG | 1. UNI MEDICOLABS UNI MEDICOLABS, PLOT NO. 21-22, PHARMACITY, SELAQUI, DEHRADUN - 248011 UTTARAKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*7*8CAPSULE STRIP | 18/12/2024 |
| 1265 | NDA/MAL/HDP/11817 | BRAWN LABORATORIES LIMITED | TATA UGANDA LIMITED | LUMIART-20 | ARTEMETHER+LUMEFANTRINE | 120 MG+120 MG+120 MG+20 MG+20 MG+20 MG | BRAWN LABORATORIES LIMITED 13, N.I.T., INDUSTRIAL AREA, FARIDABAD - 12001, HARYANA - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER | 18/12/2024 |
| 1266 | NDA/MAL/HDP/11818 | DAWA LIMITED | SUPER MEDIC LTD | PROPRIDE | ITOPRIDE HYDROCHLORIDE | 150 MG+150 MG | DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 18/12/2024 |
| 1267 | NDA/MAL/HDP/11819 | DAWA LIMITED | SUPER MEDIC LTD | NERVILIN 150 | PREGABALIN | 150 MG+150 MG | DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 18/12/2024 |
| 1268 | NDA/MAL/HDP/11820 | HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LIMITED) | TATA UGANDA LIMITED | VAXTAR-5™ | DIPHTHERIA TOXOID + TETANUS TOXOID + INACTIVATED WHOLE CELL BORDETELLA PERTUSSIS + HEPATITIS B SURFACE ANTIGEN (RDNA) + HIB POLYSACCHARIDE COVALENTLY BOUND TO TT (PRP-TT) | (? 30 IU (? 20 LF TO ?30 LF) + ? 60 IU (? 5 LF TO ? 25 LF) + > 4 IU + >10 µG + >10 µG)0.5 ML | HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LIMITED) RAKSHAPURAM, GACHIBOWLI POST, HYDERABAD - 500032, TELANGANA | INDIA | PARENTERAL ORDINARY VIALS | I. 1*1*0.5ML VIAL | 18/12/2024 |
| 1269 | NDA/MAL/HDP/11821 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LTD | CEBAY 400 | CEFIXIME TRIHYDRATE | 400 MG | LEBEN LABORATORIES PRIVATE LIMITED PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA-444 104 (MS). | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*1*10TABLET BLISTER | 06/05/2025 |
| 1270 | NDA/MAL/HDP/11822 | JOSHPA AFRICA LTD | AAFIYA (A) LIMITED | AAFISUNATE 120 MG | ARTESUNATE | 120 MG/VIAL | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*120MG VIAL + 1*2ML AMPOULE 5%W/V SODIUM BICARBONATE + 1*10ML AMPOULE 0.9%W/V SODIUM CHLORIDE | 06/05/2025 |
| 1271 | NDA/MAL/HDP/11823 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | APREZO™ 30 | APREMILAST | 30 MG | GLENMARK PHARMACEUTICALS LIMITED, PITHAMPUR PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER II. 1*4*14TABLET BLISTER | 06/05/2025 |
| 1272 | NDA/MAL/HDP/11825 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | CELCOLE 200 | CELECOXIB | 200 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101, | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 06/05/2025 |
| 1273 | NDA/MAL/HDP/11826 | AJANTA PHARMA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | CINOD 5 | CILNIDIPINE | 5 MG | AJANTA PHARMA LIMITED MIRZA - PALASHBARI ROAD, VILLAGE - KOKJHAR, PALASHBARI - 781128 KAMRUP (R. ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1274 | NDA/MAL/HDP/11827 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | CLOPA | CLOPIDOGREL BISULFATE | 75 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1275 | NDA/MAL/HDP/11828 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | ECITAPRAM-20 | ESCITALOPRAM OXALATE | 20 MG | LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1276 | NDA/MAL/HDP/11829 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO., LTD | TRIDEM PHARMA UGANDA LIMITED | GNOPAR 80MG/0.8ML | ENOXAPARIN SODIUM | 80 MG/0.8ML | GLAND PHARMA LIMITED SY. NO. 143-148, 150 & 151 NEAR GANDIMAISAMMA CROSS ROADS, D.P. PALLY DUNDIGAL POST, DUNDIGAL GANDIMAISAMMA MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500 043, TELANGANA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | I. 1*2*0.8ML PREFILLED SYRINGE | 06/05/2025 |
| 1277 | NDA/MAL/HDP/11831 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MONOASTHAL | THIOPENTAL SODIUM | 1 G/VIAL | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*1G VIAL | 06/05/2025 |
| 1278 | NDA/MAL/HDP/11832 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | QUITIDE 200 | QUETIAPINE FUMARATE | 200 MG | AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1279 | NDA/MAL/HDP/11833 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | ZINCAT-OD | ZINC SULFATE MONOHYDRATE | 20 MG/5ML | ATCO LABORATORIES LIMITED B-18, S.I.T.E, KARACHI - 75700 | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | I. 1*1*60ML BOTTLE | 06/05/2025 |
| 1280 | NDA/MAL/HDP/11834 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VACODIL 6.25 | CARVEDILOL | 6.25 MG | AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1281 | NDA/MAL/HDP/11835 | UNOSOURCE PHARMA LIMITED | MEDVIN PHARMA LIMITED | UNOGRANI | GRANISETRON HYDROCHLORIDE | 1 MG/ML | AKUMS DRUGS AND PHARMACEUTICALS LIMITED 2, 3, 4 & 5, SEC. 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR 249403, UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*10*3ML AMPOULE | 06/05/2025 |
| 1282 | NDA/MAL/HDP/11836 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B.CHEMICALS & PHARMACEUTICALS LTD.) | PLANET PHARMACEUTICALS UGANDA LTD | TOPLOVIR | ACICLOVIR | 5 %W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J. B. CHEMICALS AND PHARMACEUTICALS LIMITED) PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*1*2G TUBE II. 1*1*10G TUBE | 06/05/2025 |
| 1283 | NDA/MAL/HDP/11837 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TIMOMED | TIMOLOL MALEATE | 0.5 %W/V | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | INDIA | OPHTHALMIC DROPS | I. 1*1*10ML BOTTLE | 06/05/2025 |
| 1284 | NDA/MAL/HDP/11838 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TARIVA 20 MG | RIVAROXABAN | 20 MG | CIPLA LIMITED INDORE (UNIT I, II, III, IV). PLOT NO. 9 & 10 INDORE SPECIAL ECONOMIC ZONE, PHASE-II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 06/05/2025 |
| 1285 | NDA/MAL/HDP/11839 | PANACEA BIOTEC PHARMA LIMITED | VITACARE LIMITED | RIZAPAN 10 | RIZATRIPTAN BENZOATE | 10 MG | PANACEA BIOTEC PHARMA LIMITED MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH 173205 | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | I. 1*6*3TABLET BLISTER | 06/05/2025 |
| 1286 | NDA/MAL/HDP/11840 | PANACEA BIOTEC PHARMA LIMITED | VITACARE LIMITED | RIZAPAN 5 | RIZATRIPTAN BENZOATE | 5 MG | PANACEA BIOTEC PHARMA LIMITED MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH 173205 | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | I. 1*6*3TABLET BLISTER | 06/05/2025 |
| 1287 | NDA/MAL/HDP/11842 | MISSIONPHARMA A/S VAS | LABOREX UGANDA LIMITED | PYRIDOXINE | PYRIDOXINE HYDROCHLORIDE | 25 MG | MEDOPHARM NO. 34-B, INDUSTRIAL AREA, MALUR - 563 160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1000TABLET CONTAINER | 06/05/2025 |
| 1288 | NDA/MAL/HDP/11843 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | SCOTAMOL | PARACETAMOL | 150 MG/ML | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*2*5*2ML AMPOULE | 06/05/2025 |
| 1289 | NDA/MAL/HDP/11844 | RATNATRIS PHARMACEUTICALS PVT. LTD | JEET PHARMACEUTICALS LIMITED | RATNAZY 250 | AZITHROMYCIN | 250 MG | RATNATRIS PHARMACEUTICALS PRIVATE LIMITED - SURVEY NO. 416, AT. - INDRAD, TA. - KADI, DIST. - MEHSANA, PIN. 382715 GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*6TABLET BLISTER | 06/05/2025 |
| 1290 | NDA/MAL/HDP/11845 | RATNATRIS PHARMACEUTICALS PVT. LTD | JEET PHARMACEUTICALS LIMITED | RATNAZY 500 | AZITHROMYCIN | 500 MG | RATNATRIS PHARMACEUTICALS PRIVATE LIMITED - SURVEY NO. 416, AT. - INDRAD, TA. - KADI, DIST. - MEHSANA, PIN. 382715 GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*6TABLET BLISTER | 06/05/2025 |
| 1291 | NDA/MAL/HDP/11847 | ASTRAZENECA AB | MACNAUGHTON LIMITED | TAGRISSO 40 MG | OSIMERTINIB MESYLATE | 40 MG | ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | SWEDEN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1292 | NDA/MAL/HDP/11848 | ASTRAZENECA AB | MACNAUGHTON LIMITED | TAGRISSO 80 MG | OSIMERTINIB MESYLATE | 80 MG | ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | SWEDEN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1293 | NDA/MAL/HDP/11849 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | LEV-Q 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | MEDOPHARM NO. 34-B, INDUSTRIAL AREA, MALUR - 563 160, KARNATAKA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*5TABLET BLISTER | 06/05/2025 |
| 1294 | NDA/MAL/HDP/1185 | DAWA LIMITED | SUPER MEDIC LTD | DACOF DRY | DIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL | 12.5MG + 6.5MG + 1.10MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 1295 | NDA/MAL/HDP/11851 | MEDISEL (K) LTD | AIVEEN (U) LIMITED | AMTEL 80/10 | TELMISARTAN + AMLODIPINE BESILATE | 80MG+10MG | CORONA REMEDIES PRIVATE LIMITED VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P.) 173 223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET STRIP | 06/05/2025 |
| 1296 | NDA/MAL/HDP/11852 | ASPIRO PHARMA LIMITED | AIVEEN (U) LIMITED | ACUDOL 15 | KETOROLAC TROMETHAMINE | 15 MG/ML | M/S ASPIRO PHARMA LIMITED PLOT NO. 23, SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA (VILLAGE), MARKOOK MANDAL, SIDDIPET | INDIA | PARENTERAL ORDINARY VIALS | I. 1*1*2ML VIAL | 06/05/2025 |
| 1297 | NDA/MAL/HDP/11853 | ASPIRO PHARMA LIMITED | AIVEEN (U) LIMITED | ACUDOL 30 | KETOROLAC TROMETHAMINE | 30 MG/ML | M/S ASPIRO PHARMA LIMITED PLOT NO. 23, SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA (VILLAGE), MARKOOK MANDAL, SIDDIPET | INDIA | PARENTERAL ORDINARY VIALS | I. 1*1*2ML VIAL | 06/05/2025 |
| 1298 | NDA/MAL/HDP/11854 | PULSE PHARMACEUTICALS PVT. LTD | DELMAW ENTERPRISES LIMITED | EPINEXT 500 | LEVETIRACETAM | 500 MG | PULSE PHARMACEUTICALS PRIVATE LIMITED KHASRA NO. 400, 407 & 409, KARONDI, ROORKEE - 247667, DISTRICT: HARIDWAR, UTTARKHAND | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1299 | NDA/MAL/HDP/11855 | VRUSHIK INVESTMENTS LIMITED | VRUSHIK INVESTMENT LIMITED | ARTEMAK-60 | ARTESUNATE | 60 MG | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*60MG VIAL + 1*1ML AMPOULE 5%W/V SODIUM BICARBONATE + 1*5ML AMPOULE 0.9%W/V SODIUM CHLORIDE | 06/05/2025 |
| 1300 | NDA/MAL/HDP/11856 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AURITZ 10 | ROSUVASTATIN CALCIUM | 10 MG | INVENTIA HEALTHCARE LIMITED F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1301 | NDA/MAL/HDP/11857 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AURITZ 20 | ROSUVASTATIN CALCIUM | 20 MG | INVENTIA HEALTHCARE LIMITED F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1302 | NDA/MAL/HDP/11858 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ESEM 2.5 | AMLODIPINE BESILATE | 2.5 MG | 1. MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1303 | NDA/MAL/HDP/11859 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ESEM 5 | AMLODIPINE BESILATE | 5 MG | 1. MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1304 | NDA/MAL/HDP/1186 | DAWA LIMITED | SUPER MEDIC LTD | DACOF EXPECTORANT | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL | 14.0MG + 135.0MG + 57.0MG + 1.10MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 1305 | NDA/MAL/HDP/11860 | KHANDELWAL LABORATORIES PVT. LTD, | SURGIPHARM (U) LIMITED | GEMPOWER 1000 | GEMCITABINE HYDROCHLORIDE | 1 G/VIAL | M/S KHANDELWAL LABORATORIES PRIVATE LIMITED B-1, WAGLE INDUSTRIAL ESTATE THANE 400604 | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*50ML VIAL | 06/05/2025 |
| 1306 | NDA/MAL/HDP/11861 | KHANDELWAL LABORATORIES PVT. LTD, | SURGIPHARM (U) LIMITED | GEMPOWER 200 | GEMCITABINE HYDROCHLORIDE | 200 MG/VIAL | M/S KHANDELWAL LABORATORIES PRIVATE LIMITED B-1, WAGLE INDUSTRIAL ESTATE THANE 400604 | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*10ML VIAL | 06/05/2025 |
| 1307 | NDA/MAL/HDP/11862 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | LUCOZOL | LULICONAZOLE | 1 %W/W | LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*1*30G TUBE | 06/05/2025 |
| 1308 | NDA/MAL/HDP/11863 | MEDOCHEMIE LIMITED | LABOREX UGANDA LIMITED | MEDORISPER | RISPERIDONE | 2 MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY) 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL| MEDOCHEMIE LIMITED (AZ FACILITY) AGIOS ATHANASSIOS INDUSTRIAL AREA, MICHAIL IRAKLEOUS 2, AGIOS ATHANASSIOS, LIMASSOL, 4101 - | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*10TABLET BLISTER | 06/05/2025 |
| 1309 | NDA/MAL/HDP/11864 | UNICHEM LABORATORIES LTD. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 457 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 400 MG/5ML + 57 MG/5ML | 1. UNICHEM LABORATORIES LIMITED (UNIT I) VILLAGE BHATAULI KALAN, THE BADDI, DISTT. SOLAN, HIMACHAL PRADESH - 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*125ML BOTTLE | 06/05/2025 |
| 1310 | NDA/MAL/HDP/11865 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | NEUGALIN 75 | PREGABALIN | 75 MG | THE ACME LABORATORIES LIMITED DHULIVITA, DHAMRAI, DHAKA-1350, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1311 | NDA/MAL/HDP/11866 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | NOVAMENTIN 156.25MG/5ML | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 125 MG/5ML + 31.25 MG/5ML | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*100ML BOTTLE | 06/05/2025 |
| 1312 | NDA/MAL/HDP/11867 | PULSE PHARMACEUTICALS PVT. LTD | DELMAW ENTERPRISES LIMITED | EPINEXT 750 | LEVETIRACETAM | 750 MG | PULSE PHARMACEUTICALS PRIVATE LIMITED KHASRA NO. 400, 407 & 409, KARONDI, ROORKEE - 247667, DISTRICT: HARIDWAR, UTTARKHAND | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1313 | NDA/MAL/HDP/11868 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | PROLOXIN | CIPROFLOXACIN HYDROCHLORIDE | 3.5 MG/ML | ATCO LABORATORIES LIMITED B-18, S.I.T.E, KARACHI - 75700 | PAKISTAN | OPHTHALMIC/OTIC DROPS | I. 1*1*5ML BOTTLE | 06/05/2025 |
| 1314 | NDA/MAL/HDP/11869 | S KANT HEALTHCARE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | SKAZI 200 | AZITHROMYCIN DIHYDRATE | 200 MG/5ML | S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*15ML BOTTLE | 06/05/2025 |
| 1315 | NDA/MAL/HDP/11870 | ARCELIA LIFE SCIENCES LTD | NOVOMED HEALTHCARE LIMITED | WANE 60 | ENOXAPARIN SODIUM | 60 MG/0.6ML | MAKCUR LABORATORIES LIMITED 46/4-7, DEHGAM ROAD, ZAK VILLAGE, TAL: DEHGAM, DIST.: GANDHINAGAR - 382330, GUJARAT | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | I. 1*1*0.6ML PREFILLED SYRINGE | 06/05/2025 |
| 1316 | NDA/MAL/HDP/11871 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ZIMARC-500 | AZITHROMYCIN DIHYDRATE | 500 MG | M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*3TABLET BLISTER | 06/05/2025 |
| 1317 | NDA/MAL/HDP/11872 | RATNATRIS PHARMACEUTICALS PVT. LTD | JEET PHARMACEUTICALS LIMITED | RATAFAN-L | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | RATNATRIS PHARMACEUTICALS PRIVATE LIMITED - SURVEY NO. 416, AT. - INDRAD, TA. - KADI, DIST. - MEHSANA, PIN. 382715 GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*24TABLET BLISTER | 06/05/2025 |
| 1318 | NDA/MAL/HDP/11873 | NVS KENYA LIMITED | SURGIPHARM (U) LIMITED | OLEPTISS 90MG | DEFERASIROX | 90 MG | NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG|NOVARTIS PHARMA PRODUKTIONS GMBH OEFLINGERSTRASSE 44, 79664 WEHR| SANDOZ S.R.L. STR. LIVEZENI NR. 7A 540472 TARGU-MURES | SWITZERLAND|GERMANY|ROMANIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1319 | NDA/MAL/HDP/11874 | NVS KENYA LIMITED | SURGIPHARM (U) LIMITED | OLEPTISS 180MG | DEFERASIROX | 180 MG | NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG|NOVARTIS PHARMA PRODUKTIONS GMBH OEFLINGERSTRASSE 44, 79664 WEHR| SANDOZ S.R.L. STR. LIVEZENI NR. 7A 540472 TARGU-MURES | SWITZERLAND|GERMANY|ROMANIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1320 | NDA/MAL/HDP/11875 | NVS KENYA LIMITED | SURGIPHARM (U) LIMITED | OLEPTISS 360MG | DEFERASIROX | 360 MG | NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG|NOVARTIS PHARMA PRODUKTIONS GMBH OEFLINGERSTRASSE 44, 79664 WEHR| SANDOZ S.R.L. STR. LIVEZENI NR. 7A 540472 TARGU-MURES | SWITZERLAND|GERMANY|ROMANIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1321 | NDA/MAL/HDP/11876 | LUPIN LIMITED | AIVEEN (U) LTD | RIFAPENTINE TABLETS 300 MG | RIFAPENTINE | 300 MG | LUPIN LIMITED A-28/1, MIDC, CHIKALTHANA, AURANGABAD - 431210, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET STRIP | 06/05/2025 |
| 1322 | NDA/MAL/HDP/11877 | FDC LIMITED | AIVEEN (U) LTD | DRY C COUGH SYRUP | DEXTROMETHORPHAN HYDROBROMIDE | 15 MG/5ML | 1. FDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ, AURANGABAD, 431136 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*1*100ML BOTTLE | 06/05/2025 |
| 1323 | NDA/MAL/HDP/11878 | JEET PHARMACEUTICALS LTD | JEET PHARMACEUTICALS LIMITED | TORVAS 10 | ATORVASTATIN CALCIUM TRIHYDRATE | 10 MG | RATNATRIS PHARMACEUTICALS PRIVATE LIMITED - SURVEY NO. 416, AT. - INDRAD, TA. - KADI, DIST. - MEHSANA, PIN. 382715 GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1324 | NDA/MAL/HDP/11879 | JEET PHARMACEUTICALS LTD | JEET PHARMACEUTICALS LIMITED | TORVAS 20 | ATORVASTATIN CALCIUM TRIHYDRATE | 20 MG | RATNATRIS PHARMACEUTICALS PRIVATE LIMITED - SURVEY NO. 416, AT. - INDRAD, TA. - KADI, DIST. - MEHSANA, PIN. 382715 GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1325 | NDA/MAL/HDP/1188 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | GMYCIN-80 | GENTAMYCIN SULPHATE | 80MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE | 01/07/2013 |
| 1326 | NDA/MAL/HDP/11881 | BIOSIDUS S.A | ONCOPHARM (U) LTD | HEMAX 2000 I.U | RECOMBINANT HUMAN ERYTHROPOIETIN | 2000 IU/ML | BIOSIDUS S.A. - BERNAL PLANT AV. LOS QUILMES 137, BERNAL (B1883FIB), PROVINCE OF BUENOS AIRES | ARGENTINA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*4000I.U VIAL + 1*2ML AMPOULE WATER FOR INJECTION + 1*3ML SYRINGE FOR INJECTION + 1*2 NEEDLES FOR INJECTION | 06/05/2025 |
| 1327 | NDA/MAL/HDP/11882 | BIOSIDUS S.A | ONCOPHARM (U) LTD | HEMAX 4000 I.U | RECOMBINANT HUMAN ERYTHROPOIETIN | 4000 IU/ML | BIOSIDUS S.A. - BERNAL PLANT AV. LOS QUILMES 137, BERNAL (B1883FIB), PROVINCE OF BUENOS AIRES | ARGENTINA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*8000I.U VIAL + 1*2ML AMPOULE WATER FOR INJECTION + 1*3ML SYRINGE FOR INJECTION + 1*2 NEEDLES FOR INJECTION | 06/05/2025 |
| 1328 | NDA/MAL/HDP/11883 | BIOSIDUS S.A | ONCOPHARM (U) LTD | HEMAX 10000 I.U | RECOMBINANT HUMAN ERYTHROPOIETIN | 10,000 IU/ML | BIOSIDUS S.A. - BERNAL PLANT AV. LOS QUILMES 137, BERNAL (B1883FIB), PROVINCE OF BUENOS AIRES | ARGENTINA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*20,000I.U VIAL + 1*2ML AMPOULE WATER FOR INJECTION + 1*3ML SYRINGE FOR INJECTION + 1*2 NEEDLES FOR INJECTION | 06/05/2025 |
| 1329 | NDA/MAL/HDP/11884 | BIOSIDUS S.A | ONCOPHARM (U) LTD | HEMAX 20000 I.U | RECOMBINANT HUMAN ERYTHROPOIETIN | 20,000 IU/ML | BIOSIDUS S.A. - BERNAL PLANT AV. LOS QUILMES 137, BERNAL (B1883FIB), PROVINCE OF BUENOS AIRES | ARGENTINA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*40,000I.U VIAL + 1*2ML AMPOULE WATER FOR INJECTION + 1*3ML SYRINGE FOR INJECTION + 1*2 NEEDLES FOR INJECTION | 06/05/2025 |
| 1330 | NDA/MAL/HDP/11885 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APMALT | IRON (III) HYDROXIDE POLYMALTOSE COMPLEX | 100 MG | AJANTA PHARMA LIMITED GU NO. 11/12/14/15, CHITEGAON, PAITHAN ROAD, AURANGABAD - 431105, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | I. 1*1*12TABLET CONTAINER | 06/05/2025 |
| 1331 | NDA/MAL/HDP/11886 | UNIZA LIFECARE PRIVATE LIMITED | LEGIT MEDEQ 2007 LIMITED | FLUNIZA 200 | FLUCONAZOLE | 200 MG | UNIZA LIFECARE PRIVATE LIMITED SR. NO. 919/7, (OLD SR. NO. 404), KADI-DETROJ ROAD, BALASAR TAL: KADI, DISTRICT: MEHSANA, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*1*1CAPSULE BLISTER | 06/05/2025 |
| 1332 | NDA/MAL/HDP/11887 | UNIZA LIFECARE PRIVATE LIMITED | LEGIT MEDEQ 2007 LIMITED | FLUNIZA 150 | FLUCONAZOLE | 150 MG | UNIZA LIFECARE PRIVATE LIMITED SR. NO. 919/7, (OLD SR. NO. 404), KADI-DETROJ ROAD, BALASAR TAL: KADI, DISTRICT: MEHSANA, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*1CAPSULE BLISTER | 06/05/2025 |
| 1333 | NDA/MAL/HDP/11888 | BEKRA PHARMA UK LTD | MULTIPHAR UGANDA LIMITED | SEKALGIC | IBUPROFEN + PARACETAMOL | 100 MG/5ML + 125 MG/5ML | BAROQUE PHARMACEUTICALS PRIVATE LIMITED 192/2 & 3, 190/1 AND 202/9, AT. SOKHADA - 388620, TA.: KHAMBHAT DIST. ANAND, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*100ML BOTTLE | 06/05/2025 |
| 1334 | NDA/MAL/HDP/11889 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MAGNEISUM SULPHATE INJECTION BP | MAGNESIUM SULFATE | 50 %W/V | CIRON DRUGS & PHARMACEUTICALS PRIVATE LIMITED N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, PALGHAR 40506, MAHARASHTRA STATE | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*10*10ML AMPOULE | 06/05/2025 |
| 1335 | NDA/MAL/HDP/1189 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | DICLOMAX-75 | DICLOFENAC SODIUM | 75MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE | 01/07/2013 |
| 1336 | NDA/MAL/HDP/11890 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | FLOZIP-M | DAPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 5 MG + 1000 MG | PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 ? 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH ? 174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1337 | NDA/MAL/HDP/11892 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CHLORPROMAZINE TABLETS BP 100 MG | CHLORPROMAZINE HYDROCHLORIDE | 100 MG | CIRON DRUGS AND PHARMACEUTICALS LIMITED PLOT 35-37, 43-45 CFC-B, DIWAN UDHYOG NAGAR, ALIYALI, PALGAR, THANE, 401404 MAHARASTRA €“ | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1338 | NDA/MAL/HDP/11894 | STALLION LABORATORIES PVT. LTD. | ROYAL PHARMA 2011 LIMITED | LIPLOW 40 | ATORVASTATIN CALCIUM | 40 MG | STALLION LABORATORIES PRIVATE LIMITED C-B, 305/2, 3, 4 & 5, G.I.D.C KERALA (BAVLA), AHMEDABAD-382 220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1339 | NDA/MAL/HDP/11895 | AJANTA PHARMA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | EMPADIL M 12.5/1000 | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 12.5 MG + 1000 MG | AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1340 | NDA/MAL/HDP/11896 | DAWA LIMITED | SUPER MEDIC LTD | VIGLIPTIN M 50/1000MG | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1341 | NDA/MAL/HDP/11897 | DAWA LIMITED | SUPER MEDIC LTD | VIGLIPTIN M 50/500MG | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1342 | NDA/MAL/HDP/11898 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EPSYLAM DT 50 | LAMOTRIGINE | 50 MG | AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1343 | NDA/MAL/HDP/11899 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EPSYLAM DT 100 | LAMOTRIGINE | 100 MG | AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1344 | NDA/MAL/HDP/11901 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CASTOR OIL | CASTOR OIL | 100%/ML | AMMAN PHARMACEUTICAL INDUSTRIES KING ABDULLAH II IND. ESTATE - SAHAB - AMMAN | JORDAN | ORAL LIQUID ORDINARY OILS | I. 1*60ML BOTTLE | 06/05/2025 |
| 1345 | NDA/MAL/HDP/11902 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CARDIPIN 20 MG | NIFEDIPINE | 20 MG | STALLION LABORATORIES PRIVATE LIMITED C-1 B, 305/2, 3, 4 & 5, G.I.D.C KERALA (BAVLA), AHMEDABAD-382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1346 | NDA/MAL/HDP/11903 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CARDIPIN 10 MG | NIFEDIPINE | 10 MG | STALLION LABORATORIES PRIVATE LIMITED C-1 B, 305/2, 3, 4 & 5, G.I.D.C KERALA (BAVLA), AHMEDABAD-382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1347 | NDA/MAL/HDP/11904 | ZAIN PHARMA LIMITED | NOVOMED HEALTHCARE LIMITED | PREDNISOLONE | PREDNISOLONE | 5 MG | ZAIN PHARMA LIMITED PLOT NO. 209/13741, COLCHESTER PARK, GO-DOWN NO.. 1,2,3, OFF MOMBASA ROAD, BEHIND NICE AND LOVELY HOUSE | KENYA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1348 | NDA/MAL/HDP/11905 | BHARAT SERUMS AND VACCINES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMPHOLIP 50MG/10ML | AMPHOTERICIN B | 50 MG/10ML | BHARAT SERUMS AND VACCINES LIMITED PLOT NO. K-27, K-27 PART AND K-27/1, ANAND NAGAR, JAMBIVILI VILLAGE, ADDITIONAL MIDC, AMBERNATH (EAST), THANE 421506, MAHARASHTRA STATE | INDIA | PARENTERAL ORDINARY VIALS | I. 1*1*10ML VIAL | 06/05/2025 |
| 1349 | NDA/MAL/HDP/11906 | BLES BIOCHEMICALS INC. | PILLAR PHARMA LIMITED | BLES® | PHOSPHOLIPIDS + SURFACTANT - ASSOCIATED PROTEINS B AND C | 27 MG/ML + 176-500 MG/ML | BLES BIOCHEMICALS INC. 60 PACIFIC COURT, UNIT 8, LONDON, ONTARIO, N6M 1J2 | CANADA | SUSPENSION FOR INTRATRACHEAL ADMINISTRATION | I. 1*1*3ML VIAL II. 1*1*5ML VIAL | 06/05/2025 |
| 1350 | NDA/MAL/HDP/11907 | LEBEN LIFE SCIENCES PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | TELUCET | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10 MG + 5 MG | LEBEN LIFE SCIENCES PRIVATE LIMITED PLOT NO. C-20/1, C-21 PHASE-III, MIDC, AKOLA - 444104, M.S. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1351 | NDA/MAL/HDP/11908 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TELMODIP 80MG/5MG | TELMISARTAN + AMLODIPINE BESILATE | 80 MG + 5 MG | STALLION LABORATORIES PRIVATE LIMITED C-B, 305/2, 3, 4 & 5, G.I.D.C KERALA (BAVLA), AHMEDABAD-382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1352 | NDA/MAL/HDP/11909 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TELMODIP 80MG/10MG | TELMISARTAN + AMLODIPINE BESILATE | 80 MG + 10 MG | STALLION LABORATORIES PRIVATE LIMITED C-B, 305/2, 3, 4 & 5, G.I.D.C KERALA (BAVLA), AHMEDABAD-382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1353 | NDA/MAL/HDP/11910 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IXOBRAN 15 | RIVAROXABAN | 15 MG | INVENTIA HEALTHCARE LIMITED F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1354 | NDA/MAL/HDP/11911 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IXOBRAN 20 | RIVAROXABAN | 20 MG | INVENTIA HEALTHCARE LIMITED F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1355 | NDA/MAL/HDP/11912 | PULSE PHARMACEUTICALS PRIVATE LIMITED | DELMAW ENTERPRISES LIMITED | HISTAVERT 8 | BETAHISTINE DIHYDROCHLORIDE | 8 MG | PULSE PHARMACEUTICALS PRIVATE LIMITED KHASRA NO. 400, 407 & 409, KARONDI, ROORKEE - 247667, DISTRICT: HARIDWAR, UTTARKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*2*15TABLET BLISTER | 06/05/2025 |
| 1356 | NDA/MAL/HDP/11913 | BHARAT SERUMS AND VACCINES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF 450 I.U (33.0MCG)/0.75ML | RECOMBINANT FOLLITROPIN | 450 I.U/0.75ML | BHARAT SERUMS AND VACCINES LIMITED PLOT NO. K-27, K-27 PART AND K-27/1, ANAND NAGAR, JAMBIVILI VILLAGE, ADDITIONAL MIDC, AMBERNATH (EAST), THANE 421506, MAHARASHTRA STATE | INDIA | PARENTERAL ORDINARY PRE-FILLED PENS | I. 1*1*0.75ML PREFILLED PEN + 1*7 NEEDLES FOR INJECTION | 06/05/2025 |
| 1357 | NDA/MAL/HDP/11914 | BHARAT SERUMS AND VACCINES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF 900 IU (66.0MCG)/1.5ML | RECOMBINANT FOLLITROPIN | 900 I.U/1.5ML | BHARAT SERUMS AND VACCINES LIMITED PLOT NO. K-27, K-27 PART AND K-27/1, ANAND NAGAR, JAMBIVILI VILLAGE, ADDITIONAL MIDC, AMBERNATH (EAST), THANE 421506, MAHARASHTRA STATE | INDIA | PARENTERAL ORDINARY PRE-FILLED PENS | I. 1*1*1.5ML PREFILLED PEN + 1*14 NEEDLES FOR INJECTION | 06/05/2025 |
| 1358 | NDA/MAL/HDP/11915 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BRIZAGAN | BRIMONIDINE TARTRATE | 2 MG/ML | RAFARM SA THESI POUSI-HATZI, AGIOU LOUKA, PAIANA ATTIKI, TK 19002 TO37 | GREECE | OPHTHALMIC LIQUIDS | I. 1*1*5ML CONTAINER | 06/05/2025 |
| 1359 | NDA/MAL/HDP/11916 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DORZAWELL-T | TIMOLOL MALEATE + DORZOLAMIDE HYDROCHLORIDE | 5 MG/ML + 20 MG/ML | RAFARM SA THESI POUSI-HATZI, AGIOU LOUKA, PAIANA ATTIKI, TK 19002 TO37 | GREECE | OPHTHALMIC DROPS | I. 1*1*5ML CONTAINER | 06/05/2025 |
| 1360 | NDA/MAL/HDP/11917 | M/S SYNOKEM PHARMACEUTICALS LIMITED | KAMCARE PHARMA LIMITED | CORTRACIN L | MONTELUKAST + LEVOCETIRIZINE DIHYDROCHLORIDE | 4 MG/5ML + 2.5 MG/5ML | M/S SYNOKEM PHARMACEUTICALS LIMITED PLOT NO. 35-36, SECTOR-6A, IIE, SIDCUL, RANIPUR, DISTT. HARIDWAR, UTTARAKHAND | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*60ML BOTTLE | 06/05/2025 |
| 1361 | NDA/MAL/HDP/11918 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | ABACAVIR 600MG, DOLUTEGRAVIR 50MG AND LAMIVUDINE 300MG TABLETS | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 600 MG + 50 MG + 300 MG | APL HEALTHCARE LIMITED, UNIT-IV PLOT NO. 16, APIIC MULTI PRODUCTS SEZ, MENAKURU VILLAGE, NAIDUPETA MANDAL S.P.S.R. NELLORE DIST | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*30TABLET CONTAINER | 06/05/2025 |
| 1362 | NDA/MAL/HDP/11919 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | PRAZIQUANTEL TABLETS USP 600 MG | PRAZIQUANTEL | 600MG | MEDOPHARM NO. 34-B, INDUSTRIAL AREA, MALUR - 563 160, KARNATAKA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 06/05/2025 |
| 1363 | NDA/MAL/HDP/11920 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | CLARIZ - 500 | CLARITHROMYCIN | 500MG | THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 06/05/2025 |
| 1364 | NDA/MAL/HDP/11921 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | JENTIN MET 50 MG/500 MG | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50MG+500MG | THE SEARLE COMPANY LIMITED F-319, S.I.T.E OPPOSITE K.E.S.C, POWER STATION KARACHI - 75530 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*7TABLET BLISTER | 06/05/2025 |
| 1365 | NDA/MAL/HDP/11922 | THE SEARLE COMPANY LIMITED | SURGIPHARM (U) LIMITED | XAROBAN | RIVAROXABAN | 10MG | THE SEARLE COMPANY LIMITED F-319, S.I.T.E OPPOSITE K.E.S.C, POWER STATION KARACHI - 75530 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 06/05/2025 |
| 1366 | NDA/MAL/HDP/11924 | AUROLAB | SWASTIK PHARMACEUTICALS LTD | AUROCAINE | PROPARACAINE HYROCHLORIDE | 0.5%W/V | AUROLAB NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI - 625 020 | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML CONTAINER | 06/05/2025 |
| 1367 | NDA/MAL/HDP/11925 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | UNOTATION | TRANEXAMIC ACID | 100MG/ML | AKUMS DRUGS AND PHARMACEUTICALS LIMITED 2, 3, 4 & 5, SEC. 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR 249403, UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*5*5ML AMPOULE | 06/05/2025 |
| 1368 | NDA/MAL/HDP/11926 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B.CHEMICALS & PHARMACEUTICALS LTD.) | PLANET PHARMACEUTICALS UGANDA LTD | ESOLEK | ESOMEPRAZOLE SOIDIUM | 40MG/VIAL | NAPROD LIFESCIENCES PRIVATE LIMITED G-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRA | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*10*40MG VIAL | 06/05/2025 |
| 1369 | NDA/MAL/HDP/11927 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | TIMOLIN | TIMOLOL MALEATE | 0.5%W/V | LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | OPHTHALMIC DROPS | I. 1*1*10*40MG VIAL | 06/05/2025 |
| 1370 | NDA/MAL/HDP/11928 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAFARIV 2.5 | RIVAROXABAN | 2.5MG | MYLAN LABORATORIES LIMITED PLOT NO. H-12 AND H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD, 431136, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 06/05/2025 |
| 1371 | NDA/MAL/HDP/11929 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROPENT | CYCLOPENTOLATE HYDROCHLORIDE | 1.0%W/V | AUROLAB NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI - 625 020 | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML CONTAINER | 06/05/2025 |
| 1372 | NDA/MAL/HDP/11930 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CINOD 10 | CILNIDIPINE | 10 MG | AJANTA PHARMA LIMITED MIRZA - PALASHBARI ROAD, VILLAGE - KOKJHAR, PALASHBARI - 781128 KAMRUP (R. ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 06/05/2025 |
| 1373 | NDA/MAL/HDP/11931 | QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LTD. | Q-TIB | ISONIAZID + PYRIDOXINE HYDROCHLORIDE + SULFAMETHOXAZOLE + TRIMETHOPRIM | 300 MG + 25 MG + 800 MG + 160 MG | QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7, RING ROAD, LUZIRA INDUSTRIAL PARK, P.O. BOX 34871, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | I. 1*30TABLET CONTAINER | 06/05/2025 |
| 1374 | NDA/MAL/HDP/11932 | BIOLOGICAL E. LIMITED, HYDERABAD, INDIA | GITTOES PHARMACEUTICALS LIMITED | PNEUBEVAX 14 | PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (ADSORBED) (14 VALENT) SEROTYPES : 1 + 3,4,5,7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, AND 33F + 6B | (3.0 + 2.2 + 4.4) µG/0.5ML | BIOLOGICAL E. LIMITED, HYDERABAD, INDIA PLOT NO. 1, BIOTECH PARK, PHASE-II, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1*48*0.5ML VIAL, 1*48*2.5ML VIAL | 06/05/2025 |
| 1375 | NDA/MAL/HDP/11933 | HK INNO.N CORPORATION | ONCOPHARM (U) LTD | OMAPONE PERI INJ. 1477 ML | AMINO ACID + GLUCOSE + LIPID EMULSION | 10 %W/V + 42 %W/V + 20 %W/V | HK INNO. N CORPORATION 20 DAESOSANDAN-RO, DAESO-MYEON, EUMSEONG-GUN, CHUNGCHEONGBUK-DO, REPUBLIC OF KOREA | SOUTH KOREA | SOLUTION FOR INFUSION INTO CENTRAL VEIN | 1*750ML BAG + 1*446ML BAG 42% GLUCOSE + 1*281ML BAG 20% LIPID EMULSION | 06/05/2025 |
| 1376 | NDA/MAL/HDP/11934 | HK INNO.N CORPORATION | ONCOPHARM (U) LTD | OMAPONE PERI INJ. 1448 ML | AMINO ACID + GLUCOSE + LIPID EMULSION | 10 %W/V + 42 %W/V + 20 %W/V | HK INNO. N CORPORATION 20 DAESOSANDAN-RO, DAESO-MYEON, EUMSEONG-GUN, CHUNGCHEONGBUK-DO, REPUBLIC OF KOREA | SOUTH KOREA | SOLUTION FOR INFUSION INTO CENTRAL VEIN | 1*456ML BAG + 1*788ML BAG 42% GLUCOSE + 1*204ML BAG 20% LIPID EMULSION | 06/05/2025 |
| 1377 | NDA/MAL/HDP/11935 | LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. | ONCOPHARM (U) LTD | NORADRENALINE BASI | NORADRENALINE | 1*10*10ML AMPOULE | LABORATORIOS BASI - INDUSTRIA FARMACEUTICA PARQUE INDUSTRIAL MANUEL LOURENCO FERREIRA, LOTES 8, 15 E 16, 3450-232 MORTAGUA - PORTUGAL | PORTUGAL | PARENTERAL ORDINARY AMPOULES | 1*10*10ML AMPOULE | 06/05/2025 |
| 1378 | NDA/MAL/HDP/11936 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | FERIUM | IRON (III) POLYMALTOSE COMPLEX + FOLIC ACID | 100 MG + 550 µG | EMCURE PHARMACEUTICALS LIMITED LANE NO. 03, PHASE II, S.I.D.C.O., INDUSTRIAL COMPLEX, BARI BRAHMANA, JAMMU, (J&K) - 181133, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1*2*10CAPSULE BLISTER | 06/05/2025 |
| 1379 | NDA/MAL/HDP/11937 | PT. KALBE FARMA TBK. | ABACUS PHARMA (AFRICA) LIMITED | WOODS’ PEPPERMINT ANTITUSSIVE | DEXTROMETHORPHAN HYDROBROMIDE + DIPHENHYDRAMINE HYDROCHLORIDE | 7.5 MG/5ML + 12.5 MG/5ML | 1. PT. KALBE FARMA TBK. JI. M.H. THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON, LIPPO CIKARANG, BEKASI INDONESIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDONESIA | ORAL LIQUID ORDINARY LIQUIDS | I. 1*1*100ML BOTTLE | 06/05/2025 |
| 1380 | NDA/MAL/HDP/11938 | PT. KALBE FARMA TBK. | ABACUS PHARMA (AFRICA) LIMITED | WOODS` EXPECTORANT | BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 4 MG/5ML + 100 MG/5ML | 1. PT. KALBE FARMA TBK. JI. M.H. THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON, LIPPO CIKARANG, BEKASI INDONESIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDONESIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*1*100ML BOTTLE | 06/05/2025 |
| 1381 | NDA/MAL/HDP/11939 | AMANTA HEALTHCARE LIMITED | MEDIVERSE AFRICA LIMITED | SODIUM CHLORIDE BP | SODIUM CHLORIDE | 0.9 %W/V | 1. AMANTA HEALTHCARE LIMITED PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1.0*500.0ML BOTTLE | 27/06/2025 |
| 1382 | NDA/MAL/HDP/1194 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | PISA | PIPERACILLIN + TAZOBACTAM | 4000MG/VIAL + 500MG/VIAL | AQUA VITOE LABORATORIES- PLOT NO. 4, VILLAGE KUNJHAL, NR. JHARMAJRI, BADDI, DISTT. SOLAN (HP) 173205 - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X30.0 ML VIAL | 01/07/2009 |
| 1383 | NDA/MAL/HDP/11940 | AMANTA HEALTHCARE LIMITED | MEDIVERSE AFRICA LIMITED | GLUCOSE INTRAVENOUS INFUSION B.P. (50GM/LT) | ANHYDROUS DEXTROSE | 5.0 %W/V | 1. AMANTA HEALTHCARE LIMITED PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1.0*500.0ML BOTTLE | 27/06/2025 |
| 1384 | NDA/MAL/HDP/11942 | TABROS PHARMA PVT LTD | HEALTHCARE LTD. | CLERET GEL | CLINDAMYCIN PHOSPHATE + TRETINOIN | 1.2 %W/W + 0.025 %W/W | 1. TABROS PHARMA (PVT) LTD L-20/B, SECTOR-22 F.B. INDUSTRIAL AREA KARACHI PAKITSAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKITSAN | TOPICAL EXTERNAL GELS AND SOLS | I. 1.0*1.0*5.0G TUBE II. 1.0*1.0*20.0G TUBE | 27/06/2025 |
| 1385 | NDA/MAL/HDP/11949 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FEBURIC 80 | FEBUXOSTAT | 80.0 MG | 1. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1386 | NDA/MAL/HDP/11950 | NVS KENYA LIMITED | SURGIPHARM (U) LIMITED | NEVANAC EYE DROPS | NEPAFENAC | 1.0 MG/ML | 1. ALCON COUVREUR BELGIUM ALCON-COUVREUR NV, RZIJKSWEG 14, PUURS, 2780, BELGIUM BELGIUM SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BELGIUM | OPHTHALMIC SUSPENSIONS | I. 1.0*1.0*5.0ML BOTTLE | 27/06/2025 |
| 1387 | NDA/MAL/HDP/11951 | ARCELIA LIFE SCIENCES LTD | NOVOMED HEALTHCARE LIMITED | VITAMIN K1 | PHYTOMENADIONE | 10.0 MG/ML | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1.0*10.0*1.0ML AMPOULE | 27/06/2025 |
| 1388 | NDA/MAL/HDP/11952 | KOPRAN LIMITED | TATA UGANDA LIMITED | KLODIP-5 | AMLODIPINE BESILATE | 5.0 MG | 1. KOPRAN LIMITED PLANT I AND PLANT II, VILLAGE SAVROLI, TALUKA KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA, 410202 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1.0*10.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1389 | NDA/MAL/HDP/11953 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | LOPA | LOPERAMIDE HYDROCHLORIDE | 2.0 MG | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1.0*10.0*10.0CAPSULE BLISTER | 27/06/2025 |
| 1390 | NDA/MAL/HDP/11954 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B.CHEMICALS & PHARMACEUTICALS LTD.) | PLANET PHARMACEUTICALS UGANDA LTD | CARBAMAZEPINE EXTENDED RELEASE TABLETS USP 400 MG | CARBAMAZEPINE | 400.0 MG | 1. UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J. B. CHEMICALS AND PHARMACEUTICALS LIMITED) PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | I. 1.0*10.0*10.0TABLET BLISTER | 27/06/2025 |
| 1391 | NDA/MAL/HDP/11955 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | BRAIPORIN SYRUP | SODIUM VALPROATE | 200.0 MG/5ML | 1. AKUMS DRUGS & PHARMACEUTICALS LIMITED €“ PLANT II PLOT NO.: 22, SECTOR - 6A, IIE, SIDCUL, RANIPUR, DISTT.: HARIDWAR, UTTARAKHAND, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | I. 1.0*1.0*100.0ML BOTTLE | 27/06/2025 |
| 1392 | NDA/MAL/HDP/11956 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LASTAVIN HTZ 160/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 160.0 MG + 12.5 MG | 1. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1393 | NDA/MAL/HDP/11958 | BHARAT PARENTERALS LIMITED | LEGIT MEDEQ 2007 LIMITED | TESAM-60 | ARTESUNATE + SODIUM BICARBONATE | 60 MG + 5 %W/V | 1. BHARAT PARENTERALS LIMITED SURVEY NO. 144 & 146 VILL. HARIPURA, JAROD SAMLAYA ROAD, TA. SAVLI, DIST. VADODARA - 391520 (GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*60MG VIAL + 1*1ML AMPOULE 5%W/V SODIUM BICARBONATE + 1*5ML AMPOULE 0.9%W/V SODIUM CHLORIDE | 27/06/2025 |
| 1394 | NDA/MAL/HDP/11959 | BHARAT PARENTERALS LIMITED | LEGIT MEDEQ 2007 LIMITED | TESAM-30 | ARTESUNATE | 30 MG | 1. BHARAT PARENTERALS LIMITED SURVEY NO.144 & 146 VILL HARIPURA, JAROD SAMIAYA ROAD, TA.SAVLI DIST, VADODARA 391520, GUJARAT, INDI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*30MG VIAL + 1*1ML AMPOULE 5%W/V SODIUM BICARBONATE + 1*5ML AMPOULE 0.9%W/V SODIUM CHLORIDE | 27/06/2025 |
| 1395 | NDA/MAL/HDP/11960 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ABACAVIR AND LAMIVUDINE DISPERSIBLE TABLETS 120MG/60MG | ABACAVIR SULFATE + LAMIVUDINE | 120 MG + 60 MG | 1. MICRO LABS LIMITED PLOT NO. S-155 TO S-159 & N1, PHASE III & IV VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA 403722 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*30TABLET CONTAINER | 27/06/2025 |
| 1396 | NDA/MAL/HDP/11961 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMLOTRUST-10 | AMLODIPINE BESILATE | 10 MG | 1. CENTAUR PHARMACEUTICALS PRIVATE LIMITED PLANT I - PLOT NO. 3, 5B, 2C TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOA - 403 526 ? INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1397 | NDA/MAL/HDP/11962 | AJANTA PHARMA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | AMOQ 12-59 MONTHS | AMODIAQUINE HYDROCHLORIDE + SULFADOXINE + PYRIMETHAMINE | 153 MG + 500 MG + 25 MG | 1. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*50*1*4TABLET BLISTER | 27/06/2025 |
| 1398 | NDA/MAL/HDP/11963 | AJANTA PHARMA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | AMOQ-LS 3-<12 MONTHS | AMODIAQUINE HYDROCHLORIDE + SULFADOXINE + PYRIMETHAMINE | 76.5 MG + 250 MG + 12.5 MG | 1. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*50*1*4TABLET BLISTER | 27/06/2025 |
| 1399 | NDA/MAL/HDP/11964 | OMNIKAM PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | ARTOM 80 | ARTEMETHER | 80 MG/ML | 1. MS. KAMLA LIFE SCIENCES LIMITED G-84/1, TARAPUR M.I.D.C., BOISAR, DISTRICT PALGHAR-401506, MAHARASTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*6*1ML AMPOULE | 27/06/2025 |
| 1400 | NDA/MAL/HDP/11966 | HETERO LABS LIMITED | AIVEEN (U) LIMITED | BORTERO | BORTEZOMIB | 3.5 MG/VIAL | 1. M/S HETERO LABS LIMITED, UNIT VI SY. NO. 410-411, TSIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | DISTRICT, INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*5ML VIAL | 06/05/2025 |
| 1401 | NDA/MAL/HDP/11967 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | GAMA PHARMACEUTICALS (U) LIMITED | BRIMONDALOUS 0.33% | BRIMONIDINE TARTRATE | 3.3 MG/G | 1. AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES PART NO. 7/6 - 6TH INDUSTRIAL AREA, 6TH OCTOBER CITY GIZA - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | TOPICAL EXTERNAL GELS AND SOLS | I. 1*1*30G TUBE | 27/06/2025 |
| 1402 | NDA/MAL/HDP/11968 | ZAIN PHARMA LIMITED | NOVOMED HEALTHCARE LIMITED | CETIRIZINE SYRUP | CETIRIZINE HYDROCHLORIDE | 5 MG/5ML | 1. ZAIN PHARMA LIMITED PLOT NO. 209/13741, COLCHESTER PARK, GO-DOWN NO.. 1,2,3, OFF MOMBASA ROAD, BEHIND NICE AND LOVELY HOUSE KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL LIQUID ORDINARY SYRUPS | I. 1*60ML BOTTLE | 27/06/2025 |
| 1403 | NDA/MAL/HDP/11969 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTMIN PR 500 TABLET | METFORMIN HYDROCHLORIDE | 500.0 MG | 1. PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1.0*10.0*10.0TABLET BLISTER | 27/06/2025 |
| 1404 | NDA/MAL/HDP/11970 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTMIN PR 1000 TABLET | METFORMIN HYDROCHLORIDE | 1000.0 MG | 1. PINNACLE LIFE SCIENCE PRIVATE LIMITED KHASRA NO. 1328 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID RETARD TABLETS | I. 1.0*10.0*10.0TABLET BLISTER | 27/06/2025 |
| 1405 | NDA/MAL/HDP/11971 | KOPRAN LIMITED | TATA UGANDA LIMITED | PROGUARD | TAMSULOSIN | 0.4 MG | 1. KOPRAN LIMITED PLANT I AND PLANT II, VILLAGE SAVROLI, TALUKA KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA, 410202 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1406 | NDA/MAL/HDP/11972 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | KEYTRUDA | PEMBROLIZUMAB | 100.0 MG | 1. MSD INTERNATIONAL GMBH T/A MSD IRELAND(CARLOW), DUBLIN ROAD, CARLOW, R93 KF74 IRELAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | IRELAND | PARENTERAL ORDINARY DRY VIALS | I. 1.0*1.0*100.0MG VIAL | 27/06/2025 |
| 1407 | NDA/MAL/HDP/11973 | PULSE PHARMACEUTICALS PRIVATE LIMITED | DELMAW ENTERPRISES LIMITED | HISTAVERT 16 | BETAHISTINE DIHYDROCHLORIDE | 16.0 MG | 1. PULSE PHARMACEUTICALS PRIVATE LIMITED KHASRA NO. 400, 407 & 409, KARONDI, ROORKEE - 247667, DISTRICT: HARIDWAR, UTTARKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1408 | NDA/MAL/HDP/11974 | PULSE PHARMACEUTICALS PRIVATE LIMITED | DELMAW ENTERPRISES LIMITED | HISTAVERT 24 | BETAHISTINE DIHYDROCHLORIDE | 24.0 MG | 1. PULSE PHARMACEUTICALS PRIVATE LIMITED KHASRA NO. 400, 407 & 409, KARONDI, ROORKEE - 247667, DISTRICT: HARIDWAR, UTTARKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1409 | NDA/MAL/HDP/11976 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | G-CEFTRIA PLUS | CEFTRIAXONE SODIUM + SALBACTAM SODIUM | 1000.0 MG + 500.0 MG | 1. REYOUNG PHARMACEUTICAL COMPANY LIMITED NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P.R. CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY DRY VIALS | I. 1.0*1.0*1.5G VIAL + 1.0*10.0ML AMPOULE WATER FOR INJECTION | 27/06/2025 |
| 1410 | NDA/MAL/HDP/11977 | DAWA LIMITED | SUPER MEDIC LTD | ROXICLOT 20MG | RIVAROXABAN | 20.0 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1411 | NDA/MAL/HDP/11978 | FDC LIMITED | AIVEEN (U) LIMITED | DINOLOP | OLOPATADINE HYDROCHLORIDE | 1.0 %W/V | 1. FDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ, AURANGABAD, 431136 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1.0*1.0*5.0ML BOTTLE | 27/06/2025 |
| 1412 | NDA/MAL/HDP/1198 | THEMIS MEDICARE LTD. | STAR PHARMACEUTICALS LTD | MALITHER INJECTION | ARTEMETHER | 80MG/ML | THEMIS MEDICARE LTD , SECTOR 6A ,PLOT NO. 16,17 & 18 IIE,BHEL SIDCUL,HARIDWAR UTTARAKHAND 249403 | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2013 |
| 1413 | NDA/MAL/HDP/11980 | MIDDLE EAST PHARMACEUTICAL INDUSTRIES COMPANY LIMITED (AVALON PHARMA) | GAMA PHARMACEUTICALS (U) LIMITED | RHINASE AQUEOUS NASAL SPRAY | FLUTICASONE PROPIONATE | 0.05 %W/W | 1. MIDDLE EAST PHARMACEUTICAL INDUSTRIES COMPANY LIMITED (AVALON PHARMA) P.O. BOX 4180, RIYADH 11491, 2ND INDUSTRIAL CITY, RIYADH - SAUDI ARABIA SAUDI ARABIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | ARABIA | NASAL SYSTEMIC UNIT DOSE AEROSOLS | I. 1.0*1.0*120.0METERED DOSE BOTTLE | 27/06/2025 |
| 1414 | NDA/MAL/HDP/11981 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | FLOXIMED | CIPROFLOXACIN | 500 MG | 1. MEDOPHARM NO. 34-B, INDUSTRIAL AREA, MALUR - 563 160, KARNATAKA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1000TABLET JAR II. 1*10*10TABLET BLISTER III. 1*50*10TABLET BLISTER IV. 1*100*10TABLET BLISTER | 27/06/2025 |
| 1415 | NDA/MAL/HDP/11982 | PANACEA BIOTEC PHARMA LIMITED | VITACARE LIMITED | MYCEPT-250 | MYCOPHENOLATE MOFETIL | 250 MG | 1. PANACEA BIOTEC PHARMA LIMITED MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1416 | NDA/MAL/HDP/11983 | SHREEJI PHARMACEUTICALS LIMITED | SHREEJI PHARMACEUTICALS LIMITED | ACETAMIDE 250MG | ACETAZOLAMIDE | 250 MG | 1. CENTURION LABORATORIES PRIVATE LIMITED P-2, BIO-TECH PARK, MANJUSAR, TAL: SAVALI, VADADORA -391775 ? INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 27/06/2025 |
| 1417 | NDA/MAL/HDP/11984 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMOSTAT 10 | AMLODIPINE BESILATE | 10 MG | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1418 | NDA/MAL/HDP/11985 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMOSTAT 5 | AMLODIPINE BESILATE | 5 MG | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1419 | NDA/MAL/HDP/11987 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO., LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 180 MG | ARTESUNATE | 180 MG | 1. GUILIN PHARMACEUTICAL COMPANY LIMITED NO. 43, QILIDIAN ROAD, GUILIN 541004, GUANGXI P.R. OF CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*180MG VIAL + 1*9ML AMPOULE ARGININE + 1*9ML AMPOULE SODIUM BICARBONATE | 27/06/2025 |
| 1420 | NDA/MAL/HDP/11988 | BIOGEN PHARMA LTD | BIOGEN PHARMA LIMITED | ARTEGEN 120 | ARTESUNATE | 120 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*120MG VIAL + 1*2ML AMPOULE SODIUM BICARBONATE + 1*10ML AMPOULE SODIUM CHLORIDE | 27/06/2025 |
| 1421 | NDA/MAL/HDP/11989 | BIOGEN PHARMA LTD | BIOGEN PHARMA LIMITED | ARTEGEN 60 | ARTESUNATE | 60 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*60MG VIAL + 1*1ML AMPOULE SODIUM BICARBONATE + 1*5ML AMPOULE SODIUM CHLORIDE | 27/06/2025 |
| 1422 | NDA/MAL/HDP/1199 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | THEMISET 75 | PALONOSETRON HYDROCHLORIDE | 0.075MG/1.5ML | THEMIS MEDICARE LIMITED, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.5 ML VIAL | 01/07/2013 |
| 1423 | NDA/MAL/HDP/11991 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CANEFO PLUS | ACECLOFENAC + PARACETAMOL | 325 MG + 100 MG | 1. MEDOPHARM NO. 34-B, INDUSTRIAL AREA, MALUR - 563 160, KARNATAKA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1424 | NDA/MAL/HDP/11992 | SQUARE PHARMACEUTICALS LIMITED | GAMA PHARMACEUTICALS (U) LIMITED | CEFTRON | CEFTRIAXONE SODIUM | 2 G/VIAL | 1. SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT, KALIAKOIR, GAZIPUR - BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | PARENTERAL ORDINARY DRY VIALS | I. 1*1*2G VIAL + 2*10ML AMPOULE WATER FOR INJECTION | 27/06/2025 |
| 1425 | NDA/MAL/HDP/11993 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | CLARIZED-500 | CLARITHROMYCIN | 500 MG | 1. ZOTA HEALTHCARE LIMITED PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT- 394230 GUJARA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY COATED TABLETS | I. 1*1*10TABLET BLISTER | 27/06/2025 |
| 1426 | NDA/MAL/HDP/11994 | MACLEODS PHARMACEUTICALS LIMITED | VITACARE LIMITED | CYCLOSERINE CAPSULES, USP 125 MG | CYCLOSERINE | 125 MG | 1. MACLEODS PHARMACEUTICALS LIMITED (UNIT II) PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KUCHIGAM, DAMAN ? 396 210 (U.T) INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | I. 1*10*10CAPSULE BLISTER | 27/06/2025 |
| 1427 | NDA/MAL/HDP/11995 | DAWA LIMITED | SUPER MEDIC LTD | DAWASPIN 75 | ASPIRIN | 75 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1428 | NDA/MAL/HDP/11996 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYGLI – M (50+1000) | SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | BAFNA PHARMACEUTICALS LIMITED, UNIT II 147 MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI, CHENNAI, IN 600052, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1429 | NDA/MAL/HDP/11997 | LUPIN LIMITED | AIVEEN (U) LIMITED | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200MG AND 300 MG | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 200 MG + 300 MG | 1. LUPIN LIMITED NAGPUR PLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*30TABLET BOTTLE | 27/06/2025 |
| 1430 | NDA/MAL/HDP/11998 | AJANTA PHARMA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | ESMOLOC 20 | ESOMEPRAZOLE MAGNESIUM | 20 MG | 1. AJANTA PHARMA LIMITED PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1431 | NDA/MAL/HDP/11999 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FENSOLIN | SOLIFENACIN SUCCINATE | 10 MG | 1. JAMJOOM PHARMACEUTICALS COMPANY PLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIA SAUDI ARABIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SAUDI ARABIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1432 | NDA/MAL/HDP/12000 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | FIXET 200 | CEFIXIME TRIHYDRATE | 200 MG | 1. M/S HETERO LAB LIMITED, UNIT I, BLOCK A FOR CEPHALOSPORINS, BLOCK B FOR GENERAL VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 27/06/2025 |
| 1433 | NDA/MAL/HDP/12001 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLENMARK AIRZ | GLYCOPYRRONIUM | 50 µG | 1. GLENMARK PHARMACEUTICALS LIMITED VILLAGE - KISHANPURA, BADDI NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*1*30CAPSULE CONTAINER | 27/06/2025 |
| 1434 | NDA/MAL/HDP/12002 | GLOBELA PHARMA PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | GLOUREA 500 | HYDROXYUREA | 500 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1435 | NDA/MAL/HDP/12003 | HEALTH LINK PHARMACY LTD. | HEALTH LINK PHARMACY LIMITED | HAEMOSCOT FORTE | FERRIC AMMONIUM CITRATE + FOLIC ACID + THIAMINE HYDROCHLORIDE + PYRIDOXINE HYDROCHLORIDE + NICOTINAMIDE | 50 MG/5ML + 0.55 MG/5ML + 1.2 MG/5ML + 2.4 MG/5ML + 11 MG/5ML | 1. SCOTT-EDIL PHARMACIA LTD (UNIT II) PLOT NO. 21-22, EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P), 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*1*100ML BOTTLE | 27/06/2025 |
| 1436 | NDA/MAL/HDP/12004 | KOPRAN LIMITED | TATA UGANDA LIMITED | KLODIP-10 | AMLODIPINE BESILATE | 10 MG | 1. KOPRAN LIMITED PLANT I AND PLANT II, VILLAGE SAVROLI, TALUKA KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA, 410202 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1437 | NDA/MAL/HDP/12005 | KESAR PHARMA (P) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | KZITH-500 | AZITHROMYCIN DIHYDRATE | 500 MG | 1. KESAR PHARMA PRIVATE LIMITED PLOT SURVEY NO. 50/2, VILLAGE BILESHWARPURA, PO. CHHATRAL - 382729, TAL: KALOL, DIST. GANDHINAGAR, G INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*3TABLET BLISTER | 27/06/2025 |
| 1438 | NDA/MAL/HDP/12006 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SL-9 | SODIUM CHLORIDE | 0.9 %W/V | 1. ABACUS PARENTERAL DRUGS LIMITED (APDL) BLOCK 191, PLOT NO.114, KINGA MUKONO, P.O. BOX 31376, KAMPALA UGANDA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | PARENTERAL ORDINARY INFUSION AMPOULES | I. 1*15*5ML AMPOULE | 27/06/2025 |
| 1439 | NDA/MAL/HDP/12007 | AJANTA PHARMA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | LASTAVIN HTZ 80/12. | VALSARTAN + HYDROCHLOROTHIAZIDE | 80 MG + 12.5 MG | 1. AJANTA PHARMA LIMITED PLOT NO. B-4/5/6, MIDC, PAITHAN, AURANGABAD 431148, MAHARASHTRA STATE, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1440 | NDA/MAL/HDP/12008 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | RIVAROXABAN TABLETS 2.5 MG | RIVAROXABAN | 2.5 MG | 1. CIPLA LIMITED INDORE (UNIT I, II, III, IV). PLOT NO. 9 & 10 INDORE SPECIAL ECONOMIC ZONE, PHASE-II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*4*14TABLET BLISTER | 27/06/2025 |
| 1441 | NDA/MAL/HDP/12009 | DAWA LIMITED | SUPER MEDIC LTD | LEVOCET – M TABLET | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 10 MG + 5 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY TABLETS | I. 1*2*10TABLET BLISTER | 27/06/2025 |
| 1442 | NDA/MAL/HDP/1201 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | THEMISET | PALONOSETRON HYDROCHLORIDE | 0.25MG/5ML | THEMIS MEDICARE LIMITED, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL | 01/07/2013 |
| 1443 | NDA/MAL/HDP/12010 | DAWA LIMITED | SUPER MEDIC LTD | ROXICLOT 10MG | RIVAROXABAN | 15 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1444 | NDA/MAL/HDP/12011 | DAWA LIMITED | SUPER MEDIC LTD | ROXICLOT 15MG | RIVAROXABAN | 10 MG | 1. DAWA LIMITED PLOT NO. 7879/8, BABADOGO ROAD, RUARAKA NAIROBI - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1445 | NDA/MAL/HDP/12012 | LUPIN LIMITED | AIVEEN (U) LIMITED | RIFAPENTINE AND ISONIAZID TABLETS 300 MG/300MG | RIFAPENTINE + ISONIAZID | 300 MG + 300 MG | 1. LUPIN LIMITED A-28/1, MIDC, CHIKALTHANA, AURANGABAD - 431210, MAHARASHTRA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*12TABLET STRIP II. 1*10*10TABLET STRIP | 27/06/2025 |
| 1446 | NDA/MAL/HDP/12013 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | MASRONE | RISPERIDONE | 2 MG | 1. MICRO LABS LIMITED NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126, TAMIL NADU - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1447 | NDA/MAL/HDP/12014 | PANACEA BIOTEC PHARMA LIMITED | VITACARE LIMITED | PACLIALL | PACLITAXEL ALBUMIN | 100 MG | 1. PANACEA BIOTEC PHARMA LIMITED MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*4*1*100MG VIAL | 27/06/2025 |
| 1448 | NDA/MAL/HDP/12015 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN-250 TABLETS | METRONIDAZOLE | 250 MG | 1. RENE INDUSTRIES LIMITED PLOT 690 KAMULI KIREKA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET BOTTLE | 27/06/2025 |
| 1449 | NDA/MAL/HDP/12016 | ROYAL PHARMA 2011 LTD | ROYAL PHARMA 2011 LIMITED | PAEDIATRIC CO-TRIMOXAZOLE ORAL SUSPENSION BP 40/200 MG PER 5 ML | TRIMETHOPRIM + SULFAMETHOXAZOLE | 40 MG/5ML + 200 MG/5ML | 1. CIRON DRUGS AND PHARMACEUTICALS LIMITED PLOT 35-37, 43-45 CFC-B, DIWAN UDHYOG NAGAR, ALIYALI, PALGAR, THANE, 401404 MAHARASTRA €“ INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*60ML BOTTLE | 27/06/2025 |
| 1450 | NDA/MAL/HDP/12017 | ROYAL PHARMA 2011 LTD | ROYAL PHARMA 2011 LIMITED | LEVOFLOXACIN TABLETS USP 500MG | LEVOFLOXACIN HEMIHYDRATE | 500 MG | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 27/06/2025 |
| 1451 | NDA/MAL/HDP/12019 | LIFEWAY PHARMACEUTICAL INDUSTRIES LIMITED | LIFEWAY PHARMACEUTICAL INDUSTRIES LIMITED | SUREFENAC | DICLOFENAC SODIUM | 50 MG | 1. LIFEWAY PHARMACEUTICAL INDUSTRIES LIMITED BLOCK 198, PLOT 478 NANGWA MUKONO - UGANDA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1452 | NDA/MAL/HDP/12020 | MIDDLE EAST PHARMACEUTICAL INDUSTRIES COMPANY LIMITED (AVALON PHARMA) | GAMA PHARMACEUTICALS (U) LIMITED | CORTRIEF SPRAY | BUDESONIDE | 64 µG/DOSE | 1. MIDDLE EAST PHARMACEUTICAL INDUSTRIES COMPANY LIMITED (AVALON PHARMA) P.O. BOX 4180, RIYADH 11491, 2ND INDUSTRIAL CITY, RIYADH - SAUDI ARABIA SAUDI ARABIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | ARABIA | NASAL SYSTEMIC UNIT DOSE LIQUIDS | I. 1.0*1.0*120.0METERED DOSE BOTTLE | 27/06/2025 |
| 1453 | NDA/MAL/HDP/12021 | JAYVIHAN INVESTIMENTS (U) LTD | SUNWAVES ENTERPRISE UGANDA LIMITED | M-SUNATE 60 MG | ARTESUNATE | 60 MG | 1. INDASI LIFESCIENCES PRIVATE LIMITED PLOT NO. 73-77 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 3962110 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*60MG VIAL + 1*1ML AMPOULE 5%W/V SODIUM BICARBONATE + 1*5ML AMPOULE 0.9%W/V SODIUM CHLORIDE | 27/06/2025 |
| 1454 | NDA/MAL/HDP/12022 | SKYMAP PHARMACEUTICALS PRIVATE LIMITED | REVITAL HEALTHCARE LTD | REVISUNATE-60 | ARTESUNATE | 60.0 MG | 1. SKYMAP PHARMACEUTICALS PRIVATE LIMITED B-2, DEVBHOOMI INDUSTRIAL ESTATE POHANA - IQBALPUR ROAD, ROORKEE - 247667, DISTT. HARIDWAR, UTTARAKHAND INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1.0*1.0*60.0MG VIAL + 1.0*1.0ML AMPOULE 5%W/V SODIUM BICARBONATE + 1.0*5.0ML AMPOULE 0.9%W/V SODIUM CHLORIDE | 27/06/2025 |
| 1455 | NDA/MAL/HDP/12023 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | JINK | ZINC SULFATE | 20 MG | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*1*10TABLET BLISTER | 27/06/2025 |
| 1456 | NDA/MAL/HDP/12024 | BKRS PHARMA PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DEXA-BKRS | DEXAMETHASONE SODIUM PHOSPHATE | 4 MG/ML | 1. MAKCUR LABORATORIES LIMITED 46/4-7, DEHGAM ROAD, ZAK VILLAGE, TAL: DEHGAM, DIST.: GANDHINAGAR - 382330, GUJARAT (INDIA) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*10*1ML AMPOULE | 27/06/2025 |
| 1457 | NDA/MAL/HDP/12025 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | URSOLIV 500 | URSODEOXYCHOLIC ACID | 500 MG | 1. MEGA LIFESCIENCES PUBLIC COMPANY LIMITED PLANT 2: 515/1, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKAN 1028 THAILAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | THAILAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*5*10TABLET BLISTER | 27/06/2025 |
| 1458 | NDA/MAL/HDP/12026 | RENATA LIMITED | CLOUDCARE LIMITED | EMCON 1 | LEVONORGESTREL | 1.5 MG | 1. RAJENDRAPUR POTENT PRODUCT FACILITY (RPPF), RENATA LIMITED NOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR 1700 - BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | ORAL SOLID ORDINARY TABLETS | I. 1*1*1TABLET BLISTER | 27/06/2025 |
| 1459 | NDA/MAL/HDP/12027 | KHANDELWAL LABORATORIES PVT. LTD. | PLANET PHARMACEUTICALS UGANDA LTD | EPICHLOR -10 | EPIRUBICIN HYDROCHLORIDE | 10 MG/VIAL | 1. M/S KHANDELWAL LABORATORIES PRIVATE LIMITED B-1, WAGLE INDUSTRIAL ESTATE THANE 400604 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*10MG VIAL | 27/06/2025 |
| 1460 | NDA/MAL/HDP/12028 | BIOMATRIX HEALTHCARE PRIVATE LIMITED | MEDIWORLD PHARMA AFRICA LTD | FELOXAM | PIROXICAM | 20 MG | 1. BIOMATRIX HEALTHCARE PRIVATE LIMITED SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD ? 382 220, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*1*10CAPSULE BLISTER | 27/06/2025 |
| 1461 | NDA/MAL/HDP/12030 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MYGLIP PLUS 2.5/1000 | LINAGLIPTIN + METFORMIN HYDROCHLORIDE | 2.5 MG + 1000 MG | 1. M/S ALIDAC HEALTHCARE (MYANMAR) LIMITED LOT NO. B19, ZONE A, THILAWA SPECIAL ECONOMIC ZONE, THANLYIN TOWNSHIP, YANGON, MYANMAR MYANMAR SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MYANMAR | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1462 | NDA/MAL/HDP/12031 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MYGLIP PLUS 2.5/500 | LINAGLIPTIN + METFORMIN HYDROCHLORIDE | 2.5 MG + 500 MG | 1. M/S ALIDAC HEALTHCARE (MYANMAR) LIMITED LOT NO. B19, ZONE A, THILAWA SPECIAL ECONOMIC ZONE, THANLYIN TOWNSHIP, YANGON, MYANMAR MYANMAR SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MYANMAR | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1463 | NDA/MAL/HDP/12032 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MYGLIP PLUS 2.5/850 | LINAGLIPTIN + METFORMIN HYDROCHLORIDE | 2.5 MG + 850 MG | 1. M/S ALIDAC HEALTHCARE (MYANMAR) LIMITED LOT NO. B19, ZONE A, THILAWA SPECIAL ECONOMIC ZONE, THANLYIN TOWNSHIP, YANGON, MYANMAR MYANMAR SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MYANMAR | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1464 | NDA/MAL/HDP/12033 | LABOREX UGANDA LIMITED | MYOXERIL® | CYCLOBENZAPRINE HYDROCHLORIDE | 10 MG | 1. THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*10TABLET BLISTER | 27/06/2025 | |
| 1465 | NDA/MAL/HDP/12034 | SVIZERA LABS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | RIFAMPICIN 75MG / ISONIAZID 50MG/ PYRAZINAMIDE 150MG | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE | 75 MG + 50 MG + 150 MG | 1. SVIZERA LABS PRIVATE LIMITED D16/6, TTC INDUSTRIAL AREA, MIDC, TURBHE, NAVI MUMBAI 400073 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*24*28TABLET BLISTER | 27/06/2025 |
| 1466 | NDA/MAL/HDP/12036 | UNISON PHARMACEUTICALS PVT. LTD | KAMCARE PHARMA LIMITED | TELMIRIDE-40 | TELMISARTAN | 40 MG | 1. UNISON PHARMACEUTICALS PRIVATE LIMITED UNIT 1 UNIT I, C/6, STEEL TOWN, OPP. NOVA PETRO, MORAIYA, TA. SANAND, DIST.: AHMEDABAD - 382213, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1467 | NDA/MAL/HDP/12037 | TELMIRIDE-80 | TELMISARTAN | 80 MG | 1. UNISON PHARMACEUTICALS PRIVATE LIMITED UNIT 1 UNIT I, C/6, STEEL TOWN, OPP. NOVA PETRO, MORAIYA, TA. SANAND, DIST.: AHMEDABAD - 382213, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 | ||
| 1468 | NDA/MAL/HDP/12038 | S KANT HEALTHCARE LTD. | ABACUS PHARMA (AFRICA) LIMITED | TERBOKANT | TERBINAFINE | 1% W/W | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 27/06/2025 |
| 1469 | NDA/MAL/HDP/12039 | NABIQASIM INDUSTRIES (PVT) LTD | JEET PHARMACEUTICALS LIMITED | TRANMAX | TRANEXAMIC ACID | 500 MG | 1. M/S NABIQASIM INDUSTRIES PRIVATE LIMITED 17/24, KORANGI INDUSTRIAL AREA, KORANGI, KARACHI - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 27/06/2025 |
| 1470 | NDA/MAL/HDP/1204 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | DEXEM INJECTION | DEXMEDETOMIDINE HYDROCHLORIDE | 100 | THEMIS MEDICARE LTD, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE | 01/07/2013 |
| 1471 | NDA/MAL/HDP/12040 | VIVANZA BIOSCIENCES LTD. | INTRAMED PHARMA LIMITED | TRIMOCLAV 500 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | 1. M/S MEDICEFPHARMA PLOT NO.28,29,48, EPIP, PHASE-1, JHARMAJRI,BADDI, DIST. SOLAN, HIMACHAL PRADESH PIN:174103 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*7TABLET BLISTER | 27/06/2025 |
| 1472 | NDA/MAL/HDP/12041 | VIVANZA BIOSCIENCES LTD. | INTRAMED PHARMA LIMITED | TRIMOCLAV 875 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 875 MG + 125 MG | 1. M/S MEDICEFPHARMA PLOT NO.28,29,48, EPIP, PHASE-1, JHARMAJRI,BADDI, DIST. SOLAN, HIMACHAL PRADESH PIN:174103 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*7TABLET BLISTER | 27/06/2025 |
| 1473 | NDA/MAL/HDP/12042 | VIVANZA BIOSCIENCES LTD. | INTRAMED PHARMA LIMITED | TRIMOCLAV OS 200 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 200 MG/5ML + 28.5 MG/5ML | 1. M/S MEDICEFPHARMA PLOT NO.28,29,48, EPIP, PHASE-1, JHARMAJRI,BADDI, DIST. SOLAN, HIMACHAL PRADESH PIN:174103 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*70ML BOTTLE | 27/06/2025 |
| 1474 | NDA/MAL/HDP/12043 | VIVANZA BIOSCIENCES LTD. | INTRAMED PHARMA LIMITED | TRIMOCLAV OS 400 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 400 MG/5ML + 57 MG/5ML | 1. M/S MEDICEFPHARMA PLOT NO.28,29,48, EPIP, PHASE-1, JHARMAJRI,BADDI, DIST. SOLAN, HIMACHAL PRADESH PIN:174103 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*70ML BOTTLE | 27/06/2025 |
| 1475 | NDA/MAL/HDP/12044 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | URINORM | FEBUXOSTAT | 80 MG | 1. EMCURE PHARMACEUTICALS LIMITED (ORAL SOLID DIVISION & STERILE PRODUCT DIVISION) PLOT NO. P1 & P2, I.T.B.T., PHASE-II, PARK, M.I.D.C., HINJAWADI, PUNE - 411057, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*7TABLET BLISTER | 27/06/2025 |
| 1476 | NDA/MAL/HDP/12045 | LUPIN LIMITED | AIVEEN (U) LIMITED | RIFAMPIN, ISONIAZID AND PYRAZINAMIDE DISPERSIBLE TABLETS 75 MG, 50 MG AND 150 MG | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE | 75 MG + 50 MG + 150 MG | 1. LUPIN LIMITED A-28/1, MIDC, CHIKALTHANA, AURANGABAD - 431210, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*3*28TABLET STRIP | 06/05/2025 |
| 1477 | NDA/MAL/HDP/12046 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LIMITED | GANFORT EYE DROPS | BIMATOPROST + TIMOLOL MALEATE | 0.3 MG/ML + 5 MG/ML | 1. ALLERGAN PHARMACEUTICALS IRELAND CASTLEBAR ROAD,WESTPORT, COUNTY MAYO IRELAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | IRELAND | OPHTHALMIC DROPS | I. 1*1*3ML BOTTLE | 27/06/2025 |
| 1478 | NDA/MAL/HDP/12049 | SUNWAVES ENTERPRISE UGANDA LTD | SUNWAVES ENTERPRISE UGANDA LIMITED | SUN-SUNATE 120 MG | ARTESUNATE | 120 MG | 1. INDASI LIFESCIENCES PRIVATE LIMITED PLOT NO. 73-77 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 3962110 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*120MG VIAL + 1*10ML AMPOULE 0.9%W/V SODIUM CHLORIDE + 1*2ML AMPOULE 5%W/V SODIUM BICARBONATE | 27/06/2025 |
| 1479 | NDA/MAL/HDP/12050 | REVIVE PHARMA LTD | REVIVE PHARMA LTD | RETROGYL | METRONIDAZOLE | 200 MG | 1. REVIVE PHARMA LIMITED PLOT NO. 274, BLOCK 191 GWANYA KINGA, MUKONO DISTRICT, UGANDA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1480 | NDA/MAL/HDP/12051 | MERCK (PTY) LTD | UNITED HEALTH DISTRIBUTORS LTD | BAVENCIO 20MG/ML | AVELUMAB | 20.0 MG/ML | 1. MERCK SERONO S.A., AUBONNE ZONE INDUSTRIELLE DE I'OURIETTAZ, CH-1170 AUBONNE, SWITZERLAND SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWITZERLAND | PARENTERAL ORDINARY VIALS | I. 1*1*10ML VIAL | 27/06/2025 |
| 1481 | NDA/MAL/HDP/12052 | JIANGSU PENGYAO PHARMACEUTICAL CO., LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PREDNISOLONE TABLETS B.P. 5MG | PREDNISOLONE | 5 MG | 1. JIANGSU PENGYAO PHARMACEUTICAL CO., LIMITED NO. 10. CHAQUAN ROAD, YIXING CITY, JIANGSU, CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 27/06/2025 |
| 1482 | NDA/MAL/HDP/12053 | AUROBINDO PHARMA LIMITED. | GITTOES PHARMACEUTICALS LIMITED | ABLADO DT | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 60 MG + 5 MG + 30 MG | 1. APL HEALTHCARE LIMITED, UNIT-IV PLOT NO. 16, APIIC MULTI PRODUCTS SEZ, MENAKURU VILLAGE, NAIDUPETA MANDAL S.P.S.R. NELLORE DIST INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*90TABLET CONTAINER II. 1*1*180TABLET CONTAINER | 27/06/2025 |
| 1483 | NDA/MAL/HDP/12054 | LUPIN LIMITED | AIVEEN (U) LIMITED | RIFAPENTINE DISPERSIBLE TABLETS 150 MG | RIFAPENTINE | 150 MG | 1. LUPIN LIMITED A-28/1, MIDC, CHIKALTHANA, AURANGABAD - 431210, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*10*10TABLET BLISTER II. 1*1*28TABLET STRIP | 27/06/2025 |
| 1484 | NDA/MAL/HDP/12055 | TENTH OF RAMADAN FOR PHARMACEUTICAL INDUSTRIES AND DIAGNOSTIC | GAMA PHARMACEUTICALS (U) LIMITED | AMOFLUXIN 500/500MG | AMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM | 500 MG + 500 MG | 1. THE TENTH OF RAMADAN FOR PHARMACEUTICAL INDUSTRIES & DIAGNOSTIC REAGENTS "RAMEDA" SECOND INDUSTRIAL ZONE PLOT 5 SIXTH OF OCTOBER CITY EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*6TABLET BLISTER | 27/06/2025 |
| 1485 | NDA/MAL/HDP/12056 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 8 MG/2ML | MEDICAL UNION PHARMACEUTICALS LTD, ABU SULTAN, ISMAILLIA, EGYPT | EGYPT | PARENTERAL ORDINARY AMPOULES | I. 1*100*2ML AMPOULE | 01/07/2008 |
| 1486 | NDA/MAL/HDP/12057 | RELIANCE LIFE SCIENCES PRIVATE LIMITED | UNIHEALTH(U)LIMITED | ALBUREL 20% SOLUTION | HUMAN ALBUMIN | 200.0 G/L | 1. RELIANCE LIFE SCIENCES PRIVATE LIMITED DHIRUBHAI AMBANI LIFE SCIENCES CENTRE, NAVI MUMBAI, 400701 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1.0*1.0*100.0ML VIAL | 27/06/2025 |
| 1487 | NDA/MAL/HDP/12058 | NOBEL ILAC SAN. VE TIC. A.S. | DELMAW ENTERPRISES LIMITED | MISOL 100 MG | SERTRALINE HYDROCHLORIDE | 100 MG | 1. NOBEL LLAC SANAYII VE TICARET A.S. SANCAKLAR 81 100 DUZCE - TURKEY TURKEY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 06/05/2025 |
| 1488 | NDA/MAL/HDP/12059 | MSD PTY LIMITED | SURGIPHARM (U) LIMITED | GARDASIL 9 VIAL | HUMAN PAPILLOMA VIRUS TYPE 6 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 11 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 16 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 18 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 31 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 33 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 45 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 52 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 58 L1 PROTEIN | 30 µG/0.5ML + 40 µG/0.5ML + 60 µG/0.5ML + 40 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML | 1. MERCK SHARP & DAHME CORP. 770 SUMNEYTOWN PIKE, WEST POINT, PENNSYLVANIA, 19486 - UNITED STATES OF AMERICA UNITED STATES OF AMERICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UNITED STATES OF AMERICA | PARENTERAL ORDINARY VIALS | I. 1*1*0.5ML VIAL | 06/05/2025 |
| 1489 | NDA/MAL/HDP/1206 | THE METHOLATUM CO. LTD | HARLEYS UGANDA LIMITED | DEEP RELIEF | IBUPROFEN + MENTHOL | 5%W/W + 3% W/W | THE MENTHOLATUM CO. LTD. , 1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDE | UNITED KINGDOM | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER | 01/07/2013 |
| 1490 | NDA/MAL/HDP/12060 | MSD PTY LIMITED | SURGIPHARM (U) LIMITED | GARDASIL 9 | HUMAN PAPILLOMA VIRUS TYPE 6 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 11 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 16 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 18 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 31 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 33 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 45 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 52 L1 PROTEIN + HUMAN PAPILLOMA VIRUS TYPE 58 L1 PROTEIN | 30 µG/0.5ML + 40 µG/0.5ML + 60 µG/0.5ML + 40 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML + 20 µG/0.5ML | 1. MERCK SHARP & DAHME CORP. 770 SUMNEYTOWN PIKE, WEST POINT, PENNSYLVANIA, 19486 - UNITED STATES OF AMERICA UNITED STATES OF AMERICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. MERCK SHARP & DOHME B.V. WAARDERWEG 39, 2031 BN HAARLEM NETHERLANDS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UNITED STATES OF AMERICA|NETHERLANDS | PARENTERAL ORDINARY PRE-FILLED SYRINGES | I. 1*1*0.5ML SYRINGE | 06/05/2025 |
| 1491 | NDA/MAL/HDP/12061 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XYLOMETAZOLINE NASAL DROPS BP 0.05% | XYLOMETAZOLINE | 0.05 %W/V | 1. CIRON DRUGS & PHARMACEUTICALS PRIVATE LIMITED N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, PALGHAR 40506, MAHARASHTRA STATE - INDI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | NASAL TOPICAL SPRAY WITHOUT GAS | I. 1*10ML BOTTLE | 06/05/2025 |
| 1492 | NDA/MAL/HDP/12062 | FARBE FIRMA PVT.LTD | VITACARE LIMITED | NURASETRON | ONDANSETRON HYDROCHLORIDE | 2 MG/ML | 1. FARBE FIRMA PLOT NO. 1508, NR. ATIQUE BAKERY, GIDC ANKLESHWAR - 393002, GUJARAT INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*10*2ML AMPOULE | 27/06/2025 |
| 1493 | NDA/MAL/HDP/12063 | JSC BIOCAD | ONCOPHARM (U) LTD | HERTICAD | TRASTUZUMAB | 440.0 MG | 1. JSC BIOCAD NEUDORF, FACILITY 2 BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515 RUSSIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | RUSSIA | PARENTERAL ORDINARY DRY VIALS | I. 1.0*1.0*440.0MG VIAL + 1.0*20.0ML VIAL SOLVENT | 27/06/2025 |
| 1494 | NDA/MAL/HDP/12064 | KPI HEALTHCARE LIMITED | KPI HEALTHCARE LIMITED | CAPECITABINE-DRLA | CAPECITABINE | 500.0 MG | 1. DR. REDDY'S LABORATORIES LIMITED FORMULATIONS TECH OPS VII, PLOT NO. P1 TO P9, PHASE III, DUVVADA, VSEZ, VISAKHAPATNAM-530046, A.P. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*12.0*10.0TABLET BLISTER | 27/06/2025 |
| 1495 | NDA/MAL/HDP/12065 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ETIMIB-DENK 10MG | EZETIMIBE | 10.0 MG | 1. ARTESAN PHARMA GMBH & CO. KG WENDLANDSTR.1, 29439 LUCHOW - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | GERMANY | ORAL SOLID ORDINARY TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1496 | NDA/MAL/HDP/12066 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ROYAL PHARMA 2011 LIMITED | DAPIFLOZIN-M 10/1000 | METFORMIN HYDROCHLORIDE + DAPAGLIFLOZIN | 1000.0 MG + 10.0 MG | 1. INVENTIA HEALTHCARE LIMITED F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*3.0*10.0TABLET BLISTER | 27/06/2025 |
| 1497 | NDA/MAL/HDP/12067 | LUPIN LIMITED | AIVEEN (U) LIMITED | DOLUTEGRAVIR, EMTRICITABINE & TENOFOVIR ALAFENAMIDE TABLETS 50/200/25 MG | DOLUTEGRAVIR + EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 50.0 MG + 200.0 MG + 25.0 MG | 1. LUPIN LIMITED NAGPUR UNIT 1, PLOT NO. 6A1, 6A2, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NOTIFIED AREA, NAGPUR-441108 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*30.0TABLET CONTAINER II. 1.0*60.0TABLET CONTAINER III. 1.0*90.0TABLET CONTAINER | 27/06/2025 |
| 1498 | NDA/MAL/HDP/12068 | KPI HEALTHCARE LIMITED | KPI HEALTHCARE LIMITED | ABIRATERONE ACETATE TABLETS, 250 MG | ABIRATERONE ACETATE | 250.0 MG | 1. DR. REDDY'S LABORATORIES LIMITED FORMULATIONS TECH OPS VII, PLOT NO. P1 TO P9, PHASE III, DUVVADA, VSEZ, VISAKHAPATNAM-530046, A.P. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1.0*1.0*120.0TABLET CONTAINER | 27/06/2025 |
| 1499 | NDA/MAL/HDP/12069 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | MYCOREN TABLETS | NYSTATIN | 500,000 IU | 1. RENE INDUSTRIES LIMITED PLOT 690 KAMULI KIREKA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*100TABLET CONTAINER | 06/05/2025 |
| 1500 | NDA/MAL/HDP/12070 | KAREMAX INDUSTRIAL LTD | ROYAL PHARMA 2011 LIMITED | KAREMEGA 4 INJECTION | BENZYLPENICILLIN SODIUM + PROCAINE PENICILLIN | 4,000,000 IU + 1,000,000 IU | 1. REYOUNG PHARMACEUTICAL COMPANY LIMITED NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P.R. CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY DRY VIALS | I. 1*50*5M.U VIAL | 06/05/2025 |
| 1501 | NDA/MAL/HDP/12072 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | SANTRIAX S 1000 | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1000 MG + 500 MG | 1. INJECT CARE PARENTERALS PRIVATE LIMITED PLOT NO. 130, SILVASSA ROAD, G.I.D.C. VAPI - 396195, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*1.5G VIAL + 1*10ML AMPOULE WATER FOR INJECTION | 06/05/2025 |
| 1502 | NDA/MAL/HDP/12073 | CURETECH SKINCARE | AARON PHARMACEUTICALS LIMITED | NIOCLEAN - AD | CLINDAMYCIN PHOSPHATE + ADAPALENE | 1.0 %W/W + 0.1 %W/W | 1. CURETECH SKINCARE PLOT NO. 32, 33, 34 PHASE VI, VILLAGE BHATOLIKALAN, BADDI, DIST SOLAN, HIMACHAL PRADESH 173205 - IND INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | I. 1*1*15G TUBE | 06/05/2025 |
| 1503 | NDA/MAL/HDP/12074 | AMOUN PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HAEMOSTOP | ETAMSYLATE | 250 MG/2ML | 1. AMOUN PHARMACEUTICAL COMPANY 1ST INDUSTRIAL ZONE, EL OBOUR CITY EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | PARENTERAL ORDINARY AMPOULES | I. 1*3*2ML AMPOULE | 06/05/2025 |
| 1504 | NDA/MAL/HDP/12075 | SOFTGEL HEALTHCARE PRIVATE LIMITED | KAMCARE PHARMA LIMITED | IBUNAFEN 400 | IBUPROFEN | 400 MG | 1. SOFTGEL HEALTHCARE PRIVATE LIMITED 20/1,VANDALUR - KELAMBAKKAM ROAD, PUDUPAKKAM VILLAGE, KANCHEEPURAM DISTRICT, TAMIL NADU - 603 103, I INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | I. 1*6*1*10CAPSULE BLISTER | 06/05/2025 |
| 1505 | NDA/MAL/HDP/12078 | CARITAS HEALTHCARE PRIVATE LIMITED | MEDS & MORE | TIGRETAS 90 MG | TICAGRELOR | 90 MG | 1. EXEMED PHARMACEUTICALS PLOT NO. 133/1 & 133/2, G.I.D.C., SELVAS ROAD, VAPI, DIST. VALSAD, GUJARAT - 396195, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*1*14TABLET BLISTER | 05/09/2025 |
| 1506 | NDA/MAL/HDP/1208 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | VISCO LIQUID | ALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE | 100 MG + 250 MG + 125 MG + 50 MG | ARISTO PHARMACEUTCALS PVT LTD, PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2011 |
| 1507 | NDA/MAL/HDP/12080 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHGUARD | LULICONAZOLE | 1.0%W/W | 1. CURETECH SKINCARE PLOT NO. 32, 33, 34 PHASE VI, VILLAGE BHATOLIKALAN, BADDI, DIST SOLAN, HIMACHAL PRADESH 173205 - IND INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 05/09/2025 |
| 1508 | NDA/MAL/HDP/12081 | ASIAN CONTINENTAL PVT. LTD. | HEALTHCARE LTD. | CARANIC 75 | DICLOFENAC SODIUM | 75 MG/3ML | 1. ASIAN CONTINENTAL PRIVATE LIMITED D-32, S.I.T.E. II, SUPER HIGHWAY KARACHI-PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | PARENTERAL ORDINARY AMPOULES | I. 1*1*10*3ML AMPOULE | 05/09/2025 |
| 1509 | NDA/MAL/HDP/12082 | GLOBELA PHARMA PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | CLOTRIZOL | CLOTRIMAZOLE | 100 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | VAGINAL TABLETS | I. 1*6TABLET BLISTER | 05/09/2025 |
| 1510 | NDA/MAL/HDP/12083 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DAPAZY 10 | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 10 MG | 1. M/S ALIDAC HEALTHCARE (MYANMAR) LIMITED LOT NO. B19, ZONE A, THILAWA SPECIAL ECONOMIC ZONE, THANLYIN TOWNSHIP, YANGON, MYANMAR MYANMAR SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MYANMAR | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1511 | NDA/MAL/HDP/12084 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DAPAZY 5 | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 5 MG | 1. M/S ALIDAC HEALTHCARE (MYANMAR) LIMITED LOT NO. B19, ZONE A, THILAWA SPECIAL ECONOMIC ZONE, THANLYIN TOWNSHIP, YANGON, MYANMAR MYANMAR SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MYANMAR | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1512 | NDA/MAL/HDP/12085 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIASIT 100 | SITAGLIPTIN HYDROCHLORIDE | 100 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1513 | NDA/MAL/HDP/12086 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIASIT 50 | SITAGLIPTIN HYDROCHLORIDE | 50 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1514 | NDA/MAL/HDP/12087 | HETERO LABS LIMITED | AIVEEN (U) LIMITED | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS 200 MG / 25 MG | EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 200 MG + 25 MG | 1. M/S ANNORA PHARMA PRIVATE LIMITED SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA STATE - 502313, IND INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*30TABLET CONTAINER II. 1*60TABLET CONTAINER III. 1*90TABLET CONTAINER IV. 1*100TABLET CONTAINER | 05/09/2025 |
| 1515 | NDA/MAL/HDP/12088 | GLOBELA PHARMA PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | GLOSARTAN 100 | LOSARTAN POTASSIUM | 100 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1516 | NDA/MAL/HDP/12089 | GLOBELA PHARMA PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | GLOSARTAN 50 | LOSARTAN POTASSIUM | 50 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1517 | NDA/MAL/HDP/1209 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-80 | TELMISARTAN | 80MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1518 | NDA/MAL/HDP/12090 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | HENKA 30 | DULOXETINE HYDROCHLORIDE | 30 MG | 1. M/S HETERO LAB LIMITED, UNIT I, VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1519 | NDA/MAL/HDP/12091 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | IBUPROFEN ORAL SUSPENSION BP 100MG/5ML | IBUPROFEN | 100 MG/5ML | 1. CIRON DRUGS & PHARMACEUTICALS PRIVATE LIMITED N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, PALGHAR 40506, MAHARASHTRA STATE - INDI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*60ML BOTTLE | 05/09/2025 |
| 1520 | NDA/MAL/HDP/12092 | KAREMAX INDUSTRIAL LTD | ROYAL PHARMA 2011 LIMITED | KAREMOL | PARACETAMOL | 500 MG | 1. HEBEI JIHENG(GROUP) PHARMACEUTICAL CO., LTD NO. 368 JIANSHE STREET, HENGSHUI CITY, HEBEI PROVINCE, 053000 CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 05/09/2025 |
| 1521 | NDA/MAL/HDP/12093 | CARITAS HEALTHCARE PRIVATE LIMITED | MEDS & MORE | LEVETAS 500MG | LEVETIRACETAM | 500 MG | 1. EXEMED PHARMACEUTICALS PLOT NO. 133/1 & 133/2, G.I.D.C., SELVAS ROAD, VAPI, DIST. VALSAD, GUJARAT - 396195, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER II. 1*2*10TABLET BLISTER III. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1522 | NDA/MAL/HDP/12094 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MYGLIP 5 | LINAGLIPTIN | 5 MG | 1. M/S ALIDAC HEALTHCARE (MYANMAR) LIMITED LOT NO. B19, ZONE A, THILAWA SPECIAL ECONOMIC ZONE, THANLYIN TOWNSHIP, YANGON, MYANMAR MYANMAR SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MYANMAR | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1523 | NDA/MAL/HDP/12095 | GLOBELA PHARMA PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | PLAVIDO | CLOPIDOGREL BISULFATE | 75 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1524 | NDA/MAL/HDP/12096 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | RAZEL 10 | ROSUVASTATIN CALCIUM | 10 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 05/09/2025 |
| 1525 | NDA/MAL/HDP/12097 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | RAZEL 20 | ROSUVASTATIN CALCIUM | 20 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 05/09/2025 |
| 1526 | NDA/MAL/HDP/12098 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | RAZEL 5 | ROSUVASTATIN CALCIUM | 5 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 05/09/2025 |
| 1527 | NDA/MAL/HDP/12099 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | RESCUWAVE LS | LEVOSALBUTAMOL SULFATE | 45 µG/ACTUATION | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. B-25 MIDC, SHENDRA, AURANGABAD 431154, MAHARASHTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | I. 1*1*200METERED DOSE CANNISTER | 05/09/2025 |
| 1528 | NDA/MAL/HDP/12100 | AUROBINDO PHARMA LIMITED. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SUMAFIX 50 | SUMATRIPTAN SUCCINATE | 50 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*5*4TABLET BLISTER | 05/09/2025 |
| 1529 | NDA/MAL/HDP/12101 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | AMPOMY 2 | POMALIDOMIDE | 2.0 MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1.0*1.0*21.0CAPSULE CONTAINER | 27/06/2025 |
| 1530 | NDA/MAL/HDP/12103 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | AMPOMY 4 | POMALIDOMIDE | 4.0 MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1.0*1.0*21.0CAPSULE CONTAINER | 27/06/2025 |
| 1531 | NDA/MAL/HDP/12105 | RAM PHARMACEUTICAL COMPANY LIMITED (CEPHALOSPORIN PLANT, PENICILLIN PLANT & MAIN PLANT) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MAGNACEF 400MG | 400MG | 1. RAM PHARMACEUTICAL COMPANY LIMITED (CEPHALOSPORIN PLANT, PENICILLIN PLANT & MAIN PLANT) KING ABDULLAH THE SECOND INDUSTRIAL ESTATE SAHAB - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | ORAL SOLID ORDINARY CAPSULES | I. 1.0*1.0*6.0CAPSULE BLISTER | 27/06/2025 | |
| 1532 | NDA/MAL/HDP/12106 | M/S DMP HEALTHCARE PVT. LTD. | PHARMA VILLE LIMITED | ARSU-60 | ARTESUNATE | 60 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*60MG VIAL + 1*10ML AMPOULE SODIUM CHLORIDE + 1*2ML AMPOULE SODIUM BICARBONATE | 05/09/2025 |
| 1533 | NDA/MAL/HDP/12107 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | AZATERO 100 | AZACITIDINE | 100 MG | 1. M/S HETERO LABS LIMITED, UNIT VI SY. NO. 410-411, TSIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*100MG VIAL | 05/09/2025 |
| 1534 | NDA/MAL/HDP/12108 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CALRISE | CALCIUM GLUCONATE | 100 MG/ML | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*1*10ML VIAL | 05/09/2025 |
| 1535 | NDA/MAL/HDP/12109 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | CIPSUN 500 | CIPROFLOXACIN | 500 MG | 1. SUNRISE INTERNATIONAL LABS LIMITED PLOT NO. 100, LANE 5, SECTOR II, PHASE II, IDA CHERLAPALLY, HYDERABAD 500 051, TELANGANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 05/09/2025 |
| 1536 | NDA/MAL/HDP/1211 | ASTRA ZENECA | MACNAUGHTON LIMITED | BRILINTA | TICAGRELOR | 90MG | ASTRA ZENECA AB, SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2011 |
| 1537 | NDA/MAL/HDP/12110 | VITACURA PHARMACEUTICALS, | REDDYS PHARMA LIMITED | CURANATE 60 MG INJECTION | ARTESUNATE | 60 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHROTA, TA. HIMATNAGAR, DISTRICT SABARKANTHA, GUJARAT, INDIA. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*60MG VIAL + 1*1ML AMPOULE SODIUM BICARBONATE + 1*5ML AMPOULE SODIUM CHLORIDE | 05/09/2025 |
| 1538 | NDA/MAL/HDP/12112 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IXOBRAN 10 | RIVAROXABAN | 10 MG | 1. INVENTIA HEALTHCARE LIMITED F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1539 | NDA/MAL/HDP/12113 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LEVOZIN | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5 MG/5ML | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | I. 1*1*60ML BOTTLE | 05/09/2025 |
| 1540 | NDA/MAL/HDP/12114 | QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LUMET HS 80 | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | 1. QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7, RING ROAD, LUZIRA INDUSTRIAL PARK, P.O. BOX 34871, KAMPALA UGANDA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UGANDA | ORAL SOLID ORDINARY TABLETS | I. 1*1*6TABLET BLISTER | 05/09/2025 |
| 1541 | NDA/MAL/HDP/12115 | RAM PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MAGNACEF 200MG | CEFIXIME TRIHYDRATE | 200 MG | 1. RAM PHARMACEUTICAL COMPANY LIMITED (CEPHALOSPORIN PLANT, PENICILLIN PLANT & MAIN PLANT) KING ABDULLAH THE SECOND INDUSTRIAL ESTATE SAHAB - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | ORAL SOLID ORDINARY CAPSULES | I. 1*1*8CAPSULE BLISTER | 05/09/2025 |
| 1542 | NDA/MAL/HDP/12116 | INCEPTA PHARMACEUTICALS LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | MEDOGEN | MEDROXYPROGESTERONE ACETATE | 150 MG/ML | 1. INCEPTA PHARMACEUTICALS LIMITED, UNIT 1 KRISHNAPURA, SAHABELISHOR, DHAMRAI, DHAKA, BANGLADESH BANGLADESH SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BANGLADESH | PARENTERAL ORDINARY VIALS | I. 1*1*3ML VIAL II. 1*20*3ML VIAL | 05/09/2025 |
| 1543 | NDA/MAL/HDP/12117 | S KANT HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MICONIT CG | CLOBETASOL PROPIONATE + MICONAZOLE NITRATE + GENTAMICIN SULFATE | 0.05 %W/W + 2 %W/W + 0.1 %W/W | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*1*15G TUBE II. 1*1*30G TUBE | 05/09/2025 |
| 1544 | NDA/MAL/HDP/12118 | BIOGEN PHARMA LTD | BIOGEN PHARMA LIMITED | OMEGEN | OMEPRAZOLE SODIUM | 40 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHROTA, TA. HIMATNAGAR, DISTRICT SABARKANTHA, GUJARAT, INDIA. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*40MG VIAL + 1*10ML AMPOULE WATER FOR INJECTION | 05/09/2025 |
| 1545 | NDA/MAL/HDP/12119 | SCOTT-EDIL PHARMACIA LIMITED | ROYAL PHARMA 2011 LIMITED | PROPRANOLOL | PROPRANOLOL HYDROCHLORIDE | 40 MG | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*2*14TABLET BLISTER | 05/09/2025 |
| 1546 | NDA/MAL/HDP/12120 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | RAPIDON | OLOPATADINE HYDROCHLORIDE | 0.1 %W/V | 1. MICRO LABS LIMITED PLOT NO. 113 - 116, 4TH PHASE, KIADB, BOMMASANDRA INDUSTRIAL AREA, JIGANI LINK ROAD, ANEKAL TALUK, BOMMASANDRA, BENGALURU-560099 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML BOTTLE | 05/09/2025 |
| 1547 | NDA/MAL/HDP/12121 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | RAPIDON 0.2% | OLOPATADINE HYDROCHLORIDE | 0.2 %W/V | 1. MICRO LABS LIMITED PLOT NO. 113 - 116, 4TH PHASE, KIADB, BOMMASANDRA INDUSTRIAL AREA, JIGANI LINK ROAD, ANEKAL TALUK, BOMMASANDRA, BENGALURU-560099 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1*1*5ML BOTTLE | 05/09/2025 |
| 1548 | NDA/MAL/HDP/12122 | MACLEODS PHARMACEUTICALS LTD | REDDYS PHARMA LIMITED | THYROX 50 | LEVOTHYROXINE SODIUM | 50 µG | 1. MACLEODS PHARMACEUTICALS LIMITED, UNIT - V (H BLOCK) PLOT NO. 2209,GIDC, SARIGAM, DIST-VALSAD, GUJARAT STATE, 396 155 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 05/09/2025 |
| 1549 | NDA/MAL/HDP/12124 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAFARIV 10 | RIVAROXABAN | 10 MG | 1. MYLAN LABORATORIES LIMITED PLOT NO. H-12 AND H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD, 431136, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 05/09/2025 |
| 1550 | NDA/MAL/HDP/12125 | M/S DMP HEALTHCARE PVT. LTD. | PHARMA VILLE LIMITED | ARSU-120 | ARTESUNATE | 120 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHROTA, TA. HIMATNAGAR, DISTRICT SABARKANTHA, GUJARAT, INDIA. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*120MG VIAL + 1*10ML AMPOULE SODIUM CHLORIDE + 1*2ML AMPOULE SODIUM BICARBONATE | 05/09/2025 |
| 1551 | NDA/MAL/HDP/12126 | SERUM INSTITUTE OF INDIA PVT LTD (SIIPL) | NORVIK ENTERPRISES LIMITED | MENFIVE | N. MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TT + N. MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO CRM197 + N. MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO CRM197 + N. MENINGITIDIS GROUP W POLYSACCHARIDE CONJUGATED TO CRM197 + N. MENINGITIDIS GROUP X POLYSACCHARIDE CONJUGATED TO TT | 5 µG + 5 µG + 5 µG + 5 µG + 5 µG | 1. SERUM INSTITUTE OF INDAI PVT. LTD. (SIIPL) 212/2 HADAPSAR PUNE 411028 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*50*5DOSE VIAL + 1*5*10*2.5ML AMPOULE SODIUM CHLORIDE II. 1*50*1DOSE VIAL + 1*5*10*0.5ML AMPOULE SODIUM CHLORIDE | 05/09/2025 |
| 1552 | NDA/MAL/HDP/12127 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DEMTIBI 50MG | DELAMANID | 50 MG | 1. MYLAN LABORATORIES LIMITED FDF-1, F-4 AND F-12, MALEGAON MIDC, SINNAR, NASHIK ,422113, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*6*8TABLET BLISTER | 05/09/2025 |
| 1553 | NDA/MAL/HDP/12129 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DEEXA | DEXAMETHASONE SODIUM PHOSPHATE | 0.1 %W/V | 1. LINCOLN PHARMACEUTICALS LIMITED TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | OPHTHALMIC DROPS | I. 1*1*10ML BOTTLE | 27/06/2025 |
| 1554 | NDA/MAL/HDP/12133 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMLORIV-10 | AMLODIPINE BESILATE | 10 MG | 1. EAST AFRICAN (INDIAN) OVERSEAS 1, 8 & 8A, PHARMACITY, SELAQUI, DEHRADUN - 248011 (U.K) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1555 | NDA/MAL/HDP/12134 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMLORIV-5 | AMLODIPINE BESILATE | 5 MG | 1. EAST AFRICAN (INDIAN) OVERSEAS 1, 8 & 8A, PHARMACITY, SELAQUI, DEHRADUN - 248011 (U.K) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1556 | NDA/MAL/HDP/12135 | DAVIMED PHARMA LIMITED | DAVIMED PHARMA LIMITED | DAVIDOL-500 | PARACETAMOL | 500 MG | 1. EAST AFRICAN (INDIAN) OVERSEAS 1, 8 & 8A, PHARMACITY, SELAQUI, DEHRADUN - 248011 (U.K) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 06/05/2025 |
| 1557 | NDA/MAL/HDP/12136 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TAXIM-O FORTE | CEFIXIME TRIHYDRATE | 100 MG/5ML | 1. EAST AFRICAN (INDIAN) OVERSEAS 1, 8 & 8A, PHARMACITY, SELAQUI, DEHRADUN - 248011 (U.K) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*60ML BOTTLE | 06/05/2025 |
| 1558 | NDA/MAL/HDP/12138 | ASTRAZENECA UK LIMITED | MACNAUGHTON LIMITED | CALQUENCE | ACALABRUTINIB | 100 MG | 1. ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE SWEDEN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWEDEN | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*6*10TABLET BLISTER | 05/09/2025 |
| 1559 | NDA/MAL/HDP/12139 | ASTRAZENECA UK LIMITED | MACNAUGHTON LIMITED | LYNPARZA 100MG | OLAPARIB | 100 MG | 1. ASTRAZENECA UK OPERATIONS MACCLESFIELD SILK ROAD BUSINESS PARK, MACCLESFIELD, CHESHIRE, SK10 2NA - UNITED KINGDOM ENGLAND SCOPE:BATCH RELEASE 2.ABBVIE LIMITED - ROAD NO. 2, KM 58.0, CRUCE DAVILA, BARCELONETA, PUERTO RICO 00617 – UNITED STATES OF AMERICASCOPE:BULK MANUFACTURE | UNITED KINGDOM| UNITED STATES OF AMERICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*7*8TABLET BLISTER | 05/09/2025 |
| 1560 | NDA/MAL/HDP/1214 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NUCLEO C.M.P FORTE | CYTIDINE+URIDINE | 5MG+3MG | FERRER INTERNACIONAL, S.A, JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 01/07/2013 |
| 1561 | NDA/MAL/HDP/12140 | ASTRAZENECA UK LIMITED | MACNAUGHTON LIMITED | LYNPARZA 150MG | OLAPARIB | 150 MG | 1. ASTRAZENECA UK OPERATIONS MACCLESFIELD SILK ROAD BUSINESS PARK, MACCLESFIELD, CHESHIRE, SK10 2NA - UNITED KINGDOM ENGLAND SCOPE:BATCH RELEASE 2.ABBVIE LIMITED - ROAD NO. 2, KM 58.0, CRUCE DAVILA, BARCELONETA, PUERTO RICO 00617 – UNITED STATES OF AMERICASCOPE:BULK MANUFACTURE | UNITED KINGDOM| UNITED STATES OF AMERICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*7*8TABLET BLISTER | 05/09/2025 |
| 1562 | NDA/MAL/HDP/12141 | SHREEJI CARE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | CEFINNY DS-125 | CEPHALEXIN MONOHYDRATE | 125 MG/5ML | 1. GLOBELA LABORATORIES PRIVATE LIMITED (FORMERLY NGB LABORATORIES PRIVATE LIMITED) PLOT NO. 5536, ROAD NO. 55, GIDC ESTATE, SACHIN, SURAT - 394230, GUJARAT -INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*100ML BOTTLE | 27/06/2025 |
| 1563 | NDA/MAL/HDP/12142 | SHREEJI CARE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | CEFINNY 250 | CEPHALEXIN MONOHYDRATE | 250 MG | 1. GLOBELA LABORATORIES PRIVATE LIMITED (FORMERLY NGB LABORATORIES PRIVATE LIMITED) PLOT NO. 5536, ROAD NO. 55, GIDC ESTATE, SACHIN, SURAT - 394230, GUJARAT - INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER | 27/06/2025 |
| 1564 | NDA/MAL/HDP/12143 | FAES FARMA, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | POSITON CREAM | TRIAMCINOLONE ACETONIDE + NEOMYCIN SULFATE + NYSTATIN | 250 MG/100G + 100 MG/100G + 10,000,000 IU/100G | 1. FAES FARMA ((FORMERLY LABORATÓRIOS VITÓRIA, S.A.) RUA ELIAS GARCIA, 28 2700-327 AMADORA - PORTUGAL SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PORTUGAL | TOPICAL EXTERNAL CREAMS | I. 1*1*30G TUBE | 05/09/2025 |
| 1565 | NDA/MAL/HDP/12144 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHDERM-N | BECLOMETASONE DIPROPIONATE + NEOMYCIN SULFATE + CLOTRIMAZOLE | 0.025 %W/W + 0.5 %W/W + 1.0 %W/W | 1. CURETECH SKINCARE PLOT NO. 32, 33, 34 PHASE VI, VILLAGE BHATOLIKALAN, BADDI, DIST SOLAN, HIMACHAL PRADESH 173205 - INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1.0*1.0*30.0G TUBE | 27/06/2025 |
| 1566 | NDA/MAL/HDP/1215 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GYNANFORT VAGINAL PESSARY | METRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN | 500MG+65,000I.U+100,000I.U | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | VAGINAL SUPPOSITORIES | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1567 | NDA/MAL/HDP/1219 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | TORAS-DENK 5 | TORASEMIDE | 5MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1568 | NDA/MAL/HDP/1220 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART | ARTEMETHER + LUMEFANTRINE | 180 MG + 1080 MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BLISTER | 01/07/2008 |
| 1569 | NDA/MAL/HDP/1223 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | WHITFIELD'S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X25.0 G TUBE | 01/07/1997 |
| 1570 | NDA/MAL/HDP/1226 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | SALBUTAMOL | SALBUTAMOL | 4MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*100TABLET CONTAINER II. 1*1000TABLET CONTAINER III. 1*10*10TABLET BLISTER | 01/07/2005 |
| 1571 | NDA/MAL/HDP/1227 | AMOUN PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FUNGISAFE | TERBINAFINE HCL | 250MG | AMOUN PHARMACEUTICAL CO. S.A.E, 1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET STRIP | 01/07/2013 |
| 1572 | NDA/MAL/HDP/1242 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TOPHEN-100 | PHENYTOIN | 100MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1000 TABLET CONTAINER, 1X10X10 TABLET BLISTER | 01/07/2013 |
| 1573 | NDA/MAL/HDP/1244 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | FLEXILOR SR | LORNOXICAM | 16MG | GLENMARK PHARMACEUTICALS LTD ., VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1574 | NDA/MAL/HDP/1245 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | FLEXILOR P8 | LORNOXICAM + PARACETAMOL | 8MG + 500MG | 1. GLENMARK PHARMACEUTICALS LIMITED VILLAGE - KISHANPURA, BADDI NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 03/07/2014 |
| 1575 | NDA/MAL/HDP/1247 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROCIP | CYPROHEPTADINE | 4MG | AGOG PHARMA LTD., PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1576 | NDA/MAL/HDP/1252 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ZOY | SILDENAFIL | 50MG | TORQUE PHAMACEAUTICALS PVT LTD, VILL ISSAPUR P.O DAPPAR INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2013 |
| 1577 | NDA/MAL/HDP/1254 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSATRIM TABLETS | CO-TRIMOXAZOLE | 480MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| 1578 | NDA/MAL/HDP/1264 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | OCUCYCLINE EYE OINTMENT | TETRACYCLINE HYDROCHLORIDE | 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE,1.0X3.5 G TUBE | 01/07/2000 |
| 1579 | NDA/MAL/HDP/1265 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | COMBIPLEX | VITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B6 | 1.0 MG + 1.0 MG + 15 MG + 0.5 MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 1580 | NDA/MAL/HDP/1275 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NIFELAT 10 F.C TABLETS | NIFEDIPINE | 10MG | REMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1581 | NDA/MAL/HDP/1278 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP | DIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE | 40MG +320MG | GUILIN PHARMACEUTICAL CO LTD, NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER | 01/07/2013 |
| 1582 | NDA/MAL/HDP/1282 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | LOSABERG | LOSARTAN POTASSIUM | 50MG | 1. THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 01/07/2016 |
| 1583 | NDA/MAL/HDP/1285 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANFUR-750 | CEFUROXIME | 750MG | SANCE LABORATORIES PRIVATE LTD, PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL | 01/07/2012 |
| 1584 | NDA/MAL/HDP/1287 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANIX- DS 100 | CEFIXIME | 100MG/5ML | SANCE LABORATORIES PVT LTD, VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE, 1.0X60.0 ML BOTTLE | 01/07/2014 |
| 1585 | NDA/MAL/HDP/1290 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANIX 400 CAP | CEFIXIME | 400MG | SANCE LABORATORIES PVT LTD, VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER, 1.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 1586 | NDA/MAL/HDP/1291 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | ULTRAVIST-300 | IOPROMIDE | 300MG/ML | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2012 |
| 1587 | NDA/MAL/HDP/1292 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIZTROL 16 | BETAHISTINE DIHYDROCHLORIDE | 16MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 01/07/2013 |
| 1588 | NDA/MAL/HDP/1293 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEGRA - 100 | SILDENAFIL CITRATE | 100MG | THE MADRAS PHARMACEUTICALS.., NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2016 |
| 1589 | NDA/MAL/HDP/1294 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | ULTRAVIST 370 | IOPROMIDE | 370MG/ML | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2012 |
| 1590 | NDA/MAL/HDP/1299 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE PLUS-1000 | CEFTRIAXONE SULBACTAM | 1000/500MG | SANCE LABORATORIES PRIVATE LTD, PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL, 1.0X50.0X1.0 VIAL CARTON | 01/07/2012 |
| 1591 | NDA/MAL/HDP/1301 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | COSAMINE PLUS | GLUCOSAMINE SULPHATE + CHONDROITIN SULPHATE | 250MG + 200MG | HOVID BERHAD (CHEMOR SITE)-, LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1592 | NDA/MAL/HDP/1302 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | HIPEN CAPSULES | AMOXYCILLIN | 250MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA | ZYDUS HEALTHCARE LIMITED, DAMAN - UNIT 1, SURVEY NO. 48, RINGANWADA VILLAGE, DAMAN (U.T)-396210 - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 1593 | NDA/MAL/HDP/1304 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE PLUS 2 | GLIMEPIRIDE+ METFORMIN | 2MG + 500MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1594 | NDA/MAL/HDP/1307 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL 40 | TELMISARTAN | 40MG | MICRO LABS LTD .., 57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1595 | NDA/MAL/HDP/1312 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SLIPIZEM- 2.5 | DIAZEPAM | 2.5MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| 1596 | NDA/MAL/HDP/1324 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | TOOTH HEAL | MULTI INGREDIENT | MULTI INGREDIENT | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X18.0 ML BOTTLE | 01/07/2005 |
| 1597 | NDA/MAL/HDP/1328 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | ENGERIX-B VACCINE | HEPATITIS B SURFACE ANTIGEN | 20MCG/ML | GLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE) | 01/07/1997 |
| 1598 | NDA/MAL/HDP/1331 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM N OINTMENT | BETAMETHASONE VALERATE + NEOMYCIN | 0.1%W/W + 0.5%W/W | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/1997 |
| 1599 | NDA/MAL/HDP/1335 | INTAS PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | PREGATAS | PREGABALIN | 75MG | INTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2012 |
| 1600 | NDA/MAL/HDP/1337 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FOURTS B | THIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM | 10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCG | FOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 1601 | NDA/MAL/HDP/1338 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | GRISEBEN 500 | GRISEOFULVIN | 500 MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 1602 | NDA/MAL/HDP/1342 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL CEPHALEXIN 250 | CEPHALEXIN MONOHYDRATE | 250MG | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| 1603 | NDA/MAL/HDP/1347 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORNILOX | ORNIDAZOLE + OFLOXACIN | 500MG + 200MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| 1604 | NDA/MAL/HDP/1348 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | VALPARIN CHRONO 500 | SODIUM VALPROATE (CONTROLLED RELEASE) | 500MG | TORRENT PHARMACEUTICAL LTD, AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2009 |
| 1605 | NDA/MAL/HDP/1359 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | DIFENAC-100 SR | DICLOFENAC SODIUM | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD, PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID RETARD CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 1606 | NDA/MAL/HDP/1361 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 120MG | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE | 01/07/2016 |
| 1607 | NDA/MAL/HDP/1362 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | BACTOCLAV-1000 | AMOXICILLIN + CLAVULANATE | 875 MG + 125 MG | MICRO LABS LIMITED , PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X6.0 TABLET STRIP | 01/07/2013 |
| 1608 | NDA/MAL/HDP/1367 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1609 | NDA/MAL/HDP/1368 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D5 | GLUCOSE | 5%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2010 |
| 1610 | NDA/MAL/HDP/1369 | MEDIPHARM INDUSTRIES (E.A.) LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE CO-PACK ORANGE FLAVOUR | ZINC + ORAL REHYDRATION SALTS | 20 G + 20 G | 1. MEDICAMEN BIOTECH LIMITED SP-1192 A & B, PHASE IV, INDL. AREA, BHIWADI-301019 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. AGOG PHARMA LIMITED PLOT NO. 33, SECTOR - II, THE VASAI TALUKA INDL. CO-OP. ESTATE LIMITED, GAURAIPADA, VASAI ‚¬ DIST - INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 3. MEDIPHARM INDUSTRIES (E.A) LTD - PLOT 65, KAKAJJO ROAD, BWEYOGERERE | INDIA| UGANDA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | I. 1*2*20.8G SACHET + 1*10TABLET BLISTER ZINC SULFATE | 01/07/2016 |
| 1611 | NDA/MAL/HDP/1370 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | STERILIZED WATER FOR INJECTION | WATER FOR INJECTION | NEUTRAL | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE | 01/07/2010 |
| 1612 | NDA/MAL/HDP/1372 | AXA PARENTERALS LTD | VITACARE LIMITED | RL | LACTIC ACID + SODIUM HYDROXIDE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE | (0.24 + 0.115 + 0.6 + 0.04 + 0.027)G/100ML | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2014 |
| 1613 | NDA/MAL/HDP/1377 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | SUPER AMP | WATER FOR INJECTION | N/A | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0 ML AMPOULE | 01/07/2014 |
| 1614 | NDA/MAL/HDP/1380 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | HYCORT CREAM | HYDROCORTISONE | 1%W/W | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/1997 |
| 1615 | NDA/MAL/HDP/1382 | HOVID BERHAD | BARIKI EXIM PHARMA LTD | INOX CAPSULES | ITRACONAZOLE | 100MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0X4.0 CAPSULE BLISTER | 01/07/2012 |
| 1616 | NDA/MAL/HDP/1383 | HOVID BHD | BARIKI EXIM PHARMA LTD | KETOFEN GEL | KETOPROFEN | 2.5%W/W | HOVID BHD (IPOH SITE), 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G CONTAINER | 01/07/2013 |
| 1617 | NDA/MAL/HDP/1387 | INTAS PHARMACEUTICALS LIMITED | ZEE PHARMACEUTICALS LIMITED | LAN-30 | LANSOPRAZOLE | 30MG | INTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0X10.0 CAPSULE STRIP | 01/07/2004 |
| 1618 | NDA/MAL/HDP/1390 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN CALCIUM | 5MG | IPR PHARMACEUTICALS INC,, LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| 1619 | NDA/MAL/HDP/1392 | ASTRA ZENECA | MACNAUGHTON LIMITED | ZOLADEX | GOSERELIN | 3.6MG | ASTRA ZENECA UK LIMITED, ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON | 01/07/1997 |
| 1620 | NDA/MAL/HDP/1393 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANFUR | CEFUROXIME | 500MG | SANCE LABORATORIES PRIVATE LTD, PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 1621 | NDA/MAL/HDP/1394 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANPIME -1000 | CEFEPIME | 1000MG | SANCE LABORATORIES PRIVATE LTD, PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1000.0MG VIAL | 01/07/2010 |
| 1622 | NDA/MAL/HDP/1395 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 40MG IV | ESOMEPRAZOLE | 40MG/5ML | ASTRA ZENECA-, KVARNBERGAGATAN12, SE-151 SODERTALIJE | SWEDEN | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL | 01/07/2010 |
| 1623 | NDA/MAL/HDP/1399 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ASTHALIN | SALBUTAMOL | 100MCG/DOSE | CIPLA LTD .PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2010 |
| 1624 | NDA/MAL/HDP/1406 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | CEBAY DRY SYRUP | CEFIXIME TRIHYDRATE | 50MG/5ML | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 1625 | NDA/MAL/HDP/1411 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | CIPIUM | CHLORPHENIRAMINE | 4MG | LEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1626 | NDA/MAL/HDP/1413 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | PODINE MOUTH WASH | POVIDONE IODINE | 0.1 %W/V | 1. BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100, KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | MOUTH WASH | I. 1*100ML BOTTLE II. 1*200ML BOTTLE | 02/07/2014 |
| 1627 | NDA/MAL/HDP/1414 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN SR TABLETS | DICLOFENAC SODIUM | 100MG | UNIQUE PHARMACEUTICAL LABS LIMITED. ., 215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 1628 | NDA/MAL/HDP/1417 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | MILICAL TABLETS | CALCIUM CITRATE + VITAMIN D3 | 1000MG +200 I.U | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2001 |
| 1629 | NDA/MAL/HDP/1418 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | AMINOPHYLLINE TABLETS | AMINOPHYLLINE | 100MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1630 | NDA/MAL/HDP/1420 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | SODIUM CHLORIDE + GLUCOSE | SODIUM CHLORIDE + GLUCOSE | 0.9%W/V + 5%W/V | 1. IVEE INFUSIONS EPZ LIMITED ATHI RIVER EXPORT PROCESSING ZONE, L.R NO. 18474/84, ATHI RIVER, NAIROBI KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*500ML VIAL | |
| 1631 | NDA/MAL/HDP/1425 | LEBEN LABORATORIES PVT.LTD | MARVIN PHARMA LIMITED | L-TRIM | COTRIMOXAZOLE | 240MG/5ML | LEBEN LABORATORIES PVT. LTD, L-4, PHASE €“III, M.I.D.C, | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| 1632 | NDA/MAL/HDP/1426 | LEBEN LABORATORIES PVT.LTD | MARVIN PHARMA LIMITED | METROLEB | METRONIDAZOLE | 200MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 1633 | NDA/MAL/HDP/1427 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TENA-50 | ATENOLOL | 50MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1634 | NDA/MAL/HDP/1433 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NORISTERAT | NORETHISTERONE ENANTATE | 200MG | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL | 01/07/1997 |
| 1635 | NDA/MAL/HDP/1436 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 10 | BISOPROLOL HEMIFUMARATE | 10MG | WINTHROP PHARMACEUTICALS(PTY) LTD,, 315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)|MERCK KGAA, 250 FRANKFRUTER STRASSE 250-64293 DARMSTADT| | SOUTH AFRICA|GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1636 | NDA/MAL/HDP/1441 | AXA PARENTERALS LTD | VITACARE LIMITED | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9%W/V | AXA PARENTERALS LTD, KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2014 |
| 1637 | NDA/MAL/HDP/1445 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | AXONE 1000 | CEFTRIAXONE SODIUM | 1000MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL | 01/07/2003 |
| 1638 | NDA/MAL/HDP/1446 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAMIN B COMPLEX | VITAMINS B1 + B2 + B6 + NIACINAMIDE | 0.5 MG + 0.5MG + 7.5MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2015 |
| 1639 | NDA/MAL/HDP/1450 | GLAXOSMITHKLINE LIMITED LIKONI | UNITED HEALTHCARE DISTRIBUTORS LTD | VOLTAREN EMULGEL 1% | DICLOFENAC DIETHYLAMMONIUM | 1%W/V | GSK CONSUMER HEALTH SA, GSK CONSUMER HEALTH SA, ROUTE DE L€™ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE,1.0X50.0 G TUBE | 01/07/1997 |
| 1640 | NDA/MAL/HDP/1451 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN INJECTION | DICLOFENAC | 25 MG/ML | 1. NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG, SWITZERLAND SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | I. 1*3ML AMPOULE | 01/07/1997 |
| 1641 | NDA/MAL/HDP/1453 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZESOZ-40 | ESOMEPRAZOLE | 40MG | MADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI €“ 600 096, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 1642 | NDA/MAL/HDP/1454 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PAINEX | PARACETAMOL + ASPIRIN + CAFFEINE | 500MG + 400MG + 50 MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP | 01/07/2003 |
| 1643 | NDA/MAL/HDP/1456 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | SUCRAFIL O GEL | SUCRALFATE + OXETACAINE | 10MG + 0.2MG | FOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2013 |
| 1644 | NDA/MAL/HDP/1457 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | DYSEN FORTE | SECNIDAZOLE | 1000MG | NABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2006 |
| 1645 | NDA/MAL/HDP/1460 | VENUS REMEDIES LTD | REDDYS PHARMA LIMITED | PARIN E | ENOXAPARIN | 80MG | VENUS REMEDIES LTD -, UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X2.0X0.8 ML PRE- FILLED SYRINGE | 01/07/2009 |
| 1646 | NDA/MAL/HDP/1463 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ARISTOZYME LIQUID | DIASTASE+PEPSIN | 50MG+10MG | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE | 01/07/2015 |
| 1647 | NDA/MAL/HDP/1468 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OCID 20 | OMEPRAZOLE | 20MG | S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID RETARD CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/1998 |
| 1648 | NDA/MAL/HDP/1469 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX 125 | AMOXICILLIN | 125MG/5ML | VOGEN LABORATORIES LTD, 70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 1649 | NDA/MAL/HDP/1474 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODIC GEL | DICLOFENAC DIETHYLAMINE | 1%W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2016 |
| 1650 | NDA/MAL/HDP/1476 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | SEPTOL | SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE | 1%W/W + 0.20W/W | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X15.0 G TUBE | 01/07/2016 |
| 1651 | NDA/MAL/HDP/1478 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA | SILDENAFIL | 50MG | AJANTA PHARMA LIMITED- PLOT NO. Z/103/A, DAHEJ SEZ PART-II, BHARUCH, GUJARAT-392130 INDIA|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2001 |
| 1652 | NDA/MAL/HDP/1482 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | STAMARIL PASTEUR | YELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED) | NLT 1000 I.U | SANOFI PASTEUR, 1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | FRANCE | PARENTERAL ORDINARY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS | 01/07/1997 |
| 1653 | NDA/MAL/HDP/1484 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CLYCIN.V | CLINDAMYCIN | 2 %W/W | 1. M/S SHAIGAN PHARMACEUTICALS PRIVATE LIMITED PAKISTAN 14KM, ADYALA ROAD, P.O. BOX DAHGAL, RAWALPINDI - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | VAGINAL CREAMS | I. 1*40G TUBE + APPLICATOR | 01/07/2004 |
| 1654 | NDA/MAL/HDP/1485 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | DICLOFEN 25 | DICLOFENAC | 25MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2011 |
| 1655 | NDA/MAL/HDP/1486 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-1 | AMPICILLIN | 1G | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL | 01/07/2011 |
| 1656 | NDA/MAL/HDP/1488 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DICLO-DENK 100 RECTAL | DICLOFENAC SODIUM | 100MG | HAUPT PHARMA WULFING GMBH., BETHELNER LANDSTR. 18, 31028 GRONAU | GERMANY | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP | 01/07/2000 |
| 1657 | NDA/MAL/HDP/1493 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | KOACT 1000 | AMOXICILLIN/CLAVULANATE POTASSIUM | 875MG/125MG | 1. AUROBINDO PHARMA LIMITED, UNIT XII SY. NO. 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL - MALKAJGIRI DISTRICT, HYDERABAD - 500090, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*5TABLET BLISTER | 01/07/2007 |
| 1658 | NDA/MAL/HDP/1494 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PEITEL 0.25% | PREDNICARBATE | 0.25%W/W | FERRER INTERNACIONAL, S.A, JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2013 |
| 1659 | NDA/MAL/HDP/1497 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LAEOVATE CREAM | BETAMETHASONE VALERATE | 0.1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 01/07/1997 |
| 1660 | NDA/MAL/HDP/1499 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE | 01/07/2005 |
| 1661 | NDA/MAL/HDP/1503 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | SEDIPROCT CREAM | HYDROCORTISONE+CINCHOCAINE | 0.5%W/W + 0.5%W/W | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | TOPICAL EXTERNAL OTHER CREAMS | 1.0X20.0 G TUBE | 01/07/2003 |
| 1662 | NDA/MAL/HDP/1505 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | SERETIDE EVOHALER | SALMETEROL/ FLUTICASONE PROPIONATE | 25/50 MCG | GLAXO WELLCOME PRODUCTION, ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON | 01/07/2007 |
| 1663 | NDA/MAL/HDP/1508 | DAWA LIMITED- | SUPER MEDIC LTD | WOMNIL | ALBENDAZOLE | 200MG/5ML | DAWA, PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2009 |
| 1664 | NDA/MAL/HDP/1514 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 100MG | JOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWN| SPECPHARM HOLDINGS, 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/1997 |
| 1665 | NDA/MAL/HDP/1516 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | URGENDOL P | TRAMADOL/ PARACETAMOL | 37.5MG/ 325MG | WIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1666 | NDA/MAL/HDP/1517 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | VEST MENTAMU BALM | CAMPHOR + EUCALYPTUS OIL + L-MENTHOL + METHYL SALICYLATE | 7.5 %W/W + 1.6 %W/W + 2.6 %W/W + 2.8 %W/W | 1. NEM LABORATORIES PRIVATE LIMITED 133 KRISHNA INDUSTRIES ESTATE, VASAI , PALGHAR - 401210, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*15G TUBE | 1998-07-01 00:00:00 |
