Drug Register (March 2023)
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 | MANUFACTURER | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|---|
| 1 | NDA/MAL/HHP/10011 | GRIFFON BIOMETRIX PVT.LTD | METRO PHARMACEUTICALS LIMITED | GRIFFON BALM | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.L-CTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G BOTTLE | 28/02/2022 |
| 2 | 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 | 07/03/2022 |
| 3 | 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- | SINGAPORE | ORAL SOLID ORDINARY LOZENGES | 1.0X15.0X6.0 LOZENGE SACHET | 10/03/2022 |
| 4 | 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- | SINGAPORE | ORAL SOLID ORDINARY LOZENGES | 1.0X15.0X6.0 LOZENGE SACHET | 10/03/2022 |
| 5 | NDA/MAL/HHP/10022 | KALBE INTERNATIONAL PTE LTD | ABACUS PHARMA (AFRICA) LIMITED | WOOD'S PEPPERMINT LOZENGES (ORANGE FLAVOUR) | PT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- | SINGAPORE | ORAL SOLID ORDINARY LOZENGES | 1.0X15.0X6.0 LOZENGE SACHET | 10/03/2022 |
| 6 | NDA/MAL/HHP/10023 | KREMOINT PHARMA PVT.LTD | PLANET PHARMACEUTICALS UGANDA LTD | KOFFENGES COUGH SYRUP | KREMOINT PHARMA PRIVATE LIMITED-A-10/M.I.D.C. TALOJA - 410208, TAL-PANVEL, DIST: RAIGAD, MAHARASHTRA - INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 05/04/2022 |
| 7 | NDA/MAL/HHP/10024 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | LOZETS MENTHOMAX PLUS | PRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X50.0X2.0 LOZENGE BLISTER,1.0X10.0X2.0 LOZENGE BLISTER | 05/04/2022 |
| 8 | NDA/MAL/HHP/10025 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | HERO PAIN BALM | GAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 ML JAR | 05/04/2022 |
| 9 | NDA/MAL/HHP/10026 | NEOMI PHARMACEUTICALS PVT LTD | ROYAL PHARMA 2011 LIMITED | NEOSILS HERBAL COUGH LOZENGES | LEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY LOZENGES | 25.0X2.0 LOZENGE STRIP | 11/04/2022 |
| 10 | NDA/MAL/HHP/10027 | BHARGAVA PHYTOLAB PVT. LTD | REDDYS PHARMA LIMITED | ACTIVATED CHARCOAL TABLETS | BHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X90.0 TABLET BOTTLE | 21/04/2022 |
| 11 | NDA/MAL/HHP/10406 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | LOTUS FEMIWASH | GAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X25.0 ML BOTTLE | 04/10/2022 |
| 12 | NDA/MAL/HHP/10409 | CHETAN & DIPTI (C&D) PHARMA PVT LTD | KAMCARE PHARMA LIMITED | HERBOXIL LOZENGES | LEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X50.0X2.0 LOZENGE STRIP | 12/10/2022 |
| 13 | NDA/MAL/HHP/10411 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS ORANGE LOZENGES | LOZEN PHARMA PRIVATE LIMITED-RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER | 16/11/2022 |
| 14 | NDA/MAL/HHP/10412 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS MENTHOL LOZENGES | LOZEN PHARMA PRIVATE LIMITED-RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER | 16/11/2022 |
| 15 | NDA/MAL/HHP/10413 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS HONEY LEMON LOZENGES | LOZEN PHARMA PRIVATE LIMITED-RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER | 16/11/2022 |
| 16 | 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 | 02/12/2022 |
| 17 | NDA/MAL/HHP/10501 | SYNOKEM PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GOPAYN RUB GEL | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 02/12/2022 |
| 18 | NDA/MAL/HHP/10588 | CHETAN & DIPTI (C&D) PHARMA PVT LTD | KAMCARE PHARMA LIMITED | CHARCO PRO TABLET | M/S BHARGAVA PHYTOLAB PRIVATE LIMITED-E-1216 PHASE-I, GHATAL, RIICO INDUSTRIAL AREA, BHIWADI, DISTRICT ALWAR (RAJASTHAN) - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/01/2023 |
| 19 | NDA/MAL/HHP/3115 | SHURIK LTD | SHURIK LTD | RHINO BALM | MEHTA UNANI PHARMACY & CO LTD-INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER | 01/07/2001 |
| 20 | 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 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2000 |
| 21 | NDA/MAL/HHP/5502 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | GASEX | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE) | 01/07/2000 |
| 22 | NDA/MAL/HHP/5505 | VENUS REMIDIES LTD | HARLEYS UGANDA LIMITED | AMPUCARE HERBAL OIL | PLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X50.0 ML BOTTLE | 01/07/2008 |
| 23 | NDA/MAL/HHP/5517 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | MENTAT | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0 TABLET CONTAINER | 01/07/2004 |
| 24 | 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 | 01/07/2007 |
| 25 | NDA/MAL/HHP/5519 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | APDYL-H, HERBAL COUGH SYRUP | SAVERA PHARMACEUTICALS PVT LTD --H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. AJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2004 |
| 26 | NDA/MAL/HHP/5520 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | PILEX | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER | 01/07/2001 |
| 27 | NDA/MAL/HHP/5527 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | KOFLET | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| 28 | 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 | 01/07/2009 |
| 29 | NDA/MAL/HHP/5530 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | LIV.52 TABLETS | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE | 01/07/2000 |
| 30 | NDA/MAL/HHP/5531 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | RUMALAYA | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2000 |
| 31 | 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 | 01/07/2009 |
| 32 | NDA/MAL/HHP/5533 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | RUMALAYA | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE) | 01/07/2000 |
| 33 | NDA/MAL/HHP/5536 | ABACUS 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 | 01/07/2004 |
| 34 | NDA/MAL/HHP/5538 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | SEPTILIN | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2000 |
| 35 | 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 | 01/07/2015 |
| 36 | NDA/MAL/HHP/5547 | SHURIK LTD | SHURIK LTD | MENTHOSIL COUGH DROP | MEHTA HERBALS PVT LTD-INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X35.0X2.0 LOZENGE STRIP | 01/07/2001 |
| 37 | NDA/MAL/HHP/5549 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | BONISAN LIQUID | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 01/07/2000 |
| 38 | 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 | 01/07/2015 |
| 39 | NDA/MAL/HHP/5557 | BETA HEALTH CARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | NEW BETA GRIPE WATER | SYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136 BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2014 |
| 40 | NDA/MAL/HHP/5559 | SHURIK LTD | SHURIK LTD | STAR SKIN OINTMENT | MEHTA UNANI PHARMACY & CO LTD-INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X12.0 G TUBE | 01/07/2001 |
| 41 | NDA/MAL/HHP/5561 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | COLDDROP MEDICATED COUGH DROPS | MEHTA HERBALS PVT LTD-AMRUTMANTHAN HOUSE, SADAR,RAJKOT,GUJARAT - 360 001,INDIA, RAJKOT, GUJARAT 360001, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X1.0X100.0 LOZENGE CARTON | 01/07/2009 |