| 1667 | NDA/MAL/HDP/1519 | ZYDUS LIFESCIENCES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FORMONIDE 400 | BUDENOSIDE + FORMOTEROL FUMARATE | 120 METERED DOSES (400MCG/6MCG) | ZYDUS LIFESCIENCES LIMITED, SURVEY NO. 417, 419 & 420, SARKHEJ - BAVLA NATIONAL HIGHWAY NO. 8A, VILLAGE - MORAIYA, TALUKA - SANAND, DIST. AHMEDABAD - 382 210, GUJARAT STATE - INDIA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON | 01/07/2007 |
| 1668 | NDA/MAL/HDP/1523 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMPIREN | AMPICILLIN | 125MG/5ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 1669 | NDA/MAL/HDP/1524 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN | AMOXICILLIN TRIHYDRATE | 125 MG / 5 ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2008 |
| 1670 | NDA/MAL/HDP/1525 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | BENDEX | ALBENDAZOLE | 20MG/5ML | CIPLA LTD ,,PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454774 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2007 |
| 1671 | NDA/MAL/HDP/1526 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GAMALATE B6 | MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B6 | 75MG + 75MG + 37MG + 37MG | FERRER INTERNATIONAL, S.A., C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2015 |
| 1672 | NDA/MAL/HDP/1528 | MICRO LABS LTD | LABOREX UGANDA LIMITED | BACTOCLAV-625 | AMOXYCILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | MICRO LABS LIMITED , PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/2007 |
| 1673 | NDA/MAL/HDP/1529 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PROVIRON | MESTEROLONE | 25MG | BAYER WEIMAR GMBH & CO. KG, DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X20.0 TABLET BLISTER | 01/07/1997 |
| 1674 | NDA/MAL/HDP/1533 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | 5D | GLUCOSE | 50G/L | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2007 |
| 1675 | NDA/MAL/HDP/1535 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FORTIWIN-4 | FORTIFIED PROCAINE PENICILLIN SODIUM | 4 M.U | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA| INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL | 01/07/2011 |
| 1676 | NDA/MAL/HDP/1538 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYZOLE SUSPENSION | ALBENDAZOLE | 200MG | ELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2003 |
| 1677 | NDA/MAL/HDP/1544 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE HYDROCHLORIDE B.P | PROMETHAZINE HCL | 25MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| 1678 | NDA/MAL/HDP/1546 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LANPRO | LANSOPRAZOLE | 30MG | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205| UNICHEM LABORATORIES LTD, PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X2.0X10.0 CAPSULE BLISTER | 01/07/1999 |
| 1679 | NDA/MAL/HDP/1549 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | PREDNICOL EYE DROPS | PREDNISOLONE | 250MG | REMINGTON PHARMACEUTICAL INDUS. PVT LTD, , 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/1999 |
| 1680 | NDA/MAL/HDP/1551 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CALOSHELL-500 | CALCIUM CARBONATE + VITAMIN D3 | 1250MG + 250IU | EMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| 1681 | NDA/MAL/HDP/1553 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | VIFEX | SALBUTAMOL + BROMHEXINE + GUAIFENESIN | 1MG/5ML+2MG/5ML+50MG/5ML | EMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| 1682 | NDA/MAL/HDP/1554 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL CETIRIZINE | CETIRIZINE DIHYDROCHLORIDE | 5MG/5ML | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2010 |
| 1683 | NDA/MAL/HDP/1555 | GALENTIC PHARMA LTD | VITACARE LIMITED | GALSCRUB | CHLORHEXIDINE | 4%W/W | GALENTIC PHARMA PVT. LIMITED , R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X500.0 ML BOTTLE | 01/07/2008 |
| 1684 | NDA/MAL/HDP/1556 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMISTAT | ONDASENTRON | 2MG/ML | LINCOLN PHARMACEUTICALS LTD, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2014 |
| 1685 | NDA/MAL/HDP/1557 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | SYNFLORIX VACCINE | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE | 1MCG+3MCG+13MCG+8MCG+5MCG+0.5MG | GLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE) | 01/07/2010 |
| 1686 | NDA/MAL/HDP/1566 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | VITAVIT | MULTI-INGREDIENT | MULTI-INGREDIENT | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2009 |
| 1687 | NDA/MAL/HDP/1571 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | RHOCLONE | MONOCLONAL ANTI-D IMMUNOGLOBULIN | 300MCG | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 ML VIAL (1 DOSE VIAL) | 01/07/2013 |
| 1688 | NDA/MAL/HDP/1572 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ROSUVAS 20 | ROSUVASTATIN | 20MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1689 | NDA/MAL/HDP/1574 | INTAS, PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | AMTAS-5 | AMLODIPINE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER | 01/07/2003 |
| 1690 | NDA/MAL/HDP/1577 | SEARLE PAKISTAN LTD | SURGIPHARM (U) LIMITED | SPIROMIDE | SPIRONOLACTONE + FRUSEMIDE | 50MG+20MG | THE SEARLE COMPANY-32-KM MULTAN ROAD, LAHORE | | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP | 01/07/2005 |
| 1691 | NDA/MAL/HDP/1579 | PT SANBE FARMA | ONCOPHARM (U) LTD | PLASMINEX | TRANEXAMIC ACID | 100MG/ML | PT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE | 01/07/2011 |
| 1692 | NDA/MAL/HDP/1581 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PANTOTAB | PANTOPRAZOLE | 40MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1693 | NDA/MAL/HDP/1585 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | UDIHEP FORTE | URSODEOXYCHOLIC ACID | 300MG | WIN-MEDICARE PRIVATE LIMITED, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2010 |
| 1694 | NDA/MAL/HDP/1589 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | CENTACID SUSPENSION | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE | 40MG+200MG+250MG/5ML | CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE | 01/07/1997 |
| 1695 | NDA/MAL/HDP/1591 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | CENTIPAR ELIXIR | PIPERAZINE CITRATE | 750ML/5ML | CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 01/07/1997 |
| 1696 | NDA/MAL/HDP/1598 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIM 400 | CIMETIDINE | 400MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1697 | NDA/MAL/HDP/1605 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ASPIRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER | 01/07/2001 |
| 1698 | NDA/MAL/HDP/1615 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APCALIS SX | TADALAFIL | 20MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X2.0 TABLET BLISTER | 01/07/2005 |
| 1699 | NDA/MAL/HDP/1616 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEZIN | CETIRIZINE | 5MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2011 |
| 1700 | NDA/MAL/HDP/1627 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID-V GEL | CLOTRIMAZOLE | 2%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | VAGINAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2004 |
| 1701 | NDA/MAL/HDP/1629 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CARVETAS 12.5 | CARVEDILOL | 12.5MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1702 | NDA/MAL/HDP/1631 | AUROBINDOM PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | NEVIRAPINE ORAL SUSPENSION | NEVIRAPINE | 50MG/5ML | AUROBINDO PHARMA LTD, UNIT III , SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2007 |
| 1703 | NDA/MAL/HDP/1635 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ORITAXIM 1000MG INJECTION | CEFOTAXIME SODIUM | 1GM | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL | 01/07/1997 |
| 1704 | NDA/MAL/HDP/1636 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | VIGAMOX | MOXIFLOXACIN | 5MG/ML | S.A.ALCON COUVREUR N.V, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2013 |
| 1705 | NDA/MAL/HDP/1638 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FLADAZOLE | SECNIDAZOLE | 500MG | AMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2005 |
| 1706 | NDA/MAL/HDP/1639 | GLAXO SMITHLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL EXTRA WITH OPTIZORB | PARACETAMOL + CAFFEINE | 500MG + 65MG | GRANULES INDIA LIMITED, SY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA| GLAXOSMITHKLINE DUNGARAVAN LTD, KNOCKBRACK DUNGARVAN CO. WATERFORD | IRELAND | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON | 01/07/2003 |
| 1707 | NDA/MAL/HDP/1641 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | UNIENZYME C MPS | NICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL | 25MG+50MG+30MG+20MG+75MG | UNICHEM LABORATORIES LIMITED, C€“31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2004 |
| 1708 | NDA/MAL/HDP/1650 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL CR 200 | CARBAMAZEPINE | 200MG | NOVARTIS FARMA S.P.A., VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY | ORAL SOLID RETARD TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1709 | NDA/MAL/HDP/1651 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1710 | NDA/MAL/HDP/1652 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | VALPARIN CHRONO 300 | SODIUM VALPROATE | 300MG | TORRENT PHARMACEUTICAL LTD, AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2009 |
| 1711 | NDA/MAL/HDP/1656 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | AZIGYL-500 | AZITHROMYCIN | 500MG | MEDICO REMEDIES PVT LIMITED, 8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA| AMN LIFE PRIVATE LIMITED - VILLAGE - MOGINAND, NAHA ROAD, KALA AMB, TEHSIL-NHAN, DISTRICT SIRMOUR, HIMACHAL PRADESH, 173030 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/2015 |
| 1712 | NDA/MAL/HDP/1660 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIM-200 | CIMEDITINE | 200MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP | 01/07/2005 |
| 1713 | NDA/MAL/HDP/1663 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ALCID-PINK | ALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE | 400MG+400MG/50ML | TORQUE PHARMACEUTICALS PVT LTD, ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE | 01/07/2003 |
| 1714 | NDA/MAL/HDP/1665 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD, NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407)| MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA| CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1998 |
| 1715 | NDA/MAL/HDP/1675 | MERCK SHARP & DOHME BV | SURGIPHARM (U) LIMITED | GARDASIL | QUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18) | (20MCG+40MCG+40MCG+20MCG)/0.5ML | MERK & CO. INC, SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA | UNITED STATES | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE) | 01/07/2007 |
| 1716 | NDA/MAL/HDP/1676 | KOPRAN LIMITED | TATA UGANDA LIMITED | CLOXIN-250 | CLOXACILLIN | 250MG | KOPRAN LTD, VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 1717 | NDA/MAL/HDP/1678 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | 100MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL | 01/07/2007 |
| 1718 | NDA/MAL/HDP/1679 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LIMITED | CIPROLEB | CIPROFLOXACIN | 500MG | LEBEN LABORATORIES PVT. LTD., PLOT NO. L-4, PHASE €“III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 1719 | NDA/MAL/HDP/1680 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | H-CORT | HYDROCORTISONE | 0.1%W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 1720 | NDA/MAL/HDP/1682 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | TOFLOX-200 | OFLOXACIN | 200MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1721 | NDA/MAL/HDP/1689 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | OMESK | OMEPRAZOLE | 20MG | S.KANT HEALTHCARE LTD, PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2010 |
| 1722 | NDA/MAL/HDP/1690 | PHARMA INTERNATIONAL CO | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FINALLERG | CETIRIZINE DIHYDROCHLORIDE | 1MG/ML | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| 1723 | NDA/MAL/HDP/1691 | WIDE SPECTRUM ENTERPRISES (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZITHRORIV | AZITHROMYCIN | 500 MG | 1. RIVA PHARMA S.A.E. ST.6, PUBLIC FREE ZONE, NASR CITY - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. RIVA PHARMA S.A.E. ST.6, PUBLIC FREE ZONE, NASR CITY - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY CAPSULES | I. 1*3CAPSULE BLISTER | 2011-07-01 00:00:00 |
| 1724 | NDA/MAL/HDP/1692 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFODOX 50MG/5ML SUSPENSION | CEFPODOXIME PROXETIL | 50MG/5ML | PHARMA INTERNATIONAL CO.,, AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE | 01/07/2007 |
| 1725 | NDA/MAL/HDP/1693 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | OPTIMAL (0.05%) CREAM | TRETINOIN USP | 0.5MG/1G | PHARMA INTERNATIONAL COMPANY ., MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| 1726 | NDA/MAL/HDP/1697 | PHARMA INTERNATIONAL CO | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FINALLERG | CETIRIZINE DIHYDROCHLORIDE | 10MG | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1727 | NDA/MAL/HDP/1699 | LEBEN LABORATORIES PRIVATE LIMITED. | LEBEN LABORATORIES PVT LTD | ELCUF SYRUP | CHLORPHENIRAMINE + AMMONIUM + SODIUM CITRATE | 2.5MG + 125MG + 55MG/5ML | 1. LEBEN LABORATORIES PRIVATE LIMITED PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA-444 104 (MS). - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*100ML BOTTLE | 01/07/2007 |
| 1728 | NDA/MAL/HDP/1701 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FORMIN | METFORMIN HYDROCHLORIDE | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1729 | NDA/MAL/HDP/1702 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | DELOR | CLOBETASOL PROPIONATE | 0.05%W/W | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE | 01/07/2005 |
| 1730 | NDA/MAL/HDP/1707 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | FEBRICOL TABLETS | PARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE | 500MG / 30MG /2MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BLD , 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1731 | NDA/MAL/HDP/1708 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | DENTAMOL | ACETAMINOPHEN | 500MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1732 | NDA/MAL/HDP/1709 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | LUCIN CREAM | HYDROCORTISONE | 1%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/1997 |
| 1733 | NDA/MAL/HDP/1711 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN-250 | AMOXYCILLIN | 250MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 1734 | NDA/MAL/HDP/1714 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | REMICOL EAR DROPS | CHLORAMPHENICOL | 1%W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD, , 117 ALLAM | PAKISTAN | OTIC DROPS | 1.0X10.0 ML BOTTLE | 01/07/1999 |
| 1735 | NDA/MAL/HDP/1715 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCOLYN SYRUP | AMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE | 50MG+2MG+5MG+4MG | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | | TANZANIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2011 |
| 1736 | NDA/MAL/HDP/1716 | ACULIFE HEALTHCARE PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | NIRMIN 5S | GLYCINE + L-ALANINE + L-ARGININE + L-ASPARTIC ACID + L-CYSTEINE HYDROCHLORIDE + GLUTAMIC ACID + HISTIDINE + L-ISOLEUCINE + L-LEUCINE + L-LYSINE HYDROCHLORIDE + L-METHIONINE + L-PHENYLALANINE + L-PROLINE + L-SERINE + L-THREONINE + L-TRYPTOPHAN + L-TYROSINE + L-VALINE + SORBITOL | 0.76 G + 0.2 G + 0.5 G + 0.25 G + 0.01 G + 0.075 G + 0.25 G + 0.352 G + 0.49 G + 0.43 G + 0.225 G + 0.533 G + 0.1 G + 0.1 G + 0.25 G + 0.09 G + 0.025 G + 0.36 G + 5 G | 1. ACULIFE HEALTHCARE PRIVATE LIMITED VILLAGE: SACHANA, TALUKA: VIRAMGAM, DISTRICT: AHMEDABAD - 382150, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*500ML BOTTLE | 01/07/2010 |
| 1737 | NDA/MAL/HDP/1719 | ACULIFE HEALTHCARE PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | NIRMIN 10 PLUS | GLYCINE + POTASSIUM ACETATE + SODIUM DIHYDROGEN PHOSPHATE + ACETYL TYROSINE + L-ALANINE + L-ARGININE + L-ASPARAGINE + L-ASPARTIC ACID + L-CYSTEINE HYDROCHLORIDE + GLUTAMIC ACID + HISTIDINE + L-ISOLEUCINE + L-LEUCINE + L-LYSINE HYDROCHLORIDE + L-MALIC ACID + L-METHIONINE + L-ORNITHINE HYDROCHLORIDE + L-PHENYLALANINE + L-PROLINE + L-SERINE + L-THREONINE + L-TRYPTOPHAN + L-TYROSINE + L-VALINE + MAGNESIUM ACETATE + SODIUM ACETATE TRIHYDRATE | 0.79 G + 0.245 G + 0.14 G + 0.123 G + 1.37 G + 0.92 G + 0.372 G + 0.13 G + 0.073 G + 0.46 G + 0.52 G + 0.51 G + 0.89 G + 0.7 G + 0.1 G + 0.38 G + 0.32 G + 0.51 G + 0.89 G + 0.24 G + 0.41 G + 0.18 G + 0.03 G + 0.48 G + 0.056 G + 0.395 G | 1. ACULIFE HEALTHCARE PRIVATE LIMITED VILLAGE: SACHANA, TALUKA: VIRAMGAM, DISTRICT: AHMEDABAD - 382150, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*500ML BOTTLE | 01/07/2010 |
| 1738 | NDA/MAL/HDP/1723 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT MULTIVITAMIN DROPS | MULTI-INGREDIENT | MULTI-INGREDIENT | SAKAR HEALTHCARE PVT LTD, SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE | 01/07/2000 |
| 1739 | NDA/MAL/HDP/1724 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AVAMYS NASAL SPRAY | FLUTICASONE FUROATE | 27.5MCG/ACTUATION | GLAXO OPERATIONS UK LTD--, HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK| GLAXO WELLCOME S.A, AVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAIN | UNITED KINGDOM, SPAIN | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2009 |
| 1740 | NDA/MAL/HDP/1725 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | MYCORIL CREAM 1% | CLOTRIMAZOLE | 1%W/W | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2000 |
| 1741 | NDA/MAL/HDP/1728 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | DELISPRIN 75MG | ASPIRIN | 75MG | ARISTO PHARMACEUTICALS PVT LTD , PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP | 01/07/2007 |
| 1742 | NDA/MAL/HDP/1730 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZITHROX | AZITHROMYCIN | 500MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2008 |
| 1743 | NDA/MAL/HDP/1731 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDIVEN-S OINTMENT | BETAMETHASONE VALERATE + SALICYLIC ACID | 0.05%W/W + 3%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| 1744 | NDA/MAL/HDP/1732 | MICRO LABS LTD | LABOREX UGANDA LIMITED | CEFEX-250 | CEPHALEXIN | 250MG | MICROLABS LIMITED, PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1999 |
| 1745 | NDA/MAL/HDP/1734 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMOMINT | COMPOUND MAGNESIUM TRISILICATE | 500MG | TIL HEALTH CARE, PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER | 01/07/1997 |
| 1746 | NDA/MAL/HDP/1736 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | KLERIMED | CLARITHROMYCIN | 500MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2009 |
| 1747 | NDA/MAL/HDP/1743 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | DAPRIL | LISINOPRIL DIHYDRATE | 10MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 1748 | NDA/MAL/HDP/1748 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-500 | AZITHROMYCIN | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0 CAPSULE BLISTER | 01/07/2011 |
| 1749 | NDA/MAL/HDP/1763 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | ASPIRIN TABLETS BP | ACETYL SALICYLIC ACID | 300MG | LABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 1750 | NDA/MAL/HDP/1766 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COLDEASE CAPSULES | PARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE | 400MG+30MG+4MG+30MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 1751 | NDA/MAL/HDP/1769 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | ENGERIX-B VACCINE | HEPATITIS B SURFACE ANTIGEN | 10MCG/ML | GLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE) | 01/07/1997 |
| 1752 | NDA/MAL/HDP/1772 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | GESTID TABLETS | COMPOUND MAGNESIUM TRISILICATE | 385MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED,, INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET BLISTER | 01/07/2000 |
| 1753 | NDA/MAL/HDP/1773 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1754 | NDA/MAL/HDP/1777 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | NUZAC 20 | FLUOXETINE | 20MG | CIPLA LTD PLOT NO. L-139, VERNA, GOA 403 722 INDIA | | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| 1755 | NDA/MAL/HDP/1779 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE SOLUTION | POVIDONE IODINE | 10.0G/100ML | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD, PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1999 |
| 1756 | NDA/MAL/HDP/1780 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI KIREKA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2000 |
| 1757 | NDA/MAL/HDP/1782 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | PER 5ML: 15MG + 90MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2010 |
| 1758 | NDA/MAL/HDP/1783 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LAEOVATE OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 01/07/1997 |
| 1759 | NDA/MAL/HDP/1785 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | ACTION TABLETS | ACETYL SALICYLATE + CAFFEINE + PARACETAMOL | 600MG+50MG+300MG | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER | 01/07/1997 |
| 1760 | NDA/MAL/HDP/1790 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNITRIM TABLET | CO-TRIMOXAZOLE | 480MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 1761 | NDA/MAL/HDP/1792 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | LIPODAR | ATORVASTATIN | 20MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1762 | NDA/MAL/HDP/1795 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMPIK-250 | AMPICILLIN | 250MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 1763 | NDA/MAL/HDP/1796 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA 250 | AZITHROMYCIN | 250 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130| AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2006 |
| 1764 | NDA/MAL/HDP/1800 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMLONG-10 | AMLODIPINE | 10MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 1765 | NDA/MAL/HDP/1801 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LABESTEN PESSARIES | CLOTRIMAZOLE | 100MG | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | | KENYA | | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY STRIP | 01/07/1997 |
| 1766 | NDA/MAL/HDP/1803 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 40MG | ESOMEPRAZOLE | 40MG | ASTRAZENECA AB., GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON | 01/07/2001 |
| 1767 | NDA/MAL/HDP/1807 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AMPICLOX NEONATAL DROPS | AMPICILLIN + CLOXACILLIN | 60 MG / 0.6 ML + 30 MG / 0.6 ML | MEDREICH STERILAB LTD, 12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X8.0 ML BOTTLE | 01/07/1997 |
| 1768 | NDA/MAL/HDP/1809 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIT-6 | PYRIDOXINE | 25MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| 1769 | NDA/MAL/HDP/1810 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRI | TRIFLUOPERAZINE | 5MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2010 |
| 1770 | NDA/MAL/HDP/1812 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN TABLETS | QUININE SULPHATE | 300MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| 1771 | NDA/MAL/HDP/1813 | DAWA LIMITED | SUPER MEDIC LTD | MOXAFORTE | AMOXICILLIN + FLUCLOXACILLIN | 125 MG + 125MG | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 1772 | NDA/MAL/HDP/1815 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | SUPIROCIN OINTMENT | MUPIROCIN | 2%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL OTHER OINTMENTS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/2003 |
| 1773 | NDA/MAL/HDP/1816 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | DRESS UP CREAM | NEOMYCIN SULPHATE | 0.5%W/W | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/1998 |
| 1774 | NDA/MAL/HDP/1819 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CINAMET-200 | CIMETIDINE | 200MG | JIANGSU PENGYAO PHARMACEUTICALS CO. LTD , NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1775 | NDA/MAL/HDP/1821 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | MEFTAL 500 TABLETS | MEFENAMIC ACID | 500MG | BLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/1997 |
| 1776 | NDA/MAL/HDP/1822 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | EPHEDRINE | EPHEDRINE HYDROCHLORIDE | 30MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| 1777 | NDA/MAL/HDP/1825 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | COLDEASE SYRUP | PARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG+2MG+15MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| 1778 | NDA/MAL/HDP/1827 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ALBASOL SUSPENSION | ALBENDAZOLE | 200MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2006 |
| 1779 | NDA/MAL/HDP/1840 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | OVA-MIT | CLOMIPHENE | 50MG | REMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1780 | NDA/MAL/HDP/1841 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | FUNGNIL CREAM | CLOTRIMAZOLE | 1%W/W | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2000 |
| 1781 | NDA/MAL/HDP/1842 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | SUGAQUIN TABLETS | CHLOROQUINE PHOSPHATE | 250MG | KAMPALA PHARMACEUTICALS INDUSTIES, PLOT NO M44B STRETCHER ROAD INTINDA | UGANDA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2002 |
| 1782 | NDA/MAL/HDP/1843 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ECORIN-75 | ASPIRIN | 75MG | REMEDEX PHARMA, B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1783 | NDA/MAL/HDP/1844 | GUILIN PHARMACEUTICALS CO.LTD | TRIDEM PHARMA UGANDA LIMITED | SULFAMETHOXAZOLE / TRIMETHOPRIM | SULFAMETHOXAZOLE / TRIMETHOPRIM | 800MG /160MG | GUILIN PHARMACEUTICAL CO.LTD., NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 1784 | NDA/MAL/HDP/1846 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | ANTAGIT DS GEL ORANGE FLAVOUR | ALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE | 400MG + 400MG + 50MG | LEBEN LABORATORIES PVT. LTD., PLOT NO. L-4, PHASE €“III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X170.0 ML BOTTLE | 01/07/2013 |
| 1785 | NDA/MAL/HDP/1847 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | MOXILEB-250 CAPSULE | AMOXICILLIN | 250MG | LEBEN LABORATORIES PVT. LTD., PLOT NO. L-4, PHASE €“III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 1786 | NDA/MAL/HDP/1848 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | PARATAL | PARACETAMOL | 500MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1787 | NDA/MAL/HDP/1849 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CIFIN | CIPROFLOXACIN | 0.2%W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 1788 | NDA/MAL/HDP/1850 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ALZOL TABLETS | ALBENDAZOLE | 400MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2010 |
| 1789 | NDA/MAL/HDP/1851 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CAPSIFENAC GEL | CAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE | 0.438 G + 0.335 G + 0.135 G + 0.918 G | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL EMULSION GELS | 1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE | 01/07/2011 |
| 1790 | NDA/MAL/HDP/1852 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | VERCEF ORAL SUSPENSION | CEFACLOR | 125MG/5ML | SUN PHARMACEUTICAL INDUSTRIES LIMITED , INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1791 | NDA/MAL/HDP/1853 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AERIUS ORAL SOLUTION | DESLORATADINE | 0.5MG/ML | SCHERING-PLOUGH LABO N.V-, INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG| MSD (PTY) LTD, LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA | BELGIUM| SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1X150 ML BOTTLE, 1X1X150 ML BOTTLE, 1X1X60 ML BOTTLE | 01/07/2007 |
| 1792 | NDA/MAL/HDP/1856 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PROPRANOLOL TABLETS B.P. 40MG | PROPRANOLOL HYDROCHLORIDE | 40MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 1793 | NDA/MAL/HDP/1861 | GUILIN PHARMACEUTICALS CO LTD | TRIDEM PHARMA UGANDA LIMITED | SULFAMETHOXAZOLE / TRIMETHOPRIM | SULFAMETHOXAZOLE / TRIMETHOPRIM | 400MG /80MG | GUILIN PHARMACEUTICAL CO.LTD., NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 1794 | NDA/MAL/HDP/1863 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ORACURE GEL | LIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE | 2 GM+0.1 GM | AMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2004 |
| 1795 | NDA/MAL/HDP/1864 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | PATANOL | OLOPTADINE HYDROCHLORIDE | 0.1%W/V | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 01/07/2009 |
| 1796 | NDA/MAL/HDP/1877 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MINT-O-COOL | DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE | 120MG + 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| 1797 | NDA/MAL/HDP/1879 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPENIV | PHENOXYMETHYL PENICILLIN | 250MG | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| 1798 | NDA/MAL/HDP/1880 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| 1799 | NDA/MAL/HDP/1881 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX | AMOXYCILLIN | 250MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| 1800 | NDA/MAL/HDP/1882 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCIL | AMPICILLIN | 250MG | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| 1801 | NDA/MAL/HDP/1887 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL | PARACETAMOL | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1802 | NDA/MAL/HDP/1889 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PREDSOL | PREDNISOLONE | 5MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON | 01/07/1997 |
| 1803 | NDA/MAL/HDP/1894 | KOPRAN LIMITED | TATA UGANDA LIMITED | TRIM-480 | CO-TRIMOXAZOLE | 480MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 1804 | NDA/MAL/HDP/1895 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO (PAEDIATRIC) | CO-TRIMOXAZOLE | 100MG/20MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| 1805 | NDA/MAL/HDP/1898 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | ZAPACID - 30 | LANSOPRAZOLE | 30MG | WIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 3.0X10.0 CAPSULE BLISTER | 01/07/2001 |
| 1806 | NDA/MAL/HDP/1900 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOM 20 | OMEPRAZOLE | 20MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP | 01/07/2007 |
| 1807 | NDA/MAL/HDP/1901 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | IBUMOL | IBUPROFEN + PARACETAMOL | 100MG + 162.5 MG /5ML | AJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 1808 | NDA/MAL/HDP/1902 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMODIUM | LOPERAMIDE HYDROCHLORIDE | 2MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 1809 | NDA/MAL/HDP/1911 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CODEINE PHOSPHATE TABLETS BP 30 | CODEINE PHOSPHATE | 30MG | COSMOS LIMITED , RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 1810 | NDA/MAL/HDP/1912 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | D-WORM | ALBENDAZOLE | 200MG | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2008 |
| 1811 | NDA/MAL/HDP/1914 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CHLORPHENIRAMINE | CHLORPHENIRAMINE | 4MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2003 |
| 1812 | NDA/MAL/HDP/1919 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDIDERM CREAM | BECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN | 0.025%W/W+1%W/W+0.1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/1999 |
| 1813 | NDA/MAL/HDP/1924 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | AMPICILLIN SODIUM | AMPICILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL, 1.0X10.0X500.0 MG VIAL | 01/07/2013 |
| 1814 | NDA/MAL/HDP/1927 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | INTAPLEX TABLET | VITAMIN B COMPOUND | N/A | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1815 | NDA/MAL/HDP/1928 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX | ALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG + 250MG +250MG +250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1816 | NDA/MAL/HDP/1929 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ATORVA 40 | ATORVASTATIN | 40MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1817 | NDA/MAL/HDP/1931 | ASTRAZENECA | MACNAUGHTON LIMITED | ZOLADEX LA | GOSERELIN ACETATE | 10.8MG | ASTRA ZENECA UK LIMITED, ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | PARENTERAL RETARD PRE-FILLED SYRINGES | 1.0X10.8 MG IMPLANT | 01/07/2010 |
| 1818 | NDA/MAL/HDP/1934 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENECHLOR SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 1819 | NDA/MAL/HDP/1937 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ | EFAVIRENZ | 600MG | AUROBINDO PHARMA LIMITED (UNIT III) , AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2005 |
| 1820 | NDA/MAL/HDP/1941 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | RABELOC IV | RABEPRAZOLE | 20MG/VIAL | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL | 01/07/2005 |
| 1821 | NDA/MAL/HDP/1942 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | AMCLOREN | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER | 01/07/2009 |
| 1822 | NDA/MAL/HDP/1943 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | NITROCONTIN 2.6 | NITROGLYCERIN (CONTROLLED RELEASE) | 2.6MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD TABLETS | 1.0X25.0 TABLET CONTAINER | 01/07/2009 |
| 1823 | NDA/MAL/HDP/1948 | PFIZER LABORATORIES PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 500MG | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER | 01/07/1998 |
| 1824 | NDA/MAL/HDP/1949 | MACLEODS PHARMACEUTICALS LTDS LTD | VITACARE LIMITED | TRENAXA 500 | TRANEXAMIC ACID | 500MG | MACLEODS PHARMACEUTICALS , PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X6.0 TABLET BLISTER | 01/07/2011 |
| 1825 | NDA/MAL/HDP/1954 | ALKEM LABORATORIES LIMITEDˆŠ | ABACUS PHARMA (AFRICA) LIMITED | RAPEED-20 | RABEPRAZOLE | 20MG | EAST AFRICAN (INDIA) OVERSEAS, PLOT NO.1, 8, 8A PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP, 1.0X1.0X10.0 TABLET STRIP | 01/07/2011 |
| 1826 | NDA/MAL/HDP/1956 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY | AMOXYCILLIN | 250MG | MILAN LABORATORIES (INDIA) PVT LTD, PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2006 |
| 1827 | NDA/MAL/HDP/1958 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY | AMOXYCILLIN | 125MG/5ML | MILAN LABORATORIES (INDIA) PVT LTD, PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| 1828 | NDA/MAL/HDP/1959 | MILAN LABERATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | BETRIM 480 | CO-TRIMOXAZOLE | 480MG | MILAN LABORATORIES (INDIA) PVT LTD, PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1829 | NDA/MAL/HDP/1960 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | DIFENAC | DICLOFENAC SODIUM | 50MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD , PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2003 |
| 1830 | NDA/MAL/HDP/1961 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | MUILTIZEBEX | VITAMIN A + CHOLECALCIFEROL + THIAMINE + RIBOFLAVINE + PYRIDOXINE + NICOTINAMIDE | 2500 IU + 200IU + 1MG +1MG + 0.5MG +15MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2014 |
| 1831 | NDA/MAL/HDP/1966 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | PARACIN | PARACETAMOL | 500MG | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1832 | NDA/MAL/HDP/1969 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SR 75MG | DICLOFENAC SODIUM | 75MG | NOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY, NA | ITALY | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/1997 |
| 1833 | NDA/MAL/HDP/1970 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | CETRAMAC | CETIRIZINE | 10MG | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1834 | NDA/MAL/HDP/1971 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMPICLOX ORAL SUSPENSION | AMPICILLIN + CLOXACILLIN | 125 MG/5ML + 125 MG/5ML | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| 1835 | NDA/MAL/HDP/1975 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BET-CODERM N | BETAMETHASONE + NEOMYCIN | 0.1 W/W + 0.5 W/W | LINCOLN PHARMACEUTICALS LTD, 10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2007 |
| 1836 | NDA/MAL/HDP/1984 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | CIALIS | TADALAFIL | 20MG | LILLY SA, AVDA DE LA INDUSTRIA, LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID | SPAIN | ORAL SOLID ORDINARY TABLETS | 2.0X2.0 TABLET BLISTER | 01/07/2004 |
| 1837 | NDA/MAL/HDP/1989 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DERMOFIX | SERTACONAZOLE NITRATE | 2%W/W | FERRER INTERNATIONAL, S.A., C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2014 |
| 1838 | NDA/MAL/HDP/1990 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TAGERA FORTE | SECNIDAZOLE | 1G | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205| UNICHEM LABORATORIES LTD--, C31 & 32 INDUSTRIAL AREA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X2.0 TABLET BLISTER | 01/07/2005 |
| 1839 | NDA/MAL/HDP/1994 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | PANUM 40 | PANTOPRAZOLE | 40MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD ., 128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 1840 | NDA/MAL/HDP/1997 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TENA-100 | ATENOLOL | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X1000.0 TABLET JAR (WITH STATEMENT "FOR HOSPITAL USE ONLY".) | 01/07/2011 |
| 1841 | NDA/MAL/HDP/2000 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | CALCIGARD RETARD | NIFEDIPINE(SR) | 20MG | TORRENT PHARMACEUTICALS LTD, INDRAD-382721, TAL KADI, AHMEDABAD, INDIA| TORRENT PHARMACEUTICALS LIMITED - BHUD & MAKHNU MAJRA TEHSIL, BADDI - 173205, DIST SOLAN, HIMACHAL PRADESH - INDIA. | INDIA | ORAL SOLID RETARD TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER | 01/07/2000 |
| 1842 | NDA/MAL/HDP/2005 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA-100 | SILDENAFIL CITRATE | 100MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2005 |
| 1843 | NDA/MAL/HDP/2008 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID -B- CREAM | CLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM | 1%W/W + 0.025%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2004 |
| 1844 | NDA/MAL/HDP/2009 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZITHROX | AZITHROMYCIN | 200MG/5ML | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2010 |
| 1845 | NDA/MAL/HDP/2012 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID -B- LOTION | CLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE | 1%W/V + 0.025%W/V | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X15.0 ML BOTTLE | 01/07/2004 |
| 1846 | NDA/MAL/HDP/2014 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | CANI-MAKS | CLOTRIMAZOLE | 1%W/W | S KANT HEALTHCARE LTD, 1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 01/07/2009 |
| 1847 | NDA/MAL/HDP/2016 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID CREAM | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2000 |
| 1848 | NDA/MAL/HDP/2018 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | ORAXIN SYRUP | CYPROHEPTADINE HYDROCHLORIDE + PEPTONE + LYSINE HYDROCHLORIDE | 2MG + 25MG + 150MG | CENTAUR PHARMACEUTICALS LTD,-, KARASWADA MAPUSA GOA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1849 | NDA/MAL/HDP/2019 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOHAL | HALOPERIDOL | 10MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1850 | NDA/MAL/HDP/2020 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | QUINE | QUININE SULPHATE | 300MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER | 01/07/1997 |
| 1851 | NDA/MAL/HDP/2022 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | TORACTIN | CYPROHEPTADINE | 2MG/5ML | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| 1852 | NDA/MAL/HDP/2024 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | NEXPRO - 40 | ESOMEPRAZOLE MAGNESIUM TABLET | 40MG | TORRENT PHARMACEUTICALS LTD, INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2004 |
| 1853 | NDA/MAL/HDP/2025 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | FERRO-B COMPLEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1854 | NDA/MAL/HDP/2026 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | CORAM 10MG | AMLODIPINE BESYLATE | 10MG | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD, PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 1855 | NDA/MAL/HDP/2027 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CO-ANGINET 160/12.5MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG + 12.5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1856 | NDA/MAL/HDP/2029 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CHLORAMPHENICOL PALMITATE | CHLORAMPHENICOL PALMITATE | 125MG/5ML | MEDICAMEN BIOTECH LTD, SP-1192, A &B, PHASE €“IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 1857 | NDA/MAL/HDP/2033 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGIZAAR-50 | LOSARTAN POTASSIUM | 50MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2009 |
| 1858 | NDA/MAL/HDP/2035 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | NEOSIDAR | SULPHADOXINE + PYRIMETHAMINE | 500MG + 25MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER | 01/07/2004 |
| 1859 | NDA/MAL/HDP/2036 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | HUMULIN REGULAR | HUMAN INSULIN | 100IU | ELI LILLY & COMPANY, LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221| LILLY FRANCE SA, FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/1998 |
| 1860 | NDA/MAL/HDP/2040 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER | 01/07/2006 |
| 1861 | NDA/MAL/HDP/2042 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BURNCURE | SILVER SULFADIAZINE | 1%W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 1862 | NDA/MAL/HDP/2046 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | LORHISTINA | LORATADINE | 10MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1863 | NDA/MAL/HDP/2047 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | RITONAVIR | RITONAVIR | 100MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE | 01/07/2011 |
| 1864 | NDA/MAL/HDP/2053 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-5 | AMLODIPINE BESILATE | 5MG | EMCURE PHARMACEUTICALS LTD , LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1865 | NDA/MAL/HDP/2055 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARTESUN | ARTESUNATE | 120MG | GUILIN PHARMACEUTICAL CO. LTD., NO. 43 QILIDIAN ROAD, GUILIN 541004 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE | 01/07/2011 |
| 1866 | NDA/MAL/HDP/2056 | WOCKHARDT LTD | KAMCARE PHARMA LIMITED | BRO-ZEDEX | TERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL | 1.25MG+ 4 MG+50 MG+2.5 MG/5 ML | NAXPAR PHARMA PRIVATE LIMITED, 182, VILLAGE GURUMAJRA, TEHSIL NALAGARH, BADDI, DIST. SOLAN (H.P), 174101 INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE, 1.0X200.0 ML BOTTLE, 1.0X60.0 ML BOTTLE | 01/07/1997 |
| 1867 | NDA/MAL/HDP/2061 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | ADSOCARB TABLETS | ACTIVATED CHARCOAL | 250MG | CYANO PHARMA(P), 115-C IND ESTATE POLOGROUND, INDORE 452015 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1868 | NDA/MAL/HDP/2062 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCOLYN PAEDIATRIC SYRUP | DEXTROMETHORPHAN HYDROBROMIDE BP + CHLORPHENIRAMINE MALEATE BP + AMMONIUM CHLORIDE BP + PSEUDOEPHEDRINE HYDROCHLORIDE BP | (5MG + 2MG + 50MG + 10MG)/ 5ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2006 |
| 1869 | NDA/MAL/HDP/2063 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MICROGYNON FE | LEVONORGESTREL / ETHINYLESTRADIOL. | 0.15MG / 0.03MG | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X28.0 TABLET BLISTER | 01/07/1997 |
| 1870 | NDA/MAL/HDP/2066 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | METHOTREXATE | METHOTREXATE | 2.5MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1871 | NDA/MAL/HDP/2067 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZYNCET | CETIRIZINE DIHYDROCHLORIDE | 10MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER | 01/07/1999 |
| 1872 | NDA/MAL/HDP/2068 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | DOMADOL | TRAMADOL HYDROCHLORIDE | 50MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1999 |
| 1873 | NDA/MAL/HDP/2069 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | SK DERM | BETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN | 0.05%W/W + 1%W/W + 0.1%W/W | S KANT HEALTHCARE LTD, PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE,1.0X100.0 G TUBE, 1.0X5.0 G TUBE | 01/07/2010 |
| 1874 | NDA/MAL/HDP/2070 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MIRENA | LEVONORGESTREL | 52MG | BAYER OY, PANSIONATE 47 20210 TURKU FINLAND | FINLAND | PARENTERAL RETARD IMPLANTS | 1.0X1.0 IMPLANT CARTON | 01/07/2009 |
| 1875 | NDA/MAL/HDP/2071 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | CEFAMOR DRY SYRUP | CEFALEXIN | 125MG/5ML | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| 1876 | NDA/MAL/HDP/2073 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED) | MEASLES VIRUS | NOT LESS THAN 1000CCID50/ DOSE | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION, 1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION | 01/07/1997 |
| 1877 | NDA/MAL/HDP/2074 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN ORAL SUSPENSION | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| 1878 | NDA/MAL/HDP/2075 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPRED | PREDNISOLONE | 5MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1879 | NDA/MAL/HDP/2076 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMIDE | FUROSEMIDE | 40MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1880 | NDA/MAL/HDP/2077 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 30MG/5ML | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 1881 | NDA/MAL/HDP/2078 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | ALCLOX SYRUP | CLOXACILLIN SODIUM | 125MG/5ML | LEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 1882 | NDA/MAL/HDP/2081 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | COMPOUND SODIUM LACTATE | SODIUM LACTATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE+ CALCIUM CHLORIDE DIHYDRATE | 0.32G+0.6G+0.04+0.027/100ML | 1. IVEE INFUSIONS EPZ LIMITED ATHI RIVER EXPORT PROCESSING ZONE, L.R NO. 18474/84, ATHI RIVER, NAIROBI KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*500ML BOTTLE | |
| 1883 | NDA/MAL/HDP/2083 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | BEVAC | PURIFIED HEPATITIS B SURFACE ANTIGEN | 20MCG | BIOLOGICAL E LTD, PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL) | 01/07/2015 |
| 1884 | NDA/MAL/HDP/2089 | HOVID BHD | BARIKI EXIM PHARMA LTD | DIABETMIN XR 500MG | METFORMIN HCL EXTENDED RELEASE | 500MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1885 | NDA/MAL/HDP/2090 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CIPROREN | CIPROFLOXACIN | 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1886 | NDA/MAL/HDP/2091 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CAMSTON | CLOTRIMAZOLE | 1%W/W | KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD, PLOT M444 B STRETCHER ROAD NTINDA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2001 |
| 1887 | NDA/MAL/HDP/2094 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT-750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| 1888 | NDA/MAL/HDP/2097 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | ALCLOX | CLOXACILLIN | 250MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 1889 | NDA/MAL/HDP/2098 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO QUININE | QUININE SULPHATE | 300MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1890 | NDA/MAL/HDP/2099 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | HYDROCORTISONE 1% CREAM | HYDROCORTISONE | 1%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1998 |
| 1891 | NDA/MAL/HDP/2100 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | ORALCON - F | LEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE | 0.15MG + 0.03MG + 75MG | MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER | 01/07/2007 |
| 1892 | NDA/MAL/HDP/2101 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CARDISPRIN | ACETYL SALICYLIC ACID | 75MG | COSMOS LIMITED, RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 1893 | NDA/MAL/HDP/2108 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYMOX CAPSULES 250MG | AMOXYCILLIN | 250MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 1894 | NDA/MAL/HDP/2112 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 200MG + 50MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER | 01/07/2008 |
| 1895 | NDA/MAL/HDP/2120 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEGAPIME | CEFEPIME | 1G | SANCE LABORATORIES PVT LTD (VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 01/07/2011 |
| 1896 | NDA/MAL/HDP/2122 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYMOL | PARACETAMOL | 120MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1897 | NDA/MAL/HDP/2124 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYMOX | AMOXYCILLIN | 125MG/5ML | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1898 | NDA/MAL/HDP/2125 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | BECLATE 100 | BECLOMETASONE | 100MCG/DOSE | CIPLA LTD.- , PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2009 |
| 1899 | NDA/MAL/HDP/2129 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 500MG/125MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2011 |
| 1900 | NDA/MAL/HDP/2132 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LOPINAVIR/ RITONAVIR | LOPINAVIR/ RITONAVIR | 200MG/ 50MG | AUROBINDO PHARMA LTD, UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER | 01/07/2010 |
| 1901 | NDA/MAL/HDP/2133 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ACTRAPID | HUMAN INSULIN | 100 I.U/ML | NOVO NORDISK PHARMA, NOVO ALLE| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE | DENMARK | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| 1902 | NDA/MAL/HDP/2136 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | SEDIPROCT SUPOSITORY | HYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN | 5MG + 5MG +10MG +10MG | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | TOPICAL EXTERNAL SUPPOSITORIES | 1.0X6.0 SUPPOSITORY STRIP | 01/07/2003 |
| 1903 | NDA/MAL/HDP/2141 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | INFLAZONE | MULTIINGREDIENT | N/A | CENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 01/07/2005 |
| 1904 | NDA/MAL/HDP/2143 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GRISEOFIL | GRISEOFULVIN | 500MG | FOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1905 | NDA/MAL/HDP/2150 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | HUMULIN MIXTURE | HUMAN INSULIN | 70/30 I.U | LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,, INDIANA 46285 USA | UNITED STATES | PARENTERAL ORDINARY S C VIALS | 1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/1997 |
| 1906 | NDA/MAL/HDP/2151 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYCOMET 850 | METFORMIN | 850MG | FREDUN PHARMACEUTICALS LIMITED--, 14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| 1907 | NDA/MAL/HDP/2154 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYNASE | GLIPIZIDE | 5MG | FREDUN PHARMACEUTICALS LIMITED--, 14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| 1908 | NDA/MAL/HDP/2155 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | DOXEFIL | DOXYCYCLINE | 100MG | FOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 1909 | NDA/MAL/HDP/2158 | ACULIFE HEALTHCARE PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | NIRPID | INTRAVENOUS FAT EMULSION | 20 %W/V | 1. ACULIFE HEALTHCARE PRIVATE LIMITED VILLAGE: SACHANA, TALUKA: VIRAMGAM, DISTRICT: AHMEDABAD - 382150, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*500ML BOTTLE | 01/07/2010 |
| 1910 | NDA/MAL/HDP/2160 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ACEM-500 | CLARITHROMYCIN | 500MG | EMCURE PHARMACEUTICALS LTD, LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1911 | NDA/MAL/HDP/2161 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CYCLOVAX CREAM | ACICLOVIR | 5%W/W | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/1997 |
| 1912 | NDA/MAL/HDP/2170 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ALSARTAN-AM | LOSARTAN + AMLODIPINE | 50MG + 5MG | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2011 |
| 1913 | NDA/MAL/HDP/2173 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEVO-500 | LEVOFLOXACIN | 500MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET BLISTER | 01/07/2003 |
| 1914 | NDA/MAL/HDP/2175 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CIPLADON | PARACETAMOL | 500MG | CIPLA LTD .PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH| MEDISPRAY LABORATORIES PRIVATE LIMITED - L-1/1, L-1/2/2 & L-2, ADDITIONAL MIDC, SATARA- 415 004, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP | 01/07/2005 |
| 1915 | NDA/MAL/HDP/2176 | INTAS PHARMACUITICALS LTD | ZEE PHARMACEUTICALS LIMITED | RISPITAS-2 | RISPERIDONE | 2MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1916 | NDA/MAL/HDP/2181 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PHEN | PHENOXYMETHYLPENICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER | 01/07/1997 |
| 1917 | NDA/MAL/HDP/2183 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OCID I.V. | OMEPRAZOLE | 40MG/VIAL | SAKAR HEALTHCARE PVT LTD, BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL + 1*10ML AMPOULE OF WFI | 01/07/2007 |
| 1918 | NDA/MAL/HDP/2185 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | ROTARIX | LIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPE | NOT LESS THAN 10? CCID?? OF THE RIX4414 STRAIN | GLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART| | BELGIUM | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.5 ML TUBE (1 DOSE),1.0X50.0X1.5 ML TUBE (1 DOSE),1.0X7.5 ML TUBE (5-DOSE) FOR GAVI/UNICEF SUPPLY ONLY | 01/07/2009 |
| 1919 | NDA/MAL/HDP/2187 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VOMIZ | ONDANSETRON | 4MG/2ML | GERMAN REMEDIES PHARMACEUTICALS PRIVATE LIMITED, PF 61 & 62, SANAND GIDC II INDUSTRIAL ESTATE, SANAND, AHMEDABABD - 382110, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X4.0ML AMPOULE, 1.0X5.0X2.0ML AMPOULE | 01/07/2005 |
| 1920 | NDA/MAL/HDP/2189 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (A) LTD. | AXCEL BETAMETHASONE | BETAMETHASONE | 0.1%W/W | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/2008 |
| 1921 | NDA/MAL/HDP/2195 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | EUDERM CREAM | UREA | 10%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X45.0 G TUBE | 01/07/1997 |
| 1922 | NDA/MAL/HDP/2197 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | WHITFIELD'S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | LABORATORY & ALLIED LTD, PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 01/07/1997 |
| 1923 | NDA/MAL/HDP/2199 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 50MCG | LEVOTHYROXINE SODIUM | 50MCG | MERCK KGAA - , FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER | 01/07/2013 |
| 1924 | NDA/MAL/HDP/2201 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CLYCIN T | CLINDAMYCIN PHOSPHATE | 10 MG/ML | 1. M/S SHAIGAN PHARMACEUTICALS PRIVATE LIMITED PAKISTAN 14KM, ADYALA ROAD, P.O. BOX DAHGAL, RAWALPINDI - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | TOPICAL EXTERNAL LOTIONS | I. 1*30ML BOTTLE | 01/07/2004 |
| 1925 | NDA/MAL/HDP/2208 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (A) LTD. | AXCEL CEPHALEXIN | CEPHALEXIN MONOHYDRATE | 500MG | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| 1926 | NDA/MAL/HDP/2211 | GALENTIC PHARMA (PVT)LTD | VITACARE LIMITED | BENZYL BENZOATE | BENZYL BENZOATE | 25%W/W | GALENTIC PHARMA PVT. LIMITED, R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIA | INDIA | TOPICAL EXTERNAL EMULSIONS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 01/07/2005 |
| 1927 | NDA/MAL/HDP/2212 | DENK PHARMA | BENLE CONSULT LIMITED | CIPRO-DENK 500 | CIPROFLOXACIN | 500MG | ALLPHARMED PHARBIL ARZNEIMITTEL GMBH, 12 D377081 | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1928 | NDA/MAL/HDP/2216 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOCLOPRAMIDE | METOCLOPRAMIDE | 5MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2005 |
| 1929 | NDA/MAL/HDP/2218 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | ZINECTIL-100 | CHLORPROMAZINE | 100MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 1930 | NDA/MAL/HDP/2219 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PRIMOLUT N | NORETHISTERONE | 5MG | BAYER WEIMAR GMBH & CO. KG, DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER,1.0X2.0X15.0 TABLET BLISTER | 01/07/1997 |
| 1931 | NDA/MAL/HDP/2220 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMLODAC 5 | AMLODIPINE BESYLATE | 5MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER | 01/07/2003 |
| 1932 | NDA/MAL/HDP/2224 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX 500 | AMOXICILLIN | 500MG | VOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | | CYPRUS | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 1933 | NDA/MAL/HDP/2226 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | HEPA-MERZ GRANULES | L-ORNITHINE-L-ASPARTATE | 3G/5G | WIN-MEDICARE PRIVATE LIMITED, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X10.0X5.0 G SACHET | 01/07/2004 |
| 1934 | NDA/MAL/HDP/2231 | MEDIPHARM INDUSTRIES (E.A.) LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | PIRITEX WITH CODEINE | CODEINE PHOSPHATE + SODIUM CITRATE + DIPHENHYDRAMINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE | 5.7 MG + 57 MG + 14 MG + 30 MG | MEDIPHARM INDUSTRIES (E.A) LTD - PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SYRUPS | I. 1*100ML BOTTLE | 01/07/1997 |
| 1935 | NDA/MAL/HDP/2232 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | UNICAST | MONTELUKAST | 10MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1936 | NDA/MAL/HDP/2233 | ASTRAZENECA | MACNAUGHTON LIMITED | PULMICORT NEBULISER | BUDESONIDE | 0.25MG/ML | ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION , KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X4.0X5.0X2.0 ML VIAL | 01/07/2011 |
| 1937 | NDA/MAL/HDP/2235 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | WOSULIN-N | INSULIN HUMAN(RECOMBINANT DNA ORIGIN) | 100IU/ML | WOCKHARDT, WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/2006 |
| 1938 | NDA/MAL/HDP/2236 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL 200 | CARBAMAZEPINE | 200MG | NOVARTIS FARMA S.P.A., VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1939 | NDA/MAL/HDP/2237 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | WOSULIN-30/70 | INSULIN HUMAN(RECOMBINANT DNA ORIGIN) | 100I.U/ML | WOCKHARDT LIMITED -, WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X3.0 ML VIAL | 01/07/2006 |
| 1940 | NDA/MAL/HDP/2239 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL SYRUP | CARBAMAZEPINE | 20MG/ML | DELPHARMA HUNINGUE S.A.S, 26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2006 |
| 1941 | NDA/MAL/HDP/2241 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYPHENOCOL EYE DROPS | CHLORAMPHENICOL | 0.5 %W/V | 1. IVEE INFUSIONS EPZ LIMITED ATHI RIVER EXPORT PROCESSING ZONE, L.R NO. 18474/84, ATHI RIVER, NAIROBI KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*1*10ML VIAL II. 1*1*5ML VIAL | |
| 1942 | NDA/MAL/HDP/2242 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CYCLOVAX 200 TABLETS | ACYCLOVIR | 200MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1943 | NDA/MAL/HDP/2243 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | SIMDOL TABLETS | PARACETAMOL | 500 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 01/07/1997 |
| 1944 | NDA/MAL/HDP/2244 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXNICOL EYE DROPS | DEXAMETHASONE + CHLORAMPHENICOL | 0.1% + 1%W/V | 1. IVEE INFUSIONS EPZ LIMITED ATHI RIVER EXPORT PROCESSING ZONE, L.R NO. 18474/84, ATHI RIVER, NAIROBI KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*5ML BOTTLE | |
| 1945 | NDA/MAL/HDP/2245 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | X-PEL | MEBENDAZOLE | 100MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2008 |
| 1946 | NDA/MAL/HDP/2248 | GALENTIC PHARMA (PVT)LTD | VITACARE LIMITED | TETRACYCLINE OPHTHALMIC | TETRACYCLINE | 1%W/W | GALENTIC PHARMA PVT. LIMITED, R-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE,1.0X5.0 G TUBE | 01/07/2004 |
| 1947 | NDA/MAL/HDP/2252 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 500MG | SPECPHARM HOLDINGS, 15TH ROAD HALFWAY HOUSE| JOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2000 |
| 1948 | NDA/MAL/HDP/2254 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | BURN CUR CREAM | ACRIFLAVINE/THYMOL | N/A | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1998 |
| 1949 | NDA/MAL/HDP/2256 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN 457MG/5ML | AMOXICILLIN + CLAVULANIC ACID | 400 MG + 57 MG / 5 ML | GLAXO WELLCOME PRODUCTION, ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X70.0 ML BOTTLE | 01/07/2010 |
| 1950 | NDA/MAL/HDP/2263 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEMIN 10 PLUS | AMINO ACIDS/ELECTROLYTES | 10%W/V+10%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE | 01/07/2001 |
| 1951 | NDA/MAL/HDP/2265 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | TENOFOVIR/ LAMUVIDINE | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | 300MG + 300MG | HETERO LABS LTD (UNIT-V), SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA| HETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2010 |
| 1952 | NDA/MAL/HDP/2266 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | QUININE SULPHATE TABLETS BP | QUININE SULFATE | 300 MG | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 01/07/2011 |
| 1953 | NDA/MAL/HDP/2267 | MYLAN LABORATORIES LIMITED (OTL) | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | 300MG+300MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE|MYLAN LABORATORIES LTD -, PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA| QUESTA CARE LIMITED, PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2007 |
| 1954 | NDA/MAL/HDP/2269 | DAWA LIMITED | SUPER MEDIC LTD | DAWAMOX | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | DAWA PHARMACEUTICALS LIMITED, PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1955 | NDA/MAL/HDP/2270 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ZITHROCIN 500 | AZITHROMYCIN | 500MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD ., 128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2006 |
| 1956 | NDA/MAL/HDP/2272 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CLARANTA -500 | CLARITHROMYCIN | 500MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1957 | NDA/MAL/HDP/2282 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROPAN | PROPRANOLOL | 40MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 1958 | NDA/MAL/HDP/2283 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII DIPHTHERIA TETANUS PERTUSIS | DIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE | >25LF(>30IU) +>5LF(>40IU) +<16OU(>4PU) ADSORBED ON ?1.5MG | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL (20 DOSES), 1.0X5.0 ML VIAL (10 DOSES), 1.0X0.5 ML AMPOULE (1 DOSE) | 01/07/1997 |
| 1959 | NDA/MAL/HDP/2290 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE|MYLAN LABORATORIES LTD ,, PLOT NO. 11, 12, & 13 INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III PITHAMPUR 454775, DIST DHAR €“ MADHYA PRADESH| | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2008 |
| 1960 | NDA/MAL/HDP/2295 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ROZITTA 10 | ROSUVASTATIN CALCIUM | 10MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 1961 | NDA/MAL/HDP/2297 | DAWA LIMITED | SUPER MEDIC LTD | SABULIN SYRUP | SALBUTAMOL SULPHATE | 2MG/5ML | DAWA LIMITED , BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| 1962 | NDA/MAL/HDP/2298 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | SAFELEVO 500 | LEVOFLOXACIN | 500MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1963 | NDA/MAL/HDP/2299 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ROZITTA 20 | ROSUVASTATIN CALCIUM | 20MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 1964 | NDA/MAL/HDP/2303 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 5/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 5 MG + 6.25 MG | MERCK KGAA, FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1965 | NDA/MAL/HDP/2304 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 10/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 10 MG + 6.25 MG | MERCK KGAA, FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1966 | NDA/MAL/HDP/2305 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 2.5/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 2.5 MG + 6.25 MG | MERCK KGAA, FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1967 | NDA/MAL/HDP/2306 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MICROLUT | LEVONORGESTREL | 0.03MG | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X35.0 TABLET BLISTER | 01/07/2010 |
| 1968 | NDA/MAL/HDP/2312 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAVOMID 625 | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | REMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1969 | NDA/MAL/HDP/2314 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RABEMAC-20 | RABEPRAZOLE SODIUM | 20MG | MACLEODS PHARMACEUTICALS LTD , PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2005 |
| 1970 | NDA/MAL/HDP/2315 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-50 | CEFIXIME | 50MG/5ML | MICRO LABS LIMITED, BOMMASANDRA , PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2006 |
| 1971 | NDA/MAL/HDP/2318 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE-4 | GLIMEPIRIDE | 4MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2006 |
| 1972 | NDA/MAL/HDP/2319 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMOL | PARACETAMOL | 120MG/5ML | COSMOS LIMITED, RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1998 |
| 1973 | NDA/MAL/HDP/2320 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ERO-125 DRY SYRUP | ERYTHROMYCIN ESTOLATE | 125MG/5ML | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2006 |
| 1974 | NDA/MAL/HDP/2324 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSCLOXA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | SWISS PARENTERALS LIMITED UNIT II, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X7.5 ML VIAL | 01/07/2011 |
| 1975 | NDA/MAL/HDP/2330 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | COARTEM | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC, YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY| NOVARTIS PHARMA AG, SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER | 01/07/2005 |
| 1976 | NDA/MAL/HDP/2333 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC) | DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE | >25LF(>30IU) +>5LF(>40IU) ADSORBED ON ?1.5MG | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0 ML VIAL (20 DOSES), 1.0X5.0 ML VIAL (10 DOSES), 1.0X0.5 ML AMPOULE (1 DOSE) | 01/07/1997 |
| 1977 | NDA/MAL/HDP/2334 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII MEASLES MUMPS & RUBELLA | MEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUS | NLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50 | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT | 01/07/1997 |
| 1978 | NDA/MAL/HDP/2337 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROXETIL-500 | CEFUROXIME AXETIL | 500 MG | 1. AUROBINDO PHARMA LIMITED (UNIT-VI) SY. NO. 329/39 & 329/47 CHITKUL (VILLAGE) - 502 307. PATENCHERU MANDAL, SANGA REDDY DISTRICT, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 01/07/2007 |
| 1979 | NDA/MAL/HDP/2338 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG | GLAXO WELLCOME PRODUCTION, ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE | 01/07/2003 |
| 1980 | NDA/MAL/HDP/2339 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT-375 | AMOXICILLIN + POTASSIUM CLAVULANATE | 250 MG + 125 MG | 1. AUROBINDO PHARMA LIMITED, UNIT XII SY. NO. 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL - MALKAJGIRI DISTRICT, HYDERABAD - 500090, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*20*5TABLET BLISTER II. 1*4*5TABLET BLISTER | 01/07/2007 |
| 1981 | NDA/MAL/HDP/2342 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT-625 | AMOXICILLIN + POTASSIUM CLAVULANATE | 500 MG + 125 MG | 1. AUROBINDO PHARMA LIMITED, UNIT XII SY. NO. 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL - MALKAJGIRI DISTRICT, HYDERABAD - 500090, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*5TABLET BLISTER | 01/07/2007 |
| 1982 | NDA/MAL/HDP/2348 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LTD -MBARARA | HEPATITIS B VACCINE(RDNA) ADULT | HEPATITIS B VACCINE(RDNA) ADULT | 20MCG/ML | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X10.0 ML VIAL (10 DOSE VIAL), 1.0X50.0X1.0 ML VIAL (1 DOSE VIAL) | 01/07/2005 |
| 1983 | NDA/MAL/HDP/2350 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | PULMICORT TURBUHALER | BUDESONIDE | 200MCG | ASTRAZENECA AB,, GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X100.0 DOSE CANNISTER | 01/07/2001 |
| 1984 | NDA/MAL/HDP/2352 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP DAY TIME | PARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE | 500MG+30MG+30MG | REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X12.0 CAPSULE BLISTER | 01/07/2007 |
| 1985 | NDA/MAL/HDP/2353 | ASTRA ZENECA | MACNAUGHTON LIMITED | NEXIUM | ESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE) | 10MG | ASTRA ZENECA AB, SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID ORDINARY GRANULES | 1.0X28.0 SACHET CARTON | 01/07/2013 |
| 1986 | NDA/MAL/HDP/2356 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | QUININE | QUININE DIHYDROCHLORIDE | 600MG/2ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA| LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II, 31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2005 |
| 1987 | NDA/MAL/HDP/2359 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ASPIREM 75 | ASPIRIN | 75MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X28.0 TABLET BLISTER | 01/07/2007 |
| 1988 | NDA/MAL/HDP/2360 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | FUNGISTIN PESSARIES | NYSTATIN | 100000 IU | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | INDIA | VAGINAL TABLETS | 1.0X14.0 PESSARY PACK,5.0X3.0 PESSARY STRIP,1.0X100.0 PESSARY CONTAINER | 01/07/2002 |
| 1989 | NDA/MAL/HDP/2361 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAREM 500 | CLARITHROMYCIN | 500MG | REMEDICA LTD, AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2007 |
| 1990 | NDA/MAL/HDP/2362 | GALENTIC PHARMA (INDIA) PVT. LTD. | VITACARE LIMITED | CANDISTATIN OINTMENT | NYSTATIN | 100000 IU | 1. GALENTIC PHARMA (INDIA) PRIVATE LIMITED R-673, T.T.C., MIDC, RABALE, THANE BELAPUR ROAD, NAVI MUMBAI, 400 701 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*30G TUBE | 01/07/2009 |
| 1991 | NDA/MAL/HDP/2363 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GENTAMICIN SULPHATE | GENTAMICIN SULPHATE | 80MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2005 |
| 1992 | NDA/MAL/HDP/2364 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | VOXEL-500 | LEVOFLOXACIN | 500MG | MEDICO REMEDIES PVT LIMITED, 8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2015 |
| 1993 | NDA/MAL/HDP/2366 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | IFICIPRO INJECTION | CIPROFLOXACIN | 200MG/100ML | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)-, 304-308 ,GIDC , PANOLI 394116| UNIQUE PHARMACEUTICAL LABORATORIES, PLOT NO.4, PHASE IV, GIDC, INDUSTRIAL AREA, PANOLI- 394 116, DIST: BHARUCH, INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| 1994 | NDA/MAL/HDP/2368 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DERMIDEX CREAM | MICONAZOLE NITRATE | 2%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2007 |
| 1995 | NDA/MAL/HDP/2369 | ARISTO PHARMACEUTICALS | NORVIK ENTERPRISES LIMITED | TRANLOK 500MG INJECTION | TRANEXAMIC ACID | 500MG/5ML | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 01/07/2010 |
| 1996 | NDA/MAL/HDP/2370 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYBETANEOCIN EYE DROPS | BETAMETHASONE + ENOMYCIN | 0.1 %W/V + 0.35 %W/V | 1. IVEE INFUSIONS EPZ LIMITED ATHI RIVER EXPORT PROCESSING ZONE, L.R NO. 18474/84, ATHI RIVER, NAIROBI KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*5ML BOTTLE II. 1*10ML BOTTLE | |
| 1997 | NDA/MAL/HDP/2371 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | TOPIZONE CREAM | FUSIDIC ACID + BETAMETHASONE VALERATE | 20MG/G+1MG/G | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2007 |
| 1998 | NDA/MAL/HDP/2375 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN 1G | AMOXICILLIN + CLAVULANIC ACID | 875 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X1.0X7.0 TABLET BLISTER | 01/07/2010 |
| 1999 | NDA/MAL/HDP/2379 | PT SANBE FARMA | ONCOPHARM (U) LTD | PUMPITOR | OMEPRAZOLE | 40MG | PT SANBE FARMA JI INDUSTRI, NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT | 01/07/2014 |
| 2000 | NDA/MAL/HDP/2381 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | SIMTRIM-480 TABLETS | SULFAMETHOXAZOLE + TRIMETHOPRIM | 400 MG + 80 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 01/07/1997 |
| 2001 | NDA/MAL/HDP/2384 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CLARIX 500 | CLARITHROMYCIN | 500MG | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2007 |
| 2002 | NDA/MAL/HDP/2385 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | COZEPAM 5MG | DIAZEPAM | 5MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| 2003 | NDA/MAL/HDP/2387 | DAWA LIMITED | SUPER MEDIC LTD | VERMOUT | MEBENDAZOLE | 100MG/5ML | DAWA LIMITED , BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2010 |
| 2004 | NDA/MAL/HDP/2389 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELOCIN | ERYTHROMYCIN | 250MG | ELYS CHEMICAL INDUSTRIES LIMITED, ROAD B€™, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| 2005 | NDA/MAL/HDP/2390 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN | DIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE | 80MG /640MG | BLISS GVS PHARMA LTD, PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE | 01/07/2008 |
| 2006 | NDA/MAL/HDP/2395 | A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FASTUM GEL | KETOPROFEN | 2.5%W/W | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L, VIA SETTE SANTI 3, 50131 FIRENZE-ITALY | ITALY | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE | 01/07/2005 |
| 2007 | NDA/MAL/HDP/2397 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | VITAMAKS | MULTI-INGREDIENT | MULTI-INGREDIENT | S KANT HEALTH CARE LTD, PLOT 1802 €“ 1805 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 2008 | NDA/MAL/HDP/2399 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | VOLINI | MULTI INGREDIENT | MULTI INGREDIENT | SUN PHARMACEUTICAL INDUSTRIES LTD, KH. NO. 1335-1340, NEAR EPIP-1, VILL - BHATOLI KALAN, BADDI, DISTT. SOLAN, HIMACHAL PRADESH - 173205, INDIA | INDIA | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| 2009 | NDA/MAL/HDP/2401 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | ENAT | NATURAL VITAMIN E | 400IU | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED, 384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 2010 | NDA/MAL/HDP/2404 | UNICHEM LABORATORIES LIMITEDˆŠ | EUROPA HEALTHCARE (U) LTD | LOSAR 50 | LOSARTAN POTASSIUM | 50MG | UNICHEM LABORATORIES LTD--, VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2011 | NDA/MAL/HDP/2408 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENIRON TONIC | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2001 |
| 2012 | NDA/MAL/HDP/2410 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | DOXYREN | DOXYCYCLINE | 100MG | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 2013 | NDA/MAL/HDP/2411 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | POVIDONE IODINE + METRONIDAZOLE | 5%W/W + 1%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE | 01/07/2010 |
| 2014 | NDA/MAL/HDP/2414 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCIL | AMPICILLIN | 125MG/5ML | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| 2015 | NDA/MAL/HDP/2415 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SOLINA TABLETS | DIAZEPAM | 5MG | CENTAUR PHARMACEUTICALS LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2016 | NDA/MAL/HDP/2426 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PROBEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| 2017 | NDA/MAL/HDP/2427 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | CLONEM | CLOTRIMAZOLE | 1%W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1997 |
| 2018 | NDA/MAL/HDP/2428 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | CLOTRI-DENK 1% CREAM | CLOTRIMAZOLE | 1%W/W | C.P.M. CONTRACTPHARMA GMBH & COMPANY KG, FRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM | GERMANY | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1998 |
| 2019 | NDA/MAL/HDP/2429 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | CLOTRI-DENK 100 VAGINAL | CLOTRIMAZOLE | 100MG | ARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANY| DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | VAGINAL TABLETS | 1.0X6.0 PESSARY CARTON | 01/07/1998 |
| 2020 | NDA/MAL/HDP/2431 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FORMONIDE 200 | BUDESONIDE + FORMOTEROL FUMARATE | 200MCG/ 6MCG | ZYDUS LIFESCIENCES LTD--SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON | 01/07/2007 |
| 2021 | NDA/MAL/HDP/2452 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | DELASED CHEST COUGH SYRUP (NON DROWSY) | GUAIFENESIN + MENTHOL | 100MG/5ML + 1.1MG/5ML | REGAL PHARMACEUTICALS, PLOT 7879/18 BABA DOGO ROAD NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 2022 | NDA/MAL/HDP/2458 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | PRISTINEX 2% CREAM | KETOCONAZOLE | 2%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD, 1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 2.0X15.0 G TUBE | 01/07/2006 |
| 2023 | NDA/MAL/HDP/2459 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | P2 | LEVONORGESTREL | 0.75MG | MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET BLISTER | 01/07/2007 |
| 2024 | NDA/MAL/HDP/2462 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | HISTALIN SYRUP | CHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE | 1.0MG+ 2.5MG+5.0MG+7.5MG+90.0MG+48.0MG/ 5ML. | REGAL PHARMACEUTICALS LTD.., PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 01/07/1997 |
| 2025 | NDA/MAL/HDP/2471 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | OTRIVIN 0.1% NASAL DROPS | XYLOMETAZOLINE | 0.1%W/V | GSK CONSUMER HEALTH SA, GSK CONSUMER HEALTH SA, ROUTE DE L€™ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | NASAL SYSTEMIC DROPS | 1.0X10.0 ML BOTTLE | 01/07/2003 |
| 2026 | NDA/MAL/HDP/2472 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TRAN-GEL | DICLOFENAC DIETHYLAMMONIUM | 1%W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X20.0 G TUBE | 01/07/2011 |
| 2027 | NDA/MAL/HDP/2473 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NUGREL | CLOPIDOGREL | 75MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2028 | NDA/MAL/HDP/2475 | WIN-MEDICURE LTD | SURGIPHARM (U) LIMITED | URGENDOL INJECTION | TRAMADOL HYDROCHLORIDE | 50MG/ML | WIN- MEDICARE LTD, MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE | 01/07/2001 |
| 2029 | NDA/MAL/HDP/2476 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | DERIVA AQUEOUS GEL | ADAPALENE | 0.1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2003 |
| 2030 | NDA/MAL/HDP/2478 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL PLUS | PARACETAMOL+DICLOFENAC | 500MG+50MG | WIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR PRADESH -INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2031 | NDA/MAL/HDP/2479 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANCEPH-250 CAP | CEPHALEXIN | 250MG | SANCE LABORATORIES PVT. LTD., VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2012 |
| 2032 | NDA/MAL/HDP/2481 | GALENTIC PHARMA (PVT)LTD | VITACARE LIMITED | NETRACORT | HYDROCORTISONE | 1%W/W | GALENTIC PHARMA PVT LIMITED, R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X20.0 G TUBE | 01/07/2005 |
| 2033 | NDA/MAL/HDP/2492 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | PROFIL 25 | PROMETHAZINE HYDROCHLORIDE | 25MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2034 | NDA/MAL/HDP/2502 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | PROBETA N EYE DROP | BETAMETHASONE + NEOMYCIN | 0.1%W/V+0.5%W/V | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X7.5 ML VIAL | 01/07/1997 |
| 2035 | NDA/MAL/HDP/2504 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN | PARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL | 500MG+ 2MG+ 2MG + 30MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET STRIP | 01/07/2008 |
| 2036 | NDA/MAL/HDP/2509 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | OPELE LOTION | BENZYL BENZOATE | 25%W/V | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL LOTIONS | 1.0X50.0 ML BOTTLE | 01/07/1997 |
| 2037 | NDA/MAL/HDP/2510 | PANACEA BIOTEC PHARMA LIMITED | VITACARE LIMITED | GIRO | ORNIDAZOLE | 500 MG | 1. PANACEA BIOTEC PHARMA LIMITED MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. PANACEA BIOTEC PHARMA LIMITED MALPUR, BADDI, DIST. SOLAN, HIMACHAL PRADESH 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*5*2*10TABLET BLISTER | 01/07/2013 |
| 2038 | NDA/MAL/HDP/2512 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | DICLOFENAC SODIUM INJECTABLE SOLUTION | DICLOFENAC SODIUM | 25MG/ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE | 01/07/2009 |
| 2039 | NDA/MAL/HDP/2513 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIPEN DRY SYRUP | PHENOXYMETHYLPENICILLIN | 125MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2040 | NDA/MAL/HDP/2515 | AFRICURE PHARMACEUTICALS (INDIA) LTD | ROYAL PHARMA 2011 LIMITED | SIMFEN 200 TABLETS | IBUPROFEN | 200MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2041 | NDA/MAL/HDP/2523 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | SULPHUR OINTMENT | SULPHUR | 10%W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE | 01/07/1997 |
| 2042 | NDA/MAL/HDP/2525 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DICLO-DENK 100 RETARD | DICLOFENAC SODIUM | 100MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID RETARD TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2043 | NDA/MAL/HDP/2526 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNISTEN COMBI PACK | CLOTRIMAZOLE | 500MG & 1 %W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | VAGINAL COMBINATION PACK TABLETS | 1.0X1.0 PESSARY BLISTER + 1*20G TUBE | 01/07/2009 |
| 2044 | NDA/MAL/HDP/2528 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LABESTEN | CLOTRIMAZOLE | 1%W/W | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE | 01/07/1997 |
| 2045 | NDA/MAL/HDP/2529 | B & O PHARM | TRIDEM PHARMA UGANDA LIMITED | G-CEFTRIA | CEFTRIAXONE | 1G | CHINA NATIONAL MEDICINES, GUORUI PHARMACEUTICAL CO., LTD-CAOYANG EAST ROAD, HUAINAN ECONOMICAL AND TECHNOLOGICAL DEVELOPMENT ZONE, HUAINAN CITY ANHUI PROVINCE | | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML AMPOULE WFI,1.0X1.0X50.0 G VIAL,1.0X1.0 VIAL CARTON | 01/07/2012 |
| 2046 | NDA/MAL/HDP/2545 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | TOBREX | TOBRAMYCIN | 0.3%W/V | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| 2047 | NDA/MAL/HDP/2552 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CAROFIT | VITAMIN C/ VITAMIN A/ ZINC SULPHATE | 150MG/10MG/75MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2048 | NDA/MAL/HDP/2553 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | ESOZ-20 | ESOMEPRAZOLE | 20MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP | 01/07/2003 |
| 2049 | NDA/MAL/HDP/2554 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | ESOZ | ESOMEPRAZOLE | 40MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP | 01/07/2005 |
| 2050 | NDA/MAL/HDP/2555 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PHENOBARBITONE TABLETS BP 30MG | PHENOBARBITONE | 30MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| 2051 | NDA/MAL/HDP/2557 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | EPSITRON 25 TABLETS | CAPTOPRIL | 25MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1999 |
| 2052 | NDA/MAL/HDP/2558 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MYCOREN SUSPENSION | NYSTATIN | 100000 I.U/ML | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2007 |
| 2053 | NDA/MAL/HDP/2559 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ERYTHROREN | ERYTHROMYCIN STEARATE | 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| 2054 | NDA/MAL/HDP/2565 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | TRAMAZAC INJECTION | TRAMADOL HYDROCHLORIDE | 50MG/ML | FARBE FIRMAPLOT NO. 1508, GIDC ANKLESHWAR - 393002, GUJARAT INDIA |GERMAN REMEDIES PHARMACEUTICALS PRIVATE LIMITED - PF 61 & 62, SANAND GIDC II INDUSTRIAL ESTATE, SANAND, AHMEDABAD – 382110, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE, 1.0X5.0X2.0 ML AMPOULE | 07/01/2016 |
| 2055 | NDA/MAL/HDP/2567 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CIPROBID-500 | CIPROFLOXACIN | 500MG | S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | ZYDUS LIFESCIENCES LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2056 | NDA/MAL/HDP/2571 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | 180 MG + 1080 MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2010 |
| 2057 | NDA/MAL/HDP/2576 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEQUINE TABLETS | CHLOROQUINE PHOSPHATE | 250MG | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| 2058 | NDA/MAL/HDP/2578 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MAGNOMINT TABLETS | ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE | 125MG + 250MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2059 | NDA/MAL/HDP/2580 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | HEDON TABLETS | PARACETAMOL + ASPIRIN + CAFFEINE | 250 MG+ 300 MG + 30 MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA| LINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA| KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| MILAN LABORATORIES (INDIA) PVT LTD - , 63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP | 01/07/1998 |
| 2060 | NDA/MAL/HDP/2593 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ATENOLOL DENK 50 | ATENOLOL | 50MG | ARTESAN PHARMA GMBH & CO. KG , WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2061 | NDA/MAL/HDP/2594 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FEF | FERROUS SULPHATE + FOLIC ACID | 200MG + 0.4MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2062 | NDA/MAL/HDP/2595 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | ZEPILEN | CEFAZOLIN | 1000MG | MEDOCHEMIE (FACTORY C), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 G VIAL | 01/07/2009 |
| 2063 | NDA/MAL/HDP/2600 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE-OD | CLARITHROMYCIN(EXTENTED RELEASE) | 500MG | IND-SWIFT-LTD,, GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X1.0X7.0 TABLET BLISTER | 01/07/2008 |
| 2064 | NDA/MAL/HDP/2601 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AXETINE 750MG | CEFUROXIME | 750MG | MEDOCHEMIE (FACTORY C), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X750.0 MG VIAL | 01/07/2009 |
| 2065 | NDA/MAL/HDP/2602 | ALKEM LABORATORIES LIMITEDˆŠ | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM BID | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG/ 5 ML | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE | 01/07/2010 |
| 2066 | NDA/MAL/HDP/2604 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | SAKAR HEALTHCARE PVT LTD, SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| 2067 | NDA/MAL/HDP/2612 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENIRON | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 3.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 2068 | NDA/MAL/HDP/2614 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | DIALIN | LOPERAMIDE HCL | 2MG | REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 2069 | NDA/MAL/HDP/2615 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | SYMBICORT TURBUHALER | BUDESONIDE+FORMOTEROL | 160MCG+4.5MCG/DOSE | ASTRAZENECA AB,, GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X60.0 DOSE CANNISTER,1.0X120.0 DOSE CANNISTER | 01/07/2001 |
| 2070 | NDA/MAL/HDP/2617 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | BLUDROX TABLETS DISPERSABLE | CEFADROXIL | 250MG | BLUE CROSS LABORATORIES LIMITED, A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2001 |
| 2071 | NDA/MAL/HDP/2628 | MICRO LABS LTD 92 SIPCOT | LABOREX UGANDA LIMITED | AZILIDE-500 | AZITHROMYCIN | 500MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2004 |
| 2072 | NDA/MAL/HDP/2641 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AXETINE 250MG | CEFUROXIME AXETIL | 250MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C, 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2014 |
| 2073 | NDA/MAL/HDP/2642 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOXANUM | CEFTRIAXONE | 1G | MEDOCHEMIE (FACTORY C), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML AMPOULE WFI | 01/07/2016 |
| 2074 | NDA/MAL/HDP/2645 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANZIDIME 1000 | CEFTAZIDIME | 1000MG | SANCE LABORATORIES PVT LTD, VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1000.0MG VIAL | 01/07/2010 |
| 2075 | NDA/MAL/HDP/2647 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | IBUPROFEN DENK 400MG | IBUPROFEN | 400MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2076 | NDA/MAL/HDP/2649 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ACICONE-S ORAL SUSPENSION | MAGALDRATE + SIMETHICONE | 540MG/5ML + 40MG/5ML | MEDICAL UNION PHARMACEUTICALS , HEAD OFFICE 36 6TH DISTRICT NASR CITY CAIRO EGYPT PLANT ABUSULTAN ISMAILIA | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE | 01/07/2006 |
| 2077 | NDA/MAL/HDP/2650 | DENK PHARMA | BENLE CONSULT LIMITED | VIT-B-DENK | THIAMINE HCL + PYRIDOXINE HCL | 100MG + 200MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2078 | NDA/MAL/HDP/2651 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RINAVIT SYRUP | MULTIVITAMIN | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2079 | NDA/MAL/HDP/2653 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | SONADERM-GM | CLOBETASOL + MICONAZOLE + GENTAMICIN | 0.05%W/W + 2% W/W+ 0.1%W/W | BLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2007 |
| 2080 | NDA/MAL/HDP/2654 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | BEBE VIT | VITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B2 | 1500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MG | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 01/07/2006 |
| 2081 | NDA/MAL/HDP/2656 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMINOPHYLLINE | AMINOPHYLLINE | 100 MG | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*500TABLET CONTAINER | 01/07/2008 |
| 2082 | NDA/MAL/HDP/2661 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FUNGIFEN | CLOTRIMAZOLE | 1%W/W | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2083 | NDA/MAL/HDP/2671 | CIPLA LTD.. | ABACUS PHARMA (AFRICA) LIMITED | DUOLIN RESPULES | IPRATROPIUM BROMIDE & SALBUTAMOL | 500MG + 2.5 MG /2.5ML | CIPLA LTD.- , PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION LIQUID FOR INHALATION | 4.0X5.0X2.5 ML VIAL | 01/07/2005 |
| 2084 | NDA/MAL/HDP/2675 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | LIBITUS PLUS SYRUP | TERBUTALINE/ BROMHEXINE/ GUAIPHENESIN | 1.25MG/ 4MG/ 50 MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2085 | NDA/MAL/HDP/2678 | CIPLA LTD.. | ABACUS PHARMA (AFRICA) LIMITED | FORCAN-150 | FLUCONAZOLE | 150MG | CIPLA LTD , PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0 CAPSULE BLISTER | 01/07/2006 |
| 2086 | NDA/MAL/HDP/2679 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ALERID SYRUP | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | CIPLA LIMITEDPLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE | 01/07/2006 |
| 2087 | NDA/MAL/HDP/2680 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMPIREN CAPSULES | AMPICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER | 01/07/2007 |
| 2088 | NDA/MAL/HDP/2681 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN | AMOXICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER | 01/07/2007 |
| 2089 | NDA/MAL/HDP/2683 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAMIN C | ASCORBIC ACID | 100MG | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| 2090 | NDA/MAL/HDP/2685 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEDOL(SUSPENSION) | PARACETAMOL | 120MG/5ML | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2007 |
| 2091 | NDA/MAL/HDP/2690 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-250 | AMPICILLIN | 250MG | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2011 |
| 2092 | NDA/MAL/HDP/2691 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-500 | AMPICILLIN | 500MG | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195| REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON | 01/07/2011 |
| 2093 | NDA/MAL/HDP/2695 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | IDUMSTRA | PARACETAMOL + IBUPROFEN + CAFFEINE | 325MG + 200MG + 40MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2094 | NDA/MAL/HDP/2696 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | AMPHOTRET | AMPHOTERICIN B | 50MG | BHARAT SERUMS AND VACCINES LTD, PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2012 |
| 2095 | NDA/MAL/HDP/2697 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | LUCIN OINTMENT | HYDROCORTISONE | 1%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2096 | NDA/MAL/HDP/2698 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AZICIN-500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2009 |
| 2097 | NDA/MAL/HDP/2699 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | CARVIL 12.5 | CARVEDILOL | 12.5 MG | ZYDUS LIFESCIENCES LTD--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2098 | NDA/MAL/HDP/2702 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EUGLIM 2 | GLIMEPIRIDE | 2MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2004 |
| 2099 | NDA/MAL/HDP/2705 | ASTRAZENECA | MACNAUGHTON LIMITED | PULMICORT NEBULISER | BUDESONIDE | 0.5MG/ML | ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION , KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X4.0X5.0X2.0 ML VIAL | 01/07/2011 |
| 2100 | NDA/MAL/HDP/2707 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMCLOXA | CLOXACILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD, PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER | 01/07/1997 |
| 2101 | NDA/MAL/HDP/2708 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | HYPER TABLETS | PROPRANOLOL HYDROCHLORIDE | 40MG | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER | 01/07/2000 |
| 2102 | NDA/MAL/HDP/2710 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN BD | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/1997 |
| 2103 | NDA/MAL/HDP/2715 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE | LAMIVUDINE | 150MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 01/07/2008 |
| 2104 | NDA/MAL/HDP/2717 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | OCUMYCIN EYE OINTMENT | CHLORAMPHENICOL | 1%W/W | CENTAUR PHARMA PVT. LTD, PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA | INDIA | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE | 01/07/2000 |
| 2105 | NDA/MAL/HDP/2721 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PRIMAFEN TABLET | IBUPROFEN + PARACETAMOL | 400MG + 325MG | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2106 | NDA/MAL/HDP/2722 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | NO SORES | CHOLINE SALICYLATE/LIDOCAINE | 8.7%W/W+2%W/W | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X10.0 G TUBE | 01/07/2007 |
| 2107 | NDA/MAL/HDP/2723 | TABROS PHARMA | HEALTHCARE LTD. | DURAGESIC TABLET | PARACETAMOL + ORPHENADRINE | 450MG+35MG | TABROS PHARMA-L-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTAN | | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2108 | NDA/MAL/HDP/2726 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | QUININE INJECTION | QUININE DIHYDROCHLORIDE | 600MG/2ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD, NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| 2109 | NDA/MAL/HDP/2734 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMLODAR-10 | AMLODIPINE BESILATE | 10MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 01/07/2009 |
| 2110 | NDA/MAL/HDP/2738 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | HEPA-MERZ INFUSION | L-ORNITHINE- L-ASPARTATE | 5G/10ML | WIN-MEDICARE PRIVATE LIMITED, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | PARENTERAL ORDINARY I V VIALS | 1.0X5.0X10.0 ML VIAL | 01/07/2001 |
| 2111 | NDA/MAL/HDP/2739 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | BISPANOL TABLET | HYOSCINE BUTYLBROMIDE | 10MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2112 | NDA/MAL/HDP/2743 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | DUO-COTECXIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG + 320MG | KBN- ZHEJIANG PHARMACEUTICAL CO. LTD (NO. 340 YUNHAI ROAD JIAXING ECONOMIC DEVELOPMENT ZONE, JIAXING CITY, ZHEJIANG PROVINCE) | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X9.0 TABLET BLISTER, 1.0X30.0X9.0 TABLET BLISTER, 1.0X1.0X4.0 TABLET BLISTER, 1.0X1.0X2.0X6.0 TABLET BLISTER, 1.0X25.0X9.0 TABLET BLISTER, 1.0X25.0X6.0 TABLET BLISTER, 1.0X1.0X6.0 TABLET BLISTER | 01/07/2005 |
| 2113 | NDA/MAL/HDP/2745 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENFORMIN | METFORMIN HYDROCHLORIDE | 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 2114 | NDA/MAL/HDP/2746 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ACYCLOVIR DENK 200 | ACYCLOVIR | 200MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X25.0 TABLET BLISTER | 01/07/2000 |
| 2115 | NDA/MAL/HDP/2747 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EXLUTON (BFL) | LYNESTREROL | 0.5MG | 1. N.V ORGANON MOLENSTRAAT 110, OSS, 5342CC OSS, NETHERLANDS. KLOOSTERSTRAAT 6, OSS, 5349AB, NETHERLANDS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | 1.0*100.0*28.0 TABLET BLISTER | 01/07/2010 |
| 2116 | NDA/MAL/HDP/2753 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PRASIL | METOCLOPRAMIDE HYDROCHLORIDE | 10MG | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2117 | NDA/MAL/HDP/2754 | FDC LTD | AIVEEN (U) LIMITED | ZATHRIN 500 | AZITHROMYCIN DIHYDRATE | 500MG | FDC LIMITED , PLOT NO. L121 B PHASE 111A VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER | 01/07/2016 |
| 2118 | NDA/MAL/HDP/2760 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | DELASED DRY COUGH SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL | 14MG+6.5MG+57MG+2MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2119 | NDA/MAL/HDP/2761 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | TRIFLUOPERAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 5MG | 1. REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL - CYPRUS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CYPRUS | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 01/07/2010 |
| 2120 | NDA/MAL/HDP/2763 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | CANDISTAT | CLOTRIMAZOLE | 100MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | VAGINAL SUPPOSITORIES | 1.0X2.0X3.0 PESSARY STRIP | 01/07/1997 |
| 2121 | NDA/MAL/HDP/2773 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | BISPANOL ELIXIR | HYOSCINE-N-BUTYLBROMIDE | 5MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2004 |
| 2122 | NDA/MAL/HDP/2776 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | TENSIMIN-100 | ATENOLOL | 100MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD), 216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2123 | NDA/MAL/HDP/2777 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CO-DIOVAN 160/12.5MG TABLETS | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG + 12.5MG | NOVARTIS PHARMA AG, SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2006 |
| 2124 | NDA/MAL/HDP/2779 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE SURGICAL SCRUB | POVIDONE IODINE | 7.5%W/V | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD, PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2016 |
| 2125 | NDA/MAL/HDP/2781 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CARVETAS 6.25 | CARVEDILOL | 6.25MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2126 | NDA/MAL/HDP/2783 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 25MG | DICLOFENAC SODIUM | 25MG | DELPHARM HUNINGUE S.A.S-, SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY STRIP | 01/07/2006 |
| 2127 | NDA/MAL/HDP/2788 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | MULTIREN | MULTIINGREDIENT | N/A | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2128 | NDA/MAL/HDP/2793 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TAKEDA GMBH,PLANT ORANIENBURG, LEHNITZSTRASSE 70-98,16515,ORANIENBURG-GERMANY| PATHEON YM INC. TORONTO, TORONTO, CANADA | GERMANY|CANADA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 01/07/2004 |
| 2129 | NDA/MAL/HDP/2796 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN SODIUM | 1,000,000I.U | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON | 01/07/2001 |
| 2130 | NDA/MAL/HDP/2797 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | LUMAREN | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X8.0 TABLET BLISTER | 01/07/2010 |
| 2131 | NDA/MAL/HDP/2800 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ACTRAPID FLEXPEN 100 I.U/ML | HUMAN INSULIN | 100 I.U/ML | NOVO NORDISK PHARMA, NOVO ALLE| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE| NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN,1.0X5.0X1.5 ML PREFILLED PEN | 01/07/1997 |
| 2132 | NDA/MAL/HDP/2802 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | TASOL | CLOBETASOL | 0.05%W/W | CENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2005 |
| 2133 | NDA/MAL/HDP/2805 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NIFELAT 20R TABLETS | NIFEDIPINE | 20MG | REMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2134 | NDA/MAL/HDP/2807 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ASAQ GPSC | ARTESUNATE + AMODIAQUINE | 100 MG + 270 MG | GUILIN PHARMACEUTICALS CO. LTD, NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/2011 |
| 2135 | NDA/MAL/HDP/2811 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SULPHUR OINTMENT | SULPHUR PRECIPITATED | 10%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE | 01/07/2001 |
| 2136 | NDA/MAL/HDP/2813 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | INTACYCLINE SKIN OINTMENT | TETRACYCLINE HYDROCHLORIDE | 3%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2137 | NDA/MAL/HDP/2818 | TRIVENI FORMULATIONS LIMITED | SUPER MEDIC LTD | TRICIP | CIPROFLOXACIN | 500MG | TRIVENI FORMULATION LTD-PLOT NO.52,53,54,63,62,64, ALEAP INDUSTRIAL ESTATE SURAMPALI, AP-INDIA – 521212 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2138 | NDA/MAL/HDP/2835 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | SOLUDINE-M | POVIDONE IODINE / METRONIDAZOLE | 5%W/W / 1%W/W | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE,1.0X125.0 G TUBE | 01/07/2011 |
| 2139 | NDA/MAL/HDP/2837 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GRAMOFIL TABLETS | NALIDIXIC ACID | 500MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2140 | NDA/MAL/HDP/2838 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | DILCONTIN XL 120 | CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE | 120MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP | 01/07/2010 |
| 2141 | NDA/MAL/HDP/2843 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DICLOKANT-50 | DICLOFENAC TABLETS BP | 50MG | SK ANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2142 | NDA/MAL/HDP/2848 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROGENTA OINTMENT | GENTAMICIN SULFATE + BETAMETHASONE DIPROPIONATE | 1 MG/G + 0.5 MG/G | SCHERING-PLOUGH LABONV - INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUM | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*15G TUBE II. 1*30G TUBE | 2001-07-01 00:00:00 |
| 2143 | NDA/MAL/HDP/2850 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DISPERCAM | PIROXICAM | 20MG | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X3.0X1.0 ML AMPOULE | 01/07/2007 |
| 2144 | NDA/MAL/HDP/2869 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | PRIORIX VACCINE | MEASLES + MUMPS + RUBELLA | 103.0CCID50 + 103.7CCID50 + 103.0CCID50 | GLAXO SMITHKLINE BIOLOGICALS S.A, RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 ML VIAL (1 DOSE) | 01/07/2010 |
| 2145 | NDA/MAL/HDP/2873 | INTAS PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | HELIGO KIT | TINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE | 500MG+ 250MG+30MG | INTAS PHARMACEUTICALS LTD, PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X7.0X6.0 TABLET BLISTER | 01/07/2001 |
| 2146 | NDA/MAL/HDP/2875 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | OTRIVIN 0.05% NASAL DROPS | XYLOMETAZOLINE | 0.05%W/V | GSK CONSUMER HEALTH SA, GSK CONSUMER HEALTH SA, ROUTE DE L€™ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE | 01/07/2003 |
| 2147 | NDA/MAL/HDP/2880 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CARBIMAZOLE 5 | CARBIMAZOLE | 5MG | REMEDICA LIMITED,, LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2148 | NDA/MAL/HDP/2888 | VHB MEDI SCIENCES LTD | NORVIK ENTERPRISES LIMITED | SUCCICORT | HYDROCORTISONE SODIUM SUCCINATE | 100MG/VIAL | VHB MEDI SCIENCES LTD, PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL | 07/01/2013 |
| 2149 | NDA/MAL/HDP/2892 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | NICARDIA-20 TABLETS | NIFEDIPINE | 20MG | UNIQUE PHARMACEUTICAL LABORATORIES, PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI €” 394 116, GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2150 | NDA/MAL/HDP/2896 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | MCG CREAM | MICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE | 2.0%W/W + 0.05%W/W + 0.1 %W/W | KPI INDUSTRIES (1996) LTD, PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE | 01/07/2005 |
| 2151 | NDA/MAL/HDP/2900 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-200 | CEFIXIME | 200MG | MICRO LABS LIMITED, BOMMASANDRA , PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 2152 | NDA/MAL/HDP/2902 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MEGALIS-20 | TADALAFIL | 20MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK €“N1), VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X15.0X1.0X4.0 TABLET STRIP | 01/07/2005 |
| 2153 | NDA/MAL/HDP/2907 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART DS | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER, 1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2008 |
| 2154 | NDA/MAL/HDP/2908 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | PAINGO MEDICATED CREAM | METHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE OIL | 15%W/W + 1%W/W + 1.47%W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X2.0X15.0 G TUBE | 01/07/2010 |
| 2155 | NDA/MAL/HDP/2911 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (A) LTD. | AXCEL LORATADINE | LORATADINE | 10MG | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2156 | NDA/MAL/HDP/2914 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | CHLOROCIDE SUSPENSION | CHLORAMPHENICOL PALMITATE | 125MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2157 | NDA/MAL/HDP/2917 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CETAMOL TABLETS | PARACETAMOL | 500MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP,1.0X100.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2158 | NDA/MAL/HDP/2919 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT 5 | MONTELUKAST | 5MG | ZYDUS LIFESCIENCES LTD--SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2159 | NDA/MAL/HDP/2920 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | TRANSLIPO -C CREAM | CLOTRIMAZOLE | 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE | 01/07/2001 |
| 2160 | NDA/MAL/HDP/2940 | CENTAUR PHARMACEUTICALS PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | BENZOX 5 GEL | BENZOYL PEROXIDE | 5%W/W | CENTAUR PHARMACEUTICALS LTD, PLOT NO. 39 TIVIN IN | INDIA | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X20.0 G TUBE | 01/07/2005 |
| 2161 | NDA/MAL/HDP/2941 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ATORVA 20 | ATORVASTATIN | 20MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER | 01/07/2005 |
| 2162 | NDA/MAL/HDP/2942 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | ARGISSEPT CREAM | CHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE | 0.2%W/W / 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X10.0 G TUBE | 01/07/2005 |
| 2163 | NDA/MAL/HDP/2946 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO ORAL SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1998 |
| 2164 | NDA/MAL/HDP/2947 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO TABLETS | CO-TRIMOXAZOLE | 480MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON | 01/07/1998 |
| 2165 | NDA/MAL/HDP/2948 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | METFORMIN DENK 850 | METFORMIN HYDROCHLORIDE | 850MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER | 01/07/2007 |
| 2166 | NDA/MAL/HDP/2950 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | XALATAN | LATANOPROST | 0.005%W/V | PFIZER MANUFACTURING , NV/NA, RIJKSWEG 12 2870, PUURS | BELGIUM | OPHTHALMIC DROPS | 1.0X2.5 ML BOTTLE | 01/07/1998 |
| 2167 | NDA/MAL/HDP/2951 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART FORTE TABLETS | ARTEMETHER + LUMEFANTRINE | 40 MG + 240 MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X2.0X6.0 TABLET BLISTER | 01/07/2007 |
| 2168 | NDA/MAL/HDP/2956 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRANLOK 500MG TABLETS | TRANEXAMIC ACID | 500MG | ARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2169 | NDA/MAL/HDP/2957 | MEDIPHARM SALES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEDITROL | CALCITRIOL | 0.25MCG | MEGA LIFE SCIENCES LIMITED, : PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X5.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2170 | NDA/MAL/HDP/2959 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | CETAMOL SYRUP | PARACETAMOL | 120MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2171 | NDA/MAL/HDP/2960 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 400MG/57MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2010 |
| 2172 | NDA/MAL/HDP/2969 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | TENSIMIN-50 | ATENOLOL | 50MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD), 216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,14.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2173 | NDA/MAL/HDP/2970 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYCOMET 500 | METFORMIN | 500MG | FREDUN PHARMACEUTICALS LIMITED--, 14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| 2174 | NDA/MAL/HDP/2971 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | LEFRA-20 TABLETS | LEFLUNOMIDE | 20MG | TORRENT PHARMACEUTICALS LTD, INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2175 | NDA/MAL/HDP/2972 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ANTIMIN SYRUP | LORATIDINE | 5MG/ML | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | | PAKISTAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 01/07/2005 |
| 2176 | NDA/MAL/HDP/2974 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | TRAVATAN | TRAVOPROST | 4µG/ML | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X2.5 ML VIAL | 01/07/2009 |
| 2177 | NDA/MAL/HDP/2979 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM N CREAM | BETAMETHASONE VALERATE + NEOMYCIN | 0.1%W/W + 0.5%W/W | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/1997 |
| 2178 | NDA/MAL/HDP/2980 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART TABLETS | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | BLISS GVS PHARMA LIMITED, NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X3.0X6.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER | 01/07/2007 |
| 2179 | NDA/MAL/HDP/2982 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | NEURO-FORTE TABLETS | VITAMIN B1 + VITAMIN B6 + VITAMIN B12 | 200MG + 50MG + 1MG | CENTAUR PHARMACEUTICALS LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2180 | NDA/MAL/HDP/2983 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | FUCOL 200 | FLUCONAZOLE | 200MG | CIPLA LTD , PLOT NO. L-139, VERNA, GOA 403 722 INDIA| CIPLA LTD KURKUMBH, D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALUKA-DAUND, PUNE, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X1.0X4.0 CAPSULE BLISTER | 01/07/2004 |
| 2181 | NDA/MAL/HDP/2990 | MICRO LABS LTD | LABOREX UGANDA LIMITED | PULMOCEF-500 | CEFUROXIME AXETIL USP | 500MG | MICRO LABS LTD-, NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER | 01/07/2004 |
| 2182 | NDA/MAL/HDP/2995 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GALLOP | LOPERAMIDE HYDROCHLORIDE USP | 2MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER | 01/07/2007 |
| 2183 | NDA/MAL/HDP/3002 | LEBEN LABORATORIES LTD | MARVIN PHARMA LIMITED | KELVIN | PARACETAMOL | 500MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2184 | NDA/MAL/HDP/3003 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIR | ACICLOVIR | 200MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2185 | NDA/MAL/HDP/3009 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | SULBACTOMAX 1.5G | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | VENUS REMEDIES LTD, UNIT II,, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 01/07/2009 |
| 2186 | NDA/MAL/HDP/3012 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL TABLETS | DICLOFENAC SODIUM | 50MG | WIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2187 | NDA/MAL/HDP/3013 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOZOLE | ALBENDAZOLE | 400MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER | 01/07/2007 |
| 2188 | NDA/MAL/HDP/3015 | ZYDUS LIFESCIENCES LTD. | ABACUS PHARMA (AFRICA) LIMITED | PENEGRA-50 TABLETS | SILDENAFIL | 50MG | ZYDUS LIFESCIENCES LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER,1.0X20.0X4.0 TABLET BLISTER | 01/07/2001 |
| 2189 | NDA/MAL/HDP/3017 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | LIDOCAINE INJECTION | LIDOCAINE HYDROCHLORIDE | 20MG/ML | SANJAR PHARMA LLP, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | | CHINA| INDIA | PARENTERAL ORDINARY VIALS | 1X25X20 ML VIAL, 1X30 ML VIAL | 01/07/2008 |
| 2190 | NDA/MAL/HDP/3021 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GLIBENCLAMIDE TABLETS | GLIBENCLAMIDE | 5MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2191 | NDA/MAL/HDP/3023 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRAX | LEVAMISOLE HYDROCHLORIDE | 40MG | AGOG PHARMA LTD., PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER | 01/07/2007 |
| 2192 | NDA/MAL/HDP/3029 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOZOLE SUSPENSION | ALBENDAZOLE USP | 200 MG/ 5 ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2007 |