| 42 | NDA/MAL/HHP/5563 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | CYSTONE | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2001 |
| 43 | 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 | 01/07/2013 |
| 44 | NDA/MAL/HHP/5571 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | DRAGON LIQUID BALM | AMRUTANJAN HEALTH CARE LIMITED-PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIA | INDIA | TOPICAL EXTERNAL OTHER OINTMENTS | 1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER | 01/07/2004 |
| 45 | 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 | 01/07/2011 |
| 46 | 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 | 01/07/2009 |
| 47 | NDA/MAL/HHP/5576 | SHURIK LTD | SHURIK LTD | NO SCAR CREAM | METHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2007 |
| 48 | NDA/MAL/HHP/5583 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | EVECARE | HIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER | 01/07/2001 |
| 49 | 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 | 01/07/2016 |
| 50 | 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 | 01/07/2014 |
| 51 | 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 | 01/07/2005 |
| 52 | 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 | 01/07/2005 |
| 53 | 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 | 01/07/2000 |
| 54 | 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 | 01/07/2014 |
| 55 | 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 | 01/07/2016 |
| 56 | NDA/MAL/HHP/6850 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | BENZIM NATURAL SYRUP 120ML | WILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 03/12/2016 |
| 57 | NDA/MAL/HHP/6852 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | DE-FLU SYRUP 120ML | WILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 03/12/2016 |
| 58 | NDA/MAL/HHP/6853 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | LIV-LONG TABLET | WILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| 59 | NDA/MAL/HHP/6863 | KREMOINT PHARMA PVT.LTD | GOOD DAY PHARMACY LIMITED | KOFFENGES LOZENGES (HONEY & LEMON FLAVOUR) | KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER | 01/07/2017 |
| 60 | NDA/MAL/HHP/7929 | WOCKHARD LTD | STAR PHARMACEUTICALS LTD | 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 | 01/07/2015 |
| 61 | NDA/MAL/HHP/7931 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD | GAMA PHARMACEUTICALS (U) LIMITED | LIBLAB SYRUP | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN. | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2012 |
| 62 | NDA/MAL/HHP/7934 | STAR PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SENSUR RUBEFACIENT | GLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 01/07/2015 |
| 63 | NDA/MAL/HHP/7940 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SENSUR LOTION | GLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA | INDIA | TOPICAL EXTERNAL OTHER CREAMS | 1.0X50.0 ML BOTTLE | 01/07/2015 |
| 64 | 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 | 01/07/2016 |
| 65 | NDA/MAL/HHP/7946 | SHEBAC PHARMA | NORVIK ENTERPRISES LIMITED | APONTIS | AEROMAC (INDIA) INC-12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL SPRAYS WITHOUT GAS | 1.0X150.0 ML BOTTLE | 01/07/2015 |
| 66 | 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 | 01/07/2014 |
| 67 | 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 | 01/07/2016 |
| 68 | 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 | 01/07/2014 |
| 69 | 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 | 01/07/2014 |
| 70 | NDA/MAL/HHP/7955 | KREMOINT PHARMA PVT.LTD | PLANET PHARMACEUTICALS UGANDA LTD | DICLODAY ROLL-ON | KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA | TOPICAL EXTERNAL EMULSIONS | 1.0X50.0 ML BOTTLE | 03/12/2016 |
| 71 | 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 | 01/07/2015 |
| 72 | NDA/MAL/HHP/7958 | KREMOINT PHARMA PVT.LTD | GOOD DAY PHARMACY LIMITED | KOFFENGES(GINGER FLAVOUR) | KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER | 01/07/2017 |
| 73 | NDA/MAL/HHP/7960 | KREMOINT PHARMA PVT.LTD | GOOD DAY PHARMACY LIMITED | KOFFENGES(ORANGE FLAVOUR) | KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER | 01/07/2017 |
| 74 | NDA/MAL/HHP/7961 | KREMOINT PHARMA PVT.LTD | GOOD DAY PHARMACY LIMITED | KOFFENGES LOZENGES MINT | KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER | 01/07/2017 |
| 75 | NDA/MAL/HHP/7966 | BHARGAVA PHYTOLAB PVT LTD | REDDYS PHARMA LIMITED | KIDFLAME | BHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0 TABLET BLISTER | 01/07/2015 |
| 76 | NDA/MAL/HHP/7974 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | APPERIZE SYRUP 120ML | WILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2017 |
| 77 | NDA/MAL/HHP/8070 | LEXINE TECHNOCHEM PVT LTD | KPI HEALTHCARE LIMITED | KWIK PAIN RELIEVING CREAM | LEXINE TECHNOCHEM PVT LTD.-INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 28/07/2018 |
| 78 | NDA/MAL/HHP/8071 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MOOVE MASSAGE CREAM | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | TOPICAL EXTERNAL LOTIONS | 1.0X1.0X40.0 G TUBE | 01/07/2017 |
| 79 | NDA/MAL/HHP/8094 | BHARGAVA PHYTOLAB PVT. LTD | REDDYS PHARMA LIMITED | PROSTORAL | BHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 01/07/2017 |
| 80 | 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 | 01/07/2004 |
| 81 | 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 | 01/07/2017 |
| 82 | NDA/MAL/HHP/8379 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | M2 TONE TABLET | CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 20/09/2017 |
| 83 | 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 | 02/02/2018 |
| 84 | 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 | 02/02/2018 |
| 85 | NDA/MAL/HHP/8508 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | KOFOL SF 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 SYRUPS | 1.0X100.0 ML BOTTLE | 02/02/2018 |
| 86 | NDA/MAL/HHP/8509 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EVANOVA CAPSULE | CHARAK PHARMA PRIVATE LIMITED-PLOT NO. 371, SAYLI - RAKHOLI ROAD, SILVASSA - 396 230. U.T. OF DADRA AND NAGAR HAVELI - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER | 29/11/2017 |
| 87 | 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 | 06/03/2018 |
| 88 | NDA/MAL/HHP/8511 | BHARGAVA PHYTOLAB PVT. LTD | REDDYS PHARMA LIMITED | THUNDER-M | BHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| 89 | NDA/MAL/HHP/8513 | BHARGAVA PHYTOLAB PVT. LTD | REDDYS PHARMA LIMITED | MENIPHIB | BHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X20.0 TABLET BLISTER | 01/07/2016 |
| 90 | NDA/MAL/HHP/8548 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICAL LTD | PEPSOL | ARTURA PHARMACEUTICALS PVT LTD-PLOT NO. 1505 PORTIA ROAD SIRI CITY SEZ SATYAVEDU MANDAL CHITTOOR DISTRICT ANDHRA PRADESHI - 517 588 INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 24/10/2017 |
| 91 | 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 | 24/11/2017 |
| 92 | NDA/MAL/HHP/8553 | RAZA INTERNATIONAL | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HONEY CURE | OZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET. OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDAN | JORDAN | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE | 13/07/2017 |