| 2193 | NDA/MAL/HDP/3031 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMETHASONE | DEXAMETHASONE | 0.5MG | AGOG PHARMA LTD., NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| 2194 | NDA/MAL/HDP/3035 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFORTE TONIC | FERRIC AMMONIUM CITRATE + FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE + VITAMIN B12 | 50MG + 0.55MG + 2.4MG + 1.2MG + 11MG + 2.5MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| 2195 | NDA/MAL/HDP/3037 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIT SYRUP | VITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + NIACINAMIDE + VITAMIN B12 + VITAMIN C | 1000I.U + 200I.U + 1.5MG + 1.5MG+ 10MG + 2.5MCG + 40MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| 2196 | NDA/MAL/HDP/3040 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODOX | DOXYCYCLINE | 100MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 2197 | NDA/MAL/HDP/3044 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | PIRICAM-20 CAPSULES | PIROXICAM | 20MG | ZYDUS LIFESCIENCES LIMITED, GOA (FORMER CADILA LIFESCIENCES), KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM, GOA, 403 115 - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 2198 | NDA/MAL/HDP/3046 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 400 MG + 57 MG | GLAXO WELLCOME PRODUCTION, ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2009 |
| 2199 | NDA/MAL/HDP/3048 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO-DS TABLETS | SULFAMETHOXAZOLE/TRIMETHOPRIM | 800MG/160MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| 2200 | NDA/MAL/HDP/3051 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETROZOLE | DILOXANIDE FUROATE+METRONIDAZOLE BENZOATE+SIMETHICONE | 125MG+160MG+25MG | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE, 1.0X60.0 ML BOTTLE | 01/07/2005 |
| 2201 | NDA/MAL/HDP/3057 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | COLD-A-GO CAPSULES | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE | 400MG + 5MG + 12.5MG + 30MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 2202 | NDA/MAL/HDP/3063 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODIC-50 | DICLOFENAC SODIUM | 50MG | AGOG PHARMA LTD., NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2203 | NDA/MAL/HDP/3064 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TIN-TIN TABLETS | TINIDAZOLE | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER,1.0X24.0X4.0 TABLET BLISTER,25.0X4.0 TABLET BLISTER | 01/07/2007 |
| 2204 | NDA/MAL/HDP/3067 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMAGO SYRUP | PROMETHAZINE | 5MG/5ML | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2007 |
| 2205 | NDA/MAL/HDP/3068 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | OPTACHLOR EYE DROPS | CHLORAMPHENICOL | 0.5%W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD, , 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/1999 |
| 2206 | NDA/MAL/HDP/3069 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOVE CAPSULES | PIROXICAM | 20MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER | 01/07/2007 |
| 2207 | NDA/MAL/HDP/3072 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL TABLETS(THANE) | PARACETAMOL | 500 MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2208 | NDA/MAL/HDP/3076 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS 40 | TELMISARTAN | 40MG | ARISTO PHAMACUTLAB PVT LTD, PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2209 | NDA/MAL/HDP/3077 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | UNISTEN HC CREAM | CLOTRIMAZOLE + HYDROCORTISONE | 1%W/W + 1%W/W | REGAL PHERMACUTICALS , PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2008 |
| 2210 | NDA/MAL/HDP/3083 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS 80 | TELMISARTAN | 80MG | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP | 01/07/2007 |
| 2211 | NDA/MAL/HDP/3085 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCOLD TABLETS | PARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE | 500.MG+5.0MG+30.0MG+2.0MG | AGOG PHARMA LIMITED, PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER | 01/07/2007 |
| 2212 | NDA/MAL/HDP/3090 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFODOX | CEFPODOXIME PROXETIL | 100MG/5ML | PHARMA INTERNATIONAL CO., AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE | 01/07/2004 |
| 2213 | NDA/MAL/HDP/3091 | SAKAR HEALTH CARE PVT .LTD | MEDINOVATION ENTERPRISES LTD | ONDI | ONDANSETRON | 2MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE | 01/07/2013 |
| 2214 | NDA/MAL/HDP/3092 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | EXFORGE HCT 10MG/160MG/12.5MG | AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 10MG + 160MG +12.5MG | NOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2015 |
| 2215 | NDA/MAL/HDP/3095 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | AMPHEN SUSPENSION | CHLORAMPHENICOL PALMITATE | 125MG/5ML | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 2216 | NDA/MAL/HDP/3098 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MOSEDIN | LORATADINE | 5MG/5ML | AMOUN PHARMACEUTICALS CO. S.A.E, 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2004 |
| 2217 | NDA/MAL/HDP/3099 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | ZONA 0.1% CREAM | HYDROCORTISONE 17-BUTYRATE | 0.1%W/W | PHARMA INTERNATIONAL CO.,, AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 01/07/2007 |
| 2218 | NDA/MAL/HDP/3101 | DAWA LIMITED | SUPER MEDIC LTD | DACOLD SYRUP | PARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE | 120MG/5ML+10MG/5ML+2MG/5ML | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 2219 | NDA/MAL/HDP/3104 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | NYSTALEB ORAL SUSPENSION | NYSTATIN | 100000IU/ML | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2007 |
| 2220 | NDA/MAL/HDP/3105 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DEPIN-E RETARD | NIFEDIPINE | 20MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/1997 |
| 2221 | NDA/MAL/HDP/3111 | GLAXOSMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CALPOL | PARACETAMOL | 120MG/5ML | GLAXOSMITHKLINE LIMITED - , 78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2222 | NDA/MAL/HDP/3116 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | KLOXY | CLOXACILLIN | 125MG/5ML | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2223 | NDA/MAL/HDP/3118 | QUALITY CHEMICAL INDUSTRIES LIMITED(QCIL) | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LUMARTEM | ARTEMETHER /LUMEFANTRINE | 20MG /120MG | QUALITY CHEMICAL INDUSTRIES LIMITED. , PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2011 |
| 2224 | NDA/MAL/HDP/3122 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT CHEWABLE TABLETS | MULTI-INGREDIENT | MULTI-INGREDIENT | REMIDEX PHARMA PVT LTD, B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058. | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2002 |
| 2225 | NDA/MAL/HDP/3123 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | RECTOL 250 SUPPOSITORY | PARACETAMOL BP | 250 MG | BLISS GVS PHARMA LIMITED, PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| 2226 | NDA/MAL/HDP/3125 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMLODAR 5 | AMLODIPINE BESILATE | 5MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 01/07/2009 |
| 2227 | NDA/MAL/HDP/3134 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | TOFF PLUS | PARACETAMOL+CHLORPHENIRAMINE MALEATE+ DEXTROMETHORPHAN + PHENYLEPHRINE | 500 MG + 2 MG + 15 MG + 10 MG | PANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| 2228 | NDA/MAL/HDP/3136 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2007 |
| 2229 | NDA/MAL/HDP/3139 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | OMEDAR | OMEPRAZOLE | 20MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2009 |
| 2230 | NDA/MAL/HDP/3141 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMLOPRESS-5 | AMLODIPINE BESYLATE | 5MG | CIPLA LTD, CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2231 | NDA/MAL/HDP/3144 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ULSEC | OMEPRAZOLE | 20MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD, PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP | 01/07/2007 |
| 2232 | NDA/MAL/HDP/3145 | HOVID BHD | BARIKI EXIM PHARMA LTD | AMOXICAP | AMOXYCILLIN | 500MG | HOVID BHD , 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| 2233 | NDA/MAL/HDP/3146 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZOKAST | MONTELUKAST SODIUM | 10MG | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205| UNICHEM LABORATORIES LTD ,.,, PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 2234 | NDA/MAL/HDP/3147 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS-H 40/12.5 | TELMISARTAN/HYDROCHLOROTHIAZIDE | 40MG/12.5MG | ARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2235 | NDA/MAL/HDP/3152 | PT SANBE FARMA | SHREEJI PHARMACEUTICALS LIMITED | POLDAN MIG | PARACETAMOL + ASPIRIN + CAFFEINE | 400 MG + 250 MG + 65 MG | 1. PT CAPRIFARMINDO LABORATORIES JI. INDUSTRI CIMAREME NO. 8, DESA CIPEUNDEUY, KECAMATAN, PADALARANG, KABUPATEN BANDUNG BARAT - INDON INDONESIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDONESIA | ORAL SOLID ORDINARY TABLETS | I. 1*25*4TABLET STRIP | 01/07/2014 |
| 2236 | NDA/MAL/HDP/3159 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARTEM FORTE | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*6TABLET BLISTER | 01/07/2015 |
| 2237 | NDA/MAL/HDP/3163 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 50MG | DICLOFENAC SODIUM | 50MG | DELPHARM HUNINGUE S.A.S-, SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY STRIP | 01/07/2006 |
| 2238 | NDA/MAL/HDP/3169 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | RANOPHAGE OD | METFORMIN HCL | 1000MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED , INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2239 | NDA/MAL/HDP/3176 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | DOXYRONE-100 | DOXYCYCLINE HYDROCHLORIDE | 100 MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 2240 | NDA/MAL/HDP/3177 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/1997 |
| 2241 | NDA/MAL/HDP/3178 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENDURIC TABLETS | BENDROFLUMETHIAZIDE | 5MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| 2242 | NDA/MAL/HDP/3179 | GOOD DAY PHARMACY LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | SULFUR OINTMENT | SULPHUR | 10%W/W | KREMOINT PHARMA PVT LTD--, B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X25.0 G TUBE | 01/07/2013 |
| 2243 | NDA/MAL/HDP/3181 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | EMAL | ALPHA & BETA ARTEETHER | 150MG/2ML | THEMIS MEDICARE LIMITED, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | 3.0X2.0 ML VIAL | 01/07/2009 |
| 2244 | NDA/MAL/HDP/3191 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERECTO -100 | SILDENAFIL CITRATE | 100 MG | CIPLA LIMITED PUNE, MIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2007 |
| 2245 | NDA/MAL/HDP/3192 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ANZAVIR-R | ATAZANAVIR + RITONAVIR | 300 MG + 100 MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| 2246 | NDA/MAL/HDP/3193 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERECTO- 50 | SILDENAFIL CITRATE | 50MG | CIPLA LIMITED PUNE, MIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2005 |
| 2247 | NDA/MAL/HDP/3197 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TRIAM-DENK 40 INJECTION | TRIAMCINOLONE ACETONIDE | 40 MG/ML | FISIOPHARMA S.R.L.-NUCLEOO INDUSTRIALE, 84020, PALOMONTE (SA) - ITALY | | ITALY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2004 |
| 2248 | NDA/MAL/HDP/3200 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LETRAX | LEVAMISOLE HYDROCHLORIDE | 40MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/1997 |
| 2249 | NDA/MAL/HDP/3204 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | RELCER GEL | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE + LIQUORICE | 365MG/5ML + 80MG/5ML + 100MG/5ML + 400MG/5ML | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| 2250 | NDA/MAL/HDP/3206 | HEALTHCARE LTD. | HEALTHCARE LTD. | POSTINOR 2 | LEVONORGESTREL | 0.75MG | GEDEON RICHTER PLC, 1103 BUDAPEST GYOMROI UT 19-20 | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET BLISTER | 01/07/2010 |
| 2251 | NDA/MAL/HDP/3207 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | DILCONTIN XL 90 | CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE | 90MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP | 01/07/2010 |
| 2252 | NDA/MAL/HDP/3208 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | NIRFOL 1% | PROPOFOL | 1%W/V | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL | 01/07/2010 |
| 2253 | NDA/MAL/HDP/3214 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | INDICONTIN | INDAPAMIDE | 1.5MG | MODI MUNDIPHARMA PVT. LTD, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM €“ 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2254 | NDA/MAL/HDP/3215 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEROCORT 125 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG + 125MCG | CIPLA LTD, CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2009 |
| 2255 | NDA/MAL/HDP/3219 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPHENOL ORAL SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| 2256 | NDA/MAL/HDP/3220 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PYLO KIT | LANSOPRAZOLE+TINIDAZOLE+CLARITHROMYCIN | 30MG+500MG+250 MG | CIPLA LIMITED PUNE, MIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) | 01/07/2005 |
| 2257 | NDA/MAL/HDP/3221 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | OPTADEX-N EYE DROPS | DEXAMETHASONE + NEOMYCIN SULFATE | 1 MG + 3 MG | 1. M/S REMINGTON PHARMACEUTICAL INDUSTRIES PRIVATE LIMITED 18KM MULTAN ROAD LAHORE - PAKISTAN PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | OPHTHALMIC DROPS | I. 1*5ML VIAL | 01/07/1999 |
| 2258 | NDA/MAL/HDP/3224 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM FLUFED ELIXIR | MULTI-INGREDIENT | MULTI-INGREDIENT | TIL HEALTHCARE PVT LIMITED, PLOT 100, WEST R-5, SOUTH, SRICITY SEZ, CHERIVE9 (VI), DISTRICT: CHITOOR 517588 ANDHRA PRADESH- | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2259 | NDA/MAL/HDP/3225 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DIFLAME | DICLOFENAC DIETHYLAMINE + LINSEED OIL + METHYL SALICYLATE MENTHOL | N/A | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/2010 |
| 2260 | NDA/MAL/HDP/3231 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCOMOL | PARACETAMOL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/CHLORPHENIRAMINE MALEATE | 500MG/10MG/15MG/2MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X1.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| 2261 | NDA/MAL/HDP/3232 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | L-TRIM | SULFAMETHOXAZOLE + TRIMETHOPRIM | 400MG + 80MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2016 |
| 2262 | NDA/MAL/HDP/3237 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KONAZOL CREAM | KETOCONAZOLE | 2% W/W | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| 2263 | NDA/MAL/HDP/3239 | GLAND PHARMA LIMITED | NORVIK ENTERPRISES LIMITED | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50 MG/ML | 1. GLAND PHARMA LIMITED SY. NO. 143-148, 150 & 151 NEAR GANDIMAISAMMA CROSS ROADS, D.P. PALLY DUNDIGAL POST, DUNDIGAL GANDIMAISAMMA MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500 043, TELANGANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*5*2ML AMPOULE | |
| 2264 | NDA/MAL/HDP/3241 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CLOTRILIN | CLOTRIMAZOLE | 1%W/W | LINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X15.0 G TUBE | 01/07/2008 |
| 2265 | NDA/MAL/HDP/3246 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | COMPOUND MAGNESIUM TRISILICATE | MAGNESIUM TRISILICATE | 370MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| 2266 | NDA/MAL/HDP/3249 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LOSACAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2267 | NDA/MAL/HDP/3252 | GALENTIC PHARMA LTD | VITACARE LIMITED | PYLOOCAIN | BETAMETHASONE + PHENYLEPHRINE + LIDOCAINE | O.5 MG/G + 1 MG/G + 25 MG/G | GALENTIC PHARMA( INDIA ) PVT LTD, R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| 2268 | NDA/MAL/HDP/3255 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | SATISFIL-50 | SILDENAFIL CITRATE | 50MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2011 |
| 2269 | NDA/MAL/HDP/3259 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TIGBODERM | BETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE | 0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/W | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2270 | NDA/MAL/HDP/3261 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ | TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ | 300MG+200MG+600MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE|MYLAN LABORATORIES LIMITED , PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE| MYLAN LABORATORIES LTD -, PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2008 |
| 2271 | NDA/MAL/HDP/3262 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEGEL | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE | 250MG + 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2272 | NDA/MAL/HDP/3263 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | TRIMEX MUCOLYTIC SYRUP | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 2MG/5ML + 4MG/5ML + 100MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| 2273 | NDA/MAL/HDP/3265 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMOXICILLIN | AMOXICILLIN TRIHYDRATE | 250MG | CSPC ZHONGNUO PHARMACEUTICALS (SHIJIAZHUANG) CO. LTD-SHIJIAZHUANG CITY | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED- HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| 2274 | NDA/MAL/HDP/3266 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | SALIMIA LINIMENT | METHYL SALICYLATE+TURPENTINE OIL | 5ML+25ML | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1997 |
| 2275 | NDA/MAL/HDP/3270 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4000000 IU | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON | 01/07/2001 |
| 2276 | NDA/MAL/HDP/3273 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | BETASOL CREAM | BETAMETHASONE VALERATE | 0.1%W/W | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/1997 |
| 2277 | NDA/MAL/HDP/3275 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | MEFLIN-500 | MEFENAMIC ACID | 500MG | LINCOLN PHARMACEUTICALS LIMITED , 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2278 | NDA/MAL/HDP/3276 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | ROSUVAS 10 | ROSUVASTATIN | 10MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER,2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2279 | NDA/MAL/HDP/3279 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | HAEMOFORTE SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA| BAROQUE PHARMACEUTICALS PVT LTD -, S.NO.192/2 & S.NO.192/2 &3 SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/1997 |
| 2280 | NDA/MAL/HDP/3282 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | KOFF-GO | PHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN | 5MG/5ML + 2MG/5ML + 10MG/5ML | TORQUE PHARMACEUTICALS (P) LTD, P.O.DAPPAR VILLISS | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2009 |
| 2281 | NDA/MAL/HDP/3284 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | CHALEATE | CHLORPHENIRAMINE MALEATE | 4MG | LABORATORY & ALLIED LTD-, PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2282 | NDA/MAL/HDP/3286 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LOMAC-20 | OMEPRAZOLE | 20 MG | CIPLA LTD -PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II, SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH €“ 454 775, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2283 | NDA/MAL/HDP/3288 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED CHESTY COUGHS SYRUP | DIPHENHYDRAMINE HCL BP+AMMONIUM CHLORIDE BP+SODIUM CITRATE BP+MENTHOL BP | 14MG+135MG+57MG+1.1MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2284 | NDA/MAL/HDP/3289 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID DUSTING POWDER | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL DUSTING POWDERS | 1.0X30.0 G BOTTLE,1.0X100.0 G BOTTLE | 01/07/1999 |
| 2285 | NDA/MAL/HDP/3291 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | FINTOP | BUTENAFINE HCL | 1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2003 |
| 2286 | NDA/MAL/HDP/3292 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL | 7MG+28.5MG+0.55MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2287 | NDA/MAL/HDP/3294 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | URGENDOL CAPSULES | TRAMADOL HYDROCHLORIDE | 50 MG | WIN- MEDICARE LTD, MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| 2288 | NDA/MAL/HDP/3295 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEVATE | CLOBETASOL | 0.05%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| 2289 | NDA/MAL/HDP/3297 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | NEPIN-SR-20 | NIFEDIPINE | 20MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2290 | NDA/MAL/HDP/3300 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MUCOSOL PEDIATRIC SYRUP | CARBOCISTEINE | 125 MG/5 ML | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2003 |
| 2291 | NDA/MAL/HDP/3309 | UMEDICA LABORATORIES PVT LTD | VITACARE LIMITED | CLORIFORT VAGINAL TABLETS | CLOTRIMAZOLE | 100MG | UMEDICA LABORATORIES PVT LTDPLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP | 01/07/2002 |
| 2292 | NDA/MAL/HDP/3312 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TIDOMET FORTE | CO-CARELDOPA | 25MG/250MG | TORRENT PHARMACEUTICALS LTD , VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI €“ 173205, DIST: SOLAN, HIMACHAL PRADESH, | TORRENT PHARMACEUTICAL LTD, AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2293 | NDA/MAL/HDP/3314 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | SILVEREX | SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE | 10MG/G+10MG/G | SUN PHARMACEUTICALS LIMITED - KHASRA NO. 1335-1340 NEAR EPIP-1, VILL BHATOLI KALAN, BADDI DISTT. SOLAN, (H.P), INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE | 01/07/2004 |
| 2294 | NDA/MAL/HDP/3315 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ERO-250 TABLETS | ERYTHROMYCIN STEARATE | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2003 |
| 2295 | NDA/MAL/HDP/3316 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| 2296 | NDA/MAL/HDP/3318 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM TABLETS | CO-TRIMOXAZOLE | 480MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| 2297 | NDA/MAL/HDP/3319 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | FERROTONE CAPSULES | FERROUS FUMERATE+FOLIC ACID+VITAMIN B12 | 162MG +0.75MG +7.5MCG | MEGA LIFESCIENCES LTD., 384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| 2298 | NDA/MAL/HDP/3321 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DERMOLIN-GM | CLOBETASOL+GENTAMICIN+MICONAZOLE | 0.05%W/W+0.1%W/W+2%W/W | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| 2299 | NDA/MAL/HDP/3328 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN | 1 MU | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL | 01/07/2001 |
| 2300 | NDA/MAL/HDP/3334 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 375 | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP | 01/07/2005 |
| 2301 | NDA/MAL/HDP/3341 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AZILIN-250 | AZITHROMYCIN | 250MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER | 01/07/2008 |
| 2302 | NDA/MAL/HDP/3343 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDIVEN-CREAM | BETAMETHASONE VALERATE | 0.1%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2303 | NDA/MAL/HDP/3346 | WOCKHARDT LTD | KAMCARE PHARMA LIMITED | ZEDEX | BROMHEXINE +AMMONIUM CHLORIDE+ MENTHOL + DEXTROMETHORPHAN | 8MG+100MG+5MG+10MG | NAXPAR PHARMA PRIVATE LIMITED, 182, VILLAGE GURUMAJRA, TEHSIL NALAGARH, BADDI, DIST. SOLAN (H.P), 174101 INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2304 | NDA/MAL/HDP/3347 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIPEN TABLETS | PHENOXYMETHYLPENICILLIN | 250MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2305 | NDA/MAL/HDP/3348 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | PIMCEF | CEFEPIME USP | 1G | VENUS REMEDIES LTD., UNIT 11 HILL TOP INDUSTRIAL ESTATE JHARMAJRI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 01/07/2007 |
| 2306 | NDA/MAL/HDP/3354 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDIVEN OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2307 | NDA/MAL/HDP/3356 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | ZYCEL-100 CAPSULES | CELECOXIB | 100MG | ZYDUS LIFESCIENCES LTD--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER | 01/07/2001 |
| 2308 | NDA/MAL/HDP/3357 | CENTAUR PHAMACUITICALS | GITTOES PHARMACEUTICALS LIMITED | ESOREST 20 | ESOMEPRAZOLE | 20MG | CENTAUR PHARMACEUTICALS PVT L.T.D., CENTAUR HOUSE NEAR | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2309 | NDA/MAL/HDP/3359 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | ARTI | ARTEMETHER | 80MG/ML | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2011 |
| 2310 | NDA/MAL/HDP/3364 | CENTAUR PHAMACUITICALS | GITTOES PHARMACEUTICALS LIMITED | ESOREST 40 | ESOMEPRAZOLE | 40MG | CENTAUR PHARMACEUTICALS PVT L.T.D., CENTAUR HOUSE NEAR | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2311 | NDA/MAL/HDP/3367 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL SUSPENSION | PARACETAMOL | 125 MG/5ML | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| 2312 | NDA/MAL/HDP/3368 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | VIAGRA 50MG | SILDENAFIL | 50MG | PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X12.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER | 01/07/1998 |
| 2313 | NDA/MAL/HDP/3369 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AZILIN-500 | AZITHROMYCIN | 500MG | LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X3.0 TABLET BLISTER | 01/07/2008 |
| 2314 | NDA/MAL/HDP/3370 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | DERMOREN 500 | GRISEOFULVIN | 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2315 | NDA/MAL/HDP/3372 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | MUCOLEX | AMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN + MENTHOL | 30 MG/5ML + 1 MG/5ML + 50 MG/5ML + 0.5 MG/5ML | S KANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III VAPI 396 195 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 2316 | NDA/MAL/HDP/3373 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 625 | AMOXILLICIN/CLAVULANATE | 500MG/125MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP | 01/07/2005 |
| 2317 | NDA/MAL/HDP/3374 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | ZITHROX 250MG | AZITHROMYCIN | 250MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 01/07/2008 |
| 2318 | NDA/MAL/HDP/3377 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMILINE | AMITRIPTYLINE | 25 MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2319 | NDA/MAL/HDP/3378 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CHLOZINE TABLETS | CHLORPROMAZINE | 100MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2320 | NDA/MAL/HDP/3382 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFEN SUSPENSION | IBUPROFEN | 100MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2010 |
| 2321 | NDA/MAL/HDP/3383 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ZEPIN-200 | CARBAMAZEPINE | 200 MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2322 | NDA/MAL/HDP/3385 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | MEFTAL-P-SUSPENSION | MEFENAMIC ACID | 100MG/5ML | BLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2007 |
| 2323 | NDA/MAL/HDP/3389 | BAYER PHARMA AG | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLARINASE REPE TABS | LORATADINE + PSEUDOEPHEDRINE | 5MG + 120MG | SCHERING PLOUGH LABO N.V,, INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM | BELGIUM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2009 |
| 2324 | NDA/MAL/HDP/3390 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ALUGEL | ALUMINIUM HYDROXIDEL / MAGNESIUM TRISLICATE | 120MG/250MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X5.0 ML JERRYCAN | 01/07/1997 |
| 2325 | NDA/MAL/HDP/3391 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEZIN TABLET | CETIRIZINE | 10MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER | 01/07/2012 |
| 2326 | NDA/MAL/HDP/3393 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN 375MG | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 2.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2327 | NDA/MAL/HDP/3399 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LDNIL 10 | ROSUVASTATIN | 10MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2328 | NDA/MAL/HDP/3405 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL BABY AND INFANT 120MG/5ML | PARACETAMOL | 120MG/5ML | GLAXOSMITHKLINE LIMITED, LIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2008 |
| 2329 | NDA/MAL/HDP/3406 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | MICRONEMA | SODIUM CITRATE + SODIUM LAURYL SULPHATE + GLYCERIN | 450MG/10ML+75MG/10ML+ 90%V/V | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI, PAKISTAN | PAKISTAN | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X10.0 ML BOTTLE,1.0X20.0 ML BOTTLE | 01/07/2005 |
| 2330 | NDA/MAL/HDP/3409 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | CLARITYNE | LORATADINE | 10MG | BAYER BITTERFELD GMBH, ORTSTEIL GREPPIN SALEGASTER CHAUSSEE 1, 06803 BITTERFELD, WOLFEN - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2000 |
| 2331 | NDA/MAL/HDP/3411 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABNAL NASAL DROPS | SODIUM CHLORIDE | 0.9%W/V | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | NASAL SYSTEMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2011 |
| 2332 | NDA/MAL/HDP/3414 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 10MG/160MG | AMLODIPINE + VALSARTAN | 10 MG + 160 MG | NOVARTIS PHARMA STEIN AGH-4332 STEIN SCHAFFAUSERTRASSE | | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2007 |
| 2333 | NDA/MAL/HDP/3415 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID V-1 | CLOTRIMAZOLE | 500MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | VAGINAL TABLETS | 1.0X1.0 PESSARY STRIP | 01/07/2004 |
| 2334 | NDA/MAL/HDP/3423 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | AMOXICLAV-DENK 1000/125 | AMOXICILLIN TRIHYDTATE + POTASSIUM CLAVULANATE | 1000 MG + 125 MG | PENCEF PHARMA GMBH, BRITENBACHSTR ASSE 13 D-13509 BERLIN | GERMANY | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X12.0X3.0 G SACHET,1.0X8.0X3.0 G SACHET | 01/07/2011 |
| 2335 | NDA/MAL/HDP/3426 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RUBEM CREAM | METHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE | 1%W/W+0.1%W/W+5%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE | 01/07/1997 |
| 2336 | NDA/MAL/HDP/3429 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | EZEDE | LORATADINE | 10MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2337 | NDA/MAL/HDP/3433 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CO-DIOVAN 80/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 80 MG +12.5 MG | NOVARTIS PHARMA STEIN AG., SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND| NOVARTIS PHARMA SPA,, TORRE ANNUNZIATA ITALY | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2006 |
| 2338 | NDA/MAL/HDP/3437 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | REMYCIN 100 CAPSULES | DOXYCYCLINE HYDROCHLORIDE | 100MG | REMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 2339 | NDA/MAL/HDP/3439 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENECHLOR CAPSULE | CHLORAMPHENICOL | 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| 2340 | NDA/MAL/HDP/3440 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | HUMALOG | INSULIN LISPRO | 100IU | LILLY FRANCE SA, FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/2000 |
| 2341 | NDA/MAL/HDP/3444 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORVADIL 10 | AMLODIPINE BESILATE | 10MG | UNICHEM LABORATORIES LIMITED, UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2010 |
| 2342 | NDA/MAL/HDP/3449 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | IMMUNOX | CEFTRIAXONE SODIUM | 1000MG | VENUS REMEDIES LIMITED ,., HILL TOP,INDUSTRIAL ESTATE,JHARMAJRI, EPIP,PHASE 1,(EXTN.) ,BHATOLI KALAN,BADDI -H.P.INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL,1.0X10.0X1.0X10.0 ML VIAL | 01/07/2008 |
| 2343 | NDA/MAL/HDP/3451 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPHENOL CAPSULES (THANE0 | CHLORAMPHENICOL | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER | 01/07/1998 |
| 2344 | NDA/MAL/HDP/3458 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL 250MG | AMOXYCILLIN TRIHYDRATE | 250MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 2345 | NDA/MAL/HDP/3459 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ENEMAX | HYPERTONIC SOLUTION OF SODIUM PHOSPHATES | 6GM AND 16GM/100ML | AMOUN PHARMACEUTICALS COMPANY, 1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT | EGYPT | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X120.0 ML BOTTLE | 01/07/1997 |
| 2346 | NDA/MAL/HDP/3460 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | MALANIL ADULT TABLETS | ATOVAQUONE + PROGUANIL HCL | 250MG + 100MG | GLAXO WELLCOME S.A ARANDA, ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 01/07/2007 |
| 2347 | NDA/MAL/HDP/3465 | MONDI-MUNDI PHARMA PVT LIMITED | SURGIPHARM (U) LIMITED | FECONTIN-Z | FERROUS GLYCINE SULPHATE+ZINC SULPHATE+FOLIC ACID | 100MG+61.8MG+0.5MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2348 | NDA/MAL/HDP/3466 | DAWA LIMITED | SUPER MEDIC LTD | DAWASEC | SECNIDAZOLE | 1G | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2015 |
| 2349 | NDA/MAL/HDP/3467 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | RONEM | MEROPENEM TRIHYDRATE | 1000MG | VENUS REMEDIES LTD -, UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL | 01/07/2008 |
| 2350 | NDA/MAL/HDP/3473 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TRIXONE | CEFTRIAXONE | 1G | P.R & INJECT CARE PARENTERALS PVT LTD-PLOT 130, SILVASSA ROAD,G.I.D.C,VAPI-396195,GUJARAT,INDIA | | ZEISS PHARMA LIMITED-IGC,SIDCO, PHASE II, SAMBA, JAMMU - 184121,(J&K) | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 01/07/2016 |
| 2351 | NDA/MAL/HDP/3474 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMCLOREN DRY SYRUP | AMPICILLIN + CLOXACILLIN | 125MG+125MG/5ML | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2008 |
| 2352 | NDA/MAL/HDP/3475 | VENUS REMIDIES LTD | HARLEYS UGANDA LIMITED | RONEM | MEROPENEM | 500MG | VENUS REMEDIES LTD, UNIT II,, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL | 01/07/2010 |
| 2353 | NDA/MAL/HDP/3476 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | PARAFIL | PARACETAMOL | 500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2354 | NDA/MAL/HDP/3478 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | DICLOREN | DICLOFENAC SODIUM BP | 50MG | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2355 | NDA/MAL/HDP/3485 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | ERGOMETRINE | ERGOMETRINE MALEATE | 0.5MG/ML | CIRON DRUGS AND PHARMACEUTICALS PRIVATE LTD, N-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE | 01/07/2007 |
| 2356 | NDA/MAL/HDP/3490 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | LAXOLAC SYRUP | LACTULOSE | 67G/100ML | MEDICAL UNION PHARMACEUTICALS LTD, ABU SULTAN, ISMAILLIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2003 |
| 2357 | NDA/MAL/HDP/3494 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GAMALATE B6 SOLUTION | MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B6 | 2G + 2G + 1G +1G | FERRER INTERNATIONAL, S.A., C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X80.0 ML BOTTLE | 01/07/2015 |
| 2358 | NDA/MAL/HDP/3497 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOLIN FORTE | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES LIMITED, : PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2359 | NDA/MAL/HDP/3500 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN 300 | IRBESARTAN | 300MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2360 | NDA/MAL/HDP/3504 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BIFRIL | ZOFENOPRIL | 30MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I, VIA CAMPO DI PILE 67100 L'AQUILA | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X7.0 TABLET BLISTER | 01/07/2015 |
| 2361 | NDA/MAL/HDP/3512 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | LAMISIL 250MG | TERBINAFINE | 250 MG | 1. NOVARTIS PHARMA PRODUKTIONS GMBH OEFLINGERSTRASSE 44, 79664 WEHR - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET CARTON | 01/07/1997 |
| 2362 | NDA/MAL/HDP/3515 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 40/240 | ARTEMETHER + LUMEFANTRINE | 40 MG + 40 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO) | 01/07/2007 |
| 2363 | NDA/MAL/HDP/3516 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENZHEXOL TABLETS BP 5MG | TRIHEXYPHENIDYL HYDROCHLORIDE | 5MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET BLISTER | 01/07/1998 |
| 2364 | NDA/MAL/HDP/3517 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TOTO ZINC | ZINC SULPHATE | 20MG | MEDICAMEN BIOTECH LTD, SP-1192, A &B, PHASE €“IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2365 | NDA/MAL/HDP/3520 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ POWDER | POVIDONE IODINE + METRONIDAZOLE | 5%W/W + 1%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL POWDERS | 1.0X100.0 G BOTTLE,1.0X10.0 G BOTTLE,1.0X40.0 G CONTAINER | 01/07/2010 |
| 2366 | NDA/MAL/HDP/3522 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CLOXACILLIN SODIUM FOR INJECTION | CLOXACILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY VIALS | 1.0X10.0X500.0 MG VIAL | 01/07/2011 |
| 2367 | NDA/MAL/HDP/3525 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLLIN | AMPICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/1998 |
| 2368 | NDA/MAL/HDP/3526 | CYANO PHARMA(P) | RENE PHARMACY LTD | PROMETHAZINE TABLETS | PROMETHAZINE HYDROCHLORIDE | 25MG | CYANO PHARMA(P), 115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2369 | NDA/MAL/HDP/3533 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | LEVOZIN | LEVOCETIRIZINE | 5MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2370 | NDA/MAL/HDP/3535 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | ADIFLAM-50 | DICLOFENAC SODIUM GASTRO-RESISTANT TABLETS BP | 50MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2371 | NDA/MAL/HDP/3543 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DROX 250 | CEFADROXIL | 250MG/5ML | 1. AUROBINDO PHARMA LIMITED (UNIT-VI) SY. NO. 329/39 & 329/47 CHITKUL (VILLAGE) - 502 307. PATENCHERU MANDAL, SANGA REDDY DISTRICT, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*100ML BOTTLE | 01/07/2008 |
| 2372 | NDA/MAL/HDP/3545 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID MOUTH PAINT | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL TOPICAL LIQUIDS | 1.0X15.0 ML BOTTLE | 01/07/2000 |
| 2373 | NDA/MAL/HDP/3546 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM D.S | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2013 |
| 2374 | NDA/MAL/HDP/3547 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORBIS-10 | BISOPROLOL | 10 MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2008 |
| 2375 | NDA/MAL/HDP/3548 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BECORT 200 | BECLOMETASONE | 200MCG/DOSE | CIPLA LTD.- , PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2009 |
| 2376 | NDA/MAL/HDP/3549 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | TRIMEX PAEDIATRIC COUGH EXPECTORANT | CHLORPHENIRAMINE MALEATE+PSEUDO EPHEDRINE HCL+GUAIPHENISIN+MENTHOL | 1.0MG+15.0MG+50.0MG+0.5MG / 5ML | REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2007 |
| 2377 | NDA/MAL/HDP/3551 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA-500MG | AZITHROMYCIN | 500MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X10.0X1.0X3.0 TABLET BLISTER | 01/07/2009 |
| 2378 | NDA/MAL/HDP/3556 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | GRISACTIN-500 TABLETS | GRISEOFULVIN TABLETS | 500MG | REGAL PHARMACEUTICALS LIMITED , PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2379 | NDA/MAL/HDP/3558 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEROCORT 250 | SALMETEROL+ FLUTICASONE PROPIONATE | 25MCG + 250MCG | CIPLA LTD.- , PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2009 |
| 2380 | NDA/MAL/HDP/3561 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCILLIN ORAL SUSPENSION | AMPICILLIN TRIHYDRATE | 125MG/5ML | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| 2381 | NDA/MAL/HDP/3566 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARTESUN | ARTESUNATE | 60 MG | GUILIN PHARMACEUTICAL CO LTD-, NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5% NAHCO3 + 5 ML NACL INJECTION | 01/07/2008 |
| 2382 | NDA/MAL/HDP/3569 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CARBADAC-200 | CARBAMAZEPINE | 200MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2383 | NDA/MAL/HDP/3571 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | CADIPHEN EXPECTORANT | CHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE | 2MG//80MG/100MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2384 | NDA/MAL/HDP/3573 | VENUS REMEDIES LTD | REDDYS PHARMA LIMITED | PARIN-E | ENOXAPARIN SODIUM | 40MG/0.4ML | VENUS REMEDIES LTD -, UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 01/07/2008 |
| 2385 | NDA/MAL/HDP/3574 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOZ 2.5 TABLET | METOLAZONE TABLETS USP | 2.5MG | CENTAUR PHARMA PVT.LIMITED-PLANT I, PLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2386 | NDA/MAL/HDP/3575 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 400 CAPSULES | CEFIXIME | 400MG | PHARMA INTERNATIONAL CO.,, AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0 CAPSULE BLISTER | 01/07/2007 |
| 2387 | NDA/MAL/HDP/3577 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | METOCLOPRAMIDE | METOCLOPRAMIDE | 5MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | TIANJIN KINGYORK GROUP HUBEI TIANYAO PHARMACEUTICAL CO. LTD, NO. 99, HANJIANG BEI ROAD, XIANGYANG CITY, HUBEI PROVINCE | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2009 |
| 2388 | NDA/MAL/HDP/3578 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CINNARON 25 | CINNARIZINE | 25MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2389 | NDA/MAL/HDP/3580 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FEXOFEN-120 | FEXOFENADINE HYDROCHLORIDE | 120MG | ARISTO PHARMACEUTICALS PVT LTD, PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER | 01/07/2008 |
| 2390 | NDA/MAL/HDP/3581 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOZ 5 | METOLAZONE | 5MG | CENTAUR PHARMA PVT.LTD-PLANT I, PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2391 | NDA/MAL/HDP/3588 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FEXOFEN-180 | FEXOFENADINE | 180MG | ARISTO PHARMACEUTICALS PVT LTD, PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER | 01/07/2008 |
| 2392 | NDA/MAL/HDP/3590 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ALFOXAN 500 FC TABLETS | MEFENAMIC ACID | 500MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2393 | NDA/MAL/HDP/3593 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DROX 500 | CEFADROXIL MONOHYDRATE | 500 MG | 1. AUROBINDO PHARMA LIMITED (UNIT-VI) SY. NO. 329/39 & 329/47 CHITKUL (VILLAGE) - 502 307. PATENCHERU MANDAL, SANGA REDDY DISTRICT, TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER II. 1*10CAPSULE BLISTER | 01/07/2007 |
| 2394 | NDA/MAL/HDP/3594 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | STERILE QUININE DIHYDROCHLORIDE | QUININE DIHYDROCHLORIDE | 300MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LIMITED, N-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE | 01/07/2007 |
| 2395 | NDA/MAL/HDP/3598 | WIN-MEDICURE LTD | SURGIPHARM (U) LIMITED | MYOSPAZ | PARACETAMOL + CHLORZOXAZONE | 500MG + 250MG | WIN- MEDICARE LTD, MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2396 | NDA/MAL/HDP/3600 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN TABLETS | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG + 320MG | BLISS GVS PHARMA LTD, PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X9.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X15.0 TABLET BLISTER | 01/07/2008 |
| 2397 | NDA/MAL/HDP/3601 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | HYDROKANT | HYDROCORTISONE ACETATE | 1%W/W | SKANT HEALTH CARE LTD , 1802-1805 GIDC PHASE III VAPI GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| 2398 | NDA/MAL/HDP/3604 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | AC-FENAC | ACECLOFENAC | 100MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2399 | NDA/MAL/HDP/3607 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | LINOPRIL | LISINOPRIL DIHYDRATE | 20MG | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X14.0X2.0 TABLET BLISTER | 01/07/2004 |
| 2400 | NDA/MAL/HDP/3610 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PROMETHAZINE TABLETS BP 25MG | PROMETHAZINE HYDROCHLORIDE | 25MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| 2401 | NDA/MAL/HDP/3611 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | COLDRIL SYRUP | PARACETAMOL + CHLORPHENIRAMINE + PSEUDOEPHEDRINE | 120MG+1MG+10MG | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| 2402 | NDA/MAL/HDP/3613 | HETERO LABS LTD | AIVEEN (U) LIMITED | ZIDOVUDINE ORAL SOLUTION | ZIDOVUDINE | 50MG/5ML | HETERO LABS LTD UNIT III, 22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X240.0 ML BOTTLE | 01/07/2013 |
| 2403 | NDA/MAL/HDP/3614 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ERYTHROREN SUSPENSION | ERYTHROMYCIN STEARATE | 125MG/5ML | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2008 |
| 2404 | NDA/MAL/HDP/3618 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | CLOXACILLIN SODIUM | CLOXACILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON, 1.0X10.0 VIAL CARTON | 01/07/2011 |
| 2405 | NDA/MAL/HDP/3619 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | CAPTOPRIL DENK -25 | CAPTOPRIL | 25MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2000 |
| 2406 | NDA/MAL/HDP/3620 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | HALOXEN 10 TABLETS | HALOPERIDOL BP | 10MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2004 |
| 2407 | NDA/MAL/HDP/3626 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ORIPHEX CAPSULES | CEPHALEXIN | 250MG | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006| SAKAR HEALTHCARE LIMITED, BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT €“ INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 2408 | NDA/MAL/HDP/3628 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEMIN 5S | AMINO ACIDS/SORBITOL | 5%W/V+5%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE | 01/07/2001 |
| 2409 | NDA/MAL/HDP/3630 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | UNICONTIN 600 | THEOPHYLLINE | 600MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2410 | NDA/MAL/HDP/3631 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ENA-DENK 10 | ENALAPRIL MALEATE | 10MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2411 | NDA/MAL/HDP/3634 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPLUS | PARACETAMOL+DEXTROMETHORPHAN HCL+ CHLORPHENIRAMINE+PHENYLEPHRINE HCL | 500MG+15MG+2MG+10MG | AGOG PHARMA LTD, PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| 2412 | NDA/MAL/HDP/3635 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIROGAN | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| 2413 | NDA/MAL/HDP/3637 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TINODERM | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X18.0 G TUBE | 01/07/1997 |
| 2414 | NDA/MAL/HDP/3639 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL ADVANCE | PARACETAMOL | 500MG | GLAXOSMITHKLINE DUNGARAVAN LTD, KNOCKBRACK DUNGARVAN CO. WATERFORD|GLAXOSMITHKLINE LIMITED-P.O. BOX 78392 - 00507 INDUSTRIAL AREA, LIKONI ROAD | IRELAND| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X11.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2415 | NDA/MAL/HDP/3641 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | TRD-CONTIN 100 | TRAMADOL HYDROCHLORIDE | 100MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2416 | NDA/MAL/HDP/3645 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | NEUROBEX | THIAMINE + RIBOFLAVIN + PYRIDOXINE + CYANOCOBALAMIN+ FOLIC ACID | 250MG + 15MG + 200MG + 250MG + 500MCG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2417 | NDA/MAL/HDP/3647 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | NYSTAGO ORAL SUSPENSION | NYSTATIN | 100000 IU | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2008 |
| 2418 | NDA/MAL/HDP/3648 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | UNICONTIN 400 | THEOPHYLLINE | 400MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2419 | NDA/MAL/HDP/3649 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | LAMISIL | TERBINAFINE | 125 MG | 1. SIEGFRIED BARBERA, S.L. (FORMERLY NOVARTIS FARMACEUTICA SA) RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA - SPAIN SPAIN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SPAIN | ORAL SOLID ORDINARY TABLETS | I. 1*2*7TABLET BLISTER | 01/07/1997 |
| 2420 | NDA/MAL/HDP/3651 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | ORIPHEX SYRUP | CEPHALEXIN | 125MG/5ML | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006| SAKAR HEALTHCARE LIMITED, BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT €“ INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2421 | NDA/MAL/HDP/3653 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO) | 01/07/2008 |
| 2422 | NDA/MAL/HDP/3655 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | QUADRAJEL GEL | CHLORHEXIDINE+METRONIDAZOLE+LIDOCAINE | 5%W/W+1.61%W/W+2.13%W/W | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2008 |
| 2423 | NDA/MAL/HDP/3657 | DAWA LIMITED | SUPER MEDIC LTD | DAWASTIN | NYSTATIN | 100000IU/ML | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2009 |
| 2424 | NDA/MAL/HDP/3663 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMLODAC 10 | AMLODIPINE BESYLATE | 10MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER | 01/07/2003 |
| 2425 | NDA/MAL/HDP/3664 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | AZZY | AZITHROMYCIN | 500MG | TORQUE PHARMACEUTICALS PVT LTD, ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2011 |
| 2426 | NDA/MAL/HDP/3666 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | STROM 50 | TRAMADOL HYDROCHLORIDE | 50MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| 2427 | NDA/MAL/HDP/3668 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN BD | AMOXICILLIN + CLAVULANIC ACID | 200 MG/ 5 ML + 28.5 MG/ 5 ML | GLAXO WELLCOME PRODUCTION, ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE, 1.0X140.0 ML BOTTLE | 01/07/1998 |
| 2428 | NDA/MAL/HDP/3670 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TETRAREN CAPSULES | TETRACYCLINE HYDROCHLORIDE | 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| 2429 | NDA/MAL/HDP/3671 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN TABLETS | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET STRIP,10.0X10.0 TABLET STRIP,1.0X20.0 TABLET STRIP | 01/07/2003 |
| 2430 | NDA/MAL/HDP/3672 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | NITROCONTIN 6.4 | NITROGLYCERIN | 6.4MG | MODI MUNDIPHARMA (PVT) LTD, MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY SUBLINGUAL TABLETS | 1.0X25.0 TABLET CONTAINER | 01/07/2008 |
| 2431 | NDA/MAL/HDP/3673 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | PROMETHAZINE INJECTABLE SOLUTION | PROMETHAZINE HCL | 25MG/ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| 2432 | NDA/MAL/HDP/3674 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | INTAMINE SYRUP | PROMETHAZINE HYDROCHLORIDE | 5MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 01/07/1997 |
| 2433 | NDA/MAL/HDP/3677 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | IBUREN | IBUPROFEN | 200MG | RENE INDUSTRIES LTD, 680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2434 | NDA/MAL/HDP/3678 | FOURRTS LABORATORIES LTD | DELMAW ENTERPRISES LIMITED | REDINPLUS | IRON PENTACARBONYL + ZINC SULPHATE MONOHYDRATE + FOLIC ACID + SODIUM SELENITE + LYSINE HYDROCHLORIDE + HISTIDINE HYDROCHLORIDE + CHOLINE BITARTRATE | 100MG + 30MG + 7.5MG + 0.11MG + 26MG + 4.4MG + 52MG | FOURRTS (INDIA) LABS PVT LTD ., VANDALUR ROAD. KELAMBAKK AM-603103 TAMIL, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X30.0 CAPSULE BLISTER | 01/07/2008 |
| 2435 | NDA/MAL/HDP/3681 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEDOL | PARACETAMOL | 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| 2436 | NDA/MAL/HDP/3683 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | COLD TABS FORTINSA | PARACETAMOL + PHENYLEPHRINE +CHLORPHENIRAMINE + CAFFEINE | 500MG + 5MG + 2MG + 30MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP | 01/07/2013 |
| 2437 | NDA/MAL/HDP/3688 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX MINT FLAVOUR | ALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG +250MG + 250MG + 250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| 2438 | NDA/MAL/HDP/3694 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | LORIDIN RAPITAB | LORATADINE | 10MG | ZYDUS LIFESCIENCES LTD, KUNDAIN INDUSTRIAL ESTATE PONDA GOA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2002 |
| 2439 | NDA/MAL/HDP/3698 | CADILA HEALTHCARE PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | HIPEN SYRUP | AMOXICILLIN | 125MG/5ML | SPARSH BIO-TECH LTD , PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR €“ 361006 GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2440 | NDA/MAL/HDP/3702 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | ATORFIT-20 | ATORVASTATIN | 20MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2441 | NDA/MAL/HDP/3704 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PENEGRA 100 | SILDENAFIL | 100MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER,1.0X20.0X4.0 TABLET BLISTER | 01/07/2002 |
| 2442 | NDA/MAL/HDP/3707 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | OBETAS-120 | ORLISTAT | 120MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| 2443 | NDA/MAL/HDP/3709 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | NIGHT & DAY -N | PARACETAMOL/ DIPHENHYDRAMINE CHLORIDE + PARACETAMOL/ PSEUDOEPHEDRINE | 500MG/ 25MG +600MG/ 90MG | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2444 | NDA/MAL/HDP/3710 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LACILLIN | AMPICILLIN | 250MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 2445 | NDA/MAL/HDP/3711 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | POLY-MXB | POLYMYXIN B | 500,000 UNITS | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0 ML VIAL | 01/07/2013 |
| 2446 | NDA/MAL/HDP/3712 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMLOZAAR | LOSARTAN POTASSIUM / AMLODIPINE | 50MG + 5MG | MICRO LABS LTD, 92,SIPCOT INDUSTRIAL COMPLEX,HOSUR-635-126(T.N)INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2447 | NDA/MAL/HDP/3714 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | ADALAT LA | NIFEDIPINE | 30MG | BAYER PHARMA AG, D-51368 LEVERKUSEN, GERMANY | GERMANY | ORAL SOLID RETARD FILM-COATED TABLETS | 2.0X14.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2448 | NDA/MAL/HDP/3717 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEFTRIAXONE SODIUM | CEFTRIAXONE SODIUM | 1G | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 01/07/2011 |
| 2449 | NDA/MAL/HDP/3723 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LACILLIN | AMPICILLIN | 125MG/5ML | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 07/07/1997 |
| 2450 | NDA/MAL/HDP/3728 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DICLO-DENK 50 | DICLOFENAC SODIUM | 50MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER + 1 * 10 SAMPLE | 01/07/1998 |
| 2451 | NDA/MAL/HDP/3730 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | BAYER PHARMA AG , 51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 2.0X5.0 TABLET BLISTER,1.0X5.0 TABLET BLISTER | 01/07/2001 |
| 2452 | NDA/MAL/HDP/3732 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ALBASOL TABLETS 200MG | ALBENDAZOLE | 200MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET STRIP | 01/07/2003 |
| 2453 | NDA/MAL/HDP/3734 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | ZARICORT CREAM | MICONAZOLE + HYDROCORTISONE | 2%W/W + 1%W/W | XEPA SAUL PATTINSON MALAYSIA, 1-5 INDUSTRIAL ESTATE 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1998 |
| 2454 | NDA/MAL/HDP/3736 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | RECTOL 125 SUPPOSITORY | PARACETAMOL | 125MG | BLISS GVS PHARMA LIMITED, PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| 2455 | NDA/MAL/HDP/3741 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ACTIZINE | CETIRIZINE HYDROCHLORIDE | 10MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD, PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X15.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2456 | NDA/MAL/HDP/3744 | ABBOTT LABORATORIES S.A. (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DUPHALAC SOLUTION | LACTULOSE | 67 G/100ML | 1. ABBOTT BIOLOGICALS BV, THE NETHERLANDS VEERWEG 12, 8121 AA, OLST NETHERLANDS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | NETHERLANDS | ORAL LIQUID ORDINARY LIQUIDS | I. 1*10*15ML BOTTLE II. 1*200ML BOTTLE | 01/07/2001 |
| 2457 | NDA/MAL/HDP/3745 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | WINDERM CREAM | BECLOMETHASONE+MICONAZOLE+NEOMYCIN | 0.025%W/W + 2%W/W + 0.5%W/W | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 01/07/2008 |
| 2458 | NDA/MAL/HDP/3746 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENDRO | BENDROFLUMETHIAZIDE | 5MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2459 | NDA/MAL/HDP/3747 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ALZOL TABLETS | ALBENDAZOLE | 200MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 30.0X2.0 TABLET BLISTER | 01/07/2002 |
| 2460 | NDA/MAL/HDP/3753 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | MYFORTIC 180 | MYCOPHENOLATE SODIUM | 180MG | NORVATIS PHARMA STEIN AG, SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND| NORVATIS PHARMA PRODUCTIONS GMBH, WEHR, OEFLINGER STR. 4479664 WEHR GERMANY | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2461 | NDA/MAL/HDP/3754 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | SINAREST PD NASAL DROPS | OXYMETAZOLINE HYDROCHLORIDE | 0.025%W/V | CENTAUR PHARMACEUTICALS LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE | 01/07/2006 |
| 2462 | NDA/MAL/HDP/3757 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNITRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2463 | NDA/MAL/HDP/3760 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | COMPOUND MAGNESIUM TRISILICATE | MAGNESIUM TRISILICATE | 370MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2464 | NDA/MAL/HDP/3761 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | RIFACOS-300 | RIFAMPICIN | 300 MG | COSMOS LIMITED, RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 2465 | NDA/MAL/HDP/3763 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | NORVASC | AMLODIPINE | 5MG | PFIZER PHARMACEUTICAL LLC ROAD 689 KM 1.9 VEGA BAJA PUERTO RICO 00693 | PEURTO RICO | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2466 | NDA/MAL/HDP/3765 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ALPRIM | CO-TRIMOXAZOLE | 480MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2467 | NDA/MAL/HDP/3766 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | BUKOL TABLETS | HYOSCINE N-BUTYLBROMIDE | 10MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2468 | NDA/MAL/HDP/3768 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NIMOTOP 30MG | NIMODIPINE | 30MG | BAYER PHARMA AG , 51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2469 | NDA/MAL/HDP/3770 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XITHRONE | AZITHROMYCIN | 500 MG | AMOUN PHARMACEUTICALS COMPANY, 1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 01/07/2005 |
| 2470 | NDA/MAL/HDP/3771 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BRONQUIDIAZINA C.R | TRIMETHOPRIM/SULFAMETHOXAZOLE/BROMHEXINE/SODIUM BENZOATE/TOLU BALSAM | 80MG/400MG/4MG/250MG/325MG | FAES FARMA, S.A , MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X150.0 ML BOTTLE | 01/07/2014 |
| 2471 | NDA/MAL/HDP/3772 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | HUMULIN N NPH | HUMAN INSULIN ISOPHANE | 100IU | LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,, INDIANA 46285 USA | EGYPT | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/2005 |
| 2472 | NDA/MAL/HDP/3773 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBUTOL-4 | SALBUTAMOL SULPHATE | 4 MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2473 | NDA/MAL/HDP/3778 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XITHRONE | AZITHROMYCIN | 200MG/5ML | AMOUN PHARMACEUTICALS COMPANY, 1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X15.0 ML BOTTLE | 01/07/2004 |
| 2474 | NDA/MAL/HDP/3779 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | LOSIUM 50 | LOSARTAN POTASSIUM | 50MG | 1. CADILA PHARMACEUTICALS LIMITED 1389, TRASAD ROAD, DHOLKA-382225, DIST. AHMEDABAD, GUJARAT STATE - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*2*1*14TABLET BLISTER | 01/07/2011 |
| 2475 | NDA/MAL/HDP/3782 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LAE-PEN V | PHENOXYMETHYLPENICILLIN | 250MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2476 | NDA/MAL/HDP/3784 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | CIPIUM | CHLORPHENIRAMINE | 2MG/5ML | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2011 |
| 2477 | NDA/MAL/HDP/3787 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPENIV | PHENOXYMETHYLPENICILLIN | 125MG/5ML | SPARSH BIO-TECH PVT. LTD ., PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR €“ 361006 GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| 2478 | NDA/MAL/HDP/3790 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFLOX-P | PEFLOXACIN | 400MG | AGOG PHARMA, PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2479 | NDA/MAL/HDP/3794 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMET-200 | METRONIDAZOLE | 200MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| 2480 | NDA/MAL/HDP/3798 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROTON TABLET | MULTI-INGREDIENT | N/A | AMOUN PHARMACETICAL COMPANY, 1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPT | EGYPT | ORAL SOLID ORDINARY COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2481 | NDA/MAL/HDP/3801 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | FUNGISTIN ORAL SUSPENSION | NYSTATIN | 100000 IU/ML | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2002 |
| 2482 | NDA/MAL/HDP/3803 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LOFNAC-100 | DICLOFENAC SODIUM | 100MG | BLISS GVS PHARMA LTD, PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| 2483 | NDA/MAL/HDP/3807 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ARTEMETHER INJECTION | ARTEMETHER | 80MG/ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2008 |
| 2484 | NDA/MAL/HDP/3808 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 12.5MG | DICLOFENAC SODIUM | 12.5MG | DELPHARM HUNINGUE S.A.S-, SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 01/07/2006 |
| 2485 | NDA/MAL/HDP/3812 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | B-TONE | PHENOBARBITONE | 30MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2486 | NDA/MAL/HDP/3813 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ACTIPAR | PIPERAZINE CITRATE | 500MG/5ML | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE | 01/07/1997 |
| 2487 | NDA/MAL/HDP/3814 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | PETHIDINE INJECTION | PETHIDINE | 50MG/1ML | MARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/1997 |
| 2488 | NDA/MAL/HDP/3818 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN | RECOMBINANT HUMAN ERYTHROPOIETIN | 2000 I.U/0.5ML | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML VIAL, 1.0X0.5 ML PRE- FILLED SYRINGE | 01/07/2012 |
| 2489 | NDA/MAL/HDP/3823 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | D-WORM ORAL SUSPENSION | ALBENDAZOLE | 200MG/5ML | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2009 |
| 2490 | NDA/MAL/HDP/3827 | AJANTA PHARMA LTD | ASTRA PHARMA (U) LIMITED | ATORFIT-10 | ATORVASTATIN | 10MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2491 | NDA/MAL/HDP/3829 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETACOOL | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE, DRIED + MAGNESIUM ALUMINIUM SILICATE + SIMETICONE | 25 MG + 300 MG + 50 MG + 25 MG | 1. BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100, KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY TABLETS | I. 1*2*50TABLET STRIP | 01/07/2006 |
| 2492 | NDA/MAL/HDP/3833 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | LABSTATIN VAGINAL TABLETS | NYSTATIN | 100.000 I.U | LABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI | | KENYA | | VAGINAL TABLETS | 1.0X3.0X5.0 PESSARY STRIP | 01/07/2000 |
| 2493 | NDA/MAL/HDP/3835 | ASPEN PHARMACARE LIMITED | BETA HEALTHCARE UGANDA LIMITED | HEDEX CAPLETS | PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS | 200MG+400MG+50MG | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | SMITHKLINE BEECHAM (NAIROBI), NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET PACK,1.0X110.0 TABLET PACK,1.0X100.0 TABLET PACK | 01/07/1997 |
| 2494 | NDA/MAL/HDP/3837 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NITROFURANTOIN | NITROFURANTOIN | 100MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 2495 | NDA/MAL/HDP/3839 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLURID | ACETAMINOPHEN + PHENIRAMINE MALEATE | 500 MG + 10.5 MG | KAMPALA PHARMACEUTICALS INDUSTIES, PLOT M 444B STRETCHER NTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET BLISTER | 01/07/2006 |
| 2496 | NDA/MAL/HDP/3840 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TORACTIN TABLETS | CYPROHEPTADINE | 4MG | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X50.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| 2497 | NDA/MAL/HDP/3844 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN RETARD | DICLOFENAC SODIUM | 100MG | NOVARTIS PHARMA STEIN AG, SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.| NORVATIS FARMA SPA-, VIA PROVINCIALE SCHITO, 131 1-80052, TORRE ANNUNCIATA (NA) ITALY | SWITZERLAND | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/1997 |
| 2498 | NDA/MAL/HDP/3845 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CARDIPAC | AMLODIPINE | 5MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD, PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2499 | NDA/MAL/HDP/3850 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGIZAAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2500 | NDA/MAL/HDP/3853 | MISSION PHARMA A/S | LABOREX UGANDA LIMITED | ZINC SULPHATE TABLET USP | ZINC SULPHATE | 20MG | MEDICAMEN BIOTECH LTD, SP-1192, A &B, PHASE €“IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2501 | NDA/MAL/HDP/3854 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LOSARTAS 50 TABLETS | LOSARTAN POTASSIUM | 50MG | INTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2003 |
| 2502 | NDA/MAL/HDP/3859 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | IFIMOL | PARACETAMOL | 10MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES-, PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2503 | NDA/MAL/HDP/3860 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOLAC | LACTULOSE | 3.35MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2009 |
| 2504 | NDA/MAL/HDP/3862 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | LAMITOR 100 | LAMOTRIGINE | 100MG | TORRENT PHAMACEUTICALS LTD, TORRENT PHAMACEUTICALS LTD INDRAD 382721 DIST MEHSANA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2505 | NDA/MAL/HDP/3866 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | RL | COMPOUND SODIUM LACTATE INFUSION BP | 0.6/ 0.25 /0.04 / 0.027 % W/V | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2010 |
| 2506 | NDA/MAL/HDP/3867 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/1997 |
| 2507 | NDA/MAL/HDP/3872 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZYNCET SYRUP | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096 | | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 01/07/2006 |
| 2508 | NDA/MAL/HDP/3873 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CHLORPROMAZINE INJECTION B.P | CHLORPROMAZINE | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| 2509 | NDA/MAL/HDP/3874 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | RIDMAL 40/320 | DIHYDROARTEMISININ + PIPERAQUINE | 40MG + 320MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X8.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2010 |
| 2510 | NDA/MAL/HDP/3875 | PHAMA INTERNATIONAL CO | OMAB UGANDA LIMITED | OPTIMAL(0.05% GEL | TRETINOIN USP | 0.25MG/1G | PHARMA INTERNATIONAL COMPANY ., MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| 2511 | NDA/MAL/HDP/3881 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MOXACIL | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| 2512 | NDA/MAL/HDP/3883 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | MYFORTIC 360 | MYCOPHENOLATE SODIUM | 360MG | NOVARTIS PHARMA PRODUKTIONS GMBH, OEFLINGER STR.4479664 WEHR GERMANY| NOVARTIS PHARMA STEIN AG, SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2513 | NDA/MAL/HDP/3886 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | DELOR | CLOBETASOL PROPIONATE | 0.5 MG/G | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE | 01/07/2004 |
| 2514 | NDA/MAL/HDP/3888 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PYRIREN | PYRIDOXINE HYDROCHLORIDE | 25MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2515 | NDA/MAL/HDP/3891 | PHARMATHEN S.A | GOODMAN INTERNATIONAL LTD | LADININ | CIPROFLOXACIN | 500MG | PHARMATHEN S.A-, 6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE | GREECE | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2516 | NDA/MAL/HDP/3892 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TETRAX | LEVAMISOLE HYDROCHLORIDE | 40MG/5ML | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| 2517 | NDA/MAL/HDP/3893 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | EPINEPHRINE INJECTION USP | EPINEPHRINE HCL | 1MG/ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2008 |
| 2518 | NDA/MAL/HDP/3896 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | VALCONTIN 500 | SODIUM VALPROATE (CONTROLLED RELEASE) | 500MG | MODI MUNDIPHARMA PVT. LTD, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM €“ 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2519 | NDA/MAL/HDP/3897 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 875MG/125MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2010 |
| 2520 | NDA/MAL/HDP/3899 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FEDATE SYRUP | SODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID | 216.87MG + 1.5MG + 7.5MCG + 1.5MG | AJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| 2521 | NDA/MAL/HDP/3906 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | LEROLE | PANTOPRAZOLE | 40MG | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL 1*10ML 0.9%NACL AMPOULE | 01/07/2011 |
| 2522 | NDA/MAL/HDP/3913 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | VALCONTIN | SODIUM VALPROATE | 200 MG | MODI MUNDIPHARMA PVT. LTD, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM €“ 250110 UTTAR PRADESH | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 2523 | NDA/MAL/HDP/3914 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN | AMOXICILLIN + CLAVULANATE POTASSIUM | 875 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,, CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X1.0X7.0 TABLET BLISTER | 01/07/2010 |
| 2524 | NDA/MAL/HDP/3916 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | METOCLOPRAMIDE HYDROCHLORIDE INJECTION | METOCLOPRAMIDE HYDROCHLORIDE | 5 MG/ML | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*10*10*2ML AMPOULE II. 1*10*2ML AMPOULE | 01/07/2008 |
| 2525 | NDA/MAL/HDP/3922 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | DIAZI | DIAZEPAM | 5MG/ML | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| 2526 | NDA/MAL/HDP/3924 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUFED | PARACETAMOL+PSEUDOEPHEDRINE HYDROCHLORIDE+TRIPOLIDINE HYDROCHLORIDE | 300MG+36MG+1.5MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2527 | NDA/MAL/HDP/3928 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MALAREN | SULPHADOXINE + PYRIMETHAMINE | 500MG/25MG | RENE INDUSTRIES LTD ., PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER | 01/07/2004 |
| 2528 | NDA/MAL/HDP/3931 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COARTEM 80/480 | ARTEMETHER + LUMEFANTRINE | 80MG +480MG | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC, YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2014 |
| 2529 | NDA/MAL/HDP/3938 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | ADRENALINE INJECTION | ADRENALINE | 1MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE | 01/07/2013 |
| 2530 | NDA/MAL/HDP/3949 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MAGNOMINT SUSPENSION | COMPOUND MAGNESIUM TRISILICATE | N/A | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2531 | NDA/MAL/HDP/3951 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCLOX | AMPICILLIN + CLOXACILLIN | 125MG/5ML + 125MG/5ML | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| 2532 | NDA/MAL/HDP/3954 | WOCKHARDT LTD | KAMCARE PHARMA LIMITED | POWERCEF 1GM INJECTION | CEFTRIAXONE SODIUM | 1GM | WOCKHARDT LIMITED, B-15/2 MIDC, WALUJ, AURANGABAD 431136, MAHARASHTRA STATE, INDIA| ZEISS PHARMACEUTICALS PVT. LIMITED, PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10ML AMPOULE OF WFI | 01/07/2001 |
| 2533 | NDA/MAL/HDP/3960 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | IBUPAR | PARACETAMOL/IBUPROFEN | 325/400MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2534 | NDA/MAL/HDP/3963 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COARTEM DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | NOVARTIS URUNLERI TURKEY, YENISEHIR MAHALLESI, IHLARA VADISI SOKAK, NO. 2, TR 34912, PENDIK, INSTANBUL, TURKEY. | UNITED STATES | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2009 |
| 2535 | NDA/MAL/HDP/3965 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | OROFER SYRUP | IRON(II) HYDROXIDE POLYMALTOSE COMPLEX | 50MG/5ML | EMCURE PHARMACEUTICALS LTD , LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2004 |
| 2536 | NDA/MAL/HDP/3966 | DAWA LIMITED | SUPER MEDIC LTD | ASCORBIC ACID TABLETS | ASCORBIC ACID | 100 MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2537 | NDA/MAL/HDP/3967 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLOX-125 | CLOXACILLIN | 125MG/5ML | MILAN LABORATORIES (INDIA) PVT LTD, PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2538 | NDA/MAL/HDP/3971 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | VIRIAXONE-SL | CEFTRIAXONE + SULBACTAM | 1G+500MG | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 10 ML AMPOULE WFI | 01/07/2013 |
| 2539 | NDA/MAL/HDP/3983 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | EXTRADOL | PARACETAMOL/CAFFEINE TABLETS | 500MG/65MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER | 01/07/2008 |
| 2540 | NDA/MAL/HDP/3985 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMYCIN SUSPENSION | ERYTHROMYCIN ESTOLATE | 125MG/5ML | AGOG PHARMA, PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| 2541 | NDA/MAL/HDP/3987 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ROHISOL SYRUP | LEVAMISOLE HYDROCHLORIDE | 40MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X500.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 01/07/1997 |
| 2542 | NDA/MAL/HDP/3989 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICELIB 200 | CELECOXIB | 200MG | UNICHEM LABORATORIES LTD-, PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511| UNICHEM LABORATORIES LTD UNIT II ,.,, VILLAGE, BHATAULI KALAN BADDI DIST. SOLAN (H.P) 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| 2543 | NDA/MAL/HDP/3990 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL SYRUP | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2544 | NDA/MAL/HDP/3991 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFULVIN | GRISEOFULVIN TABLETS | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2545 | NDA/MAL/HDP/3993 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | NEM SCAB | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2546 | NDA/MAL/HDP/3996 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTOIN TABLETS | NITROFURANTOIN BP | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2547 | NDA/MAL/HDP/3998 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOKOFF SYRUP | TERBUTALINE SULPHATE +GUAIFENESIN+BROMHEXINE HYDROCHLORIDE +LEVOMENTHOL | 1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2008 |
| 2548 | NDA/MAL/HDP/4000 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIDONE SYRUP | CHLORPHENARIMINE MALEATE/DEXAMETHASONE | 2MG/5ML + 0.5MG/5ML | AMOUN PHARMACEUTICALS COMPANY, 1ST INDUSTRIAL ZONE,EL OBOUR CITY, CAIRO, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X125.0 ML BOTTLE | 01/07/2008 |
| 2549 | NDA/MAL/HDP/4001 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCOLD PLUS SYRUP | PARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE | 125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2008 |
| 2550 | NDA/MAL/HDP/4002 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCID | ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE | 250MG/5ML+ 250MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X170.0 ML BOTTLE | 01/07/2007 |
| 2551 | NDA/MAL/HDP/4004 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ANTHEL | ALBENDAZOLE | 400MG | LINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 01/07/2005 |
| 2552 | NDA/MAL/HDP/4010 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | PYRI | PYRIDOXINE HYDROCHLORIDE | 25MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2553 | NDA/MAL/HDP/4015 | CADILA PHARMACEUTICALS LIMITED | AAFIYA (A) LIMITED | TAMBAC 50 | CEFPODOXIME PROXETIL | 50MG/5ML | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2005 |
| 2554 | NDA/MAL/HDP/4016 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | COMPOUND SODIUM LACATE INTRAVENOUS INFUSION | MULTI-INGREDIENT | MULTI-INGREDIENT | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2007 |
| 2555 | NDA/MAL/HDP/4023 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST LINCTUS | CHLORPHENAMINE MALEATE+DEXTROMETHORPHAN HYDROBROMIDE+MENTHOL | (4MG +10MG +3MG)/10ML | CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2556 | NDA/MAL/HDP/4030 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | XBETA- N | BETAMETHASONE + NEOMYCIN | 0.1%W/V +0.5%W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2011 |
| 2557 | NDA/MAL/HDP/4033 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE | 7MG/5ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| 2558 | NDA/MAL/HDP/4035 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | YASMIN | DROSPIRENONE + ETHINYLESTRADIOL | 3MG+0.3MG | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X21.0 TABLET BLISTER | 01/07/2010 |
| 2559 | NDA/MAL/HDP/4038 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | PREDSONE-5 | PREDNISOLONE | 5MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| 2560 | NDA/MAL/HDP/4042 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | S-CHLOR | CHLORAMPHENICOL | 1 G | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1G VIAL | 2011-07-01 00:00:00 |
| 2561 | NDA/MAL/HDP/4049 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LEVODAY 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER,1.0X6.0X2.0X5.0 TABLET BLISTER | 01/07/2004 |
| 2562 | NDA/MAL/HDP/4055 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | BAYER ASPIRIN CARDIO | ACETYLSALICYLIC ACID | 100MG | BAYER PHARMA AG, D-51368 LEVERKUSEN, GERMANY | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2006 |
| 2563 | NDA/MAL/HDP/4057 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | LAMPY | AMPICILLIN | 250MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 2564 | NDA/MAL/HDP/4060 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | TOBRADEX | TOBRAMYCIN/DEXAMETHASONE | 0.3%W/V+ 0.1%W/V | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| 2565 | NDA/MAL/HDP/4063 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | AVOCOMB TABLET | LAMIVUDINE/ZIDOVUDINE | 150MG/300MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2003 |
| 2566 | NDA/MAL/HDP/4064 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TERAFINE | TERBINAFINE | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 01/07/2010 |
| 2567 | NDA/MAL/HDP/4067 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CATENOL-50 TABLETS | ATENOLOL | 50MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2568 | NDA/MAL/HDP/4075 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | CHERICOF COUGH FORMULAR | CHLORPHENIRAMINE/DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL | 2MG/10MG/5MG | THE MADRAS PHARMACEUTICALS, 137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| 2569 | NDA/MAL/HDP/4078 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | EPIGAB | PREGABALIN | 75MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X14.0 CAPSULE BLISTER | 01/07/2013 |
| 2570 | NDA/MAL/HDP/4079 | PHARMA INTL CO.. | OMAB UGANDA LIMITED | NERVAMINE | MECOBALAMIN | 500MCG | PHARMA INTERNATIONAL CO., AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2009 |
| 2571 | NDA/MAL/HDP/4084 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | WATER FOR INJECTION | STERILIZED WATER FOR INJECTION | N/A | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | PARENTERAL ORDINARY VIALS | I. 1*1ML VIAL | |
| 2572 | NDA/MAL/HDP/4086 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | KELVIN SUSPENSION | PARACETAMOL | 120MG/5ML | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2008 |
| 2573 | NDA/MAL/HDP/4092 | PRISMA PHARMACEUTICALS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLORANORM | SACCHAROMYCES BOULARDII | 250MG | BHARAT BIOTECH INTERNATIONAL LTD, TURKPALLY SHAMEX 500 078 MYDERAHAD INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X2.0X250.0 MG SACHET,1.0X10.0X250.0 MG SACHET | 01/07/2010 |
| 2574 | NDA/MAL/HDP/4095 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | IBUT-200 | IBUPROFEN | 200MG | LEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2575 | NDA/MAL/HDP/4097 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | DERMOVATE | CLOBETASOL PROPIONATE | 0.05%W/W | GLAXOSMITHKLINE HARMIRE , GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X30.0 G TUBE | 01/07/1997 |
| 2576 | NDA/MAL/HDP/4099 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEVO I.V | LEVOFLOXACIN | 500MG/100ML | AMANTA HEALTHCARE LIMITED, PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| 2577 | NDA/MAL/HDP/4100 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NORETHISTERONE | NORETHISTERONE | 5MG | REMEDICA LIMITED , AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2578 | NDA/MAL/HDP/4101 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | AMLOTRUST 5 | AMLODIPINE | 5MG | CENTAUR PHARMACEUTICALS PVT LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 2579 | NDA/MAL/HDP/4103 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | POLIO SABIN - ONE AND THREE [ORAL] | LIVE ATTENUATED POLIOMYELITIS VIRUS VACCINE OF THE SABIN STRAINS TYPE 1 +TYPE 2 | 10?CCID??+10?.?CCID?? | GLAXO SMITHKLINE BIOLOGICALS S.A, RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | ORAL LIQUID ORDINARY DROPS | 1.0X100.0X2.0 ML VIAL (20 DOSES) | 01/07/2016 |
| 2580 | NDA/MAL/HDP/4104 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-PROM | PROMETHAZINE HCL | 25MG | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2581 | NDA/MAL/HDP/4112 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | ERYTHRONE TABLETS 250MG | ERYTHROMYCIN | 250 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*1000TABLET CONTAINER | 01/07/2005 |
| 2582 | NDA/MAL/HDP/4113 | MICRO LABS LTD | LABOREX UGANDA LIMITED | EROSTIN 10 | EBASTINE | 10 MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2583 | NDA/MAL/HDP/4114 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RINALIN SYRUP | CHLORPHENIRAMINE MALEATE | 2MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2584 | NDA/MAL/HDP/4115 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | PREDILONE | PREDNISOLONE | 5.0 MG | REGAL PHARMACEUICALS LTD, PLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2585 | NDA/MAL/HDP/4118 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | OCUREST-AH | PHENYLEPHRINE HYDROCHLORIDE+NAPHAZOLINE HYDROCHLORIDE+CHLORPHRENIRAMINE MALEATE+MENTHOL+CAMPHOR | 0.12%+0.05%+0.1%+0.005%+0.01% | CENTAUR PHARMACEUTICALS PRIVATE LIMITED, PLOT NO.3,TIVIM INDUSTRIAL ESTATE KARASWADA MUPUSA-GOA 403 526 INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2005 |
| 2586 | NDA/MAL/HDP/4126 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICELIB 100 | CELECOXIB | 100MG | UNICHEM LABORATORIES LTD, UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| 2587 | NDA/MAL/HDP/4127 | SANOFI 410 THALES | LABOREX UGANDA LIMITED | EPILIM | SODIUM VALPROATE | 200MG/5ML | UNITHER LIQUID MANUFACTURING INDUSTRIE , COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770 | FRANCE | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X300.0 ML BOTTLE | 01/07/1998 |
| 2588 | NDA/MAL/HDP/4128 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAREN SYRUP | VITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B3 | 1500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5ML | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI- KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| 2589 | NDA/MAL/HDP/4132 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYCEL 200 | CELECOXIB | 200MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2001 |
| 2590 | NDA/MAL/HDP/4138 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYCLOX CAPSULES | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER | 01/07/1997 |
| 2591 | NDA/MAL/HDP/4141 | SANOFI 410 THALES | LABOREX UGANDA LIMITED | EPILIM 200 | SODIUM VALPROATE | 200MG | FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS), RIELL, SPAIN | SPAIN | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2592 | NDA/MAL/HDP/4143 | MODI NUNDIPHARMA PVT LTD | SURGIPHARM (U) LIMITED | TAM CONTIN 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | MODI MUNDIPHARMA PVT. LTD, MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM €“ 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP, 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 2593 | NDA/MAL/HDP/4146 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMPICLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 2594 | NDA/MAL/HDP/4147 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | NIFEDI-DENK 20 RETARD | NIFEDIPINE | 20MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2000 |
| 2595 | NDA/MAL/HDP/4148 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | AMITRIPTYLINE TABLETS | AMITRIPTYLINE | 25MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 2596 | NDA/MAL/HDP/4150 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ANGIOPRIL-25 | CAPTOPRIL | 25MG | TORRENT PHARMACEUTICALS LTD, INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2597 | NDA/MAL/HDP/4165 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZEFONE INJECTION | CEFTRIAXONE SODIUM | 1G | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | ZEISS PHARMACEUTICALS PVT LTD-72 EXPORT PROMOTION INDUSTRIAL PARK ,PHASE-1,JHARMAJRI, BADDI DIST:SOLAN H.P INDIA | ZYDUS HEALTHCARE LIMITED-SURVEY NO. 49/3, 51/1, 51/2 RINGANWADA VILLAGE, DAMAN (U.T) | GMH ORGANICS UNIT II - PLOT NO. 01, VILLAGE KUNJHAL, THARMAJRI, BADDI DISTRICT. SOLAN (H.P) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2001 |
| 2598 | NDA/MAL/HDP/4169 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FLUCOZYD-200 | FLUCONAZOLE | 200MG | ZYDUS LIFESCIENCES LTD SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER | 01/07/2008 |
| 2599 | NDA/MAL/HDP/4171 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | TOREX | MULTIINGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2600 | NDA/MAL/HDP/4172 | RENE INDUSTRIES | RENE INDUSTRIES LIMITED | KOF OFF EXPECTORANT | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES, PLOT 680 KAMULI KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X110.0 ML BOTTLE | 01/07/2005 |
| 2601 | NDA/MAL/HDP/4173 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NASONEX | MOMETASONE FUROATE MONOHYDRATE | 0.05 %W/V | 1. MSD PTY LIMITED NO. 117, 16TH ROAD HALFWAY HOUSE, MIDRAND 1685-SOUTH AFRICA SOUTH AFRICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SOUTH AFRICA | NASAL SYSTEMIC UNIT DOSE AEROSOLS | I. 1*1*120METERED DOSE CANNISTER | 2009-07-01 00:00:00 |
| 2602 | NDA/MAL/HDP/4174 | ROYAL PHARMA 2011 LIMITED | SINO AFRICA MEDICINES & HEALTH LTD | DIAZEPAM INJECTION | DIAZEPAM | 5MG | SCOTT-EDIL PHARMACIA LTD - 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2ML AMPOULE | 01/07/2007 |
| 2603 | NDA/MAL/HDP/4180 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | OSMOWIN | LACTULOSE | 10G/15ML | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2015 |
| 2604 | NDA/MAL/HDP/4182 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST- FORTE | MULTI INGREDIENT | MULTI INGREDIENT | CENTAUR PHARMACEUTICALS LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP | 01/07/2007 |
| 2605 | NDA/MAL/HDP/4187 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NORIGYNON | ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE | 5 MG+50 MG / ML | BAYER PHARMA A.G, MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/1997 |
| 2606 | NDA/MAL/HDP/4188 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPRAZ | PRAZIQUANTEL | 600MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 01/07/2013 |
| 2607 | NDA/MAL/HDP/4241 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMPICILLIN SODIUM FOR INJECTION BP | AMPICILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL | 01/07/2011 |
| 2608 | NDA/MAL/HDP/4275 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | AVASTIN 100MG/4ML | BEVACIZUMAB | 100 MG/4ML | 1. F. HOFFMANN-LA ROCHE LTD KAISERAUGST F. HOFFMANN-LA ROCHE LTD WURMISWEG CH-4303 KAISERAUGST SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. ROCHE DIAGNOSTICS, GMBH ROCHE DIAGNOSTICS GMBH, SANDHOFER STRASSE 116, 68305 MANNHEIM - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWITZERLAND| GERMANY | PARENTERAL ORDINARY VIALS | I. 1*4ML VIAL | 01/07/2016 |
| 2609 | NDA/MAL/HDP/4276 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 60MG | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 5 ML NACL + 1 ML SODIUM BICARBONATE | 01/07/2013 |
| 2610 | NDA/MAL/HDP/4280 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR SULFATE+LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 600 MG + 300 MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE|MYLAN LABORATORIES LTD ,, PLOT NO. 11, 12, & 13 INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III PITHAMPUR 454775, DIST DHAR €“ MADHYA PRADESH| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| 2611 | NDA/MAL/HDP/4284 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | AVASTIN 400MG/4ML | BEVACIZUMAB | 400MG/4ML | 1. ROCHE DIAGNOSTICS, GMBH ROCHE DIAGNOSTICS GMBH, SANDHOFER STRASSE 116, 68305 MANNHEIM - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. F. HOFFMANN-LA ROCHE LTD KAISERAUGST F. HOFFMANN-LA ROCHE LTD WURMISWEG CH-4303 KAISERAUGST SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWITZERLAND| GERMANY | PARENTERAL ORDINARY VIALS | I. 1*16ML VIAL | 01/07/2016 |
| 2612 | NDA/MAL/HDP/4286 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEGRA-50 | SILDENAFIL CITRATE | 50 MG | THE MADRAS PHARMACEUTICALS, 137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2016 |
| 2613 | NDA/MAL/HDP/4287 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE 1000 | CEFTRIAXONE | 1000MG | SANCE LABORATORIES PVT. LTD., VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1000.0MG VIAL, 1.0X50.0X1000.0MG VIAL | 01/07/2010 |
| 2614 | NDA/MAL/HDP/4291 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | VITAMIN B COMPLEX INJECTION | VITAMIN B COMPLEX | 10MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| 2615 | NDA/MAL/HDP/4303 | PFIZER LABORATORIES (PTY) | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SAYANA PRESS | MEDROXYPROGESTERONE ACETATE | 104MG/0.65ML | PFIZER MANUFACTURING , NV/NA, RIJKSWEG 12 2870, PUURS | BELGIUM | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X200.0X0.65 ML PRE- FILLED SYRINGE | 01/07/2010 |
| 2616 | NDA/MAL/HDP/4307 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | MIKACIN | AMIKACIN SULPHATE | 500MG/2ML | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0X8.0X2.0 ML VIAL,1.0X1.0X2.0 ML VIAL | 01/07/2009 |
| 2617 | NDA/MAL/HDP/4309 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | HETERO LABS LTD (UNIT-V), SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA| HETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2010 |
| 2618 | NDA/MAL/HDP/4315 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | DESLORA-DENK 5 | DESLORATIDINE | 5MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 2619 | NDA/MAL/HDP/4317 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | COLOSAR-DENK 50/12.5 | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| 2620 | NDA/MAL/HDP/4318 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | AKUGABALIN | PREGABALIN | 75 MG | AKUMS DRUGS & PHARMACEUTICALS LTD, 19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 07/01/2016 |
| 2621 | NDA/MAL/HDP/4320 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | HYOSCINE BUTYL BROMIDE | HYOSCINE BUTYL BROMIDE | 10MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1000TABLET CONTAINER II. 1*10*10TABLET BLISTER | 01/07/2005 |
| 2622 | NDA/MAL/HDP/4324 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PRASUSAFE 5 | PRASUGREL | 5MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2623 | NDA/MAL/HDP/4329 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CPM | CHLORPHENIRAMINE MALEATE | 2MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2010 |
| 2624 | NDA/MAL/HDP/4330 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCLOXACILLIN CAPSULES | FLUCLOXACILLIN | 250MG | SPARSH BIO-TECH PVT. LTD.-, PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR €“ 361006 GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP | 01/07/2016 |
| 2625 | NDA/MAL/HDP/4331 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC | ACECLOFENAC | 100MG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2626 | NDA/MAL/HDP/4333 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | CARVIBERG | CARVEDILOL USP | 6.25MG | THE MADRAS PHARMACEUTICALS, 137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 2627 | NDA/MAL/HDP/4334 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | LOSAR-DENK 50 | LOSARTAN | 50MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| 2628 | NDA/MAL/HDP/4335 | DAWA LIMITED | SUPER MEDIC LTD | CURAMOL SUSPENSION | PARACETAMOL | 120MG/5ML | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2009 |
| 2629 | NDA/MAL/HDP/4339 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | SERETIDE 125 EVOHALER | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG/125MCG | GLAXO WELLCOME PRODUCTION, ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2007 |
| 2630 | NDA/MAL/HDP/4340 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | VITAMIN B COMPLEX | VITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM | 10MG + 1.37MG + 15MG + 1MG + 0.5MG | WUHAN FUXING BIOLOGICAL PHARMACEUTICAL COMPANY LIMITED-NO. 9 FUXING ROAD HANCHUAN ECONOMIC DEVELOPMENT DISTRICT, HUBEI PROVINCE - CHINA| ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA | TIANJIN KINGYORK GROUP HUBEI TIANYAO PHARMACEUTICAL CO. LTD, NO. 99, HANJIANG BEI ROAD, XIANGYANG CITY, HUBEI PROVINCE | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| 2631 | NDA/MAL/HDP/4348 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDICLOAMP SYRUP | CLOXACILLIN+AMPICILLIN | 250MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2632 | NDA/MAL/HDP/4352 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 2633 | NDA/MAL/HDP/4356 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | FRESHEN | BISACODYL | 5 MG | ADCOCK INGRAM LIMITED , 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0 TABLET BLISTER | 01/07/2016 |
| 2634 | NDA/MAL/HDP/4365 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ACTINAC PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | AJANTA PHARMA LIMITED, PLOT NO. M-55-56-57, ISEZ, PHASE II, PITHAMPUR-454775, DISTRICT DHAR, MADHYA PRADESH STATE|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2635 | NDA/MAL/HDP/4366 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXISPA | CLOXACILLIN | 250MG | SPARSH BIO-TECH LTD, PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| 2636 | NDA/MAL/HDP/4369 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUCAP | CHLORPHENAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE+PARACETAMOL | 1.25MG+10MG+120MG | TIL HEALTH CARE, PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2637 | NDA/MAL/HDP/4375 | PFIZER LABORATORIES PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 200MG/5ML | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 01/07/1997 |
| 2638 | NDA/MAL/HDP/4379 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | SINURHON | MULTI-INGREDIENT | 5MG/ 2MG/ 500MG / 30MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/2010 |
| 2639 | NDA/MAL/HDP/4383 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEMYCIN - 150 | CLINDAMYCIN HYDROCHLORIDE BP | 150MG | THE MADRAS PHARMACEUTICALS, 137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 2640 | NDA/MAL/HDP/4388 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | TAZOBAK | PIPERACILLIN SODIUM + TAZOBACTAM SODIUM | 4.0G + 0.5G | SWISS PARENTERALS LIMITED UNIT II, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA| | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X4.5 G VIAL | 01/07/2016 |
| 2641 | NDA/MAL/HDP/4392 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CAPLOR | CLOPIDOGREL | 75MG | 1. IND SWIFT LIMITED OFF. NH-21, VILLAGE JAWAHARPUR, TEHSIL DERABASSI, DISTRICT MOHALI (SAS NAGAR), PUNJAB, 140507 - INDI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2011 |
| 2642 | NDA/MAL/HDP/4394 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | NS | SODIUM CHLORIDE | 0.9% W/V | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2010 |
| 2643 | NDA/MAL/HDP/4396 | MYLAN LABORATORIES LIMITED (OTL) | KIMSY MEDS LTD | ABACAVIR SULPHATE | ABACAVIR SULFATE | 300MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE|MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;| | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2007 |
| 2644 | NDA/MAL/HDP/4398 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9 % W/V | ACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/1997 |
| 2645 | NDA/MAL/HDP/4399 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GEFIL | COMPOUND MAGNESIUM TRISILICATE | ALUMINIUM HYDROXIDE & MAGNESIUM TRISILICATE 132 & | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| 2646 | NDA/MAL/HDP/4400 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ORAL REHYDRATION SALT (DTS) | ORAL REHYDRATION SALT | N/A | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET | 01/07/1997 |
| 2647 | NDA/MAL/HDP/4402 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CLOTRILIN | CLOTRIMAZOLE | 100MG | LINCOLN PHARMACEUTICALS LTD, 10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA | INDIA | VAGINAL TABLETS | 1.0X6.0 TABLET STRIP | 01/07/2014 |
| 2648 | NDA/MAL/HDP/4404 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF | RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE | 75I.U/ VIAL | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2016 |
| 2649 | NDA/MAL/HDP/4406 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | SATISFIL -100 | SILDENAFIL | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2011 |
| 2650 | NDA/MAL/HDP/4408 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNISTEN CREAM | CLOTRIMAZOLE | 1%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1997 |
| 2651 | NDA/MAL/HDP/4410 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-KAST 4 | MONTELUKAST | 4 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2016 |
| 2652 | NDA/MAL/HDP/4412 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-KAST 5 | MONTELUKAST SODIUM | 5 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2016 |
| 2653 | NDA/MAL/HDP/4415 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CATAFLAM 5OMG TABLETS | DICLOFENAC POTASSIUM | 50MG | NOVARTIS PHARMA SPA,, TORRE ANNUNZIATA ITALY| NOVARTIS-, URUNLERI INSTABUL TURKEY | ITALY | ORAL SOLID ORDINARY COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2654 | NDA/MAL/HDP/4425 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN FC | QUININE | 300MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2655 | NDA/MAL/HDP/4468 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TOPRAZ 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2016 |
| 2656 | NDA/MAL/HDP/4519 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | S-AMLOSAFE 5 | AMLODIPINE BESILATE | 5MG | ARISTO PHARMACEUTICALS PVT LTD, PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2657 | NDA/MAL/HDP/4522 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | S-AMLOSAFE 2.5 | AMLODIPINE BESILATE | 2.5 MG | ARISTO PHARMACEUTICALS PVT LTD, PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| 2658 | NDA/MAL/HDP/4523 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | BIGOMET SR 500 | METFORMIN HYDROCHLORIDE | 500MG | ARISTO PHARMACEUTICALS PVT. LIMITED, PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2659 | NDA/MAL/HDP/4526 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-500 | AZITHROMYCIN | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X20.0X3.0 TABLET BLISTER | 01/07/2011 |
| 2660 | NDA/MAL/HDP/4528 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PIOSAFE MF 15/500 | PIOGLITAZONE + METFORMIN | 15 MG + 500 MG | ARISTO PHARMACEUTICALS PVT LIMITED, PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2661 | NDA/MAL/HDP/4549 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL 500MG | AMOXYCILLIN TRIHYDRATE | 500MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 2662 | NDA/MAL/HDP/4553 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARTESUN | ARTESUNATE | 30MG | GUILIN PHARMACEUTICAL CO. LTD., NO. 43 QILIDIAN ROAD, GUILIN 541004 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE | 01/07/2011 |
| 2663 | NDA/MAL/HDP/4556 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 375 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 250MG + 125MG | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP | 01/07/2005 |
| 2664 | NDA/MAL/HDP/4559 | MSN LABORATORIES PRIVATE LIMITED, | AIVEEN (U) LIMITED | PREGASAFE 75 | PREGABALIN | 75MG | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 2665 | NDA/MAL/HDP/4561 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | LORVAS SR | INDAPAMIDE | 1.5MG | TORRENT PHARMACEUTICALS LTD. , AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT| TORRENT PHARMACEUTICALS LTD , VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI €“ 173205, DIST: SOLAN, HIMACHAL PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2666 | NDA/MAL/HDP/4568 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 625 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500MG + 125MG | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP | 01/07/2005 |
| 2667 | NDA/MAL/HDP/4575 | FDC LTD | AIVEEN (U) LIMITED | PYRICORT EYE/EAR DROPS | DEXAMETHASONE+GENTAMICIN | 0.1%+0.3%W/V | FDC LIMITED , B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ €“ AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2013 |
| 2668 | NDA/MAL/HDP/4581 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 1000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875MG + 125MG | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP | 01/07/2005 |
| 2669 | NDA/MAL/HDP/4587 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIRATRO | ATROPINE | 1MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTD, N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X1.0 ML AMPOULE | 01/07/2008 |
| 2670 | NDA/MAL/HDP/4588 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCAN 200 | FLUCONAZOLE | 200MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0 TABLET BLISTER | 01/07/2011 |
| 2671 | NDA/MAL/HDP/4591 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | SILVER KANT | SILVER SULPHADIAZINE USP | 1%W/W | S.KANT HEALTHCARE LTD, 1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| 2672 | NDA/MAL/HDP/4592 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PENTALINK 40 | PANTOPRAZOLE | 40MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2673 | NDA/MAL/HDP/4593 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | ERYTHROKANT-250 | ERYTHROMYCIN STEARATE | 250MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2674 | NDA/MAL/HDP/4594 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TINIBA-500 TABLETS | TINIDAZOLE | 500MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0X4.0 TABLET BLISTER,1.0X25.0X4.0 TABLET BLISTER,1.0X5.0X5.0X4.0 TABLET BLISTER | 01/07/1997 |
| 2675 | NDA/MAL/HDP/4595 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VAST-20 | ATORVASTATIN | 20MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2676 | NDA/MAL/HDP/4598 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-250 | AZITHROMYCIN | 250MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2011 |
| 2677 | NDA/MAL/HDP/4602 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | HUMALOG MIX 50 | INSULIN LISPRO | 100 .IU(50 I.U+50 I.U) | LILLY FRANCE SA, FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2000 |
| 2678 | NDA/MAL/HDP/4603 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | HALOXEN - 5 | HALOPERIDOL | 5MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2679 | NDA/MAL/HDP/4605 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODRYL SYRUP | BROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL | 4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2009 |
| 2680 | NDA/MAL/HDP/4606 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 10 | ROSUVASTATIN | 10MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2681 | NDA/MAL/HDP/4614 | GALENTIC PHARMA LTD | VITACARE LIMITED | COMPOUND BENZOIC ACID OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6 %W/W + 3 %W/W | GALENTIC PHARMA( INDIA ) PVT LTD, R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE,1.0X500.0 G TUBE | 01/07/2006 |
| 2682 | NDA/MAL/HDP/4617 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN | 10MG | IPR PHARMACEUTICALS INC,, LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| 2683 | NDA/MAL/HDP/4619 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CHLORAMPHENICOL SODIUM SUCCINATE | CHLORAMPHENICOL SODIUM SUCCINATE | 1G | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0X1.0 G VIAL | 01/07/2009 |
| 2684 | NDA/MAL/HDP/4620 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | MALANIL PAEDIATRIC TABLET | ATOVAQUONE + PROGUANIL | 62.5 MG + 25.0 MG | GLAXO WELLCOME S.A ARANDA, ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 01/07/2007 |
| 2685 | NDA/MAL/HDP/4621 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CARVIL 6.25 | CARVEDILOL | 6.25MG | ZYDUS LIFESCIENCES-KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2686 | NDA/MAL/HDP/4622 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | CLOXAREN | CLOXACILLIN | 250MG | RENE INDUSTRIES, PLOT 680 KAMULI KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 2687 | NDA/MAL/HDP/4623 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | LOPERAREN | LOPERAMIDE HYDROCHLORIDE | 2MG | RENE INDUSTRIAL LTD, RENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| 2688 | NDA/MAL/HDP/4634 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | LOSAR-DENK 100 | LOSARTAN | 100MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| 2689 | NDA/MAL/HDP/4637 | ABACUS PHARMA (A) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PARACETAMOL | PARACETAMOL | 500 MG | 1. HEBEI JIHENG(GROUP) PHARMACEUTICAL CO., LTD NO. 368 JIANSHE STREET, HENGSHUI CITY, HEBEI PROVINCE, 053000 CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 01/07/2016 |
| 2690 | NDA/MAL/HDP/4645 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN CALCIUM | 20MG | IPR PHARMACEUTICALS INC,, LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| 2691 | NDA/MAL/HDP/4650 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | DUOTRAV | TRAVOPROST + TIMOLOL MALEATE | 40MG/ML + 5MG/ML | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML VIAL | 01/07/2010 |
| 2692 | NDA/MAL/HDP/4652 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII TETANUS TOXOID VACCINE | TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE | ?5 LF (?40 IU) ON ?1.25 MG OF ALUMINIUM PHOSPHATE | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE (1 DOSE AMPOULE),1.0X10.0 ML VIAL (20 DOSE VIAL) | 01/07/1997 |
| 2693 | NDA/MAL/HDP/4657 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | VOLAR 300MG | GABAPENTIN | 300MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 2694 | NDA/MAL/HDP/4658 | PT SANBE FARMA | ONCOPHARM (U) LTD | MEROSAN 0.5 | MEROPENEM | 0.5G | PT SANBE FARMA, JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 G VIAL | 01/07/2014 |
| 2695 | NDA/MAL/HDP/4660 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | RISDONE 2MG | RISPERIDONE | 2MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2696 | NDA/MAL/HDP/4666 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ANTIPLEX | CLOPIDOGREL BISULFATE | 30MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2697 | NDA/MAL/HDP/4669 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC 100MG SUPPOSITORIES | DICLOFENAC SODIUM. | 100MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | TOPICAL EXTERNAL ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP | 01/07/2013 |
| 2698 | NDA/MAL/HDP/4680 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANCEPH DS | CEPHALEXIN | 125MG/5ML | SANCE LABORATORIES PVT. LTD., VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2699 | NDA/MAL/HDP/4694 | MERCK SHARP & DOHME INTAPHARMA | SURGIPHARM (U) LIMITED | ROTATEQ | ROTAVIRUS LIVE REASSORTANT VIRUS G1+G2+G3+G4 &P1 | 2.2M IU+2.8M IU+2.2M IU+2.0M IU | MERK & CO. INC, SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA | UNITED STATES | ORAL LIQUID ORDINARY EMULSIONS | 1.0X10.0 ML BOTTLE | 01/07/2011 |
| 2700 | NDA/MAL/HDP/4697 | PT SAMBE FARMA | ONCOPHARM (U) LTD | SANBE CLANEKSI | AMOXICILLIN + CLAVULANIC ACID | 1000 MG + 200 MG | PT SANBE FARMA, JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA | PARENTERAL ORDINARY VIALS | 1.0X6.0 VIAL CARTON | 01/07/2011 |
| 2701 | NDA/MAL/HDP/4700 | MEDIPHARM INDUSTRIES (E.A.) LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIZOLE | METRONIDAZOLE | 125 MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD - PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*100ML BOTTLE | 01/07/2006 |
| 2702 | NDA/MAL/HDP/4701 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | MEBRONE 100 TABLETS | MEBENDAZOLE | 100 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | I. 1*10*10TABLET BLISTER II. 1*6TABLET BLISTER III. 1*1000TABLET CONTAINER | 01/07/1997 |
| 2703 | NDA/MAL/HDP/4702 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABTOL 20%W/V | MANNITOL | 200MG/ML | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2704 | NDA/MAL/HDP/4703 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABGYL | METRONIDAZOLE | 500MG | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2705 | NDA/MAL/HDP/4704 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC 12.5 | DICLOFENAC SODIUM | 12.5MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2012 |
| 2706 | NDA/MAL/HDP/4705 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC-50 | DICLOFENAC | 50MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2012 |
| 2707 | NDA/MAL/HDP/4707 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL INJECTION | DICLOFENAC SODIUM | 25MG/ML | WIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR PRADESH - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE | 01/07/1998 |
| 2708 | NDA/MAL/HDP/4710 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | MEDOPRESS TABLETS 250MG | METHYLDOPA | 250MG | COSMOS LIMITED.., RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 2709 | NDA/MAL/HDP/4712 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEFINAL-500 | MEFENAMIC ACID | 500MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2710 | NDA/MAL/HDP/4715 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | MEFTAL FORTE | MEFENAMIC ACID + PARACETAMOL | 500MG + 450MG | BLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2711 | NDA/MAL/HDP/4717 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | MEFTAL-SPAS | MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE | 250MG + 10MG | BLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X3.0X10.0 TABLET BLISTER,1.0X10.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2712 | NDA/MAL/HDP/4718 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | ACNOTIN 20 | ISOTRETINOIN | 20MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED, 384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 2713 | NDA/MAL/HDP/4719 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | ACNOTIN 10 | ISOTRETINOIN | 10MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED, 384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 2714 | NDA/MAL/HDP/4721 | PT SAMBE FARMA | SHREEJI PHARMACEUTICALS LIMITED | MEGABAL | MECOBALAMIN | 5000MCG | PT SANBE FARMA,UNIT 1, JI INDUSTRI NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVA,INDONESIA | INDONESIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2011 |
| 2715 | NDA/MAL/HDP/4723 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | MEGYL SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2716 | NDA/MAL/HDP/4725 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEGYL TABLET | METRONIDAZOLE | 200MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2717 | NDA/MAL/HDP/4726 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | ADB MIN MULTIPOWER | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X300.0 ML BOTTLE | 01/07/1997 |
| 2718 | NDA/MAL/HDP/4738 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | CILOXAN | CIPROFLOXACIN | 0.3%W/V | ALCON PHARMACEUTICALS LIMITED, ALCON COUVREUR NV B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| 2719 | NDA/MAL/HDP/4739 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | MERO | MEROPENEM | 1G | SWISS PARENTERALS LIMITED (UNIT-2) PLOT NO. 402, 412-414 KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD,382220, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2011 |
| 2720 | NDA/MAL/HDP/4747 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZITHRORIV | AZITHROMYCIN | 200 MG/5ML | 1. RIVA PHARMA S.A.E. ST.6, PUBLIC FREE ZONE, NASR CITY - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. RIVA PHARMA S.A.E. ST.6, PUBLIC FREE ZONE, NASR CITY - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*23ML BOTTLE | 2011-07-01 00:00:00 |
| 2721 | NDA/MAL/HDP/4748 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ACICONE-S CHEWABLE TABLET | MAGALDRATE+SIMETHICONE | 720MG+25MG | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X5.0X4.0 TABLET BLISTER | 01/07/2006 |
| 2722 | NDA/MAL/HDP/4749 | PT SANBE FARMA | ONCOPHARM (U) LTD | MEROSAN | MEROPENEM | 1G | PT SANBE FARMA, JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2012 |
| 2723 | NDA/MAL/HDP/4751 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FEROL | FERROUS SULPHATE | 200MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2724 | NDA/MAL/HDP/4757 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | METFORMIN-DENK 500 | METFORMIN | 500MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2725 | NDA/MAL/HDP/4758 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | METFORMIN DENK 1000 | METFORMIN | 1000MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 01/07/2011 |
| 2726 | NDA/MAL/HDP/4759 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CIPRODAR | CIPROFLOXACIN | 500MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2727 | NDA/MAL/HDP/4766 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBEN SUSPENSION | MEBENDAZOLE | 100MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2001 |
| 2728 | NDA/MAL/HDP/4769 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBEX | MEBENDAZOLE | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2729 | NDA/MAL/HDP/4775 | SKAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | CIPROKANT-500 | CIPROFLOXACIN | 500MG | S KANT HEALTH CARE LTD, PLOT 1802 €“ 1805 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2730 | NDA/MAL/HDP/4781 | CYANO PHARMA(P) | RENE PHARMACY LTD | CYANO IRON TABLETS | FERROUS SULPHATE | 200MG | CYANO PHARMA(P), 115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2731 | NDA/MAL/HDP/4784 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D50 | GLUCOSE INTRAVENOUS INFUSION | 50%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2732 | NDA/MAL/HDP/4789 | PFIZER LABORATORIES PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DALACIN C | CLINDAMYCIN HYDROCHLORIDE | 300MG | FAREVA AMBOISE - , ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP | 01/07/1997 |
| 2733 | NDA/MAL/HDP/4790 | PFIZER LABORATORIES (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DALACIN C | CLINDAMYCIN HYDROCHLORIDE | 150MG | FAREVA AMBOISE - , ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | BELGIUM | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON | 01/07/1997 |
| 2734 | NDA/MAL/HDP/4792 | PFIZER LABORATORIES (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DALACIN C | CLINDAMYCIN PHOSPHATE | 150MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV, RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X4.0 ML VIAL,1.0X2.0 ML VIAL | 01/07/1997 |
| 2735 | NDA/MAL/HDP/4794 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | DALADOL | DICLOFENAC SODIUM + PARACETAMOL | 50MG+500MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| 2736 | NDA/MAL/HDP/4795 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DAROXIME | CEFUROXIME | 500MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BOTTLE | 01/07/2010 |
| 2737 | NDA/MAL/HDP/4796 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DARROWS SOLUTION (HALF STRENGTH) | POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE | 0.13%+0.20%+0.30% | ABACUS PARENTERAL DRUGS LTD, PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2011 |
| 2738 | NDA/MAL/HDP/4800 | DAWA LIMITED | SUPER MEDIC LTD | DAWAVITE SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2009 |
| 2739 | NDA/MAL/HDP/4801 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | DAZEL KIT | FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE | 150MG + 1G + 1G | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2009 |
| 2740 | NDA/MAL/HDP/4804 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN + CLAVULANIC | 200MG + 28MG /5ML | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2012 |
| 2741 | NDA/MAL/HDP/4806 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFER | FERROUS SULPHATE+FOLIC ACID | 200MG + 0.25MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2742 | NDA/MAL/HDP/4807 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFORMIN | METFORMIN | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2743 | NDA/MAL/HDP/4809 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCORT SKIN CREAM | HYDROCORTISONE | 0.1%W/W | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| 2744 | NDA/MAL/HDP/4811 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOGYL | METRONIDAZOLE | 200MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2745 | NDA/MAL/HDP/4812 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMETROL SUSPENSION | METRONIDAZOLE BENZOATE | 125MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 2746 | NDA/MAL/HDP/4815 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | FERROLIC-LF | FERROUS SULPHATE +FOLIC ACID | 200MG+0.4MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2747 | NDA/MAL/HDP/4817 | CYANO PHARMA(P) | RENE PHARMACY LTD | METOCLOPRAMIDE TABLETS | METOCLOPRAMIDE | 10MG | CYANO PHARMA(P), 115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2001 |
| 2748 | NDA/MAL/HDP/4818 | LABORATORY AND ALLIED LTD | ROYAL PHARMA 2011 LIMITED | FERROUS SULPHATE | FERROUS SULPHATE | 200MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2749 | NDA/MAL/HDP/4819 | ORANE | AIVEEN (U) LIMITED | ELECTRAL 21.8G | ORAL REHYDRATION SALT | 21.8G | FDC LIMITED , B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ €“ AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X21.8 G SACHET | 01/07/2000 |
| 2750 | NDA/MAL/HDP/4821 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | METPURE-XL 50 | METOPROLOL | 50MG | EMCURE PHARMACEUTICALS LIMITED , LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2751 | NDA/MAL/HDP/4823 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | METRIS INFUSION | METRONIDAZOLE | 5MG/ML | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2752 | NDA/MAL/HDP/4826 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL DENTA GEL | METRONIDAZOLE + CHLORHEXIDINE | 1%W/W + 0.25%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-, 216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2004 |
| 2753 | NDA/MAL/HDP/4828 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL GEL | METRONIDAZOLE | 1%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD), -304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | TOPICAL EXTERNAL EMULSION GELS | 1.0X30.0 G TUBE (ALUMINIUM TUBE),1.0X30.0 G TUBE (LAMINATED TUBE) | 01/07/2001 |
| 2754 | NDA/MAL/HDP/4830 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL INJECTION | METRONIDAZOLE | 5MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD), -304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH| UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD, PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2755 | NDA/MAL/HDP/4832 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL SUSPENSION | METRONIDAZOLE | 200MG/5ML | UNIQUE PHARMACEUTICAL LABORATORIES, PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI €” 394 116, GUJARAT, INDIA. | J.B. CHEMICALS AND PHARMACEUTICALS LTD ., 128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2756 | NDA/MAL/HDP/4834 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | FINAGEN | FINASTERIDE | 5MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*10TABLET BLISTER | 01/07/2004 |
| 2757 | NDA/MAL/HDP/4836 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | METRON | METRONIDAZOLE | 200MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2009 |
| 2758 | NDA/MAL/HDP/4838 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | METRONIDAZOLE | METRONIDAZOLE BENZOATE | 125MG/5ML | MEDICAMEN BIOTECH LTD, SP-1192, A &B, PHASE €“IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 2759 | NDA/MAL/HDP/4839 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | ANOMEX | ZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN | 5%W/W+3%W/W+0.25%W/W+0.5%W/W | BLISS GVS PHARMA LTD, PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| 2760 | NDA/MAL/HDP/4854 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN FC | METRONIDAZOLE | 200MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2014 |
| 2761 | NDA/MAL/HDP/4855 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL EXPECTORANT | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN + MENTHOL | (2MG + 4MG + 100MG + 1MG)/10ML | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| 2762 | NDA/MAL/HDP/4856 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN | METRONIDAZOLE | 200MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2001 |
| 2763 | NDA/MAL/HDP/4858 | RENE INDUSTRIES | RENE INDUSTRIES LIMITED | METROREN SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 2764 | NDA/MAL/HDP/4863 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | MICONAZ ORAL GEL | MICONAZOLE | 2%W/W | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2003 |
| 2765 | NDA/MAL/HDP/4865 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | MICONAZ CREAM | MICONAZOLE NITRATE | 2%W/W | MEDICAL UNION PHARMA .CO, ABU-SULTAN ISMAILIA EGYPT | EGYPT | VAGINAL CREAMS | 1.0X20.0 G TUBE | 01/07/2003 |
| 2766 | NDA/MAL/HDP/4867 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | MICONA ORAL GEL | MICONAZOLE | 20MG | CENTAUR PHARMACEUTICALS PVT LTD -, PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X40.0 G TUBE,1.0X20.0 G TUBE | 01/07/2003 |
| 2767 | NDA/MAL/HDP/4868 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | FLUCANIR | FLUCONAZOLE | 2MG/ML | ACULIFE HEALTHCARE PVT LTD, VILLAGE SACHANA, TALUKA, VIRAMGAM, DIST. AHMEDABAD 382150, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2768 | NDA/MAL/HDP/4871 | STEDMAN PHARMACEUTICALS PRIVATE LIMITED | VEERAM HEALTHCARE (U) LIMITED | MICOBACT POWDER | MICONAZOLE + CHLOROHEXIDINE | 2%W/W + 0.05%W/W | 1. STEDMAN PHARMACEUTICALS PRIVATE LIMITED C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR - 603110, KANCHEEPURAM DISTRICT TAMILNADU INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL POWDERS | I. 1*100G CONTAINER II. 1*30G CONTAINER III. 1*50G CONTAINER IV. 1*75G CONTAINER | |
| 2769 | NDA/MAL/HDP/4874 | SANOFI WINTHROP INDUSTRIE | LABOREX UGANDA LIMITED | ENOXAPARIN SODIUM IMPACT 6000IU | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE, 180 RUE JEAN JAURE'S BP 94702, MAISONS-ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.6 ML PRE- FILLED SYRINGE, 1.0X10.0X0.6ML PREFILLED SYRINGE | 01/07/2009 |
| 2770 | NDA/MAL/HDP/4875 | MARIE STOPES UGANDA LIMITED | MARIE STOPES UGANDA LIMITED | MISOCLEAR | MISOPROSTOL | 200MCG | ACME FORMULATION PVT LTD,, ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER, 1.0X4.0 TABLET BLISTER, 3.0X4.0 TABLET BLISTER | 01/07/2011 |
| 2771 | NDA/MAL/HDP/4876 | SANOFI WINTHROP INDUSTRIE | LABOREX UGANDA LIMITED | ENOXAPARIN SODIUM IMPACT 8000IU | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE, 180 RUE JEAN JAURE'S BP 94702, MAISONS-ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.8 ML PRE- FILLED SYRINGE, 1.0X10.0X0.8ML PREFILLED SYRINGE | 01/07/2009 |
| 2772 | NDA/MAL/HDP/4877 | SANOFI WINTHROP INDUSTRIE | LABOREX UGANDA LIMITED | ENOXAPARIN SODIUM IMPACT 4000IU | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE, 180 RUE JEAN JAURE'S BP 94702, MAISONS-ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.4 ML PRE- FILLED SYRINGE, 1.0X10.0X0.4ML PREFILLED SYRINGE | 01/07/2009 |
| 2773 | NDA/MAL/HDP/4880 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | MISOPROST 200 | MISOPROSTOL | 200MCG | CIPLA LTD ., CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER | 01/07/2014 |
| 2774 | NDA/MAL/HDP/4891 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | ASPEC TABLET | ASPIRIN+PARACETAMOL+CAFFEINE ANHYDROUS | 150MG+250MG+300MG | REGAL PHARMACEUTICALS LTD, OFF BABA DOGO RD, RUARAKA, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1997 |
| 2775 | NDA/MAL/HDP/4895 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLOMIFERT | CLOMIPHENE | 50MG | DAR AL DAWA, DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2776 | NDA/MAL/HDP/4903 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CMT-TABLETS | MAGNESIUM TRISILICATE+DRIED ALUMINIUM HYDROXIDE+PEPPERMINT OIL | 250MG+120MG+0.003ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2777 | NDA/MAL/HDP/4904 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MIXTARD 30 | INSULIN HUMAN | 100 I.U/ML | NOVO NORDISK PHARMA, NOVO ALLE| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE | DENMARK| FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| 2778 | NDA/MAL/HDP/4905 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | AVORAX CREAM | ACYCLOVIR | 5%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE | 01/07/1997 |
| 2779 | NDA/MAL/HDP/4907 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | AVORAX TABLETS | ACYCLOVIR | 400MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET STRIP | 01/07/1997 |
| 2780 | NDA/MAL/HDP/4908 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MIXTARD 30 PENFILL | BIPHASIC ISOPHANE INSULIN (HUMAN) | 100 I.U/ML | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL| NOVO NORDISK A/S , NOVO ALLE DK-2880 BAGSVAERD | DENMARK | PARENTERAL ORDINARY CARTRIDGES | 1.0X1.5 ML FLEXPEN,1.0X5.0X3.0 ML FLEXPEN | 01/07/1997 |
| 2781 | NDA/MAL/HDP/4909 | AXA PARENTERALS LTD | VITACARE LIMITED | AXAGYL | METRONIDAZOLE | 0.5%W/V | AXA PARENTERAL LIMITED, PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| 2782 | NDA/MAL/HDP/4910 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | FLUZOL | FLUCONAZOLE | 200MG | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2783 | NDA/MAL/HDP/4911 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | MOFILET-500 | MYCOPHENOLATE MOFETIL | 500MG | EMCURE PHARMACEUTICALS LIMITED , LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2784 | NDA/MAL/HDP/4915 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOGYL-S TABLETS | METRONIDAZOLE | 200MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2785 | NDA/MAL/HDP/4917 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL EVILINE FORTE SUSPENSION | MAGNESSIUM HYDROXIDE +ALUMINIUM HYDROXIDE+SIMETHICONE | 400MG/5ML+400MG/5ML+40MG/5ML | KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE | 01/07/2010 |
| 2786 | NDA/MAL/HDP/4918 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOGYL SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED , VANDALUR ROAD | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2787 | NDA/MAL/HDP/4919 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL FUSIDIC ACID- B CREAM | FUSIDIC ACID+BETAMETHASONE 17 VALERATE | 2%,W/W,+0.1% W/W | KESAR PHARMA PVT LTD, PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT| KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| 2788 | NDA/MAL/HDP/4920 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | FOLIBEN | FOLIC ACID | 5MG | LEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2789 | NDA/MAL/HDP/4922 | KOPRAN LIMITED | TATA UGANDA LIMITED | CIPROQUIN-500 | CIPROFLOXACIN | 500MG | KOPRAN LIMITED, VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER | 01/07/1999 |
| 2790 | NDA/MAL/HDP/4926 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | FOLIC ACID | FOLIC ACID | 5MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2791 | NDA/MAL/HDP/4927 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | AZOPT | BRINZOLAMIDE | 10MG/ML | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 01/07/2009 |
| 2792 | NDA/MAL/HDP/4928 | AFRICURE PHARMACEUTICALS (INDIA) LTD | AFRICURE PHARMACEUTICALS U LIMITED | FOLIC ACID TABLETS | FOLIC ACID | 5MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP | 01/07/1997 |
| 2793 | NDA/MAL/HDP/4929 | MARTINDALE AND AURUM PHARMACEUTICAL | LABOREX UGANDA LIMITED | MORPHINE INJECTION | MORPHINE | 15MG/ML | MARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/1997 |
| 2794 | NDA/MAL/HDP/4932 | MARTINDALE AND AURUM PHARMACEUTICAL | LABOREX UGANDA LIMITED | MORPHINE INJECTION | MORPHINE | 10MG/ML | MARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/1997 |
| 2795 | NDA/MAL/HDP/4933 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AZUDOX | DOXYCYCLINE HYDROCHLORIDE | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD , PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 2796 | NDA/MAL/HDP/4936 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COMBIFEN | IBUPROFEN + PARACETAMOL | 400MG + 500MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2797 | NDA/MAL/HDP/4939 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FOLIREN | FOLIC ACID | 5MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| 2798 | NDA/MAL/HDP/4940 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FOLON | FOLIC ACID | 5MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2799 | NDA/MAL/HDP/4944 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | BENA EXPECTORANT | DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE | 14MG + 135MG + 57.5MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, 1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 01/07/1997 |
| 2800 | NDA/MAL/HDP/4949 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN DRY COUGH DM | DEXTROMETHORPHAN HYDROBROMIDE | 15MG/ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2801 | NDA/MAL/HDP/4951 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN ORIGINAL | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE | 12.5 MG/5ML + 125 MG/5ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE | 01/07/1997 |
| 2802 | NDA/MAL/HDP/4952 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WITH CODEINE | DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE | 12.5MG/5ML +125MG/5ML +10MG/5ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/1997 |
| 2803 | NDA/MAL/HDP/4953 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | NAT-B | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED, 384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2804 | NDA/MAL/HDP/4955 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | COMPOUND SODIUM LACTATE INFU. | COMPOUND SODIUM LACTATE | MULTI INGREDIENT | ACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/1997 |
| 2805 | NDA/MAL/HDP/4956 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | CONTRAPAQUE 350 | IOHEXOL | 350MG | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD, PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2010 |
| 2806 | NDA/MAL/HDP/4957 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | MUMFER | IRON (111) POLYMALTOSE COMPLEX + FOLIC ACID | 100MG + 500MCG | GLENMARK PHARMACEUTICALS LTD PLOT E, PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2004 |
| 2807 | NDA/MAL/HDP/4958 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BENZOSED | MIDAZOLAM | 1MG/ML | TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL | 01/07/2011 |
| 2808 | NDA/MAL/HDP/4959 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PAEDIATRIC LINCTUS | CHLORPHENIRAMINE / PHENYLEPHRINE / DEXTROMETHORPHAN | 1MG/ 5MG/ 10MG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2809 | NDA/MAL/HDP/4962 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | BETAD | BETAMETHASONE DIPROPRIONATE | 0.05%W/W | S.KANT HEALTHCARE LTD, PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE,1.0X1.0X15.0 G TUBE | 01/07/2010 |
| 2810 | NDA/MAL/HDP/4964 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PLUS PAEDIATRIC SUSPENSION | CHLORPHENAMINE+PHENYLEPHRINE+PARACETAMOL | IMG+5MG+160MG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2811 | NDA/MAL/HDP/4966 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS-650 | CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL | 2MG + 5MG + 650MG | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2812 | NDA/MAL/HDP/4968 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FRUSEMIDE INJECTION | FUROSEMIDE | 10MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| 2813 | NDA/MAL/HDP/4969 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZATHINE PENICILLIN | BENZATHINE PENICILLIN | 2.4 M.U | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.4 MU VIAL | 01/07/2001 |
| 2814 | NDA/MAL/HDP/4971 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | FRUSEMIDE TABLETS | FUROSEMIDE | 40MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2815 | NDA/MAL/HDP/4973 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS | FOLLITROPIN ALFA/LUTROPIN ALFA | 150 I.U/75 I.U | MERCK SERONO S.A. (MSA) , 1170 SUCCURSALE D€™AUBONNE ZONE INDUSTRIELLE DE L€™OURIETTAZ, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL + 1*1ML VIAL OF WFI | 01/07/2014 |
| 2816 | NDA/MAL/HDP/4974 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | FRUSEMIDE TABLETS BP 40MG | FUROSEMIDE | 40MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 2817 | NDA/MAL/HDP/4979 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | FUROSEMIDE | FUROSEMIDE | 10MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTD, N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| 2818 | NDA/MAL/HDP/4982 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMAG TABLETS | MAGNESIUM TRISILICATE | 370MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 2819 | NDA/MAL/HDP/4983 | PT SAMBE FARMA | ONCOPHARM (U) LTD | PELASTIN | IMIPENEM + CILASTATIN | 500MG + 500MG | PT SANBE FARMA, JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2011 |
| 2820 | NDA/MAL/HDP/4998 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | HYAN | LEVONORGESTREL | 0.03MG | MYLAN LABORATORIES LIMITED.-, PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.| MYLAN LABORATORIES LIMITED.., PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER | 01/07/2006 |
| 2821 | NDA/MAL/HDP/4999 | UNIQUE PHARMACEUTICAL LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | PAMIDOL*370 | IOPAMIDOL | 755.3MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD, PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 01/07/2010 |
| 2822 | NDA/MAL/HDP/5001 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | GENTAMICIN INJECTION | GENTAMYCIN | 80MG/2ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE | 01/07/2007 |
| 2823 | NDA/MAL/HDP/5002 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | HUMALOG MIX 25 | INSULIN LISPRO + INSULIN LISPRO PROTAMINE | 25I.U+75I.U | LILLY FRANCE SA, FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/2000 |
| 2824 | NDA/MAL/HDP/5004 | ASPEN PHARMACARE LIMITED | BETA HEALTHCARE UGANDA LIMITED | COFTA TABLETS | MULTI-INGREDIENT | N/A | GLAXOSMITHKLINE LIMITED - , 78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA| BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY LOZENGES | 1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON,1.0X150.0 TABLET CARTON | 01/07/1997 |
| 2825 | NDA/MAL/HDP/5005 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | COLD GO | PARACETAMOL+PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE MALEATE+CAFFEINE | 325MG+10MG+2MG+30MG | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER | 01/07/2010 |
| 2826 | NDA/MAL/HDP/5008 | UNIMED INDIA | VEERAM HEALTHCARE (U) LIMITED | COLDAFEX | MULTI-INGREDIENT | MULTI-INGREDIENT | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059 | | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| 2827 | NDA/MAL/HDP/5010 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | ZARIN CREAM | MICONAZOLE NITRATE | 2%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD, 1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2828 | NDA/MAL/HDP/5011 | UNIMED INDIA | VEERAM HEALTHCARE (U) LIMITED | COLDAFEX TABLETS | MULTI-INGREDIENT | MULTI-INGREDIENT | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2829 | NDA/MAL/HDP/5014 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | VERMOREX SUSPENSION | MEBENDAZOLE | 100MG/5ML | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD), 216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH| J.B CHEMICALS & PHARMACEUTICALS LTD, 128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/1998 |
| 2830 | NDA/MAL/HDP/5015 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | COLDCAP CAPSULES | PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE | 5MG+4MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X8.0X12.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 2831 | NDA/MAL/HDP/5017 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP SYRUP | PARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG/5ML + 2MG/5ML + 10MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2832 | NDA/MAL/HDP/5018 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | VENTOLIN | SALBUTAMOL | 100MCG | GLAXO WELLCOME PRODUCTION., ZONE INDUSTRIELLE NO.2 23, RUE LAVOISIER 27000 EVREUX,FRANCE. | FRANCE | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/1997 |
| 2833 | NDA/MAL/HDP/5030 | PFIZER LAB LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SOLU-MEDROL | METHYLPREDNISOLONE HEMISUCCINATE | 125MG/2ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV, RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 ML VIAL,1.0X8.0 ML VIAL | 01/07/1997 |
| 2834 | NDA/MAL/HDP/5031 | THE MENTHOLATUM COMPANY LTD | HARLEYS UGANDA LIMITED | DEEP HEAT RUB | MULTI-INGREDIENT | MULTI-INGREDIENT | THE MENTHOLATUM COMPANY LTD, TWYFORD,, 1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND | UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X35.0 G TUBE,1.0X67.0 G TUBE,1.0X100.0 G TUBE | 01/07/1997 |
| 2835 | NDA/MAL/HDP/5032 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | DELASED DRY COUGH SYRUP (NON DROWSY) | DEXTROMETHORPHAN | 7.5MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| 2836 | NDA/MAL/HDP/5033 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | MEBFIL TABLETS | MEBENDAZOLE | 100MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2837 | NDA/MAL/HDP/5035 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEBENDAZOLE | MEBENDAZOLE | 100MG/5ML | MEDICAMEN BIOTECH LTD - , SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2014 |
| 2838 | NDA/MAL/HDP/5036 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DEPO PROGESTIN | MEDROXYPROGESTERONE ACETATE | 150MG | PT HARSEN LABORATORIES, JL RAYA , JL RAYA BOGOR, KM 24.6, JAKARTA TIMUR 13750 | INDONESIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 VIAL CARTON,1.0X25.0X1.0 ML VIAL | 01/07/2010 |
| 2839 | NDA/MAL/HDP/5037 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | MDOPAKANT-250 | METHYLDOPA | 250MG | SK ANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2840 | NDA/MAL/HDP/5038 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-CAM TABLETS | MELOXICAM | 15MG | UNICHEM LABORATORIES LIMITED, UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER | 01/07/2002 |
| 2841 | NDA/MAL/HDP/5040 | PFIZER LABORATORIES (PTY) LTD BELGIUM | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 40MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV, RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL,1.0X2.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/1997 |
| 2842 | NDA/MAL/HDP/5041 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | MAXITROL | DEXAMETHASONE/NEOMYCIN/POLYMYXIN B | 0.1%W/W +0.1%W/W+6000 I.U | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE | 01/07/1997 |
| 2843 | NDA/MAL/HDP/5042 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSATRIM DS TABLETS | CO-TRIMOXAZOLE | 960MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| 2844 | NDA/MAL/HDP/5043 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | MAXITROL | DEXAMETHASONE/NEOMYCIN/POLYMYXIN B | 0.1%W/W+3500I.U/ML+6000I.U/ML | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| 2845 | NDA/MAL/HDP/5044 | PFIZER LABORATORIES (PTY) LTD BELGIUM | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 150MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV, RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY I M VIALS | 1.0X3.5 ML VIAL,1.0X1.0 ML VIAL, 1.0X25.0X1.0 ML VIAL | 01/07/1997 |
| 2846 | NDA/MAL/HDP/5046 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN PLUS 150/12.5 | IRBESARTAN+HYDROCHLOROTHIAZIDE | 150MG+12.5MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 2847 | NDA/MAL/HDP/5049 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN PLUS 300/12.5 | IRBESARTAN/HYDROCHLOROTHIAZIDE | 300MG/12.5MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 2848 | NDA/MAL/HDP/5050 | NORVATIS PHARMA AG- SWITZERLAND | SURGIPHARM (U) LIMITED | MAXIDEX | DEXAMETHASONE | 0.1%W/V | ALCON COUVREUR NV, RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| 2849 | NDA/MAL/HDP/5053 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DERMX | ECONAZOLE/ TRIAMCINOLONE/ GENTAMYCIN | 1%/0.1%/0.1% | S KANT HEALTH CARE LTD, PLOT 1802 €“ 1805 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2011 |
| 2850 | NDA/MAL/HDP/5055 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | DERMOVATE | CLOBETASOL PROPIONATE | 0.05%W/W | GLAXOSMITHKLINE HARMIRE , GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X25.0 G TUBE | 01/07/1997 |
| 2851 | NDA/MAL/HDP/5064 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | MANNITOL INFUSION | MANNITOL | 20%W/V | ACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2852 | NDA/MAL/HDP/5065 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MARVELON | DESOGESTREL + ETHINYLESTRADIOL | 150 MG + 30 MG | 1. N.V ORGANON MOLENSTRAAT 110, OSS, 5342CC OSS, NETHERLANDS. KLOOSTERSTRAAT 6, OSS, 5349AB, NETHERLANDS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | I. 1*100*1*28TABLET BLISTER | 2015-07-01 00:00:00 |
| 2853 | NDA/MAL/HDP/5068 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 8MG/2ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| 2854 | NDA/MAL/HDP/5070 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-60 | ENOXAPARIN SODIUM | 60MG/0.6ML | EMCURE PHARMACEUTICALS LTD , PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 01/07/2009 |
| 2855 | NDA/MAL/HDP/5071 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-40 | ENOXAPARIN SODIUM | 40MG/0.4ML | EMCURE PHARMACEUTICALS LTD , PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 01/07/2009 |
| 2856 | NDA/MAL/HDP/5073 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DEXONA EYE/EAR DROP | DEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE | 0.35%W/V+0.1%W/V | AHLCON PARENTERALS (INDIA) LTD, SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE | 01/07/1997 |
| 2857 | NDA/MAL/HDP/5074 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEXONA INJECTION | DEXAMETHASONE DISODIUM PHOSPHATE | 4MG/ML | SAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X6.0X2.0 ML VIAL,16.0X6.0X2.0 ML VIAL | 01/07/1997 |
| 2858 | NDA/MAL/HDP/5076 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | DEXTRACIN EYE DROPS | DEXAMETHASONE + NEOMYCIN | 0.1MG + 0.5MG | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD, 1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| 2859 | NDA/MAL/HDP/5078 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | GLANDIN E2 VAGINAL | DINOPROSTONE | 3MG | NABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | VAGINAL TABLETS | 1.0X1.0 TABLET STRIP | 01/07/2006 |
| 2860 | NDA/MAL/HDP/5079 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEMONT CT 5 | MONTELUKAST | 5MG | GLENMARK PHARMACEUTICALS LTD ., VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2861 | NDA/MAL/HDP/5086 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GLIFIL M FORT | GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE | 5MG+500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2862 | NDA/MAL/HDP/5092 | MICRO LABS LTD 92 SIPCOT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE | GLIMEPIRIDE | 2MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2863 | NDA/MAL/HDP/5095 | MICRO LABS LTD | LABOREX UGANDA LIMITED | DIAPRIDE PLUS | GLIMEPIRIDE + METFORMIN | 1MG + 500MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 2864 | NDA/MAL/HDP/5096 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | SCABION | CROTAMITON + SULPHUR | 10 G + 2G/100G | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X60.0 ML BOTTLE | 01/07/2003 |
| 2865 | NDA/MAL/HDP/5098 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DIARIV | DI-IODO HYDROXYQUINOLINE + HOMATROPINE + PHTHALYLSULFATHIOZOLE + STREPTOMYCIN | 125 MG + 1 MG + 150 MG + 100 MG | 1. RIVA PHARMA S.A.E. ST.6, PUBLIC FREE ZONE, NASR CITY - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. RIVA PHARMA S.A.E. ST.6, PUBLIC FREE ZONE, NASR CITY - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*60ML BOTTLE | 2011-07-01 00:00:00 |
| 2866 | NDA/MAL/HDP/5099 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | GLUCOMET | METFORMIN | 500MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X4.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2867 | NDA/MAL/HDP/5100 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | L-GENTA | GENTAMICIN | 0.3%W/V | LINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2005 |
| 2868 | NDA/MAL/HDP/5102 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 500MG | METFORMIN | 500MG | MERCK SANTÉ, 2, RUE DU PRESSOIR VERT F 45400, SEMOY| NKUNZI PHARMACEUTICALS (PTY) LTD., 259 DAVIDSON ROAD CNR PEDDIE STREET, WADEVILLE EST. 1 GERMISTON 1422|MERCK SANTÉ, 2, RUE DU PRESSOIR VERT F 45400, SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X6.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER | 01/07/2010 |
| 2869 | NDA/MAL/HDP/5103 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 1000MG | METFORMIN | 1000MG | NKUNZI PHARMACEUTICALS (PTY) LTD -, 259 DAVIDSON ROAD, WADEVILLE, EXT 1, GERMINSTON, SOUTH AFRICA | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X15.0 TABLET BLISTER | 01/07/2010 |
| 2870 | NDA/MAL/HDP/5104 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVEMIR FLEXPEN | INSULIN DETEMIR | 100 I.U/ML | NOVO NORDISK A/S , NOVO ALLE DK-2880 BAGSVAERD| NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| 2871 | NDA/MAL/HDP/5107 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | INDOREN CAPSULES | INDOMETHACIN | 25MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2000 |
| 2872 | NDA/MAL/HDP/5109 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | LEBASMA ORAL SOLUTION | SALBUTAMOL | 2MG/5ML | LEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 2873 | NDA/MAL/HDP/5110 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | GLUCOSE INFUSION BP | DEXTROSE | 5%W/V | ACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| 2874 | NDA/MAL/HDP/5111 | FREDUN PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | LAXAFRED | BISACODYL | 5MG | FREDUN PHARMACEUTICALS LIMITED,, 14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET BLISTER | 01/07/1997 |
| 2875 | NDA/MAL/HDP/5112 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL SR TABLETS | DICLOFENAC SODIUM | 100MG | WIN MEDICARE PVT LIMITED, MEERUT, MUZAFFARNAGER ROAD, MODIPURAM €“ 250110, UTTAR PRADESH -INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2876 | NDA/MAL/HDP/5115 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | INDOS-25 | INDOMETHACIN | 25MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| 2877 | NDA/MAL/HDP/5117 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | LASTINEM | IMIPENEM + CILASTATIN | 500MG + 500MG | VENUS REMMEDIES, UNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1 BHOTOLI KALA BADDI INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 01/07/2011 |
| 2878 | NDA/MAL/HDP/5119 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | KONTRAC 200 | MISOPROSTOL | 200MCG | FOURRTS INDIA LABORATORIES PVT. LIMITED, VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2879 | NDA/MAL/HDP/5120 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GLYFORMIN 500 TABLETS | METFORMIN | 500MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/1999 |
| 2880 | NDA/MAL/HDP/5121 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN GEL | DICLOFENAC DIETHYLAMMONIUM | 1%W/W | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)-, 304-308 ,GIDC , PANOLI 394116 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X50.0 G TUBE,1.0X20.0 G TUBE | 01/07/1997 |
| 2881 | NDA/MAL/HDP/5122 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | KOFAREST SYRUP | SALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL | 2MG+30MG+100MG+5MG/10ML | CENTAUR PHARMACEUTICALS LTD, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2007 |
| 2882 | NDA/MAL/HDP/5124 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | INFANRIX-HEXA | DIPHTHERIA TOXOID+TETANUS TOXOID+PERTUSSIS TOXOID(PT)+FILAMENTOUS HAEMAGGLUTININ(FHA)+PERTACTIN(69KDA OMP)+HBSAG PURIFIED,INACTIVATED POLIO VIRUS TYPE I+INACTIVATED POLIO VIRUS TYPE II+INACTIVATED POLIO VIRUS TYPE III+PURIFIED CAPSULAR POLYSACCHARIDE OF HIB COVALENTLY BOUND TO TETANUS TOXOID(PRP-T) | MIN 30 I.U+MIN 40 I.U+25?G+25?G+8?G+10?G,40DU+8DU+32DU+10?G | GLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY COMBINATION PACK VIALS | 1.0X1.0 PACK CARTON (DTPA-HBV-IPV IN PREFILLED SYRINGE + 2 NEEDLES+FREEZE DRIED HIB IN A VIAL) | 01/07/2013 |
| 2883 | NDA/MAL/HDP/5125 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | GLYGESIC FORTE RHUMETIC CREAM | MULTI INGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1998 |
| 2884 | NDA/MAL/HDP/5128 | MEDIPHARM SALES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GOFEN 400 CLEARCAP | IBUPROFEN | 400MG | MEGA LIFESCIENCES LTD., 384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN | THAILAND | ORAL SOLID ORDINARY CAPSULES | 6.0X1.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2885 | NDA/MAL/HDP/5129 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | KLEEN ENEMA | DISODIUM BISPHOSPHATE/ SODIUM PHOSPHATE | 19.2G+7.2G/ 120ML | NABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X135.0 ML BOTTLE | 01/07/2006 |
| 2886 | NDA/MAL/HDP/5130 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN MS GEL | DICLOFENAC+METHYL SALICYLATE+MENTHOL | 1%W/W+10%W/W+5%W/W | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)-, 304-308 ,GIDC , PANOLI 394116 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2005 |
| 2887 | NDA/MAL/HDP/5131 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INSULATARD | ISOPHANE INSULIN (HUMAN) | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE| NOVO NORDISK PHARMA, NOVO ALLE | DENMARK | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| 2888 | NDA/MAL/HDP/5133 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 900IU/1.5ML(66MCG/1.5ML) | FOLLITROPIN ALFA | 66MCG/1.5ML | MERCK SERONO S.A. (MSA) , 1170 SUCCURSALE D€™AUBONNE ZONE INDUSTRIELLE DE L€™OURIETTAZ, SWITZERLAND| MERCK SERONO SPA (BARI), VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0 CARTRIDGE PREFILLED PEN + 20 NEEDLES FOR INJECTION,1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION. | 01/07/2015 |
| 2889 | NDA/MAL/HDP/5134 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | GOODMORNING COUGH TABLETS | MULTIINGREDIENT | N/A | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CARTON | 01/07/1997 |
| 2890 | NDA/MAL/HDP/5135 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | KETOZ | KETOCONAZOLE | 2%W/W | SK ANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/2010 |
| 2891 | NDA/MAL/HDP/5136 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | GOODMORNING LUNG TONIC | MULTIINGREDIENT | N/A | BETA HEALTHCARE INTERNATIONAL LTD - , PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1997 |
| 2892 | NDA/MAL/HDP/5139 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INSULATARD HM PENFILL | ISOPHANE INSULIN (HUMAN) | 100I.U/ML | NOVO NORDISK PHARMA, NOVO ALLE| NOVO NORDISK PRODUCTION SAS, 45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE| NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA, AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK | PARENTERAL ORDINARY CARTRIDGES | 1.0X5.0X3.0 ML PREFILLED PEN,1.0X5.0X1.5 ML PREFILLED PEN | 01/07/1997 |
| 2893 | NDA/MAL/HDP/5140 | PFIZER LABORATORIES PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIFLUCAN | FLUCONAZOLE | 200MG | FAREVA AMBOISE - , ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0 CAPSULE BLISTER | 01/07/1997 |
| 2894 | NDA/MAL/HDP/5142 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | INTAMINE CREAM | MEPYRAMINE MALEATE | 2%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X400.0 G TUBE | 01/07/1997 |
| 2895 | NDA/MAL/HDP/5143 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 25MG | METOPROLOL | 25MG | ASTRA ZENECA AB, GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN | SWEDEN | ORAL SOLID RETARD TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 01/07/2011 |
| 2896 | NDA/MAL/HDP/5146 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 100MG | METOPROLOL | 100MG | ASTRA ZENECA AB, SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2011 |
| 2897 | NDA/MAL/HDP/5147 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 50MG | METOPROLOL | 50MG | ASTRA ZENECA AB, GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN | SWEDEN | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2011 |
| 2898 | NDA/MAL/HDP/5148 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BETANASE TABLETS | GLIBENCLAMIDE | 5MG | ZYDUS LIFESCIENCES LIMITED-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER | 01/07/1997 |
| 2899 | NDA/MAL/HDP/5150 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | KETO PLUS SHAMPOO | KETOCONAZOLE + ZINC PYRITHIONE | 2%W/W + 1%W/W | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X60.0 ML BOTTLE | 01/07/2003 |
| 2900 | NDA/MAL/HDP/5155 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BETAVEL | MULTI-INGREDIENT | N/A | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 2901 | NDA/MAL/HDP/5157 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BETAVEL N | BETAMETHASONE+NEOMYCIN SULPHATE | 1MG+5MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X3.0 G TUBE,1.0X15.0 G TUBE | 01/07/1997 |
| 2902 | NDA/MAL/HDP/5161 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | GRISEOSIM-500 | GRISEOFULVIN | 500 MG | AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 01/07/2005 |
| 2903 | NDA/MAL/HDP/5164 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BROMSAL EXPECTORANT | SALBUTAMOL SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 1MG+2MG+50MG+0.5MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 2904 | NDA/MAL/HDP/5165 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GRISEOFULVIN 500 TABLETS | GRISEOFULVIN | 500MG | REMEDICA LIMITED, LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER | 01/07/2003 |
| 2905 | NDA/MAL/HDP/5167 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | BRUSTAN TABLETS | IBUPROFEN + PARACETAMOL | 400MG + 325MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED , INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2906 | NDA/MAL/HDP/5170 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDITRAL CAPSULE | ITRACONAZOLE | 100MG | GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE STRIP,1.0X10.0X1.0X4.0 CAPSULE STRIP | 01/07/2000 |
| 2907 | NDA/MAL/HDP/5171 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | KETAMAX-50 | KETAMINE | 50MG/ML | TROIKAA PHARMACUETICALS LIMITED, C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 01/07/2011 |
| 2908 | NDA/MAL/HDP/5176 | BAYER AG | SURGIPHARM (U) LIMITED | CANESTEN | CLOTRIMAZOLE | 100MG | BAYER AG , D-51368 LEVERKUSEN GERMANY | GERMANY | VAGINAL TABLETS | 1.0X6.0 TABLET STRIP | 01/07/1997 |
| 2909 | NDA/MAL/HDP/5179 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 200MG CAPSULES | CEFIXIME TRIHYDRATE | 200MG | PHARMA INTERNATIONAL CO.,, AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X8.0 CAPSULE BLISTER | 01/07/2007 |
| 2910 | NDA/MAL/HDP/5180 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ISORYN DROPS ( PAEDRIATRIC) | EPHEDRINE HYDROCHLORIDE | 5MG/ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| 2911 | NDA/MAL/HDP/5182 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ISORYN DROPS (ADULT) | EPHEDRINE HYDROCHLORIDE | 10MG/ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| 2912 | NDA/MAL/HDP/5186 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ISOTROY 250 | ISOFLURANE | 250ML | TROIKAA PHARMACEUTICALS LTD, THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE, 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 2913 | NDA/MAL/HDP/5187 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | HEALIT SKIN OINTMENT | BACITRACIN+POLYMYXIN B SO4+NEOMYCIN+LIDOCAINE | 500UNITS+5000UNITS+3.5MG+40MG/G | ATCO LABORATORIES PVT LTD, B-18,S.I.T.E KARACHI, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 01/07/2007 |
| 2914 | NDA/MAL/HDP/5188 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ITRAZ CAPSULES | ITRACONAZOLE | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| 2915 | NDA/MAL/HDP/5189 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | HEMOZEBEX | FERROUS SULPHATE+FOLIC ACID+PYRIDOXINE HCL+CYANOCOBALAMIN+ZINC SULPHATE | 300MG+1000MCG+1.5MG+7.5MG+61.8MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2916 | NDA/MAL/HDP/5192 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXGENT EYE/EAR DROPS | DEXAMETHASONE + GENTAMICIN | 0.1% + 0.3%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*5ML BOTTLE | |
| 2917 | NDA/MAL/HDP/5193 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXNEOCIN EYE DROPS | DEXAMETHASONE + NEOMYCIN | 0.1% + 0.35%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*10ML BOTTLE II. 1*5ML BOTTLE III. 5*5ML BOTTLE | |
| 2918 | NDA/MAL/HDP/5194 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXONE EYE DROPS | DEXAMETHASONE | 0.1%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*5ML BOTTLE II. 5ML BOTTLE | |
| 2919 | NDA/MAL/HDP/5197 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYGENTACIN EYE/EAR DROP | GENTAMICIN SULPHATE | 0.3%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*10ML BOTTLE II. 1*5ML BOTTLE III. 1*8ML BOTTLE IV. 10ML BOTTLE V. 5ML BOTTLE VI. 8ML BOTTLE | |
| 2920 | NDA/MAL/HDP/5200 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HYDRALAZINE TABLETS B.P 25MG. | HYDRALAZINE HYDROCHLORIDE | 25MG | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| 2921 | NDA/MAL/HDP/5201 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM BENDAZOLE | MEBENDAZOLE | 100MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2922 | NDA/MAL/HDP/5205 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-VENT | SALBUTAMOL | 4MG | KAMPALA PHARMACEUTICALS INDUSTIES, PLOT NO M44B STRETCHER ROAD INTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET JAR,1.0X500.0 TABLET JAR,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2923 | NDA/MAL/HDP/5207 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | DIGOXIN TABLETS | DIGOXIN | 0.25MG | NEM LABORATORIES PVT. LIMITED, 133 KRISHNA IND. ESTATE, VASAI (E), THANE €“ 401 210, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2013 |
| 2924 | NDA/MAL/HDP/5211 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DINAC GEL | DICLOFENAC | 1%W/W | S KANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2009 |
| 2925 | NDA/MAL/HDP/5214 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | NIRMET | METRONIDAZOLE | 500MG/100ML | ACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 2926 | NDA/MAL/HDP/5215 | J.B CHEMICALS & PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL TABLETS | METRONIDAZOLE | 200MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD ., 128/1, GIDC, ANKLESHWAR 393 002, GUJARAT| GLOBELA PHARMA PVT.LTD., 357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X5.0X2.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2927 | NDA/MAL/HDP/5221 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG/3ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE | 01/07/2006 |
| 2928 | NDA/MAL/HDP/5222 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | EMTRICITABINE+TENOFOVIR DF | EMTRICITABINE/TENOFOVIR | 200MG/300MG | MYLAN LABORATORIES LTD-, F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE|MYLAN LABORATORIES LIMITED , PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE| MYLAN LABORATORIES LTD -, PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA| | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 07/07/2008 |
| 2929 | NDA/MAL/HDP/5224 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | EMTRICITABINE/TENOFOVIR DISOPROXIL FUMERATE | 200MG/300MG | AUROBINDO PHARMA LTD UNIT III, AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2009 |
| 2930 | NDA/MAL/HDP/5226 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | 200MG/300MG | HETERO DRUGS LTD, UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055| HETERO LABS LTD (UNIT-V), SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| 2931 | NDA/MAL/HDP/5228 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | DICLOGENTA | DICLOFENAC SODIUM+GENTAMICIN SULPHATE | 1MG/ML+3MG/ML | CENTAUR PHARMACEUTICALS PVT LTD -, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2009 |
| 2932 | NDA/MAL/HDP/5231 | INTAS, PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ENAPRIL 10 | ENALAPRIL MALEATE | 10MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA| INTAS PHARMACEUTICALS LTD, PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2933 | NDA/MAL/HDP/5232 | INTAS, PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ENAPRIL-5 | ENALAPRIL MALEATE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION), CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| 2934 | NDA/MAL/HDP/5233 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | ENVAS 10 MG TABLETS | ENALAPRIL | 10MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2935 | NDA/MAL/HDP/5234 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | ENVAS 5MG TABLETS | ENALAPRIL MALEATE | 5MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2936 | NDA/MAL/HDP/5235 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B.CHEMICALS & PHARMACEUTICALS LTD.) | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN DELAYED-RELEASE TABLETS | DICLOFENAC SODIUM | 50 MG | 1. GLOBELA PHARMA PRIVATE LIMITED PLOT NO. 357 & 358, ROAD NO. 3, GIDC, SACHIN, SURAT - 394230, GUJARAT, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J. B. CHEMICALS AND PHARMACEUTICALS LIMITED) PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID RETARD ENTERIC-COATED TABLETS | I. 1*10*10TABLET BLISTER II. 5*2*10TABLET BLISTER III. 1*1000TABLET CONTAINER | 01/07/1997 |
| 2937 | NDA/MAL/HDP/5248 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-AMPI | AMPICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER | 01/07/1997 |
| 2938 | NDA/MAL/HDP/5249 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ENCIFER | IRON SUCROSE | 100MG/5ML | EMCURE PHARMACEUTICALS LTD , PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057| SAMRUDH PHARMACEUTICALS PVT LTD, J-174, J-168 & J-168/1, MIDC, TARAPUL, BOISAR, DIST THANE-401506 | INDIA | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 01/07/2013 |
| 2939 | NDA/MAL/HDP/5251 | PFIZER LABORATORIES (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIFLUCAN | FLUCONAZOLE | 150MG | FAREVA AMBOISE AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0 CAPSULE BLISTER | 01/07/1997 |
| 2940 | NDA/MAL/HDP/5255 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ENO LEMONFRUIT SALT | MULTI-INGREDIENT | MULTI-INGREDIENT | GLAXO SMITH KLINE LTDLIKONI RD, INDUSTRIAL AREA,NAIROBI KENYA | KENYA | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X8.0X4.5 G SACHET,1.0X10.0X4.5 G SACHET,1.0X48.0X4.5 G SACHET,1.0X4.0X4.5 G SACHET,1.0X24.0X4.5 G SACHET | 01/07/1997 |
| 2941 | NDA/MAL/HDP/5256 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROFOS INJECTION | BETAMETHASONE DIPROPIONATE + BETAMETHASONE DIPROPIONATE | 5 MG/ML + 2 MG | 1. MSD PTY LIMITED NO. 117, 16TH ROAD HALFWAY HOUSE, MIDRAND 1685-SOUTH AFRICA SOUTH AFRICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | I. 1*2ML AMPOULE II. 1*2ML VIAL | 2001-07-01 00:00:00 |
| 2942 | NDA/MAL/HDP/5260 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ERYMYCIN | ERYTHROMYCIN ESTOLATE | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2943 | NDA/MAL/HDP/5263 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROSALIC OINTMENT | SALICYLIC ACID + BETAMETHASONE DIPROPIONATE | 0.3 %W/W + 0.5 %W/W | SCHERING-PLOUGH LABO N.V - INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG, BELGIUM | BELGIUM | TOPICAL EXTERNAL OINTMENTS | I. 1*30BLISTER CONTAINER II. 1*30MG TUBE | 2001-07-01 00:00:00 |
| 2944 | NDA/MAL/HDP/5271 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | ERYTHYL SYRUP | ERYTHROMYCIN ETHYL SUCCINATE | 125MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2945 | NDA/MAL/HDP/5272 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DIX | DIGOXIN | 0.25MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| 2946 | NDA/MAL/HDP/5281 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL | EFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 600MG +200MG + 300MG | AUROBINDO PHARMA LTD UNIT VII, SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2015 |
| 2947 | NDA/MAL/HDP/5282 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DORFEN | ACECLOFENAC | 100MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2948 | NDA/MAL/HDP/5283 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX GEL | IBUPROFEN | 5%W/W | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL EMULSION GELS | 1.0X25.0 G TUBE | 01/07/2001 |
| 2949 | NDA/MAL/HDP/5288 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX SUSPENSION | IBUPROFEN | 100MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 100.0 ML BOTTLE,60.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2950 | NDA/MAL/HDP/5290 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ELOCOM CREAM | MOMETASONE FUROATE | 0.1 %W/W | ORGANON HEIST BV- INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG, BELGIUM | BELGIUM | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 2000-07-01 00:00:00 |
| 2951 | NDA/MAL/HDP/5291 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX TABLET | IBUPROFEN | 200MG | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/1997 |
| 2952 | NDA/MAL/HDP/5292 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DOMI 10 | DOMPERIDONE | 10MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| 2953 | NDA/MAL/HDP/5294 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ELOCOM OINTMENT | MOMETASONE FUROATE | 0.1 %W/W | ORGANON HEIST BV- INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG, BELGIUM | BELGIUM | TOPICAL EXTERNAL OINTMENTS | I. 1*15G TUBE | 2000-07-01 00:00:00 |
| 2954 | NDA/MAL/HDP/5295 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | DOXY | DOXYCYCLINE | 100MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X280.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| 2955 | NDA/MAL/HDP/5298 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELOGYL | METRONIDAZOLE | 200MG/5ML | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2956 | NDA/MAL/HDP/5299 | PHARMA INTERNATIONAL.CO | OMAB UGANDA LIMITED | KENAZOLE | KETOCONAZOLE | 20MG/ML | PHARMA INTERNATIONAL COMPANY ,., AL-QASTAL INDUSTRIAL AREA/AMMAN | JORDAN | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 2957 | NDA/MAL/HDP/5300 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DOLAC | KETOROLAC TROMETHAMINE | 30MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2015 |
| 2958 | NDA/MAL/HDP/5302 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | IBUGO-COMBI | IBUPROFEN + PARACETAMOL + CAFFEINE | 200MG + 325MG + 30MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 2959 | NDA/MAL/HDP/5305 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | IBUGO - 200 | IBUPROFEN | 200MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2960 | NDA/MAL/HDP/5307 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DUOTROL | GLYBURIDE + METFORMIN HYDROCHLORIDE | 5MG + 500MG | FREDUN PHARMACEUTICALS LIMITED--, 14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2961 | NDA/MAL/HDP/5311 | ABBOTT LABORATORIES S.A. (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DUPHASTON TABLETS | DYDROGESTERONE | 10 MG | 1. ABBOTT BIOLOGICALS BV, THE NETHERLANDS VEERWEG 12, 8121 AA, OLST NETHERLANDS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | NETHERLANDS | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*20TABLET BLISTER | 01/07/2001 |
| 2962 | NDA/MAL/HDP/5312 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | DOXYCYCLINE | DOXYCYCLINE | 100MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER | 01/07/2005 |
| 2963 | NDA/MAL/HDP/5316 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR | DICLOFENAC SODIUM + PARACETAMOL | 50MG + 500MG | TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 2964 | NDA/MAL/HDP/5317 | MACK BROWN | SHURIK LTD | DR MAC'S COUGH FORMULA | TERBUTALINE SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 2.5MG+8.0MG+100MG+5MG | TORQUE PHARMACEUTICALS LTD, ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2003 |
| 2965 | NDA/MAL/HDP/5318 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR AQ (1ML) | DICLOFENAC SODIUM | 75MG/ML | TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE | 01/07/2009 |
| 2966 | NDA/MAL/HDP/5320 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | INDOL | INDOMETHACIN | 25MG | LEBEN LAB PVT LTD, L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| 2967 | NDA/MAL/HDP/5321 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | IBUGESIC COLD & SINUS | IBUPROFEN/PSEUDOEPHEDRINE | 200MG/30MG | DAR AL DAWA, NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY GELATIN-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2012 |
| 2968 | NDA/MAL/HDP/5323 | STEDMAN PHARMACEUTICALS LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | IODINATED POVIDONE + METRONIDAZOLE | 5.0% W/V + 1.0% W/V | STEDMAN PHARMACEUTICALS PVT LTD..., C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML CONTAINER,1.0X30.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 01/07/2010 |
| 2969 | NDA/MAL/HDP/5324 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | IBUFIL 400 | IBUPROFEN | 400MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| 2970 | NDA/MAL/HDP/5326 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ECODAX G CREAM | ECONAZOLE NITRATE + GENTAMYCIN + BECLAMETASONE | 1%+0.1%+0.025% | UNIQUE PHARMACEUTICAL LABORATORIES, PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI €” 394 116, GUJARAT, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X100.0 G TUBE | 01/07/1997 |
| 2971 | NDA/MAL/HDP/5327 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | IBUFIL 200 | IBUPROFEN | 200MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2972 | NDA/MAL/HDP/5329 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | IBUFEN TABLETS | IBUPROFEN | 200MG | ELYS CHEMICAL INDUSTRIES LTD, ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 2973 | NDA/MAL/HDP/5330 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ-V | MICONAZOLE + METRONIDAZOLE | 2.0%W/W + 1.0%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2011 |
| 2974 | NDA/MAL/HDP/5333 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | IBUFEN | IBUPROFEN | 200MG | KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD, PLOT M444 B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,500.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,250.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 2975 | NDA/MAL/HDP/5338 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | HYDROSIL TABLETS | ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE+SIMETHICONE | 200MG+200MG+20MG | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD, 1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X20.0 TABLET BLISTER | 01/07/1997 |
| 2976 | NDA/MAL/HDP/5341 | LABORATORY&ALLIED LTD | ROYAL PHARMA 2011 LIMITED | HYDOPA | METHYLDOPA | 250MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 2977 | NDA/MAL/HDP/5346 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFUTIL 500 | CEFUROXIME AXETIL | 500MG | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET CONTAINER | 01/07/2014 |
| 2978 | NDA/MAL/HDP/5347 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | CEFUTIL 250 | CEFUROXIME AXETIL | 250MG | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 2979 | NDA/MAL/HDP/5348 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEPID 20 | INTRAVENOUS FAT EMULSION | 20%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2005 |
| 2980 | NDA/MAL/HDP/5352 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | MUMFER | IRON(111) POLYMALTOSE COMPLEX | 50MG/5ML | GLENMARK PHARMACEUTICALS LTD PLOT E, PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2005 |
| 2981 | NDA/MAL/HDP/5356 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BURNNEM | MULTI-INGREDIENT | N/A | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1997 |
| 2982 | NDA/MAL/HDP/5358 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | CADISTIN EXPECTORANT | CHLORPHENIRAMINE MALEATE + GUAIFENESIN + AMMONIUM CHLORIDE + SODIUM CITRATE + LEVOMENTHOL + TERPIN HYDRATE + TOLU BALSAM + VASAKA SYRUP | (2MG + 80MG + 100MG + 44MG + 0.8MG + 4MG + 6MG + 0.133ML)/5ML | SAKAR HEALTHCARE PVT LTD, SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| 2983 | NDA/MAL/HDP/5361 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | CALFIC | MULTI-INGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD , ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 2984 | NDA/MAL/HDP/5362 | ASTRA ZENECA | MACNAUGHTON LIMITED | CASODEX 150MG | BICALUTAMIDE | 150MG | ASTRAZENECA MACCLESFIELD, CHESHIRE | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 2.0X14.0 TABLET STRIP | 01/07/2001 |
| 2985 | NDA/MAL/HDP/5363 | ASTRA ZENECA | MACNAUGHTON LIMITED | CASODEX 50MG | BICALUTAMIDE | 50MG | BULK CORDEN PHARMA GMBH, OTT HAHN STRASSE ,68723 GERMANY| ASTRA ZENECA UK LIMITED, ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/1997 |
| 2986 | NDA/MAL/HDP/5368 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | CEFIX 100MG/5ML DRY SUSPENSION | CEFIXIME | 100MG/5ML | PHARMA INTERNATIONAL CO., AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2007 |
| 2987 | NDA/MAL/HDP/5370 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HYOSCINE BUTYLBROMIDE | HYOSCINE N-BUTYLBROMIDE | 10 MG | COSMOS LIMITED , RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 2988 | NDA/MAL/HDP/5377 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN FOUR FLU LIQUID | DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE | 25MG/20ML + 1G/20ML + 45MG/20ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2001 |
| 2989 | NDA/MAL/HDP/5379 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZOLANAS-30 | LANSOPRAZOLE | 30MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| 2990 | NDA/MAL/HDP/5380 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIROZEP | DIAZEPAM | 5MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD ., N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2013 |
| 2991 | NDA/MAL/HDP/5386 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | UDIHEP TABLETS | URSODEOXYCHOLIC ACID | 150MG | WIN- MEDICARE LTD, MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2001 |
| 2992 | NDA/MAL/HDP/5391 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | NITROFURANTOIN | NITROFURANTOIN | 100MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2008 |
| 2993 | NDA/MAL/HDP/5392 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMLO-DENK 10 | AMLODIPINE MESILATE MONOHYDRATE | 10MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2994 | NDA/MAL/HDP/5393 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMLO-DENK 5 | AMLODIPINE MESILATE MONOHYDRATE | 5MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2008 |
| 2995 | NDA/MAL/HDP/5394 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FINAZOL | ALBENDAZOLE | 400MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| 2996 | NDA/MAL/HDP/5395 | MICRO LABS LTD | LABOREX UGANDA LIMITED | OFLOX | OFLOXACIN | 200MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2997 | NDA/MAL/HDP/5400 | GLAXOSMITHKLINE TRADING SERVICES LTD, | UNITED HEALTHCARE DISTRIBUTORS LTD | ALBEN SUSPENSION | ALBENDAZOLE | 400MG/10ML | PANACEA BIOTEC LTD, MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) €“ 173 205 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/1999 |
| 2998 | NDA/MAL/HDP/5405 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OLANDUS 10 | OLANZAPINE | 10MG | ZYDUS LIFESCIENCES LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 2999 | NDA/MAL/HDP/5407 | THEMIS PHARMACEUTICALS | STAR PHARMACEUTICALS LTD | E MAL-75 | ALPHA-BETA ARTEETHER | 75MG/ML | THEMIS MEDICARE LTD, SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X1.0 ML AMPOULE | 01/07/2013 |
| 3000 | NDA/MAL/HDP/5409 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | MINTO GEL | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 150 MG + 150 MG + 25 MG | LINCOLN PHARMACEUTICAL LIMITED , TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X180.0 ML BOTTLE | 01/07/2012 |
| 3001 | NDA/MAL/HDP/5410 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | UNICTAM 1500 | AMPICILLIN + SULBACTAM | 1000 MG + 500 MG | MEDICAL UNION PHARMACEUTICALS LTD - , ABU SULTAN, CR 13363 ISMAILLIA, EGYPT | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2009 |
| 3002 | NDA/MAL/HDP/5415 | CENTAUR PHARMACEUTICALS PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST | OXYMETAZOLINE | 0.05%W/V | CENTAUR PHARMACEUTICALS PVT LTD -, PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE | 01/07/2009 |
| 3003 | NDA/MAL/HDP/5416 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CIPROX | CIPROFLOXACIN | 0.2%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| 3004 | NDA/MAL/HDP/5417 | PHARMA INTERNATIONAL.CO | OMAB UGANDA LIMITED | CIPROPHARM | CIPROFLOXACIN | 500MG | PHARMA INTERNATIONAL COMPANY, MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2007 |
| 3005 | NDA/MAL/HDP/5419 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CPM | CHLORPHENIRAMINE | 4MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2005 |
| 3006 | NDA/MAL/HDP/5427 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | NIRCIP | CIPROFLOXACIN | 200MG/100MG | ACULIFE HEALTHCARE PVT. LTD, VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 3007 | NDA/MAL/HDP/5428 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | CIPFIL 500 | CIPROFLOXACIN | 500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED, VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 3008 | NDA/MAL/HDP/5429 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CIPRO-500 | CIPROFLOXACIN | 500MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON | 01/07/2006 |
| 3009 | NDA/MAL/HDP/5433 | REGAL PHARMACEUTICALS LIMITED | COLDCAP NIGHT TIME | PARACETAMOL+CHLORPHENIRAMINE | 500MG+2MG | 1. REGAL PHARMACEUTICALS LIMITED PLOT NO. 7978/18, OFF BABA DOGO ROAD, RUARAKA - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL SOLID ORDINARY CAPSULES | I. 1*1*12CAPSULE BLISTER | 01/07/2006 | |
| 3010 | NDA/MAL/HDP/5435 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PIC | PARACETAMOL+IBUPROFEN+CAFFEINE | 500MG+200MG+30MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP | 01/07/2015 |
| 3011 | NDA/MAL/HDP/5439 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENIRON SYRUP | VITAMIN B6 + FERROUS GLUCONATE + VITAMIN B1 + VITAMIN C + VITAMIN B2 | 2MG/5ML + 200MG/5ML + 2MG/5ML + 20MG/5ML + 2MG/5ML | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 3012 | NDA/MAL/HDP/5441 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL NASATAB TABLETS | PARACETAMOL+CHLORPHENIRAMINE+PSEUDOEPHEDRINE | 500MG+4MG+60MG | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 3013 | NDA/MAL/HDP/5442 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | CHLORAMPHENICOL OPHTHALMIC OINTMENT USP 1% | CHLORAMPHENICOL | 1%W/W | NEM LABORATORIES PVT LTD, 133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | OPHTHALMIC OINTMENTS | 1.0X20.0X3.5 G TUBE | 01/07/2013 |
| 3014 | NDA/MAL/HDP/5444 | ORGANON SOUTH AFRICA (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AERIUS TABLETS | DESLORATIDINE | 5MG | MSD (PTY) LTD, LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA| SCHERING PLOUGH LABO NV, INDUSTRIE PARK 30, ZONE A, 2220, HEIST OP-DEN-BERG | BELGIUM| SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER, 1.0X5.0X6.0 TABLET BLISTER | 01/07/2001 |
| 3015 | NDA/MAL/HDP/5446 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | PHENICOL- 250 | CHLORAMPHENICOL | 250MG | JIANGSU PENGYAO PHARMACEUTICALS CO. LTD , NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 3016 | NDA/MAL/HDP/5447 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DICLOFENAC | DICLOFENAC SODIUM | 50MG | TRIVENI FORMULATION LTD-PLOT NO.52,53,54,63,62,64, ALEAP INDUSTRIAL ESTATE SURAMPALI, AP-INDIA – 521212 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| 3017 | NDA/MAL/HDP/5449 | HOVID BHD | BARIKI EXIM PHARMA LTD | CLOFENAC 50 | DICLOFENAC SODIUM | 50MG | HOVID BERHAD (CHEMOR SITE)-, LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 3018 | NDA/MAL/HDP/5454 | LEBEN LABORATORIES PVT.LTD | MARVIN PHARMA LIMITED | MOXILEB | AMOXICILLIN | 125MG/5ML | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| 3019 | NDA/MAL/HDP/5460 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ASAQ GPSC | ARTESUNATE+AMODIAQUINE | 50MG+135MG | GUILIN PHARMACEUTICALS CO. LTD, NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0X20.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/2011 |
| 3020 | NDA/MAL/HDP/5464 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER | 01/07/2007 |
| 3021 | NDA/MAL/HDP/5467 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMSIDAR | SULFADOXINE/PYRIMETHAMINE | 525MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 3022 | NDA/MAL/HDP/5469 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NIMOTOP | NIMODIPINE | 0.2MG/ML | BAYER PHARMA AG , 51368 LEVERKUSEN GERMANY| SOLUPHARM GMBH , INDUSTRIESTRASSE 3, 34212 MELSUNGEN | GERMANY | PARENTERAL ORDINARY I V VIALS | 1.0X50.0 ML VIAL | 01/07/2009 |
| 3023 | NDA/MAL/HDP/5471 | MICRO LABS LTD | LABOREX UGANDA LIMITED | AVAS 40 | ATORVASTATIN | 40MG | MICRO LABS LTD, 92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 3024 | NDA/MAL/HDP/5472 | CLARIS OTSUKA LIMITED | REDDYS PHARMA LIMITED | NS | SODIUM CHLORIDE | 0.9%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD, VILLAGE €“ VASANA €“ CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BAG | 01/07/2007 |
| 3025 | NDA/MAL/HDP/5473 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROYPOFOL | PROPOFOL | 1%W/V | TROIKAA PHARMACEUTICALS LTD ., C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2012 |
| 3026 | NDA/MAL/HDP/5474 | PHARMA INTERNATIONAL.CO | OMAB UGANDA LIMITED | CEFODOX | CEFPODOXIME PROXETIL | 200MG | PHARMA INTERNATIONAL CO., AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 3027 | NDA/MAL/HDP/5478 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | BECORT 50 | BECLOMETHASONE DIPROPIONATE | 50MCG/ACTUATION | CIPLA LTD.- , PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X1.0X200.0 METERED DOSE CANNISTER | 01/07/2010 |
| 3028 | NDA/MAL/HDP/5479 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | RANFERON 12 CAPSULES | MULTI-INGREDIENT | MULTI-INGREDIENT | SUN PHARMACEUTICAL INDUSTRIES LIMITED,, INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER | 01/07/1997 |
| 3029 | NDA/MAL/HDP/5482 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-LIN | SALBUTAMOL | 2MG/5ML | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2010 |
| 3030 | NDA/MAL/HDP/5483 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ASAQ GPSC | ARTESUNATE + AMODIAQUINE | 25 MG + 67.5 MG | GUILIN PHARMACEUTICALS CO. LTD, NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0X20.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/2011 |
| 3031 | NDA/MAL/HDP/5489 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORBIS-5 | BISOPROLOL | 5MG | UNICHEM LABORATORIES LIMITED UNIT II, VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2008 |
| 3032 | NDA/MAL/HDP/5495 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCAL TABLETS | CALCIUM LACTATE | 300MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| 3033 | NDA/MAL/HDP/5497 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | EXPEN | BENZYLPENICILLIN | 1MU | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL,1.0X100.0X1.0 MU VIAL | 01/07/2011 |
| 3034 | NDA/MAL/HDP/5591 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSCILLIN | AMPICILLIN | 500MG | SWISS PARENTERALS UNIT II, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL | 01/07/2011 |
| 3035 | NDA/MAL/HDP/5619 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | RABELOC 20 | RABEPRAZOLE SODIUM | 20MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP | 01/07/2006 |
| 3036 | NDA/MAL/HDP/5644 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4 MEGA UNITS | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP , NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | PARENTERAL ORDINARY VIALS | 1.0X4.0 MU VIAL | 01/07/2001 |
| 3037 | NDA/MAL/HDP/6034 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN -250 DT | AMOXICILLIN TRIHYDRATE | 250 MG | MILAN LABS PVT LTD, 63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3038 | NDA/MAL/HDP/6036 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | OFLOTECH-O | OFLOXACIN + ORNIDAZOLE | 200MG + 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD, 19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3039 | NDA/MAL/HDP/6037 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AVIT | VITAMIN A | 200,000 IU | OLIVE HEALTHCARE, 197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE JAR | 01/07/2017 |
| 3040 | NDA/MAL/HDP/6040 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | U-TRYP | ULINASTATIN | 100,000 I.U | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2017 |
| 3041 | NDA/MAL/HDP/6041 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CANDIZOL | CLOTRIMAZOLE | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP | 01/07/2017 |
| 3042 | NDA/MAL/HDP/6048 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | MOMATE AZ | MOMETASONE FUROATE + AZELASTINE HYDROCHLORIDE | 50MCG + 140MCG/ SPRAY | 1. GLENMARK PHARMACEUTICAL LIMITED (UNIT-III) VILLAGE: KISHNPURA, BADDI - NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | NASAL TOPICAL METERED DOSE AEROSOLS | I. 1*150METERED DOSE BOTTLE | 01/07/2017 |
| 3043 | NDA/MAL/HDP/6050 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ITACARE | ITRACONAZOLE | 100MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3044 | NDA/MAL/HDP/6055 | ALFASIGMA S.P.A | AJUMEDPHARM LIMITED | EURARTESIM | PIPERAQUINE TETRAPHOSPHATE + DIHYDROARTEMISININ | 160MG + 20MG | ALFASIGMA S.P.A, VIA PONTINA KM 30,400-00040 POMEZIA ROME, ITALY | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2017 |
| 3045 | NDA/MAL/HDP/6057 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | CORAM 5MG | AMLODIPINE BESYLATE | 5MG | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD, PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| 3046 | NDA/MAL/HDP/6059 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | NEUROZONE | MECOBALAMIN + PREGABALIN | 750MCG + 75MG | ACME FORMULATION PVT LTD., ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3047 | NDA/MAL/HDP/6061 | CIPLA LTD.. | ABACUS PHARMA (AFRICA) LIMITED | NASEHALER | MOMETASONE FUROATE | 50MCG /SPRAY | CIPLA LTD INDOREPLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 774 | INDIA | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X140.0 METERED DOSE BOTTLE | 01/07/2017 |
| 3048 | NDA/MAL/HDP/6065 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PROXYREN | PIROXICAM | 20MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3049 | NDA/MAL/HDP/6067 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | DIAZEPAM | DIAZEPAM | 5MG | NEM LABORATORIES PVT LTD, 133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3050 | NDA/MAL/HDP/6070 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | VAZKOR | AMLODIPINE BESILATE | 10MG | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3051 | NDA/MAL/HDP/6071 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | VAZKOR | AMLODIPINE BESILATE | 5MG | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3052 | NDA/MAL/HDP/6072 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY I V AMPOULES | I. 1*10*1ML AMPOULE II. 1*5*1ML AMPOULE III. 1*10*1ML VIAL | ||
| 3053 | NDA/MAL/HDP/6074 | MARCYRL PHARMACEUTICALS INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | CARDILOL CS | CARVEDILOL | 25MG | 1. MARCYRL PHARMACEUTICALS INDUSTRIES EL-OBOUR CITY, THE WEST EXTENSION BLOCK 20005 - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2017 |
| 3054 | NDA/MAL/HDP/6076 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 30MG | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*5 ML OF 0.9%W/V NACL AMPOULE + 1*1 ML OF 5%W/V NAHCO3 AMPOULE | 01/07/2017 |
| 3055 | NDA/MAL/HDP/6080 | EXPHAR SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FEBRILEX JUNIOR | PARACETAMOL+CHLORPHENIRAMINE MALEATE | 125MG+1MG/5ML | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2017 |
| 3056 | NDA/MAL/HDP/6081 | TIANJIN MNCHIP TECHNOLOGIES CO.,LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANTALGEX T | PARACETAMOL/TRAMADOL HYDROCHLORIDE | 325MG/37.5MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3057 | NDA/MAL/HDP/6082 | EXPHAR SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CROMSOL | SODIUM CROMOGLYCATE | 2%W/V | AHLCONPARENTERALS (INDIA) LIMITED, SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| 3058 | NDA/MAL/HDP/6086 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | ACEWEL-P | ACECLOFENAC+PARACETAMOL | 100MG+500MG | AKUMS DRUGS & PHARMACEUTICALS LTD, 19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3059 | NDA/MAL/HDP/6092 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 1000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875 MG + 125 MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3060 | NDA/MAL/HDP/6093 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 625 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500 MG + 125 MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3061 | NDA/MAL/HDP/6094 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 375 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 250 MG + 125 MG | SPARSH BIO-TECH PVT. LTD, PLOT NO. 1; SURVEY NO. 242/243/244, LAKHABAVAD, JAMNAGAR-361 006, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3062 | NDA/MAL/HDP/6095 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DIPGEN | BETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE | 0.64 MG/G + 1 MG/G | S KANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE | 01/07/2017 |
| 3063 | NDA/MAL/HDP/6101 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS-H 40/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3064 | NDA/MAL/HDP/6102 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS 80 | TELMISARTAN | 80MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3065 | NDA/MAL/HDP/6103 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | OZACE MD 5 | OLANZAPINE | 5MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3066 | NDA/MAL/HDP/6114 | FDC LTD | AIVEEN (U) LIMITED | ZOXAN | CIPROFLOXACIN | 0.3% W/V | FDC LIMITED , B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ €“ AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 01/07/2005 |
| 3067 | NDA/MAL/HDP/6116 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ZOLEDRO-DENK 4MG/5ML | ZOLEDRONIC ACID | 4MG/5ML | SIEGFRIED HAMELN GMBH-LANGES FELD 13, 31789 HAMELN - GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X5.0 ML VIAL | 01/07/2017 |
| 3068 | NDA/MAL/HDP/6117 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | GRAN-DENK | GRANISETRON HYDROCHLORIDE | 1MG/ML | SIEGFRIED HAMELN GMBH, LANGES FELD 13,31789 HAMELN| SOLUPHARM GMBH , INDUSTRIESTRASSE 3, 34212 MELSUNGEN | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE,1.0X5.0X3.0 ML AMPOULE | 01/07/2017 |
| 3069 | NDA/MAL/HDP/6118 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | L-TRIM DS | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3070 | NDA/MAL/HDP/6121 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LTD | DEXIREN | DEXKETOPROFEN TROMETAMOL | 25MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3071 | NDA/MAL/HDP/6126 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DERMOTRACIN | NEOMYCIN SULPHATE + BACITRACIN | 165,000 IU + 12,500 IU | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X150.0 ML CANNISTER | 01/07/2016 |
| 3072 | NDA/MAL/HDP/6132 | HOVID BHD | BARIKI EXIM PHARMA LTD | KETOVID | KETOCONAZOLE | 2%W/W | HOVID BHD , 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X120.0 ML BOTTLE | 01/07/2016 |
| 3073 | NDA/MAL/HDP/6135 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TRIXONE-S | CEFTRIAXONE SODIUM+SULBACTAM | 1000MG+500MG | ZEISS PHARMA LIMITED-IGC,SIDCO, PHASE II, SAMBA, JAMMU - 184121,(J&K) | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | INDIA| CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 01/07/2016 |
| 3074 | NDA/MAL/HDP/6136 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NUCOXIA 120 | ETORICOXIB | 120MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3075 | NDA/MAL/HDP/6137 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | LUPRODEX | LEUPROLIDE ACETATE | 3.75MG | BHARAT SERUMS AND VACCINES LIMITED,, PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS | 01/07/2016 |
| 3076 | NDA/MAL/HDP/6138 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | NUCOXIA 60 | ETORICOXIB | 60MG | ZYDUS LIFESCIENCES LTD -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3077 | NDA/MAL/HDP/6141 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | ACEWEL | ACECLOFENAC | 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD, 19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3078 | NDA/MAL/HDP/6142 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCARB | ACTIVATED CHARCOAL | 0.25GM | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3079 | NDA/MAL/HDP/6143 | IESUS GROUP | SHREEJI PHARMACEUTICALS LIMITED | CONTRACTUBEX | EXTRACT CEPAE FLUID +HEPARIN SODIUM+ALLANTOIN | 10G+5000 I.U+1G/100G | MARCYRL PHARMACEUTICAL INDUSTRIES., EL OBOUR CITY CAIRO | EGYPT | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2016 |
| 3080 | NDA/MAL/HDP/6158 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DESEFIN | CEFTRIAXONE SODIUM | 1G | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2016 |
| 3081 | NDA/MAL/HDP/6167 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AKUROSE | IRON SUCROSE | 20MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 07/01/2016 |
| 3082 | NDA/MAL/HDP/6176 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | G-GLUTAMIN | VITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID | 100MG+50MG+100MCG+50MG | BLISS GVS PHARMA LTD, PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2010 |
| 3083 | NDA/MAL/HDP/6179 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ON.SETRON-DENK 4MG ODT | ONDANSENTRON | 4MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2016 |
| 3084 | NDA/MAL/HDP/6180 | ALFASIGMA S.P.A | AJUMEDPHARM LIMITED | EURARTESIM | PIPERAQUINE TETRAPHOSPHATE + DIHYDROARTEMISININ | 320MG+40MG | ALFASIGMA S.P.A, VIA PONTINA KM 30,400-00040 POMEZIA ROME, ITALY | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X9.0 TABLET BLISTER, 1.0X3.0 TABLET BLISTER, 1.0X6.0 TABLET BLISTER, 1.0X12.0 TABLET BLISTER | 01/07/2016 |
| 3085 | NDA/MAL/HDP/6181 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | AZINOWEL-500 | AZITHROMYCIN | 500MG | AKUMS DRUGS AND PHARMACEUTICALS LTD, PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2016 |
| 3086 | NDA/MAL/HDP/6184 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 60MG | ETORICOXIB | 60MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3087 | NDA/MAL/HDP/6185 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | DOLOFORTE DENK | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3088 | NDA/MAL/HDP/6186 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 90MG F.C. TABLETS | ETORICOXIB | 90MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3089 | NDA/MAL/HDP/6188 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN 150 | IRBESARTAN | 150MG | DAR AI DAWA, NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3090 | NDA/MAL/HDP/6189 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | WORMEE-4 | ALBENDAZOLE | 400MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2016 |
| 3091 | NDA/MAL/HDP/6190 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | D-LYTE | ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE | 2.7MG+0.52MG+0.58MG+0.30MG PER 200ML SACHET,6.75MG+1.30MG+1.45MG+0.75MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG PER 1000ML SACHET | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET | 01/07/2015 |
| 3092 | NDA/MAL/HDP/6197 | ALLY PHARMA OPTIONS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN | NYSTATIN | 100,000 IU | MEDICAMEN BIOTECH LTD ., SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) | INDIA | VAGINAL TABLETS | 1.0X14.0 PESSARY STRIP | 01/07/2016 |
| 3093 | NDA/MAL/HDP/6201 | SPARSH BIO-TECH PVT.LTD. | ABACUS PHARMA (AFRICA) LIMITED | SPAMOXIFLOX | AMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM | 250MG + 250MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP | 01/07/2016 |
| 3094 | NDA/MAL/HDP/6207 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | GO!GEL | DICLOFENAC DIETHYLAMINE+METHYL SALICYLATE | 1.16%W/W + 10%W/W | S KANT HEALTHCARE LTD, PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE, 1.0X100.0 G TUBE | 01/07/2016 |
| 3095 | NDA/MAL/HDP/6211 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOFAINS | PARACETAMOL/DICLOFENAC SODIUM | 500MG/50MG | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3096 | NDA/MAL/HDP/6217 | INDIAN IMMUNOLOGICALS LTD | TATA UGANDA LIMITED | ELOVAC -B | HEPATITIS B (RDNA) | 20MCG/ML | HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LTD), RAKSHAPURAM GACHIBOWLI POST HYDERABAD 500032 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0 ML VIAL (1 DOSE VIAL) | 01/07/2016 |
| 3097 | NDA/MAL/HDP/6220 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | METHYLDOPA | METHYLDOPA | 250MG | NEM LABORATORIES PVT LTD, PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3098 | NDA/MAL/HDP/6227 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ISONIAZID | ISONIAZID | 300MG | MYLAN LABORATORIES LIMITED., PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. €“ 431136, MAHARASHTRA STATE, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2016 |
| 3099 | NDA/MAL/HDP/6228 | CACHET PHAMACUITICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | ACINET | AMOXICILLIN + POTASSIUM CLAVULANATE | 500 MG + 125 MG | INDCHEMIE HEALTH SPECIALITIES PVT. LTD, VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER, 1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3100 | NDA/MAL/HDP/6229 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CO-FLUAMPICIL CAPSULES BP 500MG | FLUCLOXACILLIN SODIUM + AMPICILLIN TRIHYDRATE | 250MG +250MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP | 01/07/2016 |
| 3101 | NDA/MAL/HDP/6230 | CACHET PHAMACUITICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EMITINO | ONDANSENTRON | 4MG | CACHET PHARMACEUTICALS PVT LTD , THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER, 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3102 | NDA/MAL/HDP/6231 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP DISPERSIBLE | DIHYDROARTEMISININ/PIPERAQUINE | 20MG/160MG | GUILIN PHARMACEUTICAL CO LTD, NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER,1.0X3.0X35.0 TABLET BLISTER | 01/07/2016 |
| 3103 | NDA/MAL/HDP/6232 | FREDUN PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | H-CURE | LANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE | 30MG + 250MG + 500MG | FREDUN PHARMACEUTICALS LTD, VEOOR PALGHAR ( E ) 401 404 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X7.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2CAPSULES OF LANSOPRAZOLE + 2 TABLETS OF CLARITHROMYCIN + 2 TABLETS OF TINIDAZOLE) | 01/07/2016 |
| 3104 | NDA/MAL/HDP/6234 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP DISPERSIBLE | DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE | 40MG/320MG | GUILIN PHARMACEUTICAL CO.,LTD, NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER,1.0X3.0X25.0 TABLET BLISTER | 01/07/2016 |
| 3105 | NDA/MAL/HDP/6235 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANGINET 160MG | VALSARTAN | 160MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD, P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3106 | NDA/MAL/HDP/6237 | HETERO LABS LTD | AIVEEN (U) LIMITED | LOPINAVIR/RITONAVIR | LOPINAVIR/ RITONAVIR | 100MG/25MG | HETERO LABS LTD, 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET BOTTLE,1.0X60.0 TABLET CONTAINER | 01/07/2016 |
| 3107 | NDA/MAL/HDP/6238 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG -AM | NEBIVOLOL HYDROCHLORIDE + AMLODIPINE BESILATE | 5MG + 5MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3108 | NDA/MAL/HDP/6239 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE | ARTESUNATE | 60MG | INDASI LIFESCIENCE PVT. LTD., PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN-396210 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE | 01/07/2016 |
| 3109 | NDA/MAL/HDP/6242 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP | DIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE | 80MG/640MG | GUILIN PHARMACEUTICAL CO LTD, NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X6.0X25.0 TABLET BLISTER | 01/07/2016 |
| 3110 | NDA/MAL/HDP/6243 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | SURVANTA | BERACTANT | 100MG/4ML | ABBVIE NORTH CHICAGO FACILITY, 1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000 | UNITED STATES | TOPICAL EXTERNAL INSTILLATION VIALS | 1.0X4.0 ML VIAL,1.0X8.0 ML VIAL | 01/07/2016 |
| 3111 | NDA/MAL/HDP/6244 | CACHET PHAMACUITICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CABALIN | PREGABALIN | 75MG | CACHET PHARMACEUTICALS PVT LTD, VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 3112 | NDA/MAL/HDP/6245 | BIOLOGICAL E. LTD | ABACUS PHARMA (AFRICA) LIMITED | COSCOPIN LINCTUS | NOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE | 7MG+2 MG+ 3.25 MG+28 MG/5 ML. | BIOLOGICAL E. LTD -PLOT NO.31 & 32 PHARMA CITY SELAQUI INDUSTRIAL AREA SELAQUI DEHRADUN-248 197 UTTARAKHAND,INDIA | | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| 3113 | NDA/MAL/HDP/6246 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | LUTHER | ARTEMETHER | 80MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT. LTD, N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2016 |
| 3114 | NDA/MAL/HDP/6247 | MILAN LABORATORIES LTD (INDIA) PVT LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY 250-DT | AMOXICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3115 | NDA/MAL/HDP/6249 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL METRONIDAZOLE -200 TABLETS | METRONIDAZOLE | 200MG | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3116 | NDA/MAL/HDP/6250 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | ROCIP EYE DROPS | CIPROFLOXACIN HYDROCHLORIDE | 3MG/ML | REMINGTON PHARMACEUTICAL INDUSTRIES (PVT) LTD, 18 KM MULTAN ROAD LAHORE 53800 PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2016 |
| 3117 | NDA/MAL/HDP/6256 | HOVID BHD | BARIKI EXIM PHARMA LTD | AZIMAX- 250 | AZITHROMYCIN DIHYDRATE | 250MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3118 | NDA/MAL/HDP/6257 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | EDURANT | RILPIVIRINE | 25MG | JANSSEN CILAG S.P.A, VIA C.JANSSEN, BORGO | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2016 |
| 3119 | NDA/MAL/HDP/6267 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | TRAMADOL DENK 50 | TRAMADOL HYDROCHLORIDE | 50MG | LOSAN PHARMA GMBH, OTTO-HAHN-STR 13 79395 NEUENBURG | GERMANY | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X10.0 TABLET BOTTLE | 01/07/2016 |
| 3120 | NDA/MAL/HDP/6275 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | BENZYL BENZOATE APPLICATION BP | BENZYL BENZOATE | 25%W/V | SEV PHARMACEUTICALS LTD, , PLOT 100 MASAKA ROAD ,NALUKOLONGO KAMPALA,UGANDA. | UGANDA | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE | 27/11/2018 |
| 3121 | NDA/MAL/HDP/6281 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | HOMAGON | CHLORPHENAMINE MALEATE + CAFFEINE ANHYDROUS + PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL | 4MG + 30MG + 30MG + 400MG | LABORATORY AND ALLIED LTD-PLOT 209/10349-MOMBASA ROAD NAIROBI | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 07/11/2018 |
| 3122 | NDA/MAL/HDP/6282 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEBUX-40 | FEBUXOSTAT | 40MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| 3123 | NDA/MAL/HDP/6283 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEBUX-80 | FEBUXOSTAT | 80 MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| 3124 | NDA/MAL/HDP/6284 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PAEDIATRIC PARACETAMOL ORAL SOLUTION | PARACETAMOL | 120MG/5ML | CIPLA LTD INDORE PLOT NO. 9 AND 10, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, 454 775, MADHYA PRADESH - INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | NONE |
| 3125 | NDA/MAL/HDP/6288 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFIX-100 DS | CEFIXIME TRIHYDRATE | 100 MG/5ML | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*1*60ML BOTTLE | 27/11/2018 |
| 3126 | NDA/MAL/HDP/6294 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | NEXAVAR | SORAFENIB TOSYLATE | 200MG | BAYER PHARMA AG , 51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X28.0 TABLET BLISTER | 07/11/2018 |
| 3127 | NDA/MAL/HDP/6302 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | PLENOX | OFLOXACIN | 200MG | AKUMS DRUGS & PHARMACEUTICALS LTD, 19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3128 | NDA/MAL/HDP/6304 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | UNOSURE 72 | LEVONORGESTREL | 1.5MG | AKUMS DRUGS & PHARMACEUTICALS LTD ., PLOT NO. 47, 48, SECTOR 6A, IIE, SIDCUL HARIDWAR, UTTRAKHAND €“ 249403, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 27/03/2019 |
| 3129 | NDA/MAL/HDP/6305 | YELURI FORMULATIONS PVT LTD | SUPER MEDIC LTD | ELMOX-CV 375 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 250 MG + 125 MG | 1. YELURI FORMULATIONS PRIVATE LIMITED SY. NO. 296/7/6, IDA BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. YELURI FORMULATIONS PRIVATE LIMITED SY. NO. 296/7/6, IDA BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*10TABLET BLISTER II. 1*3*5TABLET BLISTER | |
| 3130 | NDA/MAL/HDP/6314 | YELURI FORMULATIONS PVT LTD | SUPER MEDIC LTD | ELMOX-CV 625 | AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM | 500MG+125MG | YELURI FORMULATIONS PVT. LTD, SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X5.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3131 | NDA/MAL/HDP/6318 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | FLUSORT | FLUTICASONE PROPIONATE | 50MCG/SPRAY | GLENMARK PHARMACEUTICALS LIMITED-UNIT III,VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA | INDIA | NASAL TOPICAL SUSPENSIONS | I. 1*120METERED DOSE BOTTLE | 27/11/2018 |
| 3132 | NDA/MAL/HDP/6325 | LEBEN LABORATORIES PVT. LTD. | MALIX PHARMA (U) LIMITED | PZQ TABLET | PRAZIQUANTEL | 600MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X4.0 TABLET BLISTER,4.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3133 | NDA/MAL/HDP/6327 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENESTEN-V | CLOTRIMAZOLE | 100MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X6.0 PESSARY BLISTER | 27/11/2018 |
| 3134 | NDA/MAL/HDP/6332 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN DT 250 | AMOXICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/11/2018 |
| 3135 | NDA/MAL/HDP/6334 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | ENDOPROST 250MCG/1ML | CARBOPROST TROMETHAMINE | 250MCG/ML | BHARAT SERUM AND VACCINES LIMITED, PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (EAST) INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL | 27/03/2019 |
| 3136 | NDA/MAL/HDP/6340 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | AXYLIN CAPSULES | AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM | 250MG +250 MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| 3137 | NDA/MAL/HDP/6344 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LACTEASE | LACTULOSE SOLUTION | 66.7% W/W | S KANT HEALTHCARE LTD, PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 26/09/2018 |
| 3138 | NDA/MAL/HDP/6352 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | OMIPIN-20 | OMEPRAZOLE | 20MG | BRAWN LABORATORIES LTD ., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 28/03/2019 |
| 3139 | NDA/MAL/HDP/6353 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS 50MG/300MG/300MG | DOLUTEGRAVIR+LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE TABLETS | 50MG+300MG+300MG | LAURUS LABS LIMITED, (UNIT-2) - , PLOT NO:19, 20 & 21,WESTERN SECTOR, APSEZ, ATCHUTAPURAM MANDAL, VISAKHAPATNAM-DISTRICT-531011, ANDHRA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE,1.0X1.0X180.0 TABLET BOTTLE | 07/11/2018 |
| 3140 | NDA/MAL/HDP/6354 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TIMOSOL ® | TIMOLOL MALEATE | O.5%W/V | AHLCONPARENTERALS (INDIA) LIMITED, SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| 3141 | NDA/MAL/HDP/6358 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | ZYROVA 20 | ROSUVASTATIN CALCIUM | 20MG | ZYDUS LIFESCIENCES LTD -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 27/03/2019 |
| 3142 | NDA/MAL/HDP/6361 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSKA-P | NYSTATIN | 1,00,000 I.U/ML | S.KANT HEALTHCARE LTD, PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2018 |
| 3143 | NDA/MAL/HDP/6365 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | EASY PILL | LEVONORGESTREL | 1.5MG | CORONA REMEDIES PVT LTD, CORONA HOUSE, C MONDEAL BUSINESS PARK, NR. GURUDWARA GOVINDDHAM LANE, SG HIGHWAY, THALTEJ, AHMEDABAD 380059, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 27/03/2019 |
| 3144 | NDA/MAL/HDP/6370 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYCROM EYE DROPS | SODIUM CROMOGLYCATE | 2%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*10ML BOTTLE | |
| 3145 | NDA/MAL/HDP/6374 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | PREDLEB-5 DT | PREDNISOLONE | 5MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3146 | NDA/MAL/HDP/6377 | REGAL PHARMA U LIMITED | REGAL PHARMA U LIMITED | EPHICOL CAPSULES | CHLORPHENIRAMINE MALEATE+ PARACETAMOL+ CAFFEINE ANHYDROUS+ PHENYLEPHRINE HCL | 2MG+500 MG+30 MG+5MG | REGAL PHARMACEUTICALS LTD.., PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X12.0 CAPSULE BLISTER | 01/07/2017 |
| 3147 | NDA/MAL/HDP/6381 | MANKIND PHARM LTD | TATA UGANDA LIMITED | SERTAKIND | SERTACONAZOLE NITRATE | 2.0%W/W | CURETECH SKINCARE, PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE,1.0X20.0 G TUBE | 27/03/2019 |
| 3148 | NDA/MAL/HDP/6383 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EXXIB | CELECOXIB | 200MG | GRACURE PHARMACEUTICALS LIMITED , E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3149 | NDA/MAL/HDP/6385 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AMOXIKID-250 | AMOXICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD , PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET STRIP | 25/07/2018 |
| 3150 | NDA/MAL/HDP/6386 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | JUSDEE 60K GRANULES | COLECALCIFEROL | 60000 IU | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X8.0X1.0 G SACHET | 30/05/2018 |
| 3151 | NDA/MAL/HDP/6392 | AJANTA PHARMA LIMITED | ASTRA PHARMA (U) LIMITED | MET XL 50 | METOPROLOL SUCCINATE | 50 MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3152 | NDA/MAL/HDP/6395 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLOXSOL ® | NORFLOXACIN | 0.3%W/V | AHLCON PARENTERALS (INDIA) LIMITED, SP-917-918, PHASE 111, BHIWADI -301019, ALWAR, RAJASTHAN INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 28/05/2019 |
| 3153 | NDA/MAL/HDP/6396 | NVS KENYA LIMITED | SURGIPHARM (U) LIMITED | LETROZOLE 2.5 | LETROZOLE | 2.5 MG | 1. NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG, SWITZERLAND SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 01/07/2017 |
| 3154 | NDA/MAL/HDP/6400 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | FENSUPP-100 | DICLOFENAC SODIUM | 100MG | MERIDIAN ENTERPRISES PVT. LTD-, PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2017 |
| 3155 | NDA/MAL/HDP/6401 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | SUPPOL 250 SUPPOSITORIES | ACETAMINOPHEN | 250MG | MERIDIAN ENTERPRISES PVT. LTD, PLOT NO. 418, G.I.D.C.,KABILPORE,NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP | 01/07/2017 |
| 3156 | NDA/MAL/HDP/6404 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC GEL | ACECLOFENAC + LINSEED OIL + METHYL SALICYLATE + MENTHOL USP | 1.5%W/W + 3.0W/W +10.0%W/W + 5.0%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED, NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE,1.0X20.0 G TUBE | 01/07/2017 |
| 3157 | NDA/MAL/HDP/6405 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | CLOPRAZ | CLOPIDOGREL BISULFATE | 75MG | ZIM LABORATORIES LTD, B-21/22, M.I.D.C. AREA, KALMESHWAR €“ 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3158 | NDA/MAL/HDP/6406 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | LIDOCAINE INJECTION BP 2% | LIDOCAINE HYDROCHLORIDE | 2% W/V | LINCOLN PHARMACEUTICAL LTD TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X25.0X30.0 ML VIAL, 1.0X5.0X20.0ML VIAL | 27/11/2018 |
| 3159 | NDA/MAL/HDP/6407 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | ZIMCOX 200 | CELECOXIB | 200 MG | ZIM LABORATORIES LTD, B-21/22, M.I.D.C. AREA, KALMESHWAR €“ 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/11/2017 |
| 3160 | NDA/MAL/HDP/6414 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | IMATIB 100 | IMATINIB MESYLATE | 100MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| 3161 | NDA/MAL/HDP/6415 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | IMATIB 400 | IMATINIB MESYLATE | 400MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| 3162 | NDA/MAL/HDP/6424 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL LS | LEVOSALBUTAMOL SULPHATE + AMBROXOL HYDROCHLORIDE + GUAIFENESIN | 1 MG + 30 MG + 100 MG | GLENMARK PHARMACEUTICALS LTD ., VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 27/03/2019 |
| 3163 | NDA/MAL/HDP/6431 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUMOX 125 | AMOXICILLIN TRIHYDRATE | 125MG/5ML | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| 3164 | NDA/MAL/HDP/6432 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | UMBI-GEL | CHLORHEXIDINE GLUCONATE | 4 % W/W | KAMPALA PHARMACEUTICALS INDUSTRIES (1996)LTD, STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X50.0X1.0X5.0 G TUBE | 27/03/2019 |
| 3165 | NDA/MAL/HDP/6433 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FICYC CREAM | ACICLOVIR | 5%W/W | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2017 |
| 3166 | NDA/MAL/HDP/6435 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FIMABUTE 200 | CEFIXIME TRIHYDRATE | 200MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3167 | NDA/MAL/HDP/6437 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | PILORECT | HYDROCORTISONE ACETATE +LIDOCAINE +ZINC OXIDE +ALLANTOIN | 0.25%W/W+3%W/W+5%W/W+0.5%W/W | MERIDIAN ENTERPRISES PVT. LTD, PLOT NO. 418, G.I.D.C., KABILPORE, NAVSARI GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X6.0 SUPPOSITORY BLISTER | 29/11/2017 |
| 3168 | NDA/MAL/HDP/6438 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL PLUS | PARACETAMOL + CAFFEINE | 500 MG + 65 MG | KAMPALA PHARMACEUTICALS INDUSTRIES (1996)LTD, STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3169 | NDA/MAL/HDP/6440 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFIWEL 400 | CEFIXIME TRIHYDRATE | 400MG | MALIK LIFESCIENCES PRIVATE LIMITED, PLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3170 | NDA/MAL/HDP/6442 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | AZITO SUSPENSION | AZITHROMYCIN DIHYDRATE | 200 MG/5ML | ZIM LABORATORIES LTD, B-21/22, M.I.D.C. AREA, KALMESHWAR €“ 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 31/01/2018 |
| 3171 | NDA/MAL/HDP/6443 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | SINURHON SUSPENSION | CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL | 1MG + 5MG + 125MG | LEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 27/03/2019 |
| 3172 | NDA/MAL/HDP/6446 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | SNIP PAIN | PARACETAMOL + CAFFEINE | 500MG + 50MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/01/2019 |
| 3173 | NDA/MAL/HDP/6447 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | AZIBRU 500 | AZITHROMYCIN DIHYDRATE | 500MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2017 |
| 3174 | NDA/MAL/HDP/6449 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | DESLORAT SYRUP | DESLORATIDINE | 0.5MG/ML | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| 3175 | NDA/MAL/HDP/6455 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FICYC TABLETS | ACYCLOVIR | 200MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3176 | NDA/MAL/HDP/6457 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOXIWAR 400 | MOXIFLOXACIN HYDROCHLORIDE | 400MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*5TABLET BLISTER | 01/07/2017 |
| 3177 | NDA/MAL/HDP/6460 | MANKIND PHARM LTD | TATA UGANDA LIMITED | NUROKIND-OD | MECOBALAMIN | 1500MCG/ML | MANKIND PHARMA LTD., VILLAGE KISHANPURA, POAMTA SAHI DISTRICT SIRMOUR HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X4.0X1.0 ML AMPOULE | 27/03/2019 |
| 3178 | NDA/MAL/HDP/6462 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | AMOXYN-500 | AMOXICILLIN TRIHYDRATE | 500MG | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 26/09/2018 |
| 3179 | NDA/MAL/HDP/6463 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | SNIP | PARACETAMOL + PSEUDOEPHEDRINE + CHLORPHENAMINE | 325MG + 15MG + 1MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3180 | NDA/MAL/HDP/6466 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN ORAL TABLETS USP 500,000 I.U. | NYSTATIN | 500,000IU | S KANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3181 | NDA/MAL/HDP/6468 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CIROLAZINE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE,1.0X5.0X1.0 ML AMPOULE | 30/05/2018 |
| 3182 | NDA/MAL/HDP/6472 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV 375 | AMOXICILLIN TRIHYDRATE + CLAVULINIC ACID | 250MG + 125MG | MEDOCHEMIE LTD €“ FACTORY B, PLOT 48, IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL; AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP | 29/01/2019 |
| 3183 | NDA/MAL/HDP/6477 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOFULVIN | GRISEOFULVIN | 500 MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3184 | NDA/MAL/HDP/6479 | SHREEJI PHARMACEUTICALS LIMITED | SHREEJI PHARMACEUTICALS LIMITED | TRAMADOL HYDROCHLORIDE INJECTION 100MG/2ML | TRAMADOL HYDROCHLORIDE | 100 MG/2ML | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*10*2ML AMPOULE | 29/11/2017 |
| 3185 | NDA/MAL/HDP/6480 | MARCYRL PHARMACEUTICALS INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | NEVILOB | NEBIVOLOL HYDROCHLORIDE | 5MG | 1. MARCYRL PHARMACEUTICALS INDUSTRIES EL-OBOUR CITY, THE WEST EXTENSION BLOCK 20005 - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL SOLID ORDINARY TABLETS | I. 1*2*7TABLET BLISTER | 27/03/2019 |
| 3186 | NDA/MAL/HDP/6482 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHROX 75MCG | LEVOTHYROXINE SODIUM | 75 MCG | MERCK KGAA-PHARMA PRODUCTION DARMSTADT , FRANKFURTER STRABE 250, D-64293, DARMSTADT | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X25.0 TABLET BLISTER | 27/03/2019 |
| 3187 | NDA/MAL/HDP/6489 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | ASCORIL-SF | GUAIFENESIN + BROMHEXINE HYDROCHLORIDE + SALBUTAMOL SULFATE | 100 MG/10ML + 4 MG/10ML + 2 MG/10ML | 1. GLENMARK PHARMACEUTICAL LIMITED (UNIT-III) VILLAGE: KISHNPURA, BADDI - NALAGARH ROAD, TEHSIL - BADDI, DISTT. SOLAN, H.P., 173205 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SYRUPS | I. 1*100ML BOTTLE | 01/07/2017 |
| 3188 | NDA/MAL/HDP/6490 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | SORVATE OINTMENT | CALCITRIOL | 0.0003% W/W | 1. GLENMARK PHARMACEUTICALS LIMITED (UNIT-II) VILLAGE BHATTANWALA, P.O. RAJPURA, NALAGARH, DFISTT. SOLAN (H.P.) 174101 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*10G TUBE | 31/01/2018 |
| 3189 | NDA/MAL/HDP/6491 | INTAS PHARMACEUTICALS LIMITED | ZEE PHARMACEUTICALS LIMITED | PREGATAS ME 75 | PREGABALIN +MECOBALAMIN | 75MG+750MCG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 28/03/2018 |
| 3190 | NDA/MAL/HDP/6498 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | AMOXICILLIN DISPERSIBLE TABLETS 250 MG | AMOXICILLIN TRIHYDRATE | 250MG | MICRO LABS LIMITED PLOT , NO. 16, VEERASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE €“ 560 100. KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP | 25/07/2018 |
| 3191 | NDA/MAL/HDP/6499 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | TACROZ FORTE | TACROLIMUS USP | 0.1%W/W | GLENMARK PHARMACEUTICALS LTD ., PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 28/05/2019 |
| 3192 | NDA/MAL/HDP/6500 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | DERIVA C GEL | ADAPLENE BP + CLINDAMYCIN PHOSPHATE USP EQUIVALENT TO CLINDAMYCIN | 1MG + 10MG | GLENMARK PHARMACEUTICALS LTD ., PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 28/05/2019 |
| 3193 | NDA/MAL/HDP/6501 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTROGYL 200 TABLET | METRONIDAZOLE | 200MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3194 | NDA/MAL/HDP/6510 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | TACROZ | TACROLIMUS USP | 0.03%W/W | GLENMARK PHARMACEUTICALS LTD ., PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 28/05/2019 |
| 3195 | NDA/MAL/HDP/6512 | AXA PARENTERALS LTD | VITACARE LIMITED | AXACIP | CIPROFLOXACIN | 200MG/100ML | AXA PARENTERAL LIMITED, PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 31/01/2018 |
| 3196 | NDA/MAL/HDP/6513 | MACARTHYS LABORATORIES | LABOREX UGANDA LIMITED | GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS PER ML SOLUTION FOR INJECTION | GLYCOPYRRONIUM BROMIDE | 200MCG/ML | MACARTHYS LABORATORIES LIMITED T\A MARTINDALE PHARMA, BAMPTON ROAD, ROMFORD, ESSEX RM3 8UG, | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0 ML AMPOULE | 28/05/2019 |
| 3197 | NDA/MAL/HDP/6514 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FEBRILEX | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE | 500MG + 5M + 2MG | MILAN LABORATORIES (INDIA) PVT LTD,, 63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET STRIP | 28/05/2019 |
| 3198 | NDA/MAL/HDP/6520 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND-MD 8 | ONDASENTRON | 8MG | MANKIND PHARMA LTD-, UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3199 | NDA/MAL/HDP/6522 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EPNONE 25 | EPLERENONE | 25MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3200 | NDA/MAL/HDP/6523 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLEXDOL | IBUPROFEN+METHOCARBAMOL | 200MG+500MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3201 | NDA/MAL/HDP/6524 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | RAMGIC | TRAMADOL HYDROCHLORIDE | 50MG/ML | MSN LABORATORIES PRIVATE LIMITED - PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE, 1.0X10.0X2.0 ML AMPOULE | 27/03/2019 |
| 3202 | NDA/MAL/HDP/6525 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | DAPOXEM 30 | DAPOXETINE | 30MG | MSN LABORATORIES LTD. , PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2019 |
| 3203 | NDA/MAL/HDP/6526 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | DAPOXEM 60 | DAPOXETINE | 60MG | MSN LABORATORIES LTD. , PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2019 |
| 3204 | NDA/MAL/HDP/6527 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PULMOFIRST 62.5 | BOSENTAN MONOHYDRATE | 62.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3205 | NDA/MAL/HDP/6528 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PULMOFIRST 125 | BOSENTAN MONOHYDRATE | 125MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3206 | NDA/MAL/HDP/6537 | EXPHAR LTD. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CARBOSOL | CARMELLOSE SODIUM | 0.5%W/V | AHLCONPARENTERALS (INDIA) LIMITED, SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE | 31/01/2018 |
| 3207 | NDA/MAL/HDP/6546 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | NEOPEPTINE | ALPHA AMYLASE + PAPAIN | 100 MG + 50 MG/5G | 1. RAPTAKOS, BRETT & COMPANY LIMITED 1ST POKHRAN ROAD, THANE 400606, MIDC, MAHARASHTRA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | I. 1*60ML BOTTLE | 2019-03-27 00:00:00 |
| 3208 | NDA/MAL/HDP/6550 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | REDCEPHIN | CEFTRIAXONE | 1 G | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 27/03/2019 |
| 3209 | NDA/MAL/HDP/6553 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENSOL SOLUTION | CHLORHEXIDINE GLUCONATE + ISOPROPYL ALCOHOL | 0.5% W/W + 70% W/W | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X5.0 L CONTAINER | 27/03/2019 |
| 3210 | NDA/MAL/HDP/6554 | SEGURA PHARMA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RESPIQUIN-750 | LEVOFLOXACIN | 750MG | SAI MIRRA INNOPHARM PVT LIMITED , 288&299, SIDCO ESTATE AMBTTUR, CHENNAI 600098 | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3211 | NDA/MAL/HDP/6556 | SAVA HEALTHCARE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BECLOGEN CREAM | CLOTRIMAZOLE USP, BECLOMETASONE DIPROPIONATE BP, GENTAMICIN SULPHATE BP | 1%W/W, 0.025%W/W, 0.1%W/W | SAVA HEALTHCARE LIMITED., PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 27/03/2019 |
| 3212 | NDA/MAL/HDP/6562 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | ATROPINE EYE DROP BP 1 %W/V | ATROPINE SULPHATE | 1%W/V | SWISS PARENTERALS PVT LTD .., 809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML VIAL | 28/03/2019 |
| 3213 | NDA/MAL/HDP/6563 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANATAX ® 16MG | BETAHISTINE DIHYDROCHLORIDE | 16MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY, JORDAN - NUZHAT SAHAB | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3214 | NDA/MAL/HDP/6564 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANATAX ® 24MG | BETAHISTINE DIHYDROCHLORIDE | 24 MG | THE UNITED PHARMACEUTICALS MANUFACTURING. CO. LTD NUZHAT SAHAB, AL-RAQEEM- NEAR PUBLIC SECURITY HOUSING - AMMAN - JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 27/03/2019 |
| 3215 | NDA/MAL/HDP/6565 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | IBUPROFEN | IBUPROFEN | 200MG | TRIVENI FORMULATIONS LTD-PLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 28/03/2019 |
| 3216 | NDA/MAL/HDP/6575 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | SENSOCAIN | BUPIVACAINE HYDROCHLORIDE | 0.75% W/V | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE | 28/08/2019 |
| 3217 | NDA/MAL/HDP/6577 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | CEFIWEL-200 | CEFIXIME | 200MG | MALIK LIFESCIENCES PRIVATE LIMITED, PLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3218 | NDA/MAL/HDP/6578 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ACINET DRY SYRUP 228.5MG/5ML | AMOXYCILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 200MG + 28.5MG PER 5ML | INDCHEMIE HEALTH SPECIALITIES PVT. LTD, VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| 3219 | NDA/MAL/HDP/6579 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | PLENCOXIB 200 | CELECOXIB | 200 MG | AKUMS DRUGS AND PHARMACEUTICALS, 19,20,21, SEC.6-A, IIE, SIDCUL, RANIPUR,HARIDWAR-249403, UTTARAKHAND, INDIAINDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER,10.0X10.0 CAPSULE BLISTER | 27/08/2019 |
| 3220 | NDA/MAL/HDP/6584 | ZIFAM PINNACLE LTD | DELMAW ENTERPRISES LIMITED | ZIFLODIP 5 | AMLODIPINE BESILATE | 5 MG | 1. FREDUN PHARMACEUTICALS LIMITED 14, 15, 16 ZORABIAN INDUSTRIAL COMPLEX, VEVOOR, PALGHAR 401 404 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*3*10TABLET BLISTER | 27/08/2019 |
| 3221 | NDA/MAL/HDP/6585 | ZIFAM PINNACLE PTY. LTD. | DELMAW ENTERPRISES LIMITED | ZIFLODIP 10 | AMLODIPINE BESILATE | 10 MG | 1. FREDUN PHARMACEUTICALS LIMITED 14, 15, 16 ZORABIAN INDUSTRIAL COMPLEX, VEVOOR, PALGHAR 401 404 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER II. 1*3*10TABLET BLISTER | 27/08/2019 |
| 3222 | NDA/MAL/HDP/6587 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SEDALAM | MIDAZOLAM | 1MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X10.0X5.0 ML VIAL | 29/05/2019 |
| 3223 | NDA/MAL/HDP/6588 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SEDALAM | MIDAZOLAM | 5MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X3.0 ML VIAL | 29/05/2019 |
| 3224 | NDA/MAL/HDP/6589 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | VANBACT | VANCOMYCIN HYDROCHLORIDE | 500MG | NABIQASIM INDUSTRIES (PVT) LTD ., 17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 28/05/2019 |
| 3225 | NDA/MAL/HDP/6590 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | LOPROT | OMEPRAZOLE SODIUM | 40MG | NABIQASIM INDUSTRIES (PVT) LTD ., 17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 28/05/2019 |
| 3226 | NDA/MAL/HDP/6593 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | TRANSIC | TRANEXAMIC ACID | 500MG | SURGE LABS (PVT) LTD, 10TH KM FAISALABAD ROAD, BIKHI DISTRICT SHEIKHUPURA | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0 ML AMPOULE | 28/05/2019 |