| 93 | 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 | 10/11/2017 |
| 94 | NDA/MAL/HHP/8837 | PILLAR PHARMA LIMITED | PILLAR LOGISTICS LIMITED | HEPTOVIT | MILENNIUM HERBAL CARE LTD-12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 07/06/2018 |
| 95 | NDA/MAL/HHP/8899 | LEXINE TECHNOCHEM PVT LTD | KPI HEALTHCARE LIMITED | LEXICOF HERBAL COUGH SYRUP | LEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 14/03/2018 |
| 96 | NDA/MAL/HHP/8902 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LTD. | DE-TUZ SYRUP | WILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 28/06/2018 |
| 97 | NDA/MAL/HHP/8979 | LEXINE TECHNOCHEM PVT LTD | KPI HEALTHCARE LIMITED | KWIK PAIN BALM | LEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE,1.0X22.0 G TUBE | 14/03/2018 |
| 98 | NDA/MAL/HHP/9026 | LEXINE TECHNOCHEM PVT LTD | KPI HEALTHCARE LIMITED | BABY CARE + GRIPE WATER 130ML | LEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X130.0 ML BOTTLE | 01/07/2015 |
| 99 | NDA/MAL/HHP/9091 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | KOFCLEAN SYRUP (HERBAL COUGH SYRUP) | MAXCURE NUTRAVEDICS LTD -PLOT NO.13 SEC-6A IIE,SIDCUL,RANIPUR,HARIDWAR-249 403, UTTRAKHAND | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 28/01/2019 |
| 100 | NDA/MAL/HHP/9093 | BETA HEALTHCARE UGANDA 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 | 22/03/2019 |
| 101 | NDA/MAL/HHP/9094 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETASIL HERBAL COUGH SYSRUP | BETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 22/03/2019 |
| 102 | NDA/MAL/HHP/9099 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | CRAN MAX PRO SACHET | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0 SACHET CARTON | 31/05/2019 |
| 103 | NDA/MAL/HHP/9100 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | FIBO SACHET | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0 SACHET CARTON | 31/05/2019 |
| 104 | NDA/MAL/HHP/9101 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | FIBO SYRUP | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 31/05/2019 |
| 105 | NDA/MAL/HHP/9102 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | EPTI SYRUP | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 31/05/2019 |
| 106 | NDA/MAL/HHP/9103 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | HILGAS SYRUP | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 31/05/2019 |
| 107 | NDA/MAL/HHP/9104 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | COLOREST DROPS | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY DROPS | 1.0X30.0 ML BOTTLE | 31/05/2019 |
| 108 | NDA/MAL/HHP/9105 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | RIMONA CAPSULES | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 31/05/2019 |
| 109 | NDA/MAL/HHP/9121 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | HILGAS INSTANT SACHET | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0 SACHET CARTON | 11/03/2020 |
| 110 | NDA/MAL/HHP/9122 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | COFERB DROPS | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY DROPS | 1.0X20.0 ML BOTTLE | 11/03/2020 |
| 111 | NDA/MAL/HHP/9123 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | COFERB PLUS SYRUP | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 11/03/2020 |
| 112 | NDA/MAL/HHP/9125 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | RIMONA SACHET | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0 SACHET CARTON | 11/03/2020 |
| 113 | NDA/MAL/HHP/9126 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | CRANMAX AQUA SYRUP | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 11/03/2020 |
| 114 | NDA/MAL/HHP/9127 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | FIBO JAR | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X175.0 G JAR | 11/03/2020 |
| 115 | NDA/MAL/HHP/9128 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | ELFERB SYRUP | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 11/03/2020 |
| 116 | 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 | 29/01/2020 |
| 117 | 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 | 18/07/2020 |
| 118 | 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 | 31/08/2020 |
| 119 | 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 | 31/08/2020 |
| 120 | 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 | 1.0X60.0 ML BOTTLE | 09/02/2021 |
| 121 | NDA/MAL/HHP/9694 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | THROWCUF SYRUP | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 22/07/2021 |
| 122 | NDA/MAL/HHP/9700 | GRIFFON BIOMETRIX PVT.LTD | METRO PHARMACEUTICALS LIMITED | TOTO GRIPE WATER | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 27/08/2021 |
| 123 | NDA/MAL/HHP/9701 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | THROWCUF PLUS SYRUP | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 27/08/2021 |
| 124 | NDA/MAL/HHP/9702 | GRIFFON BIOMETRIX PVT.LTD | METRO PHARMACEUTICALS LIMITED | GRIFFON STRONG BALM | RAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X9.0 ML BOTTLE | 27/08/2021 |
| 125 | NDA/MAL/HHP/9703 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | CURODEX OINTMENT | RAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G BOTTLE | 27/08/2021 |
| 126 | NDA/MAL/HHP/9704 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | MENTHOXYL INHALER | RAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | NASAL TOPICAL LIQUID INHALATIONS | 1.0X0.5 ML INHALER | 27/08/2021 |
| 127 | NDA/MAL/HHP/9709 | HINUCON | BOOTS PHARMACEUTICALS LIMITED | LIV LIV CAPSULES | HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 02/09/2021 |
| 128 | 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 | 07/10/2021 |
| 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 | COOPER K-BRANDS LTD | 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 | 01/07/2016 |
| S/N | NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | GENERIC NAME OF DRUG | STRENGTH OF DRUG | MANUFACTURER | 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/0003 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | UMOXIL CLAV 625 | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | UNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2015 |
| 3 | NDA/MAL/HDP/0006 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 4 | 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 |
| 5 | NDA/MAL/HDP/0012 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 6 | NDA/MAL/HDP/0014 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | MONTELAIR 10MG TABLET | MONTELUKAST | 10MG | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 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 CARE 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 | 01/07/2011 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | NDA/MAL/HDP/0033 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYVATE CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| 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/0051 | H. LUNDBECK A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOPIXOL ACUPHASE | ZUCLOPENTHIXOL ACETATE | 50MG/ML | H. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY | DENMARK | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/2015 |