| 3227 | NDA/MAL/HDP/6598 | MSN LABORATORIES (PVT) LTD | AIVEEN (U) LIMITED | BREATHEZY-L (10/5) | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10MG + 5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/01/2019 |
| 3228 | NDA/MAL/HDP/6600 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PROSTALEN | ALFUZOSIN HYDROCHLORIDE | 10MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3229 | NDA/MAL/HDP/6602 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CARDIURINE | CAPTOPRIL + HYDROCHLOROTHIAZIDE | 50MG + 25MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3230 | NDA/MAL/HDP/6609 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIZOL | FLUCONAZOLE | 200MG/200ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION BAGS | 1.0X100.0 ML BAG | 28/05/2019 |
| 3231 | NDA/MAL/HDP/6610 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND | ONDANSENTRON HYDROCHLORIDE | 2MG/ML | MANKIND PHARMA LTD-, UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X4.0X2.0 ML AMPOULE,1.0X4.0X4.0 ML AMPOULE | 01/07/2014 |
| 3232 | NDA/MAL/HDP/6612 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APRAZOLE PLUS-20 | OMEPRAZOLE + SODIUM BICARBONATE | 20MG/6G + 1680MG/6G | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X20.0X6.0 G SACHET | 01/07/2008 |
| 3233 | NDA/MAL/HDP/6616 | SHIN POONG PHARMACEUTICALS CO.LTD | AAFIYA (A) LIMITED | PYRAMAX | PYRONARIDINE TETRAPHOSPHATE + ARTESUNATE | 180MG + 60MG | SHIN POONG PHARM. CO., LTD, 70, SANDAN-RO, 19 BEON-GIL, DANWON-GU, ANSAN-SI, GYEONGGI-DO, REPUBLIC OF KOREA | SOUTH KOREA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X9.0 TABLET BLISTER | 01/07/2016 |
| 3234 | NDA/MAL/HDP/6617 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APFLU | CHLOROPHENERAMINE + PARACETAMOL + VITAMIN C | 0.5MG + 120MG + 50MG | AJANTA PHARMA LIMITED, 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| 3235 | NDA/MAL/HDP/6620 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET 5MG | NEBIVOLOL HYDROCHLORIDE | 5MG | BERLIN-CHEMIE AG, BERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLIN | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2016 |
| 3236 | NDA/MAL/HDP/6621 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | BAROLE 20 | RABEPRAZOLE | 20MG | INVENTIA HEALTHCARE LIMITED, F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| 3237 | NDA/MAL/HDP/6622 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFIWEL-100 DT | CEFIXIME TRIHYDRATE | 100MG | MALIK LIFESCIENCES PRIVATE LIMITED, PLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3238 | NDA/MAL/HDP/6625 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET PLUS 5/12.5 | NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, , ) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL) TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER (FREE MEDICAL SAMPLE) | 01/07/2016 |
| 3239 | NDA/MAL/HDP/6626 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | ONEGABA 300 | GABAPENTIN | 300MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 01/07/2017 |
| 3240 | NDA/MAL/HDP/6629 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET PLUS 5/25 | NEBIVOLOL+HYDROCHLOROTHIAZIDE | 5MG+25MG | BERLIN-CHEMIE AG/MENARINI, GLIENICKER WEG 125, D-12489 BERLIN GERMANY(BATCH RELEASE)| BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION), TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 01/07/2016 |
| 3241 | NDA/MAL/HDP/6631 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBURN | SILVER SULFADIAZINE | 1%W/W | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X500.0 G JAR | 01/07/2016 |
| 3242 | NDA/MAL/HDP/6633 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | COLDRIL | PARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HCL | 500MG + 30MG + 2MG | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | | TANZANIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0X1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3243 | NDA/MAL/HDP/6636 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | COSAMIDE 100 | LACOSAMIDE | 100MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | MSN LABORATORIES LTD, PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3244 | NDA/MAL/HDP/6638 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | COSAMIDE 50 | LACOSAMIDE | 50MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3245 | NDA/MAL/HDP/6640 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI H ( 40/ 12.5) | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3246 | NDA/MAL/HDP/6641 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | CEFTRISONE- S 1.5G | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1.0G + 0.5G | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL + 10ML WFI AMPOULE | 01/07/2016 |
| 3247 | NDA/MAL/HDP/6645 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI H ( 80/ 12.5) | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3248 | NDA/MAL/HDP/6648 | UMEDICA LABORATORIES PVT LTD | VITACARE LIMITED | DEXAMETHASONE INJECTION | DEXAMETHASONE SODIUM PHOSPHATE | 4MG/ML | UMEDICA LABORATORIES PVT. LTD - PLOT 221-GIDC, 2ND PHASE, VAPI 396195, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X2.0 ML VIAL | 01/07/2016 |
| 3249 | NDA/MAL/HDP/6653 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | METSAFE 500 ER | METFORMIN HYDROCHLORIDE | 500MG | MSN LABORATORIES PVT. LIMITED, PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3250 | NDA/MAL/HDP/6658 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEBIEM 10 | NEBIVOLOL | 10MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3251 | NDA/MAL/HDP/6663 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | SITCOM | EUPHORBIA PROSTATA DRY EXTRACT | 10MG/G | PANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2013 |
| 3252 | NDA/MAL/HDP/6664 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX 125 KID | AMOXICILLIN TRIHYDRATE | 125MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3253 | NDA/MAL/HDP/6665 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SALBUMOL SYRUP | SALBUTAMOL | 2MG/5ML | REGAL PHARMACEUTICALS LTD, BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 3254 | NDA/MAL/HDP/6666 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEBIEM 5 | NEBIVOLOL HYDROCHLORIDE | 5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3255 | NDA/MAL/HDP/6667 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | SPARSH BIO-TECH PVT. LIMITED, PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2016 |
| 3256 | NDA/MAL/HDP/6669 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SUPER WELGRA -100 | SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE | 100MG + 60MG | AKUMS DRUGS AND PHARMACEUTICALS LTD, PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2016 |
| 3257 | NDA/MAL/HDP/6670 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | METROSIM-200 | METRONIDAZOLE | 200MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 3258 | NDA/MAL/HDP/6675 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNOSEMIDE -10 | FUROSEMIDE | 10MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2016 |
| 3259 | NDA/MAL/HDP/6678 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | TUSQ-DX | TERBUTALINE+BROMHEXINE+GUAIFENESIN | 1.25MG+4MG+50MG/5ML | BLUECROSS LABORATORIES LIMITED, A-12,M.I.D.C,NASHIK 422010 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| 3260 | NDA/MAL/HDP/6679 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | WOMIBAN TABLETS | ALBENDAZOLE | 400MG | BLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET STRIP | 01/07/1997 |
| 3261 | NDA/MAL/HDP/6681 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | WELQUINE | LEVOFLOXACIN | 0.5%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD. , PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| 3262 | NDA/MAL/HDP/6685 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | EVACEF | CEFOTAXIME | 1 G | NEON LABORATORIES LTD, PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2014 |
| 3263 | NDA/MAL/HDP/6686 | DAWA LIMITED | SUPER MEDIC LTD | DAWASOLONE | PREDNISOLONE | 5MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 3264 | NDA/MAL/HDP/6693 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CERTICAN1 | EVEROLIMUS | 1MG | NOVARTIS PHARMA STEIN AG., SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3265 | NDA/MAL/HDP/6694 | NOVARTIS PHARMA SERVICES INC. | SURGIPHARM (U) LIMITED | CERTICAN 0.5 | EVEROLIMUS | 0.5MG | NOVARTIS PHARMA STEIN AG., SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3266 | NDA/MAL/HDP/6708 | PHARMEDIC LABORATORIES (PVT) LTD. | HEALTHCARE LTD. | CLOMINOL TABLETS | CLOMIFENE CITRATE | 50 MG | 1. PHARMEDIC LABORATORIES (PVT) LTD. 16 KM MULTAN ROAD LAHORE, PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY TABLETS | I. 1*10TABLET BLISTER | 01/07/2017 |
| 3267 | NDA/MAL/HDP/6715 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CAZITHRO | AZITHROMYCIN | 200MG/5ML | CACHET PHARMACEUTICALS PVT LTD , THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X15.0 ML BOTTLE | 01/07/2009 |
| 3268 | NDA/MAL/HDP/6717 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CAZITHRO | AZITHROMYCIN | 500MG | CACHET PHARMACEUTICALS PVT LTD , THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2011 |
| 3269 | NDA/MAL/HDP/6719 | PHARMEDIC LABORATORIES (PVT) LTD. | HEALTHCARE LTD. | NAPROX-500 | NAPROXEN SODIUM | 500 MG | 1. PHARMEDIC LABORATORIES (PVT) LTD. 16 KM MULTAN ROAD LAHORE, PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY TABLETS | I. 1*2*10TABLET BLISTER | 01/07/2017 |
| 3270 | NDA/MAL/HDP/6728 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CIPROCOS-500 TABLETS | CIPROFLOXACIN | 500MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER | 01/07/2000 |
| 3271 | NDA/MAL/HDP/6730 | PHARMEDIC LABORATORIES (PVT) LTD. | HEALTHCARE LTD. | CEFOTRIM-1000 | CEFTRIAXONE | 1000 MG | 1. PHARMEDIC LABORATORIES (PVT) LTD. 16 KM MULTAN ROAD LAHORE, PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | I. 1.0X1000.0 MG VIAL + 5 ML AMPOULE OF WATER FOR INJECTION | 02/07/2017 |
| 3272 | NDA/MAL/HDP/6732 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSCOF EXPECTORANT ORIGINAL | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2010 |
| 3273 | NDA/MAL/HDP/6734 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EASCOF | BROMHEXINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN + MENTHOL | (4MG + 2MG + 100MG + 1MG)/10ML | CACHET PHARMACEUTICALS PVT LTD , THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| 3274 | NDA/MAL/HDP/6750 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | NYTIN | NYSTATIN | 500,000IU | KAMPALA PHARMECEUTICALS INDUSTRIES LTD., PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2005 |
| 3275 | NDA/MAL/HDP/6752 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | VITACEE | ASCORBIC ACID | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| 3276 | NDA/MAL/HDP/6753 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | TUSQ X SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | BLUECROSS LABORATORIES LIMITED, A-12,M.I.D.C,NASHIK 422010 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 3277 | NDA/MAL/HDP/6754 | INDIAN IMMUNOLOGICALS LIMITED | TATA UGANDA LIMITED | ABHAYRAB | RABIES ANTIGEN DERIVED FROM RABIES VIRUS(L.PASTEUR 2061/VERO STRAIN) | >2.5 I.U PER VIAL | HUMAN BIOLOGICALS INSTITUTE ( A DIVISION OF INDIAN IMMUNOLOGICALS LTD) ., KOZHIPANNAI PUDUMUND P.O DR. BASAVAIAH NAGAR UDHAGAMANDALAM PIN: 643007 TAMIL NADU | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.5 I.U VIAL 1*0.5ML DILUENT(0.9%W/V SODIUM CHLORIDE INJ. B.P) - 1 DOSE VIAL | 01/07/2016 |
| 3278 | NDA/MAL/HDP/6758 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | ADCO-NAPAMOL | PARACETAMOL | 500MG | ADCOCK INGRAM LIMITED , 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3279 | NDA/MAL/HDP/6759 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | BETAPYN | PARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE | 450 MG+10 MG+5 MG+50 MG | ADCOCK INGRAM LIMITED , 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X9.0 TABLET BLISTER,6.0X9.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER | 01/07/2017 |
| 3280 | NDA/MAL/HDP/6763 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | COMPRAL HEADACHE TABLETS | PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS | 100MG+400MG+130MG | ADCOCK INGRAM LIMITED , 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X48.0X2.0 TABLET STRIP | 01/07/2005 |
| 3281 | NDA/MAL/HDP/6764 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | IZRA 40 | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 40 MG | 1. UNICHEM LABORATORIES LIMITED (UNIT II) VILLAGE BHATAULI KALAN, THE BADDI, DISTT. SOLAN, HIMACHAL PRADESH - 173205, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | I. 1*10TABLET STRIP | 01/07/2016 |
| 3282 | NDA/MAL/HDP/6767 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | MEDI-KEEL A | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIES, SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN €“ 396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER | 01/07/2016 |
| 3283 | NDA/MAL/HDP/6769 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | MEDI-KEEL A HONEY & LEMON | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIES, SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN €“ 396 210 INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER | 01/07/2016 |
| 3284 | NDA/MAL/HDP/6771 | HOVID BHD | BARIKI EXIM PHARMA LTD | DIFLUVID | FLUCONAZOLE | 150MG | HOVID BERHAD,, LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER | 01/07/2016 |
| 3285 | NDA/MAL/HDP/6772 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PIOSAFE 30 | PIOGLITAZONE HCL | 30MG | ARISTO PHARMACEUTICALS PVT LTD , PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| 3286 | NDA/MAL/HDP/6775 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYSOLONE | PREDNISOLONE ACETATE | 1%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC SUSPENSIONS | I. 1*5ML VIAL | |
| 3287 | NDA/MAL/HDP/6776 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | M-FORLIN 500 | METFORMIN | 500MG | LINCOLN PHARMACEUTICAL LIMITED, TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| 3288 | NDA/MAL/HDP/6777 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL FUSIDIC ACID | FUSIDIC ACID | 2%W/W | KOTRA PHARMA (M) SDN. BHD, 1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/2016 |
| 3289 | NDA/MAL/HDP/6780 | B. BRAUN PHARMACEUTICALS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYTIMOL | TIMOLOL MALEATE | 0.5%W/V | 1. IVEE AQUA EPZ LIMITED EXPORT PROCESSING ZONE, LR NO. 18474/83, ATHI RIVER - KENYA KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | OPHTHALMIC DROPS | I. 1*5ML BOTTLE | |
| 3290 | NDA/MAL/HDP/6781 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NETAZOX-500 | NITAZOXANIDE | 500MG | IND-SWIFT LIMITED, INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2007 |
| 3291 | NDA/MAL/HDP/6785 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NETAZOX DT | NITAZOXANIDE | 200MG | IND-SWIFT LIMITED, INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2008 |
| 3292 | NDA/MAL/HDP/6787 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NETAZOX | NITAZOXANIDE | 100MG/5ML | IND-SWIFT LIMITED, INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE | 01/07/2008 |
| 3293 | NDA/MAL/HDP/6790 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIMZER | OMEPRAZOLE + DOMPERIDONE | 20MG + 30MG | INVENTIA HEALTHCARE PVT. LTD, FI €“ FI /1 ADDITIONAL AMBERNATH, M.I.D.C. AMBERNATH (EAST) €“ 421 506, DIST. THANE, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP | 01/07/2016 |
| 3294 | NDA/MAL/HDP/6794 | HETERO LABS LTD | REDDYS PHARMA LIMITED | ZOLID | LINEZOLID | 600MG | HETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3295 | NDA/MAL/HDP/6797 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | PETHIDINE INJECTION | PETHIDINE | 100MG/2ML | MARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/1997 |
| 3296 | NDA/MAL/HDP/6810 | GSK BIOLOGICALS SA | UNITED HEALTHCARE DISTRIBUTORS LTD | CERVARIX | HUMAN PAPILLOMA VIRUS VACCINE (RDNA) | TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL) | GLAXOSMITHKLINE BOILOGICALS, S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) + A 25 GAUGE NEEDLE | 01/07/2007 |
| 3297 | NDA/MAL/HDP/6812 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | NOFLOX | NORFLOXACIN | 0.3%W/V | ABACUS PARENTERAL DRUGS LIMITED, PLOT 114, BLOCK 191 | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE | 01/07/2016 |
| 3298 | NDA/MAL/HDP/6815 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCROM EYE DROPS | SODIUM CROMOGLYCATE | 2%W/V | ABACUS PARENTERAL DRUGS LTD., PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE | 01/07/2016 |
| 3299 | NDA/MAL/HDP/6817 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | LETROZOLE DENK 2.5 | LETROZOLE | 2.5MG | HAUPT PHARMA MüNSTER GMBH, SCHLEEBRüGGENKAMP 15 48159 MüNSTER GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3300 | NDA/MAL/HDP/6818 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | IMOVAX POLIO | POLIO VIRUS; (MAHONEY) TYPE 1- INACTIVE + (MEF-1) TYPE 2- INACTIVE + (SAUKETT) TYPE 3-INACTIVE | 40 D + 8D + 32 D ANTIGEN UNITS/ 0.5ML | SANOFI PASTEUR, 1541 AVENUE MARCEL MERIEUX, MARCY L'ETOILE, 69280 - FRANCE | FRANCE | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL | 01/07/2016 |
| 3301 | NDA/MAL/HDP/6820 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABBORI EAR DROPS | BORIC ACID | 1.83%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OTIC DROPS | 1.0X10.0 ML BOTTLE | 01/07/2017 |
| 3302 | NDA/MAL/HDP/6821 | LABOREX UGANDA LIMITED | LABOREX UGANDA LIMITED | MAGNESIUM SULPHATE INJECTION | MAGNESIUM SULPHATE | 50%W/V | MARTINDALE PHARMACEUTICAL LIMITED , BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X10.0 ML AMPOULE | 01/07/2016 |
| 3303 | NDA/MAL/HDP/6823 | LABOREX UGANDA LIMITED | LABOREX UGANDA LIMITED | EPHEDRINE HYDROCHLORIDE | EPHEDRINE HYDROCHLORIDE | 30MG/ML | MARTINDALE PHARMACEUTICALS ., ROMFORD ESSEX RM3 8UG UK | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 01/07/2016 |
| 3304 | NDA/MAL/HDP/6832 | PFIZER LABORATORIES LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NIMENRIX | MENINGOCOCCAL POLYSACCHARIDE SEROGROUPS A, C, W-135 & Y CONJUGATE VACCINE | 1 DOSE (0.5ML) CONTAINS 5MCG OF POLYSACCHARIDE FOR NEISSERIA MENINGITIDIS SEROGROUPS A,C,W-135 & Y | 1. GLAXOSMITHKLINE BIOLOGICALS RUE DE L’INSTITUT 89, 1330 RIXENSART, BELGIUM BELGIUM SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | BELGIUM | PARENTERAL ORDINARY VIALS | I. 1*1DOSE VIAL | |
| 3305 | NDA/MAL/HDP/6833 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ON.SENTRON-DENK 8MG ODT | ONDANSETRON | 8MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2016 |
| 3306 | NDA/MAL/HDP/6837 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEL KIT | CLARITHROMYCIN + METRONIDAZOLE + PANTOPRAZOLE SODIUM SESQUIHYDRATE | 250MG + 400MG +40MG | THE MADRAS PHARMACEUTICALS, 137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET STRIP | 01/07/2016 |
| 3307 | NDA/MAL/HDP/6843 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | FYTOBACT | CEFOPERAZONE + SULBACTAM | 0.5 G + 0.5 G | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2009 |
| 3308 | NDA/MAL/HDP/6845 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | FYTOBACT 2G | SULBACTAM SODIUM + CEFOPERAZONE SODIUM | 1G + 1G | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL | 01/07/2017 |
| 3309 | NDA/MAL/HDP/6857 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUCIPRO TABLETS | CIPROFLOXACIN | 500MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3310 | NDA/MAL/HDP/6859 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUVEL-500 TABLETS | LEVOFLOXACIN HEMIHYDRATE | 500MG | BRAWN LABORATORIES LTD.., 13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 26/09/2018 |
| 3311 | NDA/MAL/HDP/6862 | BRAWN LABORATORIES LIMITED | HEALTHCARE LTD. | DITS GEL | DICLOFENAC DIETHYLAMINE | 1%W/W | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE, 1.0X30.0 G TUBE | 01/07/2017 |
| 3312 | NDA/MAL/HDP/6870 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | HYDROSONE 100MG | HYDROCORTISONE SODIUM SUCCINATE | 100MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON (1*100MG GLASS VIAL + 1*2ML AMP WFI),1.0X50.0 VIAL CARTON | 29/11/2017 |
| 3313 | NDA/MAL/HDP/6871 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | VIVAX 100 | SILDENAFIL | 100MG | BRAWN LABORATORIES LTD.., 13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 26/09/2018 |
| 3314 | NDA/MAL/HDP/6872 | BRAWN LABORATORIES LIMITED | HEALTHCARE LTD. | NETRACORTIL EYE/EAR SUSPENSION | OXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE | 10MG+5MG+10000I.U | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| 3315 | NDA/MAL/HDP/6874 | BRAWN LABORATORIES LIMITED | HEALTHCARE LTD. | CITRAX TABLETS | CETIRIZINE | 10MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3316 | NDA/MAL/HDP/6875 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUMOX-250 CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER | 29/11/2017 |
| 3317 | NDA/MAL/HDP/6901 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ZINKORA KIT | [GLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + POTASSIUM CHLORIDE ] + [ZINC SULPHATE MONOHYDRATE] | [13.5G + 2.9G + 2.6G + 1.5G] + [20MG] | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY COMBINATION PACK POWDERS/GRANULES | 1.0X2.0X20.5 G SACHET + 1*10 TABLET BLISTER | 28/05/2019 |
| 3318 | NDA/MAL/HDP/6909 | F.HOFFMANN-LA ROCHE LTD | LABOREX UGANDA LIMITED | HERCEPTIN | TRASTUZUMAB | 600 MG | 1. F. HOFFMANN-LA ROCHE LTD KAISERAUGST F. HOFFMANN-LA ROCHE LTD WURMISWEG CH-4303 KAISERAUGST SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | I. 1*1 CARTON | 01/07/2017 |
| 3319 | NDA/MAL/HDP/6911 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | SCABION | CROTAMITON + SULPHUR | 10 G + 2 G | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2004 |
| 3320 | NDA/MAL/HDP/6913 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYROVA 10 | ROSUVASTATIN CALCIUM | 10 MG | ZYDUS LIFESCIENCES LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/08/2019 |
| 3321 | NDA/MAL/HDP/6914 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | PANZOLE TABLETS | PANTOPRAZOLE | 40MG | CORONA REMEDIES PVT LIMITED, VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH €“ 173223. INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3322 | NDA/MAL/HDP/6921 | B & O PHARM | TRIDEM PHARMA UGANDA LIMITED | DUFENAC | DICLOFENAC SODIUM | 75MG | GUILIN PHARMACEUTICAL CO LTD-, NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3323 | NDA/MAL/HDP/6922 | EXPHAR S.A. ZONING INDUSTRIEL DE NIVELLES SUD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUCAZOL | FLUCONAZOLE | 50 MG / 5 ML | GRACURE PHARMACEUTICALS LIMITED , E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDI | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 27/11/2018 |
| 3324 | NDA/MAL/HDP/6924 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | NAC MR | DICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE | 50MG+325MG+250MG | CORONA REMEDIES PVT LIMITED, VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH €“ 173223. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3325 | NDA/MAL/HDP/6927 | SEGURA PHARMA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GOPAYN MR | ACECLOFENAC BP+TIZANIDINE HYDROCHLORIDE USP+PARACETAMOL BP | 100MG+2MG+500MG | SAI MIRRA INNOPHARM PVT LIMITED , 288&299, SIDCO ESTATE AMBTTUR, CHENNAI 600098 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/05/2019 |
| 3326 | NDA/MAL/HDP/6928 | SAVA HEALTHCARE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOMENAP NS 0.05 | MOMETASONE FUROATE | 0.05%W/V | SAVA HEALTHCARE LIMITED., PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | NASAL SYSTEMIC UNIT DOSE AEROSOLS | 1.0X1.0X12.0 ML CANNISTER | 28/05/2019 |
| 3327 | NDA/MAL/HDP/6929 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RANCV1000 | RANOLAZINE | 1000MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3328 | NDA/MAL/HDP/6930 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | TAPAL 50 | TAPENTADOL | 50MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3329 | NDA/MAL/HDP/6932 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | VALATE-200 | SODIUM VALPROATE | 200 MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3330 | NDA/MAL/HDP/6933 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | VALATE 500 | SODIUM VALPROATE BP | 500MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 25/07/2018 |
| 3331 | NDA/MAL/HDP/6936 | SAVA HEALTHCARE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | RANKOF | PARACETAMOL+CAFFEINE, PHENYLEPHRINE + CHLORPHENAMINE MALEATE | 500MG+30MG+10MG+2MG | SAVA HEALTHCARE LIMITED., PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 28/05/2019 |
| 3332 | NDA/MAL/HDP/6939 | MSN LABORATORIES PRIVATE LIMITED | AIVEEN (U) LIMITED | TAPAL 100 | TAPENTADOL | 100MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3333 | NDA/MAL/HDP/6941 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLVAT 30 | TOLVAPTAN | 30MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 07/11/2018 |
| 3334 | NDA/MAL/HDP/6942 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLVAT 15 | TOLVAPTAN | 15MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 07/11/2018 |
| 3335 | NDA/MAL/HDP/6949 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | MEGAFER | IRON SUCROSE | 100MG/5ML | SURGE LABORATORIES (PVT) LTD.,,, 10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 28/05/2019 |
| 3336 | NDA/MAL/HDP/6951 | SHREEJI PHARMACEUTICALS LIMITED | SHREEJI PHARMACEUTICALS LIMITED | LIDOCAINE | LIDOCAINE HYDROCHLORIDE | 2% | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY VIALS | I. 1*2ML VIAL | 28/05/2019 |
| 3337 | NDA/MAL/HDP/6952 | SHREEJI PHARMACEUTICALS LIMITED | SHREEJI PHARMACEUTICALS LIMITED | SYN-MAL | ARTMETHER | 80MG/ML | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*6*1ML AMPOULE | 28/05/2019 |
| 3338 | NDA/MAL/HDP/6955 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SEVOTROY 250 | SEVOFLURANE | 250 | TROIKAA PHARMACEUTICALS LIMITED.., SANAND - KADI ROAD, THOL, CITY: THOL - 382 728, DIST. MEHSANA, GUJARAT STATE - INDIA | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE | 28/05/2019 |
| 3339 | NDA/MAL/HDP/6956 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | NUROTROY SR | MECOBALAMIN + FOLIC ACID + PYRIDOXINE HYDROCHLORIDE | 1500MCG + 5MG + 20MG | TROIKAA PHARMACEUTICALS LIMITED,,, C-1, SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER | 28/05/2019 |
| 3340 | NDA/MAL/HDP/6960 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | MERROBE 500 | MEROPENEM | 500MG | 1. ZEISS PHARMACEUTICALS PRIVATE LIMITED PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY VIALS | I. 1*20ML VIAL | 28/05/2019 |
| 3341 | NDA/MAL/HDP/6961 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | MERROBE 1000 | MEROPENEM | 1G | ZEISS PHARMACEUTICALS PVT LTD - , PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 29/05/2019 |
| 3342 | NDA/MAL/HDP/6967 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - | UNITED HEALTHCARE DISTRIBUTORS LTD | MICAZOLE | MICONAZOLE | 2%W/W | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE | 27/11/2019 |
| 3343 | NDA/MAL/HDP/6970 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND ORAL SOLUTION | ONDANSETRON | 4MG/5ML | MANKIND PHARMA LTD-, UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE | 01/07/2017 |
| 3344 | NDA/MAL/HDP/6973 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED DM SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + DEXTROMETHORPHAN | 1.25MG + 30MG + 10MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| 3345 | NDA/MAL/HDP/6974 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND-MD 4 | ONDANSETRON | 4MG | MANKIND PHARMA LIMITED, UNIT-II. , VILLAGE KISHANPURA, P.O JAMNIWALA, PAONTA SAHIB IN H.P. | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3346 | NDA/MAL/HDP/6981 | ZIFAM PINNACLE PTY. LTD. | DELMAW ENTERPRISES LIMITED | KIT LANZ | CLARITHROMYCIN + LANSOPRAZOLE + TINIDAZOLE | 250 MG + 30 MG + 500 MG | 1. FREDUN PHARMACEUTICALS LIMITED 14, 15, 16 ZORABIAN INDUSTRIAL COMPLEX, VEVOOR, PALGHAR 401 404 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | I. 1*7*6TABLET BLISTER | 27/08/2019 |
| 3347 | NDA/MAL/HDP/6988 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | ESZOLE | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3348 | NDA/MAL/HDP/6989 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED EXPECTORANT SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + GUAIFENESIN | 1.25MG+30MG+100MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| 3349 | NDA/MAL/HDP/6997 | HETERO LABS LTD | REDDYS PHARMA LIMITED | EC-PRAM 10 | ESCITALOPRAM OXALATE | 10MG | HETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X1.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3350 | NDA/MAL/HDP/6999 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | NYSTATIN ORAL SUSPENSION | NYSTATIN | 100000 IU/5ML | 1. CIRON DRUGS & PHARMACEUTICALS PRIVATE LIMITED N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, PALGHAR 40506, MAHARASHTRA STATE - INDI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*30ML BOTTLE | 31/01/2018 |
| 3351 | NDA/MAL/HDP/7003 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | NAC-SP | DICLOFENAC POTASSIUM + SERRATIOPEPTIDASE | 50MG + 10MG | CORONA REMEDIES PVT LTD.., VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| 3352 | NDA/MAL/HDP/7004 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | DUOCETZ | PARACETAMOL+TRAMADOL HYDROCHLORIDE | 325MG+37.5MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED.., 515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG | THAILAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3353 | NDA/MAL/HDP/7006 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | PREDNIMAX | PREDNISOLONE | 5MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/08/2019 |
| 3354 | NDA/MAL/HDP/7007 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EPNONE 50 | EPLERENONE | 50MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/11/2018 |
| 3355 | NDA/MAL/HDP/7010 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CALCAC 300 | CALCIUM LACTATE | 300MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA.| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/09/2019 |
| 3356 | NDA/MAL/HDP/7011 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | URSOLIV 250 | URSODEOXYCHOLIC ACID | 250MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED.., 515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER | 27/03/2019 |
| 3357 | NDA/MAL/HDP/7012 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYHEP DVIR | DACLATASVIR + SOFOSBUVIR | 60MG + 400MG | MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, MALEGAON, SINNAR, NASHIK -422 113, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE | 31/01/2018 |
| 3358 | NDA/MAL/HDP/7013 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AZITHRAA 500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 29/11/2017 |
| 3359 | NDA/MAL/HDP/7015 | KOPRAN LIMITED | TATA UGANDA LIMITED | LOKIT | OMEPRAZOLE | 20MG | KOPRAN LTD, VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| 3360 | NDA/MAL/HDP/7020 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | KEMOXYL 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | LABORATORY AND ALLIED LTD .., PLOT 209/10349, OFF MOMBASA ROAD | KENYA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 27/08/2019 |
| 3361 | NDA/MAL/HDP/7021 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNOFEC PLUS | ACECLOFENAC+PARACETAMOL | 100MG+500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3362 | NDA/MAL/HDP/7022 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNAFLAM PLUS | DICLOFENAC SODIUM+PARACETAMOL | 50MG+500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3363 | NDA/MAL/HDP/7023 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERZOL ORAL SUSPENSION | ALBENDAZOLE | 200 MG / 5 ML | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE,1.0X20.0X10.0 ML BOTTLE | 28/03/2018 |
| 3364 | NDA/MAL/HDP/7024 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MICOZAL | KETOCONAZOLE | 2%W/W | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 29/11/2017 |
| 3365 | NDA/MAL/HDP/7029 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | LIPIZAR 20 | ATORVASTATIN CALCIUM (TRIHYDRATE) | 20MG | ZIM LABORATORIES LTD, B-21/22, M.I.D.C. AREA, KALMESHWAR €“ 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3366 | NDA/MAL/HDP/7053 | HOVID BHD | BARIKI EXIM PHARMA LTD | KETOVID CREAM | KETOCONAZOLE | 2%W/W | HOVID BHD , 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2017 |
| 3367 | NDA/MAL/HDP/7057 | HOVID BHD | BARIKI EXIM PHARMA LTD | VIREST CREAM 5% | ACICLOVIR | 5%W/W | HOVID BHD , 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE | 01/07/2017 |
| 3368 | NDA/MAL/HDP/7058 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | NEURAN 300 MG CAPSULE | GABAPENTIN | 300MG | HOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 28/08/2019 |
| 3369 | NDA/MAL/HDP/7063 | HOVID BHD | BARIKI EXIM PHARMA LTD | GRISEOFULVIN 500MG FILM-COATED TABLET | GRISEOFULVIN | 500MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3370 | NDA/MAL/HDP/7064 | HOVID BHD | BARIKI EXIM PHARMA LTD | GLIMICRON 80MG TABLET | GLICLAZIDE | 80MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2018 |
| 3371 | NDA/MAL/HDP/7066 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MABRON SR | TRAMADOL HYDROCHLORIDE | 100MG | MEDOCHEMIE (FACTORY AZ)., 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID RETARD TABLETS | 1.0X1.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 BLISTER BLISTER | 27/08/2019 |
| 3372 | NDA/MAL/HDP/7067 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | SUPPOL 125 | PARACETAMOL | 125MG | MERIDIAN ENTERPRISES PVT. LTD-, PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 27/08/2019 |
| 3373 | NDA/MAL/HDP/7070 | HOVID BHD | BARIKI EXIM PHARMA LTD | DIABETMIN 1000 MG FILM-COATED TABLET | METFORMIN HYDROCHLORIDE | 1000MG | HOVID BERHAD (CHEMOR SITE)-, LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3374 | NDA/MAL/HDP/7071 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | FORACORT-200 | FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE | 6MCG + 200MCG | CIPLA LIMITEDPLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA. | INDIA | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0X120.0 METERED DOSE CANNISTER | 25/07/2018 |
| 3375 | NDA/MAL/HDP/7074 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | FORACORT-100 | FORMETEROL FUMARATE DIHYDRATE + BUDESONIDE | 6 MCG+100 MCG | CIPLA LIMITEDPLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA. | INDIA | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0X120.0 METERED DOSE CANNISTER | 25/07/2018 |
| 3376 | NDA/MAL/HDP/7077 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | FORACORT-400 | FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE | 6MCG + 400MCG | CIPLA LIMITEDPLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA. | INDIA | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0X120.0 METERED DOSE CANNISTER | 25/07/2018 |
| 3377 | NDA/MAL/HDP/7083 | HETERO DRUGS LTD | REDDYS PHARMA LIMITED | ETROBAX 90 | ETORICOXIB | 90MG | HETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/08/2019 |
| 3378 | NDA/MAL/HDP/7085 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | DYSEN SUSPENSION | SECNIDAZOLE | 750MG | NABIQASIM INDUSTRIES (PVT) LTD., 17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE | 27/08/2019 |
| 3379 | NDA/MAL/HDP/7086 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYLIN 75 | PREGABALIN | 75MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 27/03/2019 |
| 3380 | NDA/MAL/HDP/7088 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | PINNOX 200 | OFLOXACIN | 200MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3381 | NDA/MAL/HDP/7089 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | ES-LOPROT | ESOMEPRAZOLE SODIUM | 40MG | NABIQASIM INDUSTRIES (PVT) LTD., 17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL (+ 1*10ML AMPOULE OF 0.9% NACL) | 27/08/2019 |
| 3382 | NDA/MAL/HDP/7091 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARLEFLOX 500 TABLETS | LEVOFLOXACIN HEMIHYDRATE | 500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3383 | NDA/MAL/HDP/7092 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | PATMAC | PANTOPRAZOLE SODIUM | 40MG | NABIQASIM INDUSTRIES (PVT) LTD., 17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL (+ 1*10ML AMPOULE OF 0.9% NACL) | 27/08/2019 |
| 3384 | NDA/MAL/HDP/7094 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | GLANDIN-E2 | DINOPROSTONE | 2MG | NABIQASIM INDUSTRIES (PVT) LTD., 17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X3.0 G PRE- FILLED SYRINGE | 27/08/2019 |
| 3385 | NDA/MAL/HDP/7095 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | FREMOL EXTRA | PARACETAMOL + CAFFEINE | 500MG + 65MG | FREDUN PHARMACEUTICALS LIMITED, 14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X25.0X4.0 CAPLET STRIP | 21/11/2019 |
| 3386 | NDA/MAL/HDP/7098 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ACEFORCE SP | ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE | 100MG+325MG+15MG | AKUMS DRUGS AND PHARMACEUTICALS LTD, PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3387 | NDA/MAL/HDP/7099 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | MYGESTY | MEDROXYPROGESTERONE ACETATE | 150MG/ML | MYLAN LABORATORIES LIMITED, PLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X12.0X1.0 ML VIAL,1.0X25.0X1.0 ML VIAL | 27/11/2019 |
| 3388 | NDA/MAL/HDP/7101 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ASTHAREN | SALBUTAMOL SULPHATE | 4MG | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI- KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3389 | NDA/MAL/HDP/7102 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REPRAZINE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI- KIREKA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3390 | NDA/MAL/HDP/7103 | MACARTHYS LABORATORIES LTD | LABOREX UGANDA LIMITED | CAFFEINE CITRATE 10MG/ ML SOLUTION FOR INJECTION | CAFFEINE CITRATE | 10MG/ML | MACARTHYS LABORATORIES LIMITED T\A MARTINDALE PHARMA, BAMPTON ROAD, ROMFORD, ESSEX RM3 8UG, | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 21/11/2019 |
| 3391 | NDA/MAL/HDP/7105 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TRAMACETAL TABLETS | ACETAMINOPHEN +TRAMADOL HYDROCHLORIDE | 325MG+37.5MG | CACHET PHARMACEUTICALS PVT LTD, VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 29/01/2019 |
| 3392 | NDA/MAL/HDP/7106 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REVIVE | GLUCOSE ANHYDROUS + TRISODIUM CITRATE DIHYDRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE | 13.5G + 2.9G + 2.6G + 1.5G | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI- KIREKA | UGANDA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0 SACHET CARTON | 01/07/2016 |
| 3393 | NDA/MAL/HDP/7109 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BRUTAFLAM-60 | ETORICOXIB | 60MG | MANKIND PHARMA LTD, UNIT II ,, VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3394 | NDA/MAL/HDP/7110 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED EXTRA SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + DEXTROMETHORPHAN + GUAIFENESIN | 1.25MG + 10MG + 7.5MG + 50MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| 3395 | NDA/MAL/HDP/7112 | HETERO DRUGS LTD | REDDYS PHARMA LIMITED | ETROBAX 60 | ETORICOXIB | 60MG | HETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/08/2019 |
| 3396 | NDA/MAL/HDP/7113 | HETERO BIOPHARMA LIMITED, | REDDYS PHARMA LIMITED | RILAST 500 | RITUXIMAB | 500MG/50ML | HETERO BIOPHARMA LIMITED, SY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT €“ 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 27/08/2019 |
| 3397 | NDA/MAL/HDP/7114 | HETERO BIOPHARMA LIMITED | REDDYS PHARMA LIMITED | RILAST 100 | RITUXIMAB | 100MG/10ML | HETERO BIOPHARMA LIMITED - SY NO. 458 (PART), TSIIC-FORMULATION SEZ, PHASE-III, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOONAGAR DISTRICT, 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 27/08/2019 |
| 3398 | NDA/MAL/HDP/7115 | INTAS, PHARMACEUTICALS LTD | STAR BIOTECH UGANDA LTD | SARTEL 40H | TELMISARTAN +HYDROCHLOROTHIAZIDE | (40+12.5)MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| 3399 | NDA/MAL/HDP/7116 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE | 1.25MG + 30MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| 3400 | NDA/MAL/HDP/7117 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED TABLETS | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE | 2.5MG+60MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3401 | NDA/MAL/HDP/7118 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BRUTAFLAM-90 | ETORICOXIB | 90MG | MANKIND PHARMA LTD, UNIT II ,, VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3402 | NDA/MAL/HDP/7120 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | ANDROGEL | TESTOSTERONE | 16.2MG/G | BESINS MANUFACTURING BELGIUM (BMB), GROOT BIJGAARDENSTRAAT, 128. 1620 | BELGIUM | TOPICAL EXTERNAL EMULSION GELS | 1.0X88.0 G CANNISTER | 21/11/2019 |
| 3403 | NDA/MAL/HDP/7123 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | MARTINEZ 10 | MONTELUKAST SODIUM | 10MG | AKUMS DRUGS AND PHARMACEUTICALS LTD, PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3404 | NDA/MAL/HDP/7128 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | COTRIKANT-960 | TRIMETHOPRIM+SULFAMETHOXAZOLE | 800MG+160MG | S KANT HEALTHCARE LTD, PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 26/09/2018 |
| 3405 | NDA/MAL/HDP/7131 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV OS | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 125MG + 31.25MG/5ML | SPARSH BIO-TECH PVT. LTD.-, PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR €“ 361006 GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 26/09/2018 |
| 3406 | NDA/MAL/HDP/7135 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | CILACAR *10 | CILNIDIPINE | 10MG | UNIQUE PHARMACEUTICAL LABS LIMITED. ., 215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 29/08/2019 |
| 3407 | NDA/MAL/HDP/7147 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BIMAT | BIMATOPROST | 0.03% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML VIAL | 30/05/2018 |
| 3408 | NDA/MAL/HDP/7149 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OLOPAT OD | OLOPATADINE HYDROCHLORIDE | 0.2% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA| AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML VIAL | 30/05/2018 |
| 3409 | NDA/MAL/HDP/7150 | SAKAR HEALTHCARE LIMITED | MEDINOVATION ENTERPRISES LTD | SEFIXI - SB 1500 | CEFTRIAXONE SODIUM +SULBACTAM SODIUM | 1000 MG +500MG | SAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT – INDIA. | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL + 1X10ML FFS PLASTIC BOTTLE FOR WFI | 29/08/2019 |
| 3410 | NDA/MAL/HDP/7151 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APDROPS DX | MOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE | 5MG+1MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 30/05/2018 |
| 3411 | NDA/MAL/HDP/7152 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | MINOXIN PLUS | MINOXIDIL | 50MG/ML | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X6.0 ML BOTTLE WITH A DERMA ROLLER ADMINISTRATION DEVICE | 29/01/2019 |
| 3412 | NDA/MAL/HDP/7156 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | METFORMIN EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | 500MG | S KANT HEALTHCARE LTD, PLOT NO. 1805, G.I.D.C PHASE III, VAPI 396195, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/08/2019 |
| 3413 | NDA/MAL/HDP/7162 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | TEXAVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED, PLOT 1-7, LUZIRA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2017 |
| 3414 | NDA/MAL/HDP/7163 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | STODIL | LOPERAMIDE HYDROCHLORIDE | 2MG | TRIVENI FORMULATIONS LTD-PLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 27/08/2019 |
| 3415 | NDA/MAL/HDP/7165 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | ERYMAC | ERYTHROMYCIN STEARATE | 250MG | TRIVENI FORMULATIONS LTD-PLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/08/2019 |
| 3416 | NDA/MAL/HDP/7167 | SPARSH BIO-TECH PVT.LTD. | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV DS | AMOXICILLIN TRIHYDRATE + CLAVULANATE | 200MG + 28.5MG PER 5ML | SPARSH BIO-TECH PRIVATE LIMITED,., PLOT NO.1, SURVEY NO. 242/243/244, VILLAGE LAKHABVAD, JAMNAGAR 361006 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| 3417 | NDA/MAL/HDP/7170 | WOCKHARD LTD | ROYAL PHARMA 2011 LIMITED | PHYTON 4.5G | PIPERACILLIN + TAZOBACTAM | 4.0G + 0.5G | AQUA VITOE LABORATORIES, PLOT NO. 4, VILLAGE KUNJHAL, NEAR JHARMAJRI, BADDI, DIST. SOLAN HIMACHAL PRADESH - 173205| | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON +1X20ML WFI AMPOULE | 27/08/2019 |
| 3418 | NDA/MAL/HDP/7172 | WOCKHARD LTD | ROYAL PHARMA 2011 LIMITED | MERIMIX | MEROPENEM TRIHYDRATE + SULBACTAM SODIUM | 1G + 0.5G | 1. ZEISS PHARMACEUTICALS PRIVATE LIMITED PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1 CARTON | 29/08/2019 |
| 3419 | NDA/MAL/HDP/7173 | MISSION PHARMA A/S | LABOREX UGANDA LIMITED | TRICLOFEM® | MEDROXYPROGESTERONE ACETATE | 150MG/ML | P.T. TUNGGAL IDAMAN ABDI, JALAN ACHMAD YANI NO. 7 JAKARTA TIMUR 13230 | INDONESIA | PARENTERAL ORDINARY VIALS | 1.0X4.0X5.0 ML VIAL | 29/08/2019 |
| 3420 | NDA/MAL/HDP/7175 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS-AM 40/5 | TELMISARTAN + AMLODIPINE BESYLATE | 40MG + 5MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3421 | NDA/MAL/HDP/7179 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | AVONZA | TENOFOVIR DISOPROXIL FUMARATE+LAMIVUDINE+EFAVIRENZ | 300MG+300MG+400MG | MYLAN LABORATORIES LIMITEDD ,, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR-454775 DIST. DHAR, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER | 07/11/2018 |
| 3422 | NDA/MAL/HDP/7181 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | SURGIBION | VITAMIN B1 + VITAMIN B6 + VITAMIN B12 | 100MG, + 100MG + 1000MCG | SURGE LABORATORIES (PVT) LTD.,,, 10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0X3.0 ML AMPOULE | 27/08/2019 |
| 3423 | NDA/MAL/HDP/7186 | HETERO LABS LIMITED | REDDYS PHARMA LIMITED | TELMILO 40 | TELMISARTAN | 40 MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | |
| 3424 | NDA/MAL/HDP/7188 | HETERO LABS LTD | REDDYS PHARMA LIMITED | TELMILO 80 | TELMISARTAN | 80 MG | HETERO LABS LTD (UNIT-V) SY-SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/05/2019 |
| 3425 | NDA/MAL/HDP/7192 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TINAZOL | TINIDAZOLE | 500 MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 28/05/2019 |
| 3426 | NDA/MAL/HDP/7193 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUOXINE | CIPROFLOXACIN | 500 MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 28/05/2019 |
| 3427 | NDA/MAL/HDP/7194 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENSCRUB SOLUTION | LINEZOLID ,CHLORHEXIDINE GLUCONATE | 200 MG/100 ML ,4%W/V | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X500.0 ML BOTTLE | 29/01/2019 |
| 3428 | NDA/MAL/HDP/7197 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | RABIVAX-S | PURIFIED RABIES ANTIGEN (RABIES VIRUS PITMAN-MOORE STRAIN 3218) | NOT LESS THAN 2.5 I.U / DOSE | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0X1.0 DOSE VIAL + IML DILUENT AMPOULE | 18/05/2017 |
| 3429 | NDA/MAL/HDP/7198 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B.CHEMICALS & PHARMACEUTICALS LTD.) | PLANET PHARMACEUTICALS UGANDA LTD | SILBECOR | SILVER SULFADIAZINE | 1 %W/W | 1. UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J. B. CHEMICALS AND PHARMACEUTICALS LIMITED) PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*1*50G TUBE | 27/08/2019 |
| 3430 | NDA/MAL/HDP/7201 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | MEASLES AND RUBELLA VACCINE | LIVE, ATTENUATED MEASLES VIRUS + LIVE ATTENUATED RUBELLA VIRUS | NLT 1000 CCID50 + 1000 CCID50 / DOSE | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X10.0 DOSE VIAL + 5ML DILUENT, 1.0X50.0X1.0 DOSE VIAL + 1ML DILUENT | 29/08/2017 |
| 3431 | NDA/MAL/HDP/7211 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | PYODINE GEL | POVIDONE-IODINE | 5GM/100GM | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X20.0 G TUBE | 27/03/2019 |
| 3432 | NDA/MAL/HDP/7216 | SHIN POONG PHARMACEUTICALS CO.LTD | AAFIYA (A) LIMITED | PYRAMAX | PYRONARIDINE TETRAPHOSPHATE + ARTESUNATE | 60MG + 20MG | SHIN POONG PHARM. CO., LTD, 70, SANDAN-RO, 19 BEON-GIL, DANWON-GU, ANSAN-SI, GYEONGGI-DO, REPUBLIC OF KOREA | SOUTH KOREA | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X90.0 SACHET CARTON | 27/08/2019 |
| 3433 | NDA/MAL/HDP/7218 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTMIN 500 | METFORMIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3434 | NDA/MAL/HDP/7219 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOXONE -1 G | CEFTRIAXONE | 1 G | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1G VIAL | 29/11/2017 |
| 3435 | NDA/MAL/HDP/7223 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR | DOLUTEGRAVIR | 50MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 21/11/2019 |
| 3436 | NDA/MAL/HDP/7226 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ELICA-M | MOMETASONE FUROATE + MICONAZOLE NITRATE | 0.1%W/W + 2%W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 27/11/2019 |
| 3437 | NDA/MAL/HDP/7229 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARCIFLOX 500 | CIPROFLOXACIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3438 | NDA/MAL/HDP/7235 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | OPTIDEX-T | DEXAMETHASONE + TOBRAMYCIN | 0.1W/V + 0.3%W/V | JAMJOOM PHARMACEUTICALS CO., PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 27/11/2019 |
| 3439 | NDA/MAL/HDP/7237 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PAEDIATRIC | CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 1MG + 2.5MG | STEDMAN PHARMACEUTICALS PVT. LTD., C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE | 21/11/2019 |
| 3440 | NDA/MAL/HDP/7238 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-10 | NEBIVOLOL HYDROCHLORIDE | 10MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3441 | NDA/MAL/HDP/7241 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GENTASOL | GENTAMICIN SULFATE | 0.3%W/V | AHLCON PARENTERAL (I) LTD.-, SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 29/11/2017 |
| 3442 | NDA/MAL/HDP/7242 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | AMINORICH | MULTIVITAMINS, MINERALS | NA | STEDMAN PHARMACEUTICALS PVT. LTD., C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X15.0 CAPSULE BLISTER,1.0X1.0X2.0 CAPSULE BLISTER | 21/11/2019 |
| 3443 | NDA/MAL/HDP/7246 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | DESLORAT | DESLORATIDINE | 5MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET STRIP | 01/07/2017 |
| 3444 | NDA/MAL/HDP/7247 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | VITAFIL-Z | MULTIVITAMINS, MINERALS | NA | STEDMAN PHARMACEUTICALS PVT. LTD., C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 21/11/2019 |
| 3445 | NDA/MAL/HDP/7248 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | ESOMELODAN 20 | ESOMEPRAZOLE | 20MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3446 | NDA/MAL/HDP/7249 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | UNITED HEALTHCARE DISTRIBUTORS LTD | ESOMELODAN 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3447 | NDA/MAL/HDP/7250 | QUALITY CHEMICAL INDUSTRIES LIMITED(QCIL) | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DOLUTEGRAVIR SODIUM, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | DOLUTEGRAVIR SODIUM +LAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | QUALITY CHEMICAL INDUSTRIES LIMITED. , PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 21/11/2019 |
| 3448 | NDA/MAL/HDP/7251 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | HYDROXYUREA | HYDROXYCARBAMIDE | 500MG | HAUPT PHARMA AMAREG GMBH, DONAUSTAUFER STRASSE 378, 93055 REGENSBURG | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3449 | NDA/MAL/HDP/7253 | MANKIND PHARM LTD | TATA UGANDA LIMITED | MONTICOPE | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10MG + 5MG | MANKIND PHARMA LTD, UNIT II ,, VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3450 | NDA/MAL/HDP/7257 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PAARPIN TABLET | PARACETAMOL | 650 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3451 | NDA/MAL/HDP/7258 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | DESCOVY 200MG/10MG | EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 200MG/10MG | PATHEON INC.-, TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9| ROTTENDORF PHARMA GMBH, OSTENFELDER STRAßE 51-61,59320 ENNIGERLOH,GERMANY| | CANADA| GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 31/01/2018 |
| 3452 | NDA/MAL/HDP/7260 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ESOFAG-40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3453 | NDA/MAL/HDP/7267 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ESOFAG-20 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3454 | NDA/MAL/HDP/7269 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FEBRILEX SYRUP | PARACETAMOL+DEXTROMETORPHAN HYDROBROMIDE+CHLORPHENAMINE MALEATE | 125MG+5MG+1MG/5 ML | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2017 |
| 3455 | NDA/MAL/HDP/7271 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TURBOVAS CP | ROSUVASTATIN CALCIUM + CLOPIDOGREL | 5MG + 75MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3456 | NDA/MAL/HDP/7275 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TILYPTIN 20 | TENELIGLIPTIN HYDROBROMIDE HYDRATE | 20MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | TOPICAL EXTERNAL TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3457 | NDA/MAL/HDP/7284 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LTD | LIVERCOL 10 | ROSUVASTATIN CALCIUM | 10MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?.-3. 42050 SELÇUKLU / KONYA TURKEY | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/07/2018 |
| 3458 | NDA/MAL/HDP/7288 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KETESSE FILM COATED TABLETS | DEXKETOPROFEN TROMETAMOL | 25MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I, VIA CAMPO DI PILE 67100 L'AQUILA | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3459 | NDA/MAL/HDP/7292 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | IBUPLUS SUSPENSION | IBUPROFEN+.PARACETAMOL | 100MG + 125MG / 5ML | LEBEN LABORATORIES PVT LTD ., L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 21/11/2019 |
| 3460 | NDA/MAL/HDP/7293 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LTD | ALRINAST | DESLORATADINE | 5MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3461 | NDA/MAL/HDP/7295 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | LAMIFEN | TERBINAFINE HYDROCHLORIDE | 1%W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 27/11/2019 |
| 3462 | NDA/MAL/HDP/7296 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDAXONUM 2G | CEFTRIAXONE SODIUM | 2G | MEDOCHEMIE (FACTORY C), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X2.0 G VIAL | 29/01/2019 |
| 3463 | NDA/MAL/HDP/7298 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-2.5 | NEBIVOLOL HYDROCHLORIDE | 2.5 MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3464 | NDA/MAL/HDP/7301 | HETERO LABS LTD | REDDYS PHARMA LIMITED | PACLITERO 300 | PACLITAXEL | 60 MG/ML | HETERO LABS LIMITED UNIT-VI , APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DISTRICT) ANDHRA PRADESH-509301, , INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL | 26/09/2018 |
| 3465 | NDA/MAL/HDP/7303 | AXA PARENTERALS LTD | VITACARE LIMITED | AXATOL-20 | MANNITOL | 20%W/V | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 29/01/2019 |
| 3466 | NDA/MAL/HDP/7305 | HETERO LABS LTD | REDDYS PHARMA LIMITED | PACLITERO 30 | PACLITAXEL | 6 MG/ML | HETERO LABS LIMITED UNIT-VI , APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DISTRICT) ANDHRA PRADESH-509301, , INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL | 26/09/2018 |
| 3467 | NDA/MAL/HDP/7306 | HETERO LABS LTD | REDDYS PHARMA LIMITED | PACLITERO 100 | PACLITAXEL | 100 MG/16.7 ML | HETERO LABS LIMITED UNIT-VI , APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DISTRICT) ANDHRA PRADESH-509301, , INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X16.7 ML VIAL | 26/09/2018 |
| 3468 | NDA/MAL/HDP/7307 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERZOL | ALBENDAZOLE | 400 MG | GRACURE PHARMACEUTICAL LTD, E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 28/05/2019 |
| 3469 | NDA/MAL/HDP/7310 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ACRETIN 0.05% | TRETINOIN | 0.05%W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 27/11/2019 |
| 3470 | NDA/MAL/HDP/7311 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FLUCA OPTHALMIC SUSPENSION | FLUOROMETHOLON + SODIUM CROMOGLICATE | 1%W/V + 2%W/V | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 27/11/2019 |
| 3471 | NDA/MAL/HDP/7312 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE OINTMENT 5%W/W | POVIDONE IODINE | 5%W/W | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X125.0 G TUBE,1.0X250.0 G JAR | 01/07/2017 |
| 3472 | NDA/MAL/HDP/7315 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AROXICAM 7.5 | MELOXICAM | 7.5MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 21/11/2019 |
| 3473 | NDA/MAL/HDP/7316 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | I-UP TABLETS | FOLIC ACID + FERROUS ASCORBATE | 1.5 MG + 100 MG | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 21/11/2019 |
| 3474 | NDA/MAL/HDP/7317 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMITINO TABLETS 8MG | ONDANSETRON | 8MG | CACHET PHARMACEUTICAL PVT LTD. , VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH - 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3475 | NDA/MAL/HDP/7318 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV 625 | AMOXICILLIN TRIHYDRATE + CLAVULINIC ACID | 500MG + 125MG | MEDOCHEMIE LTD €“ FACTORY B, PLOT 48, IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL; AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP | 29/01/2019 |
| 3476 | NDA/MAL/HDP/7321 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | ASCORIL-D | DEXTROMETHORPHAN HYDROBROMIDE + TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + MENTHOL | 10MG + 1.25MG + 30MG + 1.5MG / 5ML | GLENMARK PHARMACEUTICALS LTD ., PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 27/11/2019 |
| 3477 | NDA/MAL/HDP/7329 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR- MR | PARACETAMOL +ACECLOFENAC+CHLORZOXAZONE | 500 MG+100 MG +375 MG | DAWA LTD , PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3478 | NDA/MAL/HDP/7330 | SENADOR LABORATORIES PRIVATE LIMITED | KIMSY MEDS LTD | FAMY-POP | LEVONORGESTREL | 0.03MG | MYLAN LABORATORIES LIMITED, PLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X35.0 TABLET BLISTER | 27/11/2019 |
| 3479 | NDA/MAL/HDP/7335 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE 5% | POVIDONE IODINE | 5%W/V | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/2017 |
| 3480 | NDA/MAL/HDP/7336 | MODI NUNDIPHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE GERMICIDE GARGLE 2% MINT | POVIDONE IODINE | 2%W/V | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | ORAL TOPICAL LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 31/01/2018 |
| 3481 | NDA/MAL/HDP/7338 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | IBUPLUS | IBUPROFEN + PARACETAMOL | 400MG + 325MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X15.0X2.0X20.0 TABLET BLISTER | 27/08/2019 |
| 3482 | NDA/MAL/HDP/7341 | M/S.MAXHEAL PHARMACEUTICALS(INDIA) | ABACUS PHARMA (AFRICA) LIMITED | ZITHROHEAL 500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 28/11/2019 |
| 3483 | NDA/MAL/HDP/7342 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ZEALARGY | RUPATADINE FUMERATE | 10 MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3484 | NDA/MAL/HDP/7345 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | DELTACEF | CEFEPIME | 1G | MEDOCHEMIE (FACTORY C), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 21/11/2019 |
| 3485 | NDA/MAL/HDP/7346 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REZN TABLETS | ZINC SULFATE MONOHYDRATE | 20MG | RENE INDUSTRIES LIMITED, PLOT 680 KAMULI- KIREKA | UGANDA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3486 | NDA/MAL/HDP/7348 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | ISENTRESS 25 MG | RALTEGRAVIR POTASSIUM | 25MG | MSD (PTY) LTD. , 117-16TH ROAD, HALFWAY HOUSE, 1685 SOUTH AFRICA| PATHEON PHARMACEUTICALS INC., 2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA| MERCK SHARP & DOHME BV., WAARDERWEG 39 HAARLEM, - 2031 BN, NETHERLANDS | UNITED STATES| NETHERLANDS| SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X60.0 TABLET BOTTLE | 28/03/2018 |
| 3487 | NDA/MAL/HDP/7350 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | SULCEF | CEFOPERAZONE+ SULBACTUM | 1G+1G | MEDOCHEMIE (FACTORY C), 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 ML VIAL | 27/03/2019 |
| 3488 | NDA/MAL/HDP/7353 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 500MG | METFORMIN HYDROCHLORIDE | 500MG | MERCK SANTÉ S.A.S., 2 RUE DU PRESSOIR VERT 45400 SEMOY FRANCE|MERCK KGAA-PHARMA PRODUCTION DARMSTADT , FRANKFURTER STRABE 250, D-64293, DARMSTADT| | FRANCE|GERMANY | ORAL SOLID RETARD TABLETS | 1.0X6.0X15.0 TABLET BLISTER | 28/03/2018 |
| 3489 | NDA/MAL/HDP/7355 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN SUSPENSION | ARTEMETHER+LUMEFANTRINE | 180MG+1080MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 31/01/2018 |
| 3490 | NDA/MAL/HDP/7356 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN TABLET 500MG | METFORMIN HYDROCHLORIDE | 500MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X20.0 TABLET BLISTER | 01/07/2017 |
| 3491 | NDA/MAL/HDP/7357 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | PAMAGIN-C SYRUP | CETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL | 2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5ML | CACHET PHARMACEUTICALS PVT LTD , THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 31/01/2018 |
| 3492 | NDA/MAL/HDP/7359 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | INDCLAV 625 | AMOXICILLIN+CLAVULANATE POTASSIUM | 500MG+125MG | INDCHEMIE HEALTH SPECIALITIES PVT LTD, VILLAGE THANA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER | 01/07/2017 |
| 3493 | NDA/MAL/HDP/7361 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | DOLUTEGRAVIR | DOLUTEGRAVIR SODIUM | 50MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET BOTTLE | 21/11/2019 |
| 3494 | NDA/MAL/HDP/7362 | RESONANT PHARMACEUTICALS PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | TRAM-DOL-50 | TRAMADOL HYDROCHLORIDE | 50 MG | 1. ACME FORMULATION PRIVATE LIMITED ROPAR ROAD, NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 174101, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER | 01/07/2017 |
| 3495 | NDA/MAL/HDP/7363 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | INDCLAV 228 | AMOXICILLIN+CLAVULANATE POTASSIUM | 200MG+28MG/5ML | INDCHEMIE HEALTH SPECIALITIES PVT. LTD., VILLAGE & P.O €“ THANA, TEHSIL €“ BADDI, DIST- SOLAN, HIMACHAL | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| 3496 | NDA/MAL/HDP/7364 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | MOKSEFEN 400 MG | MOXIFLOXACIN HYDROCHLORIDE | 400MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER, 1.0X7.0 X15.0 TABLET BLISTER | 01/07/2017 |
| 3497 | NDA/MAL/HDP/7365 | OCHOA LABORATORIES | SUPER MEDIC LTD | DOLOACT MR | PARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE | 500 MG+50 MG+250 MG | AUROCHEM PHARMACEUTICALS INDIA PRIVATE LIMITED, 58, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401 404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/01/2019 |
| 3498 | NDA/MAL/HDP/7381 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE ANTISEPTIC CREAM 5% | POVIDONE-IODINE | 5%W/W | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X20.0 G TUBE | 01/07/2017 |
| 3499 | NDA/MAL/HDP/7389 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - | UNITED HEALTHCARE DISTRIBUTORS LTD | GAROPRIDE | ITOPRIDE HYDROCHLORIDE | 50MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES, 176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3500 | NDA/MAL/HDP/7391 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | TAVIN-EM | TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE | 300MG + 200MG | EMCURE PHARMACEUTICALS LTD ., PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 27/11/2018 |
| 3501 | NDA/MAL/HDP/7394 | AXA PARENTERALS LTD | VITACARE LIMITED | AXADEX (D50%) | GLUCOSE ANHYDROUS | 50%W/V | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 21/11/2019 |
| 3502 | NDA/MAL/HDP/7406 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ARENA | ADRENALINE | 0.1% W/V | LINCOLN PHARMACEUTICALS LTD LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT | | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2017 |
| 3503 | NDA/MAL/HDP/7409 | SK AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT DISPERSIBLE | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*6TABLET BLISTER | 21/11/2019 |
| 3504 | NDA/MAL/HDP/7410 | MEDOPHARM, INDIA | PLANET PHARMACEUTICALS UGANDA LTD | COTRIMOXAZOLE TABLETS BP 960 MG | TRIMETHOPRIM +SULPHAMETHOXAZOLE | 960MG | WATERLAND LABORATORIES, 34 B, INDUSTRIAL AREA, MALUR - 563160, KARNATAKA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 26/09/2018 |
| 3505 | NDA/MAL/HDP/7411 | SK AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT 180-1080 | ARTEMETHER + LUMEFANTRINE | 180 MG/60ML + 1080 MG/60ML | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*60ML BOTTLE | 21/11/2019 |
| 3506 | NDA/MAL/HDP/7413 | SK AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | 1. S KANT HEALTHCARE LIMITED PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI - 396 195, GUJARAT INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*24TABLET BLISTER | 21/11/2019 |
| 3507 | NDA/MAL/HDP/7414 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | RIBOREA | HYDROXYUREA | 500MG | KHANDELWAL LABORATORIES PVT. LTD, B-1, WAGLE INDUSTRIAL ESTATE, THANE €“ 400 604 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3508 | NDA/MAL/HDP/7417 | INTAS PHARMACUITICALS LTD | STAR BIOTECH UGANDA LTD | SARTEL-40 | TELMISARTAN | 40MG | INTAS PHARMACEUTICALS LTD ...,, CAMP ROAD, SELAQUI, DEHRADUN- 248197, UTTARKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3509 | NDA/MAL/HDP/7425 | OCHOA LABORATORIES | AIVEEN (U) LIMITED | DOLOACT PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | AUROCHEM PHARMACEUTICALS - PLOT NO. 58, PTICE LTD PALGHAR 401404, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*1*10TABLET BLISTER II. 1*3*10TABLET BLISTER | 21/11/2019 |
| 3510 | NDA/MAL/HDP/7426 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOFED | GUAIFENESIN + DEXTROMETHORPHAN HYDROBROMIDE + PSEUDOEPHEDRINE HYDROCHLORIDE AND + TRIPROLIDINE HYDROCHLORIDE | 100MG + 15MG + 20MG + 1.25MG/5ML | MEDOCHEMIE ACTORY)....., 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL | CYPRUS | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 21/11/2019 |
| 3511 | NDA/MAL/HDP/7428 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TELPERZID | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40.0 MG + 12.5 MG | 1. ZIM LABORATORIES LIMITED B-21/22, MIDC AREA, KALMESHWAR - 441501, DIST. NAGPUR, MAHARASHTRA STATE €“ INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. PSA CHEMICALS & PHARMACEUTICALS PRIVATE LIMITED PLOT NO. A-2 & A-3, SEZ-II, PITHAMPUR, DISTT. DHAR, MADHYA PRADESH - 454 774, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | |
| 3512 | NDA/MAL/HDP/7429 | SAKAR HEALTHCARE LIMITED | ROYAL PHARMA 2011 LIMITED | SEFIXI 1000 | CEFTRIAXONE SODIUM | 1G | SAKAR HEALTHCARE PVT LTD, BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL, 1.0X1.0 G VIAL | 28/11/2019 |
| 3513 | NDA/MAL/HDP/7431 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | MOVICOL | MACROGOL 3350 (POLYETHYLENE GLYCOL)+SODIUM CHLORIDE+SODIUM BICARBONATE+ POTASSIUM CHLORIDE | 13.125G+350.7MG+178.5MG+46.6MG | WIN-MEDICARE PVT. LTD, MODIPURAM-250 110, UTTAR PRADESH,INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X13.81 G SACHET | 26/09/2018 |
| 3514 | NDA/MAL/HDP/7432 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | MENAFRIVAC | MENINGOCOCCAL A POLYSACCHARIDE + TETANUS TOXOID | 5µG + 5µG /0.5ML | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0 ML VIAL + 1*5ML AMPOULE FOR DILUENT | 28/11/2019 |
| 3515 | NDA/MAL/HDP/7439 | DAWA PHARMACEUTICALS LIMITED | SUPER MEDIC LTD | LORVIC | LORATADINE | 5MG/5ML | DAWA LIMITED, 16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 21/11/2019 |
| 3516 | NDA/MAL/HDP/7441 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYORTH XL | SODIUM HYALURONATE | 8MG/ML | VIRCHOW BIOTECH PRIVATE LIMITED, SURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0 ML PRE- FILLED SYRINGE | 29/11/2017 |
| 3517 | NDA/MAL/HDP/7442 | DAWA LIMITED- | SUPER MEDIC LTD | NERVILIN NT | PREGABALIN + NORTRIPTYLINE HYDROCHLORIDE | 75MG + 10MG | DAWA LIMITED, 16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3518 | NDA/MAL/HDP/7444 | AXA PARENTERALS LTD | VITACARE LIMITED | FRESH EYES | CARMELLOSE SODIUM | 0.5%W/V | AXA PARENTERAL LIMITED, PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 20/12/2018 |
| 3519 | NDA/MAL/HDP/7446 | AXA PARENTERALS LTD | VITACARE LIMITED | CIPLUME | CIPROFLOXACIN HYDROCHLORIDE | 0.3% W/V | AXA PARENTERAL LIMITED, PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2017 |
| 3520 | NDA/MAL/HDP/7447 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | LORADIN 10 | LORATADINE | 10MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3521 | NDA/MAL/HDP/7448 | OCHOA LABORATORIES | SUPER MEDIC LTD | SORID OINTMENT | CALCIPOTRIOL MONOHYDRATE + BETAMETHASONE DIPROPIONATE | 50MCG +0.5MG | AUROCHEM LABORATORIES (I) PVT LTD, 8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 29/11/2017 |
| 3522 | NDA/MAL/HDP/7450 | OCHOA LABORATORIES | SUPER MEDIC LTD | DOLOACT GEL | KETOPROFEN + CAPSICUM OLEORESIN | 2.50%W/W + 0.25%W/W | AUROCHEM LABORATORIES (I) PVT LTD-, 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 29/11/2017 |
| 3523 | NDA/MAL/HDP/7451 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | MYTHRO 500 | AZITHROMYCIN DIHYDRATE | 500MG | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C., JEJURI DIST PUNE 412303, MAHARASHTRA,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*3TABLET BLISTER | 21/11/2019 |
| 3524 | NDA/MAL/HDP/7456 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUTRAX | CEFTRIAXONE SODIUM | 1G | M/S ZEISS PHARMACEUTICALS PVT LTD,,, PLOT 72, EPIP PHASE 1, JHARMAJRI BADDI, DIST: SOLAN HP-INDIA|GMH ORGANICS UNIT II PLOT NO. 01, VILLAGE KUNJHAL, THARMAJRI, BADDI DISTRICT, SOLAN (H.P)| INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)|VENUS REMEDIES LIMITED ,., HILL TOP, INDUSTRIAL ESTATE, JHARMAJRI, EPIP, PHASE 1, EXT. BBATOLI KALAN, BADDI-SOLAN HIMACHAL PRADESH, INDIA PIN 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 21/11/2019 |
| 3525 | NDA/MAL/HDP/7457 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CIPLADON | PARACETAMOL EFFERVESCENT | 1000MG | CIPLA LTD ,,PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 | INDIA | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X2.0X4.0 TABLET BLISTER | 21/11/2019 |
| 3526 | NDA/MAL/HDP/7458 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | DERISE™25 | DARBEPOETIN ALFA | 25MCG/0.42ML | HETERO BIOPHARMA LIMITED - SY NO. 458 (PART), TSIIC-FORMULATION SEZ, PHASE-III, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOONAGAR DISTRICT, 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.42 ML PRE- FILLED SYRINGE (SINGLE DOSE) | 21/11/2019 |
| 3527 | NDA/MAL/HDP/7459 | HETERO BIOPHARMA LIMITED | AIVEEN (U) LIMITED | DERISE™40 | DARBEPOETIN ALFA | 40MCG/0.4ML | HETERO BIOPHARMA LIMITED - SY NO. 458 (PART), TSIIC-FORMULATION SEZ, PHASE-III, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOONAGAR DISTRICT, 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL RETARD PRE-FILLED SYRINGES | 1.0X0.2 ML PRE- FILLED SYRINGE | 21/11/2019 |
| 3528 | NDA/MAL/HDP/7463 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ACURON | ATRACURIUM BESYLATE | 10MG/ML | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 27/08/2019 |
| 3529 | NDA/MAL/HDP/7465 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN TS | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 120MG + 960MG | M/S BLISS GVS PHARMA LIMITED , PLOT 10, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE PALGHAR, DIST. THANE - 401404 | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0 TABLET BLISTER, 1.010.0X1.0X3.0 TABLET BLISTER | 21/11/2019 |
| 3530 | NDA/MAL/HDP/7466 | HETERO DRUGS LIMITED | REDDYS PHARMA LIMITED | VALSAR HT 80/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | 1. M/S HETERO LABS LIMITED, UNIT-V (V, VA & VB BLOCKS) SY. NO. 439, 440, 441 & 458, TSIIC, PHARMA SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301 TELANGANA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 21/11/2019 |
| 3531 | NDA/MAL/HDP/7467 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | TEZOLE CREAM | KETOCONAZOLE | 20 MG | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 27/08/2019 |
| 3532 | NDA/MAL/HDP/7468 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | GYNO PLUS | METRONIDAZOLE + MICONAZOLE NITRATE | 100MG + 100MG | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C., JEJURI DIST PUNE 412303, MAHARASHTRA,INDIA | INDIA | VAGINAL TABLETS | I. 1*1*10TABLET BLISTER | 28/11/2019 |
| 3533 | NDA/MAL/HDP/7469 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ECZEMUS 0.03% OINTMENT | TACROLIMUS MONOHYDRATE | 0.03%W/W | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 25/07/2018 |
| 3534 | NDA/MAL/HDP/7470 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | AKSONE | CEFTRIAXONE SODIUM | 1 G | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C., JEJURI DIST PUNE 412303, MAHARASHTRA,INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1G VIAL | 21/11/2019 |
| 3535 | NDA/MAL/HDP/7476 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | AKRIDOL 12.5 | CARVEDILOL | 12.5MG | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C., JEJURI DIST PUNE 412303, MAHARASHTRA,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 21/11/2019 |
| 3536 | NDA/MAL/HDP/7480 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | AMOKLAVIN BID | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 200MG + 28.5MG/5ML | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 21/11/2019 |
| 3537 | NDA/MAL/HDP/7482 | OCHOA LABORATORIES | DELMAW ENTERPRISES LIMITED | FUSIDEL-B CREAM | FUSIDIC ACID BP + BETAMETHASONE VALERATE BP | 2.0 % W/W + 0.1 % W/W | 1. AUROCHEM LABORATORIES INDIA PRIVATE LIMITED PLOT NO 8, PALGHAR TALUKA IND. CO. OP. ESTATE LIMITED, BOISAR ROAD, PALGHAR €“ 401404, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 29/11/2017 |
| 3538 | NDA/MAL/HDP/7484 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ATORVA AM 10/20 | AMLODIPINE BESYLATE + ATORVASTATIN CALCIUM | 10MG + 20MG | ZYDUS LIFESCIENCES-KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3539 | NDA/MAL/HDP/7486 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORVA AM 5/20 | AMLODIPINE BESYLATE + ATORVASTATIN CALCIUM | 5MG + 20MG | ZYDUS LIFESCIENCES LTD -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET CARTON | 21/11/2019 |
| 3540 | NDA/MAL/HDP/7487 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | BETASALIC | BETAMETHASONE DIPROPIONATE + SALICYLIC ACID | 0.05%W/W + 3%W/W | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 21/11/2019 |
| 3541 | NDA/MAL/HDP/7488 | INTAS PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | FINTAS 5 | FINASTERIDE | 5MG | INTAS PHARMACEUTICALS LTD ., PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| 3542 | NDA/MAL/HDP/7491 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | CIPRO-DENK 750 | CIPROFLOXACIN HYDROCHLORIDE | 750MG | ALLPHAMED PHARBIL ARZNEIMITTEL GMBH. , HILDEBRANDSTRABE 12 37081 GOTTINGEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3543 | NDA/MAL/HDP/7493 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | CEFRAZ 200 | CEFIXIME TRIHYDRATE | 200 MG | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/11/2019 |
| 3544 | NDA/MAL/HDP/7495 | LINCOLN PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | MEBEX | MEBENDAZOLE | 100MG | LINCO N PHARMACEUTICALS LIMITED, TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 28/08/2019 |
| 3545 | NDA/MAL/HDP/7498 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CELDOL 100 | CELECOXIB | 100MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 21/11/2019 |
| 3546 | NDA/MAL/HDP/7499 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CELDOL 200 | CELECOXIB | 200 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 21/11/2019 |
| 3547 | NDA/MAL/HDP/7503 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DUTABIT 0.5 | DUTASTERIDE | 0.5MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 21/11/2019 |
| 3548 | NDA/MAL/HDP/7514 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | ILFLOX 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | ILKO ILAC SANAYI VE TICARET A.S-3.ORGANIZE SANAYI BOLGESI, BUYUK KAYACIK MAH. KUDDISI CAD.23 SOKAKNO. 1 42050 SELCUKLU, KONYA | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 21/11/2019 |
| 3549 | NDA/MAL/HDP/7515 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | HEPBEST | PREGABALIN + NORTRIPTYLINE (AS HYDROCHLORIDE) | 75MG + 10MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 21/11/2019 |
| 3550 | NDA/MAL/HDP/7517 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | LEVOCET-M | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | RESONANT PHARMACEUTICALS PRIVATE LIMITED - PLOT NO – 430-1-A NEAR SAFFRO MELLOW COLOUR FACTORY, VILLAGE, NAVAGAM, DISTRICT KHEDA, GUJARAT - 387540, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3551 | NDA/MAL/HDP/7518 | RESONANT PHARMACEUTICALS | SHREEJI PHARMACEUTICALS LIMITED | LEVOCET-M SUSPENSION | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 2.5MG / 5ML + 4MG / 5ML | HOF PHARMACEUTICALS LIMITED - SURVEY NO. 211-4/5/6, VILLAGE: PIPAN, SANAND - BAVLA ROAD, AHMEDABAD, GUJARAT - 382110 – INDIA| CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 21/11/2019 |
| 3552 | NDA/MAL/HDP/7520 | DAWA LIMITED | SUPER MEDIC LTD | LEVOXCIN | LEVOFLOXACIN HEMIHYDRATE | 750 MG | DAWA LIMITED , 16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3553 | NDA/MAL/HDP/7523 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | LEVOFLOX-DENK 5 MG/ML | LEVOFLOXACIN HEMIHYDRATE | 5MG/ML | SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH, -INDUSTRIESTR. 3 34212 MELSUNGEN GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML VIAL | 01/07/2017 |
| 3554 | NDA/MAL/HDP/7525 | DAWA LIMITED | SUPER MEDIC LTD | LORVIC | LORATADINE | 10 MG | DAWA LIMITED, 16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3555 | NDA/MAL/HDP/7526 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | MANIGRA 100 | SILDENAFIL CITRATE | 100 MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 27/11/2019 |
| 3556 | NDA/MAL/HDP/7527 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | MANIGRA 50 | SILDENAFIL CITRATE | 50MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 21/11/2019 |
| 3557 | NDA/MAL/HDP/7529 | FDC LTD | AIVEEN (U) LIMITED | MOSI EYE DROPS | MOXIFLOXACIN HYDROCHLORIDE | 5 MG/ML | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML VIAL | 21/11/2019 |
| 3558 | NDA/MAL/HDP/7530 | HETERO LABS LTD | AIVEEN (U) LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR | 50MG | HETERO LABS LTD UNIT III, 22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,| HETERO LABS LIMITED (UNIT V), SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 07/11/2018 |
| 3559 | NDA/MAL/HDP/7533 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ASUNATE 60 | ARTESUNATE | 60 MG | INDASI LIFESCIENCE PRIVATE LIMITED, PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1*5ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1*1ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE | 26/09/2018 |
| 3560 | NDA/MAL/HDP/7535 | ACME FORMULATION PVT. LTD. | MARIE STOPES UGANDA LIMITED | MARIPRIST | MIFEPRISTONE + MISOPROSTOL | 200MG + 200MCG | ACME FORMULATION PVT. LTD, ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0XX5.0 TABLET BLISTER | 27/08/2019 |
| 3561 | NDA/MAL/HDP/7539 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | COUGH LINCTUS | CHLORPHENIRAMINE | 2MG/5ML | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1000.0 ML JERRYCAN,1.0X200.0 ML BOTTLE | 01/07/2011 |
| 3562 | NDA/MAL/HDP/7541 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | CHLORHEXIDINE SCRUB | CHLORHEXIDINE GLUCONATE | 4%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X1000.0 ML JERRYCAN | 01/07/2012 |
| 3563 | NDA/MAL/HDP/7544 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | GLYCERIN OF BORAX | GLYCERINE+BORAX | 12%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X22.0 ML BOTTLE | 01/07/2013 |
| 3564 | NDA/MAL/HDP/7546 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | HYDROGEN PEROXIDE | HYDROGEN PEROXIDE | 6%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 01/07/2012 |
| 3565 | NDA/MAL/HDP/7548 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | IODINE TINCTURE | IODINE + POTASSIUM IODIDE | 2.5%W/V+2.5%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X22.0 ML BOTTLE | 01/07/2013 |
| 3566 | NDA/MAL/HDP/7552 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | MAGNESIUM TRISILICATE MIXTURE | MAGNESIUM TRISILICATE + LIGHT MAGNESIUM CARBONATE + SODIUM BICARBONATE | 250MG + 250MG + 250MG/5ML | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2010 |
| 3567 | NDA/MAL/HDP/7554 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | POVIDONE IODINE BP | POVIDONE IODINE | 10%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN | 01/07/2013 |
| 3568 | NDA/MAL/HDP/7556 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | SEVASTAT | CETRIMIDE + CHLORHEXIDINE | 3%W/V+0.3%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L BOTTLE | 01/07/2012 |
| 3569 | NDA/MAL/HDP/7559 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | SURGICAL SPIRIT | METHYL SALICYLATE | 0.5%V/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL SPIRITS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| 3570 | NDA/MAL/HDP/7560 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | VIOLGENT | CRYSTAL VIOLET | 0.5%W/V | SEV PHARMACEUTICALS LIMITED, PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X25.0 ML BOTTLE | 01/07/2014 |
| 3571 | NDA/MAL/HDP/7571 | HOVID BHD | BARIKI EXIM PHARMA LTD | NEUROVIT FILM-COATED TABLET | THIAMINE MONONITRATE + PYRIDOXINE HCL + CYANOCOBALAMINE | 97MG + 50MG + 100MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 3572 | NDA/MAL/HDP/7586 | OCHOA LABORATORIES | SUPER MEDIC LTD | CLEAR-T GEL | CLINDAMYCIN PHOSPHATE + TRETINOIN | 1.0%W/W + 0.025%W/W | AUROCHEM LABORATORIES LTD , PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 29/11/2017 |
| 3573 | NDA/MAL/HDP/7587 | DAWA LIMITED | SUPER MEDIC LTD | NERVILIN 75 | PREGABALIN | 75 MG | DAWA LIMITED, 16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3574 | NDA/MAL/HDP/7588 | OCHOA LABORATORIES | SUPER MEDIC LTD | EXEVATE-MF OINTMENT | BETAMETHASONE DIPROPIONATE + SALICYLIC ACID + UREA + LACTIC ACID + SODIUM LACTATE SOLUTION | 0.05 % W/W + 3.0 % W/W + 10.0 % W/W + 3.0 % W/W + 2.0 % W/W | AUROCHEM LABORATORIES (I) PVT LTD, 8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 29/11/2017 |
| 3575 | NDA/MAL/HDP/7589 | OCHOA LABORATORIES | SUPER MEDIC LTD | LACX SYRUP | LACTULOSE | 10G/15ML | AUROCHEM LABORATORIES (I) PVT LTD-, 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 29/11/2017 |
| 3576 | NDA/MAL/HDP/7598 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | RABEFLUX-DSR | RABEPRAZOLE SODIUM + DOMPERIDONE | 20MG + 30MG | STEDMAN PHARMACEUTICALS PVT. LTD., C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3577 | NDA/MAL/HDP/7605 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | STRIPOLE | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40 MG | GUFIC BIOSCIENCES LIMITED (UNIT 2), SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 27/11/2019 |
| 3578 | NDA/MAL/HDP/7607 | FDC LTD | AIVEEN (U) LIMITED | TEARMAX EYE DROPS | CARMELLOSE SODIUM | 5MG/ML | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML VIAL | 21/11/2019 |
| 3579 | NDA/MAL/HDP/7610 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | TERBIDERM FORTE | TERBINAFINE HYDROCHLORIDE | 250 MG | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3580 | NDA/MAL/HDP/7611 | FERRING GMBH | MACNAUGHTON LIMITED | PABAL | CARBETOCIN | 100MCG/ML | FERRING GMBH., 11, WITTLAND | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X5.0X1.0 ML VIAL | 01/07/2017 |
| 3581 | NDA/MAL/HDP/7612 | PSYCHTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | SOTHREX -BR | TERBUTALINE SULFATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 2.5MG+8MG+100MG+5MG/10ML | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 30/05/2018 |
| 3582 | NDA/MAL/HDP/7615 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | AIVCLAV-625 | AMOXICILLIN + CLAVULANIC ACID | 500MG + 125MG | MEDICEF PHARMA, NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP)| AMN LIFE SCIENCE PVT LTD, 67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER | 21/11/2019 |
| 3583 | NDA/MAL/HDP/7622 | HOVID BHD | BARIKI EXIM PHARMA LTD | MONTELAIR 5 | MONTELUKAST SODIUM | 5MG | HOVID BHD, LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2018 |
| 3584 | NDA/MAL/HDP/7656 | A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SPASMOMEN | OTILONIUM BROMIDE | 40MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L, VIA CAMPO DI PILE, L€™AQUILA (AQ), ITALY | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER (FREE PHYSICIAN'S SAMPLE, NOT FOR SALE ) | 01/07/2017 |
| 3585 | NDA/MAL/HDP/7673 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | VALSARTAN | VALSARTAN | 80MG | 1. SIEGFRIED BARBERA, S.L. (FORMERLY NOVARTIS FARMACEUTICA SA) RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA - SPAIN SPAIN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG, SWITZERLAND SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SPAIN|SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 01/07/2017 |
| 3586 | NDA/MAL/HDP/7674 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABLEVOX | LEVOFLOXACIN HEMIHYDRATE | 5G/L | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| 3587 | NDA/MAL/HDP/7675 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | VALSARTAN | VALSARTAN | 160 MG | 1. SIEGFRIED BARBERA, S.L. (FORMERLY NOVARTIS FARMACEUTICA SA) RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA - SPAIN SPAIN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. NOVARTIS PHARMA STEIN AG SHAFFHAUSERSTRASSE 4332 STEIN AG, SWITZERLAND SWITZERLAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | SPAIN|SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 01/07/2017 |
| 3588 | NDA/MAL/HDP/7681 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEECEL 200 | CELECOXIB | 200MG | THE MADRAS PHARMACEUTICALS.., NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3589 | NDA/MAL/HDP/7682 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AB-TETRA-250 | TETRACYCLINE | 250MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA.| JIANGSU PENGYAO PHARMACEUTICAL CO LTD ., NO. 10 CHAQUAN ROAD YICHENG TOWN YIXING CITY JIANGSU PROVINCE | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3590 | NDA/MAL/HDP/7688 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 850MG TABLET | METFORMIN HYDROCHLORIDE | 850MG | NKUNZI PHARMACEUTICALS, 259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X300.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER,1.0X4.0X15.0 TABLET BLISTER | 01/07/2017 |
| 3591 | NDA/MAL/HDP/7695 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | CORTUM 500 | CEFUROXIME AXETIL | 500MG | MALIK LIFESCIENCES PRIVATE LIMITED, PLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3592 | NDA/MAL/HDP/7708 | LEBEN LABORATORIES PVT.LTD | MARVIN PHARMA LIMITED | LAMPYKLOX CAPSULES | AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM | 250MG+250MG | LEBEN LABORATORIES PVT. LTD, PLOT NO. L-4, PHASE-III, MIDC, AKOLA€“ 444 104 (MS). | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3593 | NDA/MAL/HDP/7711 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN 850 MG | METFORMIN HYDROCHLORIDE | 850MG | HOVID BHD, LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3594 | NDA/MAL/HDP/7716 | CORE ACCESS LIMITED | CORE ACCESS LTD | ALRINAST 2.5 MG / 5 ML SYRUP | DESLORATIDINE | 2.5 MG / 5 ML | NOBEL ?LAÇ SAN. VE TIC. A.?-SANCAKLAR, DÜZCE, 81100 | | TURKEY | | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 29/11/2017 |
| 3595 | NDA/MAL/HDP/7724 | FERRING GMBH | MACNAUGHTON LIMITED | MENOPUR | HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] | 75 IU + 75 IU/ 4ML VIAL | FERRING (PTY) LTD, WITTLAND II 24146 KIEL | GERMANY | PARENTERAL ORDINARY DRY VIALS | 10.0X4.0 ML VIAL 10*1ML CLEAR COLOURLESS GLASS AMPOULES CONTAINING 9.0MG/ML OF NACL | 01/07/2017 |
| 3596 | NDA/MAL/HDP/7735 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IBUMOL 400 | PARACETAMOL + IBUPROFEN | 325MG + 400MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3597 | NDA/MAL/HDP/7745 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | TAZOGARD | PIPERACILLIN +TAZOBACTAM | 4G + 0.5G | AKUMS DRUGS & PHARMACEUTICALS LTD., 2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X4.5 G VIAL ,2X10ML LDPE AMPOULES OF WFI | 01/07/2017 |
| 3598 | NDA/MAL/HDP/7747 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | THERMODOL | PARACETAMOL | 1.0%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD., 2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| 3599 | NDA/MAL/HDP/7751 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNODEX COUGH SYRUP | BROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE | 8MG + 10MG + 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II, PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| 3600 | NDA/MAL/HDP/7760 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | OZACE MD 10 | OLANZAPINE | 10MG | PSYCHOTROPICS INDIA LTD PLOT-, NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND| PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3601 | NDA/MAL/HDP/7903 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MELMET-1000SR | METFORMIN HYDROCHLORIDE | 1000MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID RETARD COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| 3602 | NDA/MAL/HDP/7905 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | ACEFYL | ACEFYLINE PIPERAZINE + DIPHENHYDRAMINE HYDROCHLORIDE | 45MG +8MG | NABIQASIM INDUSTRIES (PVT) LIMITED, 17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2016 |
| 3603 | NDA/MAL/HDP/7906 | AXA PARENTERALS LTD | VITACARE LIMITED | IVMOL | PARACETAMOL | 10MG/ML | AXA PARENTERAL LIMITED, PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| 3604 | NDA/MAL/HDP/7907 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | HUCOG 5000 HP | CHORIONIC GONADOTROPHIN | 5000 I.U/ VIAL | BHARAT SERUMS & VACCINES LIMITED , PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (E) MAHARASHTRA STATE 421501 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE | 01/07/2017 |
| 3605 | NDA/MAL/HDP/7910 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | LANTUS | INSULIN GLARGINE | 100 UNITS/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH , INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY CARTRIDGES | 1.0X5.0X3.0 ML CARTRIDGE | 01/07/2017 |
| 3606 | NDA/MAL/HDP/7911 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | INSULIN GLARGINE IMPACT SOLOSTAR | INSULIN GLARGINE | 100 UNITS/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH , INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2017 |
| 3607 | NDA/MAL/HDP/8015 | SHREEJI PHARMACEUTICALS LIMITED | SHREEJI PHARMACEUTICALS LIMITED | D-FEN | DICLOFENAC SODIUM | 25 MG/ML | 1. SWISS PARENTERALS LIMITED (UNIT-1) 808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 1*5*3ML AMPOULE II. *10*1*10*3ML AMPOULE | 01/07/2011 |
| 3608 | NDA/MAL/HDP/8023 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMOXICLAV-DENK 500/62.5 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 62.5 MG | PENCEF PHARMA GMBH, BRITENBACHSTR ASSE 13 D-13509 BERLIN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X8.0 TABLET BLISTER | 01/07/2011 |
| 3609 | NDA/MAL/HDP/8073 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TRILEPTAL | OXCARBAZEPINE | 300 MG | NOVARTIS FARMA S.P.A. - VIA PROVINCIALE SCHITO, 131 I-80058 TORRE ANNUNZIATA (NAPOLI) - ITALY. | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*50TABLET CONTAINER | 01/07/1997 |
| 3610 | NDA/MAL/HDP/8085 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CIPROL-500 | CIPROFLOXACIN | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD , PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 3611 | NDA/MAL/HDP/8089 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-AMOXY | AMOXYCILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - , STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER | 01/07/1997 |
| 3612 | NDA/MAL/HDP/8091 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEGEL SUSPENSION | ALUMINIUM HYDROXIDE+MAGNESIUM TRISILICATE | 120MG+250MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| 3613 | NDA/MAL/HDP/8092 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | KEMOXYL 250MG | AMOXYCILLIN | 250MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 3614 | NDA/MAL/HDP/8095 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | COLOSAR-DENK 100/12.5 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 100MG + 12.5MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2016 |
| 3615 | NDA/MAL/HDP/8096 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | BENZALIN | BENZATHINE BENZYLPENICILLIN SODIUM | 2.4MEGA/ VIAL | REYOUNG PHARMACEUTICAL CO. LIMITED, NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON,1.0X100.0X2.4 VIAL CARTON,1.0X10.0X2.4 VIAL CARTON | 01/07/2011 |
| 3616 | NDA/MAL/HDP/8097 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN 5000 | ERYTHROPOIETIN | 5000IU/ 0.5ML | SERUM INSTITUTE OF INDIA LTD, 212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0X0.5 ML PRE- FILLED SYRINGE | 22/09/2017 |
| 3617 | NDA/MAL/HDP/8103 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | WELQUINE 500 | LEVOFLOXACIN | 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD., PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3618 | NDA/MAL/HDP/8104 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS 40 | TELMISARTAN | 40MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3619 | NDA/MAL/HDP/8105 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | XERIN | LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | AKUMS DRUGS AND PHARMACEUTICALS LTD, PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3620 | NDA/MAL/HDP/8107 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | WELRAB 20 | RABEPRAZOLE SODIUM | 20MG | AKUMS DRUGS & PHARMACEUTICALS LTD -, 19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3621 | NDA/MAL/HDP/8109 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | IRON FOLATE | FERROUS SULPHATE + FOLIC ACI | 200MG + 0.4MG | MEDICAMEN BIOTECH LTD, SP-1192, A &B, PHASE €“IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET JAR | 01/07/2017 |
| 3622 | NDA/MAL/HDP/8112 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV | AMOXICILLIN + CLAVULANIC ACID | 156.25MG/5ML | MEDOCHEMIE LTD €“ FACTORY B, PLOT 48, IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL; AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| 3623 | NDA/MAL/HDP/8113 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV FORTE | AMOXICILLIN + CLAVULANIC ACID | 312.5MG/5ML | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY, 2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| 3624 | NDA/MAL/HDP/8119 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | 50MG/ML | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE | 01/07/2017 |
| 3625 | NDA/MAL/HDP/8121 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSQUINE | QUININE | 300MG/ML | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| 3626 | NDA/MAL/HDP/8125 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD | GAMA PHARMACEUTICALS (U) LIMITED | MATADOR | LEVOFLOXACIN | 500MG | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD, , NA€™UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 01/07/2009 |
| 3627 | NDA/MAL/HDP/8127 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% W/V | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X30.0 ML VIAL | 01/07/2016 |
| 3628 | NDA/MAL/HDP/8130 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DEGRA 100 | SILDENAFIL CITRATE | 100MG | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 30/05/2018 |
| 3629 | NDA/MAL/HDP/8131 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DEGRA | SILDENAFIL CITRATE | 50MG | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2017 |
| 3630 | NDA/MAL/HDP/8142 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | XARELTO | RIVAROXABAN | 2.5MG | BAYER PHARMA AG 51368 LEVERKUSEN, BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| 3631 | NDA/MAL/HDP/8143 | NAARI LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | LYDIA POSTPIL | LEVONORGESTREL | 1.5MG | NAARI PHARMA PRIVATE LIMITED, PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2013 |
| 3632 | NDA/MAL/HDP/8144 | NAARI LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | MA KARE | MIFEPRISTONE + MISOPROSTOL | 200MG+ 200MCG | NAARI PHARMA PRIVATE LIMITED, PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0 TABLET BLISTER | 01/07/2017 |
| 3633 | NDA/MAL/HDP/8145 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR 10 | MONTELUKAST SODIUM | 10MG | DENK PHARMA GMBH & CO. KG , GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| 3634 | NDA/MAL/HDP/8148 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCLOXACILLIN | FLUCLOXACILLIN | 500MG | SPARSH BIO-TECH PVT. LTD.-, PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR €“ 361006 GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| 3635 | NDA/MAL/HDP/8151 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-C | VITAMIN C | 100MG | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP | 01/07/2005 |
| 3636 | NDA/MAL/HDP/8155 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 5MG | NOVARTIS PHARMA STEIN AG., SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2017 |
| 3637 | NDA/MAL/HDP/8157 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | D LYTE- PLAIN | ANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE | 13.50G + 2.60G + 2.90G +1.50G/ 1L | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X20.5 G SACHET | 01/07/2016 |
| 3638 | NDA/MAL/HDP/8159 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 100MG + 25MG | AUROBINDO PHARMA LIMITED, UNIT III, SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2017 |
| 3639 | NDA/MAL/HDP/8160 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID (CHERRY FLAVOUR) | ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE | 200MG+250MG+250MG+250MG+125MG/15ML | STEDMAN PHARMACEUTICALS PVT LTD..., C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR|SAI MIRRA INNOPHARM PVT LIMITED , 288&299, SIDCO ESTATE AMBTTUR, CHENNAI 600098| SAI MIRRA INNOPHARM PVT LTD, PLOT NO. 288, 298 & 299 SIDCO INDUSTRIAL ESTATE, AMBATTUR, CHENNAI- 600098 TAMIL NADU | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2017 |
| 3640 | NDA/MAL/HDP/8162 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | HUMOG 75 HP | HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U | 75 IU + 75 IU/ 150 I.U VIAL | BHARAT SERUMS AND VACCINES LTD, PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL | 01/07/2017 |
| 3641 | NDA/MAL/HDP/8163 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE SURGICAL SCRUB | POVIDONE-IODINE | 7.5%W/W | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 26/09/2018 |
| 3642 | NDA/MAL/HDP/8167 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE STANDARDISED MICROBICIDAL SOLUTION 10% W/V | POVIDONE-IODINE | 10%W/W | G.S. PHARMBUTOR PRIVATE LIMITED -B-172, INDUSTRIAL AREA, BEHROR - 301701, DIST: ALWAR, RAJASTHAN – INDIA. | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| 3643 | NDA/MAL/HDP/8170 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID (PINEAPPLE FLAVOUR) | ALGINIC + MAGNESIUM HYDROXIDE +DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE | 200MG+250MG+250MG+250MG+125MG/15ML | STEDMAN PHARMACEUTICALS PVT LTD..., C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR| SAI MIRRA INNOPHARM PRIVATE LIMITED, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2017 |
| 3644 | NDA/MAL/HDP/8177 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | CILZEC PLUS | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 3645 | NDA/MAL/HDP/8178 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | NYSTAGO TABLETS | NYSTATIN | 500,000I.U | AGOG PHARMA LTD, PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 3646 | NDA/MAL/HDP/8184 | AFRICURE PHARMACEUTICALS (INDIA) LTD | AFRICURE PHARMACEUTICALS U LIMITED | TETRASIM | TETRACYCLINE HYDROCHLORIDE | 250MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER | 01/07/2008 |
| 3647 | NDA/MAL/HDP/8185 | AFRICURE PHARMACEUTICALS (INDIA) LTD | AFRICURE PHARMACEUTICALS U LIMITED | INDOSIM | INDOMETHACIN | 25MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| 3648 | NDA/MAL/HDP/8201 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CENTROZINE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-, N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2017 |
| 3649 | NDA/MAL/HDP/8206 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRULEXIN | CEFALEXIN MONOHYDRATE | 125MG/5ML | BRAWN LABORATORIES LTD., 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2018 |
| 3650 | NDA/MAL/HDP/8210 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP | HYDROCORTISONE | 100MG | CIRON DRUGS & PHARMACEUTICALS PVT LTD-, N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X100.0 MG VIAL | 01/07/2007 |
| 3651 | NDA/MAL/HDP/8211 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCO-ASTHALIN SYRUP | BROMHEXINE HYDROCHLORIDE + SALBUTAMOL SULFATE | 4 MG/5G + 2 MG/5ML | 1. BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100, KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100, KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 3. BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. L.R 209/6554, MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P.O BOX 42569 00100, KENYA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | KENYA | ORAL LIQUID ORDINARY SYRUPS | I. 1*100ML BOTTLE | |
| 3652 | NDA/MAL/HDP/8212 | ORANE | AIVEEN (U) LIMITED | BACTIGEN EYE/EAR DROPS | GENTAMICIN | 0.3%W/V | FDC LIMITED , B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ €“ AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC VIALS | 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/1998 |
| 3653 | NDA/MAL/HDP/8213 | FDC LTD | AIVEEN (U) LIMITED | ZOCON 200 | FLUCONAZOLE | 200MG | FDC LTD., L-56/L-57,PHASE II-D, VERNA INDUSTRIAL ESTATE,VERNA-403722, SALCETE,GOA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0 TABLET BLISTER | 01/07/2001 |
| 3654 | NDA/MAL/HDP/8216 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SEFOTAX | CEFOTAXIME SODIUM | 1G | SWISS PARENTERALS LIMITED UNIT II, PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2017 |
| 3655 | NDA/MAL/HDP/8217 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | METFOKANT | METFORMIN HYDROCHLORIDE | 850MG | S KANT HEALTHCARE LTD, PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3656 | NDA/MAL/HDP/8225 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | ARTELIN 60 | ARTESUNATE | 60MG | LINCOLN PHARMACEUTICAL LTD TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*1 ML AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION B.P + 1*5 ML AMPOULE OF 0.9%W/V NACL | 01/07/2017 |
| 3657 | NDA/MAL/HDP/8226 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | SALRES | SALBUTAMOL SULPHATE | 120.5MCG/SPRAY | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2017 |
| 3658 | NDA/MAL/HDP/8227 | HETERO LABS LTD | REDDYS PHARMA LIMITED | ALZER 5 | DONEPEZIL HYDROCHLORIDE | 5MG | HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3659 | NDA/MAL/HDP/8228 | AFRICURE PHARMACEUTICALS (INDIA) LTD | AFRICURE PHARMACEUTICALS U LIMITED | VITAMIN B-COMPLEX (BEEKO) | VITAMINS B1 + B2 + B6 + NIACINAMIDE | 1MG +1MG +1MG +15MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3660 | NDA/MAL/HDP/8232 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | MOMATE | MOMETASONE FUROATE MONOHYDRATE | 50MCG/ SPRAY | GLENMARK PHARMACEUTICALS LTD, VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA| GLENMARK PHARMACEUTICALS LTD, VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X120.0 METERED DOSE BOTTLE | 01/07/2017 |
| 3661 | NDA/MAL/HDP/8235 | DAWA LIMITED- | SUPER MEDIC LTD | ACEPAR | ACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL | 100MG + 15MG + 500MG | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3662 | NDA/MAL/HDP/8243 | OCHOA LABORATORIES | SUPER MEDIC LTD | TX-MF | TRANEXAMIC ACID + MEFENAMIC ACID | 500MG + 250MG | AUROCHEM PHARMACEUTICALS INDIA PRIVATE LIMITED, 58, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401 404 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 3663 | NDA/MAL/HDP/8254 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-CV | CEFIXIME TRIHYDRATE + CLAVULANIC ACID | 200MG + 125MG | MICRO LABS LIMITED, BOMMASANDRA , PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2017 |
| 3664 | NDA/MAL/HDP/8264 | CACHET PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EMITINO ORAL SOLUTION | ONDANSETRON | 2MG/5ML | CACHET PHARMACEUTICALS PVT LTD , THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 01/07/2017 |
| 3665 | NDA/MAL/HDP/8274 | HETERO LABS LTD | REDDYS PHARMA LIMITED | BICATERO 50 | BICALUTAMIDE | 50MG | HETERO LABS LTD (UNIT-VI), "SY.NO. 439, 440 & 458,APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| 3666 | NDA/MAL/HDP/8275 | HETERO LABS LTD | REDDYS PHARMA LIMITED | LETERO | LETROZOLE | 2.5MG | HETERO LABS LTD (UNIT-VI), "SY.NO. 439, 440 & 458,APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| 3667 | NDA/MAL/HDP/8276 | HETERO LABS LTD | REDDYS PHARMA LIMITED | GEMTERO 1G | GEMCITABINE | 1G | HETERO LABS (UNIT VI), INDIA, APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL | 01/07/2013 |
| 3668 | NDA/MAL/HDP/8277 | HETERO LABS LTD | REDDYS PHARMA LIMITED | GEMTERO 200MG | GEMCITABINE | 200MG | HETERO LABS (UNIT VI), INDIA, APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X200.0 MG VIAL | 01/07/2013 |
| 3669 | NDA/MAL/HDP/8278 | HETERO LABS LTD | REDDYS PHARMA LIMITED | ANATERO | ANASTROZOLE | 1MG | HETERO LABS LTD, UNIT VI, INDIA, APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| 3670 | NDA/MAL/HDP/8299 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | DICLOFENAC TABLETS BP | DICLOFENAC SODIUM | 50MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 3671 | NDA/MAL/HDP/8300 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | CIPRONE-500 | CIPROFLOXACIN HYDROCHLORIDE | 500 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER | 01/07/2007 |
| 3672 | NDA/MAL/HDP/8302 | NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | SIMFEN 400MG | IBUPROFEN | 400MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| 3673 | NDA/MAL/HDP/8308 | NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | PREDNISOLONE 5MG | PREDNISOLONE | 5MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 3674 | NDA/MAL/HDP/8312 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TRICORT 40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL | 29/11/2017 |
| 3675 | NDA/MAL/HDP/8316 | AUROBINDOM PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DOLUTEGRAVIR 50 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | AUROBINDO PHARMA LIMITED, UNIT X, PLOT NO.16, APIIC MULTIPRODUCT SEZ TELANGANA DISTRICT- 509302 MENAKURU, NAIDUPET MANDAL, NELLORE DISTRICT, PIN CODE: 524421, ANDHRA PRADESH. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE, 1.0X180.0 TABLET BOTTLE | 30/05/2018 |
| 3676 | NDA/MAL/HDP/8318 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | B-CANE HEAVY | BUPIVACAINE HYDROCHLORIDE BP | 5 MG/ML | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X4.0 ML AMPOULE | 29/11/2017 |
| 3677 | NDA/MAL/HDP/8319 | KOPRAN LIMITED | TATA UGANDA LIMITED | ERYKO-250 | ERYTHROMYCIN STEARATE TABLETS BP | 250MG | KOPRAN LTD, VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER | 29/11/2017 |
| 3678 | NDA/MAL/HDP/8321 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PROSTAR- 200 CAPSULES | PROGESTERONE | 200 MG | AKUMS DRUGS & PHARMACEUTICALS LTD ., PLOT NO. 47, 48, SECTOR 6A, IIE, SIDCUL HARIDWAR, UTTRAKHAND €“ 249403, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| 3679 | NDA/MAL/HDP/8322 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEMONT L | MONTELUKAST SODIUM+LEVOCETIRIZINE DIHYDROCHLORIDE | 10 MG + 5 MG | GLENMARK PHARMACEUTICALS LIMITED-UNIT III, VILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BOTTLE | 29/11/2017 |
| 3680 | NDA/MAL/HDP/8324 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LOOBID TABLETS | OFLOXACIN + ORNIDAZOLE | 200MG + 500 MG | CACHET PHARMACEUTICAL PVT LTD. HIMACHAL, THANA, BADDI, HIMACHAL PRADESH-173 205, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3681 | NDA/MAL/HDP/8326 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | MEDOMOX 250 DT | AMOXICILLIN | 250MG | MEDOPHARM PVT LTD., NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER (EMBOSSED WITH "GOU NOT FOR SALE" & NON-EMBOSSED) | 29/11/2017 |
| 3682 | NDA/MAL/HDP/8328 | RESONANT PHARMACEUTICALS PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | AZITHROCIN | AZITHROMYCIN | 500 MG | 1. ACME FORMULATION PRIVATE LIMITED ROPAR ROAD, NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 174101, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*3TABLET BLISTER | 29/11/2017 |
| 3683 | NDA/MAL/HDP/8329 | LEBEN LABORATORIES PVT LTD | MARVIN PHARMA LIMITED | ARTEFLO - 40 | PROPANOLOL | 40MG | LEBEN LABORATORIES PVT LTD -, L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3684 | NDA/MAL/HDP/8330 | RESONANT PHARMACEUTICALS PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | COART | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | 1. ACME FORMULATION PRIVATE LIMITED ROPAR ROAD, NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 174101, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*6TABLET BLISTER | 29/11/2017 |
| 3685 | NDA/MAL/HDP/8331 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TORSINEX-20 | TORSEMIDE | 20MG | MICRO LABS LTD-, NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3686 | NDA/MAL/HDP/8332 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | AZITRO 500 MG | AZITHROMYCIN | 500MG | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 29/11/2017 |
| 3687 | NDA/MAL/HDP/8333 | MICRO LABS LTD 92 SIPCOT INDUSTRIAL | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AVAS-20 | ATORVASTATIN | 20MG | MICRO LABS LTD 92 SIPCOT , 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3688 | NDA/MAL/HDP/8335 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIVAMOX | AMOXICILLIN TRIHYDRATE | 500MG | RIVA PHARMA FREE ZONE, NASR CITY CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| 3689 | NDA/MAL/HDP/8338 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | ACEAAR P | ACECLOFENAC + PARACETAMOL | 100MG +325MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3690 | NDA/MAL/HDP/8341 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | GENVOYA | ELVITEGRAVIR+COBICISTAT+EMTRICISTABINE+TENOFOVIR ALAFENAMIDE | 150MG + 150MG + 200MG + 10MG | PATHEON INC.-, TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 31/01/2018 |
| 3691 | NDA/MAL/HDP/8343 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XYKAA EXTEND 1000 | PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE) | 325MG+675MG | TROIKAA PHARMACEUTICALS LTD ., SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER | 29/11/2017 |
| 3692 | NDA/MAL/HDP/8344 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CELZA DRY SYRUP | CEFUROXIME AXETIL USP | 125 MG/5 ML | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE | 29/11/2017 |
| 3693 | NDA/MAL/HDP/8345 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CELZA 500 | CEFUROXIME AXETIL USP | 500 MG | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3694 | NDA/MAL/HDP/8347 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | FENTWELL 0.05MG/ML | FENTANYL CITRATE | 0.05MG/ML | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD., NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0 ML AMPOULE | 30/05/2018 |
| 3695 | NDA/MAL/HDP/8348 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | IRBECOR PLUS 300MG/12.5MG | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 29/11/2017 |
| 3696 | NDA/MAL/HDP/8350 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | FENTWELL 0.05MG/ML | FENTANYL CITRATE | 0.05MG/ML | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD., NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 30/05/2018 |
| 3697 | NDA/MAL/HDP/8352 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KETESSE | DEXKETOPROFEN TROMETAMOL | 50MG/2ML | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L, VIA SETTE SANTI 3, 50131 FIRENZE | ITALY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 AMPOULE CARTON,1.0X6.0 AMPOULE CARTON,1.0X20.0 AMPOULE CARTON,1.0X5.0 AMPOULE CARTON | 21/11/2019 |
| 3698 | NDA/MAL/HDP/8353 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FEDATE CAPSULES | CARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE | 100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/11/2017 |
| 3699 | NDA/MAL/HDP/8354 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | ZORUXA | ZOLEDRONIC ACID | 5MG/100ML | GLAND PHARMA LIMITTED 143-148, D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 29/11/2017 |
| 3700 | NDA/MAL/HDP/8356 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | LORFACT-D | DESLORATIDINE | 5MG, | AKUMS DRUGS & PHARMACEUTICALS LTD, 19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| 3701 | NDA/MAL/HDP/8359 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ASUNATE 120 | ARTESUNATE | 120MG | INDASI LIFESCIENCE PVT. LTD., PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN-396210 | LINCOLN PHARMACEUTICALS LIMITED - 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1*10 ML SODIUM CHLORIDE IN GLASS AMPOULE + 1*2 ML SODIUM BICARBONATE IN GLASS AMPOULE | 29/11/2017 |
| 3702 | NDA/MAL/HDP/8392 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | IRBECOR PLUS 150MG/12.5MG | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 29/11/2017 |
| 3703 | NDA/MAL/HDP/8396 | MARIE STOPES INTERNATIONAL | MARIE STOPES UGANDA LIMITED | BACK-UP | LEVONORGESTREL | 1.5MG | ACME FORMULATION PVT LTD., ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 29/11/2017 |
| 3704 | NDA/MAL/HDP/8411 | LABORATORY & ALLIED LTD | ROYAL PHARMA 2011 LIMITED | RHEUMAC GEL | DICLOFENAC | 1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | | KENYA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 29/11/2017 |
| 3705 | NDA/MAL/HDP/8413 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CHLORAMPHENICOL CAPSULE BP | CHLORAMPHENICOL | 250MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 3706 | NDA/MAL/HDP/8419 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | VB COMPLEX | VIT B1+ VIT B2 +VIT B3 + NICOTINAMIDE+PANTOTHENOL | 10MG +1MG +1MG +16MG +0.5MG | SCOTT-EDIL PHARMACIA LTD (UNIT I), 56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA| | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE, 1.0X100.0X2.0 ML AMPOULE | 01/07/2018 |
| 3707 | NDA/MAL/HDP/8424 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | HAEMRICH | FERRIC AMMONIUM CITRATE+ FOLIC ACID+PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE | 50MG + 0.55MG +2.4MG + 1.2MG +11MG /5ML | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE | 01/07/2017 |
| 3708 | NDA/MAL/HDP/8434 | DAWA LIMITED | SUPER MEDIC LTD | DACINAZOLE | MICONAZOLE NITRATE | 2%W/W | DAWA LTD, BABA DOGO ROAD RUARAKA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| 3709 | NDA/MAL/HDP/8468 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOMOX-500 | AMOXICILLIN | 500 MG | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER | 31/01/2018 |
| 3710 | NDA/MAL/HDP/8473 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN VAGINAL INSERTS | NYASTATIN | 100,000 I.U | S KANT HEALTHCARE LTD, 1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | VAGINAL TABLETS | 1.0X10.0X10.0 TABLET STRIP | 31/01/2018 |
| 3711 | NDA/MAL/HDP/8477 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | GLARITUS 100IU/ML | INSULIN GLARGINE | 100IU/ML | WOCKHARDT LIMITED -, WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY CARTRIDGES | 1.0X10.0 ML VIAL, 1.0X3.0 ML CARTRIDGE | 31/01/2018 |
| 3712 | NDA/MAL/HDP/8484 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AVERNOL | CARVEDILOL | 25MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3713 | NDA/MAL/HDP/8485 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHMAX-400 | CEFIXIME | 400MG | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0 TABLET BLISTER | 31/01/2018 |
| 3714 | NDA/MAL/HDP/8489 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | MEDOL | TRAMADOL HYDROCHLORIDE | 100 MG / 2 ML | SWISS PARENTERALS LTD, 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE | 31/01/2018 |
| 3715 | NDA/MAL/HDP/8490 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9% W/V | ALTHEA PHARMA PVT LTD --PLOT NO. 374 SHED NO. E,.ALPHA INDUSTRIAL PARK , ATHIYAWAD DABHEL ,NANI DAMAN (U.T) 396210, INDIA | | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 31/01/2018 |
| 3716 | NDA/MAL/HDP/8491 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CETROTIDE 0.25MG | CETRORELIX | 0.25MG | FAREVA PAU 1, AVENUE DU BEARN, F-64320 IDRON, FRANCE| | FRANCE | PARENTERAL ORDINARY COMBINATION PACK VIALS | 1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON | 31/01/2018 |
| 3717 | NDA/MAL/HDP/8493 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | DESCOVY 200MG/25MG | EMTRICITABINE/TENOFOVIR ALAFENAMIDE | 200MG + 25 MG | PATHEON INC.-, TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9| ROTTENDORF PHARMA GMBH, OSTENFELDER STRAßE 51-61,59320 ENNIGERLOH,GERMANY| | CANADA| GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 31/01/2018 |
| 3718 | NDA/MAL/HDP/8499 | YELURI FORMULATIONS PVT LTD | SUPER MEDIC LTD | SOLOCEF 1000 MG | CEFTRIAXONE SODIUM | 1000MG | YELURI FORMULATIONS PVT. LTD, SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 31/01/2018 |
| 3719 | NDA/MAL/HDP/8522 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | DAYPENAM | MEROPENEM TRIHYDRATE | 500 MG | 1. ZEISS PHARMACEUTICALS PRIVATE LIMITED PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*10*500MG VIAL | 01/07/2017 |
| 3720 | NDA/MAL/HDP/8566 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | AZINOWEL | AZITHROMYCIN | 200MG/5ML | AKUMS DRUGS & PHARMACEUTICALS LTD, PLANT II, PLOT NO. 22, SECTOR- 6A, IIE, SIDCUL, RANIPUR, DISTT.: HARIDWAR, UTTARAKHAND | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 21/11/2019 |
| 3721 | NDA/MAL/HDP/8639 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | ISENTRESS 100MG | RALTEGRAVIR POTASSIUM | 100MG | PATHEON PHARMACEUTICALS INC., 2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA| MSD (PTY) LTD. , 117-16TH ROAD, HALFWAY HOUSE, 1685 SOUTH AFRICA| MERCK SHARP & DOHME BV., WAARDERWEG 39 HAARLEM, - 2031 BN, NETHERLANDS | UNITED STATES| NETHERLANDS| SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X60.0 TABLET BOTTLE | 28/03/2018 |
| 3722 | NDA/MAL/HDP/8641 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELI H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | CADILA PHARMACEUTICALS LIMITED, 1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3723 | NDA/MAL/HDP/8643 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ARTESUNATE 60MG | ARTESUNATE | 60MG | M/S SCOTT-EDIL PHARMACIA LTD , 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL + 1*1*5ML AMPOULE OF 0.9%W/V NACL + 1*1*1ML AMPOULE OF 5%W/V NAHCO3 | 28/03/2018 |
| 3724 | NDA/MAL/HDP/8649 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | CEFCARE | CEFTRIAXONE SODIUM | 1G | INJECTCARE PARENTERALS PVT. LTD., PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 31/01/2018 |
| 3725 | NDA/MAL/HDP/8650 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | CEFDIA 400MG | CEFIXIME TRIHYDRATE | 400MG | NOBEL ?LAÇ SAN. VE TIC. A.?.-81100 SANCAKLAR, DÜZCE-TURKEY | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER,1.0X2.0X1.0X5.0 TABLET BLISTER | 28/03/2018 |
| 3726 | NDA/MAL/HDP/8655 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 1000MG | METFORMIN HYDROCHLORIDE | 1000MG | MERCK SANTÉ S.A.S., 2 RUE DU PRESSOIR VERT 45400 SEMOY FRANCE|MERCK KGAA-PHARMA PRODUCTION DARMSTADT , FRANKFURTER STRABE 250, D-64293, DARMSTADT| | FRANCE|GERMANY | ORAL SOLID RETARD TABLETS | 1.0X4.0X15.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3727 | NDA/MAL/HDP/8660 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | VEMLIDY | TENOFOVIR ALAFENAMIDE | 25MG | PATHEON INC.-, TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 28/03/2018 |
| 3728 | NDA/MAL/HDP/8661 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR SODIUM | 50MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC, PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 28/03/2018 |
| 3729 | NDA/MAL/HDP/8662 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | AMOXIREN-DS | AMOXICILLIN TRIHYDRATE | 250MG/5ML | RENE INDUSTRIES LTD ., PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 28/03/2018 |
| 3730 | NDA/MAL/HDP/8665 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PAMAGIN-C | CETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE | 5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MG | CACHET PHARMACEUTICALS PVT LTD, VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/03/2018 |
| 3731 | NDA/MAL/HDP/8685 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RANCV 500 | RANOLAZINE | 500 MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3732 | NDA/MAL/HDP/8688 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DURART 600 | DARUNAVIR | 600 MG | MYLAN LABORATORIES LTD -, H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 30/05/2018 |
| 3733 | NDA/MAL/HDP/8689 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DURART 800 | DARUNAVIR | 800 MG | MYLAN LABORATORIES LTD -, H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 30/05/2018 |
| 3734 | NDA/MAL/HDP/8692 | PHARMA BAVARIA INTERNACIONAL(PBI) PORTUGUAL | GOODMAN INTERNATIONAL LTD | PARAFUSIV | PARACETAMOL | 10 MG/ML | S.M FARMACEUTICI SRL, ZONA INDUSTRIALE, 85050 TITO-POTENZA (PZ) ITALY | ITALY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 30/05/2018 |
| 3735 | NDA/MAL/HDP/8694 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ERBITUX | CETUXIMAB | 5MG/ML | MERCK KGAA-250 FRANKFURTERSTRASSE, D-6100 DARMSTADT | | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X20.0 ML VIAL | 07/11/2018 |
| 3736 | NDA/MAL/HDP/8699 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ACETAZOLAMIDE | ACETAZOLAMIDE | 250 MG | REMEDICA LTD., AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3737 | NDA/MAL/HDP/8779 | M/S HETERO LABS LIMITED | REDDYS PHARMA LIMITED | STATINOR 20 | ROSUVASTATIN | 20MG | HETERO LABS LIMITED UNIT V-TSIIC FORMULATION SEZ, S.NO 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DIST) –509301, TELANGANA INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/05/2019 |
| 3738 | NDA/MAL/HDP/8780 | HETERO DRUGS LTD | REDDYS PHARMA LIMITED | STATINOR 10 | ROSUVASTATIN CALCIUM | 10 MG | HETERO LABS LIMITED UNIT V-TSIIC FORMULATION SEZ, S.NO 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DIST) –509301, TELANGANA INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| 3739 | NDA/MAL/HDP/8783 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | AIVCLAV-375 | AMOXICILLIN + CLAVULANIC ACID | 250MG + 125MG | MEDICEF PHARMA, NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP)| AMN LIFE SCIENCE PVT LTD, 67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3740 | NDA/MAL/HDP/8795 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 60/360 | ARTEMETHER + LUMEFANTRINE | 60MG + 360MG | AJANTA PHARMA LIMITED, PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392131|AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X1.0X6.0 TABLET BLISTER | 26/11/2019 |
| 3741 | NDA/MAL/HDP/8796 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | AMITRIP-25 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | PSYCHOTROPICS INDIA LTD, PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3742 | NDA/MAL/HDP/8814 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ACRIPTEGA | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | MYLAN LABORATORIES LIMITEDD ,, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR-454775 DIST. DHAR, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 30/05/2018 |
| 3743 | NDA/MAL/HDP/8815 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | ZIMAGRA €“ ODS 50 | SLIDENAFIL CITRATE | 50 MG | ZIM LABORATORIES LTD, B-21/22, M.I.D.C. AREA, KALMESHWAR €“ 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | OTHER SYSTEMIC SPECIAL SOLIDS | 1.0X1.0X10.0 SACHET CARTON | 30/05/2018 |
| 3744 | NDA/MAL/HDP/8816 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABPARA | PARACETAMOL | 1%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1.0X100.0 ML BOTTLE | 30/05/2018 |
| 3745 | NDA/MAL/HDP/8818 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVOTOP-PF | LEVOFLOXACIN HEMIHYDRATE | 1.5%W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA| AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 30/05/2018 |
| 3746 | NDA/MAL/HDP/8819 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LORFACT-D SYRUP | DESLORATADINE | 5MG/5ML | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II, PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 30/05/2018 |
| 3747 | NDA/MAL/HDP/8820 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | T-DOL P RAPID | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | TROIKAA PHARMACEUTICALS LTD ., C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 30/05/2018 |
| 3748 | NDA/MAL/HDP/8821 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ROFAST 10 | ROSUVASTATIN CALCIUM | 10MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 30/05/2018 |
| 3749 | NDA/MAL/HDP/8822 | ABACUS PARENTERAL DRUGS LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | ALIDO | LIDOCAINE HYDROCHLORIDE | 2%W/V | LINCOLN PHARMACEUTICALS LTD- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X30.0 ML VIAL | 30/05/2018 |
| 3750 | NDA/MAL/HDP/8823 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | EPCLUSA | SOFOSBUVIR + VELPATASIR | 400MG + 100MG | PATHEON INC.-, TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 30/05/2018 |
| 3751 | NDA/MAL/HDP/8824 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NEPAFLAM | NEPAFENAC | 0.1% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML VIAL | 30/05/2018 |
| 3752 | NDA/MAL/HDP/8825 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LAXALINK | LACTULOSE | 3.35G/5ML | LINCOLN PHARMACEUTICAL LTD TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X150.0 ML BOTTLE | 30/05/2018 |
| 3753 | NDA/MAL/HDP/8829 | HETERO LABS LTD | AIVEEN (U) LIMITED | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | HETERO LABS LIMITED (UNIT V), SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301| M/S. ANNORA PHARMA PRIVATE LIMITED, SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE €“ 502313, INDIA| HETERO LABS PRIVATE LIMITED UNIT III, SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 20/12/2018 |
| 3754 | NDA/MAL/HDP/8830 | HETERO LABS LTD | SHREEJI PHARMACEUTICALS LIMITED | IRBIS-HT | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | HETERO LABS LIMITED (UNIT V), SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3755 | NDA/MAL/HDP/8831 | HETERO LABS LTD | REDDYS PHARMA LIMITED | PREGA 75 | PREGABALIN | 75MG | HETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | HETERO LABS LIMITED (UNIT I)-VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE 173205 | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 26/11/2019 |
| 3756 | NDA/MAL/HDP/8835 | RESONANT PHARMACEUTICALS PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | TRIO-FAS(KIT) | AZITHROMYCIN DIHYDRATE + FLUCONAZOLE + SECNIDAZOLE | 1000 MG + 150 MG + 2 G | 1. ACME FORMULATION PRIVATE LIMITED ROPAR ROAD, NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 174101, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*4TABLET BLISTER | 25/07/2018 |
| 3757 | NDA/MAL/HDP/8836 | EXPHAR S.A. ZONING INDUSTRIEL DE NIVELLES SUD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GASTRICID | FAMOTIDINE BP + MAGNESIUM HYDROXIDE BP + CALCIUM CARBONATE BP | 10 MG + 165 MG + 800 MG | MILAN LABORATORIES (INDIA ) PVT LTD, PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X4.0 TABLET STRIP, 1.0X50.0X4.0 TABLET STRIP | 07/11/2018 |
| 3758 | NDA/MAL/HDP/8838 | HETERO LABS LTD | REDDYS PHARMA LIMITED | PREGA 150 | PREGABALIN | 150MG | HETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | HHETERO LABS LIMITED (UNIT III)-KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH INDIA | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 26/11/2019 |
| 3759 | NDA/MAL/HDP/8839 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | HEALTH RICH | FERRIC AMMONIUM CITRATE + FOLIC ACID + VITAMIN B1 HCL + VITAMIN B6 HCL + NICOTINAMIDE + VITAMIN B12 | 900MG + 10MG + 20MG + 40MG + 200MG + 360MG /5ML | TORQUE PHARMACEUTICALS PVT LTD , VILL. ISSAPUR, P.O. DAPPAR, PUNJAB-140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 26/11/2019 |
| 3760 | NDA/MAL/HDP/8845 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FUROSEMIDE | FUROSEMIDE | 10MG/ML | SWISS PARENTERALS PVT LTD .., 809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 21/11/2019 |
| 3761 | NDA/MAL/HDP/8914 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PEFLOREN 400 | PEFLOXACIN MESILATE DIHYDRATE | 400 MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3762 | NDA/MAL/HDP/8915 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 120 MG | ETORICOXIB | 120 MG | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD-, P.O. BOX 69 AMMAN 11591 - AL-RAGEEM SAHAB - JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 25/07/2018 |
| 3763 | NDA/MAL/HDP/8917 | SVIZERA LABS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | SCC-2 LLW TABLETS | RIFAMPICIN + ISONIAZID | 150MG + 75MG | SVIZERA LABS PRIVATE LIMITED, PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI 400703, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 25/07/2018 |
| 3764 | NDA/MAL/HDP/8918 | SVIZERA LABS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | SCC-3 LLW TABLETS | RIFAMPICIN + ISONIAZID + ETHAMBUTOL HYDROCHLORIDE | 150MG + 75MG + 275MG | SVIZERA LABS PRIVATE LIMITED, PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI 400703, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 25/07/2018 |
| 3765 | NDA/MAL/HDP/8919 | SVIZERA LABS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | SCC-4 TABLETS | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE | 150MG + 75MG + 400MG + 275MG | SVIZERA LABS PRIVATE LIMITED, PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI 400703, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 25/07/2018 |
| 3766 | NDA/MAL/HDP/8926 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLUSIS 1000 ER | METFORMIN HYDROCHLORIDE | 1000 MG | MSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION) - , PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3767 | NDA/MAL/HDP/8927 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | DIPHTHERIA AND TETANUS VACCINE (ADSORBED REDUCED ANTIGEN(S) CONTENT) | DIPHTHERIA TOXOID + TETANUS TOXOID | 2 LF ( NOT LESS THAN 2 IU) + 8.8 LF (NOT LESS THAN 20 IU)/ 0.5ML | BIOLOGICAL E. LIMITED-, PLOT NO.1 SHAPOORJI PALLONJI BIOTECH PARK PHASE II, KOLTHUR VILLAGE, SHAMEERPET, MANDAL, R.R. DISTRICT, ANDRA PRADESH 500078, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X24.0X1.0X10.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL | 25/07/2018 |
| 3768 | NDA/MAL/HDP/8929 | OCTAPHARMA AG | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ALBUNORM | HUMAN ALBUMIN | 20%W/V | OCTAPHARMA PRODUKTIONSGESELLSCHAFT DEUTSCHLAND MBH-, WOLFGANG-MARGUERRE-ALLEE 1 31832 SPRINGE GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 25/07/2018 |
| 3769 | NDA/MAL/HDP/8930 | RESONANT PHARMACEUTICALS PRIVATE LIMITED | SHREEJI PHARMACEUTICALS LIMITED | GASTRISAFE-(KIT) | CLARTHROMYCIN + ESOMEPRAZOLE MAGNESIUM DIHYDRATE + TINIDAZOLE | 5000MG + 40MG + 500MG | 1. ACME FORMULATION PRIVATE LIMITED ROPAR ROAD, NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 174101, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*7*6TABLET STRIP | 25/07/2018 |
| 3770 | NDA/MAL/HDP/8931 | CARITAS HEALTHCARE PVT. LTD | REDDYS PHARMA LIMITED | SODIUM CHLORIDE INTRAVENOUS INFUSION BP | SODIUM CHLORIDE | 0.9%W/V | SICHUAN KELUN PHARMACEUTICAL CO., LTD, SOUTH OF NO.2 ROAD, XINDU SATELLITE CITY INDUSTRIAL DEVELOPMENT ZONE, CHENGDU, SICHUAN PROVINCE 610500, P. R. CHINA | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 25/07/2018 |
| 3771 | NDA/MAL/HDP/8934 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CYCLO P EYE DROPS | CYCLOPENTOLATE HYDROCHLORIDE | 1.0%W/V | ABACUS PARENTERAL DRUGS LIMITED, BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 25/07/2018 |
| 3772 | NDA/MAL/HDP/8940 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | RABIZA 20MG | RABEPRAZOLE SODIUM | 20MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?.-3. 42050 SELÇUKLU / KONYA TURKEY | | TURKEY | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/07/2018 |
| 3773 | NDA/MAL/HDP/8941 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | LIVERCOL 20MG | ROSUVASTATIN CALCIUM | 20MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?.-3. 42050 SELÇUKLU / KONYA TURKEY | | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER, 1.0X2.0X15.0 TABLET BLISTER | 25/07/2018 |
| 3774 | NDA/MAL/HDP/8943 | HETERO LABS LTD | REDDYS PHARMA LIMITED | IRBIS-HT 150/12.5 | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | HETERO LABS LIMITED (UNIT V)-SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3775 | NDA/MAL/HDP/8944 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | GAMOK 625MG | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500MG + 125MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD, OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 25/07/2018 |
| 3776 | NDA/MAL/HDP/8946 | B & O PHARM ZAC | TRIDEM PHARMA UGANDA LIMITED | GAMOK 0.6G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 500MG + 100MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD, OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X0.6 G VIAL | 25/07/2018 |
| 3777 | NDA/MAL/HDP/8947 | B & O PHARM ZAC | TRIDEM PHARMA UGANDA LIMITED | GAMOK 1.2G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 1G + 0.2G | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD, OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.2 G VIAL | 25/07/2018 |
| 3778 | NDA/MAL/HDP/8950 | ABACUS PHARMA (A) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VAXCEL CEFEPIME-1G INJECTION | CEFEPIME | 1G | 1. KOTRA PHARMA (M) SDN. BHD NO. 1, 2 & 3, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA - MALAYSIA MALAYSIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | MALAYSIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*1G VIAL | 25/07/2018 |
| 3779 | NDA/MAL/HDP/8952 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFLEX -500 | CEFALEXIN MONOHYDRATE | 500 MG | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER | 7/25/2018 |
| 3780 | NDA/MAL/HDP/8953 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN CHILDREN'S WET COUGH | GUAIFENESIN | 100MG PER 10ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 25/07/2018 |
| 3781 | NDA/MAL/HDP/8954 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WET COUGH | GUAIFENESIN | 200MG PER 10ML | JOHNSON&JOHNSON PTY LTD., EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 25/07/2018 |
| 3782 | NDA/MAL/HDP/9053 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | MABTHERA® 100MG/10ML | RITUXIMAB | 100 MG/10ML | 1. ROCHE DIAGNOSTICS, GMBH ROCHE DIAGNOSTICS GMBH, SANDHOFER STRASSE 116, 68305 MANNHEIM - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*2*10ML VIAL | 26/09/2018 |
| 3783 | NDA/MAL/HDP/9054 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | MABTHERA® 500MG/50ML | RITUXIMAB | 500 MG/50ML | 1. ROCHE DIAGNOSTICS, GMBH ROCHE DIAGNOSTICS GMBH, SANDHOFER STRASSE 116, 68305 MANNHEIM - GERMANY GERMANY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | I. 1*1*50ML VIAL | 26/09/2018 |
| 3784 | NDA/MAL/HDP/9057 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP® | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 60MG + 480MG | GUILIN PHARMACEUTICAL CO LTD-, NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X6.0X25.0 TABLET BLISTER | 26/09/2018 |
| 3785 | NDA/MAL/HDP/9058 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP® DISPERSIBLE | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 30MG + 240MG | GUILIN PHARMACEUTICAL CO LTD-, NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER,1.0X3.0X25.0 TABLET BLISTER | 26/09/2018 |
| 3786 | NDA/MAL/HDP/9063 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | TENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MG | TENOFOVIR DISOPROXIL FUMARATE | 300 MG | LAURUS LABS LIMITED, (UNIT-2) - , PLOT NO:19, 20 & 21,WESTERN SECTOR, APSEZ, ATCHUTAPURAM MANDAL, VISAKHAPATNAM-DISTRICT-531011, ANDHRA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 26/09/2018 |
| 3787 | NDA/MAL/HDP/9064 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOMOX-250 | AMOXICILLIN TRIHYDRATE | 250 MG | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER | 26/09/2018 |
| 3788 | NDA/MAL/HDP/9065 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFLEX -250 | CEFALEXIN MONOHYDRATE | 250 MG | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*10*10CAPSULE BLISTER | 26/09/2018 |
| 3789 | NDA/MAL/HDP/9066 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFIX-200 | CEFIXIME TRIHYDRATE | 200 MG | 1. THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL - NALAGARH, DISTRICT SOLAN 174101, HIMACHAL PRADESH - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*10TABLET BLISTER | 26/09/2018 |
| 3790 | NDA/MAL/HDP/9129 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LOXAMOX | LEVOFLOXACIN HEMIHYDRATES | 250MG/50ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION BAGS | 1.0X50.0 ML BAG | 21/11/2019 |
| 3791 | NDA/MAL/HDP/9137 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | DOM R | RABEPRAZOLE SODIUM + DOMPERIDONE SR | 20MG + 30MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3792 | NDA/MAL/HDP/9140 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| 3793 | NDA/MAL/HDP/9141 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | RABZOLE | RABEPRAZOLE SODIUM + LEVOSULPIRIDE | 20MG + 75MG | CORONA REMEDIES PVT. LTD, VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| 3794 | NDA/MAL/HDP/9143 | MSN LABORATORIES PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | PALOHALT | PALONOSETRON HYDROCHLORIDE | 0.25 MG/5ML | 1. MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT - 502 325, TELANGANA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY VIALS | I. 1*5ML VIAL | |
| 3795 | NDA/MAL/HDP/9146 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ISONIAZID | ISONIAZID | 300MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER,1.0X1000.0 TABLET BOTTLE | 21/11/2019 |
| 3796 | NDA/MAL/HDP/9165 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | VAGID-100 | CLOTRIMAZOLE | 100 MG | M/S BLISS GVS PHARMA LIMITED , PLOT 10, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE PALGHAR, DIST. THANE - 401404 | INDIA | VAGINAL SUPPOSITORIES | 1.0X1.0X7.0 PESSARY BLISTER,1.0X1.0X6.0 PESSARY BLISTER | 21/11/2019 |
| 3797 | NDA/MAL/HDP/9169 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | PROCTICAD | LACTITOL MONOHYDRATE | 10 GM/15ML | CADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 27/11/2019 |
| 3798 | NDA/MAL/HDP/9191 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANDOX-DS 50 | CEFPODOXIME PROXETIL | 50 MG/5ML | SANCE LABORATORIES PVT LTD, VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| 3799 | NDA/MAL/HDP/9192 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANDOX- 200 | CEFPODOXIME PROXETIL | 200 MG | SANCE LABORATORIES PVT LTD, VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3800 | NDA/MAL/HDP/9193 | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD | TATA UGANDA LIMITED | LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MG | LAMIVUDINE + ZIDOVUDINE | 150 MG + 300 MG | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD, 1479 ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE SHANGHAI, CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 08/09/2020 |
| 3801 | NDA/MAL/HDP/9195 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SOBISIS | SODIUM BICARBONATE | 500 MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3802 | NDA/MAL/HDP/9196 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SOBISIS FORTE | SODIUM BICARBONATE | 1000 MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3803 | NDA/MAL/HDP/9197 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SEVLAREN 400 | SEVELAMER CARBONATE | 400 MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3804 | NDA/MAL/HDP/9198 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | PBREN 75 | PREGABALIN | 75 MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| 3805 | NDA/MAL/HDP/9199 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | KCHEK | CALCIUM POLYSTYRENE SULPHONATE | 15 MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X15.0 G SACHET | 08/09/2020 |
| 3806 | NDA/MAL/HDP/9200 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | LEVIGRESS 250 | LEVETIRACETAM | 250 MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3807 | NDA/MAL/HDP/9201 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | LEVIGRESS 500 | LEVETIRACETAM | 500MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3808 | NDA/MAL/HDP/9202 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | ESCIGRESS 5 | ESCITALOPRAM OXALATE | 5MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3809 | NDA/MAL/HDP/9203 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | ESCIGRESS 10 | ESCITALOPRAM OXALATE | 10MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3810 | NDA/MAL/HDP/9204 | SUN PHARMACEUTICAL INDUSTRIES LTD | STAR PHARMACEUTICALS LTD | CHERIFLU PLUS WITH VITAMIN C | CHLORPHENAMINE MALEATE + PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE +VITAMIN C | 4 MG + 650 MG + 10 MG + 30 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED , INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3811 | NDA/MAL/HDP/9206 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | FLIPTOR 5 | ROSUVASTATIN CALCIUM | 5 MG | 1. THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 08/09/2020 |
| 3812 | NDA/MAL/HDP/9207 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | FLIPTOR 10 | ROSUVASTATIN CALCIUM | 10 MG | 1. THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 08/09/2020 |
| 3813 | NDA/MAL/HDP/9209 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | NOFONG | TERBINAFINE HYDROCHLORIDE | 1 %W/W | 1. THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL CREAMS | I. 1*15G TUBE | 08/09/2020 |
| 3814 | NDA/MAL/HDP/9210 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC | IRBESARTAN | 300 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3815 | NDA/MAL/HDP/9211 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 10000 IU | CHOLECALCIFEROL | 10,000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X30.0 CAPSULE CONTAINER | 08/09/2020 |
| 3816 | NDA/MAL/HDP/9212 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 50000 IU | CHOLECALCIFEROL | 50,000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X8.0 CAPSULE CONTAINER | 08/09/2020 |
| 3817 | NDA/MAL/HDP/9213 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | COMBIART SUSPENSION | ARTEMETHER + LUMEFANTRINE | 15 MG/5ML + 90 MG/5ML | 1. THE MADRAS PHARMACEUTICALS 137 - B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600 096 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*60ML BOTTLE | 08/09/2020 |
| 3818 | NDA/MAL/HDP/9214 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 2000 IU | CHOLECALCIFEROL | 2000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X30.0 CAPSULE CONTAINER | 08/09/2020 |
| 3819 | NDA/MAL/HDP/9215 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 2000 IU/5 DROPS | CHOLECALCIFEROL | 2000IU/ 5 DROPS | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL LIQUID ORDINARY DROPS | 1.0X1.0X10.0 ML BOTTLE | 08/09/2020 |
| 3820 | NDA/MAL/HDP/9219 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TESS | TRIAMCINOLONE ACETONIDE | 0.1% W/W | TROIKAA PHARMACEUTICALS LTD, BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE | INDIA | TOPICAL EXTERNAL PASTES | 1.0X1.0X5.0 G TUBE | 08/09/2020 |
| 3821 | NDA/MAL/HDP/9223 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | LAXIWAL | LACTULOSE | 10 G/15 ML | WALLACE PHARMACEUTICALS PVT LTD, BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 08/09/2020 |
| 3822 | NDA/MAL/HDP/9224 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | XAAR | PREGABALIN | 75 MG | 1. WILSHIRE LABS (PVT) LTD 124/1, QUAID-E-AZAM INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. WILSHIRE LABS (PVT) LTD 124/1, QUAID-E-AZAM INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE PAKISTAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | I. 1*4*5CAPSULE BLISTER | 2020-09-08 00:00:00 |
| 3823 | NDA/MAL/HDP/9226 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | ZURIG 80 | FEBUXOSTAT | 80MG | ZYDUS LIFESCIENCES LTD , KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3824 | NDA/MAL/HDP/9229 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | TRADMIN | TRAMADOL HYDROCHLORIDE | 50MG | AKUMS DRUGS & PHARMACEUTICALS LTD, 19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| 3825 | NDA/MAL/HDP/9234 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | I-UP | FERROUS ASCORBATE + FOLIC ACID | 30 MG + 550 µG/5ML | 1. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. CACHET PHARMACEUTICALS PRIVATE LIMITED VILLAGE - THANA BADDI, SOLAN DISTRICT, - 173 205, HIMACHAL PRADESH. INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*200ML BOTTLE | 08/09/2020 |
| 3826 | NDA/MAL/HDP/9236 | LUPIN LTD | AIVEEN (U) LIMITED | RIFAMPICIN, ISONIAZID AND ETHAMBUTOL HYDROCHLORIDE TABLETS | RIFAMPIN + ISONIAZID + ETHAMBUTOL HYDROCHLORIDE | 150 MG + 75 MG + 275 MG | LUPIN LIMITED , A-28/1 MIDC CHIKALTHANA AURANGABAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 08/09/2020 |
| 3827 | NDA/MAL/HDP/9237 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AZITHRO-DENK 250 MG | AZITHROMYCIN MONOHYDRATE | 250MG | ARTESAN PHARMA GMBH & CO. KG, WENDLANDSTR.1, 29439, LUCHOW | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 08/09/2020 |
| 3828 | NDA/MAL/HDP/9238 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | AZITHRO-DENK 500 MG | AZITHROMYCIN MONOHYDRATE | 500MG | ARTESAN PHARMA GMBH & CO. KG, WENDLANDSTR.1, 29439, LUCHOW | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 08/09/2020 |
| 3829 | NDA/MAL/HDP/9241 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | LEXAR | LEVOFLOXACIN HEMIHYDRATE | 500MG | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND|HIGGS HEALTHCARE PVT. LIMITED, KHASRA NO. 480/1, BHATOLIKALAN BADDI, DISTT SOLAN, (H.P) - INDIA|HIGGS HEALTHCARE PVT. LIMITED, KHASRA NO. 480/1, BHATOLIKALAN BADDI, DISTT SOLAN, (H.P) - INDIA| | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| 3830 | NDA/MAL/HDP/9246 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | CLAMOXIN | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | MEDOPHARM PVT LIMITED, NO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 19/02/2021 |
| 3831 | NDA/MAL/HDP/9248 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ESOFAG-D | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE + DOMPERIDONE | 40MG + 30MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP | 08/09/2020 |
| 3832 | NDA/MAL/HDP/9249 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LOXAMOX | LEVOFLOXACIN HEMIHYDRATE | 5 MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1.0X100.0 ML BAG | 08/09/2020 |
| 3833 | NDA/MAL/HDP/9251 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIBOFAN | TIROFIBAN HYDROCHLORIDE | 12.5 MG/50ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL | 28/09/2020 |
| 3834 | NDA/MAL/HDP/9252 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | FLUCO-BKRS | FLUCONAZOLE | 0.2% W/V | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND| HIGGS HEALTHCARE PVT. LIMITED, KHASRA NO. 480/1, BHATOLIKALAN BADDI, DISTT SOLAN, (H.P) - INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| 3835 | NDA/MAL/HDP/9253 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | ERVEBO | EBOLA ZAIRE VACCINE (RVSV?G-ZEBOV-GP, LIVE ATTENUATED) | 72MILLION PFU/ML | MSD SITE-BURGWEDEL BIOTECH GMBH-IM LANGEN FELDE 5, 30938 BURGWEDEL | GERMANY| UNITED STATES | PARENTERAL ORDINARY VIALS | 1.0X10.0 VIAL CARTON | 08/09/2020 |
| 3836 | NDA/MAL/HDP/9262 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | DOMIPAN | PANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE | 40 MG + 30 MG | 1. FREDUN PHARMACEUTICALS LIMITED 14, 15, 16 ZORABIAN INDUSTRIAL COMPLEX, VEVOOR, PALGHAR 401 404 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1*1*10CAPSULE BLISTER| 1*3*10CAPSULE BLISTER | 08/09/2020 |
| 3837 | NDA/MAL/HDP/9263 | FREDUN PHARMACEUTICALS LTD | REDDYS PHARMA LIMITED | ETCOX-90 | ETORICOXIB | 90 MG | 1. FREDUN PHARMACEUTICALS LIMITED 14, 15, 16 ZORABIAN INDUSTRIAL COMPLEX, VEVOOR, PALGHAR 401 404 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 08/09/2020 |
| 3838 | NDA/MAL/HDP/9264 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APRITANT IV | FOSAPRIPITANT DIMEGLUMINE | 150 MG/VIAL | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION, PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL VIAL | 08/09/2020 |
| 3839 | NDA/MAL/HDP/9265 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYHEP ALL | SOFOSBUVIR + VELPATASVIR | 400 MG + 100 MG | MYLAN LABORATORIES LTD ., F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET CONTAINER | 28/09/2020 |
| 3840 | NDA/MAL/HDP/9266 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR (AS SULFATE) / LAMIVUDINE DISPERSIBLE TABLETS | ABACAVIR SULFATE + LAMIVUDINE | 120 MG + 60 MG | MYLAN LABORATORIES LIMITED, NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA| MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER | 08/09/2020 |
| 3841 | NDA/MAL/HDP/9269 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | EMTRICITABINE/TENOFOVIR ALAFENAMIDE TABLETS | EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE | 200 MG + 25 MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 28/09/2020 |
| 3842 | NDA/MAL/HDP/9276 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZYLODINE | LIDOCAINE HYDROCHLORIDE | 20MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X25.0X50.0 ML VIAL | 28/09/2020 |
| 3843 | NDA/MAL/HDP/9278 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | CANDIFORCE-100 | ITRACONAZOLE | 100 MG | COHANCE LIFESCIENCES LIMITED, PLOT NO. A-19/C, ROAD NO. 18, IDA NACHARAM, HYDERABAD-500076, TELENGANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| 3844 | NDA/MAL/HDP/9285 | GALENTIC PHARMA (INDIA) PVT. LTD. | VITACARE LIMITED | NEBA-SPORIN | NEOMYCIN SULFATE + BACITRACIN | 5 MG/G + 500 IU/G | 1. GALENTIC PHARMA (INDIA) PRIVATE LIMITED R-673, T.T.C., MIDC, RABALE, THANE BELAPUR ROAD, NAVI MUMBAI, 400 701 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*15G TUBE | 08/09/2020 |
| 3845 | NDA/MAL/HDP/9286 | GALENTIC PHARMA LTD | VITACARE LIMITED | SELDRUF | SELENIUM SULFIDE | 2.5% W/V | GALENTIC PHARMA (INDIA) LTD ., R-673, MIDC, TTC, RABALE, THANE-BELAPUR ROAD, NAVI MUMBAI | INDIA | TOPICAL EXTERNAL SUSPENSIONS | 1.0X100.0 ML BOTTLE | 08/09/2020 |
| 3846 | NDA/MAL/HDP/9287 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CANDID-V3 | CLOTRIMAZOLE | 200MG | GLENMARK PHARMACEUTICALS LTD ., PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | VAGINAL TABLETS | 1.0X1.0X3.0 TABLET STRIP | 08/09/2020 |
| 3847 | NDA/MAL/HDP/9290 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFIXIME 200 | CEFIXIME TRIHYDRATE | 200MG | INNOVA CAPTAB PVT. LTD, 1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3848 | NDA/MAL/HDP/9291 | INTAS PHARMACEUTICALS LIMITED | STAR BIOTECH UGANDA LTD | SARTEL-80 LH | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80 MG + 12.5 MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3849 | NDA/MAL/HDP/9294 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WET COUGH MENTHOL | GUAIFENESIN | 200 MG/10 ML | JOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| 3850 | NDA/MAL/HDP/9296 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | VAGID-CL | CLINDAMYCIN + CLOTRIMAZOLE | 100 MG + 200 MG | BLISS GVS PHARMA LIMITED, 10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | VAGINAL SUPPOSITORIES | 1.0X1.0X3.0 SUPPOSITORY STRIP | 08/09/2020 |
| 3851 | NDA/MAL/HDP/9305 | KOPRAN LIMITED | TATA UGANDA LIMITED | CELEKOP-200 | CELECOXIB | 200MG | KOPRAN LIMITED, VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| 3852 | NDA/MAL/HDP/9306 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FUNBACT-A | CLOTRIMAZOLE + BETAMETHASONE DIPROPIONATE + NEOMYCIN SULFATE | 1.0 % W/W + 0.05 % W/W + 0.5 % W/W | KREMOINT PHARMA PVT LTD. , B-8, ADDITIONAL AMBERNATH M.I.D.C, OPP. ANAND NAGIAR POLICE CHECK POST, AMBERNATH (E), DIST. THANE.| BUSHAL CHEMI PHARMA PRIVATE LIMITED - PLOT NO.- F33, MIDC, BADLAPUR, MAHARASHTRA – 421503, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 08/09/2020 |
| 3853 | NDA/MAL/HDP/9307 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | PYL-X OINTMENT | LIDOCAINE + ZINC OXIDE + ALLANTOIN + HYDROCORTISONE ACETATE | 3.0%W/W + 5.0% W/W + 0.5%W/W + 0.25W/W | 1. KREMOINT PHARMA PRIVATE LIMITED B-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (E), DIST. THANE 421506, MAHARASHTRA - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*1*30G TUBE | 08/09/2020 |
| 3854 | NDA/MAL/HDP/9313 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE-30 | ARTESUNATE | 30 MG/VIAL | BLISS INDAS LIFESCIENCE P. LTD.., PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON + 0.5 ML OF 5.0 %W/V SODIUM BICARBONATE VIAL + 2.5 ML OF 0.9% W/V SODIUM CHLORIDE VIAL | 08/09/2020 |
| 3855 | NDA/MAL/HDP/9315 | CENTAUR PHARMACEUTICALS PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | ACETAMOX | ACETAZOLAMIDE | 250 MG | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1), PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| 3856 | NDA/MAL/HDP/9316 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | TERBIDERM | TERBINAFINE HYDROCHLORIDE | 1% W/W | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 08/09/2020 |
| 3857 | NDA/MAL/HDP/9317 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | FEPAR | ALBENDAZOLE | 200 MG/5ML | AL FAZAL PHARMA INDUSTRIES (PVT) LTD - PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SUSPENSIONS | I. 1*1*10ML BOTTLE | 08/09/2020 |
| 3858 | NDA/MAL/HDP/9320 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ONCHOFIN 250 | TERBINAFINE HYDROCHLORIDE | 250 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*2*7TABLET BLISTER | 08/09/2020 |
| 3859 | NDA/MAL/HDP/9325 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | OESTROGEL | ESTRADIOL HEMIHYDRATE | 0.06W/W | BESINS MANUFACTURING BELGIUM (BMB), GROOT BIJGAARDENSTRAAT, 128. 1620 | BELGIUM | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X80.0 G CONTAINER | 08/09/2020 |
| 3860 | NDA/MAL/HDP/9327 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | OXCIN-D | MOXIFLOXACIN + DEXAMETHASONE SODIUM PHOSPHATE | 0.5%W/V + 0.1% W/V | ATCO LABS LTD,, B-18, S.I.T.E, KARACHI | PAKISTAN | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 08/09/2020 |
| 3861 | NDA/MAL/HDP/9331 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | PARA-BKRS | PARACETAMOL | 1.0%W/V | HIGGS HEALTHCARE PVT. LIMITED, KHASRA NO. 480/1, BHATOLIKALAN BADDI, DISTT SOLAN, (H.P) - INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 26/10/2020 |
| 3862 | NDA/MAL/HDP/9348 | PHARCO B INTERNATIONAL, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PARACETAMOL - PHARCO B INTERNATIONAL | PARACETAMOL | 1G/100ML | PHARCO-B INTERNATIONAL PHARMACEUTICALS, BORG EL-ARAB 3D INDUSTRIAL ZONE, BLOCK 18 AREA, 10, 11, ALEXANDRIA EGYPT | EGYPT | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML VIAL | 09/12/2020 |
| 3863 | NDA/MAL/HDP/9356 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | IRIS | DESLORATADINE | 5MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3864 | NDA/MAL/HDP/9358 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROZAPINE OD 30 | MIRTAZAPINE | 30 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | I. 1*5*6TABLET BLISTER | 09/12/2020 |
| 3865 | NDA/MAL/HDP/9359 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROZAPINE OD 15 | MIRTAZAPINE | 15 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | I. 1*5*6TABLET BLISTER | 09/12/2020 |
| 3866 | NDA/MAL/HDP/9361 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PEGASET 75 | PREGABALIN | 75 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*4*7CAPSULE BLISTER | 09/12/2020 |
| 3867 | NDA/MAL/HDP/9365 | HETERO BIOPHARMA LIMITED, | REDDYS PHARMA LIMITED | BEVAAS 100 | BEVACIZUMAB | 100MG/4ML | HETERO BIOPHARMA LIMITED, SY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT €“ 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X4.0 ML VIAL | 09/12/2020 |
| 3868 | NDA/MAL/HDP/9367 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XENAMEX | TRANEXAMIC ACID | 100MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X10.0X5.0 ML VIAL | 09/12/2020 |
| 3869 | NDA/MAL/HDP/9368 | HETERO BIOPHARMA LIMITED, | REDDYS PHARMA LIMITED | BEVAAS 400 | BEVACIZUMAB | 400MG/16ML | HETERO BIOPHARMA LIMITED, SY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT €“ 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X16.0 ML VIAL | 09/12/2020 |
| 3870 | NDA/MAL/HDP/9373 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATORKEY 10 | ATORVASTATIN CALCIUM TRIHYDRATE | 10 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/12/2020 |
| 3871 | NDA/MAL/HDP/9375 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATORKEY 20 | ATORVASTATIN CALCIUM TRIHYDRATE | 20 MG | 1. AUROBINDO PHARMA LIMITED, UNIT - XV PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 53102 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/12/2020 |
| 3872 | NDA/MAL/HDP/9376 | KOPRAN LIMITED | TATA UGANDA LIMITED | AZ-1 500 | AZITHROMYCIN DIHYDRATE | 500 MG | KOPRAN LIMITED, VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER | 09/12/2020 |
| 3873 | NDA/MAL/HDP/9377 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN DT 250 | AMOXICLLIN TRIHYDRATE | 250 MG | KOPRAN LIMITED, VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0X15.0 TABLET STRIP, 10.0X10.0 TABLET STRIP | 09/12/2020 |
| 3874 | NDA/MAL/HDP/9379 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN DT 125 | AMOXICILLIN TRIHYDRATE | 125 MG | KOPRAN LIMITED, VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0X15.0 TABLET STRIP, 10.0X10.0 TABLET STRIP | 09/12/2020 |
| 3875 | NDA/MAL/HDP/9383 | SUN PHARMACEUTICAL INDUSTRIES LTD | STAR PHARMACEUTICALS LTD | DOLUTEGRAVIR, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 09/12/2020 |
| 3876 | NDA/MAL/HDP/9384 | HETERO LABS LIMITED | AIVEEN (U) LIMITED | ZOLDRO | ZOLEDRONIC ACID MONOHYDRATE | 4MG/VIAL | 1. M/S ASPIRO PHARMA LIMITED PLOT NO. 23, SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA (VILLAGE), MARKOOK MANDAL, SIDDIPET DI INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*4MG VIAL | |
| 3877 | NDA/MAL/HDP/9387 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | DIPHTHERIA AND TETENUS VACCINE ADSORBED FOR ADULTS AND ADOLESCENTS | DIPHTHERIA + TETANUS + ALUMINIUM PHOSPHATE | ? 5 LF (? 2 IU) + ? 5 LF (? 40 IU) + ? 1.25 MG/DOSE | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X10.0 DOSE VIAL, 1.0X5.0X10.0X1.0 DOSE AMPOULE | 22/12/2020 |
| 3878 | NDA/MAL/HDP/9389 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | DIPHTHERIA, TETANUS, PERTUSSIS, HEPATITIS B AND HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE ADSORBED | DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE + ALUMINIUM PHOSPHATE | ? 25 LF (? 30 IU) + ? 2.5 LF (? 40 IU) + ? 16 OU (? 4.0 IU) + ? 10 MCG + ? 10 MCG + ? 1.25 MG/DOSE | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X10.0 DOSE VIAL | 23/12/2020 |
| 3879 | NDA/MAL/HDP/9390 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIZTROL 8 | BETAHISTINE DIHYDROCHLORIDE | 8 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 09/12/2020 |
| 3880 | NDA/MAL/HDP/9393 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | LESS-K | CALCIUM POLYSTYRENE SULFONATE | 5 GM/SACKET | MEGA LIFESCIENCES PUBLIC COMPANY LTD, PLANT 2; 515/1 MOO 4, SOI 8 BANGPOO INDUSTRIAL ESTATE PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280, THAILAND | THAILAND | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0X5.0 G SACHET | 09/12/2020 |
| 3881 | NDA/MAL/HDP/9401 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | UTROGESTAN | PROGESTERONE | 100 MG | CYNDEA PHARMA, S.L, POLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 09/12/2020 |
| 3882 | NDA/MAL/HDP/9403 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARTEM | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER | 09/12/2020 |
| 3883 | NDA/MAL/HDP/9404 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SOFTDROPS | CARBOXYMETHYLCELLULOSE SODIUM + GLYCERIN | 0.5% W/V + 0.5% W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD ., N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE| AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 09/12/2020 |
| 3884 | NDA/MAL/HDP/9405 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | TELMA 80 | TELMISARTAN | 80 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*4*7TABLET BLISTER | 09/12/2020 |
| 3885 | NDA/MAL/HDP/9406 | GALENTIC PHARMA (INDIA) PVT. LTD. | VITACARE LIMITED | CHLORHEXIDINE GLUCONATE GEL BP | CHLORHEXIDINE GLUCONATE | 7.1 %W/V | 1. GALENTIC PHARMA (INDIA) PRIVATE LIMITED R-673, T.T.C., MIDC, RABALE, THANE BELAPUR ROAD, NAVI MUMBAI, 400 701 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | I. 1*1*10G TUBE II. 1*1*20G TUBE | 09/12/2020 |
| 3886 | NDA/MAL/HDP/9407 | GALENTIC PHARMA (INDIA) PVT. LTD. | VITACARE LIMITED | OROMUCORAL GEL | MICONAZOLE | 2 %W/W | 1. GALENTIC PHARMA (INDIA) PRIVATE LIMITED R-673, T.T.C., MIDC, RABALE, THANE BELAPUR ROAD, NAVI MUMBAI, 400 701 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL TOPICAL GELS AND SOLS | I. 1*1*20G TUBE | 09/12/2020 |
| 3887 | NDA/MAL/HDP/9408 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | ZIRIN | CETIRIZINE DIHYDROCHLORIDE | 10 MG | MEGA LIFESCIENCES PUBLIC COMPANY LTD, PLANT 2; 515/1 MOO 4, SOI 8 BANGPOO INDUSTRIAL ESTATE PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER | 09/12/2020 |
| 3888 | NDA/MAL/HDP/9409 | HETERO LABS LTD | REDDYS PHARMA LIMITED | STAVANCE 500 | VANCOMYCIN HYDROCHLORIDE | 500 MG/VIAL | ASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X500.0 MG VIAL | 09/12/2020 |
| 3889 | NDA/MAL/HDP/9410 | HETERO LABS LTD | REDDYS PHARMA LIMITED | STAVANCE 1 | VANCOMYCIN HYDROCHLORIDE | 1G/VIAL | ASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 09/12/2020 |
| 3890 | NDA/MAL/HDP/9411 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 5 +5 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 5MG + 5MG | EGIS PHARMACEUTICALS PLC, BOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3891 | NDA/MAL/HDP/9412 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EBASTO - 10 | EBASTINE | 10 MG | 1. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 09/12/2020 |
| 3892 | NDA/MAL/HDP/9413 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 10 + 5 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 10MG + 5MG | EGIS PHARMACEUTICALS PLC, BOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3893 | NDA/MAL/HDP/9414 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLANGEM OD 10 | OLANZAPINE | 10 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLET | I. 1*4*7TABLET BLISTER | 09/12/2020 |
| 3894 | NDA/MAL/HDP/9415 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 10 + 10 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 10MG + 10MG | EGIS PHARMACEUTICALS PLC, BOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3895 | NDA/MAL/HDP/9416 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 5 + 10 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 5MG + 10MG | EGIS PHARMACEUTICALS PLC, BOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3896 | NDA/MAL/HDP/9418 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400 MG + 300 MG + 300 MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 09/12/2020 |
| 3897 | NDA/MAL/HDP/9421 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MUCOSIL AM | TERBUTALINE SULFATE + GUAIFENESIN + AMBROXOL HYDROCHLORIDE + MENTHOL | 1.25 MG + 50 MG + 15 MG + 2.5 MG/5 ML | RAVIAN LIFE SCIENCE PVT LTD, PLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 09/12/2020 |
| 3898 | NDA/MAL/HDP/9424 | PHARCO B INTERNATIONAL, | GAMA PHARMACEUTICALS (U) LIMITED | CEFAXONE 1G I.V. | CEFTRIAXONE SODIUM HYDRATE | 1G | PHARCO-B INTERNATIONAL PHARMACEUTICALS-BORG EL-ARAB 3D INDUSTRIAL ZONE, BLOCK 18 AREA, 10, 11, ALEXANDRIA EGYPT | | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 09/12/2020 |
| 3899 | NDA/MAL/HDP/9425 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CIATUFF 20 | TADALAFIL | 20 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*4TABLET BLISTER | 09/12/2020 |
| 3900 | NDA/MAL/HDP/9426 | PHARCO B INTERNATIONAL, | GAMA PHARMACEUTICALS (U) LIMITED | CEFAXONE 2G I.V. | CEFTRIAXONE SODIUM HYDRATE | 2G | PHARCO-B INTERNATIONAL PHARMACEUTICALS-BORG EL-ARAB 3D INDUSTRIAL ZONE, BLOCK 18 AREA, 10, 11, ALEXANDRIA EGYPT | | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL | 09/12/2020 |
| 3901 | NDA/MAL/HDP/9428 | LUPIN LIMITED | AIVEEN (U) LIMITED | RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS | RIFAMPIN + ISONIAZID | 75 MG + 50 MG | LUPIN LIMITED , A-28/1 MIDC CHIKALTHANA AURANGABAD | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X14.0X6.0 TABLET STRIP | 09/12/2020 |
| 3902 | NDA/MAL/HDP/9430 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VALK PLUS SP | ACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE | 100 MG + 500 MG + 10 MG | 1. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*10*10TABLET BLISTER II. 1*1*10TABLET BLISTER | 09/12/2020 |
| 3903 | NDA/MAL/HDP/9433 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ADACIN | ADAPALENE + CLINDAMYCIN PHOSPHATE | 0.1 %W/W + 1.0% W/W | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X15.0 G TUBE | 09/12/2020 |
| 3904 | NDA/MAL/HDP/9434 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | LAVAGEM | BISACODYL | 5MG | FREDUN PHARMACEUTICALS LIMITED, 14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3905 | NDA/MAL/HDP/9437 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOFLORAN | TERBINAFINEHYDROCHLORIDE | 250 MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 09/12/2020 |
| 3906 | NDA/MAL/HDP/9438 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | URACTONUM | SPIRONOLACTONE | 25 MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3907 | NDA/MAL/HDP/9439 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | HYFRESH | SODIUM HYALURONATE | 0.2% W/V | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 18/12/2020 |
| 3908 | NDA/MAL/HDP/9441 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PARAVIN | PARACETAMOL | 10MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X12.0X100.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 09/12/2020 |
| 3909 | NDA/MAL/HDP/9442 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VOMIRAN | ONDANSETRON HYDROCHLORIDE | 2MG/ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X2.0 ML VIAL | 22/12/2020 |
| 3910 | NDA/MAL/HDP/9446 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FUSIBACT | SODIUM FUSIDATE | 2%W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 18/12/2020 |
| 3911 | NDA/MAL/HDP/9447 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FUSIBACT-B | FUSIDIC ACID + BETAMETHASONE VALERATE | 2% W/W + 0.1% W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 09/12/2020 |
| 3912 | NDA/MAL/HDP/9448 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ELICA | MOMETASONE FUROATE | 0.1%W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 18/12/2020 |
| 3913 | NDA/MAL/HDP/9451 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-KAST 10 | MONTELUKAST SODIUM | 10 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 09/12/2020 |
| 3914 | NDA/MAL/HDP/9452 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BNOXIPARIN 40 | ENOXAPARIN SODIUM | 40 MG/0.4 ML | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.4 ML PRE- FILLED SYRINGE | 09/12/2020 |
| 3915 | NDA/MAL/HDP/9453 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BNOXIPARIN 60 | ENOXAPARIN SODIUM | 60 MG/0.6 ML | BRAWN LABORATORIES LIMITED, 13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.6 ML PRE- FILLED SYRINGE | 09/12/2020 |
| 3916 | NDA/MAL/HDP/9455 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | BISPEC-5 | SOLIFENACIN SUCCINATE | 5MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3917 | NDA/MAL/HDP/9456 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | BISPEC-10 | SOLIFENACIN SUCCINATE | 10MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/12/2020 |
| 3918 | NDA/MAL/HDP/9481 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | OFLO-BKRS | OFLOXACIN | 0.2% W/V | AXA PARENTERALS LTD, PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND|HIGGS HEALTHCARE PVT. LIMITED, KHASRA NO. 480/1, BHATOLIKALAN BADDI, DISTT SOLAN, (H.P) - INDIA|HIGGS HEALTHCARE PVT. LIMITED, KHASRA NO | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 09/12/2020 |
| 3919 | NDA/MAL/HDP/9482 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NUCLOFAR | CLOFARABINE | 20 MG/20ML | MSN LABORATORIES PRIVATE LIMITED - UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | PARENTERAL ORDINARY VIALS | I. 1*1*20ML VIAL | |
| 3920 | NDA/MAL/HDP/9490 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | IPEN-CIL | IMIPENEM + CILASTATIN | 500 MG + 500 MG/VIAL | ZEISS PHARMACEUTICALS PVT LTD - , PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 09/12/2020 |
| 3921 | NDA/MAL/HDP/9496 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OXYSPRAY | OXYMETAZOLINE HYDROCHLORIDE | 0.05% W/V | ZYDUS LIFESCIENCES. PLOT NO. 417, 419 & 420, SARKHEJ-BAVLA N.H. NO. 8A, MORAIYA, TAL: SANAND, DIST. AHMEDABAD - 382210, GUJARAT, INDIA | INDIA | OTHER SYSTEMIC SPRAYS WITHOUT GAS | 1X1X15 ML BOTTLE | 04/03/2021 |
| 3922 | NDA/MAL/HDP/9497 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ETOHOPE 60 | ETORICOXIB | 60 MG | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST. DHAR (M.P), PINCODE: 454775 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 04/03/2021 |
| 3923 | NDA/MAL/HDP/9498 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ETOHOPE 90 | ETORICOXIB | 90 MG | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST. DHAR (M.P), PINCODE: 454775 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 04/03/2021 |
| 3924 | NDA/MAL/HDP/9499 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ETOHOPE 120 | ETORICOXIB | 120 MG | GLENMARK PHARMACEUTICALS LIMITED, PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST. DHAR (M.P), PINCODE: 454775 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 04/03/2021 |
| 3925 | NDA/MAL/HDP/9502 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | UTROGESTAN VAGINAL 200 MG | PROGESTERONE | 200 MG | CYNDEA PHARMA, S.L, POLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | VAGINAL CAPSULES | 1.0X1.0X7.0X1.0X8.0 CAPSULE BLISTER | 24/02/2021 |
| 3926 | NDA/MAL/HDP/9504 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETA COOL DOUBLE ACTION ANTACID SUSPENSION | SODIUM ALGINATE + SODIUM BICARBONATE | (500 MG + 267 MG)/10 ML | BETA HEALTHCARE INTERNATIONAL LTD , PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 24/02/2021 |
| 3927 | NDA/MAL/HDP/9505 | CADILA HEALTHCARE LIMITED €ŒZYDUS TOWER€ - | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT-LC | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST | 5 MG + 10 MG | RAVIAN LIFE SCIENCE PVT LTD, PLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3928 | NDA/MAL/HDP/9506 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TROFENTYL | FENTANYL CITRATE | 50 MCG/ML | TROIKAA PHARMACEUTICALS LIMITED,,, C-1, SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE | 24/02/2021 |
| 3929 | NDA/MAL/HDP/9510 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | GEODERM | BETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE + CLOTRIMAZOLE | (0.5 MG + 1.0 MG + 10.0 MG)/G | KREMOINT PHARMA PVT LTD PLANT II, B-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST) DIST. THANE 421506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE, 1.0X30.0 G TUBE | 24/02/2021 |
| 3930 | NDA/MAL/HDP/9513 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | METRONIDAZOLE INFUSION BP | METRONIDAZOLE | 0.5% W/V | ALTHEA PHARMA PRIVATE LIMITED-WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 24/02/2021 |
| 3931 | NDA/MAL/HDP/9515 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BACTAFUZ-B | FUSIDIC ACID + BETAMETHASONE VALERATE | 2% W/W + 0.1%W/W | ENCUBE ETHICALS PVT LTD, PLOT C-1, MADKAIM INDUSTRIAL ESTATE, MADKAIM, POST: MARDOL, PONDA GOA-403404 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 24/02/2021 |
| 3932 | NDA/MAL/HDP/9524 | STRIDES PHARMA SCIENCE LIMITED | DELMAW ENTERPRISES LIMITED | TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIR TABLETS | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE + DOLUTEGRAVIR SODIUM | 300 MG + 300 MG + 50 MG | STRIDES PHARMA SCIENCE LIMITED - KRS GARDENS, 36/7SURAGAJAKKANAHALLI, INDLAVADI CROSS, ANEKAL TAKUL, BENGALURU, INDIA|UNIVERSAL CORPORATION LIMITED CLUB ROAD, PAST POST OFFICE, PLOT NO. 13777, P.O. BOX 1748-00902, KIKUYU TOWN - KENYA | INDIA| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 24/02/2021 |
| 3933 | NDA/MAL/HDP/9525 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | SPAQ-CO DISP | (SULFADOXINE + PYRIMETHAMINE) + AMODIAQUINE HYDROCHLORIDE | (250 MG + 12.5 MG) +76.5 MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER,1.0X25.0X1.0X12.0 TABLET BLISTER | 24/02/2021 |
| 3934 | NDA/MAL/HDP/9526 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | SPAQ-CO DISP | (SULFADOXINE + PYRIMETHAMINE) + AMODIAQUINE HYDROCHLORIDE | (500 MG + 25 MG) +153 MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER | 24/02/2021 |
| 3935 | NDA/MAL/HDP/9527 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | PARASYP | PARACETAMOL | 120 MG/5 ML | AL FAZAL PHARMA INDUSTRIES (PVT) LTD, PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 24/02/2021 |
| 3936 | NDA/MAL/HDP/9528 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SOLANDIS ODT 8MG | ONDANSETRON | 8MG | ATHENA DRUG DELIVERY SOLUTIONS PVT LTD ,.-PLOT A-1 TO A-5, MIDC CHEMICAL ZONE, AMBERNATH (W) THANE 421501, MAHARASHTRA | | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3937 | NDA/MAL/HDP/9533 | LUPIN LTD | AIVEEN (U) LIMITED | ISONIAZID TABLETS BP 100MG | ISONIAZID | 100 MG | LUPIN LTD, A-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3938 | NDA/MAL/HDP/9534 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | PHLORO-G | PHLOROGLUCINOL DIHYDRATE | 80MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3939 | NDA/MAL/HDP/9535 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO DURATAZ INJECTION 4.5 G | PIPERACILLIN + TAZOBACTAM | (4 G + 0.5 G)/VIAL | ARISTO PHARMACEUTICALS PVT LTD, PLOT 208, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP 462046 DIST. RAISEN (MP) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL | 24/02/2021 |
| 3940 | NDA/MAL/HDP/9537 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | SENSOCAIN SPINAL 0.5% INJECTION | BUPIVACAINE HYDROCHLORIDE | 5MG/ML | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X4.0 ML AMPOULE | 24/02/2021 |
| 3941 | NDA/MAL/HDP/9538 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ECZEMUS 0.1 % OINTMENT | TACROLIMUS MONOHYDRATE | 0.1% W/W | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 24/02/2021 |
| 3942 | NDA/MAL/HDP/9540 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TENGLYN | TENELIGLIPTIN HEMIPENTAHYDROBROMIDE HYDRATE | 20MG | ZYDUS LIFESCIENCES- KUNDAIM INDUSTRIAL ESTATE PLOT NO.2023-213 KUDAIM GOA 403115 GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3943 | NDA/MAL/HDP/9541 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERLOCIP 25 | ERLOTINIB HYDROCHLORIDE | 25MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3944 | NDA/MAL/HDP/9542 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERLOCIP 100 | ERLOTINIB HYDROCHLORIDE | 100MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3945 | NDA/MAL/HDP/9543 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERLOCIP 150 | ERLOTINIB HYDROCHLORIDE | 150MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| 3946 | NDA/MAL/HDP/9551 | DEVA HOLDING A.S- | SHREEJI PHARMACEUTICALS LIMITED | LUXAT | MONTELUKAST SODIUM | 10MG | DEVA HOLDING A.S, CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 24/02/2021 |
| 3947 | NDA/MAL/HDP/9552 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | HOPEIN 1000 MG | MEROPENEM TRIHYDRATE | 1000MG | ZEISS PHARMACEUTICALS PVT LTD - , PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 24/02/2021 |
| 3948 | NDA/MAL/HDP/9572 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | TELMA 80H PLUS | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 25MG | 1. GLENMARK PHARMACEUTICALS LIMITED, PITHAMPUR PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*5*10TABLET BLISTER | 21/11/2019 |
| 3949 | NDA/MAL/HDP/9576 | SAVA HEALTHCARE LIMITED - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUTIAIR | FLUTICASONE PROPIONATE | 0.05%W/V | SAVA HEALTHCARE LIMITED., PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X10.0 ML VIAL | 24/02/2021 |
| 3950 | NDA/MAL/HDP/9577 | ZYDUS LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | ZURIG 40 | FEBUXOSTAT | 40 MG | ZYDUS LIFESCIENCES LTD, KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3951 | NDA/MAL/HDP/9585 | OCHOA LABORATORIES | SUPER MEDIC LTD | TACROVATE | TACROLIMUS | 0.03 %W/W | 1. AUROCHEM LABORATORIES INDIA PRIVATE LIMITED PLOT NO 8, PALGHAR TALUKA IND. CO. OP. ESTATE LIMITED, BOISAR ROAD, PALGHAR €“ 401404, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL OINTMENTS | I. 1*1*10G TUBE | |
| 3952 | NDA/MAL/HDP/9586 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMVA DENK 5/160 MG | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | BALKANPHARMA-DUPNITSA AD, 3, SAMOKOVSKO SHOSSE STR. 2600 DUPNITSA | BULGARIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 02/06/2021 |
| 3953 | NDA/MAL/HDP/9588 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMVA DENK 10/160 MG | AMLODIPINE BESILATE + VALSARTAN | 10 MG + 160 MG | BALKANPHARMA-DUPNITSA AD, 3, SAMOKOVSKO SHOSSE STR. 2600 DUPNITSA | BULGARIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 02/06/2021 |
| 3954 | NDA/MAL/HDP/9591 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | AZITOZ-500 | AZITHROMYCIN DIHYDRATE | 500 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 04/06/2021 |
| 3955 | NDA/MAL/HDP/9593 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SARANTO 50 | LOSARTAN POTASSIUM | 50 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 02/06/2021 |
| 3956 | NDA/MAL/HDP/9595 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | ROSUVASTATIN DENK 20 MG | ROSUVASTATIN CALCIUM | 20 MG | PHARMACEUTICAL WORKS POLPHARMA SA (ZAKLADY FARMACEUTYCZNE POLPHARMA SA), 19 PELPLINSKA STREET, 83-200 STAROGARD GDANSKI | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3957 | NDA/MAL/HDP/9597 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | MALACURE | SULFADOXINE + PYRIMETHAMINE | 500 MG + 25 MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 03/06/2021 |
| 3958 | NDA/MAL/HDP/9600 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC 150 MG | IRBESARTAN | 150 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3959 | NDA/MAL/HDP/9601 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY 5/160MG | AMLODIPINE BESYLATE + VALSARTAN | 5 MG + 160 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3960 | NDA/MAL/HDP/9602 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY 10/160MG | AMLODIPINE BESYLATE + VALSARTAN | 10 MG + 160 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3961 | NDA/MAL/HDP/9603 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | KOCITAF | DOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE | 50 MG + 200 MG + 25 MG | MYLAN LABORATORIES LTD, PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 02/06/2021 |
| 3962 | NDA/MAL/HDP/9610 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | LASOFLOX-O | OFLOXACIN + ORNIDAZOLE | 200 MG + 500 MG | 1. FREDUN PHARMACEUTICALS LIMITED 14, 15, 16 ZORABIAN INDUSTRIAL COMPLEX, VEVOOR, PALGHAR 401 404 - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*10TABLET BLISTER | 02/06/2021 |
| 3963 | NDA/MAL/HDP/9611 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ESOMAC-40 MUPS | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 40 MG | CIPLA LIMITED., PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3964 | NDA/MAL/HDP/9612 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | ESOMAC-20 MUPS | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 20 MG | CIPLA LIMITED., PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3965 | NDA/MAL/HDP/9613 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | IVABEAT 5 | IVABRADINE HYDROCHLORIDE | 5 MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 02/06/2021 |
| 3966 | NDA/MAL/HDP/9614 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | IVABEAT 7.5 | IVABRADINE HYDROCHLORIDE | 7.5 MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 02/06/2021 |
| 3967 | NDA/MAL/HDP/9615 | ARTEPHARM CO., LTD., | BHL HEALTHCARE LIMITED | ARTEQUICK | ARTEMISININ + PIPERAQUINE | 62.5 MG + 375 MG | ARTEPHARM CO. LTD, 4 ROAD STREET AVENUE ECONOMY DEVELOPMENT ZONE OF FENGSHUN COUNTY MEIZHOU CITY GUANGDONG PRONVINCE | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 02/06/2021 |
| 3968 | NDA/MAL/HDP/9618 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMCAP 500 | CAPECITABINE | 500 MG | MSN LABORATORIES PRIVATE LIMITED, UNIT II, SY. NO. 1277 & 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANDAREDDY DISTRICT, PIN CODE, 509 228, TELENGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3969 | NDA/MAL/HDP/9620 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | DOLUTEGRAVIR TABLETS | DOLUTEGRAVIR SODIUM | 50 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 02/06/2021 |
| 3970 | NDA/MAL/HDP/9621 | ORANE | AIVEEN (U) LIMITED | ELECTRAL-Z KIT | ZINC SULPHATE MONOHYDRATE + (SODIUM CHLORIDE + POTASSIUM CHLORIDE + SODIUM CITRATE + ANHYDROUS GLUCOSE) | 20 MG + (2.6 G + 1.5 G + 2.9 G + 13.5 G)/SACHET | FDC LTD., L-56&L-57, PHASE II- D, VERNA INDUSTRIAL ESTATE, VERNA-403 722, SALCETE, GOA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X21.8 G SACHET COMBIPACK | 02/06/2021 |
| 3971 | NDA/MAL/HDP/9624 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | ADCO-IBUPROFEN 400 MG | IBUPROFEN | 400 MG | ADCOCK INGRAM LIMITED , 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 02/06/2021 |
| 3972 | NDA/MAL/HDP/9626 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | BIKTARVY | BICTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 50 MG + 200 MG + 25 MG | GILEAD SCIENCES IRELAND UC,CORK, IDA BUSINESS & TECHNOLOGY PARK, CARRIGTOHILL, COUNTY CORK, | IRELAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 02/06/2021 |
| 3973 | NDA/MAL/HDP/9627 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIMEXA | ROCURONIUM BROMIDE | 50 MG/5ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X10.0X5.0 ML VIAL | 03/06/2021 |
| 3974 | NDA/MAL/HDP/9628 | UNICHEM LABORATORIES LIMITEDˆŠ | EUROPA HEALTHCARE (U) LTD | MPLIFY 20 | TADALAFIL | 20 MG | UNICHEM LABORATORIES BADI-UNIT II, VILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIA| UNICHEM LABORATORIES LTD, PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X1.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 02/06/2021 |
| 3975 | NDA/MAL/HDP/9631 | DAWA LIMITED | SUPER MEDIC LTD | DAWASOLONE | PREDNISOLONE SODIUM PHOSPHATE | 5 MG/5 ML | DAWA LIMITED, PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X60.0 ML BOTTLE | 02/06/2021 |
| 3976 | NDA/MAL/HDP/9634 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | RABISHIELD - 100 | RABIES HUMAN MONOCLONAL ANTIBODY (RDNA) | 40 IU/ ML | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.5 ML VIAL | 03/06/2021 |
| 3977 | NDA/MAL/HDP/9636 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALTHEMOL | PARACETAMOL | 1.0 % W/V (1G/100 ML) | ALTHEA PHARMA PRIVATE LIMITED-WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 02/06/2021 |
| 3978 | NDA/MAL/HDP/9637 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE | PNEUMOCOCCAL SACCHARIDE FOR SEROTYPE 1, 5, 6A, 7F, 9V, 14, 19A, 19F AND 23F + SACCHARIDE FOR SEROTYPE 6B | (2 MCG OF PNEUMOCOCCAL SACCHARIDE FOR SEROTYPE 1, 5, 6A, 7F, 9V, 14, 19A, 19F AND 23F + 4 MCG OF SACCHARIDE FOR SEROTYPE 6B)/ DOSE | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X1.0 DOSE VIAL, 1.0X50.0X5.0 DOSE VIAL | 03/06/2021 |
| 3979 | NDA/MAL/HDP/9638 | LUPIN LIMITED- | AIVEEN (U) LIMITED | RIFAMPICIN AND ISONIAZID TABLETS | RIFAMPICIN + ISONIAZID | 150 MG + 75 MG | LUPIN LTD, A-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 02/06/2021 |
| 3980 | NDA/MAL/HDP/9639 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | ZOMEP-ES-40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/06/2021 |
| 3981 | NDA/MAL/HDP/9640 | BERLIN-CHEMIE AG - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PRILIGY 30 MG | DAPOXETINE HYDROCHLORIDE | 30 MG | MENARINI - VON HEYDEN GMBH, LEIPZIGER STRABE 7-13, 01097 DRESDEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 02/06/2021 |
| 3982 | NDA/MAL/HDP/9641 | BERLIN-CHEMIE AG - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PRILIGY 60 MG | DAPOXETINE HYDROCHLORIDE | 60 MG | MENARINI - VON HEYDEN GMBH, LEIPZIGER STRABE 7-13, 01097 DRESDEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 02/06/2021 |
| 3983 | NDA/MAL/HDP/9642 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | OFLOMIL | AMOROLFINE HYDROCHLORIDE | 5% W/V | GLENMARK PHARMACEUTICALS LTD ., PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X2.5 ML VIAL + 1*12, ISOPROPYL ALCOHOL 70% SWAB SACHETS | 03/06/2021 |
| 3984 | NDA/MAL/HDP/9643 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ABACAVIR (AS SULFATE) AND LAMIVUDINE TABLETS | ABACAVIR SULFATE + LAMIVUDINE | 600MG + 300 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER, 1.0X1.0X90.0 TABLET CONTAINER | 02/06/2021 |
| 3985 | NDA/MAL/HDP/9645 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | HALOPERIDOL INJECTION BP 5 MG/ML | HALOPERIDOL | 5 MG/ML | SWISS PARENTERALS PVT LTD .., 809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE | 02/06/2021 |
| 3986 | NDA/MAL/HDP/9648 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FUSIBACT CREAM | FUSIDIC ACID | 2%W/W | JAMJOOM PHARMACEUTICALS CO.-PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 04/06/2021 |
| 3987 | NDA/MAL/HDP/9651 | PT SANBE FARMA | ONCOPHARM (U) LTD | SANTOCYN | OXYTOCIN | 10 IU/ML | PT SANBE FARMA UNIT 3., JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNG | INDONESIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 02/06/2021 |
| 3988 | NDA/MAL/HDP/9652 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 300 MG/300 MG TABLETS | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300 MG + 300 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED), VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BLISTER | 02/06/2021 |
| 3989 | NDA/MAL/HDP/9657 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | GLEMONT-IR 10 | MONTELUKAST SODIUM | 10MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*1*30TABLET CONTAINER | 02/06/2021 |
| 3990 | NDA/MAL/HDP/9658 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | TELMA 40 | TELMISARTAN | 40 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*4*7TABLET BLISTER | 02/06/2021 |
| 3991 | NDA/MAL/HDP/9660 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | TELMA 80H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80 MG + 12.5 MG | 1. GLENMARK PHARMACEUTICALS LIMITED, PITHAMPUR PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*5*10TABLET BLISTER | 02/06/2021 |
| 3992 | NDA/MAL/HDP/9661 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | TELMA H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40 MG + 12.5 MG | 1. GLENMARK PHARMACEUTICALS LIMITED, PITHAMPUR PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*2*14TABLET BLISTER | 02/06/2021 |
| 3993 | NDA/MAL/HDP/9663 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | POVIREN | POVIDONE + IODINE | 10% W/V | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 02/06/2021 |
| 3994 | NDA/MAL/HDP/9665 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYNAC-SP | ACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE | 100 MG + 325 MG + 15 MG | RAVIAN LIFE SCIENCE PVT. LIMITED, PLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHAND | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| 3995 | NDA/MAL/HDP/9666 | SCOTT-EDIL PHARMACIA LTD., | ROYAL PHARMA 2011 LIMITED | VOLIGESIC-GEL | DICLOFENAC DIETHYLAMINE | 1 %W/W | 1. M/S SCOTT-EDIL PHARMACIA LIMITED 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | I. 1*1*30G TUBE | 02/06/2021 |
| 3996 | NDA/MAL/HDP/9669 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZOCOLD | PARACETAMOL + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 500 MG + 2 MG + 5 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP | 04/06/2021 |
| 3997 | NDA/MAL/HDP/9670 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | CDGREL-75 | CLOPIDOGREL BISULFATE | 75MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 04/06/2021 |
| 3998 | NDA/MAL/HDP/9672 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NASO B12 | METHYLCOBALAMIN | 250 MCG/ACTUATION | TROIKAA PHARMACEUTICALS LIMITED.., SANAND - KADI ROAD, THOL, CITY: THOL - 382 728, DIST. MEHSANA, GUJARAT STATE - INDIA | INDIA | NASAL SYSTEMIC UNIT DOSE AEROSOLS | 1.0X1.0X2.3 ML BOTTLE | 02/06/2021 |
| 3999 | NDA/MAL/HDP/9675 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OD-TAM 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-VII (SEZ), TSIIC PLOT NO. S1, SURVEY NOS: 411/P, 425/P, 434/P, 435/P AND 458/P, GREEN INDUSTRIAL PARK, POLEPALLY INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | I. 1*3*10CAPSULE BLISTER | 02/06/2021 |
| 4000 | NDA/MAL/HDP/9678 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AXABAN-DENK 2.5 MG | APIXABAN | 2.5 MG | COMBINO PHARM (MALTA) LIMITED, HF60 HAL FAR INDUSTRIAL ESTATE BBG3000 | MALTA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 02/06/2021 |
| 4001 | NDA/MAL/HDP/9679 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AXABAN-DENK 5 MG | APIXABAN | 5MG | COMBINO PHARM (MALTA) LIMITED, HF60 HAL FAR INDUSTRIAL ESTATE BBG3000 | MALTA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 02/06/2021 |
| 4002 | NDA/MAL/HDP/9713 | I CARE PHARMA LIMITED | SUPER MEDIC LTD | AZOL 400 | ALBENDAZOLE | 400MG | MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | | INDIA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X1.0 TABLET BLISTER | 15/09/2021 |
| 4003 | NDA/MAL/HDP/9719 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | ESOME | ESOMEPRAZOLE | 20MG | GETZ PHARMA (PVT) LIMITED, 29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 29/09/2021 |
| 4004 | NDA/MAL/HDP/9724 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | METFORMIN TABLETS BP 500 MG | METFORMIN HYDROCHLORIDE | 500 MG | 1. AFRICURE PHARMACEUTICALS INDIA PRIVATE LIMITED PLOT NO. 9 - 12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR - 401404, PALGHAR DIST., MAHARASHTRA S INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*10*10TABLET BLISTER | 05/10/2021 |
| 4005 | NDA/MAL/HDP/9725 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | MOCIN | MOXIFLOXACIN HYDROCHLORIDE | 0.5%W/V | ABACUS PARENTERAL DRUGS LTD (APDL), PLOT 114, BLOCK 191, KINGA - MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 05/10/2021 |
| 4006 | NDA/MAL/HDP/9726 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ABLEPT €“ 300 | GABAPENTIN | 300MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 05/10/2021 |
| 4007 | NDA/MAL/HDP/9731 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MELANOV-M | GLICLAZIDE + METFORMIN HYDROCHLORIDE | 80MG + 500MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4008 | NDA/MAL/HDP/9733 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | KEMIN | KETAMINE HYDROCHLORIDE | 50MG/ML | SWISS PARENTERALS PVT LTD .., 809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL | 05/10/2021 |
| 4009 | NDA/MAL/HDP/9747 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 60 MG | ARTESUNATE | 60MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE | 05/10/2021 |
| 4010 | NDA/MAL/HDP/9748 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 30 MG | ARTESUNATE | 30MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X30.0 MG VIAL 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE | 05/10/2021 |
| 4011 | NDA/MAL/HDP/9749 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 120 MG | ARTESUNATE | 120MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X120.0 MG VIAL 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE | 05/10/2021 |
| 4012 | NDA/MAL/HDP/9755 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORILAM ODT-100 | LAMOTRIGINE | 100MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4013 | NDA/MAL/HDP/9756 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORILAM ODT-25 | LAMOTRIGINE | 25MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4014 | NDA/MAL/HDP/9758 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SKUDEXA | TRAMADOL HYDROCHLORIDE + DEXKETOPROFEN | 75MG + 25MG | MENARINI - VON HEYDEN GMBH, LEIPZIGER STRABE 7-13, 01097 DRESDEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 12/10/2021 |
| 4015 | NDA/MAL/HDP/9765 | PANACEA BIOTEC LTD | VITACARE LIMITED | LIVOLUK | LACTULOSE | 10.0 G/15 ML | PANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 05/10/2021 |
| 4016 | NDA/MAL/HDP/9766 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | NEOMYCIN SULFATE CREAM USP | NEOMYCIN SULPHATE | 0.5%W/W | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 05/10/2021 |
| 4017 | NDA/MAL/HDP/9767 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | PREZEL 75 | PREGABALIN | 75MG | IND-SWIFT LIMITED ,., PHASE 1, INDUSTRIAL GROWTH CENTRE, SAMBA-184121, JAMMU & KASHMIR | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 05/10/2021 |
| 4018 | NDA/MAL/HDP/9769 | FERRING INTERNATIONAL CENTER SA | MACNAUGHTON LIMITED | CARBETOCIN FERRING, 100 µG/ML | CARBETOCIN | 100 µG/ML | M/S STERIL-GENE LIFE SCIENCES (P) LTD45, MAIN ROAD, MANGALAM VILLAGE, VILLIANUR COMMUNE, PUDUCHERRY-605110| FERRING PHARMACEUTICALS (CHINA) COMPANY LIMITED - NO.6 HUILING LU (FERRING ROAD), NATIONAL HEALTH TECHNOLOGY PARK, ZHONGSHAN CITY, GUANGDONG PROVINCE, P.R. CHINA, POSTAL CODE: 528437 | INDIA| CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 05/10/2021 |
| 4019 | NDA/MAL/HDP/9771 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SARANTO-H 50/12.5 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50 MG +12.5 MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 05/10/2021 |
| 4020 | NDA/MAL/HDP/9774 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | DOLOFIT | PARACETAMOL + DICLOFENAC SODIUM | 500MG + 50MG | MEDICO REMEDIES PVT LTD,., 8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4021 | NDA/MAL/HDP/9776 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEFAL DROPS | DEFLAZACORT | 22.75MG/ML | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X13.0 ML BOTTLE | 05/10/2021 |
| 4022 | NDA/MAL/HDP/9777 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEFAL 30 MG | DEFLAZACORT | 30MG | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4023 | NDA/MAL/HDP/9778 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEFAL 6MG | DEFLAZACORT | 6 MG | FAES FARMA SA, MAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4024 | NDA/MAL/HDP/9779 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | EYLEA | AFLIBERCEPT | 40 MG/ML | BAYER AG, BERLIN, MULLERSTRABE 178, 13353 BERLIN - GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL | 05/10/2021 |
| 4025 | NDA/MAL/HDP/9780 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE DS 125 | CLARITHROMYCIN | 125 MG/5 ML | IND-SWIFT LIMITED ,., PHASE 1, INDUSTRIAL GROWTH CENTRE, SAMBA-184121, JAMMU & KASHMIR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE | 12/10/2021 |
| 4026 | NDA/MAL/HDP/9781 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE DS 250 | CLARITHROMYCIN | 250 MG/5 ML | IND-SWIFT LIMITED ,., PHASE 1, INDUSTRIAL GROWTH CENTRE, SAMBA-184121, JAMMU & KASHMIR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE | 12/10/2021 |
| 4027 | NDA/MAL/HDP/9782 | LUPIN LIMITED- | AIVEEN (U) LIMITED | ATAZANAVIR SULFATE AND RITONAVIR TABLETS 300 MG AND 100 MG | ATAZANAVIR SULFATE + RITONAVIR | 300 MG + 100 MG | LUPIN LTD, PLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 05/10/2021 |
| 4028 | NDA/MAL/HDP/9785 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VAROXA-10 | RIVAROXABAN | 10MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4029 | NDA/MAL/HDP/9786 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VAROXA-20 | RIVAROXABAN | 20MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4030 | NDA/MAL/HDP/9788 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | AFRICURE PHARMACEUTICALS U LIMITED | CHLOROSIM-250 | CHLORAMPHENICOL | 250MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793), PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 05/10/2021 |
| 4031 | NDA/MAL/HDP/9789 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | AFRICURE PHARMACEUTICALS U LIMITED | NALIDIXIC ACID TABLETS BP 500 MG | NALIDIXIC ACID | 500MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/10/2021 |
| 4032 | NDA/MAL/HDP/9790 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | WILLGO CR | ACECLOFENAC | 200MG | PANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4033 | NDA/MAL/HDP/9791 | IMPACT RH360 | UNITED HEALTHCARE DISTRIBUTORS LTD | AVIBELA | LEVONORGESTREL | 52 MG/ SYSTEM | ODYSSEA PHARMA SPRL, RUE DU TRAVAIL 16, 4460 GRACE-HOLLOGNE | BELGIUM | VAGINAL INTRA UTERINE DEVICES | 1.0X1.0X52.0 MG DEVICE | 05/10/2021 |
| 4034 | NDA/MAL/HDP/9794 | VERVE HUMAN CARE LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | VERMOR-10 | MORPHINE SULFATE | 10 MG/ML | 1. VERVE HUMAN CARE LABORATORIES PLOT NO. 15-A, PHARMA CITY, SELAQUI, DEHRADUN - 248011 (UTTARAKHAND), INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY AMPOULES | I. 10*10*1ML AMPOULE | 05/10/2021 |
| 4035 | NDA/MAL/HDP/9796 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APDROPS | MOXIFLOXACIN HYDROCHLORIDE | 0.5%W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD, N-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 05/10/2021 |
| 4036 | NDA/MAL/HDP/9799 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VOMIRAN 8 MG/ 4ML | ONDANSETRON HYDROCHLORIDE DIHYDRATE | 8MG/4ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X4.0 ML VIAL | 12/10/2021 |
| 4037 | NDA/MAL/HDP/9801 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LENOSIDE 10 | LENALIDOMIDE | 10MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER | 05/10/2021 |
| 4038 | NDA/MAL/HDP/9802 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LENOSIDE 15 | LENALIDOMIDE | 15MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER | 05/10/2021 |
| 4039 | NDA/MAL/HDP/9803 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LENOSIDE 25 | LENALIDOMIDE | 25MG | CIPLA LTD, UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER | 05/10/2021 |
| 4040 | NDA/MAL/HDP/9820 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | PHENYTOIN INJECTION BP 50 MG/ML, 5 ML | PHENYTOIN SODIUM | 50 MG/ML | SWISS PARENTERALS PVT LTD , 809 KERALA INDUSTRIAL ESTATE GIDC NR. BAVLA DIST. AHMEDABAD-380220 GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 05/10/2021 |
| 4041 | NDA/MAL/HDP/9822 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SOLANDIS ODT 4MG | ONDANSETRON | 4MG | ATHENA DRUG DELIVERY SOLUTIONS PVT LTD ,.-PLOT A-1 TO A-5, MIDC CHEMICAL ZONE, AMBERNATH (W) THANE 421501, MAHARASHTRA | | INDIA | ORAL SOLID ORDINARY DISPERSIBLE TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 05/10/2021 |
| 4042 | NDA/MAL/HDP/9828 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | OXYTOCIN INJECTION BP 10 IU/ML | OXYTOCIN | 10 IU/ML | SWISS PARENTERALS PVT LTD .., 809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 05/10/2021 |
| 4043 | NDA/MAL/HDP/9829 | RENATA LIMITED | MARIE STOPES UGANDA LIMITED | WELL-PLAN | LEVONORGESTREL + ETHINYLESTRADIOL | 0.15MG + 0.03 MG | RAJENDRAPUR POTENT PRODUCT FACILITY (RPPF), RENATA LIMITED, NOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR 1700 - BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X28.0 TABLET BLISTER | 05/10/2021 |
| 4044 | NDA/MAL/HDP/9830 | GLOBELA PHARMA PVT. LTD. | ROYAL PHARMA 2011 LIMITED | ROFENAC | DICLOFENAC SODIUM | 50MG | LABORATE PHARMACEUTICALS INDIA LIMITED - UNIT II, 31, RAJBAN ROAD, NAIWALA, PAONTA SAHIB, DISTT. SIRMOUR, HIMACHAL PRADESH - INDIA|GLOBELA PHARMA PVT.LTD.-357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 11/10/2021 |
| 4045 | NDA/MAL/HDP/9832 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FEBEX | FERROUS FUMARATE + FOLIC ACID + VITAMIN B12 + DIBASIC CALCIUM PHOSPHATE | 300 MG + 1.5 MG + 15 µG + 100 MG | 1. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 05/10/2021 |
| 4046 | NDA/MAL/HDP/9834 | ABACUS PARENTERAL DRUGS LTD (APDL) | ABACUS PARENTERAL DRUGS LIMITED | TFEN | KETOTIFEN FUMARATE | 0.025%W/V | ABACUS PARENTERAL DRUGS LTD (APDL), PLOT 114, BLOCK 191, KINGA - MUKONO | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 08/12/2021 |
| 4047 | NDA/MAL/HDP/9835 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | METAPROMIDE | METOCLOPRAMIDE HYDROCHLORIDE | 10 MG | PINNACLE LIFE SCIENCE PVT LTD, KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/12/2021 |
| 4048 | NDA/MAL/HDP/9836 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | DIOVOL FORTE SUSPENSION | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 300MG + 250MG + 40MG | WALLACE PHARMACEUTICALS PVT LTD, BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X170.0 ML BOTTLE | 19/01/2022 |
| 4049 | NDA/MAL/HDP/9845 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALTLEVO | LEVOFLOXACIN HEMIHYDRATE | 500MG/100ML | ALTHEA PHARMA PRIVATE LIMITED, WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 08/12/2021 |
| 4050 | NDA/MAL/HDP/9847 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD | GAMA PHARMACEUTICALS (U) LIMITED | PROCTOHEAL NEW® SUPPOSITORIES | LIDOCAINE HYDROCHLORIDE + FLUOCINOLONE ACETONIDE | 40.0 MG + 0.1MG | DAR AL DAWA, NA€™UR €“ PRINCE HASHEM BIN AL-HUSSEIN STREET P.O. BOX 9364 AMMAN 11191 JORDAN | JORDAN | SUPPOSITORIES | 1.0X2.0X10.0 SUPPOSITORY BLISTER | 16/12/2021 |
| 4051 | NDA/MAL/HDP/9848 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | STERILIZED WATER FOR INJECTION | WATER FOR INJECTION | N/A | ALTHEA PHARMA PRIVATE LIMITED, WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0 ML AMPOULE | 08/12/2021 |
| 4052 | NDA/MAL/HDP/9849 | HETERO BIOPHARMA LIMITED, | REDDYS PHARMA LIMITED | PAMERA 40 | ADALIMUMAB (R-DNA ORIGIN) | 40MG/ SYRINGE | HETERO BIOPHARMA LIMITED, SY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT €“ 509 301, TELANGANA STATE, INDIA. | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X0.8 ML SYRINGE | 08/12/2021 |
| 4053 | NDA/MAL/HDP/9850 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZEDGRA 50 | SILDENAFIL CITRATE | 50 MG | ZOTA HEALTHCARE LIMITED, PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 16/12/2021 |
| 4054 | NDA/MAL/HDP/9851 | INJECTCARE PARENTERALS PVT. LTD | REDDYS PHARMA LIMITED | INJZATHINE | BENZATHINE BENZYLPENICILLIN | 2400000 IU/VIAL | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2.0 G VIAL | 16/12/2021 |
| 4055 | NDA/MAL/HDP/9853 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | MYCOREN V | NYSTATIN | 100,000 IU | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | PESSARIES | 1.0X1.0X15.0 PESSARY BLISTER | 08/12/2021 |
| 4056 | NDA/MAL/HDP/9854 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FLUZOLE | FLUCONAZOLE | 200MG | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X4.0 CAPSULE STRIP | 08/12/2021 |
| 4057 | NDA/MAL/HDP/9855 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TRADOX | TRAMADOL HYDROCHLORIDE | 10 MG/2 ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X2.0 ML VIAL | 08/12/2021 |
| 4058 | NDA/MAL/HDP/9856 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARTEM DISPERSIBLE | ARTEMETHER + LUMEFANTRINE | 20MG +120MG | S KANT HEALTHCARE LIMITED, 1802 €“ 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 16/12/2021 |
| 4059 | NDA/MAL/HDP/9860 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CLINDACIN 300 MG | CLINDAMYCIN HYDROCHLORIDE | 300 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X8.0 CAPSULE BLISTER | 08/12/2021 |
| 4060 | NDA/MAL/HDP/9867 | ASTRA PHARMA UGANDA LTD | ASTRA PHARMA (U) LIMITED | CEFTRIAXONE | CEFTRIAXONE SODIUM | 1G | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195| CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD, NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, (WORKSHOP 402)CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 21/12/2021 |
| 4061 | NDA/MAL/HDP/9871 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RETALEX | ATRACURIUM BESYLATE | 50MG/5ML | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X5.0 ML VIAL | 21/12/2021 |
| 4062 | NDA/MAL/HDP/9872 | SAGA LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | COL-COL | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + ANYDROUS CAFFEINE + CHLORPHENIRAMINE MALEATE | 500 MG + 5 MG + 15 MG + 2 MG | 1. SAGA LIFESCIENCES LIMITED SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*50*4TABLET BLISTER II. 1*10*10TABLET BLISTER | 08/12/2021 |
| 4063 | NDA/MAL/HDP/9873 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OMISEC | OMEPRAZOLE SODIUM | 40MG/VIAL | MS PHARMA - JORDAN, PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL,1.0X5.0X40.0 MG VIAL | 08/12/2021 |
| 4064 | NDA/MAL/HDP/9874 | OCTAPHARMA AG | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OCTANATE 500 IU | HUMAN COAGULATION FACTOR VIII | 500IU PER VIAL | OCTAPHARMA DESSAU GMBH, OTTO-REUTER-STR.3 06847 DESSAU, ROSSLAU | GERMANY| SWEDEN | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 I.U VIAL + 1*5ML APOULE OF WATER FOR INJECTION + 1 SYRINGE + 1 TRANSFER SET + 1 INFUSION SET + 2 ALCOHOL SWABS | 21/12/2021 |
| 4065 | NDA/MAL/HDP/9875 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | TALIMUS 0.1% | TACROLIMUS | 0.1% W/W | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 08/12/2021 |
| 4066 | NDA/MAL/HDP/9876 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | LENIOL | PARACETAMOL | 1000MG/100 ML | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED, SURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BAG,1.0X100.0 ML BOTTLE (GLASS BOTTLE),1.0X100.0 ML BOTTLE (NIPPLE HEAD PLASTIC BOTTLE),1.0X100.0 ML BOTTLE (EURO HEAD PLASTIC BOTTLE) | 08/12/2021 |
| 4067 | NDA/MAL/HDP/9877 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LACOMA-T | LATANOPROST + TIMOLOL MALEATE | (50MCG + 5MG)/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTD ., N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML BOTTLE | 08/12/2021 |
| 4068 | NDA/MAL/HDP/9878 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LACOMA | LATANOPROST | 0.005%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD ., N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML BOTTLE | 08/12/2021 |
| 4069 | NDA/MAL/HDP/9881 | HETERO LABS LTD | AIVEEN (U) LIMITED | DOLUTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS 50MG/200MG/25MG | DOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE HEMIFUMARATE | 50MG+200MG+25MG | HETERO LABS LIMITED (UNIT III)..., 22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 08/12/2021 |
| 4070 | NDA/MAL/HDP/9882 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA CT 50 | SILDENAFIL CITRATE | 50MG | AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 08/12/2021 |
| 4071 | NDA/MAL/HDP/9883 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | LAMOTRIX 100MG | LAMOTRIGINE | 100MG | MEDOCHEMIE LIMITED (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL - CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 4072 | NDA/MAL/HDP/9887 | AKRITI PHARMACEUTICALS PVT. LTD | PHARMA VILLE LIMITED | FOLIC ACID 5 MG TABLETS | FOLIC ACID | 5MG | AKRITI PHARMACEUTICALS PVT LTD. PLOT NO. D -10, D-11, M.I.D.C.INDUSTRIAL ESTATE, JEJURI-NIRA ROAD,TAL PURANDHAR (SASWAD), PUNE 412303,MAHARASHTRA,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | I. 1*3*10TABLET BLISTER | 08/12/2021 |
| 4073 | NDA/MAL/HDP/9889 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MOMADERM | MOMETASONE FUROATE | 0.1%W/W | AJANTA PHARMA LIMITED, MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 08/12/2021 |
| 4074 | NDA/MAL/HDP/9897 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | CO-TRIMOXAZOLE TABLETS BP | TRIMETHOPRIM + SULPHAMETHOXAZOLE | 400MG + 80MG | MEDOPHARM PVT LTD. , 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY VILLAGE, 603 203 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 11/12/2021 |
| 4075 | NDA/MAL/HDP/9898 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | NOSIL 0.1% | XYLOMETAZOLINE HYDROCHLORIDE | 0.1%W/V | LINCOLN PHARMACEUTICALS LTD-, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | | INDIA | NASAL TOPICAL DROPS | 1.0X1.0X10.0 ML BOTTLE | 08/12/2021 |
| 4076 | NDA/MAL/HDP/9899 | MEDICAL UNION PHARMACEUTICALS. | KARURI PHARMACEUTICALS LTD. | MUCOSOL ADULT SYRUP | CARBOCYSTEINE | 250MG/5ML | MEDICAL UNION PHARMACEUTICAL CO., PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 08/12/2021 |
| 4077 | NDA/MAL/HDP/9900 | GLENMARK PHARMACEUTICALS LIMITED | STAR PHARMACEUTICALS LTD | TELMA 20 | TELMISARTAN | 20 MG | 1. GLENMARK PHARMACEUTICALS LIMITED PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*2*14TABLET BLISTER | 08/12/2021 |
| 4078 | NDA/MAL/HDP/9902 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SEVLAREN 800 | SEVELAMER CARBONATE | 800MG | STANFORD LABORATORIES PVT LIMITED, 8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| 4079 | NDA/MAL/HDP/9903 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | MEDICLOAMP 500MG | AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM | 250MG + 250MG | REGAL PHARMACEUTICALS LTD , PLOT NO. 7879/18, OFF BABA DOGO ROAD, RUARAKA - NAIROBI | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/12/2021 |
| 4080 | NDA/MAL/HDP/9904 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CLEDOMOX 228.5 DT | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 200 MG + 28.5 MG | MEDOPHARM PVT LTD. , 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY VILLAGE, 603 203 | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X2.0X10.0 TABLET STRIP | 11/12/2021 |
| 4081 | NDA/MAL/HDP/9906 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | NEBTAS-5 | NEBIVOLOL HYDROCHLORIDE | 5MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| 4082 | NDA/MAL/HDP/9911 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BISOPROL® 5 | BISOPROLOL FUMARATE | 5MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| 4083 | NDA/MAL/HDP/9912 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | IBUREN SUSPENSION | IBUPROFEN | 100MG/5ML | RENE INDUSTRIES LTD, PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE | 08/12/2021 |
| 4084 | NDA/MAL/HDP/9913 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BRUTAFLAM-120 | ETORICOXIB | 120MG | MANKIND PHARMA LTD, UNIT II ,, VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| 4085 | NDA/MAL/HDP/9915 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | TELCARD 80 H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80 MG + 12.5 MG | ZIM LABORATORIES LIMITED, B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 11/12/2021 |
| 4086 | NDA/MAL/HDP/9918 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | POWERCORT | CLOBETASOL PROPIONATE | 0.05% W/W | GLENMARK PHARMACEUTICALS LTD ., VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE,1.0X1.0X30.0 G TUBE | 11/12/2021 |
| 4087 | NDA/MAL/HDP/9920 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | CIS-CURON | CIS-ATRACURIUMBESYLATE | 10MG/5ML | BROOKES PHARMA (PRIVATE) LIMITED, 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 08/12/2021 |
| 4088 | NDA/MAL/HDP/9921 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | SONATEC MOUTHWASH MENTHOL BREEZE | CETYLPYRIDINIUM CHLORIDE | 0.05%W/V | REGAL PHARMACEUTICALS LTD , PLOT NO. 7879/18, OFF BABA DOGO ROAD, RUARAKA - NAIROBI | KENYA | ORAL TOPICAL LIQUIDS | 1.0X250.0 ML BOTTLE | 08/12/2021 |
| 4089 | NDA/MAL/HDP/9924 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | OPTIZOLINE EYE DROPS | TETRAHYDROZOLINE HYDROCHLORIDE | 0.5%W/V | XEPA-SOUL PATTINSON (MALAYSIA) SDN.BHD., 1-5 CHENG INDUSTRIAL ESTATE, 75250, MELAKA | MALAYSIA | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 17/01/2022 |
| 4090 | NDA/MAL/HDP/9925 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | TUSSIDEX LINCTUS | DEXTROMETHORPHAN | 10MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN.BHD., 1-5 CHENG INDUSTRIAL ESTATE, 75250, MELAKA | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 17/01/2022 |
| 4091 | NDA/MAL/HDP/9931 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | CLOSUPP 100 | CLOTRIMAZOLE | 100MG | MERIDIAN ENTERPRISES PVT. LTD-, PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY STRIP | 08/12/2021 |
| 4092 | NDA/MAL/HDP/9932 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUDEXA | DEXAMETHASONE | 0.5MG | FREDUN PHARMACEUTICALS LIMITED, 14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/03/2022 |
| 4093 | NDA/MAL/HDP/9933 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BISOPROL® 10 | BISOPROLOL FUMARATE | 10MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY, JORDAN - NUZHAT SAHAB | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| 4094 | NDA/MAL/HDP/9934 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ISONIAZID 100 MG BP | ISONIAZID 100 MG BP | 100MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 31/03/2022 |
| 4095 | NDA/MAL/HDP/9935 | APEX LABORATORIES PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | ZINCOFER CAPSULES | FERROUS FUMARATE + FOLIC ACID BP + CYANOCOBALAMIN + ASCORBIC ACID + PYRIDOXINE HYDROCHLORIDE+ ZINC SULPHATE MONOHYDRATE | 350MG + 1MG + 5MCG +75MG + 1.5 MG +55MG | APEX LABORATORIES PRIVATE LIMITED- PLANT 1, B-23, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, KANCHEEPURAM DISTRICT 603 110 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 31/03/2022 |
| 4096 | NDA/MAL/HDP/9936 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | VAMOCIN 1GM | VANCOMYCINHYDROCHLORIDE | 1G/VIAL | GUFIC BIOSCIENCES LIMITED (UNIT 2), SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 31/03/2022 |
| 4097 | NDA/MAL/HDP/9942 | FOSUN PHARMACEUTICAL DISTRIBUTION JIANGSU CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 31/03/2022 |
| 4098 | NDA/MAL/HDP/9943 | FOSUN PHARMACEUTICAL DISTRIBUTION JIANGSU CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 40MG + 240MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 31/03/2022 |
| 4099 | NDA/MAL/HDP/9944 | FOSUN PHARMACEUTICAL DISTRIBUTION JIANGSU CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 60MG + 360MG | GUILIN PHARMACEUTICAL CO LTD ., NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 31/03/2022 |
| 4100 | NDA/MAL/HDP/9948 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | SANTRIAX-1000 | CEFTRIAXONE SODIUM | 1000MG/VIAL | INJECT CARE PARENTERALS PVT LTD, PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195| EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.: 1, 8 AND 8A, PHARMACITY, SELAQUI, DEHRADUN-248011 (U.K), INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X25.0X1000.0 MG VIAL,1.0X10.0 ML VIAL | 24/03/2022 |
| 4101 | NDA/MAL/HDP/9950 | XL LABORATORIES PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | RETOVIT | VITAMIN A | 200000 IU | 1. XL LABORATORIES PRIVATE LIMITED A-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. XL LABORATORIES PRIVATE LIMITED A-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 3. XL LABORATORIES PRIVATE LIMITED A-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY CAPSULES | I. 1*3*10CAPSULE BLISTER | 24/03/2022 |
| 4102 | NDA/MAL/HDP/9951 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | ARCELIA ARTESUNATE FOR INJECTION | ARTESUNATE | 60 MG | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. INDASI LIFESCIENCES PRIVATE LIMITED PLOT NO. 73-77 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 3962110 INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 1*1*60MG VIAL | 24/03/2022 |
| 4103 | NDA/MAL/HDP/9953 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | ARCELIA AMIKACIN SULFATE INJECTION USP 500MG/2ML | AMIKACIN SULFATE | 500MG/2ML | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.0 ML VIAL | 31/03/2022 |
| 4104 | NDA/MAL/HDP/9955 | VEERAM HEALTHCARE (U) LIMITED | VEERAM HEALTHCARE (U) LIMITED | DICLONI | DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL | 1.16%W/W+ 1.0% W/W+3.0%W/W+ 10%W/W+2.0% W/W | 1. KESAR PHARMA PRIVATE LIMITED PLOT SURVEY NO. 50/2, VILLAGE BILESHWARPURA, PO. CHHATRAL - 382729, TAL: KALOL, DIST. GANDHINAGAR, INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | I. 1*1*15G TUBE II. 1*1*30G TUBE | 24/03/2022 |
| 4105 | NDA/MAL/HDP/9956 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | ARCELIA OMEPRAZOLE FOR INJECTION | OMEPRAZOLE SODIUM | 40 MG/VIAL | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL +10ML GLASS AMPOULE OF WATER FOR INJECTION | 31/03/2022 |
| 4106 | NDA/MAL/HDP/9957 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | TERBICON CREAM | TERBINAFINE HYDROCHLORIDE | 1.0%W/W | INDCHEMIE HEALTH SPECIALITIES PVT. LTD, VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 24/03/2022 |
| 4107 | NDA/MAL/HDP/9958 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | MUPRICON | MUPIROCIN | 2.0%W/W | INDCHEMIE HEALTH SPECIALITIES PVT. LTD, VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X5.0 G TUBE | 24/03/2022 |
| 4108 | NDA/MAL/HDP/9959 | MARVIN PHARMA LTD (BURUNDI) | MARVIN PHARMA LIMITED | MARISUNATE 60MG | ARTESUNATE | 60MG/VIAL | SANJAR PHARMA LLP, SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA| INDASI LIFESCIENCES PRIVATE LIMITED- PLOT NO. 73-77 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 3962110 INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1, CLEAR GLASS AMPOULE OF SODIUM BICARBONATE + 1 CLEAR GLASS AMPOULE SODIUM CHLORIDE | 31/03/2022 |
| 4109 | NDA/MAL/HDP/9961 | ORANE | AIVEEN (U) LIMITED | ALLERCROM EYE DROPS | SODIUM CROMOGLICATE | 2%W/V | FDC LIMITED, WALUJ ., PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 31/03/2022 |
| 4110 | NDA/MAL/HDP/9962 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | ARTEMETHER INJECTION 80 MG/ML | ARTEMETHER | 80 MG/ML | 1. SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHHROTA, HIMATNAGAR-VIJAPUR HIGHWAY, DIST ? SABRKANTHA, GUJARAT, 383220 - IN INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | PARENTERAL ORDINARY DRY VIALS | I. 2*3*1ML AMPOULE | 24/03/2022 |
| 4111 | NDA/MAL/HDP/9963 | SEARLE PAKISTAN LIMITED | SURGIPHARM (U) LIMITED | SEA-MOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | SEARLE PAKISTAN LIMITED,, F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 31/03/2022 |
| 4112 | NDA/MAL/HDP/9969 | PRIVATE JOINT STOCK COMPANY "INDAR" | CORE ACCESS LIMITED | HUMODAR R 100R | INSULIN HUMAN (RDNA ORIGIN) | 100IU/ML | 1. PRIVATE JOINT STOCK COMPANY "INDAR" 5, ZROSHUVALNA STR. KYIV, 02099 UKRAINE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. PRIVATE JOINT STOCK COMPANY "INDAR" 5, ZROSHUVALNA STR. KYIV, 02099 UKRAINE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UKRAINE | PARENTERAL ORDINARY DRY VIALS | I. 1*1*10ML VIAL | |
| 4113 | NDA/MAL/HDP/9970 | PRIVATE JOINT STOCK COMPANY "INDAR" | CORE ACCESS LIMITED | HUMODAR B 100R | INSULIN HUMAN (RDNA ORIGIN) | 100IU/ML | 1. PRIVATE JOINT STOCK COMPANY "INDAR" 5, ZROSHUVALNA STR. KYIV, 02099 UKRAINE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. PRIVATE JOINT STOCK COMPANY "INDAR" 5, ZROSHUVALNA STR. KYIV, 02099 UKRAINE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UKRAINE | PARENTERAL ORDINARY VIALS | I. 1*1*10ML VIAL | |
| 4114 | NDA/MAL/HDP/9971 | PRIVATE JOINT STOCK COMPANY "INDAR" | CORE ACCESS LIMITED | HUMODAR C25 100R | INSULIN HUMAN (RDNA ORIGIN) | 100IU/ML | 1. PRIVATE JOINT STOCK COMPANY "INDAR" 5, ZROSHUVALNA STR. KYIV, 02099 UKRAINE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. PRIVATE JOINT STOCK COMPANY "INDAR" 5, ZROSHUVALNA STR. KYIV, 02099 UKRAINE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UKRAINE | PARENTERAL ORDINARY VIALS | I. 1*1*10ML VIAL | |
| 4115 | NDA/MAL/HDP/9973 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL 80 H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | MICRO LABS LIMITED .,, 92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| 4116 | NDA/MAL/HDP/9974 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | NEBTAS-H | NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE | 5MG + 12.5 MG | INTAS PHARMACEUTICALS LIMITED , CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| 4117 | NDA/MAL/HDP/9976 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EZIFLO | TAMSULOSIN HYDROCHLORIDE | 0.4 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD CO, AL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| 4118 | NDA/MAL/HDP/9977 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 MG/ 300 MG | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 200MG + 300MG | LAURUS LABS LTD (UNIT 2), PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER | 24/03/2022 |
| 4119 | NDA/MAL/HDP/9978 | ASPIRO PHARMA LIMITED | AIVEEN (U) LIMITED | PALOX | PALONOSETRON HYDROCHLORIDE | 0.25MG/5ML | ASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X0.25 MG VIAL | 31/03/2022 |
| 4120 | NDA/MAL/HDP/9983 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 25 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 25MG + 1000MG | CIPLA LIMITED., PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| 4121 | NDA/MAL/HDP/9984 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 12.5 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 12.5MG + 1000MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| 4122 | NDA/MAL/HDP/9985 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 5 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 5MG + 1000MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| 4123 | NDA/MAL/HDP/9986 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 10 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 10MG + 1000MG | CIPLA LTD, GOA UNIT V & UNIT X, L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| 4124 | NDA/MAL/HDP/9987 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SACROFER | IRON SUCROSE | 100MG/5ML | AMOUN PHARMACEUTICAL COMPANY..., 1ST INDUSTRIAL ZONE, EL-OBOUR CITY, CAIRO | EGYPT | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 24/03/2022 |
| 4125 | NDA/MAL/HDP/9991 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EASCOF-LS | LEVOSALBUTAMOL SULPHATE + AMBROXOL HYDROCHLORIDE + GUAIPHENESIN | 1MG + 30MG + 50 MG | CACHET PHARMACEUTICALS PVT LTD ., VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 24/03/2022 |
| 4126 | NDA/MAL/HDP/9992 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | ASPEC EXTRA | ASPIRIN + PARACETAMOL + CAFFEINE ANHYDROUS | 300MG + 250MG + 30MG | REGAL PHARMACEUTICALS LTD , PLOT NO. 7879/18, OFF BABA DOGO ROAD, RUARAKA - NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP | 24/03/2022 |
| 4127 | NDA/MAL/HDP/9993 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KLAR 250 | CLARITHROMYCIN | 250MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 24/03/2022 |
| 4128 | NDA/MAL/HDP/9994 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KLAR 500 | CLARITHROMYCIN | 500MG | 1. AUROBINDO PHARMA LIMITED, UNIT-III SURVEY NO. 313 & 314, BACHUPALLY (VILLAGE), BACHUPALLY (MANDAL) MEDCHAL - MALKAJGIRI (DISTRICT), HYDERABAD - 500090 TELANGANA (STATE) INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 24/03/2022 |
| 4129 | NDA/MAL/HDP/9997 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | RIVATAS 10 | RIVAROXABAN | 10 MG | INTAS PHARMACEUTICALS LTD - PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | I. 1*3*10TABLET BLISTER | 24/03/2022 |
| 4130 | NDA/MAL/HDP/9998 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DERMOCIN | MUPIROCIN | 2.0%W/W | LINCOLN PHARMACEUTICALS LTD, 10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 24/03/2022 |
| 4131 | NDA/MAL/HDP/9999 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | POLIOMYELITIS VACCINE (ORAL), BIVALENT TYPES 1 AND 3. | POLIO VIRUS (SABIN) | TYPE - I ?106.0 CCID50 TYPE - III ?105.8 CCID50 | SERUM INSTITUTE OF INDIA PVT LTD ., 212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0X2.0 ML VIAL (20DOSES) | 31/03/2022 |
| S/N | NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | GENERIC NAME OF DRUG | STRENGTH OF DRUG | MANUFACTURING SITE | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NDA/MAL/VDP/10000 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | ALBENDEX 100 | ALBENDAZOLE. | 100MG/ML | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X40.0 ML CONTAINER,1.0X120.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X5.0 L JERRYCAN | 3/24/22 |
| 2 | NDA/MAL/VDP/10001 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | ALBENDEX 25 | ALBENDAZOLE. | 25MG/ML | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X5.0 L JERRYCAN | 3/24/22 |
| 3 | NDA/MAL/VDP/10002 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | BIOSOL WDP | TRIMETHOPRIM + SULFAMETHOXAZOLE | (0.2 + 1.0)G PER 10G | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X25.0 G SACHET,1.0X12.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 3/24/22 |
| 4 | NDA/MAL/VDP/10004 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS SG 9R | LIVE, SALMONELLA GALLINARUM ORGANISMS, STRAIN 9R | 2 X 10^7 - 2 X 10^8 CFU PER DOSE | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL | 3/24/22 |
| 5 | NDA/MAL/VDP/10005 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | MURTRYP PLUS | DIMINAZENE DIACETURATE + PHENAZONE + VITAMIN B6 + VITAMIN B12 | (444.3 MG + 555.3 MG + 0.8 MG 0.4 MG)/G | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X10.0X2.37 G SACHET,1.0X10.0X23.7 G SACHET | 3/24/22 |
| 6 | NDA/MAL/VDP/10008 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | AMPRONOR 300MG® | AMPROLIUM HYDROCHLORIDE | 300MG/G | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X1.0 KG SACHET,1.0X50.0 G SACHET,1.0X100.0 G SACHET | 3/31/22 |
| 7 | NDA/MAL/VDP/10009 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | D.COLINOR EXTRA | DOXYCYCLINE HYDROCHLORIDE + COLISTIN SULFATE + AMBROXOL HYDROCHLORIDE | (400MG + 800000 IU + 10MG)/G | HEBEI KEXING PHARMACEUTICALS CO. LTD, NO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X100.0 G SACHET,1.0X50.0 G SACHET,1.0X1.0 KG SACHET | 3/31/22 |
| 8 | NDA/MAL/VDP/10010 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | POULVAC®IB QX | LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN L1148 | 10^3.0 - 10^5.0 EID50/DOSE | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.L, CTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2000.0 DOSE VIAL | 3/31/22 |
| 9 | NDA/MAL/VDP/10120 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | ERYCONOR® | COLISTIN SULPHATE + ERYTHROMYCIN THIOCYANATE | (600,000 IU + 200MG) PER G | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 7/14/22 |
| 10 | NDA/MAL/VDP/10121 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | TETRANOR® 25% WSP | OXYTETRACYCLINE HYDROCHLORIDE | 25%W/W | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 7/14/22 |
| 11 | NDA/MAL/VDP/10122 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | VITRANOR-EGG FORMULA® WSP | OXYTETRACYCLINE HYDROCHLORIDE+ NEOMYCIN SULPHATE + VITAMIN A+VITAMIN D3+VITAMIN E+VITAMIN B1+VITAMIN B2+VITAMIN B6+VITAMIN B12+VITAMIN C+CALCIUM PANTOTHENATE+VITAMIN K3+NICOTINAMIDE+FOLIC ACID+METHIONINE+LYSINE+COPPER SULPHATE | (60MG + 40MG + 7500IU + 1750IU + 35MG + 1MG + 3MG + 2MG + 7.5 MCG + 25MG + 7.5MG + 5MG + +15MG + 0.3MG + 30MG + 50MG + 12.25MG) PER G | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 7/14/22 |
| 12 | NDA/MAL/VDP/10123 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | PARAMECTIN | IVERMECTIN | 10MG/ML | PHARMA SWEDE - EGYPT, 10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 | EGYPT | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 7/6/22 |
| 13 | NDA/MAL/VDP/10124 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | PARAMECTIN SUPER | IVERMECTIN + CLORSULON | (10MG + 100MG) PER ML | PHARMA SWEDE - EGYPT, 10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 | EGYPT | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 7/6/22 |
| 14 | NDA/MAL/VDP/10125 | INTRACIN PHARMACEUTICAL PVT LTDˆŠ | VEERAM HEALTHCARE (U) LIMITED | MELOXIN-I | MELOXICAM | 5MG/ML | INTRACIN PHARMACEUTICAL PVT. LTD., C-1B/53, G.I.D.C. ESTATE, NADIAD 387 001, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X15.0 ML VIAL,1.0X30.0 ML VIAL,1.0X100.0 ML VIAL | 7/6/22 |
| 15 | NDA/MAL/VDP/10128 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | NOBILIS® RISMAVAC+CA126 | LIVE, CHICKEN HERPES VIRUS, STRAIN CVI-988 (SEROTYPE I) + LIVE, TURKEY HERPES VIRUS, STRAIN FC-126 (SEROTYPE 3) | (≥ 3.0 LOG10 PFU + ≥ 3.0 LOG10 PFU) PER BIRD DOSE | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | PARENTERAL ORDINARY AMPOULES | 1.0X1000.0 DOSE AMPOULE,1.0X2000.0 DOSE AMPOULE | 7/14/22 |
| 16 | NDA/MAL/VDP/10130 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY 10% LA | OXYTETRACYLINE DIHYDRATE | 100MG/ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/14/22 |
| 17 | NDA/MAL/VDP/10131 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY 20% LA | OXYTETRACYCLINE DIHYDRATE | 200MG/ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/14/22 |
| 18 | NDA/MAL/VDP/10133 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIENRO 10% | ENROFLOXACIN | 100MG/ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 7/14/22 |
| 19 | NDA/MAL/VDP/10334 | NEOGEN CHEMICALS (U) LTD | NEOGEN CHEMICALS (U) LTD | IVERGEN PLUS | IVERMECTIN + CLORSULON | 10 MG/ML + 100 MG/ML | 1. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*100ML BOTTLE II. 1*1*250ML BOTTLE III. 1*1*500ML BOTTLE | 9/9/22 |
| 20 | NDA/MAL/VDP/10339 | VAPCO VETERINARY AND AGRICULTURAL PRODUCTS CO LTD | GOODMAN INTERNATIONAL LTD | TYLOXIN | TYLOSIN TARTRATE + DOXYCYCLINE HYDROCHLORIDE | (200MG + 200MG ) PER GRAM | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 9/29/22 |
| 21 | NDA/MAL/VDP/10344 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | EVAMINOR 200MG | LEVAMISOLE HYDROCHLORIDE | 200MG PER GRAM | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X50.0 G SACHET,1.0X100.0 G SACHET | 9/9/22 |
| 22 | NDA/MAL/VDP/10345 | NEOGEN CHEMICALS (U) LTD | NEOGEN CHEMICALS (U) LTD | MULTIGEN | VITAMIN A + VITAMIN D3 +VITAMIN B1 + VITAMIN B6 + VITAMIN B2 + VITAMIN B12 + VITAMIN E ACETATE + NICOTINAMIDE + D-PANTOTHENOL + D-BIOTIN | (2000 IU + 2000 IU + 10 MG + 5 MG + 1MG + 10 MCG + 4 MG + 10 MG + 1MG + 10 MCG) PER ML | 1. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*100ML VIAL | 9/9/22 0:00 |