| 16 | 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 |
| 17 | NDA/MAL/HDP/0053 | H. LUNDBECK A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUANXOL DEPOT | FLUPENTIXOL DECANOATE | 20MG/ML | H. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK | PARENTERAL RETARD AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/2015 |
| 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/0055 | H.LUNDBECK A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOPIXOL DEPOT | ZUCLOPENTHIXOL DECANOATE | 200MG/ML | H. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/2015 |
| 20 | 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 |
| 21 | NDA/MAL/HDP/0059 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | VAGIBACT CREAM | CLINDAMYCIN PHOSPHATE | 2%W/W | NABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X40.0 G TUBE + 1 APPLICATOR | 01/07/2006 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | NDA/MAL/HDP/0065 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 26 | NDA/MAL/HDP/0069 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | LIPITOR | ATORVASTATIN | 10MG | PFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER | 01/07/1999 |
| 27 | NDA/MAL/HDP/0070 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | LIPITOR | ATORVASTATIN | 20MG | PFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/1999 |
| 28 | 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 |
| 29 | 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 |
| 30 | NDA/MAL/HDP/0079 | MYLAN LABORATORIES 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 |
| 31 | NDA/MAL/HDP/0083 | MYLAN LABORATORIES 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 |
| 32 | 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 |
| 33 | NDA/MAL/HDP/0097 | MSN LABORATORIES LTD | METRO PHARMACEUTICALS 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 |
| 34 | NDA/MAL/HDP/0098 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | 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 |
| 35 | 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 |
| 36 | NDA/MAL/HDP/0102 | MSN LABORATORIES PRIVATE LIMITED, | GOOD DAY PHARMACY 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 |
| 37 | NDA/MAL/HDP/0103 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS 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 |
| 38 | NDA/MAL/HDP/0104 | MSN LABORATORIES PRIVATE LIMITED | GOOD DAY PHARMACY 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 |
| 39 | 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 |
| 40 | NDA/MAL/HDP/0107 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | ASUNRA | DEFERASIROX | 400MG | NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE | SWITZERLAND | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X5.0X6.0 TABLET BLISTER | 01/07/2015 |
| 41 | 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 |
| 42 | 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 |
| 43 | NDA/MAL/HDP/0112 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 5MG/160MG | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2007 |
| 44 | NDA/MAL/HDP/0114 | MSN LABORATORIES PRIVATE LIMITED | GOOD DAY PHARMACY LIMITED | BREATHEZY 4 | MONTELUKAST SODIUM | 4MG | MSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 45 | NDA/MAL/HDP/0116 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | BREATHEZY CW 5 | MONTELUKAST SODIUM | 5MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 46 | NDA/MAL/HDP/0117 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 1.5G | CEFUROXIME SODIUM | 1.5G | ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL + 1 AMPOULE OF WFI | 01/07/2013 |
| 47 | NDA/MAL/HDP/0118 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 750MG | CEFUROXIME SODIUM | 750MG | ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL + 1 AMPOULE WFI | 01/07/2013 |
| 48 | 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 |
| 49 | NDA/MAL/HDP/0121 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | PEDZINC | ZINC SULPHATE | 20MG | BETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2015 |
| 50 | 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 |
| 51 | 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 |
| 52 | NDA/MAL/HDP/0127 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CORYCARDON | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | DELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 53 | NDA/MAL/HDP/0128 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CORYCARDON | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | DELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 54 | 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 LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| 55 | 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 |
| 56 | NDA/MAL/HDP/0141 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NYCOSTAT SUSPENSION | NYSTATIN | 100,000 I.U/ML | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/1998 |
| 57 | NDA/MAL/HDP/0152 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | RYCARDON 150 | IRBESARTAN | 150MG | DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 58 | NDA/MAL/HDP/0153 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | RYCARDON 300 | IRBESARTAN | 300MG | DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 59 | NDA/MAL/HDP/0155 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ASTHATOR 10 | MONTELUKAST SODIUM | 10MG | 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 |
| 60 | 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 |
| 61 | NDA/MAL/HDP/0158 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | KIPEL 10 | MONTELUKAST SODIUM | 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 | 01/07/2015 |
| 62 | 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 |
| 63 | 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 |
| 64 | 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 |
| 65 | 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 |
| 66 | 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 |
| 67 | 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 |
| 68 | 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 |
| 69 | 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 |
| 70 | NDA/MAL/HDP/0168 | MSN LABORATORIES PRIVATE LIMITED | GOOD DAY PHARMACY 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 |
| 71 | 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 |
| 72 | 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 |
| 73 | NDA/MAL/HDP/0182 | MSN LABORATORIES PRIVATE LIMITED | GOOD DAY PHARMACY 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 |
| 74 | 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 |
| 75 | 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 |
| 76 | NDA/MAL/HDP/0188 | AMOUN PHARMACEUTICALS LTD | BOOTS PHARMACEUTICALS LIMITED | LEVOXIN | LEVOFLOXACIN | 500MG | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER | 01/07/2014 |
| 77 | NDA/MAL/HDP/0191 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | 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 |
| 78 | NDA/MAL/HDP/0192 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | AMOCOMB CREAM | NEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN | 0.25GM + 0.1G + 100000IU + 0.025G/100G | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2014 |
| 79 | NDA/MAL/HDP/0193 | MEDOPHARM, INDIA | PLANET PHARMACEUTICALS UGANDA LTD | 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 |
| 80 | NDA/MAL/HDP/0196 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LAMIVUDINE AND ZIDOVUDINE TABLETS | LAMIVUDINE/ZIDOVUDINE | 150MG/300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2013 |
| 81 | NDA/MAL/HDP/0203 | GLAXOSMITHLINE 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 |
| 82 | NDA/MAL/HDP/0204 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | TIVICAY | DOLUTEGRAVIR SODIUM | 50MG | GLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM GLAXOSMITHKLINE PHARMACEUTICALS SA-GRUNWALDZKA 189 STREET, 60-322 POZNANA | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2015 |
| 83 | NDA/MAL/HDP/0205 | MACLEODS PHARMACEUTICALS LTDS LTD | VITACARE LIMITED | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| 84 | NDA/MAL/HDP/0207 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300MG +300MG | MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| 85 | 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 |
| 86 | 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 |
| 87 | 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 |
| 88 | NDA/MAL/HDP/0217 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | PALETHER | ARTEMETHER | 80MG/ML | LINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT | INDIA | PARENTERAL ORDINARY I M AMPOULES | 2.0X3.0X1.0 ML AMPOULE | 01/07/2014 |
| 89 | 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 |
| 90 | NDA/MAL/HDP/0222 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | AVIR-200 | ACYCLOVIR | 200MG | 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 S KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 91 | NDA/MAL/HDP/0227 | AMOUM PHARMACEUTICALS LTD | BOOTS PHARMACEUTICALS LIMITED | CYRINOL SYRUP | PHOLCODINE+EPHEDRINE HCL +CARBINOXAMINE MALEATE | 4MG+7MG+2MG /5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2014 |
| 92 | NDA/MAL/HDP/0230 | STRIDES SHASUN 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 | 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 |
| 93 | 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 |
| 94 | 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 |
| 95 | 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 |
| 96 | 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 |
| 97 | 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 |
| 98 | NDA/MAL/HDP/0248 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PANTONEX DR-40 | PANTOPRAZOLE | 40 MG | IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 99 | 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 |
| 100 | NDA/MAL/HDP/0254 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 5 | BISOPROLOL HEMIFUMARATE | 5MG | MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 101 | NDA/MAL/HDP/0256 | HETERO LABS LTD | AIVEEN (U) 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 |
| 102 | NDA/MAL/HDP/0266 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | BENZATHINE PENICILLIN INJECTION | BENZATHINE PENICILLIN | 2.400.000 IU | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON | 01/07/2001 |
| 103 | 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 | 01/07/2014 |
| 104 | NDA/MAL/HDP/0270 | HETERO LABS LTD | AIVEEN (U) 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 |
| 105 | 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 |
| 106 | NDA/MAL/HDP/0275 | GLAXO SMITHLINE LIMITED | 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 |
| 107 | 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 |
| 108 | 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 |
| 109 | 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 |
| 110 | NDA/MAL/HDP/0288 | UNIVERSAL CORPORATION LTD | PHARMA VILLE LIMITED | DUXCOSPAN | HYOSCINE BUTYL BROMIDE | 10MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 111 | NDA/MAL/HDP/0290 | LABORATORY & ALLIED LTD | HARLEYS UGANDA 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 |
| 112 | NDA/MAL/HDP/0293 | HETERO LABS LTD | AIVEEN (U) LIMITED | DARUNAVIR | DARUNAVIR | 600 MG | 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 |
| 113 | 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 |
| 114 | NDA/MAL/HDP/0301 | HETERO LABS LTD | AIVEEN (U) 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 |
| 115 | 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 |
| 116 | NDA/MAL/HDP/0305 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFAX-250 DRY SYRUP | CEFALEXIN | 250MG/5ML | 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 SOLUBLE POWDERS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2013 |
| 117 | NDA/MAL/HDP/0307 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | LAMIVUDINE ORAL SOLUTION | LAMIVUDINE | 10MG/ML | HETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X240.0 ML CONTAINER | 01/07/2013 |
| 118 | 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 |
| 119 | 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 |
| 120 | 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 |
| 121 | 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 |
| 122 | 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 |
| 123 | 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 |
| 124 | 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 |
| 125 | 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 |
| 126 | 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 |
| 127 | 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 | 01/07/2014 |
| 128 | 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 | 01/07/2014 |
| 129 | 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 |
| 130 | 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 |
| 131 | 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 |
| 132 | NDA/MAL/HDP/0349 | SWISS PARENTERALS PVT LTD | SHREEJI CARE LIMITED | CLAXY 1.2 G | COAMOXICLAV | 1.2G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL | 01/07/2013 |
| 133 | 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 |
| 134 | NDA/MAL/HDP/0351 | MANKIND PHARM LTD | TATA UGANDA LIMITED | DEPREGDINA | LEVONORGESTREL | 1.5MG | ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2014 |
| 135 | NDA/MAL/HDP/0353 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DEROX-10 | AMLODIPINE BESILATE | 10MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER | 01/07/2015 |
| 136 | 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 |
| 137 | NDA/MAL/HDP/0355 | SWISS PARENTERALS LTD | SHREEJI CARE LIMITED | 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 |
| 138 | NDA/MAL/HDP/0356 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | LEVO DENK 50O | LEVOFLOXACIN HEMIHYDRATE | 500MG | ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 139 | NDA/MAL/HDP/0358 | SWISS PARENTERALS LTD | SHREEJI CARE LIMITED | STREPTOCIN | STREPTOMYCIN SULPHATE | 1GM | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X1.0 G VIAL | 01/07/2014 |
| 140 | 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 |
| 141 | NDA/MAL/HDP/0362 | SWISS PARENTERALS LTD | SHREEJI CARE 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 |