| 23 | NDA/MAL/VDP/10359 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | SYNULOX BOLUS 500MG | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 400MG + 100MG | HAUPT PHARMA LATINA S.R.L,-S.S. 156 MONTI LEPINI, KM 47.600, 04100 BORGO SAN MICHELE (LT) - ITALY | | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X4.0 TABLET STRIP | 9/9/22 |
| 24 | NDA/MAL/VDP/10397 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVIZURIL LIQUID | DICLAZURIL | 10 MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE, 1.0X500.0 ML BOTTLE, 1.0X1000.0 ML BOTTLE | 9/9/22 |
| 25 | NDA/MAL/VDP/10399 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | DEXAPHAN | DEXAMETHASONE SODIUM PHOSPHATE | 2MG/ML | PHARMA SWEDE EGYPT, 10TH OF RAMADAN CITY €“ INDUSTRIAL ZONE B3 | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 9/19/22 |
| 26 | NDA/MAL/VDP/10400 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | IMICARBZOLE | IMIDOCARB DIPROPIONATE | 120MG/ML | PHARMA SWEDE EGYPT, 10TH OF RAMADAN CITY €“ INDUSTRIAL ZONE B3 | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL,1.0X35.0X10.0 ML VIAL | 9/19/22 |
| 27 | NDA/MAL/VDP/10403 | NEOGEN CHEMICALS (U) LTD | NEOGEN CHEMICALS (U) LTD | IVERGEN LA-TS | IVERMECTIN | 3.15 %W/V | 1. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*100ML BOTTLE II. 1*1*250ML BOTTLE III. 1*1*500ML BOTTLE | 9/9/22 |
| 28 | NDA/MAL/VDP/10404 | NEOGEN CHEMICALS (U) LTD | NEOGEN CHEMICALS (U) LTD | OXY-GEN® LA | OXYTETRACYCLINE HYDROCHLORIDE | 20%W/V | 1. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*100ML VIAL II. 1*1*250ML VIAL III. 1*1*500ML VIAL | 9/9/22 0:00 |
| 29 | NDA/MAL/VDP/10405 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVIMEC | IVERMECTIN | 1%W/V | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL, 1.0X1.0X100.0 ML VIAL, 1.0X1.0X250.0 ML VIAL | 9/9/22 |
| 30 | NDA/MAL/VDP/10415 | INTERCHEMIE | VET CENTRE UGANDA LIMITED | LIMOXIN WS | OXYTETRACYCLINE HYDROCHLORIDE | 1000 MG/G | INTERCHEMIE WERKEN "DE ADEKAAR" BV, METAALWEG 85804 CG VENRY | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G JAR | 2/8/23 |
| 31 | NDA/MAL/VDP/10416 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOTRIM | SULPHADIAZINE SODIUM + TRIMETHOPRIM | (200MG + 40MG) PER ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 2/8/23 |
| 32 | NDA/MAL/VDP/10580 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIVER FORTE | IVERMECTIN + CLORSULON | (10MG + 100MG)/ML | ASHISHI LIFE SCIENCE PVT LTD, J-137, MIDC, TARAPUR, BOISAR 401501 DIST. THANE, MAHARASHTRA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL | 2/10/23 |
| 33 | NDA/MAL/VDP/10581 | NEOGEN CHEMICALS (U) LTD | NEOGEN CHEMICALS (U) LTD | OXY-GEN® | OXYTETRACYCLINE HYDROCHLORIDE | 3.15%W/V | 1. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*100ML BOTTLE II. 1*1*250ML BOTTLE III. 1*1*500ML BOTTLE | 2/8/23 0:00 |
| 34 | NDA/MAL/VDP/10582 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | POULVAC MAREK CVI + HVT (RISPENS-HVT) FROZEN | MAREK’S DISEASE CHICKEN HERPES VIRUS-INFECTED CELL SUSPENSION (CVI 988 STRAIN) + MAREK’S DISEASE TURKEY HERPES VIRUS-INFECTED CELL SUSPENSION (FC #126 STRAIN) | (≥1,046 PFU + ≥992 PFU)/ DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | PARENTERAL ORDINARY DRY AMPOULES | 1.0X5.0X1000.0 DOSE AMPOULE + (1*200ML OF DILUENT IN GLASS VIALS OR PLASTIC BAGS) | 2/10/23 |
| 35 | NDA/MAL/VDP/10583 | VETCARE KENYA LTD | VETCARE UGANDA LIMITED | TYLODOXY 200 | TYLOSIN TARTRATE + DOXYCYCLINE HYCLATE | (100MG + 100MG)/ GRAM | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X25.0 G SACHET,1.0X12.0X100.0 G SACHET,1.0X1000.0 G JAR | 2/10/23 |
| 36 | NDA/MAL/VDP/10584 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | WORMIFAS DRENCH | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT (II) CARBONATE | (15MG + 30MG + 1.5MG) PER ML | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X150.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 2/10/23 |
| 37 | NDA/MAL/VDP/10585 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | WORMIFAS MZITO SUSPENSION | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT (II) CARBONATE + SODIUM SELENITE | (30MG + 60MG + 3.0MG + 0.32MG) PER ML | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 2/10/23 |
| 38 | NDA/MAL/VDP/10586 | VETCARE KENYA LTD | VETCARE UGANDA LIMITED | WORMITREX 7.5 POULTRY | LEVAMISOLE HYDROCHLORIDE | 7.5%W/V | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X5000.0 ML BOTTLE | 2/10/23 |
| 39 | NDA/MAL/VDP/10739 | NEOGEN CHEMICALS (U) LTD | NEOGEN CHEMICALS (U) LTD | BUPARGEN | BUPARVAQUONE | 5%W/V | 1. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT 2. HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*20ML VIAL II. 1*1*50ML VIAL | 2/15/23 0:00 |
| 40 | NDA/MAL/VDP/10740 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | COMBAT SHAMPOO | PERMETHRIN + CETRIMIDE | 0.05%W/V + 1%W/V | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X1.0X200.0 ML BOTTLE | 2/15/23 |
| 41 | NDA/MAL/VDP/10741 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCO DIGEST | SODIUM PROPIONATE + MAGNESIUM SULPHATE + IRON II SULPHATE + ZINC SULPHATE + MANGANESE SULPHATE + COPPER SULPHATE + COBALT CHLORIDE + SODIUM SELENITE | 600 MG + 125 MG + 0.40 MG + 0.10 MG + 0.20 MG + 0.45 MG + 0.40 MG + 0.10 MG | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 3/6/23 |
| 42 | NDA/MAL/VDP/10861 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | NEWCASTLE-BRONCHITIS VACCINE | NEWCASTLE DISEASE VIRUS, B1 TYPE, LASOTA STRAIN + AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS SEROTYPE, STRAIN #1263 | (≥ 10^6.0 EID50/DOSE + ≥ 10^3.8 EID50) PER DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | LYOPHILISATES (ASEPTICALLY FILLED) | 1.0X10.0X1000.0 DOSE VIAL | 5/25/23 |
| 43 | NDA/MAL/VDP/10864 | VETCARE KENYA LTD | VETCARE UGANDA LIMITED | OXYSOL PLUS | OXYTETRACYCLINE HYDROCHLORIDE + VITAMIN A + VITAMIN D3 + VITAMIN E + VITAMIN K + VITAMIN B1+ VITAMIN B2 + VITAMIN B6 + VITAMIN B12 + VITAMIN C + NICOTINIC ACID + D-CALPAN (VITAMIN B5) + CHOLINE BITARTRATE | (62 MG + 5.1 MG + 3.6 MG + 3.5 MG + 5.6 MG + 0.5 MG + 3.6 MG + 0.30 MG + 0.30 MG + 0.1 MG + 15.70 MG + 3.10 MG + 10.90 MG) PER G | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X12.0X25.0 G SACHET,1.0X12.0X100.0 G SACHET,1.0X1000.0 G JAR | 5/3/23 |
| 44 | NDA/MAL/VDP/10869 | BAODING SUNLIGHT HERB MEDICAMENT CO.LTD | BD PHARMACEUTICALS LTD | MECTIN | IVERMECTIN | 1%W/V | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED-NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA. | CHINA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL, 1.0X1.0X100.0 ML VIAL | 5/3/23 |
| 45 | NDA/MAL/VDP/10872 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | CATACURE | BUTAPHOSPHAN + CYANOCOBALAMIN E | 100 MG + 50 MCG | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 8/17/23 |
| 46 | NDA/MAL/VDP/10995 | VMD NV HOGE MAUW | ERAM UGANDA LIMITED | DOXYVETO-CITRIX 500 MG/G | DOXYCYCLINE HYCLATE | 500 MG/G | LABORATORIES BIOVE' , 3, RUE DE LORRAINE, F-62510 ARQUES| VMD NV , HOGE MUW 900, 2370, ARENDONK | BELGIUM| FRANCE | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G JAR,1.0X1000.0 G JAR | 8/17/23 |
| 47 | NDA/MAL/VDP/10996 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ZEROKRIM® CH | PRAZIQUANTEL + PYRANTEL PAMOATE + FENBENDAZOLE | 50.00 MG + 144.00 MG + 500.00 MG | ASHISH LIFE SCIENCE PVT. LTD, J-137, MIDC,TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X10.0 TABLET STRIP | 8/17/23 |
| 48 | NDA/MAL/VDP/11005 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ALBECTIN SUSPENSION | ALBENDAZOLE + IVERMECTIN | (100MG +2 MG) PER ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 8/17/23 |
| 49 | NDA/MAL/VDP/11006 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIENRO® - BH | ENROFLOXACIN + BROMHEXINE HYDROCHLORIDE | (200MG + 15MG) PER ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 8/17/23 |
| 50 | NDA/MAL/VDP/11100 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | INTERTRIM-480 WS | SULFADIAZINE SODIUM + TRIMETHOPRIM | (400MG + 80MG)/G | INTERCHEMIE WERKEN DE ADELAAR BV, METAALWEG 8 5804 (G VENRA) | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET, 1.0X1000.0 G JAR | 12/13/23 |
| 51 | NDA/MAL/VDP/11123 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | ALBEX PLUS® | ALBENDAZOLE | 100MG/G | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD, AL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 12/13/23 |
| 52 | NDA/MAL/VDP/11126 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | CLOTIN 1% | IVERMECTIN | 10 MG/ML | INTRACIN PHARMACEUTICALS PVT LTD ,.,., C-1, B-53, GIDC ESTATE, NADIAD-387001 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X1.0X50.0 ML VIAL | 12/13/23 |
| 53 | NDA/MAL/VDP/11127 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | FLASIN | TYLOSIN | 200 MG/ML | INTRACIN PHARMACEUTICALS PVT LTD ,.,., C-1, B-53, GIDC ESTATE, NADIAD-387001 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 12/13/23 |
| 54 | NDA/MAL/VDP/11185 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | NEFLUK 2.5% | ALBENDAZOLE | 2.5% W/V | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML CONTAINER | 2/2/24 |
| 55 | NDA/MAL/VDP/11186 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | DECTOMAX® INJECTABLE SOLUTION | DORAMECTIN | 10MG/ML | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.L, CTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL, 1.0X50.0 ML VIAL | 2/2/24 |
| 56 | NDA/MAL/VDP/11388 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | AMPROLIUM 20% | AMPROLIUM HYDROCHLORIDE | 20% W/W | HEBEI YUANZHENG PHARMACEUTICALS COMPANY, NO.16 LIUYUAN ROAD CHANG€™AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X50.0 G SACHET,1.0X100.0 G SACHET | 6/1/24 |
| 57 | NDA/MAL/VDP/11391 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | COCCIMED POWDER | AMPROLIUM HYDROCHLORIDE | 200MG /G | MEDISEL (K) LTD, PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | KENYA | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X30.0 G SACHET,1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G JAR | 6/1/24 |
| 58 | NDA/MAL/VDP/11433 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVITRYL | ENROFLOXACIN | 100 MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 5/22/24 |
| 59 | NDA/MAL/VDP/11487 | ERAM UGANDA LIMITED | ERAM UGANDA LIMITED | TYLORAM - 20 | TYLOSIN TARTRATE | 200MG/G | HEBEI YUANZHENG PHARMACEUTICALS COMPANY, NO.16 LIUYUAN ROAD CHANG€™AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 6/4/24 |
| 60 | NDA/MAL/VDP/11489 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | NEWCASTLE-BRONCHITIS VACCINE (B1 TYPE, B1 STRAIN, MASSACHUSETTS TYPE, LIVE VIRUS) | NEWCASTLE DISEASE (B1 TYPE, B1 STRAIN) LIVE VIRUS + AVIAN INFECTIOUS BRONCHITIS (MASSACHUSETTS SEROTYPE, # 1263 STRAIN) LIVE VIRUS | ( ‰¥ 10^6.0 EID50 + ‰¥ 10^3.8 EID50) PER DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X1000.0 DOSE VIAL + 1*10*30 ML OF DILUENT | 6/4/24 |
| 61 | NDA/MAL/VDP/11493 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | AE POXINE® | AVIAN ENCEPHALOMYELITIS VIRUS + FOWL POX VIRUS | ‰¥ 10^3.0 EID50 + ‰¥ 10^2.6 EID50) PER DOSE (0.03ML) | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL + 1*10*10 ML STERILE DILUENT VIALS | 6/4/24 |
| 62 | NDA/MAL/VDP/11503 | NILE SERVICES LTD | NILE SERVICES LTD | AMITRAZ 12.5% | AMITRAZ | 125 MG /ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO. 80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING - CHINA | CHINA | TOPICAL EXTERNAL EMULSIONS | 1.0X50.0 ML BOTTLE, 1.0X100.0 ML BOTTLE, 1.0X250.0 ML BOTTLE, 1.0X500.0 ML BOTTLE, 1.0X1.0 L BOTTLE, 1.0X5.0 L BOTTLE | 9/25/24 |
| 63 | NDA/MAL/VDP/11642 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LTD | POULVAC® E. COLI | ESCHERICHIA COLI VACCINE, LIVE CULTURE | ≥ 1.7 X 107.0 CFU/DOSE | ZOETIS-2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | | UNITED STATES | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0X10.0 ML VIAL | 9/25/24 |
| 64 | NDA/MAL/VDP/11643 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | COCCINOR | SULPHAQUINOXALINE + DIAVERIDINE B.P.V + VITAMIN K3 + NICOTINAMIDE | (200 MG + 24 MG + 20 MG + 24 MG)/G | HEBEI KEXING PHARMACEUTICALS-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X50.0 G SACHET,1.0X100.0 G SACHET | 9/25/24 |
| 65 | NDA/MAL/VDP/11645 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | SYNULOXTM LACTATING COW | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE + PREDNISOLONE | (200 MG + 50 MG + 10 MG)3G | HAUPT PHARMA LATINA S.R.L,-S.S. 156 MONTI LEPINI, KM 47.600, 04100 BORGO SAN MICHELE (LT) - ITALY | | ITALY | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X12.0X3.0 G PRE- FILLED SYRINGE | 9/25/24 |
| 66 | NDA/MAL/VDP/11646 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | BRAVECTO 112.5 MG | FLURALANER | 112.5 MG | INTERVET GESMBH-SIEMENSTRASSE 107, 1210 VIENNA - AUSTRIA | | AUSTRIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 9/25/24 |
| 67 | NDA/MAL/VDP/11647 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | BRAVECTO 250 MG | FLURALANER | 250 MG | INTERVET GESMBH-SIEMENSTRASSE 107, 1210 VIENNA - AUSTRIA | | AUSTRIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 9/25/24 |
| 68 | NDA/MAL/VDP/11648 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | BRAVECTO 500 MG | FLURALANER | 500 MG | INTERVET GESMBH-SIEMENSTRASSE 107, 1210 VIENNA - AUSTRIA | | AUSTRIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 9/25/24 |
| 69 | NDA/MAL/VDP/11649 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | BRAVECTO 1000 MG | FLURALANER | 1000 MG | INTERVET GESMBH-SIEMENSTRASSE 107, 1210 VIENNA - AUSTRIA | | AUSTRIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 9/25/24 |
| 70 | NDA/MAL/VDP/11702 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | BRAVECTO 1400 MG | FLURALANER | 1400MG | INTERVET GESMBH-SIEMENSTRASSE 107, 1210 VIENNA - AUSTRIA | | AUSTRIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 9/25/24 |
| 71 | NDA/MAL/VDP/11703 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | TYLOVET 20% | TYLOSIN TARTRATE | 200MG/ML | PHARMA SWEDE EGYPT-10TH OF RAMADAN CITY – INDUSTRIAL ZONE B3 | | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 9/25/24 |
| 72 | NDA/MAL/VDP/11704 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD | KWEWAYO (U) VET PHARMACY LIMITED | MEDOMYCIN 35 | ERYTHROMYCIN THIOCYANATE | 350 MG/GM | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD-AL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 G SACHET | 9/25/24 |
| 73 | NDA/MAL/VDP/11710 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | ERYTHROVET 20% W/W | ERYTHROMYCIN THIOCYANATE | 200MG/G | PHARMA SWEDE EGYPT-10TH OF RAMADAN CITY – INDUSTRIAL ZONE B3 | | EGYPT | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1.0 KG CONTAINER | 9/25/24 |
| 74 | NDA/MAL/VDP/11711 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ENRODAC-10 VET INJECTION | ENROFLOXACIN | 100 MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED PLOT NO. F1/1, SECTOR - 6B, IIE, SIIDCUL, HARIDWAR-249403, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X1X100ML VIAL, 1X1X50ML VIAL | 12/18/24 |
| 75 | NDA/MAL/VDP/11712 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FUROZYD | FUROSEMIDE | 50 MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED PLOT NO. F1/1, SECTOR - 6B, IIE, SIIDCUL, HARIDWAR-249403, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X1X50ML VIAL, 1X1X100ML VIAL | 12/18/24 |
| 76 | NDA/MAL/VDP/11713 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEOPROFEN | KETOPROFEN | 100 MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED PLOT NO. F1/1, SECTOR - 6B, IIE, SIIDCUL, HARIDWAR-249403, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X1X100ML VIAL | 12/18/24 |
| 77 | NDA/MAL/VDP/11714 | CEVA SANTE ANIMAL S.A | SCOPEVET DEVELOPMENTS LTD | VECTOCLOR PLUS | CYPERMETHRIN+ CHLORPYRIFOS+PIPERONYL BUTOXIDE | 25.0 G/100ML+15.0 G/100ML+15.0 G/100ML | IPANEMA INDUSTRIA DE PRODUTOS VETERINARIOS LTDA RAPOSO TAVARES ROAD, KM 113 - ARACOIABA DA SERRA / SAO PAULO, BRAZIL | BRAZIL | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X1000.0ML BOTTLE | 12/18/24 |
| 78 | NDA/MAL/VDP/11715 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTIZONE INJECTION | PHENYLBUTAZONE | 200 MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED PLOT NO. F1/1, SECTOR - 6B, IIE, SIIDCUL, HARIDWAR-249403, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0ML VIAL | 12/18/24 |
| 79 | NDA/MAL/VDP/11716 | BIOPHARMA - SOCIETE DE PRODUCTIONS BIOLOGIQUES ET PHARMACEUTIQUES | EAGLEVET UGANDA LIMITED | IMMUNAFTPLUS | INACTIVATED PURIFIED ANTIGEN OF EACH STRAIN OF FMD VIRUS, SEROTYPES (A, O, SAT 1 & SAT 2) | 6 PD50 PER 3ML/DOSE | BIOPHARMA MOROCCO RABAT, AVENUE HASSAN II, KM 2, ROUTE CASABLANCA, AKKARI, BP: 4569, ROYAUAME DU MAROC | MOROCCO | PARENTERAL ORDINARY OTHER VIALS | 1.0X1.0X210.0ML VIAL, 1.0X1.0X105.0ML VIAL, 1.0X1.0X51.0ML VIAL | 12/18/24 |
| 80 | NDA/MAL/VDP/11940 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM (U) LTD | NOBIVAC® RABIES | INACTIVATED, RABIES VIRUS STRAIN PASTEUR RIV | ≥ 2.0 I.U PER DOSE | INTERVET INTERNATIONAL B.V. 35 WIM DE KÖRVER STREET, BOXMEER, THE NETHERLANDS | NETHERLANDS | PARENTERAL ORDINARY VIALS | 1*1*3ML VIAL + 1*1*10ML VIAL | 5/6/25 |
| 81 | NDA/MAL/VDP/11943 | INTERVET SOUTH AFRICA (PTY) LTD PHYSICAL ADDRESS: 20 SPARTAN ROAD, SPARTAN 1619, SOUTH AFRICA POSTAL ADDRESS: P.O. BOX 2026, ISANDO 1600, SOUTH AFRICA | AGROTECH LTD | RB-51 | BRUCELLA ABORTUS, STRAIN RB-51, LIVE CULTURE: | 10-34 X 109 CFU/2 ML DOSE | COLORADO SERUM COMPANY 4950 YORK STREET, DENVER, COLORADO 80216-0428 USA (SUBSIDIARY: AMERICANA LABORATORIES, INC. PROFESSIONAL BIOLOGICAL COMPANY) | UNITED STATES OF AMERICA | PARENTERAL ORDINARY DRY VIALS | 1*5 DOSE VIAL + 10 ML SOLVENT, 1* 25 DOSE VIAL + 50 ML SOLVENT | 6/27/25 |
| 82 | NDA/MAL/VDP/11945 | JUBAILI AGROTEC LTD ADDRESS: PLOT 1659, SUPPER TERRAZO, KAKAJJO ZONE, BWEYOGERERE, WAKISO DISTRICT, UGANDA P.O BOX 515 KAMPALA | JUBAILI AGROTEC LTD | GENTANOR | GENTAMICIN SULFATE | 10%W/V | HEBEI KEXING PHARMACEUTICAL CO, LTD, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG, HEBEI, CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1*1*100 ML BOTTLE | 6/27/25 |
| 83 | NDA/MAL/VDP/11946 | NILE SERVICES LTD, PLOT 11 NAKIVUBO MEWS, P.O. BOX 2146, KAMPALA, UGANDA UGANDA | NILE SERVICES LTD | ALBENDASTAR 2500 MG | ALBENDAZOLE HYDROCHLORIDE | 2500 MG/6G | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO., LTD, NO.80 EAST PART OF CHANGZHOU ROAD, RONGCHANG, CHONGQING, CHINA | CHINA | ORAL SOLID ORDINARY TABLET | 1*10*5 TABLET BLISTER | 6/27/25 |
| 84 | NDA/MAL/VDP/11947 | INTRACIN PHARMACEUTICAL PVT LTD, C-1 B/53, G.I.D.C., ESTATE, NADIAD 387001 GUJARAT INDIA | VEERAM HEALTHCARE (U) LTD | PIZINE WS | PIPERAZINE CITRATE | 1000 MG/G | INTRACIN PHARMACEUTICAL PVT LTD, C-1, B -52,53,56 G.I.D.C ESTATE, NADIAD 387001 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY POWDERS | 1*100 G SACHET | 6/27/25 |
| 85 | NDA/MAL/VDP/11948 | INTRACIN PHARMACEUTICAL PVT LTD, C-1 B/53, G.I.D.C., ESTATE, NADIAD 387001 GUJARAT INDIA | VEERAM HEALTHCARE (U) LTD | DONECIN | DOXYCYCLINE HYCLATE + NEOMYCIN SULFATE | (100 MG + 100 MG)/G | INTRACIN PHARMACEUTICAL PVT LTD, C-1, B -52,53,56 G.I.D.C ESTATE, NADIAD 387001 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY POWDERS | 1*100 G SACHET | 6/27/25 |
| 86 | NDA/MAL/VDP/11952 | MEDISEL (KENYA) LIMITED, GENERAL KAGO ROAD OFF GARISSA ROAD, P.O BOX 540-01000, THIKA KENYA | DAWA LIFESCIENCES (U) LTD | IVEM | IVERMECTIN | 10 MG/ML | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED - NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1*1*50 ML BOTTLE + 1*1*100 ML BOTTLE | 6/27/25 |
| 87 | NDA/MAL/VDP/12051 | KEPRO B.V | QUALITY CHEMICALS LTD | TYLO-DOX EXTRA WSP | TYLOSIN TARTRATE + DOXYCYCLINE HYCLATE | 100 MG/G + 200 MG/G | 1. LELYPHARMA B.V. ZUIVERINGWEG 42, 8243 PZ LELYSTAD NETHERLANDS SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | I. 1*100G SACHET, 1*1000 G BOTTLE | 5/6/25 |
| 88 | NDA/MAL/VDP/12052 | ELANCO ANIMAL HEALTH (PTY) LTD, PHYSICAL ADDRESS: N1 BUSINESS PARK, OLD PRETORIA ROAD, KOSMOSDAL EXT. 7, GAUTENG, 0157, RSA | ULTRAVETIS UGANDA LTD | AVIPRO™ 441 ND-IB-BTO-REO | • NEWCASTLE DISEASE VIRUS, B1 TYPE, LASOTA STRAIN + INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS TYPE, DG STRAIN + INFECTIOUS BURSAL DISEASE VIRUS, STANDARD CHALLENGE STRAIN + AVIAN REOVIRUS, 1733 STRAIN + AVIAN REOVIRUS, S1133 STRAIN | ONE DOSE (0.5 ML) CONTAINS A MINIMUM TITRE/ANTIGENIC CONTENT (BEFORE INACTIVATION) OF: -10^7.7 EID50 * + 10^6.9 EID50 + 10^3.3 EID50 + 10^5.8 TCID50** + 10^6.3 TCID50 *EID50 =50% EMBRYO INFECTIOUS DOSE **TCID50=50% TISSUE CULTURE INFECTIOUS DOSE | ELANCO US INC.- 375 CHINA ROAD, WINSLOW, MAINE, 04901 - UNITED STATES OF AMERICA. | UNITED STATES OF AMERICA | PARENTERAL ORDINARY VIALS | 1*500 ML BOTTLE | 6/27/25 |
| 89 | NDA/MAL/VDP/12053 | ARAB VETERINARY INDUSTRIAL COMPANY, AVICO - AMMAN | K.S. VET PHARMACY LIMITED | AVIDEXOCAL INJECTION | CALCIUM BOROGLUCONATE + MAGNESIUM CHLORIDE HEXAHYDRATE + SODIUM HYPOPHOSPHITE | 230 MG/ML + 45 MG/ML + 28.5 MG/ML | 1. ARAB VETERINARY INDUSTRIAL COMPANY, AVICO - AMMAN JORDAN - AMMAN - NAURE ALQUDS STREET, JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | PARENTERAL ORDINARY BOTTLES | I. 1.0*1.0*500.0ML BOTTLE II. 1.0*1.0*100.0ML BOTTLE | 5/6/25 |
| 90 | NDA/MAL/VDP/12054 | INTRACIN PHARMACEUTICAL PVT LTD C-1 B/53, G.I.D.C., ESTATE, NADIAD 387001 GUJARAT INDIA | VEERAM HEALTHCARE (U) LTD | TYLOXY WS | DOXYCYCLINE HYCLATE + TYLOSIN TARTRATE | 100MG + 100MG | INTRACIN PHARMACEUTICAL PVT LTD, C-1, B-52/B-53/56 G.I.D.C., ESTATE, NADIAD 387001 (GUJARAT) INDIA | INDIA | ORAL SOLID ORDINARY POWDERS | 1*100 G SACHETS | 5/6/25 |
| 91 | NDA/MAL/VDP/12055 | HEBEI KEXING PHARMACEUTICAL COMPANY LIMITED | JUBAILI AGROTEC LIMITED | IVANOR ORAL 1% | IVERMECTIN | 10 MG/ML | 1. HEBEI KEXING PHARMACEUTICAL COMPANY LIMITED NO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI - CHINA CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | ORAL LIQUID ORDINARY LIQUIDS | I. 1*100ML CONTAINER II. 1*1L CONTAINER | 5/6/25 |
| 92 | NDA/MAL/VDP/12056 | ZOETIS INC | VET CENTRE UGANDA LIMITED | POULVAC® SE | SALMONELLA ENTERITIDIS – STRAIN D1758, PHAGE TYPE 4 + SALMONELLA ENTERITIDIS – STRAIN 52-1, PHAGE TYPE 13A | MORE THAN 5.0 ×10^7 CFU/DOSE + MORE THAN 5.0 ×10^7 CFU/DOSE | 1. ZOETIS INC 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 - UNITED STATES OF AMERICA UNITED STATES OF AMERICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UNITED STATES OF AMERICA | PARENTERAL ORDINARY BOTTLES | I. 1*300ML BOTTLE | 5/6/25 |
| 93 | NDA/MAL/VDP/12057 | ARAB VETERINARY INDUSTRIAL CO. "AVICO" ALQUDS STREET- NAUR- AMMAN- JORDAN | K.S VET PHARMACY LTD | AVICYCLINE 20% L.A. | OXYTETRACYCLINE DIHYDRATE | 200 MG/ML | ARAB VETERINARY INDUSTRIAL CO. "AVICO", ALQUDS STREET- NAUR- AMMAN JORDAN | JORDAN | PARENTERAL ORDINARY BOTTLES | 1*1*100 ML BOTTLE + 1*1* 250 ML BOTTLE | 5/6/25 |
| 94 | NDA/MAL/VDP/12058 | PHARMA SWEDE - EGYPT | KWEWAYO (U) VET PHARMACY LIMITED | DOXIN | DOXYCYCLINE HYCLATE | 200 MG/G | 1. PHARMA SWEDE - EGYPT 10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | ORAL LIQUID ORDINARY SOLUBLE POWDERS | I. 1*100G SACHET II. 1*1KG CONTAINER | 6/27/25 |
| 95 | NDA/MAL/VDP/12059 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED, 9 TH FLOOR, N. G. TOWER, SATELLITE CROSS ROADS, AHMEDABAD 380015 GUJARAT, INDIA | ABACUS PHARMA (A) LTD | DOXYSOL 50 | DOXYCYCLINE HYCLATE | 500 MG/G | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED, PLOT NO. F-1/1, SECTOR - 6B, IIE, SIDCUL, HARIDWAR -249403, UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY POWDERS | 1*1 KG SACHET | 6/27/25 |
| 96 | NDA/MAL/VDP/12060 | PHARMA SWEDE - EGYPT | KWEWAYO (U) VET PHARMACY LIMITED | GENTACURE-10 | GENTAMICIN SULFATE | 100 MG/ML | 1. PHARMA SWEDE - EGYPT 10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | PARENTERAL ORDINARY VIALS | I. 1*1*50ML VIAL II. 1*100ML VIAL | 6/27/25 |
| 97 | NDA/MAL/VDP/12061 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD. 3RD FLOOR, NISREEN BUILDING, UM – MUTWA’ AL-ASLAMEYA STREET, AL-JANDAWEEL, AMMAN, JORDAN | MEDMAC VETERINARY PHARMACY | DOXYMED SUPER® | DOXYCYCLINE HYCLATE | 500 MG/G | MEDMAC (VETERINARY DIVISION), AL HUSSUN, ST. OPPOSITE TO AL-ASSER SUITE COMPANY, IRBID – AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN | JORDAN | ORAL SOLID ORDINARY POWDERS | 1*100 G SACHET + 1*500 G CONTAINER | 5/6/25 |
| 98 | NDA/MAL/VDP/12062 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD. 3RD FLOOR, NISREEN BUILDING, UM – MUTWA’ AL-ASLAMEYA STREET, AL-JANDAWEEL, AMMAN, JORDAN. | MEDMAC VETERINARY PHARMACY | MACTIL® 250 ML | TILMICOSIN PHOSPHATE | 250 MG/ML | MEDMAC (VETERINARY DIVISION), AL HUSSUN, ST. OPPOSITE TO AL-ASSER SUITE COMPANY, IRBID – AL RUMTHA / AL HASSAN INDUSTRIAL CITY, JORDAN. | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1*60 ML BOTTLE + 1*240 ML BOTTLE | 5/6/25 |
| 99 | NDA/MAL/VDP/12063 | V.M.D. N.V. HOGUE MAUW 900 – 2370 ARENDONK - BELGIUM | ERAM (U) LTD | SURRICOXX | AMPROLIUM HYDROCHLORIDE | 400 MG/ML | LABORATOIRES BIOVÉ, 3 RUE DE LORRAINE, 62510 ARQUES, FRANCE (COMPLETE MANUFACTURING) + V.M.D. N.V., HOGUE MAUW 900, 2370 ARENDONK BELGIUM (ONLY SECONDARY PACKAGING AND BATCH RELEASE) | FRANCE | ORAL LIQUID ORDINARY LIQUIDS | 1*100 ML BOTTLE + 1*1L BOTTLE, 1*5 L BOTTLE | 5/6/25 |
| 100 | NDA/MAL/VDP/12064 | INTERVET SOUTH AFRICA (PTY) LTD. | ERAM UGANDA LIMITED | NOBIVAC CANINE 1-DAPPVL2 | MODIFIED LIVE CANINE DISTEMPER VIRUS (CDV), DISTEMPERED STRAIN + MODIFIED LIVE CANINE ADENOVIRUS TYPE-2 (CAV-2), DITCHFIELD STRAIN + MODIFIED LIVE CANINE PARAINFLUENZA VIRUS (CPI), CPI-PR STRAIN + MODIFIED LIVE CANINE PARVOVIRUS (CPV), SAH-CPV-2B STRAIN + BACTERIN LEPTOSPIRA CANICOLA (LC), LC-NY STRAIN + BACTERIN LEPTOSPIRA ICTEROHAEMORRHAGIAE (LI), LI-11403 J STRAIN | NOT LESS THAN 10^3.7 TCID50/DOSE + NOT LESS THAN 10^4.8 TCID50/DOSE + NOT LESS THAN 10^4.3 TCID50/DOSE + NOT LESS THAN 10^5.1 FAID50/DOSE + 80 HAMSTER PD80/DOSE + 80 HAMSTER PD80/DOSE | 1. INTERVET INC. 21401 WEST CENTER ROAD, ELKORN, NEBRASKA 68022 - UNITED STATES OF AMERICA UNITED STATES OF AMERICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UNITED STATES OF AMERICA | PARENTERAL ORDINARY DRY VIALS | I. 1*25*1ML VIAL + 25*1ML VIAL DILUENT | 5/6/25 |
| 101 | NDA/MAL/VDP/12065 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD | MEDMAC VETERINARY PHARMACY | ENROL 20® | ENROFLOXACIN | 200 MG/ML | MEDMAC (VETERINARY DIVISION), AL HUSSUN, ST. OPPOSITE TO AL-ASSER SUITE COMPANY, IRBID AL RUMTHA/AL HASSAN INDUSTRIAL CITY, JORDAN | IRBID | ORAL LIQUID ORDINARY LIQUIDS | 1*100 ML BOTTLE + 1*250 ML BOTTLE + 1*500 ML BOTTLE + 1*1L BOTTLE | 5/6/25 |
| 102 | NDA/MAL/VDP/12066 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LTD | AMPROCIN 20% | AMPROLIUM HYDROCHLORIDE | 20% W/W | INTRACIN PHARMACEUTICAL PVT LTD, C-1, B-52, G.I.D.C ESTATE, NADIAD 387001 GUJARAT INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1*100 G SACHET | 6/27/25 |
| 103 | NDA/MAL/VDP/12067 | PHARMA SWEDE EGYPT | KWEWAYO (U) VET PHARMACY LIMITED | CANIMAG P | CALCIUM GLUCONATE + MAGNESIUM CHLORIDE HEXAHYDRATE + SODIUM HYPOPHOSPHITE MONOHYDRATE + POTASSIUM CHLORIDE + DEXTROSE MONOHYDRATE | 230 MG/ML + 45 MG/ML + 34.3 MG/ML + 2 MG/ML + 250 MG/ML | 1. PHARMA SWEDE - EGYPT 10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 - EGYPT EGYPT SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | EGYPT | PARENTERAL ORDINARY BOTTLES | I. 1*1*500ML BOTTLE | 6/27/25 |
| 104 | NDA/MAL/VDP/12068 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | COXIWIN 2.5% | TOLTRAZURIL | 25 MG/ML | 1. ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED PLOT NO. F1/1, SECTOR - 6B, IIE, SIIDCUL, HARIDWAR-249403, UTTARAKHAND - INDIA INDIA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | I. 1*1*100ML BOTTLE II. 1*1*500ML BOTTLE III. 1*1*1000ML BOTTLE | 6/27/25 |
| 105 | NDA/MAL/VDP/12069 | MEDISEL (KENYA) LIMITED | DAWA LIFESCIENCES (U) LTD | IVEM CL EXTRA | IVERMECTIN + CLOSANTEL SODIUM DIHYDRATE | 10 MG + 100 MG/ML | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED-NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA. | CHINA. | PARENTERAL ORDINARY VIALS | 1*1*250 ML BOTTLE | 6/27/25 |
| 106 | NDA/MAL/VDP/12070 | PHARMA SWEDE EGYPT | KWEWAYO (U) VET PHARMACY LIMITED | LEVAFLUKE | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE | 30 MG + 60 MG/ML | PHARMA SWEDE EGYPT, 10TH OF RAMADAN CITY INDUSTRIAL ZONE B3, EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1*1*50 ML CONTAINER + 1*1*100ML CONTAINER | 6/27/25 |
| 107 | NDA/MAL/VDP/12071 | BOEHRINGER INGELHEIM ANIMAL HEALTH SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | GALLIVAC IBD S706 NEO | LIVE ATTENUATED, AVIAN INFECTIOUS BURSAL DISEASE (GUMBORO DISEASE) VIRUS, STRAIN S706 | 10 ^ 4.0 -10 ^ 5.3 CCID50 | 1. LABORATOIRE PORTE DES ALPES, RUE DE I'AVIATION 69800 SAINT PRIEST - FRANCE LABORATOIRE PORTE DES ALPES, RUE DE I'AVIATION 69800 SAINT PRIEST - FRANCE FRANCE SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | FRANCE | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | I. 1*1*10*5000DOSE BLISTER | 6/27/25 |
| 108 | NDA/MAL/VDP/12072 | MEDISEL (KENYA) LIMITED | DAWA LIFESCIENCES (U) LTD | OXY-T 20 % | OXYTETRACYCLINE HYDROCHLORIDE | 200 MG/G | MEDISEL (KENYA) LIMITED, P.O BOX 540-01000 PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA, KENYA | KENYA | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1*100 G SACHETS | 6/27/25 |
| 109 | NDA/MAL/VDP/12073 | INTERVET SOUTH AFRICA (PTY) LTD. | ERAM UGANDA LIMITED | NOBILIS®MG INAC | INACTIVATED CELLS OF MYCOPLASMA GALLISEPTICUM , STRAIN S6/85 | MORE THAN 0.23 O. D UNITS/DOSE | INTERVET INC., MILLSBORO, 29160 INTERVET LANE, MILLSBORO, DELAWARE USA (MANUFACTURE) + INTERVET INTERNATIONAL, B.V., WIM DE KORYERSTRAAT 35, BOXMEER THE NETHERLANDS (BATCH RELEASE) | UNITED STATES OF AMERICA| NETHERLANDS | EMULSION FOR SUBCUTANEOUS INJECTION | 1*500 ML BOTTLE | 9/5/25 |
| 110 | NDA/MAL/VDP/12074 | INTERVET SOUTH AFRICA (PTY) LTD. | ERAM UGANDA LIMITED | NOBILIS®MG 6/85 | LIVE ATTENUATED MYCOPLASMA GALLISEPTICUM STRAIN 6/85 | MORE THAN 10^6.9 CFU/DOSE | INTERVET INC., MILLSBORO, 29160 INTERVET LANE, MILLSBORO, DELAWARE USA (MANUFACTURE) + INTERVET INTERNATIONAL, B.V., WIM DE KORYERSTRAAT 35, BOXMEER THE NETHERLANDS (BATCH RELEASE) | UNITED STATES OF AMERICA| NETHERLANDS | OPHTHALMIC DRY VIALS | 1*10*1000 DOSES VIAL + 1*10*2000 DOSES VIAL | 9/5/25 |
| 111 | NDA/MAL/VDP/12075 | PITCO INDUSTRY BV | EKAR AGROSCIENCE LTD | PENPIT | PENICILLIN + DIHYDROSTREPTOMYCIN SULFATE | 200000 IU + 200 MG | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, BIAQIAO INDUSTRIAL PARK, RONGCHANG, CHONQING | CHINA. | PARENTERAL ORDINARY VIALS | I. 1*100ML VIAL | 7/1/10 |
| 112 | NDA/MAL/VDP/12128 | ZOETIS INC | VET CENTRE UGANDA LIMITED | POULVAC® PROCERTATM HVT-ND | HERPESVIRUS OF TURKEYS (HVT), STRAIN FC + NEWCASTLE DISEASE VIRUS (NDV: B1 STRAIN) | 2518 PFU/DOSE + 2493 PFU/DOSE | 1. ZOETIS INC 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 - UNITED STATES OF AMERICA UNITED STATES OF AMERICA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | UNITED STATES OF AMERICA | PARENTERAL ORDINARY AMPOULES | I. 1*5*2000DOSE AMPOULE + 1*400ML BAG PRO-CELL DILUENT WITH INFUSION SET | 9/5/25 |
| 113 | NDA/MAL/VDP/1536 | NORBROOK KENYA LTD | NORBROOK (U) LTD | LEVAFAS X-TRA | LEVAMISOLE +OXYCLOZANIDE | 7.5% W/V +15% W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X40.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 7/1/14 |
| 114 | NDA/MAL/VDP/1617 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | EVACIDE | OXYCLOZANIDE + LEVAMISOLE HYDROCHLORIDE | 30MG + 15MG /ML | HEBEI YUANZHENG PHARMACEUTICAL CO., LTD , INDUSTRIAL AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE. P.R. CHINA. | CHINA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X1.0 L CONTAINER | 7/1/13 |
| 115 | NDA/MAL/VDP/1619 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | TRIMOXOL-VET ORAL POWDER | TRIMETHOPRIM+SULFAMETHOXAZOLE | 2.0%W/W+10%W/W | MEDISEL KENYA LTD - , LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X30.0 G SACHET,1.0X100.0 G SACHET | 1/7/15 |
| 116 | NDA/MAL/VDP/1621 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | IVERMECTIN | IVERMECTIN | 1%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY S C VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/13 |
| 117 | NDA/MAL/VDP/1644 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | DIMINAZENE PLUS | DIMINAZENE DIACETURATE + ANTIPYRINE + VITAMIN B12 | 1.05G + 1.31G +1MG/ 2.36G | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | OTHER SYSTEMIC POWDER | 1.0X23.6 G SACHET,1.0X2.36 G SACHET | 7/1/14 |
| 118 | NDA/MAL/VDP/1667 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTRAFER 100 B12 | IRON DEXTRAN + CYANOCOBALAMIN | 100MG + 0.1MG / ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/14 |
| 119 | NDA/MAL/VDP/2443 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | DABENDAZOLE 2.5%W/V | ALBENDAZOLE | 2.5%W/V | MEDISEL KENYA LTD - , LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE,1.0X5000.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 1/7/09 |
| 120 | NDA/MAL/VDP/2520 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | IMIVET | IMIDOCARB DIPROPIONATE | 120MG/ML | INTRACIN PHARMACEUTICALS PVT LTD, C-1, B-53, GIDC ESTATE NADAID-387 001(GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML BOTTLE | 7/1/15 |
| 121 | NDA/MAL/VDP/2550 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | INTERMECTIN SUPER | IVERMECTIN + CLORSULON | 10MG + 100MG | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X500.0 ML BOTTLE | 7/1/14 |
| 122 | NDA/MAL/VDP/2551 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | INTRACOX ORAL | TOLTRAZURIL | 45MG/ML | INTERCHEMIE WERKEN DE ADELAAR, EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAA | ESTONIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 123 | NDA/MAL/VDP/2590 | LAPROVET S.A.S | EVERVICTORY LIMITED | TETRACOLIVIT | OXYTETRACYCLINE+COLISTIN | 10G/100G+7MUI/100G | LABORATOIRES BIOVE SAS, 3 RUE DE LORRAINE, BP 45 62510 ARQUES FRANCE | FRANCE | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1000.0 G CONTAINER,1.0X100.0 G SACHET | 7/1/12 |
| 124 | NDA/MAL/VDP/2623 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | IMOCHEM 120 | IMIDOCARB DIPROPIONATE | 120MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL (STERILE PRODUCT) | 7/1/14 |
| 125 | NDA/MAL/VDP/2839 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | EGOCIN 20 % | OXYTETRACYCLINE | 200MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD., NO. 16, LIUYUAN ROAD, CHANGAN DISTRICT, SHIJIAZHUANG, HEBEI, | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 1/7/11 |
| 126 | NDA/MAL/VDP/2847 | NILE SERVICES LTD | NILE SERVICES LTD | STARMECTIN 1% | IVERMECTIN | 10MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE | 7/1/13 |
| 127 | NDA/MAL/VDP/2866 | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD | EVERVICTORY LIMITED | EVALBEN-2.5 | ALBENDAZOLE | 2.5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L JERRYCAN | 7/1/12 |
| 128 | NDA/MAL/VDP/2871 | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD | EVERVICTORY LIMITED | EVALBEN-10 | ALBENDAZOLE | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L JERRYCAN,1.0X1000.0 ML CONTAINER | 7/1/12 |
| 129 | NDA/MAL/VDP/2881 | NORBROOK KENYA LTD | NORBROOK (U) LTD | DUODIP 50:5 % | CHLORPYRIFOS + CYPERMETHRIN | 50%W/V + 5%W/V | NORBROOK KENYA LIMITED.P.O BOX 1287,00606 OLD LIMURU ROAD KARURI NAIROBI,KENYA(REPACKAGING) | UNITED KINGDOM | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X50.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/13 |
| 130 | NDA/MAL/VDP/4157 | NILE SERVICES LTD | NILE SERVICES LTD | MULTISTAR | VIT( A + D3 + E + B1 + B2 + B6 +B12) + NICOTINAMIDE + PANTOTHENOL | 15000 IU + 1000 IU + 20MG + 10MG + 5MG + 3MG + 50MG + 35MG + 25MG | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/13 |
| 131 | NDA/MAL/VDP/4214 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | IROFLOX | ENROFLOXACIN | 10%W/V | INTRACIN PHARMACEUTICAL PVT LTD , C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIA | INDIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X100.0 ML BOTTLE,1.0X50.0 ML VIAL | 7/1/16 |
| 132 | NDA/MAL/VDP/4240 | NORBROOK KENYA LTD | NORBROOK (U) LTD | ALBAFAS 2.5% | ALBENDAZOLE | 25MG/ML | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 7/1/09 |
| 133 | NDA/MAL/VDP/4258 | VAPCO | GOODMAN INTERNATIONAL LTD | LEVOZAN | LEVAMIZOLE HCL +OXYCLOZANIDE | 30MG/ML+60MG/ML | VAPCO, DHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 7/1/08 |
| 134 | NDA/MAL/VDP/4262 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIDOX-N | DOXYCYCLINE+NEOMYCIN | 100MG+100MG/G | ASHISH LIFE SCIENCE PVT. LTD. ., AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 7/1/13 |
| 135 | NDA/MAL/VDP/4265 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIALBEN 300 | ALBENDAZOLE | 300MG | ASHISH LIFE SCIENCE PVT. LTD, J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X11.0X5.0 BOLUS BLISTER | 7/1/13 |
| 136 | NDA/MAL/VDP/4270 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | MEDMAC VETERINARY PHARMACY | ZANIDE | LEVAMISOLE/OXYCLOZANIDE | 15MG/30MG | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD, AL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITY | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 7/1/14 |
| 137 | NDA/MAL/VDP/4427 | NORBROOK KENYA LTD | NORBROOK (U) LTD | ALBAFAS 10% | ALBENDAZOLE | 10%W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 7/1/08 |
| 138 | NDA/MAL/VDP/4435 | V.M.D.N.V | ERAM UGANDA LIMITED | ENROVETO-20 | ENROFLOXACIN | 200MG/ML | VMD NV HOGE MAUW, -HOGE MUW 900-B2370, ARENDONK | BELGIUM | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/10 |
| 139 | NDA/MAL/VDP/4437 | NORBROOK KENYA | NORBROOK (U) LTD | SYPERTIX 10% EC | ALPHACYPERMETHRIN | 10%W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | TOPICAL EXTERNAL EMULSION GELS | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN | 7/1/09 |
| 140 | NDA/MAL/VDP/4445 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | FASOVERM DS SUSPENSION | OXYCLOZANIDE + LEVAMISOLE HCL + COBALT SULPHATE | 6%W/V + 3%W/V + 0.704%W/V | MEDISEL KENYA LTD - , LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X150.0 ML BOTTLE,1.0X500.0 ML JERRYCAN | 1/7/10 |
| 141 | NDA/MAL/VDP/4449 | COSMOS LTD | ERAM UGANDA LIMITED | COSVITA | MULTIVITAMIN | N/A | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 10.0X30.0 G SACHET | 7/1/10 |
| 142 | NDA/MAL/VDP/4452 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY 20% | OXYTETRACYCLINE HYDROCHLORIDE | 200MG/G | ASHISH LIFE SCIENCE PVT. LTD. ., AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X100.0 G SACHET,1.0X10.0X5.0 G SACHET,1.0X10.0X25.0 G SACHET | 7/1/10 |
| 143 | NDA/MAL/VDP/4453 | PITCO INDUSTRY BV | EKAR AGROSCIENCE LTD | PITMECTIN 1% | IVERMECTIN | 1 %W/V | 1. CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LIMITED NO. 80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*50ML VIAL | 7/1/10 |
| 144 | NDA/MAL/VDP/4459 | PITCO INDUSTRY BV | EKAR AGROSCIENCE LTD | OXYPIT 20% | OXYTETRACYCLINE | 20 %W/V | 1. CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LIMITED NO. 80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*100ML VIAL | 7/1/10 |
| 145 | NDA/MAL/VDP/4471 | PITCO INDUSTRY BV | EKAR AGROSCIENCE LTD | OXYPIT 10% | OXYTETRACYCLINE | 10 %W/V | 1. CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LIMITED NO. 80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | CHINA | PARENTERAL ORDINARY VIALS | I. 1*100ML VIAL II. 1*250ML VIAL | 7/1/10 |
| 146 | NDA/MAL/VDP/4476 | VMD NV HOGE MAUW | ERAM UGANDA LIMITED | DOXYVET-50S | DOXYCYCLINE | 500MG/G | VMD NV HOGE MAUW, HOGE MUW 900, 2370, ARENDONK | BELGIUM | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G BOTTLE,1.0X1.0 KG JAR | 7/1/05 |
| 147 | NDA/MAL/VDP/4478 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIALBEN 10% | ALBENDAZOLE | 500MG/5ML | ASHISH LIFE SCIENCE PVT. LIMITED, J-137, MIDC, TARAPUR, BOISAR, THANE 401 501, MAHARASTRA INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X250.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/13 |
| 148 | NDA/MAL/VDP/4479 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZ-PENSTREPTO 20/20 SUSPENSION | PENICILLIN G/DIHYDROSTREPTOMYCIN SUPHATE | 200MG/ML+200MG/ML | HEBEI YUANZHENG PHARM.CO.LTD, NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/12 |
| 149 | NDA/MAL/VDP/4502 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY CHICK FORMULA | OXYTETRACYCLINE+ VIT A+ D3 + E + K3 + B2 +B12 + CALCIUM + NICOTINAMIDE | 6G + 0.4G +0.09MG +0.147MG 72MG + 260MG +200MCG + 465MG +1.2MG | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X25.0 G SACHET, 1.0X10.0X100.0 G SACHET,1.0X10.0X25.0 G SACHET, 1.0X1.0 KG JAR | 7/1/12 |
| 150 | NDA/MAL/VDP/4649 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | TOLTRACOX | TOLTRAZURIL | 50MG/ML | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X15.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 7/1/14 |
| 151 | NDA/MAL/VDP/4653 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ALBECTIN | ALBENDAZOLE+IVERMECTIN | 3000MG+100MG | ASHISH LIFE SCIENCE PVT. LTD, J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X1.0 BOLUS BLISTER | 7/1/14 |
| 152 | NDA/MAL/VDP/4659 | INTRACINE PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | I- TIN | IVERMECTIN | 1% W/V | INTRACIN PHARMACEUTICAL PVT LTD , C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/14 |
| 153 | NDA/MAL/VDP/4664 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | IMOLY 10% | OXYTETRACYCLINE | 10% W/V | INTRACIN PHARMACEUTICAL PVT. LTD, C-1 B/53, G.I.D.C ESTATE, NADIAD-387001 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/14 |
| 154 | NDA/MAL/VDP/4667 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | PHENYLJECT | PHENYLBUTAZONE | 200MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 155 | NDA/MAL/VDP/4668 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | OXYNAL 20 LA | OXYTETRACYCLINE | 200MG/ML | HEBEI YUANZHENG PHARMACEUTICAL COMPANY LIMITED - NO.16 LIUYUAN ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, PEOPLE’S REPUBLIC OF CHINA | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/14 |
| 156 | NDA/MAL/VDP/4673 | NILE SERVICES LTD | NILE SERVICES LTD | DIMINASTAR | DIMINAZENE DIACETURATE | 1.05G | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X2.36 G SACHET,1.0X10.0X23.6 G SACHET | 7/1/14 |
| 157 | NDA/MAL/VDP/4676 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | INTERMECTIN | IVERMECTIN | 10MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X50.0 ML VIAL | 7/1/14 |
| 158 | NDA/MAL/VDP/4689 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | GENTA 100 | GENTAMYCIN | 100MG/ ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 159 | NDA/MAL/VDP/4691 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | INTERFLOX ORAL | ENROFLOXACIN | 100MG/ML | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, HOLLAND | ESTONIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE | 7/1/14 |
| 160 | NDA/MAL/VDP/4699 | NILE SERVICES LTD | NILE SERVICES LTD | TETRASTAR 130 | OXYTETRACYCLINE | 13%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 7/1/14 |
| 161 | NDA/MAL/VDP/5637 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | DASCARNIL WORM POWDER | PIPERAZINE CITRATE B.P | 0.35G/G | MEDISEL KENYA LTD - , LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 5.0X30.0 G SACHET,1.0X100.0 G SACHET | 1/8/13 |
| 162 | NDA/MAL/VDP/5645 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVACIDE POULTRY | LEVAMISOLE HYDROCHLORIDE | 7.5%W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 7/1/98 |
| 163 | NDA/MAL/VDP/5646 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVACIDE WORM DRENCH | LEVAMISOLE HYDROCHLORIDE | 15MG/ML | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L JERRYCAN,1.0X2.5 L JERRYCAN,1.0X5.0 L JERRYCAN,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 7/1/97 |
| 164 | NDA/MAL/VDP/5649 | NILE SERVICES LTD | NILE SERVICES LTD | ALBENDASTAR 10% | ALBENDAZOLE | 10%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | NON-HUMAN USE LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L JERRYCAN | 7/1/13 |
| 165 | NDA/MAL/VDP/5651 | NILE SERVICES LTD | NILE SERVICES LTD | ALBENDASTAR 2.5% | ALBENDAZOLE | 25MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L JERRYCAN | 7/1/14 |
| 166 | NDA/MAL/VDP/5652 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVAFAS DIAMOND | LEVAMISOLE+OXYCLOZANIDE | 30G+60G | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X5.0 L JERRYCAN,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/97 |
| 167 | NDA/MAL/VDP/5653 | VAPCO | GOODMAN INTERNATIONAL LTD | PIROPLASMIN | DIMINAZENE ACETURATE + ANTIPYRINE + VITAMIN B12 | 75 MG + 250 MG + 0.04 MCG | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD), DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/13 |
| 168 | NDA/MAL/VDP/5654 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVAFAS FLUKE & WORM DRENCH | LEVAMISOLE HCL+OXYCLOZANIDE | 15G+30G | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 7/1/97 |
| 169 | NDA/MAL/VDP/5657 | COSMOS LTD | ERAM UGANDA LIMITED | POLTRICIN CHICK FORMU | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 5.0X25.0 G SACHET | 7/1/98 |
| 170 | NDA/MAL/VDP/5659 | COSMOS LTD | ERAM UGANDA LIMITED | POLTRICIN MAYAI FORMULA | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 5.0X25.0 G SACHET | 7/1/98 |
| 171 | NDA/MAL/VDP/5660 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID 150 TABLETS | LEVAMISOLE HYDROCHLORIDE | 150MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 7/1/97 |
| 172 | NDA/MAL/VDP/5661 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | ALBENOL-100 ORAL | ALBENDAZOLE | 100MG/ML | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 7/1/04 |
| 173 | NDA/MAL/VDP/5662 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID 1G BOLUS | LEVAMISOLE HYDROCHLORIDE | 1G | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X30.0 BOLUS CARTON | 7/1/97 |
| 174 | NDA/MAL/VDP/5663 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID LIQUID DEWORMER | LEVAMISOLE HYDROCHLORIDE | 1.5W/V | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE, 1.0X5.0L BOTTLE | 7/1/97 |
| 175 | NDA/MAL/VDP/5665 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID PLUS-O | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE+CALCIUM SULFATE | 1.5W/V+3%W/V+0.382%W/V | MEDISEL (K) LTD, PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA| COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 7/1/04 |
| 176 | NDA/MAL/VDP/5668 | COSMOS LTD | ERAM UGANDA LIMITED | WORMITA SUSPENSION | ALBENDAZOLE | 2.5%W/V | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/97 |
| 177 | NDA/MAL/VDP/5670 | COSMOS LTD | ERAM UGANDA LIMITED | WORMITA-150 TABLETS | ALBENDAZOLE | 150MG | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 7/1/97 |
| 178 | NDA/MAL/VDP/5676 | VMD NV | ERAM UGANDA LIMITED | DIAZIPRIM 48% | SULPHADIAZINE + TRIMETHOPRIM | 400 MG + 80 MG | VMD NV HOGE MAUW, HOGE MUW 900, 2370, ARENDONK | BELGIUM | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 7/1/00 |
| 179 | NDA/MAL/VDP/5677 | LABORATOIRES LAPROVET | EVERVICTORY LIMITED | LEVALAP | LEVAMISOLE | 20%W/W | LABORATOIRES BIOVE , 3 RUE DE LORRAINE BP 45 62510 ARQUES | FRANCE | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X10.0X100.0 G SACHET,1.0X1000.0 G SACHET | 7/1/14 |
| 180 | NDA/MAL/VDP/5680 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | LEVAMISOLE | LEVAMISOLE | 75MG/ML | HEBEI YUANZHENG PHARMACEUTICALS COMPANY, NO.16 LIUYUAN ROAD CHANG€™AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/12 |
| 181 | NDA/MAL/VDP/5681 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | LEVAMISOLE | LEVAMISOLE | 100MG/ML | HEBEI YUANZHENG PHARMACEUTICALS COMPANY, NO.16 LIUYUAN ROAD CHANG€™AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/12 |
| 182 | NDA/MAL/VDP/5682 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | DIMINACIN | DIMINAZENE ACETERATE | 7%W/V | INTRACIN PHARMACEUTICAL PVT. LTD, C-1 B/53, G.I.D.C ESTATE, NADIAD-387001 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/14 |
| 183 | NDA/MAL/VDP/5688 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | LIMOXIN-200 LA | OXYTETRACYCLINE | 200MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 184 | NDA/MAL/VDP/5690 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | MACROLAN-200 | TYLOSIN | 200MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 185 | NDA/MAL/VDP/5692 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | MACROLAN WS | TYLOSIN TARTRATE | 1000MG | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 7/1/15 |
| 186 | NDA/MAL/VDP/5695 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | DIMINAZENE DIACETURATE | DIMINAZENE DIACETURATE | 2.36G/ SACHET, 23.6G/ SACHET | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | OTHER SYSTEMIC POWDER | 10.0X2.36 G SACHET | 7/1/14 |
| 187 | NDA/MAL/VDP/5701 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | DIPEN | DIHYDROSTREPTOMYCIN/ BENZYL PENICILLIN | 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | SHANGHAI GONGYI PHARMACEUTICAL COMPANY LIMITED - NO. 298 HUANCHENG EAST ROAD FENGXIAN TOWN SHANGHAI - CHINA | CHINA | NON-HUMAN USE LIQUIDS | 1.0X50.0 ML BOTTLE, 1.0X100.0 ML BOTTLE, 1.0X250.0 ML BOTTLE | 7/1/97 |
| 188 | NDA/MAL/VDP/5702 | COSMOS LTD | ERAM UGANDA LIMITED | DISEPTOPRIM BOLUS | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X10.0 TABLET STRIP | 7/1/97 |
| 189 | NDA/MAL/VDP/5705 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | PIPERIN WS | PIPERAZINE CITRATE | 1000MG | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X30.0 G SACHET,1.0X1.0 KG JAR | 7/1/15 |
| 190 | NDA/MAL/VDP/5706 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | DOXIN 200 WS | DOXYCYCLINE HYCLATE+TYLOSIN TARTRATE | 100MG+100MG | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, ˆŠ HOLLAND | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER,1.0X30.0 G SACHET | 7/1/15 |
| 191 | NDA/MAL/VDP/5719 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | TYLOVAP | TYLOSIN | 200MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD), DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/13 |
| 192 | NDA/MAL/VDP/5722 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCODIMIDINE | SULPHADIMIDINE | 33%W/V | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD), DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/13 |
| 193 | NDA/MAL/VDP/5726 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | DUOTECH DRENCH | OXFENDAZOLE+CLOSANTEL | 25MG/ML + 50MG/ML | NORBROOK LABERATORIES LTD , OLD LIMURU RD NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5000.0 ML CONTAINER,1.0X60.0 ML CONTAINER | 7/1/05 |
| 194 | NDA/MAL/VDP/5727 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOZIN | AMITRAZ | 125MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD), DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/14 |
| 195 | NDA/MAL/VDP/5730 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAZURIL | TOLTRAZURIL | 2.5%W/V | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD), DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN | 7/1/13 |
| 196 | NDA/MAL/VDP/5733 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | ENDOSPEC 10% | ALBENDAZOLE | 100MG/ML | MEDISEL (K) LTD-PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 7/1/97 |
| 197 | NDA/MAL/VDP/5734 | VAPCO | GOODMAN INTERNATIONAL LTD | ENROSOL-S | ENROFLOXACIN | 10%W/V | VAPCO, DHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X500.0 ML JAR | 7/1/05 |
| 198 | NDA/MAL/VDP/5738 | VAPCO | GOODMAN INTERNATIONAL LTD | ERYTHROMYCIN THIOCYANATE | ERYTHROMYCIN THIOCYANATE | 20%W/W | VAPCO, DHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 7/1/09 |
| 199 | NDA/MAL/VDP/5749 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | TETROXY CHICK FORMULA | MULTI-VITAMIN | MULTI-INGREDIENT | CHONGQING FANTONG ANIMAL PHARMACEUTICAL COMPANY LIMITED-NO. 80, EAST PART OF CHANGZHOU ROAD, RONGCHANG, CHONGQING - CHINA. | IRELAND | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X120.0 G SACHET | 7/1/97 |
| 200 | NDA/MAL/VDP/5750 | NILE SERVICES LTD | NILE SERVICES LTD | PENSTAR | PENICILLIN G PROCAINE + DIHYDROSTREPTOMYCIN SULPHATE | 200,000IU/ML + 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/13 |
| 201 | NDA/MAL/VDP/5751 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | TETROXY EGG FORMULA | MULTI-VITAMIN | MULTI-INGREDIENT | CHONGQING FANTONG ANIMAL PHARMACEUTICAL COMPANY LIMITED-NO. 80, EAST PART OF CHANGZHOU ROAD, RONGCHANG, CHONGQING - CHINA. | IRELAND | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X120.0 G SACHET | 7/1/97 |
| 202 | NDA/MAL/VDP/5752 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | TETROXY INJECTION | OXYTETRACYCLINE HYDROCHLORIDE | 100MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHONGOING FANGTONG ANIMAL PHARMACEUTICALS CO. LTDBANQIAO INDUSTRIAL PARK, RONGCHANG, CHONGOING, CHINA | | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 7/1/97 |
| 203 | NDA/MAL/VDP/5753 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | PEN & STREP | DIHYDROSTREPTOMYCIN SULPHATE + PROCAINE PENICILLIN BP | 250MG + 200MG | NORBROOK LABARATORIES LIMITED, STAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UK | UNITED KINGDOM | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/97 |
| 204 | NDA/MAL/VDP/5754 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | ALISERYL WS | ERYTHROMYCIN + OXYTETRACYCLINE +STREPTOMYCIN + COLISTIN + VITAMINS (A + D3 + B1 + B2 + B6 + B12 + C) + CALCIUM + VIT K3 + NICOTINAMIDE + INOSITOL | 35MG +50MG + 35MG + 200 0001U + 3000 IU + 1500 IU + 2MG + 2MG + 4MG + 2MG + 10MCG + 20MG + 10MG + 2MG + 20MG +1MG | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V - , METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X30.0 G SACHET,1.0X1.0 KG JAR | 7/1/15 |
| 205 | NDA/MAL/VDP/5755 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | TETROXY LA | OXYTETRACYCLINE HYDROCHLORIDE | 200MG/ML | CHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 7/1/97 |
| 206 | NDA/MAL/VDP/5756 | INTRACIN PHARMACEUTICAL PVT LTDˆŠ | VEERAM HEALTHCARE (U) LIMITED | PAVEX | PARVAQUONE | 150MG/ML | INTRACIN PHARMACEUTICALS PVT LTD, C-1, B-53, GIDC ESTATE NADAID-387 001(GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 7/1/15 |
| 207 | NDA/MAL/VDP/5757 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | EVACIDE PLUS | OXYCLOZANIDE + LEVAMISOLE HYDROCHLORIDE | 60MG + 30MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/13 |
| 208 | NDA/MAL/VDP/5761 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | PARVEXON INJECTION | PARVAQUONE | 150MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY COMPANY LIMITED 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/97 |
| 209 | NDA/MAL/VDP/5763 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | PARVEXON PLUS | PARVAQUONE + FRUSEMIDE | 150MG + 55MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY COMPANY LIMITED 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/00 |
| 210 | NDA/MAL/VDP/5776 | VAPCO | GOODMAN INTERNATIONAL LTD | OXYVITAMIN | OXYTETRACYCLINE HCL+VIT A+VIT D3+VIT E+VIT C+FERROUS SO4+MAGNESIUM SO4+ZINC SO4+COPPER SO4+COBALT CH | 250G+2,500,000IU+500,000IU+1,000IU+10,000MG+500MG+400MG+150MG+40MG+10MG / 1000G | VAPCO, DHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G SACHET | 7/1/07 |
| 211 | NDA/MAL/VDP/5777 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | FLUCONIX 340 | NITROXINIL | 340MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/14 |
| 212 | NDA/MAL/VDP/5778 | VMD NV | ERAM UGANDA LIMITED | OXYVETO 50 S POWDER | OXYTETRACYCLINE HCL | 500MG/G | VMD NV, HOGE MAUW 900-B2370, ARENDOK | BELGIUM | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G SACHET | 7/1/00 |
| 213 | NDA/MAL/VDP/5779 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | AMIDIOSTAT-PLUS | AMPROLIUM HCL +SULFAQUINOXALINE SODIUM + VITAMIN K3 + VITAMIN A | 200MG +150MG +5MG + 15000 IU/ G | MEDISEL KENYA LTD - , LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | KENYA | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X30.0 G SACHET | 1/9/15 |
| 214 | NDA/MAL/VDP/5784 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZ-PENSTREPTO 20/25 SUSPENSION | PENICILLIN G/DIHYDROSTREPTOMYCIN | 200MG/ML+250MG/ML | HEBEI YUANZHENG PHARMACEUTICALS COMPANY, NO.16 LIUYUAN ROAD CHANG€™AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/11 |
| 215 | NDA/MAL/VDP/5789 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | OXYTOCIN-10 | OXYTOCIN | 10 IU/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 7/1/14 |
| 216 | NDA/MAL/VDP/5791 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | AMPROCOX WS | AMPROLIUM HYDROCHLORIDE + SULFAQUINOXALINE + VITAMIN A + VITAMIN K3 | 200MG +150MG +15 000 IU + 5MG | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G SACHET | 7/1/15 |
| 217 | NDA/MAL/VDP/5793 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 30% | OXYTETRACYCLINE HCL | 30%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/09 |
| 218 | NDA/MAL/VDP/5795 | VAPCO | GOODMAN INTERNATIONAL LTD | OXYTETRACYCLINE | OXYTETRACYCLINE | 25%W/W | VAPCO -, DHULIEIL PROVINCE, KING HUSSEIN STREET NO. IT 1 IZARKA, JORDAN | JORDAN | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 7/1/09 |
| 219 | NDA/MAL/VDP/5796 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 20% | OXYTETRACYCLINE DIHYDRATE | 20%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/09 |
| 220 | NDA/MAL/VDP/5797 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 12.5% | OXYTETRACYCLINE HCL | 12.5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/09 |
| 221 | NDA/MAL/VDP/5800 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 10% | OXYTETRACYCLINE HCL | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 7/1/09 |
| 222 | NDA/MAL/VDP/5811 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | AMPROLIN-300 WS | AMPROLIUM | 30%W/W | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V - , METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1.0 KG JAR | 7/1/04 |
| 223 | NDA/MAL/VDP/5813 | VMD NV | ERAM UGANDA LIMITED | AMPROLIUM-20S | AMPROLIUM HYDROCHLORIDE | 200MG/G | VMD NV, HOGE MAUW 900-B2370, ARENDOK | BELGIUM | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 7/1/00 |
| 224 | NDA/MAL/VDP/5815 | LABORATORIES HIPRA SA | LUNADKA UGANDA LIMITED | GENTAMOX | AMOXYCILLIN + GENTAMICIN | 150 MG + 40 MG | LABORATORIES HIPRA SA, AVDA LASELVA 135-17170, AME | SPAIN | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 7/1/97 |
| 225 | NDA/MAL/VDP/5818 | NILE SERVICES LTD | NILE SERVICES LTD | OXYSTAR 10% | OXYTETRACYCLINE | 100MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/13 |
| 226 | NDA/MAL/VDP/5820 | NILE SERVICES LTD | NILE SERVICES LTD | OXYSTAR 20% | OXYTETRACYCLINE | 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/13 |
| 227 | NDA/MAL/VDP/5827 | LAPROVET S.A.S | EVERVICTORY LIMITED | ANTICOX | SULFADIMIDINE SODIUM + DIAVERIDINE | 80%W/W + 8%W/W | BIOVE LABORATORY, 3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCE | FRANCE | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X30.0 G SACHET,1.0X10.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 7/1/13 |
| 228 | NDA/MAL/VDP/5830 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | GLUCORTIN 20 | DEXAMETHASONE | 2MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 7/1/14 |
| 229 | NDA/MAL/VDP/5831 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASAMPRO | AMPROLIUM | 20%W/W | ASHISH LIFE SCIENCE PVT. LTD, J-137, MIDC,TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 7/1/11 |
| 230 | NDA/MAL/VDP/5832 | COSMOS LTD | ERAM UGANDA LIMITED | ASCAREX WORM POWDER | PIPERAZINE CITRATE | 360MG/G | COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X30.0 G SACHET, 1.0X250.0G SACHET, 1.0X100.0G SACHET | 7/1/97 |
| 231 | NDA/MAL/VDP/5833 | COSMOS LTD | ERAM UGANDA LIMITED | ASCATEN-P | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 10.0X6.0 TABLET BLISTER | 7/1/01 |
| 232 | NDA/MAL/VDP/5834 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | ASCAZINE | PIPERAZINE CITRATE | 360MG/G | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) , KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDAN | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1000.0 G SACHET,1.0X100.0 G SACHET | 7/1/07 |
| 233 | NDA/MAL/VDP/5835 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIALBEN 2500 | ALBENDAZOLE | 2500MG | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 TABLET BLISTER | 7/1/11 |
| 234 | NDA/MAL/VDP/5837 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | GRENADE EC | CYHALOTHRIN | 5%W/V | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 7/1/97 |
| 235 | NDA/MAL/VDP/5846 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIENRO 10% | ENROFLOXACIN | 100MG/ML | ASHISH LIFE SCIENCE PVT. LTD, J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/15 |
| 236 | NDA/MAL/VDP/5849 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NOROMECTIN INJECTION | IVERMECTIN | 1%W/V | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL,1.0X20.0 ML VIAL | 7/1/00 |
| 237 | NDA/MAL/VDP/5851 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NOROTRAZ | AMITRAZ | 12.5%W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X1.0 L JERRYCAN | 7/1/97 |
| 238 | NDA/MAL/VDP/5863 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NORODINE 24 | SULFADIAZINE + TRIMETHOPRIM | 200MG + 40MG | NORBROOK LABARATORIES LIMITED, STAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UK | UNITED KINGDOM | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/97 |
| 239 | NDA/MAL/VDP/5865 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHPIRAZINE | PIPERAZINE CITRATE | 1000MG/G | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 7/1/15 |
| 240 | NDA/MAL/VDP/5873 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NORBROOK MILKING SALVE | DICHLOREPHEN/LANOLIN | 0.55%W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X250.0 G CONTAINER,1.0X100.0 G CONTAINER,1.0X500.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X2.0 KG CONTAINER | 7/1/98 |
| 241 | NDA/MAL/VDP/5874 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHTYL | TYLOSIN | 20%W/W | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1.0 KG CONTAINER,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 7/1/13 |
| 242 | NDA/MAL/VDP/5877 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | NITRODOX | NITROXINIL METHYL GLUCAMINE | 34%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY SC VIALS | 1*100ML BOTTLE | 7/1/14 |
| 243 | NDA/MAL/VDP/5878 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | NILZASH S FORTE | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE | 30MG/ML+60MG/ML | ASHISH LIFE SCIENCE PVT. LTD, J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X1000.0 ML BOTTLE, 1.0X250.0 ML BOTTLE | 7/1/15 |
| 244 | NDA/MAL/VDP/5879 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHULPHA 5 | SULPHADIMIDINE | 5G | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 BOLUS BLISTER | 7/1/14 |
| 245 | NDA/MAL/VDP/5880 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | NILZAN BOLUS | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE | 1G + 1.4G | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X20.0X1.0 TABLET STRIP | 7/1/97 |
| 246 | NDA/MAL/VDP/5881 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASTRISUL 480 | SULPHADIAZINE+TRIMETHOPRIM | 400MG+80MG | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 7/1/13 |
| 247 | NDA/MAL/VDP/5882 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | NILZAN PLUS | LEVAMISOLE HYDROCHLORIDE+ OXYCLOZANIDE | 15MG+30MG | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X150.0 ML BOTTLE | 7/1/97 |
| 248 | NDA/MAL/VDP/5884 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | MULTIVITAMIN INJECTION | VIT A + VIT B2 +VIT B6 + VIT B12 +VIT D3 | 15,000 IU + 10MG +3MG +60 MCG + 7500 IU | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X250.0 ML VIAL | 7/1/13 |
| 249 | NDA/MAL/VDP/5885 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTERTRIM | SULFAMETHOXAZOLE + TRIMETHOPRIM | 200MG + 40MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 250 | NDA/MAL/VDP/5886 | LABORATORIOS HIPRA S.A | LUNADKA UGANDA LIMITED | AVISAN SECURE | INACTIVATED SALMONELLA ENTERITIDIS PT-4 FAGOTYPE MAT + INACTIVATED SALMONELLA TYPHIMURIUM, DT-4 FAGOTYPE MAT | INACTIVATED SALMONELLA ENTERITIDIS ≥ 1/13 + INACTIVATED SALMONELLA TYPHIMURIUM ≥ 1/40 | LABORATORIOS HIPRA, S.A, AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL | 7/1/15 |
| 251 | NDA/MAL/VDP/5887 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | MULTIVITAMIN INJECTION | VITAMIN A + B1 + B2 +B6 +B12 + D3 + E + DEXPANTHENOL + FOLIC | 15,000 IU + 10MG + 5MG +3MG + 25MCG + 1000IU +20MG + 25MG | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/13 |
| 252 | NDA/MAL/VDP/5889 | NILE SERVICES LTD | NILE SERVICES LTD | BACLEAN | SULFAMONOMETHOXINE SODIUM + TRIMETHOPRIM | 50MG +10MG /ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 7/1/15 |
| 253 | NDA/MAL/VDP/5891 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | MURTRYP 1050 | DIMINAZENE DIACETURATE + PHENAZONE | 1.05G + 1.31G /2.36G | ASHISH LIFE SCIENCE PVT. LTD., AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | NON-HUMAN USE POWDERS | 1.0X23.6 G SACHET,1.0X10.0X23.6 G SACHET | 7/1/13 |
| 254 | NDA/MAL/VDP/5896 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | INTRADINE POULTRY | SULPHADIMIDINE SODIUM | 33.3%W/V | NORBROOK LABERATORIES LTD , OLD LIMURU RD NAIROBI | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 7/1/98 |
| 255 | NDA/MAL/VDP/5898 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | MULTIVITAMIN INJECTION | MULTIVITAMIN | MULTI-INGREDIENT | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 7/1/97 |
| 256 | NDA/MAL/VDP/5900 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | OPTICLOX EYE OINTMENT | CLOXACILLIN BENZATHINE | 835MG/5G | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | NON-HUMAN USE PASTES | 1.0X5.0 G PRE- FILLED SYRINGE | 7/1/97 |
| 257 | NDA/MAL/VDP/5904 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTROVIT A+ WS | VITAMINS A + D3 + E + B1 + B2 + B6 + B12 +C) + CA + VIT K3 + NICOTINAMIDE + FOLATE + BIOTIN + CL + FESO4 +MNSO4 + ZNSO4 + NACL | 20000 IU + 6000 IU + 60MG + 6MG +12MG +8MG +60 MCG + 20MG + 20MG +4MG + 80MG +2MG + 300MCG + 5MG + 12MG + 12MG +12MG + 12MG + 100MG | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, ˆŠ HOLLAND | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 SACHET CARTON | 7/1/15 |
| 258 | NDA/MAL/VDP/5910 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | BETAMOX | AMOXICILLIN TRIHYDRATE | 150 MG/ML | 1. NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, NEWRY, BT35 6JP - NORTHERN IRELAND NORTHERN IRELAND SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | IRELAND | PARENTERAL ORDINARY VIALS | I. 1*100ML VIAL | 7/1/05 |
| 259 | NDA/MAL/VDP/5912 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | BETAMOX LA | AMOXYCILLIN TRIHYDRATE | 150MG/ML | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/07 |
| 260 | NDA/MAL/VDP/5913 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | BILOSIN | TYLOSIN TARTRATE | 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD, BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING| HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITED, NO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/16 |
| 261 | NDA/MAL/VDP/5916 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | BIMECTIN DS | IVERMECTIN | 2%W/W | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD, BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | CHINA | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML BOTTLE | 7/1/16 |
| 262 | NDA/MAL/VDP/5917 | BIMEDA UGANDA LIMITED | BIMEDA UGANDA LIMITED | BIMECTIN INJECTION | IVERMECTIN | 10MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | CHINA | PARENTERAL ORDINARY S C VIALS | 1.0X500.0 ML VIAL, 1.0X50.0 ML VIAL, 1.0X20.0 ML VIAL, .0X100.0 ML VIAL | 7/1/98 |
| 263 | NDA/MAL/VDP/5918 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | BIMECTIN PLUS | IVERMECTIN+CLORSULON | 10MG/ML+100MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD, BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | CHINA | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML VIAL | 7/1/14 |
| 264 | NDA/MAL/VDP/5920 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | BIOGENTA | AMOXYCILLIN TRIHYDRATE + GENTAMYCIN SULPHATE | 150MG + 40MG/ ML | INTERCHEMIE WERKEN DE ADELAAR , EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAA | ESTONIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/14 |
| 265 | NDA/MAL/VDP/5931 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | TRYPASHISH | ISOMETAMIDIUM HYDROCHLORIDE | 1G/SACHET | ASHISH LIFE SCIENCE PVT. LIMITED. , J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X1.0 G SACHET,1.0X10.0X125.0 MG SACHET | 7/1/13 |
| 266 | NDA/MAL/VDP/5932 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | MULTIJECT IMM | NEOMYCIN SULPHATE + PREDNISOLONE PROCAINE PENICILLIN G MONOHYDRATE | 20MG + 2MG | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X5.0 G PRE- FILLED SYRINGE | 7/1/97 |
| 267 | NDA/MAL/VDP/5938 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | LEVA 200 | LEVAMISOLE HYDROCHLORIDE | 200MG | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, ˆŠ HOLLAND | NETHERLANDS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 7/1/15 |
| 268 | NDA/MAL/VDP/5941 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVACIDE INJECTION | LEVAMISOLE HYDROCHLORIDE | 75MG/ML | NORBROOK LABERATORIES LTD , STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOM | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/97 |
| 269 | NDA/MAL/VDP/5942 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | NEMOVIT WS (EGG FORMULA) | OXYTETRACYCLINE + NEOMYCIN + VITAMINS( A + D3 + E + B1 + B2 + B6 + B12 +C) + CALCIUM + VIT K3 + NICOTINAMIDE + FOLATE + METHIONINE + LYSINE | 60MG + 40MG + 7500 I.U + 1500I.U + 5MG + 1MG + 2MG + 7.5MCG + 25MG + 7.5MG + 5MG + 15MG + 30MG +0.3MG +30MG +50MG | INTERCHEMIE WERKENS DE ADELAAR B.V, METAALWEG 8, 5804 VENARY, NETHERLANDS | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G JAR, 1.0X30.0 G SACHET | 7/1/15 |
| 270 | NDA/MAL/VDP/5954 | MATUGGA INDUSTRIES AND LOGISTICS | MATUGGA INDUSTRIES AND LOGISTICS | VETPEN 20/25 | PROCAINE PENICILLIN/DIHYDROSTREPTOMYCIN | 200000 I.U/250000 I.U | SHANGHAI GONGYIN VETERINARY MEDICINES PLANT - NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/11 |
| 271 | NDA/MAL/VDP/5955 | MATUGGA INDUSTRIES AND LOGISTICS HUB LTD | MATUGGA INDUSTRIES AND LOGISTICS HUB LTD | VETMYCIN 20% | OXYTETRACYCLINE | 200.0 MG/ML | SHANGHAI GONGYIN VETERINARY MEDICINES PLANT - NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINA | CHINA | PARENTERAL ORDINARY VIALS | I. 1*100ML VIAL II. 1*250ML VIAL | 7/1/10 |
| 272 | NDA/MAL/VDP/5959 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | BOVACLOX DC | AMPICILLIN + CLOXACILLIN | 250 MG + 500 MG | NORBROOK LABARATORIES LIMITED, STAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UK | IRELAND | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X4.5 G PRE- FILLED SYRINGE | 7/1/97 |
| 273 | NDA/MAL/VDP/5961 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | BUPACIN | BUPARVAQUONE | 50MG/ML | INTRACIN PHARMACEUTICAL PVT LTD , C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE | 7/1/14 |
| 274 | NDA/MAL/VDP/5962 | INTERVET SA (PTY) LTD | ERAM UGANDA LIMITED | TAKTIC | AMITRAZ | 125G/L | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X20.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X40.0 ML BOTTLE,1.0X500.0 ML JAR | 7/1/97 |
| 275 | NDA/MAL/VDP/5965 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | BUPALEX | BUPARVAQUONE | 50MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD., NO. 16, LIUYUAN ROAD, CHANGAN DISTRICT, SHIJIAZHUANG, HEBEI, | CHINA | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML VIAL | 7/1/13 |
| 276 | NDA/MAL/VDP/5966 | UNIVET LTD | BIMEDA UGANDA LIMITED | TEREXINE | CEPHALEXIN+KANAMYCIN | 200MG+10000I.U | UNIVET LTD, TULLYVIN, COOTEHILL, COUNTY CAVAN, IRELAND. | IRELAND | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0 G PRE- FILLED SYRINGE | 7/1/97 |
| 277 | NDA/MAL/VDP/5967 | NORBROOK KENYA LTD | NORBROOK (U) LTD | BUPANOR INJECTION | BUPARVAQUONE | 50MG/ML | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL,1.0X50.0 ML BOTTLE | 7/1/14 |
| 278 | NDA/MAL/VDP/5968 | UNIVET LTD | BIMEDA UGANDA LIMITED | TRAMAZOLE | ALBENDAZOLE | 10%W/V | MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | | IRELAND | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X2.5 L JERRYCAN,1.0X120.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 7/1/00 |
| 279 | NDA/MAL/VDP/5969 | BIMEDA CHEMICAL EXPORTS LTD | BIMEDA UGANDA LIMITED | BUPARVEX | BUPARVAQUONE | 50MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | | BULGARIA| CHINA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 7/1/05 |
| 280 | NDA/MAL/VDP/5970 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | BUTACHEM-50 | BUPARVAQUONE | 50MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI AS, VANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 2.0X50.0 ML VIAL,1.0X20.0 ML VIAL (STERILE PRODUCT) | 7/1/11 |
| 281 | NDA/MAL/VDP/5974 | ZOETIS BELGIUM SA | ERAM UGANDA LIMITED | SUPONA EXTRA | CHLORPHENVINPHOS | 1000G | ZOETIS MANUFACTURING ITALIA S.R.L, VIA F. GORGONE, SNC., 95121, CATANIA | ITALY | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/97 |
| 282 | NDA/MAL/VDP/5977 | NILE SERVICES LTD | NILE SERVICES LTD | BUTARSTAR | BUPARVAQUONE | 50 MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X30.0 ML VIAL,1.0X20.0 ML VIAL | 7/1/13 |
| 283 | NDA/MAL/VDP/5982 | ZOETIS BELGIUM SA | ERAM UGANDA LIMITED | PROTAID | CHLORFENVINPHOS+ALPHACYPERMETHRIN | 30%W/V+3%W/V | ZOETIS MANUFACTURING ITALIA S.R.L.,, VIA FRANCO GORGONE S.N.C., 95121 CATANIA, ITALY | ITALY | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/04 |
| 284 | NDA/MAL/VDP/5983 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | CALCIJECT | BORIC ACID+CALCIUM GLUBIONATE | 6.84G+33.3G | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X400.0 ML BOTTLE | 7/1/97 |
| 285 | NDA/MAL/VDP/5986 | COSMOS LTD | ERAM UGANDA LIMITED | S-DIME 16% SOLUTION | SULPHADIMIDINE | 16%W/V | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/97 |
| 286 | NDA/MAL/VDP/5987 | COSMOS LTD | ERAM UGANDA LIMITED | S-DIME 5G BOLUS | SULPHADIMIDINE | 5G | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 BOLUS BLISTER,1.0X10.0 BOLUS BLISTER | 7/1/97 |
| 287 | NDA/MAL/VDP/5994 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | CEFTIONEL 50 | CEFTIOFUR | 50MG/ML | INTERCHEMIE WERKEN DE ADELAAR , EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAA | ESTONIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/14 |
| 288 | NDA/MAL/VDP/5998 | VAPCO | GOODMAN INTERNATIONAL LTD | CHOLIVIT-AM | MULTI-INGREDIENT | N/A | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) , DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G CONTAINER,1.0X5.0 KG CONTAINER | 7/1/08 |
| 289 | NDA/MAL/VDP/6001 | MATUGGA INDUSTRIES AND LOGISTICS HUB LTD | MATUGGA INDUSTRIES AND LOGISTICS HUB LTD | VETMYCIN 10% | OXYTETRACYCLINE | 100.0 MG/ML | SHANGHAI GONGYIN VETERINARY MEDICINES PLANT - NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINA | CHINA | PARENTERAL ORDINARY VIALS | I. 1*1*100ML VIAL II. 1*1*250ML VIAL | 7/1/10 |
| 290 | NDA/MAL/VDP/6003 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | CLOSAMECTIN | IVERMECTIN+CLOSANTEL | 5MG/ML+125MG/ML | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY S C VIALS | 1.0X20.0 ML VIAL,1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 7/1/04 |
| 291 | NDA/MAL/VDP/6008 | COSMOS LTD | ERAM UGANDA LIMITED | COCCID GRANULES | AMPROLIUM HYDROCHLORIDE | 20%W/W | MEDISEL (K) LTD, PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA| COSMOS LTD., RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY GRANULES | 10.0X30.0 G SACHET | 7/1/97 |
| 292 | NDA/MAL/VDP/6010 | VMD NV HOGE MAUW | ERAM UGANDA LIMITED | COLIVETO-4800 | COLISTINE SULPHATE | 4.8 MILLION I.U/G | VMD NV HOGE MAUW, HOGE MUW 900, 2370, ARENDONK | BELGIUM | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G CONTAINER,1.0X1.0 KG JAR | 7/1/05 |
| 293 | NDA/MAL/VDP/6011 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | COLVASONE INJECTION | DEXAMETHASONE SODIUM PHOSPHATE | 0.2%W/V | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 7/1/00 |
| 294 | NDA/MAL/VDP/6014 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | CKL MILKING SALVE | DICLOROPHEN/LANOLIN | 0.55 % W/W / 3.00%W/W | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X100.0 G CONTAINER,1.0X250.0 G CONTAINER,1.0X400.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X2.0 KG CONTAINER,1.0X50.0 G CONTAINER | 7/1/05 |
| 295 | NDA/MAL/VDP/6018 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | ALAMYCIN 10 | OXYTETRACYCLINE HYDROCHLORIDE | 10%W/V | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 7/1/97 |
| 296 | NDA/MAL/VDP/6022 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | ALAMYCIN LA 20 | OXYTETRACYCLINE HYDROCHLORIDE | 20%W/V | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/97 |
| 297 | NDA/MAL/VDP/6023 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | ALAMYCIN LA 300 | OXYTETRACYCLINE HYDROCHLORIDE | 30%W/V | NORBROOK LABORATORIES LTD, STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/97 |
| 298 | NDA/MAL/VDP/6028 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | CYPERMETHRIN-10 EC | CYPERMETHRIN | 10%W/V | VAPCO., DHULIEIL ARA, KING HUSSEIN STREET 120/ZARKA HALLOBAT | JORDAN | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 7/1/05 |
| 299 | NDA/MAL/VDP/6029 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | DABENDAZOLE 10% | ALBENDAZOLE | 10%W/V | MEDISEL KENYA LTD - , LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X40.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 1/8/10 |
| 300 | NDA/MAL/VDP/6083 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | LIMOXIN-400 WS | OXYTETRACYCLINE HYDROCHLORIDE | 400MG/G | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V - , METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1.0 KG JAR | 7/1/16 |
| 301 | NDA/MAL/VDP/6084 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOTRIM BOLUS | TRIMETHOPRIM + SULFADIAZINE | 200MG + 1000MG | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO), DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 BOLUS BLISTER | 7/1/17 |
| 302 | NDA/MAL/VDP/6255 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | NEFLUK 10% | ALBENDAZOLE | 10%W/V | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/16 |
| 303 | NDA/MAL/VDP/6258 | HEBEI YUANZHENG PHARMACEUTICAL CO., LTD | ERAM UGANDA LIMITED | OXYTET-10% | OXYTETRACYCLINE HYDROCHLORIDE | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/16 |
| 304 | NDA/MAL/VDP/6260 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | ERAM UGANDA LIMITED | OXYTET-30% | OXYTETRACYCLINE HYDROCHLORIDE | 30%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/16 |
| 305 | NDA/MAL/VDP/6262 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | INTROMIDIUM | ISOMETAMIDIUM HYDROCHLORIDE | 1G/SACHET | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, ˆŠ HOLLAND | NETHERLANDS | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X1.0 G SACHET,1.0X125.0 MG SACHET | 7/1/16 |
| 306 | NDA/MAL/VDP/6265 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | INTERZAN GOLD ORAL | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE | 30MG+60MG/ML | INTERCHEMIE WERKEN "DE ADEKAAR" BV, METAALWEG 85804 CG VENRY | NETHERLANDS | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 ML BOTTLE | 7/1/16 |
| 307 | NDA/MAL/VDP/6266 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | COLEXIL ORAL | COLISTIN/ENROFLOXACIN | 1200000IU+100MG/ML | INTERCHIEME WENKEN "DE ADELAAR" B.V., HORSTERWEG 26A 5811 AC CASTENERY HOLLAND | NETHERLANDS | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML CONTAINER | 7/1/16 |
| 308 | NDA/MAL/VDP/6827 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | HEXASOLLA | OXYTETRACYCLINE+FLUNIXIN | 300MG+20MG | NORBROOK LABERATORIES LTD , STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOM | UNITED KINGDOM | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 7/1/03 |
| 309 | NDA/MAL/VDP/6849 | BIMEDA UGANDA LIMITED | BIMEDA UGANDA LIMITED | TETROXY 12.5% | OXYTETRACYCLINE | 125MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITED, NO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA| CHONGQING FANGTONG ANIMAL, BANGQIAO INDUSTRIAL PARK | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 7/1/17 |
| 310 | NDA/MAL/VDP/6851 | BIMEDA UGANDA LIMITED | BIMEDA UGANDA LIMITED | TETROXY 30% | OXYTETRACYCLINE | 300MG/ML | CHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 7/1/17 |
| 311 | NDA/MAL/VDP/6889 | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD | ERAM UGANDA LIMITED | OXYTET- 12.5% | OXYTETRACYCLINE HYDROCHLORIDE | 12.5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 7/1/16 |
| 312 | NDA/MAL/VDP/7032 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | BUPARVANOR | BUPARVAQUONE | 5 % W/V | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 11/29/17 |
| 313 | NDA/MAL/VDP/7036 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | DIMINOR PLUS | DIMINAZENE DIACETURATE + ANTIPYRINE + VITAMIN B12 | 10.5G + 13.1G + 10MG / SACHET OF 23.6G, 1.05G + 1.31G + 1MG / SACHET OF 2.36G | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED - NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA | CHINA | POWDERS/ GRANULES IN SACHETS | 1.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET | 11/27/18 |
| 314 | NDA/MAL/VDP/7040 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | DIMINAL | DIMINAZINE DIACETURATE + PHENAZONE | 445MG + 555MG / 1G | EAGLE VET TECH. CO. LTD, 235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | CHINA | OTHER SYSTEMIC POWDER | 1.0X2.36 G SACHET | 3/27/19 |
| 315 | NDA/MAL/VDP/7041 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | COCCITOLTRAZOL | TOLTRAZURIL | 25G/L | EAGLE VET TECH. CO. LTD, 235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | CHINA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML CONTAINER, 1.0X500.0 ML CONTAINER | 3/27/19 |
| 316 | NDA/MAL/VDP/7056 | NORBROOK KENYA LTD | NORBROOK (U) LTD | EPRIZERO | EPRINOMECTIN | 5MG/ML | NORBROOK LABS LTDFACTORY 4, CARNBANE INDUSTRIAL ESTATE, NEWRY BT35 6QQ, CO DOWN, NORBROOK LABS LTD FACTORY 3, 105 ARMAGH ROAD, NEWRY, BT35 6PU CO.; / | UNITED KINGDOM | TOPICAL EXTERNAL LIQUIDS | 1.0X5.0 L CONTAINER,1.0X0.25 L CONTAINER,1.0X2.5 L CONTAINER,1.0X1.0 L CONTAINER,1.0X1.0 L CONTAINER,1.0X2.5 L CONTAINER | 3/27/19 |
| 317 | NDA/MAL/VDP/7061 | BAODING SUNLIGHT HERB MEDICAMENT CO., LTD | BD PHARMACEUTICALS LTD | OXY-100 | OXYTETRACYCLINE | 100MG/ML | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED - NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X1.0X500.0 ML BOTTLE, 1.0X1.0X100.0 ML VIAL | 7/1/17 |
| 318 | NDA/MAL/VDP/7176 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD(VAPCO) | GOODMAN INTERNATIONAL LTD | ERYXIN | ERYTHROMYCIN THIOCYNATE + BROMHEXINE HYDROCHLORIDE | 350MG + 10MG/G | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO), DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G SACHET | 1/29/19 |
| 319 | NDA/MAL/VDP/7262 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | BUPACIN PLUS | BUPARVAQUONE + FUROSEMIDE | 50MG + 55MG / ML | INTRACIN PHARMACEUTICAL PVT. LTD., C-1B/53, G.I.D.C. ESTATE, NADIAD 387 001, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X20.0 ML VIAL | 11/27/18 |
| 320 | NDA/MAL/VDP/7265 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | V-MULTINOR | VITAMINS (A+D3 + E+ B12 + C + B1 + B6 +B2 ) + NIACINAMIDE + D-PANTHENOL + D- BIOTIN | 3000 I.U + 2000 I.U + 4MG + 10MCG + 1 MG + 10MG + 5MG + 1MG + 12.5MG + 10MG + 10MCG | HEBEI KEXING PHARMACEUTICALS CO. LTD -, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.| | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL + 5ML SYRINGE AS A MEASURING DEVICE,1.0X50.0 ML VIAL + 5ML SYRINGE AS A MEASURING DEVICE,1.0X250.0 ML VIAL + 5ML SYRINGE,1.0X250.0 ML VIAL ( WITH A 10ML SYRINGE),1.0X500.0 ML BOTTLE( WITH A 10ML SYRINGE) | 7/1/17 |
| 321 | NDA/MAL/VDP/7398 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | EAGLE TYLOSIN 200 INJECTION | TYLOSIN TARTRATE | 200MG/ML | EAGLE VET TECH CO. LTD, 235-34, CHUSA-RO, SHINAM-MYUN, YESAN-GUN, CHUNGCHEONGNAM- DO, KOREA | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL | 7/1/17 |
| 322 | NDA/MAL/VDP/7399 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | OXYVET-10% | OXYTETRACYCLINE HYDROCHLORIDE | 100MG/ML | EAGLE VET TECH. CO. LTD, 235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL, 1.0X250.0 ML VIAL, 1.0X500.0 ML VIAL | 7/1/17 |
| 323 | NDA/MAL/VDP/7400 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | OXYVET-LA INJECTION | OXYTETRACYCLINE DIHYDRATE | 200MG/ML | EAGLE VET TECH. CO. LTD, 235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/17 |
| 324 | NDA/MAL/VDP/7402 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | DAWAFER INJECTABLE SOLUTION | IRON DEXTRAN | 100G/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL | 1/7/17 |
| 325 | NDA/MAL/VDP/7540 | LABORATOIRES LAPROVET | EVERVICTORY LIMITED | SECURIDIUM | ISOMETAMIDIUM CHLORHYDRATE | 125MG /SACHET | CEVA SANTE ANIMALE ZONE INDUSTRIELLE, TRES LE BOIS 22600 LOUDEAC | FRANCE | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X6.2 G SACHET,1.0X10.0X775.0 MG SACHET | 7/1/16 |
| 326 | NDA/MAL/VDP/7542 | LABORATOIRES LAPROVET | EVERVICTORY LIMITED | SURVIDIM | DIMINAZENE DIACETURATE + VIT B12 + VIT B6 | 10.5G + 10MG + 50MG/ SACHET | CEVA SANTE ANIMALE ZONE INDUSTRIELLE, TRES LE BOIS 22600 LOUDEAC | FRANCE | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 2.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET | 7/1/16 |
| 327 | NDA/MAL/VDP/7543 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | AVIAN INFECTIOUS BRONCHITIS VACCINE | LIVE AVIAN INFECTIOUS BRONCHITIS VACCINE (MILD MASS TYPE STRAIN) | ≥10³·⁵EID₅₀/DOSE. | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 7/1/16 |
| 328 | NDA/MAL/VDP/7545 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE , AVIAN INFECTIOUS BRONCHITIS AND AVIAN REOVIRUS VACCINE, INACTIVATED | INFECTIOUS BURSAL DISEASE (STANDARD TYPE 1 STRAIN, VARIANT DELAWARE 1084A STRAIN, & MAY LAND STRAIN); NEWCASTLE DISEASE (LASOTA STRAIN); AVIAN INFECTIOUS BRONCHITIS (MASS &ARK TYPE STRAINS) AND AVIAN REOVIRUS ( 1133 & 1733 STRAINS) | MULTIPLE STRAINS/ DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 7/1/17 |
| 329 | NDA/MAL/VDP/7547 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE AND AVIAN INFECTIOUS BRONCHITIS VACCINE, INACTIVATED. | INFECTIOUS BURSAL DISEASE (STANDARD TYPE 1 STRAIN); NEWCASTLE DISEASE (LASOTA STRAIN) AND AVIAN INFECTIOUS BRONCHITIS (MASS TYPE STRAIN) | INFECTIOUS BURSAL DISEASE VIRUS - ≥10⁶·²TCID₅₀/DOSE; NEW CASTLE DISEASE VIRUS - ≥10⁹EID₅₀/DOSE AND AVAIN INFECTIOUS BROCHITIS VIRUS - ≥10⁶·⁹EID₅₀/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 7/1/17 |
| 330 | NDA/MAL/VDP/7549 | LAPROVET S.A.S | EVERVICTORY LIMITED | DICLACOX | DICLAZURIL | 1G/100ML | BIOVE LABORATORY, 3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCE | FRANCE | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L BOTTLE | 7/1/16 |
| 331 | NDA/MAL/VDP/7550 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | EVAMIDIUM | ISOMETAMIDIUM | 1G/ SACHET & 125MG SACHET | HEBEI YUANZHENG PHARM.CO.LTD, NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | OTHER SYSTEMIC POWDER | 1.0X10.0X1.0 G SACHET,10.0X1.0X125.0 MG SACHET | 7/1/16 |
| 332 | NDA/MAL/VDP/7551 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | FOWL POX VACCINE, LIVE | FOWL POX VACCINE (FOWL POX STRAIN) | ≥10² TCID₅₀FP VIRUS/DOSE. | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL,1.0X10.0X500.0 DOSE VIAL | 7/1/16 |
| 333 | NDA/MAL/VDP/7553 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE VACCINE | INFECTIOUS BURSAL DISEASE VACCINE, LIVE (INTERMEDIATE STRAIN) | ≥10³ EID₅₀IBD VIRUS/DOSE. | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X10.0X200.0 DOSE VIAL | 7/1/16 |
| 334 | NDA/MAL/VDP/7555 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE VACCINE | INFECTIOUS BURSAL DISEASE VACCINE ,LIVE (INTERMEDIATE INVASIVE STRAIN) | ≥10³ EID₅₀IBD VIRUS/DOSE. | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 7/1/16 |
| 335 | NDA/MAL/VDP/7557 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE VACCINE INACTIVATED | INFECTIOUS BURSAL DISEASE VACCINE , INACTIVATED (STANDARD TYPE 1 STRAIN) | ≥10⁶·²TCID₅₀IBD VIRUS/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 7/1/16 |
| 336 | NDA/MAL/VDP/7558 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS CORYZA INACTIVATED VACCINE | INFECTIOUS CORYZA VACCINE, INACTIVATED (HAEMOPHILUS PARAGALLINARUM SEROTYPES A, B & C) | ≥10⁸CFU/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 7/1/16 |
| 337 | NDA/MAL/VDP/7561 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | MAREK'S DISEASE VACCINE | MAREK'S DISEASE VACCINE, LIVE (HVT FC126 STRAIN) | ≥10³ PFU/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL | 7/1/16 |
| 338 | NDA/MAL/VDP/7570 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | DOXY TYLOVET PLUS | DOXYCYCLINE HYCLATE+TYLOSIN TARTRATE+VITAMIN A ACETATE+ CHOLECALCIFEROL+VITAMIN E +RIBOFLAVIN + CYANOCOBALAMIN + CALCIUM PANTHOTHENATE +NICOTINAMIDE +VITAMIN K3 + ASCORBIC ACID +THIAMINE HYDROCHLORIDE +PYRIDOXINE HYDROCHLORIDE | 200MG +100MG + 750I.U + 300I.U + 3MG + 6MG + 0.015MG + 15MG + 30MG + 3MG + 30MG + 3MG + 3MG | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET, 1.0X500.0 G SACHET | 1/31/18 |
| 339 | NDA/MAL/VDP/7572 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE & AVIAN INFECTIOUS BRONCHITIS VACCINE | NEWCASTLE DISEASE & AVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (B1 & MILD MASS TYPE STRAINS) | NEW CASTLE DISEASE VIRUS - ≥10⁶EID₅₀/DOSE & AVAIN INFECTIOUS BROCHITIS VIRUS - ≥10³·⁵EID₅₀/DOSE. | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X200.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL | 7/1/16 |
| 340 | NDA/MAL/VDP/7574 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE & AVIAN INFECTIOUS BRONCHITIS VACCINE | NEWCASTLE DISEASE & AVIAN INFECTIOUS BRONCHITIS VACCINE , LIVE (LASOTA + MASS TYPE STRAINS) | NEW CASTLE DISEASE VIRUS - ≥10⁶EID₅₀/DOSE & AVAIN INFECTIOUS BROCHITIS VIRUS - ≥10³·⁵EID₅₀/DOSE. | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL | 7/1/16 |
| 341 | NDA/MAL/VDP/7576 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE DISEASE VACCINE | NEWCASTLE DISEASE VACCINE , LIVE (LASOTA STRAIN) | ≥10⁶EID₅₀ND VIRUS/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL,1.0X10.0X500.0 DOSE VIAL,1.0X10.0X100.0 DOSE VIAL,1.0X10.0X200.0 DOSE VIAL | 7/1/16 |
| 342 | NDA/MAL/VDP/7577 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE DISEASE VACCINE | NEWCASTLE DISEASE , VACCINE (B1 STRAIN) | ≥10⁶EID₅₀ND VIRUS/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X500.0 DOSE VIAL,1.0X200.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 7/1/16 |
| 343 | NDA/MAL/VDP/7578 | INTRACIN PHARMACEUTICAL PVT LTDˆŠ | VEERAM HEALTHCARE (U) LIMITED | CLOTIN FORTE | IVERMECTIN + CLORSULON | 10MG +100MG/ML | INTRACIN PHARMACEUTICAL PVT. LTD, C-1 B/53, G.I.D.C ESTATE, NADIAD-387001 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/16 |
| 344 | NDA/MAL/VDP/7579 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE DISEASE VACCINE INACTIVATED | NEWCASTLE DISEASE VACCINE, INACTIVATED (LASOTA STRAIN) | ≥10⁸·⁵EID₅₀ND VIRUS/DOSE | HESTER BIOSCIENCES LIMITED, MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 7/1/16 |
| 345 | NDA/MAL/VDP/7581 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | NITROXYNIL-34 | NITROXYNIL | 34%W/V | HEBEI YUANZHENG PHARM.CO.LTD, NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/17 |
| 346 | NDA/MAL/VDP/7582 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | MEDMAC VETERINARY PHARMACY | ZANIDE SUPER | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE | 30MG+60MG/ML | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD, AL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITY | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X5.0 L BOTTLE | 7/1/17 |
| 347 | NDA/MAL/VDP/7584 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | PARVAQUONE -15 | PARVAQUONE | 150MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/17 |
| 348 | NDA/MAL/VDP/7665 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | MEDMAC VETERINARY PHARMACY | BOVAR | BUPARVAQUONE | 50MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 7/1/17 |
| 349 | NDA/MAL/VDP/7669 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | DEXAJET | DEXAMETHASONE SODIUM PHOSPHATE | 2MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 1/7/17 |
| 350 | NDA/MAL/VDP/7672 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | DEXAPOWER | DEXAMETHASONE | 2MG/ML | EAGLE VET TECH CO. LTD., 235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DO | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL, 1.0X50.0 ML VIAL | 7/1/17 |
| 351 | NDA/MAL/VDP/7676 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | IVANOR PLUS | IVERMECTIN + CLOSANTEL SODIUM | 1%W/V + 10%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 7/1/17 |
| 352 | NDA/MAL/VDP/7679 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | TYLONOR 20 | TYLOSIN TARTRATE | 20%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.|HEBEI NEW CENTURY PHARMACEUTICAL COMPANY LIMITED NO. 189 TAIHANG STREET, SHIJIAZHUANG, HEBEI PROVINCE - CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 7/1/17 |
| 353 | NDA/MAL/VDP/7680 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | TYLOSIN 20% | TYLOSIN | 20%W/V | HEBEI YUANZHENG PHARM.CO.LTD, NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 7/1/17 |
| 354 | NDA/MAL/VDP/7684 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | OCCTAN-D | OXYTETRACYCLINE HYDROCHLORIDE + VIT ( A + D3 +E + K3 +B2 + B6 + B12)+CALCIUM PANTOTHENATE + NIACINAMIDE | 60G +2,250,000 I.U + 450,000IU + 660IU + 880MG + 3000MG + 2000MG +2200µG +4650MG + 14000MG/KG | EAGLE VET TECH. CO. LTD, 235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | CHINA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 G SACHET, 1.0X100.0 G SACHET | 7/1/17 |
| 355 | NDA/MAL/VDP/7690 | INTERCHIEME WENKEN "DE ADELAAR" B.V | VET CENTRE UGANDA LIMITED | TRYPONIL | DIMINAZENE ACETURATE + PHENAZONE | 1.05G +1.31G/ 2.36G | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | ORAL SOLID ORDINARY GRANULES | 1.0X10.0X2.36 G SACHET | 7/1/17 |
| 356 | NDA/MAL/VDP/7691 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | VETGENTA | GENTAMICIN SULPHATE | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD., NO. 16, LIUYUAN ROAD, CHANGAN DISTRICT, SHIJIAZHUANG, HEBEI, | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 1/7/17 |
| 357 | NDA/MAL/VDP/7693 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | LIMOXIN 25 SPRAY | OXYTETRACYCLINE HYDROCHLORIDE | 25MG/ML | INTERCHEMIE WERKEN €ŒDE ADELAAR€ B.V, METAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X200.0 ML CANNISTER | 7/1/17 |
| 358 | NDA/MAL/VDP/7696 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | NILZAN SUPER | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT SULPHATE HEPTAHYDRATE + SODIUM SELENATE | 3.0%W/V + 6.0%W/V + 0.764%W/V+ 0.0766%W/V | CKL AFRICA LIMITED, MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/17 |
| 359 | NDA/MAL/VDP/7700 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | ERAM UGANDA LIMITED | OXYTET- 20% | OXYTETRACYCLINE HYDROCHLORIDE | 20%W/V | HEBEI YUANZHENG PHARM.CO.LTD, NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X500.0 ML VIAL | 7/1/16 |
| 360 | NDA/MAL/VDP/7717 | NILE SERVICES LTD | NILE SERVICES LTD | PARVASTAR | PARVAQUONE | 150MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 5/28/19 |
| 361 | NDA/MAL/VDP/7718 | NILE SERVICES LTD | NILE SERVICES LTD | SAMOSTAR | ISOMETAMIDIUM CHLORIDE HYDROCHLORIDE | 125MG/DOSE | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | NON-HUMAN USE POWDERS | 1.0X10.0X1.0 DOSE SACHET,1.0X10.0X8.0 DOSE SACHET | 5/28/19 |
| 362 | NDA/MAL/VDP/7720 | NILE SERVICES LTD | NILE SERVICES LTD | TYLOSTAR | TYLOSIN TARTRATE | 20% W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 5/28/19 |
| 363 | NDA/MAL/VDP/7723 | NILE SERVICES LTD | NILE SERVICES LTD | TYPHOCOSTAR | SULFAQUINOXALINE SODIUM + TRIMETHOPRIM | 536.5MG + 165MG/ G | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 5/28/19 |
| 364 | NDA/MAL/VDP/8033 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID PLUS - O BOLUS | MULTI-INGREDIENT | N/A | COSMOS LIMITED-, RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X2.0X15.0 BOLUS STRIP | 7/1/04 |
| 365 | NDA/MAL/VDP/8181 | UNIVET LTD | BIMEDA UGANDA LIMITED | CURAFLUKE | FENBENDAZOLE+RAFOXANIDE | 5%W/V+5%W/V | MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | | IRELAND | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L JERRYCAN | 7/1/17 |
| 366 | NDA/MAL/VDP/8214 | LAPROVET S.A.S | EVERVICTORY LIMITED | OXYTETRACYCLINE | OXYTETRACYCLINE | 50%W/W | LABOTOIRES BIOVE, 3 RUE DE LORRAINE F-6251O ARQUES | FRANCE | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X100.0 G SACHET,1.0X1.0 KG SACHET | 7/1/17 |
| 367 | NDA/MAL/VDP/8256 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 2500 | ALBENDAZOLE | 2500MG | HEBEI KEXING PHARMACEUTICAL COMPANY LIMITED - NO.114 CHANGSHENG STREET, LIQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY HEBEI PROVINCE, P.R. CHINA | CHINA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X20.0 BOLUS BLISTER | 3/28/18 |
| 368 | NDA/MAL/VDP/8258 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | ALBENDA 10% SOL | ALBENDAZOLE | 100G/1L | EAGLE VET TECH CO. LTD., 235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DO | CHINA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L CONTAINER, 1.0X250.0 ML BOTTLE, 1.0X500.0 ML BOTTLE, 1.0X5.0 L JERRYCAN | 3/28/18 |
| 369 | NDA/MAL/VDP/8259 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | ENPROTIL | ENROFLOXACIN | 100G/L | EAGLE VET TECH CO. LTD., 235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DO | CHINA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE, 1.0X500.0 ML BOTTLE | 3/28/18 |
| 370 | NDA/MAL/VDP/8260 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | TETRANOR 10 | OXYTETRACYCLINE HYDROCHLORIDE | 10%W/V | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | PARENTERAL ORDINARY VIALS | 1.0X250.0 ML VIAL,1.0X500.0 ML VIAL,1.0X100.0 ML VIAL | 3/28/18 |
| 371 | NDA/MAL/VDP/8268 | GOODMAN INTERNATIONAL LTD | GOODMAN INTERNATIONAL LTD | OXYTETRACYCLINE HYDROCHLORIDE | OXYTETRACYCLINE HYDROCHLORIDE | 50%W/W | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO), DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET | 7/1/17 |
| 372 | NDA/MAL/VDP/8269 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 2.5% | ALBENDAZOLE | 2.5%W/V | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED-NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA. | CHINA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L CONTAINER,1.0X125.0 ML BOTTLE | 3/28/18 |
| 373 | NDA/MAL/VDP/8270 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | TETRANOR 20 L.A | OXYTETRACYCLINE DIHYDRATE | 20%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD, NO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | PARENTERAL ORDINARY VIALS | 1.0X250.0 ML VIAL,1.0X100.0 ML VIAL,1.0X500.0 ML VIAL | 3/28/18 |
| 374 | NDA/MAL/VDP/8271 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | TETRANOR 30 L.A | OXYTETRACYCLINE HYDROCHLORIDE | 30%W/V | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 3/28/18 |
| 375 | NDA/MAL/VDP/8272 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | BUPAQUONE | BUPARVAQUONE | 50MG/ML | EAGLE VET TECH. CO. LTD, 235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 7/1/17 |
| 376 | NDA/MAL/VDP/8298 | NORBROOK LABORATORIES | NORBROOK (U) LTD | NOROMECTIN ORAL DRENCH | IVERMECTIN | 0.08%W/V | NORBROOK KENYA LTD, OLD KIMURU RD- KARURI | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,2.5 L JERRYCAN,1.0X1.0 L JERRYCAN,1.0X5000.0 ML JERRYCAN | 7/1/00 |
| 377 | NDA/MAL/VDP/8360 | FATRO S.P.A | GLOBAL VET (U) LIMITED | VAIOL-VAC | LIVE ATTENUATED AVIAN FOWLPOX VIRUS, HP-2 STRAIN-2 | ≥10⁴EID₅₀/DOSE | FATRO S.P.A, VIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | CHINA | ORAL LIQUID ORDINARY DROPS | 1.0X10.0X1000.0 DOSE VIAL | 1/31/18 |
| 378 | NDA/MAL/VDP/8361 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | FLOXINOR | ENROFLOXACIN | 200MG/ML | BAODING SUNLIGHT HERB MEDICAMENT COMPANY LIMITED - NO. 2 PING AN EAST ROAD, EAST ZONE, ECONOMIC DEVELOPMENT DISTRICT, GAOYANG COUNTY, BAODING CITY, HEBEI PROVINCE, CHINA | CHINA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 11/29/17 |
| 379 | NDA/MAL/VDP/8362 | FATRO S.P.A | GLOBAL VET (U) LIMITED | S.E.T-VAC | INACTIVATED CULTURE OF SALMONELLA ENTERITIDIS + INACTIVATED CULTURE OF SALMONELLA TYPHIMURIUM | 1,000,000,000CFU/DOSE + 1,000,000,000CFU/DOSE | FATRO S.P.A, VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)| FATRO S.P.A., VIA EMILIA 285, OZZANO EMILIA (BO, ITALY) | ITALY | PARENTERAL ORDINARY VIALS | 1.0X500.0 DOSE VIAL (250ML),1.0X1000.0 DOSE VIAL (500ML) | 1/31/18 |
| 380 | NDA/MAL/VDP/8365 | LAPROVET S.A.S | EVERVICTORY LIMITED | SANIMIX | DIMINAZENE DIACETURATE + LEVIMISOLE | 1.05G + 1.5G | CEVA SANTE ANIMALE ZONE INDUSTRIELLE, TRES LE BOIS 22600 LOUDEAC | FRANCE | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X10.0X4.9 G SACHET,1.0X10.0X49.0 G SACHET | 11/29/17 |
| 381 | NDA/MAL/VDP/8366 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | COLLIE- AM | AMPICILLIN TRIHYDRATE + COLLISTIN SULPHATE | 100G + 25,000,000IU | EAGLE VET TECH CO. LTD., 235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DO | CHINA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET, 1.0X500.0 G SACHET | 11/29/17 |
| 382 | NDA/MAL/VDP/8367 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | V.H. + H-120 COMBINED VACCINE, NEWCASTLE DISEASE | NEWCASTLE DISEASE VIRUS (V.H STRAIN) + INFECTIOUS BRONCHITIS VIRUS (H-120 STRAIN) | NOT LESS THAN 10^6.0 EID50 + NOT LESS THAN 10^3.5 EID50 PER DOSE | ABIC BIOLOGICAL LABORATORIES LTD.-3 HAMELACHA ST.WEST INDUSTRIAL ZONE,BEIT SHEMESH,ISRAEL | | ISRAEL | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X10.0X2000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL | 9/26/18 |
| 383 | NDA/MAL/VDP/8368 | FATRO S.P.A | GLOBAL VET (U) LIMITED | IBA-VAC | LIVE ATTENUATED VIRUS OR GUMBORO DISEASE, 1/65PV STRAIN | ≥10³EID₅₀/DOSE | FATRO S.P.A, VIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 DOSE VIAL, 1.0X2500.0 DOSE VIAL, 1.0X5000.0 DOSE VIAL, 1.0X10.0X1000.0 DOSE VIAL, 1.0X10.0X2500.0 DOSE VIAL, 1.0X10.0X5000.0 DOSE VIAL | 1/31/18 |
| 384 | NDA/MAL/VDP/8370 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BI-VAC 1º | AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS H120 STRAIN VACCINE(FREEZE DRIED ) | ≥10⁴EID₅₀/DOSE | 1. FATRO S.P.A VIO MOLINO EMILI, 2 MACLODIO (BS) 25030 ITALY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*10*2500DOSE VIAL II. 1*10*1000DOSE VIAL III. 1*10*5000DOSE VIAL | 1/31/18 |
| 385 | NDA/MAL/VDP/8371 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BIO-VAC LA SOTA | NEWCASTLE DISEASE VIRUS (STRAIN LA SOTA) | 3162277.66 | FATRO S.P.A, VIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1000.0 DOSE VIAL, 1.0X2500.0 DOSE VIAL, 1.0X500.0 DOSE VIAL, 1.0X10.0X1000.0 DOSE VIAL, 1.0X10.0X2500.0 DOSE VIAL, 1.0X10.0X5000.0 DOSE VIAL | 1/31/18 |
| 386 | NDA/MAL/VDP/8374 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | ND+IB+VP2 | INACTIVATED, NEWCASTLE DISEASE VIRUS (V.H STRAIN) + INACTIVATED, INFECTIOUS BRONCHITIS VIRUS (M41 STRAIN) + INFECTIOUS BURSAL DISEASE VIRUS (ISRAELI STRAIN VP2 PROTEIN) | INACTIVATED, ND VIRUS (V.H STRAIN) ≥10⁸·⁴EID₅₀/DOSE + INACTIVATED, IB VIRUS (M41 STRAIN) ≥10⁷·¹EID₅₀/DOSE + IBD VIRUS, VP2 PROTEIN - 25 µG/DOS | ABIC BIOLOGICAL LABORATORIES-WESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAEL | | ISRAEL | | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X1000.0 DOSE BOTTLE (500ML) | 11/29/17 |
| 387 | NDA/MAL/VDP/8375 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | IC- QUADRO INACTIVATED VACCINE | INFECTIOUS CORYZA (AVIBACTERIUM PARAGALLINARUM) VACCINE, INACTIVATED | 221 STRAIN -10⁸·⁴CFU/DOSE, SPROSS STRAIN - 10⁸·⁵CFU/DOSE - MODESTO STRAIN - 10⁸·⁵CFU/DOSE & AKKO STRAIN - 10⁸·⁶CFU/DOSE. | ABIC BIOLOGICAL LABORATORIES-WESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAEL | | ISRAEL | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE BOTTLE (300ML),1.0X2000.0 DOSE BOTTLE (600ML) | 11/29/17 |
| 388 | NDA/MAL/VDP/8376 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | NECTIV FORTE | INACTIVATED, NEWCASTLE DISEASE VIRUS (V.H STRAIN | ≥10⁸·¹EID₅₀/DOSE 90.1 ML) | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X5000.0 DOSE BOTTLE (500ML) | 11/29/17 |
| 389 | NDA/MAL/VDP/8377 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | V.H. LIVE VACCINE | ND VIRUS, LIVE (V.H. STRAIN) | ND VIRUS, V.H STRAIN (LYOPHILIZED) ≥10⁶ EID₅₀/DOSE | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | ORAL LIQUID ORDINARY DROPS | 1.0X1000.0 DOSE VIAL | 11/29/17 |
| 390 | NDA/MAL/VDP/8378 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | TABIC IB VAR VACCINE | AVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (233A STRAIN) | IB VIRUS (233A STRAIN) ≥10³·²EID₅₀/DOSE | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X1.0X10.0 TABLET BLISTER (10,000 DOSES) | 11/29/17 |
| 391 | NDA/MAL/VDP/8380 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | TABIC V.H. LIVE VIRUS VACCINE | LIVE ATTENUATED NEWCASTLE DISEASE VIRUS, V.H. STRAIN | 10⁶ - 10⁷·⁵EID₅₀/DOSE | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X1.0X10.0 TABLET BLISTER (100 DOSES),1.0X1.0X10.0 TABLET BLISTER (500 DOSES),1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X1.0X10.0 TABLET BLISTER (10,000 DOSES) | 11/29/17 |
| 392 | NDA/MAL/VDP/8381 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | TABIC MB LIVE VIRUS VACCINE | INFECTIOUS BURSAL DISEASE (IBD) VACCINE, LIVE (M.B STRAIN) | INFECTIOUS BURSAL DISEASE VIRUS,M.B STRAIN : 10²·⁵ - 10³·¹EID₅₀/DOSE | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X1.0X10.0 TABLET BLISTER (500 DOSES),1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES) | 11/29/17 |
| 393 | NDA/MAL/VDP/8384 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | SALMABIC | INACTIVATED SALMONELLA ENTERITIDIS (C8, B3) AND SALMONELLA TYPHIMURIUM [2(+4)] STRAINS | S. ENTERITIDIS (PT C8 - 1X10⁸ CFU/DOSE & PT B3 - 1X10⁸ CFU/DOSE)+ S. TYPHIMURIUM - PT 2(4+) -1X10⁸ CFU/DOSE | ABIC BIOLOGICAL LABORATORIES-WESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAEL | | ISRAEL | | PARENTERAL ORDINARY S C VIALS | 1.0X500.0 DOSE BOTTLE (250ML),1.0X1000.0 DOSE BOTTLE (500ML) | 11/29/17 |
| 394 | NDA/MAL/VDP/8387 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BI-VAC 2º | ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS H-52 STRAIN | ≥10⁴EID₅₀/DOSE | 1. FATRO S.P.A VIO MOLINO EMILI, 2 MACLODIO (BS) 25030 ITALY SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | I. 1*10*1000DOSE VIAL II. 1*10*2500DOSE VIAL III. 1*10*5000DOSE VIAL | 1/31/18 |
| 395 | NDA/MAL/VDP/8391 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | VITAPOWER | MULITVITAMIN | MULTI-INGREDIENT | EAGLE VET TECH CO. LTD., 35-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN, CHUNGCHEONGNAM-DO, KOREA | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML BOTTLE | 11/29/17 |
| 396 | NDA/MAL/VDP/8398 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 300 | ALBENDAZOLE | 300MG | HEBEI KEXING PHARMACEUTICALS CO. LTD, NO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG| | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 11/29/17 |
| 397 | NDA/MAL/VDP/8399 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | AMINOVITAL | MULTIVITAMIN | MULTI-INGREDIENT | MEDISEL (K) LTD-PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X1.0 L BOTTLE | 7/1/98 |
| 398 | NDA/MAL/VDP/8402 | MELO PHARMACEUTICALS LIMITED | MELO PHARMACEUTICALS LIMITED | ENROTRIL-100 | ENROFLOXACIN | 100MG | PHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET) - PHO NOI A INDUSTRIAL ZONE, BAN YEN NHAN TOWN, MY HAO DISTRICT, HUNG YEN PROVINCE - VIETNAM | VIETNAM | ORAL LIQUID ORDINARY LIQUIDS | 1.0x100.0 ML BOTTLE, 1.0x500.0 ML BOTTLE, 1.0x1000.0 ML BOTTLE | 11/29/17 |
| 399 | NDA/MAL/VDP/8414 | MELO PHARMACEUTICALS LIMITED | MELO PHARMACEUTICALS LIMITED | HANMECTIN-100 | IVERMECTIN | 10MG/ML | PHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET) - PHO NOI A INDUSTRIAL ZONE, BAN YEN NHAN TOWN, MY HAO DISTRICT, HUNG YEN PROVINCE - VIETNAM | VIETNAM | PARENTERAL ORDINARY I M VIALS | 1.0x50.0 ML VIAL, 1.0x100.0 ML VIAL | 11/29/17 |
| 400 | NDA/MAL/VDP/8435 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | BRONCHIN | INACTIVATED NDV, V.H. STRAIN + INACTIVATED IBV, M-41 STRAIN | INACTIVATED NDV, V.H. STRAIN ≥10⁸·⁴EID₅₀/DOSE + INACTIVATED IBV, M-41 STRAIN≥10⁶·⁷EID₅₀/DOSE | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | OTHER SYSTEMIC LIQUIDS | 1.0X1000.0 DOSE BOTTLE (500ML) | 11/29/17 |
| 401 | NDA/MAL/VDP/8478 | MELO PHARMACEUTICALS LIMITED | MELO PHARMACEUTICALS LIMITED | HANEGG-PLUS | OXYTETRACYCLINE HCL+NEOMYCIN (AS SULFATE)+VITAMIN A+VITAMIN D3+VITAMIN K3+VITAMIN B1+VITAMIN B2+VITAMIN B6+VITAMIN B12+NICOTINAMIDE+CA PANTOTHENATE+FOLIC ACID+VITAMIN C+METHIONINE+LYSINE | 10 G + 4MG + 750 000 IU + 150 000 IU + 250 MG + 100MG + 200MG + 200MG + 750MG + 1500MG + 750MG + 30MG + 2500MG + 3MG + 5MG | PHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET) - PHO NOI A INDUSTRIAL ZONE, BAN YEN NHAN TOWN, MY HAO DISTRICT, HUNG YEN PROVINCE - VIETNAM | VIETNAM | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0x1.0 KG SACHET | 1/31/18 |
| 402 | NDA/MAL/VDP/8492 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | MB (GUMBORO) VACCINE | LIVE ATTENUATED IBD VIRUS M.B. | 10²·⁵ - 10³·¹EID₅₀/DOSE | ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | | ISRAEL | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL | 1/31/18 |
| 403 | NDA/MAL/VDP/8701 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | BUPARVAQUONE-5 | BUPARVAQUONE INJECTION | 5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-, NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 5/30/18 |
| 404 | NDA/MAL/VDP/8707 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | HEXAVET LA | FLUNIXIN + OXYTETRACYCLINE HYDROCHLORIDE | 20 MG + 300 MG/ML | 1. THE ARAB PESTICIDES AND VETERINARY DRUGS MANUFACTURING COMPANY (MOBEDCO-VET) AL-HASSAN INDUSTRIAL ESTATE - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | PARENTERAL ORDINARY I M VIALS | I. 1*100ML VIAL | 7/7/14 |
| 405 | NDA/MAL/VDP/9154 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS®IB 4-91 | LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN 4-91 | AT LEAST LOG10^3.6 EID50 / DOSE | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS | 1.0X1000.0 DOSE VIAL, 1.0X12.0X1000.0 DOSE CUP, 1.0X12.0X2500.0 DOSE CUP, 1.0X12.0X5000.0 DOSE CUP, 1.0X12.0X10000.0 DOSE CUP, 1.0X6.0X10000.0 DOSE CUP | 11/21/19 |
| 406 | NDA/MAL/VDP/9155 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS® GUMBORO D78 | LIVE,ATTENUATED, INFECTIOUS BURSAL DISEASE (GUMBORO DISEASE) VIRUS, STRAIN D78 | AT LEAST 4.0 LOG10 TCID50 OF INFECTIOUS BURSAL DISEASE (GUMBORO) VIRUS STRAIN D78 (OR ≥10^4.0 TCID50/DOSE) | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS | 1.0X10.0X1000.0 DOSE VIAL | 11/21/19 |
| 407 | NDA/MAL/VDP/9156 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS® IB MA5 | LIVE INFECTIOUS BRONCHITIS VIRUS, STRAIN MA5 (SEROTYPE MASSACHUSETTS) | ATLEAST 103.0 EID50 OFINFECTIOUS BRONCHITIS VIRUS, STRAIN MA5, SEROTYPE MASSACHUSETTS I.E. ≥ 103.0 EID50 /DOSE | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS | 1.0X1000.0 DOSE VIAL, 1.0X12.0X1000.0 DOSE CUP, 1.0X12.0X2500.0 DOSE CUP, 1.0X12.0X5000.0 DOSE CUP, 1.0X12.0X10000.0 DOSE CUP, 1.0X6.0X10000.0 DOSE CUP | 11/21/19 |
| 408 | NDA/MAL/VDP/9158 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD - VET | DO-CARB | IMIDOCARB DIPROPIONATE | 120MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X1.0X50.0 ML VIAL, 1.0X1.0X20.0 ML VIAL | 11/21/19 |
| 409 | NDA/MAL/VDP/9221 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD - VET | PROTEIN 100 | PROTEIN HYDROLYSATE | 98 GM/100 GM | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET | 9/28/20 |
| 410 | NDA/MAL/VDP/9227 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | POULVAC IB PRIMER | LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN H120 + LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN D274 CLONE | 10^3.0 - 10^5.4 EID50 + 10^3.0 - 10^5.4 EID50/DOSE | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.L, CTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2500.0 DOSE VIAL | 2/15/23 |
| 411 | NDA/MAL/VDP/9292 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | NOBILIS GUMBORO 228E, LYOPHILIZATE FOR SUSPENSION FOR CHICKEN | LIVE AVIAN INFECTIOUS GUMBORO DISEASE VIRUS STRAIN 228E | NLT 2.0 LOG10EID50/DOSE | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X1000.0 DOSE VIAL, 1.0X12.0X1000.0 DOSE CUP, 1.0X12.0X2500.0 DOSE CUP, 1.0X12.0X5000.0 DOSE CUP, 1.0X12.0X10000.0 DOSE CUP, 1.0X6.0X10000.0 DOSE CUP | 9/8/20 |
| 412 | NDA/MAL/VDP/9293 | INTRACIN PHARMACEUTICAL PVT LTDˆŠ | VEERAM HEALTHCARE (U) LIMITED | CRAMINE | CHLORPHENAMINE MALEATE | 10 MG/ML | INTRACIN PHARMACEUTICAL PVT. LTD., C-1B/53, G.I.D.C. ESTATE, NADIAD 387 001, GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X30.0 ML VIAL,1.0X50.0 ML VIAL | 9/28/20 |
| 413 | NDA/MAL/VDP/9309 | LABORATORIOS HIPRA S.A | LUNADKA UGANDA LIMITED | SELECTAN | FLORFENICOL | 300MG/ML | LABORATORIOS HIPRA S.A ,, AVDA. LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | PARENTERAL ORDINARY VIALS | 1.0X3.0X50.0 ML BOTTLE,1.0X2.0X100.0 ML BOTTLE,1.0X1.0X250.0 ML BOTTLE | 9/8/20 |
| 414 | NDA/MAL/VDP/9468 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | NEROCIN | METHYLCOBALAMIN + PYRIDOXINE HYDROCHLORIDE + NICOTINAMIDE | (500 MCG + 50 MG + 50 MG)/ML | INTRACIN PHARMACEUTICALS PVT LTD ,.,, C-1, B-53, GIDC ESTATE, NADIAD-387001 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 12/9/20 |
| 415 | NDA/MAL/VDP/9477 | NORBROOK KENYA LTD | NORBROOK (U) LTD | BENDAMEC | ALBENDAZOLE + IVERMECTIN | 10%W/V + 0.2%W/V | NORBROOK KENYA LTD, OLD LIMURU ROAD, KARURI, NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X40.0 ML CONTAINER,1.0X120.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1.0 L CONTAINER,1.0X5.0 L CONTAINER | 12/9/20 |
| 416 | NDA/MAL/VDP/9478 | NILE SERVICES LTD | NILE SERVICES LTD | OXYTETRACYCLINE WSP 20% | OXYTETRACYCLINE HYDROCHLORIDE | 200 MG/G | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 G SACHET,1.0X10.0X5.0 G SACHET | 12/9/20 |
| 417 | NDA/MAL/VDP/9479 | NILE SERVICES LTD | NILE SERVICES LTD | STARMECTIN PLUS | IVERMECTIN + CLORSULON | 1%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD, NO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 12/9/20 |
| 418 | NDA/MAL/VDP/9520 | MEDISEL(K) LTD | DAWA LIFESCIENCES (U) LTD | DAWA-TYLODOX 200 POWDER | DOXYCYCLINE HYCLATE + TYLOSIN TARTRATE | (200 MG + 200 MG)/G | MEDISEL (K) LTD, PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | KENYA | ORAL SOLID ORDINARY POWDERS | 1.0X30.0 G SACHET, 1.0X100.0 G SACHET, 1.0X250.0 G SACHET, 1.0X500.0 G SACHET, 1.0X1.0 KG CONTAINER | 4/3/21 |
| 419 | NDA/MAL/VDP/9521 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | THEIL-CURE | BUPARVAQUONE | 50MG/ML | ORCHIDIA, 10TH RAMADHAN CITY INDUSTRIAL AREA-B1 , P. O. BOX 149 TENTH, EGYPT | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL,1.0X1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 2/24/21 |
| 420 | NDA/MAL/VDP/9531 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | COCCIDIOPAN | SULPHAQUINOXALINE SODIUM + SULPHADIMIDINE SODIUM + SULPHADIAZINE SODIUM + VITAMIN K3 + VITAMIN A | (150 MG + 70 MG + 70 MG + 2 MG + 8000 I.U)/G | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X100.0 G SACHET, 1.0X200.0 G SACHET, 1.0X500.0 G SACHET, 1.0X1.0 KG SACHET | 2/24/21 |
| 421 | NDA/MAL/VDP/9532 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | BACTECLEAN 50% | DOXYCYCLINE HYCLATE | 500 MG/G | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X200.0 G SACHET, 1.0X500.0 G CONTAINER, 1.0X1.0 KG CONTAINER, 1.0X100.0 G SACHET | 2/24/21 |
| 422 | NDA/MAL/VDP/9554 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS MA5+CLONE 30 | AVIAN INFECTIOUS BRONCHITIS + NEW CASTLE DISEASE VACCINE, LIVE. | AT LEAST 3.0 LOG10 EID50 + AT LEAST 6.0 LOG10 EID50/DOSE | INTERVET INTERNATIONAL BV, WIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2500.0 DOSE VIAL + 1*80ML DILUENT IN HDPE CONTAINER,1.0X10.0X1000.0 DOSE VIAL + 1*80ML DILUENT IN HDPE CONTAINER | 2/24/21 |
| 423 | NDA/MAL/VDP/9561 | DYNTEC SPOL. S R. O | GLOBAL VET (U) LIMITED | CANVAC P | LIVE ATTENUATED CANINE PARVOVIRUS STRAIN ENTERITIDIS (PARVOVIRUS ENTERITIDIS CANIS ATTENUATUM) | 10^2.1 - 10^3.6 HAU/DOSE | DYNTEC SPOL. S.R.O.PRAZSKA 328, 411 55 TEREZIN – CZECH REPUBLIC | CZECH REPUBLIC | PARENTERAL ORDINARY DRY VIALS | 1.0X6.0X1.0 DOSE VIAL + 1*6*1ML CLEAR GLASS VIAL DILUENT | 2/24/21 |
| 424 | NDA/MAL/VDP/9562 | DYNTEC SPOL. S R. O | GLOBAL VET (U) LIMITED | CANVAC R | INACTIVATED RABIES VACCINE | NOT LESS THAN 2 IU/DOSE | DYNTEC SPOL. S.R.O., PRAZSKA 328, 411 55 TEREZIN – CZECH REPUBLIC | CZECH REPUBLIC | PARENTERAL ORDINARY VIALS | 1.0X60.0X1.0 DOSE VIAL, 1.0X5.0X10.0 DOSE VIAL | 3/24/21 |
| 425 | NDA/MAL/VDP/9564 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | MEDMAC VETERINARY PHARMACY | MEDACOX | TOLTRAZURIL | 25MG/ML | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD, AL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 2/24/21 |
| 426 | NDA/MAL/VDP/9565 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVITRYL 10% | ENROFLOXACIN | 100 MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML BOTTLE, 1.0X1.0X100.0 ML BOTTLE | 2/24/21 |
| 427 | NDA/MAL/VDP/9566 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVIMEC SUPER | IVERMECTIN + CLORSULON | 10MG + 100MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML BOTTLE, 1.0X1.0X50.0 ML BOTTLE, 1.0X1.0X100.0 ML BOTTLE, 1.0X1.0X250.0 ML BOTTLE | 12/9/20 |
| 428 | NDA/MAL/VDP/9567 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | ERYTHROMYCIN €“ AVICO 25% | ERYTHROMYCIN THIOCYANATE | 330 MG/G | ARAB VETERINARY INDUSTRIAL COMPANY AVICO, ALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET, 1.0X500.0 G SACHET, 1.0X1.0 KG SACHET | 3/4/21 |
| 429 | NDA/MAL/VDP/9578 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | THEILACIDE | BUPARVAQUONE | 50 MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD), KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 12/9/20 |
| 430 | NDA/MAL/VDP/9579 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | PRO VAC® 4 | INACTIVATED INFECTIOUS BURSAL DISEASE VIRUS-BEARING FLUIDS (LUKERT STRAIN) + INACTIVATED NEWCASTLE DISEASE VIRUS-BEARING FLUIDS (KIMBER STRAIN) | ≥10^5.2 TCID50 + ≥10^7.7 EID50 + ≥ 10^6.9 EID50 + ≥10^6.2 TCID50 + ≥10^6.2 TCID50/DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | PARENTERAL ORDINARY OTHER VIALS | 1.0X100.0 ML CONTAINER (1000 DOSES) | 6/2/21 |
| 431 | NDA/MAL/VDP/9580 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | LEVAPAN LIQUID | LEVAMISOLE HYDROCHLORIDE | 118 MG/ML | PHARMA SWEDE - EGYPT, 10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 | EGYPT | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML CONTAINER,1.0X100.0 ML BOTTLE | 6/2/21 |
| 432 | NDA/MAL/VDP/9582 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | PIPERANOR | PIPERAZINE CITRATE | 360 MG/G | HEBEI KEXING PHARMACEUTICALS, NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | POWDERS/ GRANULES IN SACHETS | 1.0X100.0 G SACHET,1.0X50.0 G SACHET, 1.0X1.0 KG CONTAINER | 6/2/21 |
| 433 | NDA/MAL/VDP/9583 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | PIPERAZINE CITRATE WSP | PIPERAZINE CITRATE | 100%W/W | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | POWDERS/ GRANULES IN SACHETS | 1.0X12.0X100.0 G SACHET,1.0X10.0X25.0 G SACHET,1.0X1.0X1.0 KG POUCH CONTAINER | 6/2/21 |
| 434 | NDA/MAL/VDP/9697 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | TRI-REO® | AVIAN REOVIRUS VACCINE, (STRAIN NO. 1133 + STRAIN NO.2408 + STRAIN NO. 3005) | (≥ 10^5.9 TCID50 + ≥ 10^6.0 TCID50 + ≥ 104.8 TCID50) PER DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 ML CONTAINER (1000 DOSES) | 6/2/21 |
| 435 | NDA/MAL/VDP/9736 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | VETOXY 20 | OXYTETRACYCLINE HYDROCHLORIDE | 200MG/G | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X10.0X25.0 G SACHET,1.0X1.0 KG JAR | 10/5/21 |
| 436 | NDA/MAL/VDP/9738 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | MG-BAC® | MYCOPLASMA GALLISEPTICUM BACTERIN, STRAIN R-980 | ≥1000 MGCFU/DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | PARENTERAL ORDINARY OTHER VIALS | 1.0X500.0 ML CONTAINER (1000 DOSES) | 10/5/21 |
| 437 | NDA/MAL/VDP/9739 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | MEDMAC VETERINARY PHARMACY | TETRAMED | OXYTETRACYCLINE HYDROCHLORIDE | TETRAMED | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD, AL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET | 10/5/21 |
| 438 | NDA/MAL/VDP/9740 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | MELOXICASH | MELOXICAM | 5MG/ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 10/5/21 |
| 439 | NDA/MAL/VDP/9741 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | AMPROLIUM 20 | AMPROLIUM HYDROCHLORIDE | 200MG/G | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X12.0X100.0 G SACHET,1.0X10.0X25.0 G SACHET,1.0X1.0 KG CONTAINER | 10/5/21 |
| 440 | NDA/MAL/VDP/9742 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | DOXYVET 500 | DOXYCYCLINE HYCLATE | 433.3MG/G | 1. THE ARAB PESTICIDES AND VETERINARY DRUGS MANUFACTURING COMPANY (MOBEDCO-VET) AL-HASSAN INDUSTRIAL ESTATE - JORDAN JORDAN SCOPE:COMPLETE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCT | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | I. 1*100G SACHET II. 1*500G SACHET III. 1*1000G SACHET | 10/5/21 |
| 441 | NDA/MAL/VDP/9744 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | BURSINE®-2 | LIVE, INFECTIOUS BURSAL DISEASE VIRUS (LUKERT STRAIN) | NOT LESS THAN 10^3.6 TCI D50 AT RELEASE/DOSE | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL | 10/5/21 |
| 442 | NDA/MAL/VDP/9745 | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA | VETCARE UGANDA LIMITED | WORMITREX | LEVAMISOLE HYDROCHLORIDE | 15 MG/ML | VETCARE KENYA LIMITED ALIAS VETCARE AFRICA, UNIT 7 & 8 PLOT NO. 336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L JERRYCAN | 10/5/21 |
| 443 | NDA/MAL/VDP/9890 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | BURSINE® PLUS | LIVE, INFECTIOUS BURSAL DISEASE VIRUS (LUKERT STRAIN) | NOT LESS THAN 10^2.4 TCID50 AT EXPIRATION/DOSE (0.005ML) | ZOETIS, 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL | 10/5/21 |
| 444 | NDA/MAL/VDP/9892 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | FENACURE 10% | FENBENDAZOLE | 100MG/ML | ASHISH LIFE SCIENCES PVT LTD, J-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 12/21/21 |
| S/N | NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | MANUFACTURING SITE | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|---|
| 1 | HDA094 | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA HERBAL SOAP | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA,TEL: 0414 271 214 | UGANDA | SOAP | 100GM & 120GM | 29/08/2017 |
| 2 | HDA095 | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA HERBAL JELLY | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA,TEL: 0414 271 214 | UGANDA | OINTMENT | 50GM,100GM,150GM,250GM,& 500GM | 29/08/2017 |
| 3 | HDA129/02/16 | NSIMYE HERBAL MEDICINE RESEARCHERS | NSIMYE HERBAL MEDICINE RESEARCHERS | KABUUTI HERBAL SYRUP | NSIMYE HERBAL MEDICINE RESEARCHERS,KIKUUBO ZONE IV,KANYANYA PARISH,KAWEMPE DIV,TEL: +256 414660508/+256 200911877 | UGANDA | SYRUP | 1*100ML HDPE BOTTLE IN A CARTON | 25/01/2022 |
| 4 | THA 1020 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELO-ENJO | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA [email protected] | UGANDA | LIQUID | 200 MLS | 27/02/2023 |
| 5 | THA 346 | ZALUGAVE HERBAL MEDICINE LTD MENGO HILL ROAD, KAMPALA-UGANDA | ZALUGAVE HERBAL MEDICINE LTD MENGO HILL ROAD, KAMPALA-UGANDA | NANA HERBAL MOUTHWASH | ZALUGAVE HERBAL MEDICINE LTD MENGO HILL ROAD, KAMPALA-UGANDA | UGANDA | SPRAY | 60ML BOTTLE | 3/10/17 |
| 6 | THA 582 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | CARMILEX DIGESTIVE TONIC | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | LIQUID | 1*100ML. AMBER PET BOTTLE | 7/5/19 |
| 7 | THA 585 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | PAIN NIL HERBAL CREAM | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | CREAM | 1*25GWHITE PET BOTTLE | 2/10/19 |
| 8 | THA 819 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD, P.O. BOX 36766, KAMPALA, UGANDA 0758329111 | ELOLAX | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA [email protected] | UGANDA | LIQUID | 100 MLS | 27/02/2023 |
| 9 | THA018 | KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE | KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE | KIPO HERBAL SKIN OINTMENT | KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE P.O.BOX 25562, KAMPALA 0782351873/0753-807748 | UGANDA | OINTMENT | 1*50 & 100G IN PET JAR | 3/3/18 |
| 10 | THA1000 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | COFFVOP HERBAL MIXTURE | VAX ORGANIC PRODUCTS BULOBA ALONG MITYANA ROAD ,WAKISO DISTRICT TEL:0775827379/0755540110 | UGANDA | LIQUID | 200ML PET BOTTLE | 27/02/2023 |
| 11 | THA1001 | KATEREGGA HUSSEIN TEL: 0701466596 | KATEREGGA HUSSEIN TEL: 0701466596 | AFRI BALM | KATEREGGA PHYSIOTHERAPY SERVICES KIBULI DIPPO TEL: 0781466596/0700414277/0701466596 | UGANDA | OINTMENT | 20 AND 80G PET CONTAINER | 27/02/2023 |
| 12 | THA1002 | EARTH NATURAL LIFE LTD, MAWANDA ROAD,NEAR YUDESI PRIMARY SCHOOL,KAMPALA | EARTH NATURAL LIFE LTD, MAWANDA ROAD,NEAR YUDESI PRIMARY SCHOOL,KAMPALA | INFLA | EARTH NATURAL LIFE LTD, MAWANDA ROAD,NEAR YUDESI PRIMARY SCHOOL,KAMPALA,UGANDA TEL: 0779412612/0758 654620 EMAIL: [email protected] | UGANDA | LIQUID | 1*500ML WHITE HDPE BOTTLE | 7/9/22 |
| 13 | THA1007 | BAMAKOOLA HERBAL PRODUCTS NEAR MENGO POST OFFICE TEL: +256(0)712406847 | BAMAKOOLA HERBAL PRODUCTS NEAR MENGO POST OFFICE TEL: +25690)712406847 | ZUUKUKA HERBL POWDER | BAMAKOOLA HERBAL PRODUCTS NEAR MENGO POST OFFICE TEL: +25690)712406847 | UGANDA | POWDER | 100GM HDPE CONTAINER | 7/9/22 |
| 14 | THA1008 | MUHUMUZA JAMES TEL: 0772460171/0755460171 E-MAIL: [email protected] | MUHUMUZA JAMES TEL: 0772460171/0755460171 E-MAIL: [email protected] | AHACOD-II HERBAL SYRUP | TROPICAL ALOELANDS FOUNDATION TEL: +256772460171,+256755460171 E-MAIL: [email protected] KAMPLALA,UGANDA | UGANDA | SYRUP | 1*200ML PLASTIC BOTTLE | 26/05/2023 |
| 15 | THA1013 | ZAMURI HAIR ESSENTIALS SMS LTD MUTUNDWE KAMPALA ROAD UGANDA TEL:0200926769/0755108006 | ZAMURI HAIR ESSENTIALS SMS LTD MUTUNDWE KAMPALA ROAD UGANDA TEL:0200926769/0755108006 | ZAMURI ORGANIC POWDERED SHAMPOO | ZAMURI HAIR ESSENTIALS SMS LTD MUTUNDWE KAMPALA ROAD UGANDA TEL:0200926769/0755108006 | UGANDA | POWDER | 100GM ALU/ALU SACHET | 9/2/22 |
| 16 | THA1014 | NGOBI MUKADASI, PEARL HERBALS (U) LIMITED | NGOBI MUKADASI, PEARL HERBALS (U) LIMITED | BANUTWE FLU & COUGH HERBAL SYRUP | PEARL HERBALS (U) LIMITED, KAYUNGA DISTRICT,KAYONZA SUB COUNTY,KANYWERO PARISH TEL:0752837021,0782837021 | UGANDA | LIQUID | 200ML HDPE BOTTLE | 7/9/22 |
| 17 | THA1015 | PEARL HERBALS (U) LIMITED KAYUNGA DISTRICT,KAYONZA SUB COUNTY KANYWERO PARISH | PEARL HERBALS (U) LIMITED KAYUNGA DISTRICT,KAYONZA SUB COUNTY KANYWERO PARISH | KAWEN | NGOBI MUKADASI PEARL HERBALS (U) LIMITED KAYUNGA DISTRICT,KAYONZA SUB COUNTY KANYWERO PARISH TEL:0752837021,0782837021 | UGANDA | LIQUID | 300ML & 500ML PLASTIC BOTTLE | 5/3/24 |
| 18 | THA1017 | MR TAYEBWA WYCLIFF, KASHASHA CELL, ITOJO PARISH, RUHAMA SUBCOUNTY, NTUNGAMO | SAUDA HEALTHY PRODUCT (U) LTD | SAUDA HERBAL SYRUP | SAUDA HEALTHY PRODUCT (U) LTD KASHASHA CELL-ITOJO PARISH, RUHAMA SUBCOUNTY, NTUNGAMO DISTRICT | UGANDA | LIQUID | 100ML | 4/5/23 |
| 19 | THA1021 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOCID MIXTURE | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA [email protected] | UGANDA | LIQUID | 200 MLS | 16/12/2022 |
| 20 | THA1038 | MR.AMBROSE OGWANG AMBROSOLI HERBAL PRODUCTS AMOLATADISTRICT AMIRIMIRI WARD TEL:0773312693 | MR.AMBROSE OGWANG AMBROSOLI HERBAL PRODUCTS AMOLATADISTRICT AMIRIMIRI WARD TEL:0773312693 | DIAPUTEX | MR.AMBROSE OGWANG AMBROSOLI HERBAL PRODUCTS AMOLATAR DISTRICT AMIRI MIRI WARD TEL:0773312693 | UGANDA | POWDER | 1*250GM IN A TRANSPARENT PLASTIC JAR | 7/9/22 |
| 21 | THA1040 | RUDI INTERNATIONAL COMPANY LTD P.O BOX 634 TORORO 0782371007 | RUDI INTERNATIONAL COMPANY LTD P.O BOX 634 TORORO 0782371007 | RUDII HERBAL MIXTURE | RUDII INTERNATIONAL COMPANY LTD PLOT 6A LUWUM RD EASTERN DIVISION TMC P. O. BOX 634 TORORO UGANDA 0786803404 | UGANDA | LIQUID | 100ML LIQUID AMBER COLOURED PET BOTTLE | 19/03/2024 |
| 22 | THA1041 | RUDI INTERNATIONAL COMPANY LTD P.O BOX 634 TORORO 0782371007 | RUDI INTERNATIONAL COMPANY LTD P.O BOX 634 TORORO 0782371007 | RUDII TITHO HERBAL EXTRACT | RUDII INTERNATIONAL COMPANY LTD PLOT 6A LUWUM RD EASTERN DIVISION TMC P. O. BOX 634 TORORO UGANDA 0786803404 | UGANDA | LIQUID | 100ML AMBER COLOURED PET BOTTLE | 17/06/2024 |
| 23 | THA1044 | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI, KIREKA, P.O BOX 6034, KAMPALA, UGANDA | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI, KIREKA, P.O BOX 6034, KAMPALA, UGANDA | PAINEX BALM | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI, KIREKA, P.O BOX 6034, KAMPALA, UGANDA TEL:+256414236595 E-MAIL: [email protected] | UGANDA | BALM | 9G GLASS JAR | 27/01/2023 |
| 24 | THA1045 | UGANICS REPELLENTS LTD TEL: +256(0)702100900 +256(0)777211055 +256(0)752315007 | UGANICS REPELLENTS LTD TEL: +256(0)702100900 +256(0)777211055 +256(0)752315007 | CLEANMATE MOSQUITO REPELLENT CREAM | UGANICS REPELLENTS LTD,NSOZIBILYE,PLOT 61,KABASANDA, P.O.BOX 102330,KAMPALA ,UGANDA | UGANDA | CREAM | 90ML HDPE BOTTLE | 27/05/2022 |
| 25 | THA1050 | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | SIBMOS MOSQUITO REPELLANT SPRAY | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE P.O.BOX 12889,KAMPALA +256761670543 | UGANDA | AEROSOL | 60ML SPRAY | 7/9/22 |
| 26 | THA1051 | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | LUNAKOFF | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE P.O.BOX 12889,KAMPALA +256761670543 | UGANDA | LIQUID | 200ML AND 100ML PET AMBER BOTTLE | 7/9/22 |
| 27 | THA1072 | HELLEN NYILAK BIGGI HERBAL CLINIC | HELLEN NYILAK BIGGI HERBAL CLINIC | BIGGI PELCER | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD TEL 0772484882 0705484882 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 28/11/2023 |
| 28 | THA1073 | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD | BIGGI SINA SYRUP | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD TEL 0772484882 0705484882 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 4/8/23 |
| 29 | THA1079 | AHHUU BARINTUMYE HERBAL CLINICAL RESEARCH LTD 0772392795/0756438883 | AHHUU BARINTUMYE HERBAL CLINICAL RESEARCH LTD 0772392795/0756438883 | AHHUU STAMINA DRINK | AHHUU BARINTUMYE HERBAL CLINICAL RESEARCH LIMITED KIKUMBI-KANSOLEETI PLOT 104,BUSINZIGGO ROAD – MITYANA TEL: 0754392795/0772392795 | UGANDA | LIQUID | 180ML & 300ML IN AMBER COLOURED PLASTIC BOTTLE | 26/05/2023 |
| 30 | THA1081 | KAZIRE HEALTH PRODUCTS LTD PLOT 178, KABALE RD P.O.BOX 1802 MBARARA CITY TEL 0782801622 | KAZIRE HEALTH PRODUCTS LTD PLOT 178, KABALE RD P.O.BOX 1802 MBARARA CITY TEL 0782801622 | ALSATON | KAZIRE HEALTH PRODUCTS LTD PLOT 178, KABALE RD P.O.BOX 1802 MBARARA CITY TEL 0782801622 | UGANDA | LIQUID | 200ML PET BOTTLE | 7/9/22 |
| 31 | THA1082 | EARTH NATURAL LIFE LTD MAWANDA ROAD NEAR YUDESI PRIMARY SCHOOL TEL: 0779412612, 0756654620 | EARTH NATURAL LIFE LTD MAWANDA ROAD NEAR YUDESI PRIMARY SCHOOL TEL: 0779412612, 0756654620 | ZEPOR TEA MATRIX | ELOIPHARM UGANDA LTD PLOT 160 MULAGO 11 ZONE ALONG LOWER NSOOBA ROAD P.O. BOX. 36766. KAMPALA UGANDA EAST AFRICA TEL :0758329111 | UGANDA | POWDER | 100G PLASTIC CONTAINER | 9/4/24 |
| 32 | THA1083 | KASTEL HERBALS LIMITED KAZIMOTO STEVEN 1 KM OFF NANSANA-NNABWERU ROAD WAKISO DISTRICT | KASTEL HERBALS LIMITED KAZIMOTO STEVEN 1 KM OFF NANSANA-NNABWERU ROAD WAKISO DISTRICT | KASTEL COUGH MIXTURE | KASTEL HERBALS LIMITED NANSANA-KABUMBI ROAD BUJAGALI WAKISO UGANDA TEL:+25674195201/07877741684 [email protected] | UGANDA | LIQUID | 200ML PET BOTTLE | 27/02/2023 |
| 33 | THA1087 | BUSITEMA UNIVERSITY NATURAL PRODUCTS AND DRUGS RESEARCH GROUP (BUNAPREG) | BUSITEMA UNIVERSITY NATURAL PRODUCTS AND DRUGS RESEARCH GROUP (BUNAPREG) | TAZCOV SYRUP | BUSITEMA UNIVERSITY NATURAL PRODUCTS AND DRUGS RESEARCH GROUP (BUNAPREG), TEL; +256704946479/+256785466337 | UGANDA | LIQUID | 100ML PET BOTTLE | 7/9/22 |
| 34 | THA1093 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA, | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA, | KIRUNGI KAZI BOOSTER | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | LIQUID | 270ML | 4/5/23 |
| 35 | THA1094 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | KAZI BOOSTER MULONDO EXTRA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | LIQUID | 270ML | 26/05/2023 |
| 36 | THA1097 | BAMU INTERNATIONAL GROUP OF RESEARCHERS. | BAMU INTERNATIONAL GROUP OF RESEARCHERS. | BAMU HERBAL COUGH SYRUP | BAMU INTERNATIONAL GROUP OF RESEARCHERS. KIREKA-KAMULI ROAD ST.GONZAGA GONZA CATHOLIC PARISH0776992091/0755992091 | UGANDA | LIQUID | 1*2OOML AMBER PLASTIC BOTTLE | 25/07/2023 |
| 37 | THA1098 | BAMU INTERNATIONAL GROUP OF RESEARCHERS. KIREKA-KAMULI ROAD ST.GONZAGA GONZA CATHOLIC PARISH | BAMU INTERNATIONAL GROUP OF RESEARCHERS. KIREKA-KAMULI ROAD ST.GONZAGA GONZA CATHOLIC PARISH | BAMU B.P. LIQUID | BAMU INTERNATIONAL GROUP OF RESEARCHERS. KIREKA-KAMULI ROAD ST.GONZAGA GONZA CATHOLIC PARISH 0776992091/0755992091 | UGANDA | LIQUID | 250ML PET BOTTLE | 9/5/25 |
| 38 | THA1104 | SSENDEGE ISMAIL NSAMBYA 0761099626 | SSENDEGE ISMAIL NSAMBYA 0761099626 | MUQ CHARCOAL TOOTH PASTE | MUQ HABO PRODUCTS KAMPALA UGANDA NEAR KATWE PRIMARY SCHOOL TEL: +256761099626 +256755206349 | UGANDA | GEL | 50GM | 27/01/2023 |
| 39 | THA1110 | PHARMA FLEX LIMITED | PHARMA FLEX LIMITED | ULCEFLEX HERBAL POWDER | PHARMA FLEX LIMITED, NAMUGONGO BULOOLI ,WABUSAANA ,KIRA MUNICIPALITY , WAKISO DISTRICT , UGANDA, 0771756555 | UGANDA | POWDER | 1*3 SACHETS EACH 5G IN A CARTON | 4/5/23 |
| 40 | THA1113 | PROSS KABAALU LWADDA MATUGGA 0702885702,0779517027 | PROSS KABAALU LWADDA MATUGGA 0702885702,0779517027 | MPK HERBAL JELLY | MPK HERBAL PRODUCTS LWADDA MATUGGA NANSANA MUNICIPALITY WAKISO DISTRICT 0702885702,0779517027 | UGANDA | JELLY | 120GMS PLASTIC CONTAINER | 8/7/24 |
| 41 | THA1119 | KAGIMU BRAIZE BEN [email protected] 0775202561 / 0756575711 | KAGIMU BRAIZE BEN [email protected] 0775202561 / 0756575711 | DERMALIC TINCTURE | AKO LIFE SCIENCES UG LTD THE INNOVATION VILLAGE PLOT 34-38 FORTPORTAL ROAD RWEBIKOONA MBARARA | UGANDA | LIQUID | 1*20ML PET BOTTLE | 25/11/2024 |
| 42 | THA1122 | KABATERINE EDMAND, 0787870908 [email protected] NANTABULIRWA, GOMA, MUKONO DISTRICT | KABATERINE EDMAND, 0787870908 [email protected] NANTABULIRWA, GOMA, MUKONO DISTRICT | ZERO BYTE MOSQUITO REPELLENT BATHING BAR | KAKIE ORGANICS AND NUTRACEUTICALS LTD, WANDEGEYA,KAMPALA-UGANDA 0787 870908/0757 613026 | UGANDA | SOAP | 60GMS IN A BOX CARTON | 25/07/2023 |
| 43 | THA1132 | NSAALE HEALTH PRODUCTS PLOT 424 RUBAGA WAKALIGA B ZONE 0789261851/0753275292 | NSAALE HEALTH PRODUCTS PLOT 424 RUBAGA WAKALIGA B ZONE 0789261851/0753275292 | NSAALE ANTISEPTIC SOLUTION | NSAALE HEALTH PRODUCTS PLOT 424 RUBAGA WAKALIGA B ZONE 0789261851/0753275292 | UGANDA | LIQUID | 100ML AND 500ML CLEAR PLASTIC BOTTLE | 13/10/2023 |
| 44 | THA1136 | MUKWAYA JAMIR LUTAKOME, 0772538794/0702538794, NDEEBA OPP. TOTAL PETROL STATION | MUKWAYA JAMIR LUTAKOME, 0772538794/0702538794, NDEEBA OPP. TOTAL PETROL STATION | ZAMZAM HERBAL COUGH MIXTURE | BWAKEDDE MPULIRA TRADITIONAL MEDICINES NDEEBA OPP TOTAL PETROL STATION | UGANDA | LIQUID | 238ML PET BOTTLE | 27/02/2023 |
| 45 | THA1139 | MWEYUNDO HEALTH PRODUCTS LTD PLOT 4, RIVERSIDE ROAD, CENTRAL DIVISION | MWEYUNDO HEALTH PRODUCTS LTD PLOT 4, RIVERSIDE ROAD, CENTRAL DIVISION | MWECODEX | MWEYUNDO HEALTH PRODUCTS LTD PLOT 4, RIVERSIDE ROAD, CENTRAL DIVISION P.O.BOX 390051, FORT PORTAL TEL: +256752852051 +256786746493 | UGANDA | LIQUID | 200ML PET AMBER BOTTLE | 11/9/23 |
| 46 | THA1143 | NSAALE HEALTH PRODUCTS, PLOT 424, WAKALIGA B ZONE P.O BOX 174 NATEETE, KAMPALA,UGANDA | NSAALE HEALTH PRODUCTS, PLOT 424, WAKALIGA B ZONE P.O BOX 174 NATEETE, KAMPALA,UGANDA | NSAALE OINTMENT | NSAALE HEALTH PRODUCTS, PLOT 424, WAKALIGA B ZONE P.O BOX 174 NATEETE, KAMPALA,UGANDA TEL:+256789261851/+256753275292 | UGANDA | OINTMENT | 30ML BOTTLE | 9/5/25 |
| 47 | THA1159 | JOURNEY HST-SMC LIMITED,KABATEMA VILLAGE,LYANTONDE DISTRICT | JOURNEY HST-SMC LIMITED,KABATEMA VILLAGE,LYANTONDE DISTRICT | VH HERBAL SYRUP | JOURNEY HST-SMC LIMITED,KABATEMA VILLAGE,LYANTONDE DISTRICT TEL:0761 447901/0705207956/0777236550/0761434273 | UGANDA | LIQUID | 100ML AMBER PLASTIC BOTTLE | 28/05/2024 |
| 48 | THA1160 | JENNIFER BARUGAHARE KAVULE, SEMUTO ROAD,WAKISO,UGANDA 0772541880 | JENNIFER BARUGAHARE KAVULE, SEMUTO ROAD,WAKISO,UGANDA 0772541880 | B-JENNY HERBAL MEDICINE | JENNIFER BARUGAHARE KAVULE, SEMUTO ROAD,WAKISO,UGANDA 0772541880 | UGANDA | LIQUID | 280MLS PLASTIC BOTTLE | 5/3/24 |
| 49 | THA1164 | MAKULA HERBAL MEDICINE SEGUKU ALONG ENTEBBE ROAD,0759359275/0761836970 | MAKULA HERBAL MEDICINE SEGUKU ALONG ENTEBBE ROAD,0759359275/0761836970 | MAKULA COUGH MIXTURE | MAKULA HERBAL MEDICINE SEGUKU ALONG ENTEBBE ROAD,0759359275/0761836970 | UGANDA | LIQUID | 200ML COLOURED PLASTIC BOTTLE | 26/03/2024 |
| 50 | THA1166 | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO | MEDO BATHING BAR SOAP | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | UGANDA | SOAP | 120GMS | 14/06/2024 |
| 51 | THA1169 | FABEL KANYANYA GABRIEL KIREKA +256772457024 +447958288067 | FABEL KANYANYA GABRIEL KIREKA +256772457024 +447958288067 | STAMINA HERBAL BOOST | FABROSE PREMIUM HEALTH BOOSTER LTD KIREKA ZONE A WAKISO, UGANDA TEL:0700422378/0765101408 | UGANDA | POWDER | 100GM PET JAR | 25/11/2024 |
| 52 | THA1170 | FABEL KANYANYA GABRIEL KIREKA +256772457024 +447958288067 | FABEL KANYANYA GABRIEL KIREKA +256772457024 +447958288067 | CONNECT HERBAL BOOST | FABROSE PREMIUM HEALTH BOOSTER LTD KIREKA ZONE A WAKISO, UGANDA TEL:0700422378/0765101408 | UGANDA | POWDER | 100GM PET JAR | 25/11/2024 |
| 53 | THA1171 | FABEL KANYANYA GABRIEL +256772457024 +44795828806 KIREKA | FABEL KANYANYA GABRIEL +256772457024 +44795828806 KIREKA | ACTIMAX HERBAL BOOST | FABROSE PREMIMIUM HEALTH BOOSTER LTD KIREKA ZONE A TEL:+44958288067 +246772457024 | UGANDA | POWDER | 100G PET CONTAINER | 13/10/2023 |
| 54 | THA1172 | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | MEDO MOSQUITO REPELLANT JELLY | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | UGANDA | JELLY | 50GMS ,60GMS,120GMS AND 200GMS PLASTIC JAR | 25/07/2023 |
| 55 | THA1176 | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | BACTOFLEX | KATEREGGA ISMAEL,NAMUGONGO BULOOLI KIRA WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | UGANDA | CREAM | 10G AND 60 G COLLAPSIBLE PLASTIC TUBE | 17/11/2023 |
| 56 | THA1177 | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | CUREFLEX HERBAL CREAM CREAM | KATEREGGA ISMAEL,NAMUGONGO BULOOLI KIRA WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | UGANDA | CREAM | 10G AND 60 G COLLAPSIBLE PLASTIC TUBE | 17/11/2023 |
| 57 | THA1178 | MUSOKE H. TAMALE | MUSOKE H. TAMALE | SEAET SOLUTION | MUSOKE H. TAMALE KALAMA VILLAGE, KIKONGE-NSYAMBYA ROAD MITYANA DISTRICT P.BOX 11301, KAMPALA TEL: 0772306061, 0200961133 | UGANDA | LIQUID | 500ML PLASTIC BOTTLE | 15/09/2023 |
| 58 | THA1181 | KAYITARE JOHN,SHANGWE GROUP LTD,P.O.BOX 112226 KAMPALA ,TEL:0703188383/0771612736 | KAYITARE JOHN,SHANGWE GROUP LTD,P.O.BOX 112226 KAMPALA ,TEL:0703188383/0771612736 | SHANGWE HERBAL JELLY | SHANGWE GROUP LTD NYANAMA KAMPALA P.O.BOX 112226 KAMPALA UG NEAR NEW HOTEL BENCO TEL:0784106335 | UGANDA | JELLY | 120GMS PET JAR | 28/11/2023 |
| 59 | THA1182 | TK PHYTO ORGANICS NAMUYENJE- MUKONO 0787870908 [email protected] | TK PHYTO ORGANICS NAMUYENJE- MUKONO 0787870908 [email protected] | TK MILKING SALVE | TK PHYTO ORGANICS NAMUYENJE- MUKONO 0787870908 [email protected] | UGANDA | JELLY | 120GMS PET JAR | 4/1/24 |
| 60 | THA1184 | ZALUGAVE HERBAL MEDICINE LTD. P.O.BOX 10815,BULOBA OFF MITYANA ROAD 0392081170 | ZALUGAVE HERBAL MEDICINE LTD. P.O.BOX 10815,BULOBA OFF MITYANA ROAD 0392081170 | CHOCOMEL | ZALUGAVE HERBAL MEDICINE LTD. P.O.BOX 10815,BULOBA OFF MITYANA ROAD | UGANDA | LIQUID | 250ML PET BOTTLE | 15/07/2023 |
| 61 | THA1185 | BIGGI HERBAL CLINIC | BIGGI HERBAL CLINIC | BIGGI GO KOF | HELLEN NYILAK BIGGI HERBAL CLINIC P.O.BOX 10479 KAMPALA PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD TEL:0772484882/0705484882 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 8/7/24 |
| 62 | THA1189 | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088 | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088 | ARTHRITONE VASELINE | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088 | UGANDA | JELLY | 30G PLASTIC JAR | 2/4/25 |
| 63 | THA1191 | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088 | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088 | LINFATI IMMUNE UP | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088/077466 690A UGANDA | UGANDA | LIQUID | 100ML PET BOTTLE | 5/5/25 |
| 64 | THA1200 | JENA HERBALS (U) LTD | JENA HERBALS (U) LTD | JENAMOS | JENA HERBALS (U) LTD, PLOT 232, HOUSE NO.11 WALNUT AVENUE ALKRIGHT CITY, ENTEBBE ROAD-UGANDA TEL: +256709036598 +256700412666 | UGANDA | LOTION | 1*60ML, 1*100ML, 1*200ML PLASTIC BOTTLE | 23/06/2025 |
| 65 | THA1215 | BULEGA JOSEPH 0772661257, 0751794315 MASAKA CITY | BULEGA JOSEPH 0772661257, 0751794315 MASAKA CITY | KWESIIMA HERBAL POWDER | KWESIIMA HERBAL MEDICINE LTD P.O.BOX MASAKA TEL: 0772661257/ 0751794315/ 0705518257 EMAIL: [email protected] | UGANDA | POWDER | 10G SACHET | 30/09/2024 |
| 66 | THA1223 | JADWIGA NOWAK, MSC., N.D., PHD. MUSOSIERA KABOGO RD, BUNGA, KAWUKU,+256781703171 | JADWIGA NOWAK, MSC., N.D., PHD. MUSOSIERA KABOGO RD, BUNGA, KAWUKU | SUPPORT + | DOCTOR’S CHOICE LTD PLOT 9-17 JINJA INDUSTRIAL AREA P.O. BOX 314 JINJA, UGANDA | UGANDA | CAPSULES | 1*60 VEG CAPSULES IN HDPE CONTAINER | 5/4/24 |
| 67 | THA1228 | TENDO MUYO ORGANIC HERBALS LTD KIJABIJO, OFF GAYAZA ROAD TEL:0772166541 | TENDO MUYO ORGANIC HERBALS LTD KIJABIJO, OFF GAYAZA ROAD TEL:0772166541 | REXA SYRUP | TENDO MUYO ORGANIC HERBALS LTD KIJABIJO, OFF GAYAZA ROAD TEL:0772166541 | UGANDA | LIQUID | 120 & 200ML PET BOTTLE | 17/02/2025 |
| 68 | THA1230 | MIOWA PHARMACEUTICALS LIMITED PLOT 60, BUKOTO STREET, KAMPALA | MIOWA PHARMACEUTICALS LIMITED PLOT 60, BUKOTO STREET, KAMPALA | COOL STING PAIN RELIEF LOTION | MIOWA PHARMACEUTICALS LIMITED PLOT 60, BUKOTO STREET, KAMPALA TEL: 0706688288/0777717481 EMAIL: [email protected] | UGANDA | LOTION | 1*30ML PLASTIC BOTTLE IN A CARTON | 18/09/2024 |
| 69 | THA1231 | WONDER PLANTS LTD | WONDER PLANTS LTD | BEWAIBO TINCTURE | WONDER PLANTS LTD, BUJUUKO TRADING CENTER,MITYANA ROAD OFF KAKIRI,RODA KATEETE VILLAGE TEL: 0751 702317 | UGANDA | LIQUID | 20ML IN A PLASTIC BOTTLE | 17/02/2025 |
| 70 | THA1234 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | VIROMIN | AMIREC MEDICINE OYAM DISTRICT-UGANDA TEL:+256776525482 +256750304429 +256776192198 EMAIL: [email protected] | UGANDA | LIQUID | 500ML PET BOTTLE | 5/6/25 |
| 71 | THA1235 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | HAEMOTECH D2 | AMIREC MEDICINE OYAM DISTRICT-UGANDA TEL:+256776525482 +256750304429 +256776192198 EMAIL: [email protected] | UGANDA | LIQUID | 500ML PET BOTTLE | 5/6/25 |
| 72 | THA1236 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | AYUU 23 | AMIREC MEDICINE OYAM DISTRICT-UGANDA TEL:+256776525482 +256750304429 +256776192198 EMAIL: [email protected] | UGANDA | LIQUID | 500ML PET BOTTLE | 5/6/25 |
| 73 | THA1237 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | AGOLE PETER EMAIL: [email protected] TEL: 0776525482/0750304429 | DIATOX DT | AMIREC MEDICINE OYAM DISTRICT-UGANDA TEL:+256776525482 +256750304429 +256776192198 EMAIL: [email protected] | UGANDA | LIQUID | 500ML PET BOTTLE | 5/6/25 |
| 74 | THA1243 | MUKISA EMMANUEL, FINCET INVESTMENTS LTD. P.O.BOX 150365, KIYUNGA, KABEMBE, MUKONO | MUKISA EMMANUEL, FINCET INVESTMENTS LTD. P.O.BOX 150365, KIYUNGA, KABEMBE, MUKONO | CLINELA LINCTUS | FINCET INVESTMENTS LTD. P.O.BOX 150365, KIYUNGA, KABEMBE, MUKONO, +2560704439431 | UGANDA | LIQUID | 200ML AMBER COLOURED PLASTIC BOTTLE | 27/08/2024 |
| 75 | THA1246 | DR. KAWOOYA FRANCIS, PHARMD, MPS ALOESHA ORGANIC NATURAL HEALTH PRODUCTS | DR. KAWOOYA FRANCIS, PHARMD, MPS ALOESHA ORGANIC NATURAL HEALTH PRODUCTS | ALOEMIX LIQUID | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, PRODUCE ON FACILITY, KIYANJA ZONE, MPERERWE 075140144/0777110158 | UGANDA | LIQUID | 720ML PLASTIC CONTAINER | 17/07/2024 |
| 76 | THA1251 | LUK VITAL HERBAL GROUP PRIME VILLAGE MALL-ROOM D19,TEL:0757964871 | LUK VITAL HERBAL GROUP PRIME VILLAGE MALL-ROOM D19,TEL:0757964871 | VITALIA | YECO ORGANIC MANAGEMENT LTD,MATUGGA-BOMBO ROAD,PLOT 1972 | UGANDA | LIQUID | 500ML PLASTIC BOTTLE | 18/04/2024 |
| 77 | THA1253 | KANSIIME VICTOR 0782939682/0702401422 [email protected] | KANSIIME VICTOR 0782939682/0702401422 [email protected] | VICTACID | MILLIONSTARS HEALTH PRODUCTS CO. LTD UIA SMES INDUSTRIAL PARK, MAKENKE-MBARARA CONTACT: 0702401422 / 0782939682 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 31/03/2025 |
| 78 | THA1255 | PUBUNGU HERBALS,PLOT 11621, KAYEBE ROAD,GAYAZA,WAKISO DISTRICT, UGANDA, P.O.BOX 114,WAKISO | PUBUNGU HERBALS,PLOT 11621, KAYEBE ROAD,GAYAZA,WAKISO DISTRICT, UGANDA, P.O.BOX 114,WAKISO | P-AKINI HERBAL GEL | PUBUNGU HERBALS,PLOT 11621, KAYEBE ROAD,GAYAZA,WAKISO DISTRICT, UGANDA, P.O.BOX 114,WAKISO TEL: 0777060854/0703460747 | UGANDA | GEL | 20GRAMS PACKED IN A COLLAPSIBLE LAMINATED TUBE | 8/7/24 |
| 79 | THA1260 | AGRIM AYUCARE LTD,P.O BOX 690088, KYOTERA SSESAMIREMBE, UGANDA | AGRIM AYUCARE LTD,P.O BOX 690088, KYOTERA SSESAMIREMBE, UGANDA | AGRIM SHULAHARA TAIL | AGRIM AYUCARE LTD,P.O BOX 690088, KYOTERA SSESAMIREMBE, UGANDA TEL: +256759073920 ,+256786738090,+919016585934 EMAIL: [email protected] | UGANDA | LIQUID | 25ML IN A PLASTIC BOTTLE | 28/06/2024 |
| 80 | THA1263 | MUYOMBYA SOLOMON 0772166541/0787368458/0703531491 | MUYOMBYA SOLOMON 0772166541/0787368458/0703531491 | MAZA-LACT | MANUFACTURED AT YECO ORGANICS FOR TENDO MUYO ORGANIC HERBALS LTD | UGANDA | LIQUID | 1*200MLS IN AMBER PLASTIC BOTTLE IN A CARTON | 3/10/24 |
| 81 | THA1264 | TK PHYTO ORGANICS NAMUYENJE, MUKONO, 0787870908/0775508556 | TK PHYTO ORGANICS NAMUYENJE, MUKONO, 0787870908/0775508556 | WONDX WOUND SPRAY | TK PHYTO ORGANICS,PLOT 42A,UGANDA INDUSTRIAL RESEARCH INSTITUTE,NAKAWA INDUSTRIAL AREA, TEL:0775 508 556/0200 938 877 | UGANDA | LIQUID | 1*120ML PLASTIC BOTTLE | 24/01/2025 |
| 82 | THA1265 | EARTH NATURAL LIFE LIMITED MAWANDA ROAD NEAR YUDESI PRIMARY SCHOOL | EARTH NATURAL LIFE LIMITED MAWANDA ROAD NEAR YUDESI PRIMARY SCHOOL | INFLA OINTMENT | YECO ORGANIC MANAGEMENT LTD. BOMBO ROAD,MATUGGA,WAKISO | UGANDA | OINTMENT | 1*30GM | 18/09/2024 |
| 83 | THA1266 | MERCY HERBAL PRODUCTS, LUWEERO TOWN ALONG GULU HIGHWAY | MERCY HERBAL PRODUCTS, LUWEERO TOWN ALONG GULU HIGHWAY | ZELO HERBAL COUGH SOLUTION | MERCY HERBAL PRODUCTS, LUWEERO TOWN ALONG GULU HIGHWAY TEL: 0787356626/0703586042 | UGANDA | LIQUID | 1*150 ML PLASTIC BOTTLE | 7/10/24 |
| 84 | THA1273 | C-HER FOUNDATION LTD UGANDA,CENTRAL, KAMPALA, MAKINDYE DIVISION, BUZIGA, UPPER BUZIGA | C-HER FOUNDATION LTD UGANDA,CENTRAL, KAMPALA, MAKINDYE DIVISION, BUZIGA, UPPER BUZIGA | C-HER HERBAL BALM | C-HER FOUNDATION LTD UGANDA,CENTRAL, KAMPALA, MAKINDYE DIVISION, BUZIGA, UPPER BUZIGA (+256)706111531/780878585 [email protected] | UGANDA | OINTMENT | 80GMS | 30/09/2024 |
| 85 | THA1277 | BWERA INNOVATIONS LTD P.O BOX 151839, MUKONO,UGANDA. TEL: 0787870908 0885508556 | BWERA INNOVATIONS LTD P.O BOX 151839, MUKONO,UGANDA. TEL: 0787870908 0885508556 | KEIRAVIT PLUS | BWERA INNOVATIONS LTD. PLOT 42A, UGANDA INDUSTRIAL RESEARCH INSTITUTE TEL: +2560200938877 +256775508556 | UGANDA | SOLUTION | 1*120ML 1*250ML 1*500ML 1* 1 LITER OPAQUE HDPE BOTTLE | 16/01/2025 |
| 86 | THA1301 | ZALUGAVE HERBAL MEDICINE, P.O BOX 181544, BULOBA OFF MITYANA +256703513645/0774499894 | ZALUGAVE HERBAL MEDICINE, P.O BOX 181544, BULOBA OFF MITYANA +256703513645/0774499894 | SOLANGE WOMEN SYRUP | ZALUGAVE HERBAL MEDICINE, P.O BOX 181544, BULOBA OFF MITYANA +256703513645/0774499894 | UGANDA | LIQUID | 60ML PET BOTTLE | 25/11/2024 |
| 87 | THA1302 | KYAMBALAGO MUTWALIB BUDDO, KASOZI TEL: 0702230262/070223062/0787706674 | KYAMBALAGO MUTWALIB BUDDO, KASOZI TEL: 0702230262/070223062/0787706674 | AL BASSAAM COUGH SYRUP | YECO ORGANIC MANAGEMENT LTD, MATUGA, BOMBO ROAD. FOR: AL BASSAM LOCATED AT MUKWANO ARCADE, SHOP DG07A TEL: 0702-230262/0787706674/0759680536 | UGANDA | SYRUP | 200ML AND 100ML AMBER PET BOTTLES | 23/06/2025 |
| 88 | THA1324 | JADWIGA NORWAK, MSC, N.D, PHD.KAWUKU, KAMPALA. UGANDA. P.O.BOX 9490 +256781703171 | JADWIGA NORWAK, MSC, N.D, PHD.KAWUKU, KAMPALA. UGANDA. P.O.BOX 9490 +256781703171 | GLUCO+ | MANUFACTURED BY DOCTOR’S CHOICE LTD PLOT 9-17 JINJA INDUSTRIAL AREA P. O. BOX 314 JINJA, UGANDA. | UGANDA | ORAL CAPSULES | 1*60 CAPSULE PLASTIC BOTTLE | 23/06/2025 |
| 89 | THA1338 | DR. SAMUEL BAKER OBAKIRO, PH.D NATURAL PRODUCTS RESEARCH AND INNOVATION CENTER | DR. SAMUEL BAKER OBAKIRO, PH.D NATURAL PRODUCTS RESEARCH AND INNOVATION CENTER | GLUCOTAK HERBAL SYRUP | NATURAL PRODUCTS RESEARCH AND INNOVATION CENTRE, BUSITEMA UNIVERSITY FACULTY OF HEALTH SCIENCE, P.O BOX 1460, MBALE (U), 0704946479 | UGANDA | ORAL SOLUTION | 1*200ML AMBER PLASTIC BOTTLE | 2/6/25 |
| 90 | THA137 | DEI NATURAL PRODUCTS INTERNATIONAL LTD | DEI NATURAL PRODUCTS INTERNATIONAL LTD | ARTAVOL | DEI NATURAL PRODUCTS INTERNATIONAL LTD,PLOT 5685-KABAGAMBE CLOSE-MUYENGA P.O.BOX 35854,KAMPALA UGANDA TEL: +256 414-660-519 MOB: +256-752- | UGANDA | POWDER | 1*100GM IN A METALLIC TIN | 17/06/2019 |
| 91 | THA171 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | DARACUF HERBAL COUGH MIXTURE | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | UGANDA | LIQUID | 120ML PET BOTTLE WITH PRINTED LABEL AND SEALED WITH A WHITE LDPE CAP | 1/10/21 |
| 92 | THA183 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | KWESIIMA COUGH MIXTURE | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | UGANDA | SUSPENSION | 1*200ML PET BOTTL | 3/2/20 |
| 93 | THA197 | NAKAGWA HENRICA,KISAASI,KAMPALA | NAKAGWA HENRICA,KISAASI,KAMPALA | PALANS COUGH MIXTURE | NAKAGWA HENRICA,KISAASI,KAMPALA,TEL 0700 665917/0782 007752 | UGANDA | SYRUP | 1*100ML,PET BOTTLE | 28/08/2021 |
| 94 | THA198 | AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA | AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA | STILE HERBAL SOLUTION | AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA +256782361761/ +256753361761 EMAIL: [email protected] | UGANDA | LIQUID | 1*500ML PET BOTTLE | 17/07/2018 |
| 95 | THA206 | GREEN PHARMACY | GREEN PHARMACY | AGNUS CACTUS | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA A MASAKA,TEL: 0779 829914 | UGANDA | ORAL SOLUTION | 1*100ML AMBER PET BOTTLE | 6/2/17 |
| 96 | THA207 | GREEN PHARMACY | GREEN PHARMACY | CALENDULA | GREEN PHARMACY 11 POKINO LUZIGE ROAD, KIRUMBA “A” MASAKA,TEL:0779 829914 | UGANDA | OINTMENT | 50GRAMS | 28/08/2021 |
| 97 | THA209 | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA ‘A’ MASAKA P.O BOX 886, MASAKA. TEL:0779829914 | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA ‘A’ MASAKA P.O BOX 886, MASAKA. TEL:0779829914 | BODY REJUVENATING TONIC | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA ‘A’ MASAKA P.O BOX 886, MASAKA. TEL:0779829914 | UGANDA | LIQUID | 100ML HDPE BOTTLE | 9/11/20 |
| 98 | THA210 | GREEN PHARMACY | GREEN PHARMACY | AMBER PAIN STOP | GREEN PHARMACY 11 POKINO LUZIGE ROAD, KIRUMBA “A” MASAKA TEL: 0779 829914 | UGANDA | OINTMENT | 50GRAMS | 28/08/201 |
| 99 | THA211 | GREEN PHARMACY | GREEN PHARMACY | BLOOD CLEANSER AND DETOXIFIER | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA A MASAKA,TEL: 0779 829914 | UGANDA | ORAL LIQUID | 100ML PET BOTTLE | 6/2/17 |
| 100 | THA212 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | TEEMAC A4 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 40GMS AND 18GMS | 6/4/18 |
| 101 | THA213 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | MONITEEMAC BA4 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 18GMS AND 32 GMS | 6/4/18 |
| 102 | THA214 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | TEEMONI B4 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 50GMS & 35GMS | 6/4/18 |
| 103 | THA215 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | TEEBUO | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 15GMS & 6GMS | 6/4/18 |
| 104 | THA226 | MBUNDA HEALTH PRODUCTS | MBUNDA HEALTH PRODUCTS | MBUNDA HERBAL COUGH SYRUP | MBUNDA HEALTH PRODUCTS 0771-448469/ 0758-555876/0700-507258 KATEMBWA, BUNYANGABO, KASESE DISTRICT | UGANDA | SYRUP | 100MLS IN A WHITE BOTTLE | 26/04/2019 |
| 105 | THA229/01/16 | CREST NATURAL HEALTH CENTRE | CREST NATURAL HEALTH CENTRE | PROST TINCTURE | CREST NATURAL HEALTH CENTRE A.K PLAZA OPPOSITE ALOYSIUS COMPLEX KALERWE, ,DR.LUTWAAMA GEORGE TEL: 0770 704 880/ 0750 185 580 | UGANDA | SOLUTION | 1*20ML HDPE | 31/05/2016 |
| 106 | THA247 | YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD | YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD | YECO COUGH DOCTOR | YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD, TEL: +256 705 454951 | UGANDA | SYRUP | 1*120ML HDPE AMBER BOTTLE | 6/2/17 |
| 107 | THA248 | BULUNSI NEDAGALA LYAAYO TEL: 0782277324 | BULUNSI NEDAGALA LYAAYO TEL: 0782277324 | BNL-FEVALEX HERBAL MEDICINE | BULUNSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 23/01/2025 |
| 108 | THA249 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULUNSI NEDAGALA LYAAYO TEL: 0782277324 | SEHILADUM HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 23/01/2025 |
| 109 | THA250 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | LS HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 23/01/2025 |
| 110 | THA251 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | TRANO HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 24/01/2025 |
| 111 | THA252 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | SIRIKOFF HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 23/01/2025 |
| 112 | THA253 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | KIRIB HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 6/3/25 |
| 113 | THA271 | MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748 | MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748 | MATIA SSETUTEMBA HERBAL REMEDIES | MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748 | UGANDA | LIQUID | 5 L HDPE CAN | |
| 114 | THA284 | RUTEDA HERBAL PRODUCTS, NTUNGAMO,RUBAARE 0772369781/0752 369 781 [email protected] | RUTEDA HERBAL PRODUCTS, NTUNGAMO,RUBAARE 0772369781/0752 369 781 [email protected] | RUTEDA LADY’S MANTLE | RUTEDA HERBAL PRODUCTS, NTUNGAMO,RUBAARE 0772369781/0752 369 781 [email protected] | UGANDA | LIQUID | 1*400ML AND 1*800ML PET BOTTLE | 1/10/21 |
| 115 | THA289 | PIPAX LTD | PIPAX LTD | DERMACOL | PIPAX LTD,PLOT 20 BUZIGA RING ROAD KAMPALA, MR.EGUMAH PIE,TEL:0754 618691 | UGANDA | ORAL SUSPENSION | 100ML AMBER PET BOTTLE | 6/2/17 |
| 116 | THA290 | JONITA INVESTMENTS,MUTUNDWE, MIREMBE ZONE | JONITA INVESTMENTS,MUTUNDWE, MIREMBE ZONE | SAVANAH HERBAL SYRUP | JONITA INVESTMENTS,MUTUNDWE, MIREMBE ZONE TEL: 0756 636262/0784908004EMAIL: [email protected] | UGANDA | SYRUP | 1*100ML PLASTIC AMBER BOTTLE | 25/01/2019 |
| 117 | THA291 | DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338 | DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338 | DAMALEO VERA TABLETS | DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338 | UGANDA | TABLETS | 1*5*10 ALU-PVC BLISTERS | 12/3/18 |
| 118 | THA292 | GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD | GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD | GABOGOLA SYRUP | GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD,TEL:0772 532353,EMAIL:[email protected] | UGANDA | SYRUP | 300ML GLASS BOTTLE | 29/03/2018 |
| 119 | THA294 | KIWANUKA AND SONS HERBAL SERVICES | KIWANUKA AND SONS HERBAL SERVICES | LUCAS SYRUP | KIWANUKA AND SONS HERBAL SERVICES,BWEYOGERERE NTEBETEBE ZONE,P.O.BOX 9263,KAMPALA-UGANDA TEL: 0772 511153/0754 280 718 | UGANDA | SYRUP | 1*100ML AMBER GLASS BOTTLE | 14/11/2018 |
| 120 | THA295 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL COUGH SYRUP | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | UGANDA | SYRUP | 100ML &200ML PET BOTTLE | 10/10/17 |
| 121 | THA296 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI ULCER HERBAL MEDICINE | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | UGANDA | SYRUP | 100ML &200ML PET BOTTLE | 10/10/17 |
| 122 | THA297 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL MALARIA SYRUP | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | UGANDA | SYRUP | 100ML &200ML PET BOTTLE | 10/10/17 |
| 123 | THA301 | MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA | MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA | MALARID | MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA | UGANDA | SYRUP | 1*60ML PET BOTTLE | 29/08/2017 |
| 124 | THA302 | BANGI BALISIMA UNITED AFRICAN MEDICINE INDUSTRY AND PHARMACY RESEARCH CENTRE, NAKASEKE,SEMUTO | BANGI BALISIMA UNITED AFRICAN MEDICINE INDUSTRY AND PHARMACY RESEARCH CENTRE, NAKASEKE,SEMUTO | SUPER MULABE | BANGI BALISIMA UNITED AFRICAN MEDICINE INDUSTRY AND PHARMACY RESEARCH CENTRE,NAKASEKE,SEMUTO +256 75000580 | UGANDA | LIQUID | 300ML HDPE BOTTLE | 9/11/20 |
| 125 | THA321 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | IPS HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 23/01/2025 |
| 126 | THA322 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | DIAHERB HERBAL MEDICIINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | SUSPENSION | 1*100ML PET BOTTLE | 23/01/2025 |
| 127 | THA323 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | TULAR HERBAL MEDICINE | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 24/04/2025 |
| 128 | THA324 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | FRESTONE HERBAL MEDICINE | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 23/06/2025 |
| 129 | THA325 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | KIDZOREN HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 6/3/25 |
| 130 | THA326 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | BULINSI NEDAGALA LYAAYO TEL: 0782277324 | TRACTDUM HERBAL MEDICINE | BULINSI NEDAGALA LYAAYO, KIGOOGWA-MITYANA, UGANDA TEL: 0782277324/0705268684 EMAIL; [email protected] | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 6/3/25 |
| 131 | THA327 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA | LIVOHERT HERBAL MEDICINE | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 31/03/2025 |
| 132 | THA328 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA | LEUKAID HERBAL MEDICINE | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 20/03/2025 |
| 133 | THA329 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | RESPILUN HERBAL MEDICINE | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 20/03/2025 |
| 134 | THA330 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | EMODEN HERBAL MEDICINE | BULINSI N’EDAGALA LYAAYO KIGOOGWA – MITYANA, UGANDA TEL: +256 782 277 324, +256 705 268 684 | UGANDA | ORAL SUSPENSION | 1*100ML PLASTIC BOTTLE IN A CARTON | 20/03/2025 |
| 135 | THA331 | AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115 | AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115 | BAYAN HERBAL SYRUP | AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115 | UGANDA | SYRUP | 50ML AMBER PLASTIC BOTTLE | 8/11/17 |
| 136 | THA333 | MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT | MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT | MAMULA COUGH MIXTURE | MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT | UGANDA | LIQUID | 400ML BOTTLE | 27/02/2018 |
| 137 | THA342 | ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA | ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA | ROPER FREE MOSQUITO REPELLENT | ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA,TEL:+256 770838356/+256 772 421235, [email protected] | UGANDA | EMULSION | 1*100 ML & 1* 60 ML HDPE BOTTLE | 23/01/2018 |
| 138 | THA344 | SSEKANDI HAKIM HASHA PRODUCT (U) LTD, 0751110866/0703110866 [email protected] | SSEKANDI HAKIM HASHA PRODUCT (U) LTD, 0751110866/0703110866 [email protected] | HASHA HERBAL COUGH MIXTURE | HASHA PRODUCT (U) LTD,KAMPALA,NSANGI,KYENGERA,MASAKA ROAD,UGANDA | UGANDA | LIQUID | 1*60ML PET BOTTLE | 7/9/22 |
| 139 | THA347 | RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO | RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO | DEFENDER TONIC | RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO | UGANDA | POWDER | 1*100G BOTTLE | 20/09/2017 |
| 140 | THA354 | GWOWONYA EGGERE HERBAL SERVICES | GWOWONYA EGGERE HERBAL SERVICES | HEG HERBAL MOUTHWASH | GWOWONYA EGGERE HERBAL SERVICES 0704578355 [email protected] P. O. BOX 30982 KAMPALA UGANDA | UGANDA | SOLUTION | 200ML PET BOTTLE | 27/02/2018 |
| 141 | THA355 | ZURI HOMEOPATHICS | ZURI HOMEOPATHICS | TYPHO-CURUM | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 [email protected] | UGANDA | SYRUP | 1*60ML AMBER PET BOTTLE | 8/11/17 |
| 142 | THA357 | VISIONARY HEALTH LINK KAMPALA UGANDA 0751501406 | VISIONARY HEALTH LINK KAMPALA UGANDA 0751501406 | BREMOXI | VISIONARY HEALTH LINK KAMPALA UGANDA 0751501406 | UGANDA | SYRUP | 1*100ML PET BOTTLE | 14/11/2018 |
| 143 | THA359 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | MZAVA | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | UGANDA | POWDER | 150GM POWDER | 2/12/22 |
| 144 | THA361 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | SIMMA HERBAL COUGH SYRUP | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | UGANDA | SYRUP | 1*120ML IN AMBER LDPE BOTTLE | 21/05/2019 |
| 145 | THA362 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | HERBEM NATURAL MOUTHWASH | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | UGANDA | SOLUTION | 120ML IN LDPE BOTTLE | 21/05/2019 |
| 146 | THA363 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | RUMATI | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | UGANDA | OINTMENT | 1*30G IN LDPE JAR | 21/05/2019 |
| 147 | THA364 | TAYEBWA HEALTH PRODUCTS LTD | TAYEBWA HEALTH PRODUCTS LTD | TAYEBWA HERBAL COUGH SYRUP | TAYEBWA HEALTH PRODUCTS LTD KASHASHA CELL – ITOJO PARISH RUHAMA SUBCOUNTY, NTUNGAMO DISTRICT 0772-927206 | UGANDA | SYRUP | 1*100ML AMBER PET BOTTLE | 1/12/17 |
| 148 | THA366 | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION | TESOCOKO “B” | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION SABAGABO-MAKINDYE MUNICIPALITY WAKISO DISTRICT 0779071321/0704510148 | UGANDA | POWDER | 1*100G IN A CLEAR PET JAR | 20/09/2017 |
| 149 | THA367 | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION | TESOCOKO “G” | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION SABAGABO-MAKINDYE MUNICIPALITY WAKISO DISTRICT 0779071321/0704510148 | UGANDA | POWDER | 1*100G IN A CLEAR PET JAR | 20/09/2017 |
| 150 | THA368 | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA | HEG HERBAL COUGH MIXTURE | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 0700 3134484 | UGANDA | LIQUID | 200ML | 6/4/18 |
| 151 | THA369 | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448 | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448 | HEG HERBAL ULCER SOLUTION | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448 | UGANDA | SOLUTION | 500ML IN AN HDPE BOTTLE | 31/01/2018 |
| 152 | THA371 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | MUCURA HERBAL MEDICINE | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 153 | THA372 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | WAMPEMBE SYRUP | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 154 | THA373 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | GANYANA HERBAL MEDICINE | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 155 | THA374 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | MWAMBALA HERBAL MEDICINE | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 156 | THA377 | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 [email protected] | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 [email protected] | MUWEREZA HERBAL COUGH REMEDIES | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 [email protected] | UGANDA | SYRUP | 1*200ML IN AN HDPE BOTTLE | 31/01/2018 |
| 157 | THA378 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | MUWEBWA INTESTINAL CLEANSER | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | UGANDA | POWDER | 1*10G SACCHET | 3/2/20 |
| 158 | THA380 | SKY HEALTH CARE LTD BUGOBA ZONE SEETA-MUKONO DISTRICT | SKY HEALTH CARE LTD BUGOBA ZONE SEETA-MUKONO DISTRICT | ZYLAM HERBAL MIXTURE | SKY HEALTH CARE LTD BUGOBA ZONE SEETA-MUKONO DISTRICT. KAMPALA OFFICE: PT. 7 MARKET STREET OFF SUITE A2 1ST FLOOR TEL:0781492638 | UGANDA | LIQUID | 200ML AMBER PET BOTTLE IN A CARTON | 19/03/2021 |
| 159 | THA381 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | GASTUM HERBAL MIXTURE | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | UGANDA | LIQUID | 120ML PET BOTTLE WITH PRINTED LABEL AND SEALED WITH A WHITE LDPE CAP | 1/10/21 |
| 160 | THA382 | TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA | TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA | KKATALEMWA HERBAL COUGH MIXTURE | TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA 0703678484/ 0774464843 | UGANDA | LIQUID | *200ML WHITE PET BOTTLE AND 1*100ML WHITE PET BOTTLE. | 4/6/18 |
| 161 | THA383 | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 [email protected] | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 [email protected] | REZA LIN FOR ULCER | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 [email protected] | UGANDA | SYRUP | 200ML AND 500ML IN HDPE BOTTLES | 31/01/2018 |
| 162 | THA384 | HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492 | HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492 | MABIRA HERBAL TEA SPICE | HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492 | UGANDA | POWDER | 100GMS IN A TRANSPARENT PLASTIC JAR | 31/01/2018 |
| 163 | THA385 | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | N’ZURI DEWORMER | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 [email protected] | UGANDA | SOLUTION | 60ML AND 100ML PET BOTTLE | 12/3/18 |
| 164 | THA386 | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | GUT REPLENISHER | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 [email protected] | UGANDA | SOLUTION | 100ML PET BOTTLE | 12/3/18 |
| 165 | THA387 | SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA | SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA | RENA ULCER SOLUTION | SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA +256-775-199-750/ +256-703-830-538 | UGANDA | SOLUTION | 1*500ML PET BOTTLE | 6/4/18 |
| 166 | THA388 | JAGGWE MARIAM [email protected] HAJJAT MASITUULAH HERBAL PRODUCTS LTD | JAGGWE MARIAM [email protected] HAJJAT MASITUULAH HERBAL PRODUCTS LTD | SUPER ROCK | JAGGWE MARIAM [email protected] HAJJAT MASITUULAH HERBAL PRODUCTS LTD SALAAMA ROAD, KULEKAANA STAGE 0773303330/0701400412/0751303330 | UGANDA | POWDER | 1*200G IN A TRANSPARENT HDPE JAR | 17/06/2019 |
| 167 | THA389 | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD | SACCO SYRUP | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD P.O.BOX 7876 PLOT 17, TULA ROAD, KIYANJA ZONE, MPERERWE, KAMPALA, UGANDA 0704356951/0776290548 | UGANDA | SYRUP | 1*110ML PET AMBER BOTTLE | 7/3/18 |
| 168 | THA390 | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE | REVITAL | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE P.O.BOX 7876 KAMPALA,PLOT 17 0752940747/0414692983 | UGANDA | SOLUTION | 1*720ML HDPE BOTTLE | 16/01/2018 |
| 169 | THA393 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | WATER FORM | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | UGANDA | LIQUID | 500MLS | 20/08/2019 |
| 170 | THA394 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | RED LIQUID | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | UGANDA | LIQUID | 500MLS | 20/08/2019 |
| 171 | THA398 | MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249 | MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249 | POMADAT | MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249 | UGANDA | OINTMENT | 1*50G HDPE JAR | 13/02/2018 |
| 172 | THA399 | RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 [email protected] | RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 [email protected] | HIBISC HERBAL MIXTURE | RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 [email protected] | UGANDA | SOLUTION | 1*500ML HDPE BOTTLE | 13/02/2018 |
| 173 | THA400 | RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO [email protected] 0785374627 | RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO [email protected] 0785374627 | RWEHIDI DETOXER | RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO [email protected] 0785374627 | UGANDA | SOLUTION | 1*500MLS IN A PET BOTTLE | 23/01/2018 |
| 174 | THA405 | DAMA MEDICINAL HERBS. | DAMA MEDICINAL HERBS. SEROMA SHOPPERS STOP PLAZA 1ST FLOOR, ROOM A/F/11 P.O.BOX 25216 KLA,UG | DAMA TOOTH GEL | DAMA MEDICINAL HERBS. SEROMA SHOPPERS STOP PLAZA 1ST FLOOR, ROOM A/F/11 P.O.BOX 25216 KLA,UG 0758684274/0772684274 [email protected] | UGANDA | GEL | 1*50ML TUBE | 6/4/18 |
| 175 | THA407 | DOCTOR’S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:[email protected] | DOCTOR’S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:[email protected] | REPLENISH+ | DOCTOR’S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:[email protected] | UGANDA | CAPSULES | 1*90 IN AN HDPE BOTTLE,1*10 AND 1*3*10 BLISTERS | 19/09/2018 |
| 176 | THA410 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | KIRUNGI AYI AYI | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | OINTMENT | 20GMS HDPE JAR | 26/05/2023 |
| 177 | THA411 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | KIRUNGI HERBAL MOUTHWASH | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | LIQUID | 50ML HDPE BOTTLE | 26/05/2023 |
| 178 | THA413 | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | TOWA BUTWA | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | UGANDA | POWDER | 150G | 18/03/2020 |
| 179 | THA414 | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | ROZE POWDER | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | UGANDA | POWDER | 150G | 18/03/2020 |
| 180 | THA415 | EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299. | EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299. | CLEDARI HERBAL HYDRO GEL | EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299. | UGANDA | OINTMENT | 200GMS AND 50GMS | 16/01/2018 |
| 181 | THA416 | RASHID SADAM LUKWAGO,WAKALIGA NATEETETEL: 0772 512372 | RASHID SADAM LUKWAGO,WAKALIGA NATEETETEL: 0772 512372 | SHID COUGH SYRUP | RASHID SADAM LUKWAGO,WAKALIGA NATEETETEL: 0772 512372 | UGANDA | LIQUID | 1*250ML PLASTIC BOTTLE | 25/01/2019 |
| 182 | THA417 | UGANDAN WISDOM HERBAL RESEARCH CENTRE, SAZA ROAD, IGANGA TOWN- UGANDA | UGANDAN WISDOM HERBAL RESEARCH CENTRE, SAZA ROAD, IGANGA TOWN- UGANDA | FUNGUA | UGANDAN WISDOM HERBAL RESEARCH CENTRE, SAZA ROAD, IGANGA TOWN- UGANDA 0782196350/0752196350 | UGANDA | SUSPENSION | 1*500ML IN LDPE BOTTLE | 9/9/19 |
| 183 | THA419 | ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, [email protected] 0703062799 | ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, [email protected] 0703062799 | USHA HERBAL ULCER SYRUP | ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, [email protected] 0703062799 | UGANDA | LIQUID | 500MLS PET BOTTLE | 7/3/18 |
| 184 | THA425 | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWATTE 7 MILES OFF GAYAZA ROAD 0773219404/0705005896 | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWATTE 7 MILES OFF GAYAZA ROAD 0773219404/0705005896 | SMCU HERBAL TONIC | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWATTE 7 MILES OFF GAYAZA ROAD 0773219404/0705005896 | UGANDA | POWDER | 170G IN POLYTHENE IN A UNIT CARTON | 19/02/2021 |
| 185 | THA426 | SMCU HERBAL RESEARCH CENTRE,KUNGU,DUWAATE,KIRA MUNICIPALITY | SMCU HERBAL RESEARCH CENTRE,KUNGU,DUWAATE,KIRA MUNICIPALITY | BURN MASTER L | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWAATE,KIRA MUNICIPALITY 0773219404/0705005896 | UGANDA | OINTMENT | 250G PET JAR | 29/03/2018 |
| 186 | THA427 | HEALTH LIVING HERBAL RESEARCH ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718 | HEALTH LIVING HERBAL RESEARCH ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718 | FOCUS HERBAL COUGH SYRUP | HEALTH LIVING HERBAL RESEARCH LTD ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718 | UGANDA | LIQUID | 100ML | 17/09/2018 |
| 187 | THA428 | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | PRIKINO | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. TEL:0757 577692/0782 577692 | UGANDA | TABLETS | 1*180 IN A PET JAR | 17/06/2019 |
| 188 | THA429 | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | TASANO | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. TEL:0757 577692/0782 577692 | UGANDA | TABLETS | 1*180 IN A PET JAR | 17/06/2019 |
| 189 | THA436 | RUSIGWA E SIMON BUSEGA KAMPALA | RUSIGWA E SIMON BUSEGA KAMPALA | NOURISH | RUSIGWA E SIMON BUSEGA KAMPALA P.O. BOX 1189 BUSEGA (PETRO CITY) 0758444222 | UGANDA | POWDER | 1*150G PET JAR | 7/1/19 |
| 190 | THA438 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | SIGWA ONE | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | UGANDA | POWDER | 150GM POWDER | 2/12/22 |
| 191 | THA439 | RUSIGWA E SIMON 0758444222 BUSEGA | RUSIGWA E SIMON 0758444222 BUSEGA | KRG | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL: 0758444222/0781222271 | UGANDA | POWDER | 150GM PET BOTTLE | 4/11/22 |
| 192 | THA446 | NIVIKA ORGANIC | NIVIKA ORGANIC | DW LIQUID | NIVIKA ORGANIC,PLOT 33,SHAMBA COMPLEX,NAKIVUBO ROAD,OPP KISEKA MARKET, TEL: 0754 674010/0701627712 EMAIL:[email protected] | UGANDA | LIQUID | 1*500ML PET BOTTLE | 18/02/2019 |
| 193 | THA449 | ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. | ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. | ROPER FREE AROMETHERAPHY | ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. TEL:+256772489739, +256773782977 EMAIL: [email protected] | UGANDA | LIQUID | 60ML &100 ML HDPE BOTTLE | 25/04/2018 |
| 194 | THA450 | JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR | JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR | JOYVA COUGH MIXTURE | JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR 0755 878 779 0712 878 779 | UGANDA | LIQUID | 200 ML PET BOTTLE | 7/5/18 |
| 195 | THA451 | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | KATS MANTOPS | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. TEL.0759100200 0758651913 0785151891 | UGANDA | LIQUID | 1*750ML PET BOTTLE | 23/10/2019 |
| 196 | THA452 | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | VIGOR MEN PLUS | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. TEL.0759100200 0758651913 0785151891 | UGANDA | LIQUID | 1*750ML PET BOTTLE | 23/10/2019 |
| 197 | THA455 | CHAMUKA PHARMACEUTICAL RESEARCH HALF A MILE, LUTEEYE, GAYAZA ROAD | CHAMUKA PHARMACEUTICAL RESEARCH HALF A MILE, LUTEEYE, GAYAZA ROAD | CHAM DETOX | CHAMUKA PHARMACEUTICAL RESEARCH HALF A MILE, LUTEEYE, GAYAZA ROAD EMAIL: [email protected] TEL: +256-782-054723 / +256-759-481 793 | UGANDA | POWDER | 64.3 GRAMS | 21/05/2019 |
| 198 | THA458 | SSEWANKAMBO MARTIN NAMUNGOONA STAGE,KAMPALA,UGANDA TEL: 0700247264 | SSEWANKAMBO MARTIN NAMUNGOONA STAGE,KAMPALA,UGANDA TEL: 0700247264 | MARTIN HERBAL JELLY | SSEWANKAMBO MARTIN NAMUNGOONA STAGE,KAMPALA,UGANDA TEL: 0700247264 | UGANDA | OINTMENT | 1*100GM IN HDPE JAR | 19/03/2021 |
| 199 | THA465 | ALINYIKIRA ECO-INVESTMENTS LTD, KABAAWO ZONE NALUKOLONGO OFF MASAKA TEL 0701121873 /0782121873 | ALINYIKIRA ECO-INVESTMENTS LTD, KABAAWO ZONE NALUKOLONGO OFF MASAKA TEL 0701121873 /0782121873 | AHP 10+ | ALINYIKIRA ECO-INVESTMENTS LTD, KABAAWO ZONE NALUKOLONGO OFF MASAKA TEL 0701121873 /0782121873 | UGANDA | POWDER | 1*150GMS | 14/11/2019 |
| 200 | THA470 | BULAMU NATURAL ORGANIC HERBAL PRODUCTS, BULENGA ,NAKUWADDE. | BULAMU NATURAL ORGANIC HERBAL PRODUCTS, BULENGA ,NAKUWADDE. | COUGH &FLUE MIXTURE | SSEKAMWA PETER AND MUKISA PAUL BULAMU NATURAL ORGANIC HERBAL PRODUCTS, BULENGA ,NAKUWADDE. TEL: 0752772600 , 0751200946 | UGANDA | MIXTURE | 100ML AMBER COLOURED PET BOTTLE WITH A GREEN HDPE LID | 8/8/19 |
| 201 | THA471 | YAKUBU LUKWAGO, SHANA GENITAL SOLUTION, UGANDA. TEL:+256772444221/+256392964961 | YAKUBU LUKWAGO, SHANA GENITAL SOLUTION, UGANDA. TEL:+256772444221/+392964961 | SHANA HERBAL GENTLE WASH | YAKUBU LUKWAGO, SHANA GENITAL SOLUTION, UGANDA. TEL:+256772444221/+256392964961 | UGANDA | SOLUTION | 1*100ML PET TRANSPARENT BOTTLE | 29/03/2019 |
| 202 | THA474 | KATONDA YA AWONYA HERBAL MEDICINES | KATONDA YA AWONYA HERBAL MEDICINES | ACACIA NICOTICA | MUGISHA MUHAMMAD. KATONDA YA AWONYA HERBAL MEDICINES, WILLIAM STREET GAZA LAND PLAZA, LEVEL 5, ROOM 743, KAMPALA. TEL: 0782408819 / 0702408819 | UGANDA | LIQUID | 1 LITRE IN A WHITE PLASTIC OPAQUE BOTTLE | 20/08/2019 |
| 203 | THA475 | KATONDA YA AWONYA HERBAL MEDICINES | KATONDA YA AWONYA HERBAL MEDICINES | KIGERIA AFRICANA | MUGISHA MUHAMMAD. KATONDA YA AWONYA HERBAL MEDICINES, WILLIAM STREET GAZA LAND PLAZA, LEVEL 5, ROOM 743, KAMPALA. TEL: 0782408819 / 0702408819 | UGANDA | LIQUID | 1 LITRE IN A WHITE PLASTIC OPAQUE BOTTLE | 20/08/2019 |
| 204 | THA477 | KATONDA YA AWONYA HERBAL MEDICINES | KATONDA YA AWONYA HERBAL MEDICINES | KIFUULA | MUGISHA MUHAMMAD. KATONDA YA AWONYA HERBAL MEDICINES, WILLIAM STREET GAZA LAND PLAZA, LEVEL 5, ROOM 743, KAMPALA. TEL: 0782408819 / 0702408819 | UGANDA | LIQUID | 1 LITRE IN A WHITE PLASTIC OPAQUE BOTTLE | 20/08/2019 |
| 205 | THA478 | UGANDA JOINT HERBAL RESEARCH CLINIC, BUSABALA VALLEY CLINIC, TEL: 0772 327111/0701 327111 | UGANDA JOINT HERBAL RESEARCH CLINIC, BUSABALA VALLEY CLINIC, TEL: 0772 327111/0701 327111 | IMMUNE BOOSTER | UGANDA JOINT HERBAL RESEARCH CLINIC, BUSABALA VALLEY CLINIC, TEL: 0772 327111/0701 327111 | UGANDA | LIQUID | 1 LITRE IN A PET BOTTLE | 15/01/2019 |
| 206 | THA479 | DR.ODOCH PASCAL 0774783006/0789-866-534,P.O BOX 79, PLOT 3,GREENSTAR BUILDING,NYARAVUR-NEBBI | DR.ODOCH PASCAL 0774783006/0789-866-534 | MAISHA | DR.ODOCH PASCAL 0774783006/0789-866-534,P.O BOX 79, PLOT 3,GREENSTAR BUILDING,NYARAVUR-NEBBI | UGANDA | POWDER | 100GMS | 20/08/2019 |
| 207 | THA482 | JENA HERBALS LTD | JENA HERBALS LTD | JENACID | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD PLOT 232 WALNUT AVENUE, HOUSE NO. 11 0700412666/0785374967 | UGANDA | SYRUP | 1*100ML,200ML AND 1 L PET BOTTLE | 15/12/2021 |
| 208 | THA484 | JENA HERBALS LTD | JENA HERBALS LTD | JENACOF DS | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD PLOT 232 WALNUT AVENUE, HOUSE NO. 11 0700412666/0785374967 | UGANDA | SYRUP | 1*100ML AND 200ML PET BOTTLE | 15/12/2021 |
| 209 | THA488 | JUROSE ORGANIC EQUATORIAL MALL ROOM 125, TEL: +256 779707047 | JUROSE ORGANIC EQUATORIAL MALL ROOM 125, TEL: +256 779707047 | LIVALIS DETOXIFIER | JUROSE ORGANIC EQUATORIAL MALL ROOM 125, TEL: +256 779707047 | UGANDA | POWDER | 1*125GM IN LDPE JAR | 17/06/2019 |
| 210 | THA489 | STEMAR AROMATIC OIL DISTILLERS 0751-569009,0782-432534,0705-780688 | STEMAR AROMATIC OIL DISTILLERS 0751-569009,0782-432534,0705-780688 | STEMAR ORGANIC MOSQUITO REPELLANT | STEMAR AROMATIC OIL DISTILLERS 0751-569009,0782-432534,0705-780688 | UGANDA | OINTMENT | 30G AND 50G IN TRANSPARENT HDPE JAR | 17/06/2019 |
| 211 | THA490 | ELOIPHARM (U) LTD | ELOIPHARM (U) LTD | ELOCOF HERBAL COUGH MIXTURE | ELOIPHARM (U) LTD. KYEBANDO,CENTRAL ZONE,KAWEMPE DIVISION P.O.BOX 36766,KAMPALA, +256 758329 111 | UGANDA | SYRUP | 1*200 ML PET BOTTLE IN A UNIT CARTON | 18/02/2019 |
| 212 | THA507 | ABL HERBAL PRODUCTS. KATWE OPP QUALITY CHEMICALS, TEL; 0782447722 | ABL HERBAL PRODUCTS. KATWE OPP QUALITY CHEMICALS, TEL; 0782447722 | VITAL LADY | ABL HERBAL PRODUCTS. KATWE OPP QUALITY CHEMICALS, TEL; 0782447722 | UGANDA | POWDER | 200G TIN | 20/08/2019 |
| 213 | THA508 | ABL HERBAL PRODUCTS | ABL HERBAL PRODUCTS, KATWE OPPOSITE QUALITY CHEMICAL LTD. | WITCH HAZEL | ABL HERBAL PRODUCTS, KATWE OPPOSITE QUALITY CHEMICAL LTD. 0782447722. | UGANDA | LIQUID | 100ML | 7/1/19 |
| 214 | THA510 | FRIENDS DRUG SHOP AND COSMETICS, 0755922605/0704310191/0772310191 KYENGERA, MASAKA ROAD | FRIENDS DRUG SHOP AND COSMETICS, 0755922605/0704310191/0772310191 KYENGERA, MASAKA ROAD | FRIENDS HERBAL JELLY | FRIENDS DRUG SHOP AND COSMETICS, 0755922605/0704310191/0772310191 KYENGERA, MASAKA ROAD | UGANDA | OINTMENT | 120G/60G | 26/04/2019 |
| 215 | THA511 | DR. ISSA MABIRIZI MAGERE, GAYAZA 070124945 | DR. ISSA MABIRIZI MAGERE, GAYAZA 070124945 | ZED SYRUP | DR. ISSA MABIRIZI MAGERE, GAYAZA 070124945 | UGANDA | SOLUTION | 500ML HDPE BOTTLE | 19/02/2021 |
| 216 | THA516 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | TUM SOLUTION | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | UGANDA | LIQUID | 1*250ML HDPE RED BOTTLE WITH GREEN HDPE LID. | 19/02/2020 |
| 217 | THA518 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | HEAL HERBAL COUGH MIXTURE | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | UGANDA | LIQUID | 1*500MLS IN HDPE BOTTLE | 19/02/2020 |
| 218 | THA522 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | RENA HERBAL JELLY | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA TEL: +256782518060 EMAIL;[email protected] | UGANDA | OINTMENT | 1*100G IN WHITE PET JAR | 15/10/2019 |
| 219 | THA523 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | RENA HERBAL CREAM | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA TEL: +256782518060 EMAIL;[email protected] | UGANDA | CREAM | 1*100G IN WHITE PET JAR | 15/10/2019 |
| 220 | THA524 | RUDII INTERNATIONAL CO LTD.P.O.BOX 637 TORORO, UGANDA | RUDII INTERNATIONAL CO LTD.P.O.BOX 637 TORORO, UGANDA | RUDII DETOX DRINK | RUDII INTERNATIONAL CO LTD.P.O.BOX 637 TORORO, UGANDA. +2656782371007 OR +256701371371 EMAIL:[email protected] | UGANDA | SUSPENSION | 1L,500ML,250ML,& 200ML | 18/02/2019 |
| 221 | THA525 | AKATUSIIMA PEACE MITI HERBAL COMPANY LTD KAWEMPE | AKATUSIIMA PEACE MITI HERBAL COMPANY LTD KAWEMPE | MITI HERBAL COUGH SYRUP | AKATUSIIMA PEACE MITI HERBAL COMPANY LTD KAWEMPE 5MILES ALONG BOMBO ROAD TEL:0704218078 | UGANDA | SYRUP | 1*100ML AND 60ML PET BOTTLE | 18/02/2019 |
| 222 | THA534 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272, BUSIA, TEL: 0712 002220 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272, BUSIA, TEL: 0712 002220 | GEKASA ORGANIC POWDER | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272, BUSIA, TEL: 0712 002220 | UGANDA | POWDER | 1*125GMS | 14/11/2019 |
| 223 | THA535 | MUHAMMAD LUTAAYA 0776-835780 MAKERERE,KAVULE, | MUHAMMAD LUTAAYA 0776-835780 MAKERERE,KAVULE, | EASY WAY BLACK SEED OIL | MUHAMMAD LUTAAYA 0776-835780 MAKERERE,KAVULE, | UGANDA | LIQUID | 1*50MLS,100MLS, 300MLS AND 500MLS | 15/10/2019 |
| 224 | THA543 | MS. SSENDYOSE MASITULLAH TEL; 0700-570125 P.O BOX 282 KAMPALA WANDEGEYA, ANNEX S.A BUILDING | MS. SSENDYOSE MASITULLAH TEL; 0700-570125 P.O BOX 282 KAMPALA WANDEGEYA, ANNEX S.A BUILDING | HEWO COUGH DOCTOR | MS. SSENDYOSE MASITULLAH TEL; 0700-570125 P.O BOX 282 KAMPALA WANDEGEYA, ANNEX S.A BUILDING | UGANDA | LIQUID | 1*120MLS IN PET BOTTLE | 27/01/2020 |
| 225 | THA544 | YECO ORGANIC MANAGEMENT LTD KAGOMA - KAWEMPE TEL; 0705 454951; 0781505806 | YECO ORGANIC MANAGEMENT LTD KAGOMA - KAWEMPE TEL; 0705 454951; 0781505806 | YECO ANTI-ULCER HERBAL SYRUP | YECO ORGANIC MANAGEMENT LTD KAGOMA - KAWEMPE TEL; 0705 454951; 0781505806 | UGANDA | SYRUP | 1*200ML PET BOTTLE IN A UNIT CARTON | 1/8/19 |
| 226 | THA545 | NALONGO MUSANA HERBAL CLINIC GAYAZA OPP. FISH FACTORY | NALONGO MUSANA HERBAL CLINIC GAYAZA OPP. FISH FACTORY | NALONGO MUSANA ORAL HERBAL SUSPENSION | NALONGO MUSANA HERBAL CLINIC GAYAZA OPP. FISH FACTORY TEL; 0701-693848; 0781-544591 | UGANDA | SOLUTION | 1*750ML IN AN HDPE BOTTLE | 17/06/2019 |
| 227 | THA546 | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI HERBAL CREAM | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA ABABIRI, ENTEBBE ROAD, KITUBULU OPPOSITE SESE GATEWAY P.O.BOX 74 0752524060/0782524060 | UGANDA | CREAM | 1*100G PET JAR | 7/1/19 |
| 228 | THA547 | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI HERBAL JELLY | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA ABABIRI, ENTEBBE ROAD, KITUBULU OPPOSITE SESE GATEWAY P.O.BOX 74 0752524060/0782524060 | UGANDA | OINTMENT | 1*100G PET JAR | 7/1/19 |
| 229 | THA548 | KSOVITI INTERNATIONAL HOLDING LIMITED, | KSOVITI INTERNATIONAL HOLDING LIMITED, | PSIDIUM COUGH MIXTURE | KSOVITI INTERNATIONAL HOLDING LIMITED, ABAYITA ABABIRI, ENTEBBE ROAD, KITUBULU OPPOSITE SESE GATEWAY 0752524060 | UGANDA | SOLUTION | 1*200ML IN LDPE IN A CARTON | 3/9/19 |
| 230 | THA552 | MAMA POWER LIMITED KAWAALA KAMPALA, UGANDA | MAMA POWER LIMITED KAWAALA KAMPALA, UGANDA | MAMA POWER NATURAL POWER | MAMA POWER LIMITED KAWAALA KAMPALA, UGANDA [email protected] +256 771266692 | UGANDA | POWDER | 1*200G IN A POLYTHENE IN A UNIT CARTON | 17/06/2019 |
| 231 | THA553 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS HAND SANITIZER GEL | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | GEL | 1*500ML IN A TRANSPARENT PET BOTTLE | 20/03/2019 |
| 232 | THA554 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PAIN BALM | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | OINTMENT | 1*20GM IN A PET JAR | 20/03/2019 |
| 233 | THA555 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS ALOE LIP BALM | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | OINTMENT | 1*20GM IN A PET JAR | 20/03/2019 |
| 234 | THA556 | PHYTO HERBALS LTD,KAGOMA-BOMBO ROAD | PHYTO HERBALS LTD,KAGOMA-BOMBO ROAD | PHYCOF COUGH SYRUP | PHYTO HERBALS LTD,KAGOMA-BOMBO ROAD TEL: +256 783 811801/+256 752 540 140 | UGANDA | SYRUP | 1*100ML IN AMBER PET BOTTLE IN A UNIT CARTON | 20/03/2019 |
| 235 | THA563 | MS KAYANJA GORRETH 0752842145/ 0776842145 MASAKA(GRAMMER) KYENGERA | MS KAYANJA GORRETH 0752842145/ 0776842145 MASAKA(GRAMMER) KYENGERA | HOME EASY BALM | MS KAYANJA GORRETH 0752842145/ 0776842145 MASAKA(GRAMMER) KYENGERA | UGANDA | CREAM | 60G IN A PLASTIC CONTAINER | 20/08/2019 |
| 236 | THA565 | HAJJAT JEMEWO HERBAL CENTRE NATEETE 0701499579 | HAJJAT JEMEWO HERBAL CENTRE NATEETE 0701499579 | P21 | HAJJAT JEMEWO HERBAL CENTRE NATEETE 0701499579 | UGANDA | SOLUTION | 1*1 LITER PLASTIC JERRYCAN | 17/06/2019 |
| 237 | THA566 | KISA KYAMUZADDE GENERAL AGENCIES NALUKOLONGO INDUSTRIAL AREA, MASAKA ROAD. | KISA KYAMUZADDE GENERAL AGENCIES NALUKOLONGO INDUSTRIAL AREA, MASAKA ROAD. | KISA KYAMUZADDE ORIGINAL HERBAL | KISA KYAMUZADDE GENERAL AGENCIES NALUKOLONGO INDUSTRIAL AREA, MASAKA ROAD. REG NO. 127581 MOB: 0712 831375/ 0772 335874 | UGANDA | LIQUID | 200MLS LDPE BOTTLE. | 9/11/20 |
| 238 | THA574 | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | MUBEEZE HERBAL SOLUTION | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | UGANDA | SOLUTION | 1*750ML PLASTIC BOTTLE | 19/02/2021 |
| 239 | THA575 | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD | RP HERBAL LIQUID | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | UGANDA | LIQUID | 750 ML HDPE BOTTLE | 19/02/2021 |
| 240 | THA580 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | KOFNIL COUGH SYRUP | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | LIQUID | 1*100ML. AMBER PET BOTTLE | 16/04/2019 |
| 241 | THA581 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | ACINIL ANTACID SYRUP | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | LIQUID | 1*100ML AMBER PET BOTTLE | 16/04/2019 |
| 242 | THA583 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | Q-DENT | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | LIQUID | 20ML PET BOTTLE | 16/04/2019 |
| 243 | THA584 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | AKE OFF HERBAL CREAM | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | CREAM | 1*25GM WHITE PET BOTTLE | 2/10/19 |
| 244 | THA587 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | Q-DERM HERBAL CREAM | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA [email protected],TEL: 0776856931 | UGANDA | CREAM | 20GM PET BOTTLE | 2/10/19 |
| 245 | THA588 | SURE DEAL BEAUTY CENTRE MUTUNDWE OPPOSITE SERENE HOTEL | SURE DEAL BEAUTY CENTRE MUTUNDWE OPPOSITE SERENE HOTEL | SURE DEAL SENNA SOLUTION | SURE DEAL BEAUTY CENTRE MUTUNDWE OPPOSITE SERENE HOTEL +256 772 329181/+256 701 863001 | UGANDA | SOLUTION | 500ML HDPE | 20/08/2019 |
| 246 | THA591 | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | SURE DEAL MANGIFERA SOLUTION | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD 0701 863001/0772 329181 | UGANDA | SOLUTION | 1*500ML IN LDPE BOTTLE | 17/06/2019 |
| 247 | THA592 | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | BIDEN MIXTURE | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD 0701 863001/0772 329181 | UGANDA | SOLUTION | 1*500ML IN LDPE BOTTLE | 17/06/2019 |
| 248 | THA595 | SEREEYI HERBAL RESEARCH CLINIC,LWEZA,KAJJANZI 0781 020 108/0200-904 813 | SEREEYI HERBAL RESEARCH CLINIC,LWEZA,KAJJANZI 0781 020 108/0200-904 813 | SONSOMOLA | SEREEYI HERBAL RESEARCH CLINIC,LWEZA,KAJJANZI 0781 020 108/0200-904 813 | UGANDA | LIQUID | 250ML | 9/11/20 |
| 249 | THA596 | TINEX LOGISTICS LTD, P.O BOX 37030, ZONE II,KASUBI-KAWALA ROAD KAMPALA,UGANDA | TINEX LOGISTICS LTD, P.O BOX 37030, ZONE II,KASUBI-KAWALA ROAD KAMPALA,UGANDA | TINEX HERBALMOUTHWASH | TINEX LOGISTICS LTD, P.O BOX 37030, ZONE II,KASUBI-KAWALA ROAD KAMPALA,UGANDA [email protected] 0782 992 257/0200-904 813 | UGANDA | SOLUTION | 1*50ML PET BOTTLE | 17/06/2019 |
| 250 | THA601 | BIVA ORGANICS & NATURAL HEALTH PRODUCTS P.O.BOX 1459,SENTEMA,KAMPALA | BIVA ORGANICS & NATURAL HEALTH PRODUCTS P.O.BOX 1459,SENTEMA,KAMPALA | PRUNUS TONIC | BIVA ORGANICS & NATURAL HEALTH PRODUCTS P.O.BOX 1459,SENTEMA,KAMPALA +256 752 602 427/0702 754 502 | UGANDA | LIQUID | 1*700ML PLASTIC BOTTLE | 26/09/2024 |
| 251 | THA602 | MULABIKIRWA HERBAL, NSAMBIA, ARUA TEL: 0772740186 | MULABIKIRWA HERBAL, NSAMBIA, ARUA TEL: 0772740186 | SSENGA MULABIKIRWA HERBAL MEDICINE | MULABIKIRWA HERBAL, NSAMBIA, ARUA TEL: 0772740186 | UGANDA | POWDER | 1*100GM IN A PLASTIC TIN | 27/01/2020 |
| 252 | THA603 | RASHID LUKWAGO HERBAL GROUP. KYENGERA OFF MASAKA ROAD. TEL: 0782413626 | RASHID LUKWAGO HERBAL GROUP. KYENGERA OFF MASAKA ROAD. TEL: 0782413626 | LUK COUGH SYRUP | RASHID LUKWAGO HERBAL GROUP. KYENGERA OFF MASAKA ROAD. TEL: 0782413626 | UGANDA | SYRUP | 1*500ML AMBER COLORED PET BOTTLE | 27/01/2020 |
| 253 | THA604 | RASHID LUKWAGO HERBAL GROUP 0782413626. KYENGERA OFF MASAKA ROAD | RASHID LUKWAGO HERBAL GROUP 0782413626. KYENGERA OFF MASAKA ROAD | NEOMORBUS | RASHID LUKWAGO HERBAL GROUP 0782413626. KYENGERA OFF MASAKA ROAD | UGANDA | LIQUID | 500ML | 9/11/20 |
| 254 | THA606 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | AMBA LIQUID | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | UGANDA | LIQUID | 1*500ML PLASTIC BOTTLE | 19/02/2021 |
| 255 | THA607 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | BYANSI COUGH MIXTURE | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | UGANDA | LIQUID | 1*200ML PLASTIC BOTTLE | 19/02/2021 |
| 256 | THA608 | KALASO HERBAL PRODUCTS.NATEETE NEAR BOOM HOTEL | KALASO HERBAL PRODUCTS.NATEETE NEAR BOOM HOTEL | KALASO KOKOLILOKO EXTRA | KALASO HERBAL PRODUCTS.NATEETE NEAR BOOM HOTEL 075399073 0752048389 | UGANDA | LIQUID | 1*500ML YELLOW PET BOTTLE. | 4/10/19 |
| 257 | THA611 | SSENGA PROSSY NABUKEERA, KATWE I, MUWONGE ZONE, NEAR MUSA BODY MACHINERY | SSENGA PROSSY NABUKEERA, KATWE I, MUWONGE ZONE, NEAR MUSA BODY MACHINERY | LUWAWU | SSENGA PROSSY NABUKEERA, KATWE I, MUWONGE ZONE, NEAR MUSA BODY MACHINERY, TEL: 0700505780/0780525090 [email protected] | UGANDA | POWDER | 1*500GM HDPE JAR | 19/02/2021 |
| 258 | THA615 | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | CAYEN LUWOMBO TEA | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | UGANDA | POWDER | 60G, 120G, 250G, AND 400G IN A PLASTIC CONTAINER | 27/01/2020 |
| 259 | THA616 | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | VILLALI NATURAL TEA | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | UGANDA | POWDER | 60G, 120G, 250G AND 400G IN A PLASTIC CONTAINER | 27/01/2020 |
| 260 | THA617 | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | DABUTO SSICABRA TREE OIL | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | UGANDA | LIQUID | 1*15ML IN A PLASTIC BOTTLE | 27/01/2020 |
| 261 | THA618 | CURE ORGANIC LIVING PRODUCTS (U) LTD BUDDU HOUSE WANDEGEYA. TEL:0700801609 | CURE ORGANIC LIVING PRODUCTS (U) LTD BUDDU HOUSE WANDEGEYA. TEL:0700801609 | DIABEX PRO | CURE ORGANIC LIVING PRODUCTS (U) LTD BUDDU HOUSE WANDEGEYA. TEL:0700801609 | UGANDA | POWDER | 1*50G AND 120G IN A WHITE PLASTIC TIN | 5/3/20 |
| 262 | THA621 | MUKWAYA JAMIR LUTAAKOME | MUKWAYA JAMIR LUTAAKOME | SMAKO HERBAL MEDICINE PRODUCT | MUKWAYA JAMIR LUTAAKOME NDEEBA- YW COMPLEX- OPPOSITE TOTAL PETROL STATION TEL:0772538794/0702538794 | UGANDA | POWDER | 250GM HDPE CONTAINER | 13/01/2022 |
| 263 | THA623 | BISUBI BUSINESS SOLUTIONS KAYUNGA WAKISO GOMBE AT FUTUREBELL HIGH SCHOOL TEL: 0756405871/0772801508 | BISUBI BUSINESS SOLUTIONS KAYUNGA WAKISO GOMBE AT FUTUREBELL HIGH SCHOOL TEL: 0756405871/0772801508 | BISUBI HERBAL JELLY | BISUBI BUSINESS SOLUTIONS KAYUNGA WAKISO GOMBE AT FUTUREBELL HIGH SCHOOL TEL: 0756405871/0772801508 | UGANDA | OINTMENT | 1*250GMS | 14/11/2019 |
| 264 | THA624 | NEW LIFE COMPANY,P.O BOX 29,FORTPORTAL,KABAROLE DISTRICT TEL: 0789 931467/0702-319514 | NEW LIFE COMPANY,P.O BOX 29,FORTPORTAL,KABAROLE DISTRICT TEL: 0789 931467/0702-319514 | STINKWOOD HERBAL POWDER | NEW LIFE COMPANY,P.O BOX 29,FORTPORTAL,KABAROLE DISTRICT TEL: 0789 931467/0702-319514 | UGANDA | POWDER | 1*100G IN A TRANSPARENT PLASTIC TIN | 5/3/20 |
| 265 | THA634 | KYEMEZA HERBAL RESEARCH P.O.BOX 1328 MASAKA-UGANDA TEL: +256772517535 | KYEMEZA HERBAL RESEARCH P.O.BOX 1328 MASAKA-UGANDA TEL: +256772517535 | EARLIER COUGH MIXTURE | KYEMEZA HERBAL RESEARCH P.O.BOX 1328 MASAKA-UGANDA TEL: +256772517535 | UGANDA | LIQUID | 1*200ML PLASTIC BOTTLE | 19/03/2021 |
| 266 | THA636 | KYABAGGU JOSEPH, LISAAKYE HEALTHCARE | KYABAGGU JOSEPH, LISAAKYE HEALTHCARE | KHC KISAKYE COUGH MIXTURE | KYABAGGU JOSEPH, LISAAKYE HEALTHCARE, P.O.BOX 28712, KAMPALA, UGANDA +256 752697378/ 783737678 | UGANDA | LIQUID | 1*125ML HDPE BOTTLE | 19/02/2021 |
| 267 | THA639 | JOY INDUSTRIES NABBINGO- MASAKA ROAD TEL: 0778 164596, 0754 757490, 0701 713388 | JOY INDUSTRIES NABBINGO- MASAKA ROAD TEL: 0778 164596, 0754 757490, 0701 713388 | JOY HERBAL JELLY | JOY INDUSTRIES NABBINGO- MASAKA ROAD TEL: 0778 164596, 0754 757490, 0701 713388 | UGANDA | OINTMENT | 100G HDPE CONTAINER | 9/11/20 |
| 268 | THA640 | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | SAAMI HERBAL JELLY | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE EMAIL: [email protected] TEL: 0704175890, 0778976418 UGANDA | UGANDA | JELLY | 120GM IN PLASTIC CONTAINER | 1/10/21 |
| 269 | THA642 | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | SAAMI SOAP | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE EMAIL: [email protected] TEL: 0704175890, 0778976418 UGANDA | UGANDA | SOAP | 120GM | 1/10/21 |
| 270 | THA646 | SMARTECH SUPPLY TEL; 0773 924357 | SMARTECH SUPPLY TEL; 0773 924357 | T.BALM OINTMENT | ELOIPHARM (U) LTD, KABATEREINE BUILDING, KYEBANDO CENTRAL ZONE, P.O BOX 36766, KAMPALA. | UGANDA | OINTMENT | 1*20G IN LDPE JAR IN A CARTON | 1/8/19 |
| 271 | THA647 | KATTA ORGANIC AND NATURAL PRODUCTS | KATTA ORGANIC AND NATURAL PRODUCTS | WHITKATTA HERBAL MOUTH WASH | KATTA ORGANIC AND NATURAL PRODUCTS, LOCATED AT JESCO BEAUTY CENTRE, ROOM KD20,3RD FLOOR 0700928623 | UGANDA | SOLUTION | 50ML HDPE BOTTLE | 19/02/2021 |
| 272 | THA648 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA GARLIC | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/19 |
| 273 | THA649 | VICTORIA HEALTHCARE LIMITED,KAMPALA TEL: 0751432584/ 0705501076 | VICTORIA HEALTHCARE LIMITED,KAMPALA TEL: 0751432584/ 0705501076 | VICTORIA CHARCOAL | VICTORIA HEALTHCARE LIMITED,KAMPALA TEL: 0751432584/ 0705501076 | UGANDA | TABLETS | 1*60 IN A GREEN LDPE BOTTLE | 27/01/2020 |
| 274 | THA650 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HIBISCUS | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/19 |
| 275 | THA651 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA TURMERIC | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/19 |
| 276 | THA652 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA ALOE VERA | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/19 |
| 277 | THA654 | BAMWEYANA HERBAL GROUP LOCATED AT ENTEBBE ROAD, OPPOSITE FREEDOM CITY. | BAMWEYANA HERBAL GROUP LOCATED AT ENTEBBE ROAD, OPPOSITE FREEDOM CITY. | JELLO HERBAL POWDER | BAMWEYANA HERBAL GROUP LOCATED AT ENTEBBE ROAD, OPPOSITE FREEDOM CITY. +256702536879/+2567025380 | UGANDA | POWDER | 200G PET BOTTLE | 19/02/2021 |
| 278 | THA659 | SMARTECH SUPPLY TEL; 0773 924357 | SMARTECH SUPPLY TEL; 0773 924357 | T NASAL INHALER | ELOIPHARM (U) LTD, KABATEREINE BUILDING, KYEBANDO CENTRAL ZONE, P.O BOX 36766, KAMPALA | UGANDA | INHALER | 1*1G IN HDPE | 28/08/2019 |
| 279 | THA678 | DA-MERAN HERBAL DUTCH LOCATED AT KIBUYE NEAR XING XING FURNITURE ALONG RING ROAD | DA-MERAN HERBAL DUTCH LOCATED AT KIBUYE NEAR XING XING FURNITURE ALONG RING ROAD | PIXSTER V | DA-MERAN HERBAL DUTCH LOCATED AT KIBUYE NEAR XING XING FURNITURE ALONG RING ROAD. 0708222444 0781222444 | UGANDA | POWDER | 1*200G IN PLASTIC JAR | 19/02/2021 |
| 280 | THA684 | THE EDENS HERBAL PHARMACY SEGUKU OPP MPUNGU PLAZA TEL;0785120896/0751746467 | THE EDENS HERBAL PHARMACY SEGUKU OPP MPUNGU PLAZA TEL;0785120896/0751746467 | VENEREUS | THE EDENS HERBAL PHARMACY SEGUKU OPP MPUNGU PLAZA TEL;0785120896/0751746467 | UGANDA | POWDER | 1*250G WHITE HDPE JAR WITH A GREEN HDPE LID | 19/02/2021 |
| 281 | THA685 | WANFUKO HENRY MOHPANS HERBAL MEDICINE | WANFUKO HENRY MOHPANS HERBAL MEDICINE | MOHPANS NFUKO POWDER | MOHPANS HERBAL MEDICINE BULANGA TOWN COUNCIL WANFUKO ZONE P.O.BOX 578, IGANGA-UGANDA MOB: 0782646495/0700859430/0759479206 | UGANDA | POWDER | 1*25G HDPE JAR | 10/1/25 |
| 282 | THA690 | MORPHANS HERBAL MEDICINE, BULANGA TOWN COUNCIL,WANFUKO ZONE,P.O.BOX 578,IGANGA,UGANDA | MORPHANS HERBAL MEDICINE, BULANGA TOWN COUNCIL,WANFUKO ZONE,P.O.BOX 578,IGANGA,UGANDA | MOHPANS HERBAL COUGH MIXTURE | MORPHANS HERBAL MEDICINE, BULANGA TOWN COUNCIL,WANFUKO ZONE,P.O.BOX 578,IGANGA,UGANDA TEL:0782 646495/0700859430/0759 479206 | UGANDA | LIQUID | 1*200ML PET BOTTLE | 30/07/2021 |
| 283 | THA697 | DAMA MEDICINAL HERBS, P.O BOX 25216, KAMPALA UGANDA | DAMA MEDICINAL HERBS, P.O BOX 25216, KAMPALA UGANDA | SHAKE OUT | DAMA MEDICINAL HERBS, P.O BOX 25216, KAMPALA UGANDA. +256777733338 [email protected] 0772774338 | UGANDA | POWDER | 18.2 GRAMS | 19/02/2021 |
| 284 | THA699 | SEZ MEDICAL CENTRE LTD.BWAISE NABWERU RD(KAZOC/U PRIMARY SCHOOL),0774009790/ 0700384840 | SEZ MEDICAL CENTRE LTD.BWAISE NABWERU RD(KAZOC/U PRIMARY SCHOOL),0774009790/ 0700384840 | SEZ CHARCOAL TOOTHPASTE | SEZ MEDICAL CENTRE LTD.BWAISE NABWERU RD(KAZOC/U PRIMARY SCHOOL),0774009790/ 0700384840 | UGANDA | PASTE | 50G | 19/02/2021 |
| 285 | THA701 | HEAL THE WORLD ORGANICS, WANDEGEYA OPPOSITE YMCA,ANNEX S.A BUILDING TEL: 0700 570125/0774 050470 | HEAL THE WORLD ORGANICS, WANDEGEYA OPPOSITE YMCA,ANNEX S.A BUILDING TEL: 0700 570125/0774 050470 | HEWO IMMUNE EXTRACT HERBAL DECOCTION | HEAL THE WORLD ORGANICS, WANDEGEYA OPPOSITE YMCA,ANNEX S.A BUILDING TEL: 0700 570125/0774 050470 | UGANDA | LIQUID | 1*750ML IN A PLASTIC BOTTLE | 8/7/24 |
| 286 | THA703 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | LUK HERBAL TONIC | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | UGANDA | LIQUID | 500 ML PET BOTTLE | 19/03/2021 |
| 287 | THA704 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | RED LIQUID PLUS | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | UGANDA | LIQUID | 500 ML PET BOTTLE | 19/03/2021 |
| 288 | THA705 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD√ TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | BAYCONE HERBAL MEDICINE FOR ALLERGY | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | LIQUID | 1*200ML WHITE PET BOTTLE | 5/11/19 |
| 289 | THA706 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | ALSAGON | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | POWDER | 38G HDPE TIN & 75G HDPE TIN | 5/11/19 |
| 290 | THA712 | SCENSOR INVESTMENTS, LWASA STAGE-SALAAMA RD,MUNYONYO,MAKINDYE DIVISION | SCENSOR INVESTMENTS, LWASA STAGE-SALAAMA RD,MUNYONYO,MAKINDYE DIVISION | SCENSOR HENA HERBAL OINTMENT | SCENSOR INVESTMENTS, LWASA STAGE-SALAAMA RD,MUNYONYO,MAKINDYE DIVISION 0758 111966/0788 802892 | UGANDA | OINTMENT | 1*150GM PET JAR | 15/07/2021 |
| 291 | THA713 | SCENSOR INVESTMENTS | SCENSOR INVESTMENTS | SCENSOR PAMSA HERBAL POWDER | SCENSOR INVESTMENTS,LWASA STAGE-SALAAMA RD, MUNYONYO, MAKINDYE DIVISION +256758111966 +256756439989 | UGANDA | POWDER | 1*100GM PLASTIC JAR | 19/02/2021 |
| 292 | THA714 | SCENSOR INVESTMENTS | SCENSOR INVESTMENTS | SCENSOR SATA HERBAL POWDER | SCENSOR INVESTMENTS,LWASA STAGE-SALAAMA RD, MUNYONYO, MAKINDYE DIVISION +256758111966 +256756439989 | UGANDA | POWDER | 1*60GM PLASTIC JAR | 19/02/2021 |
| 293 | THA722 | AISHA PHYTO CENTRE NAMASUBA ENTEBBE ROAD | AISHA PHYTO CENTRE NAMASUBA ENTEBBE ROAD | STRICKER PLUS | AISHA PHYTO CENTRE NAMASUBA ENTEBBE ROAD 0782193367/0750382437 [email protected] TEL: 0782193367 / 0750382437 | UGANDA | POWDER | 60GM WHITE HDPE CONTAINER | 19/02/2021 |
| 294 | THA742 | SANYU NATURAL HEALTH PRODUCT MASAJJA ZONE A, KAMPALA TEL: +256700865708/0770827218 | SANYU NATURAL HEALTH PRODUCT MASAJJA ZONE A, KAMPALA TEL: +256700865708/0770827218 | SAWA SAWA HERBAL SOLUTION | SANYU NATURAL HEALTH PRODUCT MASAJJA ZONE A, KAMPALA TEL: +256700865708/0770827218 | UGANDA | LIQUID | 120 ML AMBER COLOURED PET BOTTLE | 19/03/2021 |
| 295 | THA752 | AISHA PHYTOCENTRE,NAMASUBA ENTEBBE ROAD 078219367/075382437 [email protected] | AISHA PHYTOCENTRE,NAMASUBA ENTEBBE ROAD 078219367/075382437 [email protected] | GUAVA NATURAL TEA | AISHA PHYTOCENTRE,NAMASUBA ENTEBBE ROAD 078219367/075382437 [email protected] | UGANDA | POWDER | 100GM | 7/9/22 |
| 296 | THA757 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | POTEN DETOX RELIEF | MUPHEN HERBALISTS,NDEJJE WAKISO TEL:0782922421 | UGANDA | LIQUID | 500ML WHITE PET BOTTLE | 9/2/22 |
| 297 | THA758 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | POTEN COUGH MIXTURE | MUPHEN HERBALISTS,NDEJJE WAKISO TEL:0782922421 | UGANDA | LIQUID | 200ML GREEN PET BOTTLE | 9/2/22 |
| 298 | THA759 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | POTEN SYRUP | MUPHEN HERBALISTS,NDEJJE WAKISO TEL:0782922421 | UGANDA | LIQUID | 500ML WHITE PET BOTTLE | 9/2/22 |
| 299 | THA760 | AL-HAJI SADAM RASHID LUKWAGO NATEETE WAKALIGA TEL:0772512372 0700875051 | AL-HAJI SADAM RASHID LUKWAGO NATEETE WAKALIGA TEL:0772512372 0700875051 | SHID V-WASH | AL-HAJI SADAM RASHID LUKWAGO NATEETE WAKALIGA TEL:0772512372 0700875051 | UGANDA | LIQUID | 50ML PINK HDPE CANISTER SEALED WITH A WHITE HDPE SPRAY PUMP | 21/11/2021 |
| 300 | THA762 | NAMIREMBE PRODUCTS.BULENGA. NANKUWADDE ZONE KAMPALA-UGANDA TEL: 0774843982/0705792111 | NAMIREMBE PRODUCTS.BULENGA. NANKUWADDE ZONE KAMPALA-UGANDA TEL: 0774843982/0705792111 | NAMBIREMBE HERBAL COUGH & FLU SYRUP | NAMIREMBE PRODUCTS.BULENGA. NANKUWADDE ZONE KAMPALA-UGANDA TEL: 0774843982/0705792111 | UGANDA | SYRUP | 200ML AND 60ML IN AMBER PET BOTTLE | 19/02/2021 |
| 301 | THA768 | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LIMITED LOCATED IN KAGOMA-BOMBO ROAD | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LIMITED LOCATED IN KAGOMA-BOMBO ROAD | TONSOZIN ORAL DROPS | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LIMITED LOCATED IN KAGOMA-BOMBO ROAD. TEL:0783811801 0752540140 | UGANDA | SOLUTION | 30ML | 9/11/20 |
| 302 | THA770 | DR.SSEGWANYI GODFREY,SMAT MEDS INDUSTRIES | DR.SSEGWANYI GODFREY,SMAT MEDS INDUSTRIES | MENTHOTOP | DR.SSEGWANYI GODFREY,SMAT MEDS INDUSTRIES TEL:0751 762 135,SMAT MEDS LTD, PLOT 738 MAYA. MASAKA ROAD | UGANDA | OINTMENT | 9G | 30/07/2021 |
| 303 | THA774 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | JENAPEP | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | LIQUID | 200ML PET BOTTLE | 2/12/22 |
| 304 | THA775 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | ARTEMUNE | JENA HERBALS UGANDA LTD, PLOT 11.WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: [email protected] +256 779-617612/0756-299255 | UGANDA | POWDER | 100G CONTAINER | 27/02/2023 |
| 305 | THA776 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENAFLU | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: [email protected] +256 779-617612/0756-299255 | UGANDA | LIQUID | 1*60ML PET BOTTLE | 2/12/22 |
| 306 | THA777 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENAMAL | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: [email protected] +256 779-617612/0756-299255 | UGANDA | GRANULES | 1*100GM | 13/01/2022 |
| 307 | THA778 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | JENA DM | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | PELLETS | 100G PET JAR | 4/11/22 |
| 308 | THA779 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | JENA HT | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | POWDER | 100G PET JAR | 2/12/22 |
| 309 | THA781 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENAFIT | JENA HERBALS UGANDA LTD, PLOT 11.WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: [email protected] +256 779-617612/0756-299255 | UGANDA | POWDER | 100G CONTAINER | 27/02/2023 |
| 310 | THA782 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: [email protected] | JENACURE | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | LIQUID | 15ML HDPE DROPPER BOTTLE | 4/11/22 |
| 311 | THA783 | S.R BODY SOLUTION | S.R BODY SOLUTION | FOZ HERBAL MIXTURE | SEMPIJJA RONALD, S.R BODY SOLUTION, KAWEMPE TULA ROAD(KIGANDA) TEL:0759080579/0779189962 EMAIL [email protected] | UGANDA | LIQUID | 1*200ML PET BOTTLE | 7/9/22 |
| 312 | THA785 | AAFIYA (A) LTD TAHARI TOWER-NAMIREMBE ROAD,UGANDA TEL: 0772030835 | AAFIYA (A) LTD TAHARI TOWER-NAMIREMBE ROAD,UGANDA TEL: 0772030835 | AAF-FLU DROPS | AAFIYA (A) LTD TAHARI TOWER-NAMIREMBE ROAD,UGANDA TEL: 0772030835 | UGANDA | LIQUID | 1*5ML PLASTIC BOTTLE | 1/10/21 |
| 313 | THA786 | AFIYA INDUSTRIES KASANGATI KITI A-WAKISO TEL: +256772030835 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS COUGH SYRUP | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | SYRUP | 100ML AMBER COLOURED PET BOTTLE | 15/07/2021 |
| 314 | THA792 | BUKABEMPA (U) LTD P.O BOX 71, RUSHERE KIRUHURA DISTRICT TEL: 0772852054/0701852054 | BUKABEMPA (U) LTD P.O BOX 71, RUSHERE KIRUHURA DISTRICT TEL: 0772852054/0701852054 | MPAWARB HERBAL POWDER | BUKABEMPA (U) LTD P.O BOX 71, RUSHERE KIRUHURA DISTRICT TEL: 0772852054/0701852054 | UGANDA | POWDER | 50 GMS IN A TRANSPARENT PLASTIC JAR | 30/10/2023 |
| 315 | THA798 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | CEFTY COUGH SYRUP | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | UGANDA | SYRUP | 1*100ML AMBER PET BOTTLE | 15/07/2021 |
| 316 | THA799 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | CEFU | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | UGANDA | LIQUID | 1*125ML PET BOTTLE | 15/07/2021 |
| 317 | THA801 | WILAN PRODUCTS KIGUMIRA-BUKUSU ON GULU NORTHEN HIGHWAY P.O BOX 207,WOBULENZI | WILAN PRODUCTS KIGUMIRA-BUKUSU ON GULU NORTHEN HIGHWAY P.O BOX 207,WOBULENZI | NATURAL MEDICINAL TEA BAGS | WILAN PRODUCTS KIGUMIRA-BUKUSU ON GULU NORTHEN HIGHWAY P.O BOX 207,WOBULENZI UGANDA TEL: 0772867533,+256-77-464365 | UGANDA | POWDER | 1*200GMS | 7/9/22 |
| 318 | THA808 | NAMARA APOLLO TEL;0777496080 APROHEN-UGANDA FORTPORTAL KABALORE | NAMARA APOLLO TEL;0777496080 APROHEN-UGANDA FORTPORTAL KABALORE | CINCHONA HONEY SYRUP | NAMARA APOLLO TEL;0777496080 APROHEN-UGANDA FORTPORTAL KABALORE | UGANDA | LIQUID | 200ML AMBER PET BOTTLE | 27/09/2021 |
| 319 | THA809 | KISITU JOHN, TENDO BAKERY LIMITED, NANSANA EAST II-WAKISO, 0754064318 | KISITU JOHN, TENDO BAKERY LIMITED, NANSANA EAST II-WAKISO, 0754064318 | EMBOGO HERBAL MIXTURE | KISITU JOHN, TENDO BAKERY LIMITED, NANSANA EAST II-WAKISO, 0754064318 | UGANDA | LIQUID | 1*300ML AMBER PLASTIC BOTTLE | 12/8/24 |
| 320 | THA814 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELODIABET | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA [email protected] | UGANDA | LIQUID SOLUTION | 200 MLS | 16/12/2022 |
| 321 | THA815 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD, P.O. BOX 36766, KAMPALA, UGANDA 0758329111 | ELOPROSTINE | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA [email protected] | UGANDA | LIQUID SOLUTION | 200MLS | 27/02/2023 |
| 322 | THA816 | MUBIRU HADIJAH KALAGALA MUKONO TEL: 0752618771 | MUBIRU HADIJAH KALAGALA MUKONO TEL: 0752618771 | GO ORGANIC OIL | TRAMI MEDICINAL FOODS AND NATURAL PRODUCTS,LOCATED AT KALAGALA,MUKONO ON GAYAZA KALAGI ROAD,18 MILES FROM KAMPALA | UGANDA | OIL | 20ML AMBER PET BOTTLE | 27/05/2022 |
| 323 | THA828 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | BAYCONE HERBAL COUGH REMEDY | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | LIQUID | 100MLS WHITE PET BOTTLE. | 9/11/20 |
| 324 | THA838 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | BAYCONE.G.I | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | LIQUID | 100MLS WHITE PET BOTTLE. | 9/11/20 |
| 325 | THA844 | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD WAKISO | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD WAKISO | GENWASH LADY OIL | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD WAKISO TEL: 0709900200 0759100200 0758651913 0776664207 | UGANDA | LIQUID | 30ML SOLUTION IN PET BOTTLE | 27/05/2022 |
| 326 | THA852 | PRINCESS PHARMACY-OPPOSITE AVIS INDUSTRY TULA ROAD | PRINCESS PHARMACY-OPPOSITE AVIS INDUSTRY TULA ROAD | SKY COUGH SYRUP | PRINCESS PHARMACY-OPPOSITE AVIS INDUSTRY TULA ROAD MUTEBI RAMATHAN TEL: 0772030835 E-MAIL: [email protected] | UGANDA | SYRUP | 100ML AMBER COLOURED PET BOTTLE | 21/11/2021 |
| 327 | THA854 | NAKIBUUKA HARRIET GARLIC MIRACULOUS CHLOROPHYLL (U) LTD | NAKIBUUKA HARRIET GARLIC MIRACULOUS CHLOROPHYLL (U) LTD | NDERM | NAKIBUUKA HARRIET GARLIC MIRACULOUS CHLOROPHYLL (U) LTD NAKAWA MARKET P.O BOX 70546 KAMPALA-UGANDA LTD TEL: 0780326213/07688405 | UGANDA | OINTMENT | 60G TRANSPARENT WHITE BOTTLE WITH BLACK LID & 25G TRANSPARENT BOTTLE WITH WHITE LID | 9/2/22 |
| 328 | THA855 | WHITE MARK COSMETICS LOCATION: KABULENGWA NANSANA IN WAKISO DISTRICT ALONG HOIMA ROAD | WHITE MARK COSMETICS LOCATION: KABULENGWA NANSANA IN WAKISO DISTRICT ALONG HOIMA ROAD | HONEY POT HERBAL GENTLE WASH | WHITE MARK COSMETICS LOCATION: KABULENGWA NANSANA IN WAKISO DISTRICT ALONG HOIMA ROAD. TEL: 0701 188367 | UGANDA | LIQUID | 100ML TRANSPARENT PET BOTTLE | 1/10/21 |
| 329 | THA856 | ASUMAN NUWAMANYA RWEBIKONA KAMUKUZI MBARARA TEL:256772911286/+256702911286 | ASUMAN NUWAMANYA RWEBIKONA KAMUKUZI MBARARA TEL: +256772911286/+256702911286 | B4 AMAZIIMA | ASUMAN NUWAMANYA AHW MEDICINAL HERBS RESEARCH AND TREATMENT CENTRE RWEBIKONA KAMUKUZI MBARARA CITY TEL:+256772911286/+256702911286 | UGANDA | LIQUID | 500ML HDPE BOTTLE | 7/9/21 |
| 330 | THA859 | BENEBYONA HERBAL CLINIC NATEETE OPPOSITE TOTAL PETROL STATION TEL: 078039335 | BENEBYONA HERBAL CLINIC NATEETE OPPOSITE TOTAL PETROL STATION TEL: 078039335 | PESHA V POWDER | BENEBYONA HERBAL CLINIC NATEETE OPPOSITE TOTAL PETROL STATION TEL: 078039335 | UGANDA | POWDER | 1*200GM IN WHITE PET JAR | 19/02/2021 |
| 331 | THA861 | MICHEAL SSANGO, 9 MILES MITYANA ROAD BULAGA SSUMBWE B PARISH. | MICHEAL SSANGO, 9 MILES MITYANA ROAD BULAGA SSUMBWE B PARISH. | GYNO FORMULA BULOBA | MICHEAL SSANGO, 9 MILES MITYANA ROAD BULAGA SSUMBWE B PARISH. TEL: 0785114009/0758665451 EMAIL:[email protected] | UGANDA | LIQUID | 700ML HDPE BOTTLE | 29/10/2021 |
| 332 | THA863 | KAMPALA UNIVERSITY BODY CARE (U) LTD. | KAMPALA UNIVERSITY BODY CARE (U) LTD. | PILOSA HERBAL PAIN RELIEF | KAMPALA UNIVERSITY BODY CARE (U) LTD. P.O.BOX 25454 KAMPALA, BUZIGA, KATUUSO RISE. TEL: 0703593862/0772450601/0775289297 | UGANDA | OINTMENT | 1*25GM IN WHITE PET JAR SEALED WITH GREEN SCREW CAP. | 15/07/2021 |
| 333 | THA864 | SHAKA ORGANICS, NDEJJE,KAMPALA UGANDA | SHAKA ORGANICS, NDEJJE,KAMPALA UGANDA | SHAKA ORGANIC COLD &FLU SYRUP | SSERUNJOGI SHAFIQ. MANAGING DIRECTOR.SHAKA ORGANICS,NDEJJE ,KAMAPALA ,UGANDA TEL: 0787 366726/0706347173 | UGANDA | LIQUID | 1*200ML IN AMBER PET BOTTLE | 19/02/2021 |
| 334 | THA868 | KIIZA MUZAMIRU KYOGA WAKISO TOWN 0777863654/ 0758358990/ 0701888617 | KIIZA MUZAMIRU KYOGA WAKISO TOWN 0777863654/ 0758358990/ 0701888617 | BUTONDE COUGH SYRUP | BUTONDE AFRICAN SOLUTIONS KIIZA MUZAMIRU KYOGA WAKISO TOWN 0777863654/ 0758358990 /0701888617 | UGANDA | LIQUID | 100ML AMBER HDPE BOTTLE SEALED WITH A RED HDPE SCREW CAP. | 9/12/21 |
| 335 | THA874 | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE | UBV-01 | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE. PLOT 2B,LOURDEL ROAD KAMPALA P.O.BOX 4864, KAMPALA UGANDA. | UGANDA | SOLUTION | 20OML HDPE | 25/02/2021 |
| 336 | THA875 | ZALUGAVE HERBAL MEDICINE, P.O BOX 181544, BULOBA OFF MITYANA +256703513645/0774499894 | ZALUGAVE HERBAL MEDICINE, P.O BOX 181544, BULOBA OFF MITYANA +256703513645/0774499894 | MUNA HERBAL MOUTH WASH | ZALUGAVE HERBAL MEDICINE, P.O BOX 181544, BULOBA OFF MITYANA +256703513645/0774499894 | UGANDA | LIQUID | 1*60ML PET BOTTLE | 15/07/2021 |
| 337 | THA876 | RUPEX HEALTH PRODUCTS TEL: +256755927058 +256783653309 | RUPEX HEALTH PRODUCTS TEL: +256755927058 +256783653309 | CUREXI53 | RUPEX HEALTH PRODUCTS LIMITED NAJJERA BULABIRA E-MAIL: [email protected] TEL: +256756378785, +256775575752 | UGANDA | LOTION | 65GM HDPE CONTAINER | 16/11/2023 |
| 338 | THA877 | DR. ABALA PATRICK, MPERERWE SEKATTE ZONE,TEL:0782977283/0705170096 | DR. ABALA PATRICK, MPERERWE SEKATTE ZONE,TEL:0782977283/0705170096 | TARAMEL TOOTH TABS | BALMOI ORALCARE LTD,MPERERWE GAYAZA ROAD.KAMAPALA.UGANDA TEL:0782977283/ 0705170096 | UGANDA | TABLETS | 1*120 TABLETS HDPE BOTTLE | 7/9/21 |
| 339 | THA879 | LUKWAGO ISMAIL ADDRESS:KAMPALA, NAJJANANKUMBI TEL: 0708766496/0705346041 | LUKWAGO ISMAIL ADDRESS:KAMPALA, NAJJANANKUMBI TEL: 0708766496/0705346041 | RENA HERBAL MOUTHWASH | KAMEKETA ENTERPRISES LTD P.O.BOX 6555 KAMPALA UGANDA TEL: +256705346041 | UGANDA | LIQUID | 60ML PET SPRAY BOTTLE | 27/02/2023 |
| 340 | THA881 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | REPLENISH + MAMA CARE | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | UGANDA | HARD GELATIN CAPSULES | 6*10 ALU-PVC BLISTER PACK | 4/6/21 |
| 341 | THA882 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | REPLENISH + JUNIOR | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | UGANDA | TABLETS | 30`S HDPE BOTTLE | 4/6/21 |
| 342 | THA907 | MWENYA UGANDA DENTAL CLINIC, P.O.BOX 467, MPIGI TOWN,KULUMBA HILL 0758021933/0703826185 | MWENYA UGANDA DENTAL CLINIC, P.O.BOX 467, MPIGI TOWN,KULUMBA HILL 0758021933/0703826185 | MWENYA NATURAL MOUTH WASH | MWENYA LIFE UGANDA LTD P.O.BOX 467 MPIGI TOWN.KULUMBA HILL 0758021933/0703826185 EMAIL: [email protected] | UGANDA | LIQUID | 200ML HDPE BOTTLE | 7/9/22 |
| 343 | THA917 | KALUMIRA STEVEN HERBAL TALK (U) LTD LUGALA-MASANAFU, SENTEMA RD TEL: 0704644322 | KALUMIRA STEVEN HERBAL TALK (U) LTD LUGALA-MASANAFU, SENTEMA RD TEL: 0704644322 | KOFFLEX HERBAL COUGH SYRUP | HERBAL TALK (U) LTD LUGALA-MASANAFU, SENTEMA RD TEL: 0704644322 E-MAIL:[email protected] | UGANDA | LIQUID | 100ML AND 200ML LIQUID HDPE AMBER BOTTLE | 27/05/2022 |
| 344 | THA918 | MED BIIN PHARMACEUTICALS LTD, PLOT 1512,MAWANDA ROAD KAMPALA-UGANDA TEL:+256 393 246 090 | MED BIIN PHARMACEUTICALS LTD, PLOT 1512,MAWANDA ROAD KAMPALA-UGANDA TEL:+256 393 246 090 | MINTOCID | MED BIIN PHARMACEUTICALS LTD, PLOT 1512,MAWANDA ROAD KAMPALA-UGANDA TEL:+256 393 246 090 | UGANDA | LIQUID | 100ML & 200ML AMBER PET BOTTLE | 13/01/2022 |
| 345 | THA926 | KALULE HUSSEIN 0755711423 | KALULE HUSSEIN 0755711423 | BLACK TONIC SOLUTION | INTER-CONTINENTAL HERBAL MEDICINE RESEARCH LIMITED. LOCATED AT MAKINDYE-LUWAFU TEL: 0700408516/0772425881 | UGANDA | SOLUTION | 200ML BOTTLE | 2/6/25 |
| 346 | THA927 | TRANSFORM ABAFRICA PRODUCTS LIMITED P.O.BOX 6332 KAMPALA 0774495428/0704088886 | TRANSFORM ABAFRICA PRODUCTS LIMITED P.O.BOX 6332 KAMPALA 0774495428/0704088886 | ABAFRICA COUGH SYRUP | TRANSFORM ABAFRICA PRODUCTS LIMITED P.O.BOX 6332 KAMPALA 0774495428/0704088886 BUKINDA-RUKIGA DISTRICT | UGANDA | SOLUTION | 1*100ML AMBER PET BOTTLE | 26/05/2023 |
| 347 | THA928 | JENA HERBALS (U) LTD AKRIGHT CITY, ENTEBBE ROAD PLOT 11, WALNUT | JENA HERBALS (U) LTD AKRIGHT CITY, ENTEBBE ROAD PLOT 11, WALNUT | COVIDEX | JENA HERBALS (U) LTD AKRIGHT CITY, ENTEBBE ROAD PLOT 11, WALNUT TEL: 0785374967/0700412666 0779617612/0702450938 | UGANDA | LIQUID | 20 MLS IN WHITE HDPE DROPPER BOTTLE WITH GREEN LID | 29/06/2021 |
| 348 | THA932 | MUYOMBYA SOLOMON TEL: 0703531491/0787368458 | MUYOMBYA SOLOMON TEL: 0703531491/0787368458 | DELAY TEA | TENDO-MUYO ORGANIC HERBALS LTD, TEL: 070-531491/0787-368458 LOCATION: KIJABO-GAYAZA RD | UGANDA | POWDER | 180G HDPE CONTAINER | 2/12/22 |
| 349 | THA933 | MUYOMBYA SOLOMON 0772166541 | MUYOMBYA SOLOMON 0772166541 | CHAMA | TENDO HERBS TEL: 0703-531491/ 0787-368458 ANNET PLAZA BELOW OLD TAXI PARK LEVEL 2 ROOM S.04 MPERERWE NAMERE | UGANDA | POWDER | 100GM POWDER IN HDPE CONTAINER | 26/05/2023 |
| 350 | THA935 | BAANA BAKINTU HERBAL PRODUCTS, MUBENDE MUNICIPALITY | BAANA BAKINTU HERBAL PRODUCTS, MUBENDE MUNICIPALITY | BB001 GREEN TEA | BAANA BAKINTU HERBAL PRODUCTS, MUBENDE MUNICIPALITY, BAKIJULULA LC 1 TEL: 0772-913916/0752-150387 | UGANDA | POWDER | 200GM PLASTIC CONTAINER | 7/9/22 |
| 351 | THA936 | KIGGUNDU HERBAL GROUP NDEEBA NEAR SHELL PETROL STATION WAMALA ROAD O7O2839934 | KIGGUNDU HERBAL GROUP NDEEBA NEAR SHELL PETROL STATION WAMALA ROAD O7O2839934 | STK POWDER | KIGGUNDU HERBAL GROUP NDEEBA NEAR SHELL PETROL STATION WAMALA ROAD O7O2839934 | UGANDA | POWDER | 200GM PET JAR | 7/9/22 |
| 352 | THA937 | NALONGO MUSANA HERBAL CLINIC, KINZINGISA OFF GAYAZA ROAD 0701693848/0781544591 | NALONGO MUSANA HERBAL CLINIC, KINZINGISA OFF GAYAZA ROAD 0701693848/0781544591 | NALONGO MUSANA B.E HERBAL SOLUTION | NALONGO MUSANA HERBAL CLINIC, KINZINGISA OFF GAYAZA ROAD 0701693848/0781544591 | UGANDA | POWDER | 750ML PET BOTTLE | 7/9/22 |
| 353 | THA938 | KAZIRE HEALTH PRODUCTS LIMITED, PLOT 178 KABALE ROAD, MBARARA CITY. | KAZIRE HEALTH PRODUCTS LIMITED, PLOT 178 KABALE ROAD, MBARARA CITY. | VIDICINE | KAZIRE HEALTH PRODUCTS LIMITED, PLOT 178 KABALE ROAD, MBARARA CITY. PHONE: +256704714736 EMAIL: [email protected] | UGANDA | LIQUID | 200ML PLASTIC BOTTLE | 7/9/21 |
| 354 | THA939 | PHERB FORMULATIONS (U) LTD, P.O BOX 4462, KAMPALA – UGANDA 0704356951 / 0776290548 | PHERB FORMULATIONS (U) LTD, P.O BOX 4462, KAMPALA – UGANDA 0704356951 / 0776290548 | MINTEX DROPS-5MLS | YECO ORGANICS MANAGEMENT LTD,KYEBANDO,KATALE ZONE,GAYAZA ROAD, KAMPALA – UGANDA | UGANDA | LIQUID | 1*5ML WHITE PET CAPPED BOTTLE WITH A WHITE DROPPER PER CARTON | 29/10/2021 |
| 355 | THA943 | NARURAL HEALTH CARE CONSULTATIONS PLOT 2B, LOURDEL ROAD, KAMPALA P.O BOX 2004,KAMPALA-UGANDA | NARURAL HEALTH CARE CONSULTATIONS PLOT 2B, LOURDEL ROAD, KAMPALA P.O BOX 2004,KAMPALA-UGANDA | NAHECCO HERBAL COUGH SYRUP | NARURAL HEALTH CARE CONSULTATIONS PLOT 2B, LOURDEL ROAD, KAMPALA P.O BOX 2004,KAMPALA-UGANDA TEL: +256704187510/+256706553709 | UGANDA | SYRUP | 1*100 & 200ML AMBER PET BOTTLE | 26/05/2023 |
| 356 | THA948 | OCHEN ANTHONY, SHUMUK HOUSE COLVILLE STREET KAMPALA 0772192567/O705395388 | OCHEN ANTHONY, SHUMUK HOUSE COLVILLE STREET KAMPALA 0772192567/O705395388 | HEAMORIX | HHEMORIX UGANDA SSHUMUK HOUSE, COLVILLE STREET, KAMPALA 0771473717/0709861096 | UGANDA | OINTMENT | 1*1*20G PET JAR. | 4/11/22 |
| 357 | THA949 | WAISWA DANIEL 07707567718 TUMWINE PIUS 0778003721 | WAISWA DANIEL 07707567718 TUMWINE PIUS 0778003721 | ZOE PURE NATURAL SYRUP | LIFE IMPACT CONSORTIUM (LIC) LTD,P.O.BOX 4674 KAMPALA(U) KIREKA- NAMUGONGO ROAD TEL+256(0) 200 920 929 | UGANDA | SYRUP | 100ML PLASTIC BOTTLE | 7/9/22 |
| 358 | THA950 | NAMBATYA JOANITAH KYENGERA-MUGONGO, OFF MASAKA KAMPALA ROAD 0754884766 | NAMBATYA JOANITAH KYENGERA-MUGONGO, OFF MASAKA KAMPALA ROAD 0754884766 | GARRY HERBAL POWDER | GARRY HERBS KINAAWA HILL MUSOKE ROAD KYENGERA OFF MASAKA ROAD TEL:0774088895 0754884766 | UGANDA | POWDER | 250GMS IN AN HDPE TIN | 27/05/2022 |
| 359 | THA951 | TORWOMWE SEMA FRANCIS MUNYONYO, GABA ROAD 0705666333 /078266661 | TORWOMWE SEMA FRANCIS MUNYONYO, GABA ROAD 0705666333 /078266661 | VIGOR IMMUNE PLUS | WORLD- WIDE HAPPINESS INTERNATIONALKAMPALA ROAD MABIRIZI COMPLEX.LEVEL 4.ROOM NO:15 (L4-15) P.O.BOX 71233 CLOCK TOWER KAMPALA | UGANDA | POWDER | 1*50GM GLASS JAR | 9/12/21 |
| 360 | THA957 | INDUSTRIAL HEMP PHARMACEUTICLS | INDUSTRIAL HEMP PHARMACEUTICLS | CANCARE HEMP SEED OIL | INDUSTRIAL HEMP PHARMACEUTICLS,KYADONDO BLOCK 196, KOMAMBOGA, KAWEMPE DIVISION KAMPALA UGANDA P.O.BOX 37613 TEL:0414 660 825/0786421148 | UGANDA | LIQUID | 1*110ML IN AMBER PLASTIC BOTTLE | 23/04/2024 |
| 361 | THA961 | INDUSTRIAL HEMP PHARMACEUTICALS | INDUSTRIAL HEMP PHARMACEUTICALS | CANCCARE HEMPRO+150 | INDUSTRIAL HEMP PHARMACEUTICALS KYADONDO BLOCK 196, KOMAMBOGA, KAWEMPE DIVISION, KAMPALA, UGANDA, P.O.BOX 37613 +256775274159. | UGANDA | POWDER | 250 GRAMS IN A PLASTIC JAR | 12/8/24 |
| 362 | THA966 | INDUSTRIAL HEMP PHARMACEUTICALS | INDUSTRIAL HEMP PHARMACEUTICALS | CANCARE NATURAL BALANCE | INDUSTRIAL HEMP PHARMACEUTICALS KYADONDO BLOCK 196, KOMAMBOGA, KAWEMPE DIVISION, KAMPALA, UGANDA, P.O.BOX 37613 +256775274159. | UGANDA | LIQUID | 110 ML IN AN AMBER PLASTIC COLOURED BOTTLE | 12/8/24 |
| 363 | THA970 | MALUGGE ARNOLD TEL: 0783811801 | MALUGGE ARNOLD TEL: 0783811801 | MOMMY`S LACTATION TEA | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LTD LOCATED IN KAGOMA-BOMBO RD P,O BOX 16843, WANDEGEYA, UGANDA TEL: +256782769582/+256752540140 | UGANDA | POWDER | 200G LDPE BAG PACKED THE SECONDARY BOX | 9/2/22 |
| 364 | THA971 | MALUGGE ARNOLD TEL: 0783811801 | MALUGGE ARNOLD TEL: 0783811801 | IMMUNE UP | JOLIKA LTD P.O BOX 23333, KAMPALA,UGANDA TEL: +256-706353088/773466690 WWW.JOLIKAUG.COM | UGANDA | LIQUID | 200ML AMBER PET BOTTLE | 9/2/22 |
| 365 | THA975 | TENDO ORGANIC HERBALS LTD LOCATED:KIJABIJO OFF GAYAZA ROAD,WAKISO 0703531491/0787368458 | TENDO ORGANIC HERBALS LTD LOCATED:KIJABIJO OFF GAYAZA ROAD,WAKISO 0703531491/0787368458 | IMUNOX 23RD-WELLNESS | TENDO ORGANIC HERBALS LTD LOCATED:KIJABIJO OFF GAYAZA ROAD,WAKISO 0703531491/0787368458 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 6/7/23 |
| 366 | THA976 | MUYOMBYA SOLOMON TENDO ORGANIC COMPANY NAMEERE-MPERRERWE,WAKISO 0786481190 | MUYOMBYA SOLOMON TENDO ORGANIC COMPANY NAMEERE-MPERRERWE,WAKISO 0786481190 | TEATOX | TENDO ORGANIC COMPANY NAMEERE-MPERRERWE,WAKISO ANNET PLAZA L.2 ROOM S.04 0703531491/0787368458 | UGANDA | POWDER | 50G PLASTIC CONTAINER | 20/12/2023 |
| 367 | THA982 | DAMA MEDICINAL HERBS P.O.BOX 25216 KAMPALA | DAMA MEDICINAL HERBS P.O.BOX 25216 KAMPALA | DAMA TONIC SOLUTION | DAMA MEDICINAL HERBS,P.O.BOX 25216 KAMPALA,PLOT 3118 BBIIRA,BULENGA TEL:0772684274/0774258892/0777733338/0754318926 | UGANDA | LIQUID | 1*670ML PET BOTTLE | 26/05/2023 |
| 368 | THA988 | VIGOR DOCTOR (U) LTD/ VIGOR IMMUNE PLUS (U) LTD | VIGOR DOCTOR (U) LTD/ VIGOR IMMUNE PLUS (U) LTD | VGR-IMM-PLUS | VIGOR DOCTOR (U) LTD/ VIGOR IMMUNE PLUS (U) LTD MUKWANO MALL, PLOT 1, KYAGWE RD P.O BOX 456, KAMPALA, UGANDA TEL: 0701074540/0781960612 | UGANDA | POWDER | 700G PLASTIC CONTAINER | 27/05/2022 |
| 369 | THA995 | KAGOYA DIANA BUSABALA WAKISO TEL: 0753509324 | KAGOYA DIANA BUSABALA WAKISO TEL: 0753509324 | KAGOYA HERBAL JELLY | KAGOYA DIANA BUSABALA WAKISO TEL: 0753509324 | UGANDA | JELLY | 60GM,100GM & 250GM,PLASTIC CONTAINER | 7/9/22 |
| 370 | THA998 | TWINAMATSIKO FRANK SHAKUR HERBAL GROUP KAWEMPE 0704463646/0775252041 | TWINAMATSIKO FRANK SHAKUR HERBAL GROUP KAWEMPE 0704463646/0775252041 | SHAKUR MODERN HERBAL TEA | SHAKUR HERBAL GROUP TTULA-KIROKOLE NEAR LUUKA PLASTICS, KAWEMPE, KAMPALA, UGANDA. 0704463646/0775252041 | UGANDA | POWDER | 75 AND 160 GRAMS PET BOTTLE | 4/10/23 |
| 371 | THA999 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | ULVOP HERBAL MIXTURE | VAX ORGANIC PRODUCTS BULOBA ALONG MITYANA ROAD ,WAKISO DISTRICT TEL:0775827379/0755540110 | UGANDA | LIQUID | 200ML PET BOTTLE | 27/02/2023 |
| 372 | THA1196 | SENTEZA SYDNEY KITENDE KAJJANSI, WAKISO DISTRICT. 0752568899/ 0776568899 | SENTEZA SYDNEY KITENDE KAJJANSI, WAKISO DISTRICT. 0752568899/ 0776568899 | CYCLE CARE FORMULAE | LUSUSU SECRETS LIMITED, P. O. BOX, 23349, KAMPALA – UGANDA | UGANDA | POWDER | 1*150G IN WHITE PET BOTTLE | 18/08/2025 |
| 373 | THA1190 | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088/077466 690 | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088/077466 690 | HAEMOFAN SYRUP | JOLIKA LTD UPPER MULAGO HILL ROAD P.O.BOX 102253 KAMPALA UGANDA TEL 0706 353088/077466 690 | UGANDA | SYRUP | 100ML PET BOTTLE | 29/08/2025 |
| 374 | THA991 | MR. BUSINGE WILLY, TOPA PRODUCTS P. O BOX 1022 FORT PORTAL CITY TEL: 0773983944/ 0704280923 | MR. BUSINGE WILLY, TOPA PRODUCTS P. O BOX 1022 FORT PORTAL CITY TEL: 0773983944/ 0704280923 | TOPA HERBAL MIXTURE | TOPA PRODUCTS P.O BOX 1022, FORT PORTAL- UGANDA, TEL: 0773983944/ 0704280923 | UGANDA | LIQUID | 76 ML PLASTIC BOTTLE | 29/08/2025 |
| 375 | THA1320 | BHM RESEARCHERS, KAWEMPE – KAMPALA TEL;0788507775 | BHM RESEARCHERS, KAWEMPE – KAMPALA TEL;0788507775 | B.H.M ORAL SOLUTION | BHM RESEARCHERS, KAWEMPE – KAMPALA TEL;0788507775 | UGANDA | ORAL SOLUTION | 218 MLS | 29/08/2025 |
| 376 | THA1305 | AIM 2 LIFE CO. LTD TEL: 070089511/0787870908 NKIZI ROAD WANDEGEYA, KAMPALA | AIM 2 LIFE CO. LTD TEL: 070089511/0787870908 NKIZI ROAD WANDEGEYA, KAMPALA | MEDFLEX SPRAY HERBAL LINIMENT | AIM 2 LIFE CO. LTD TEL: 070089511/0787870908 NKIZI ROAD WANDEGEYA, KAMPALA | UGANDA | LIQUID | 60ML PET BOTTLE | 30/07/2025 |
| 377 | THA1212 | ABBAS MUTUMBA NAKAWUKA- ENTEBBE, WAKISO, 0701314664/0772330333 | ABBAS MUTUMBA NAKAWUKA- ENTEBBE, WAKISO, 0701314664/0772330333 | PROPELEX | FINE FIELD SERVICES LTD KASUKU- NAKAWUKA,KAJJANSI TEL: +256701314664/ +256772330333 EMAIL: [email protected] | UGANDA | ORAL SPRAY | 30ML | 22/07/2025 |
| 378 | THA1270 | PES HERBALS, MUST PATHOGEN EPIDEMIOLOGICAL STUDIES,0782725491 [email protected] | PES HERBALS, MUST PATHOGEN EPIDEMIOLOGICAL STUDIES,0782725491 [email protected] | PESGYNO | PHARMBIOTRAC MUST, SOUTH WESTERN,UGANDA TEL: 0701725491 FOR: PES HERBALS, P.O BOX 651,MBARARA, UGANDA | UGANDA | PESSARY | 7 PESSARIES | 22/07/2025 |
| 379 | THA1332 | KANSIIME VICTOR 0782939682/0702401422 [email protected] | KANSIIME VICTOR 0782939682/0702401422 [email protected] | SAMORA | MILLIONSTARS HEALTH PRODUCTS CO. LTD UIA SMES INDUSTRIAL PARK MAKENKE MBARARA. TEL.NO. 0782939682/0702401422 | UGANDA | ORAL LIQUID | 725ML PLASTIC AMBER BOTTLE | 30/07/2025 |
| 380 | THA1269 | PES HERBALS, MUST PATHOGEN EPIDEMIOLOGICAL STUDIES | PES HERBALS, MUST PATHOGEN EPIDEMIOLOGICAL STUDIES | PES HERBAL SKIN OINTMENT | PHARMBIOTRAC MUST, SOUTH WESTERN,UGANDA TEL: 0701725491 FOR: PES HERBALS, P.O BOX 651,MBARARA, UGANDA | UGANDA | OINTMENT | 15G | 22/07/2025 |
| 381 | THA1304 | AIM 2 LIFE CO. LTD TEL: 070089511/0787870908 NKIZI ROAD WANDEGEYA, KAMPALA. | AIM 2 LIFE CO. LTD TEL: 070089511/0787870908 NKIZI ROAD WANDEGEYA, KAMPALA. | MEDCID SYRUP | AIM 2 LIFE CO. LTD TEL: 070089511/0787870908 NKIZI ROAD WANDEGEYA, KAMPALA. | UGANDA | LIQUID | 100ML PET BOTTLE | 30/07/2025 |
| 382 | THA1313 | TENDO MEDICINAL HERBS WAKISO-MUTUNDWE TEL: +256700753361 +256781716209 | TENDO MEDICINAL HERBS WAKISO-MUTUNDWE TEL: +256700753361 +256781716209 | TENDO HERBAL MIXTURE | TENDO MEDICINAL HERBS WAKISO-MUTUNDWE TEL: +256700753361 +256781716209 | UGANDA | MIXTURE | 200ML PET BOTTLE | 4/9/25 |
| 383 | THA1314 | TENDO MEDICINAL HERBS WAKISO-MUTUNDWE TEL: +256700753361 +256781716209 | TENDO MEDICINAL HERBS WAKISO-MUTUNDWE TEL: +256700753361 +256781716209 | MIREMBE COUGH MIXTURE | TENDO MEDICINAL HERBS WAKISO-MUTUNDWE TEL: +256700753361 +256781716209 | UGANDA | MIXTURE | 200ML PET BOTTLE | 4/9/25 |
| 384 | THA1274 | DELAFRIQUE DEOGRATIAS DARM HERBALS PHARMBIOTRAC- MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY | DELAFRIQUE DEOGRATIAS DARM HERBALS PHARMBIOTRAC- MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY | VEP HERBAL WOUND SPRAY | DARM HERBALS. PHARMBIOTRAC MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY 0772863976 / 0752172415 MBARARA-UGANDA | UGANDA | SPRAY | 60ML PET BOTTLE | 9/9/25 |
| 385 | THA1352 | MR. OGWANG PETER, AMACH, ERUTE SOUTH LIRA-UGANDA TEL;0782002010 | MR. OGWANG PETER, AMACH, ERUTE SOUTH LIRA-UGANDA TEL;0782002010 | PYLORDEK | JNP AGROVET LTD, AWIODYEK VILLAGE, AWIODYEK SUB-COUNTY, ERUTE SOUTH, LIRA-UGANDA TEL;0782002010 | UGANDA | ORAL SUSPENSION | 100 ML AND 200ML | 10/9/25 |
| 386 | THA1325 | BWERA INNOVATIONS LTD,TEL.NO. 0775508556 | BWERA INNOVATIONS LTD,TEL.NO. 0775508556 | FLONITA ACTIVATED CHARCOAL | BWERA INNOVATIONS LTD UGANDA INDUSTRIAL RESEARCH INSTITUTE UIRI, MUKABYA ROAD NAKAWA INDUSTRIAL AREA P.O.BOX 70886, KAMPALA TEL.NO. 0775508556 | UGANDA | POWDER | 50G SACHET | 16/09/2025 |
| 387 | THA1351 | ULTRADEM PRODUCTS, P.O BOX 173599, KAMPALA ,UGANDA TEL:0709707991 | ULTRADEM PRODUCTS, P.O BOX 173599, KAMPALA ,UGANDA TEL:0709707991 | ULTRADEM HERBAL MOUTH WASH | ULTRADEM PRODUCTS, P.O BOX 173599, KAMPALA ,UGANDA TEL:0709707991 | UGANDA | LIQUID | 1*200ML PLASTIC BOTTLE | 30/09/2025 |
| 388 | THA1195 | RWENZORI NATURAL HERBAL MEDICINES, P.O.BOX 1164, BUNDIBUGYO UGANDA 0772 669 941/0704 330 344 | RWENZORI NATURAL HERBAL MEDICINES, P.O.BOX 1164, BUNDIBUGYO UGANDA 0772 669 941/0704 330 344 | THOXY | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE (NCRI) PLOT 2B LOURDEL RD, KAMPALA P.O.BOX 4864, KAMPALA, UGANDA | UGANDA | POWDER | 120GMS IN A TRANSPARENT PLASTIC JAR POWDER | 30/09/2025 |
| 389 | THA1192 | RWENZORI NATURAL HERBAL MEDICINES, P.O.BOX 1164, BUNDIBUGYO UGANDA 0772 669 941/0704 330 344 | RWENZORI NATURAL HERBAL MEDICINES, P.O.BOX 1164, BUNDIBUGYO UGANDA 0772 669 941/0704 330 344 | WAP | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE (NCRI) PLOT 2B LOURDEL RD, KAMPALA P.O.BOX 4864, KAMPALA, UGANDA | UGANDA | POWDER | 120GMS | 30/09/2025 |
| 390 | THA1331 | LUKWAGO MUHAMAD POST OFFICE BUILDING MASAKA CITY, 0705666868/0785912073 | LUKWAGO MUHAMAD POST OFFICE BUILDING MASAKA CITY, 0705666868/0785912073 | DISA VITALITY POWDER | DISA ORGANIC POST OFFICE BUILDING MASAKA CITY | UGANDA | POWDER FOR ORAL SUSPENSION | 100G | 30/09/2025 |
| 391 | THA1363 | SANTE BIO-TECH LTD, MULANGILA HOUSE, KIJJABWEMI, MASAKA, TEL: 0701717171 | SANTE BIO-TECH LTD, MULANGILA HOUSE, KIJJABWEMI, MASAKA, TEL: 0701717171 | SANTE MIXTURE | SANTE BIO-TECH LTD, MULANGILA HOUSE, KIJJABWEMI, MASAKA, TEL: 0701717171 | UGANDA | LIQUID | 200 ML IN AN AMBER COLORED PLASTIC BOTTLE WITH A BLUE CAP | 23/10/2025 |
| 392 | THA1346 | LUBUULWA ERICK MWANGUIRE HERBALIST INNOVATIVE CENTER LIMITED, P.O. BOX 197, MBARARA CITY | LUBUULWA ERICK MWANGUIRE HERBALIST INNOVATIVE CENTER LIMITED, P.O. BOX 197, MBARARA CITY | ALOE-VERA NATURAL ORGANIC CAPSULES | PRODUCTION UNIT, PHARMABIOTRAC. MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY 0782694224 | UGANDA | CAPSULES FOR ORAL USE | 30 CAPSULES IN PLASTIC BOTTLE | 10/10/25 |
| 393 | THA994 | SSEMIRIMU YASIIN ZZIWA 0774009790/0700384840 BWAISE-KAZO | SSEMIRIMU YASIIN ZZIWA 0774009790/0700384840 BWAISE-KAZO | SEZ NATURAL TEA | SEZ MEDICINAL CENTRE LTD NEAR KAZO C/U PRI. SCH. BWAISE-NWABWERU RD. TEL: +256(0) 700384840,+256(0)774009790 EMAIL: [email protected] | UGANDA | POWDER FOR ORAL SUSPENSION | 100G | 10/10/25 |
| S/N | REGISTRATION NUMBER OF AUTHORITY | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF SURGICAL INSTRUMENT | COMMON NAME | CLASS OF SURGICAL INSTRUMENT | COMPONENTS/ACCESSORIES | GMDN CODE | GMDN CATEGORY | MANUFACTURER | COUNTRY OF MANUFACTURE | PACK SIZE | DOSAGE FORM IF APPLICABLE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NDA/MAL/SI/0001 | PREVENT PLUS LLC 4220 DUNCAN AVE, SUITE 201 ST. LOUIS, MO 63110 U.S.A | PLASTERGEN CO. LIMITED | PREVENTOGEN | LIQUID BANDAGE | CLASS A | N/A | 62535 | TISSUE ADHESIVES/SEALANTS; DERMAL DRESSINGS; SINGLE USE | APERTUS PHARMACEUTICALS LLC 331 CONSORT DRIVE BALLWIN, MO 63110, USA. | USA | 1*1*25, 20ML CLEAR GLASS BOTTLE, + 1*3*5, 1.5ML STERILE SINGLE-USE APPLICATOR | LIQUID | 5/6/25 |
Updated on 5th December 2025