| 142 | NDA/MAL/HDP/0363 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | AGYCIN | AZITHROMYCIN | 250MG | 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 | 1.0X6.0 TABLET BLISTER | 01/07/2014 |
| 143 | NDA/MAL/HDP/0365 | UNIVERSAL CORPORATION LTD | PHARMA VILLE LIMITED | SULFRAN- DS | TRIMETHOPRIM/SULFAMETHOXAZOLE | 160MG/800MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/2015 |
| 144 | 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 |
| 145 | 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 |
| 146 | NDA/MAL/HDP/0372 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | LEZYNCET | LEVOCETIRIZINE | 5MG | 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 FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER | 01/07/2009 |
| 147 | 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 |
| 148 | NDA/MAL/HDP/0382 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | KETAMINE FRESENIUS | KETAMINE HYDROCHLORIDE | 50MG/ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY VIALS | 1.0X10.0X10.0 ML VIAL | 01/07/2014 |
| 149 | NDA/MAL/HDP/0383 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | MANNITOL FRESENIUS | MANNITOL | 20%W/V | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BAG | 01/07/2014 |
| 150 | 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 |
| 151 | NDA/MAL/HDP/0389 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | 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 |
| 152 | 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 |
| 153 | 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 |
| 154 | NDA/MAL/HDP/0401 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | L MONTUS | 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 |
| 155 | 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 |
| 156 | NDA/MAL/HDP/0404 | GLAXOSMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ACTIFED WET COUGH & COLD | TRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN | 1.25MG/30MG/100MG | GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN | 01/07/1997 |
| 157 | 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 |
| 158 | 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 |
| 159 | NDA/MAL/HDP/0408 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | 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 |
| 160 | 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 |
| 161 | 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 |
| 162 | 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 |
| 163 | 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 |
| 164 | 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 |
| 165 | NDA/MAL/HDP/0418 | ASTRA ZENECA | MACNAUGHTON LIMITED | KOMBIGLYZE XR 5MG/1000 | SAXAGLIPTIN + METFORMIN | 5MG + 1000MG | ASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X4.0X7.0 TABLET BLISTER | 01/07/2013 |
| 166 | NDA/MAL/HDP/0419 | ASTRAZENECA | MACNAUGHTON LIMITED | KOMBIGLYZE XR 2.5MG/1000MG | SAXAGLIPTIN + METFORMIN | 2.5MG + 1000MG | ASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2013 |
| 167 | NDA/MAL/HDP/0421 | MSN LABORATORIES PRIVATE LIMITED | STAR PHARMACEUTICALS LTD | 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 |
| 168 | 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 |
| 169 | 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 |
| 170 | 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 |
| 171 | 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 |
| 172 | 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 |
| 173 | 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 |
| 174 | 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 | 01/07/2013 |
| 175 | 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 |
| 176 | NDA/MAL/HDP/0433 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | 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 |
| 177 | NDA/MAL/HDP/0434 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) 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 |
| 178 | NDA/MAL/HDP/0435 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | LIGNOCAINE HCL FRESENIUS | LIGNOCAINE HYDROCHLORIDE | 2%W/V | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY VIALS | 1.0X10.0X20.0 ML VIAL | 01/07/2015 |
| 179 | NDA/MAL/HDP/0437 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | NALOXONE HCL NEONATAL FRESENIUS | NALOXONE HYDROCHLORIDE | 0.02MG/ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2014 |
| 180 | NDA/MAL/HDP/0439 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | NALOXONE HCL FRESENIUS 0.4MG/1ML | NALOXONE HYDROCHLORIDE | 0.4MG/1ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2015 |
| 181 | NDA/MAL/HDP/0440 | AGIO PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | AGICLOB-GM | CLOBETASOL/GENTAMICIN/MICONAZOLE | 0.5MG+3.4MG+20MG/1G | AGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2014 |
| 182 | NDA/MAL/HDP/0441 | AGIO PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | AGISEC | SECNIDAZOLE | 1GM | AGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2015 |
| 183 | NDA/MAL/HDP/0444 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | NEOSTIGMINE METHYLSUIPHATE FRESENIUS | NEOSTIGMINE METHYLSULPHATE | 2.5MG\ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2015 |
| 184 | NDA/MAL/HDP/0447 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | 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 |
| 185 | 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 |
| 186 | NDA/MAL/HDP/0451 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANEXON®500 | METHYLPREDNISOLONE SODIUM SUCCINATE | 500MG/VIAL | PT SANBE FARMA UNIT 3.-JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNG | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI | 01/07/2014 |
| 187 | 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 |
| 188 | NDA/MAL/HDP/0454 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | 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 |
| 189 | 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 |
| 190 | NDA/MAL/HDP/0457 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | UNIBROL 250MG | AMINOSIDINE | 250MG | UNIVERSAL CORPORATION LTD-UNIVERSAL CORPORATION LTD | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER | 01/07/2012 |
| 191 | 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 |
| 192 | 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 |
| 193 | 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 |
| 194 | NDA/MAL/HDP/0468 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | CEFUAXIT 750 | CEFUROXIME | 750MG | NECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI, P.O BAROTIWALA DIST SOLAN H.P 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL + 10ML WFI AMPOULE | 01/07/2013 |
| 195 | NDA/MAL/HDP/0470 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVOMIX 30 FLEXPEN | INSULIN ASPART | 100I.U/ML | NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD 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 DRY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| 196 | NDA/MAL/HDP/0471 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVORAPID FLEXPEN | INSULIN ASPART | 100 I.U/ML | NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD 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 | 01/07/2014 |
| 197 | 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 SERUM INSTITUTE OF INDIA PRIVATE LIMITED-PLOT NO.: 105-110, MANJARI BUDRUK, TAL-HAVELI, PUNE - 412 307, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL,1.0X0.5 ML VIAL | 01/07/2015 |
| 198 | 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 |
| 199 | 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 | 01/07/2014 |
| 200 | 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 |
| 201 | NDA/MAL/HDP/0483 | FOUNTIL LIFE SCIENCES PVT LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID TABLETS | ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE | 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 CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 202 | 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 |
| 203 | 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 |
| 204 | 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 00:00 |
| 205 | NDA/MAL/HDP/0497 | LABORATORY&ALLIED LTD | HARLEYS UGANDA 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 |
| 206 | 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 |
| 207 | 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 |
| 208 | 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 |
| 209 | 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 |
| 210 | 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 |
| 211 | 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 |
| 212 | 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 |
| 213 | 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 |
| 214 | NDA/MAL/HDP/0521 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PAN 40 | PANTOPRAZOLE SODIUM | 40MG | ALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 215 | NDA/MAL/HDP/0522 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | VAZORTAN 50 | LOSARTAN POTASSIUM | 50MG | MEDLEY PHARMACEUTICALS LTD -PLOT NO. 18 AND 19, SURVEY NO. 378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM , DAMAN-396 210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 216 | 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 |
| 217 | NDA/MAL/HDP/0531 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | ENDERM-GM | CLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE | 0.05%W/W + 0.10%W/W + 2.0%W/W | LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE | 01/07/2014 |
| 218 | 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 |
| 219 | NDA/MAL/HDP/0540 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | HYDRICORT | HYDROCORTISONE SODIUM SUCCINATE | 100MG | LINCOLN PARENTERAL 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 | 01/07/2014 |
| 220 | 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 |
| 221 | 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 |
| 222 | NDA/MAL/HDP/0543 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 223 | 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 |
| 224 | 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 |
| 225 | 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 |
| 226 | 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 |
| 227 | 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 |
| 228 | NDA/MAL/HDP/0555 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 229 | 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 |
| 230 | 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 |
| 231 | NDA/MAL/HDP/0560 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GLIMERYL 1 | GLIMEPIRIDE | 1MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 232 | 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 |
| 233 | 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 |
| 234 | 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 |
| 235 | NDA/MAL/HDP/0572 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA 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 |
| 236 | NDA/MAL/HDP/0573 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | 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 |
| 237 | NDA/MAL/HDP/0574 | IPCA LABORATOIES LTD | MEDVIN PHARMA LIMITED | ARTESUNATE AND AMODIAQUINE TABLETS 100/270 | ARTESUNATE AND AMODIAQUINE | 100MG+270MG | IPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2013 |
| 238 | NDA/MAL/HDP/0576 | GLAXO SMITH KLINE 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 |
| 239 | 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 |
| 240 | 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 |
| 241 | 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 |
| 242 | 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 |
| 243 | NDA/MAL/HDP/0588 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROFORT | PREDNISOLONE ACETATE | 1%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 01/07/2013 |
| 244 | 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 |
| 245 | NDA/MAL/HDP/0592 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROCHROME | CROMOLYN SODIUM | 2%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC LIQUIDS | 1.0X10.0 ML CONTAINER | 01/07/2013 |
| 246 | 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 |
| 247 | 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 |
| 248 | 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 |
| 249 | NDA/MAL/HDP/0598 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LIPICURE-20 | ATORVASTATIN | 20MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2003 |
| 250 | 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 |
| 251 | 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 |
| 252 | NDA/MAL/HDP/0603 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | GROMIN SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/1999 |
| 253 | 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 |
| 254 | 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 |
| 255 | 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 |
| 256 | NDA/MAL/HDP/0614 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA 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 |
| 257 | NDA/MAL/HDP/0617 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | SILVEX | SILVER SULFADIAZINE + CHLORHEXIDINE | 1%W/W + 0.2%W/W | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2014 |
| 258 | NDA/MAL/HDP/0618 | HETERO LABS LTD | AIVEEN (U) LIMITED | VALSAR 160 | VALSARTAN | 160MG | 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 | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 259 | 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 |
| 260 | NDA/MAL/HDP/0621 | HETERO LABS LTD | AIVEEN (U) LIMITED | ALZER | DONEPEZIL HYDROCHLORIDE | 10MG | 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 | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 261 | 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 | 01/07/2015 |
| 262 | 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 |
| 263 | 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 |
| 264 | 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 |
| 265 | NDA/MAL/HDP/0634 | MEDLEY PHARMACEUTICALS | MEDVIN PHARMA LIMITED | TRISOLIV | ANDROGRAPHOLIDES/TRICHOLINE CITRATE | 50MCG+50MG/ML | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2014 |
| 266 | 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 |
| 267 | NDA/MAL/HDP/0636 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | REVOKE-1.5 | LEVONORGESTREL | 1.5MG | 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 | 1.0X1.0 TABLET BLISTER | 01/07/2014 |
| 268 | 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 |
| 269 | 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 |
| 270 | 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 |
| 271 | 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 |
| 272 | 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 |
| 273 | 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 |
| 274 | NDA/MAL/HDP/0665 | HETERO LABS LTD | AIVEEN (U) 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 |
| 275 | NDA/MAL/HDP/0666 | HETERO LABS LTD | AIVEEN (U) 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 |
| 276 | 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 |
| 277 | NDA/MAL/HDP/0669 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | 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 |
| 278 | 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 | 01/07/2014 |
| 279 | NDA/MAL/HDP/0672 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGONOR TABLETS | NORFLOXACIN | 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 FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2013 |
| 280 | 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 |
| 281 | NDA/MAL/HDP/0675 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL METRONIDAZOLE 400 | METRONIDAZOLE | 400MG | 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 |
| 282 | 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 |
| 283 | NDA/MAL/HDP/0678 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL HYDROCORTISONE CREAM | HYDROCORTISONE | 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 | 01/07/2014 |
| 284 | 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 |
| 285 | 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 |
| 286 | 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 |
| 287 | 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 |
| 288 | 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 |
| 289 | 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 |
| 290 | 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 |
| 291 | NDA/MAL/HDP/0691 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-20 | OLMESARTAN MEDOXOMIL | 20 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 | 01/07/2013 |
| 292 | 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 |
| 293 | 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 |
| 294 | 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 |
| 295 | NDA/MAL/HDP/0696 | BYANSI SERVICES LIMITED | 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 |
| 296 | NDA/MAL/HDP/0698 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | WHITFIELD'S OINTMENT | BENZOIC ACID+SALICYLIC CID | 6%W/W + 3%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 01/07/2003 |
| 297 | NDA/MAL/HDP/0700 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | VAXIRAB N | INACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN) | >2.5 I.U | CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL) | 01/07/2015 |
| 298 | 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 |
| 299 | 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 |
| 300 | NDA/MAL/HDP/0704 | HETERO LABS LTD UNIT IX | AIVEEN (U) 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 |
| 301 | 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 |
| 302 | 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 |
| 303 | 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 |
| 304 | NDA/MAL/HDP/0712 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZENTEL | ALBENDAZOLE | 100MG/5ML | ASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSE-INDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOE | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE | 01/07/1997 |
| 305 | NDA/MAL/HDP/0713 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 20 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 20MG | ADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2015 |
| 306 | NDA/MAL/HDP/0715 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40MG | ADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2015 |
| 307 | 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 |
| 308 | NDA/MAL/HDP/0719 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | WEPOX 4000 | RECOMBINANT HUMAN ERYTHROPOIETIN | 4000 I.U | WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.4 ML PRE- FILLED SYRINGE | 01/07/2011 |
| 309 | 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 |
| 310 | NDA/MAL/HDP/0721 | MISSION PHARMA | METRO PHARMACEUTICALS LIMITED | ARH-A | ARTEMETHER | 80MG/ML | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, 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 |
| 311 | 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 |
| 312 | 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 |
| 313 | 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 |
| 314 | NDA/MAL/HDP/0728 | IPCA LABORATOIES LTD | MEDVIN PHARMA LIMITED | ARTESUNATE AND AMODIAQUINE 25/67.5 | ARTESUNATE+AMODIAQUINE | 25MG+67.5MG | IPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2013 |
| 315 | NDA/MAL/HDP/0731 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | ARTESUNATE AND AMODIAQUINE 50/135 | ARTESUNATE + AMODIAQUINE | 50/135MG | IPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2013 |
| 316 | NDA/MAL/HDP/0732 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | VOLTAMED-100 | DICLOFENAC | 100 MG | MEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 317 | 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 |
| 318 | 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 |
| 319 | NDA/MAL/HDP/0737 | SANOFI AVENTIS | SURGIPHARM (U) LIMITED | TAXOTERE 80MG | DOCETAXEL TRIHYDRATE | 80MG/4ML | SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X4.0 ML VIAL | 01/07/2014 |
| 320 | 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 |
| 321 | 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 |
| 322 | NDA/MAL/HDP/0745 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELI 80 | TELMISARTAN | 80MG | B. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 323 | 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 |
| 324 | 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 |
| 325 | 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 |
| 326 | NDA/MAL/HDP/0754 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TORAS DENK 10 | TORASEMIDE | 10MG | DENK PHARMA GMBH & COMPANY KG - GOLLSTR. 1, 84529 TITTMONING - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 327 | NDA/MAL/HDP/0759 | MICRO LABS LTD | PHARMA VILLE 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 |
| 328 | NDA/MAL/HDP/0760 | BEIJING HOLLEY-COTEC PHARMACEUTICALS CO.,LTD | SUPER PHARMACEUTICALS LIMITED | CEFAX | CEFTRIAXONE | 1G | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 G VIAL | 01/07/2013 |
| 329 | 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 |
| 330 | NDA/MAL/HDP/0768 | FDC LTD | AIVEEN (U) LIMITED | PYRIMON EYE DROP | DEXAMETHASONE/CHLORAMPHENICOL | 1%W/V + 0.1%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 | 01/07/1999 |
| 331 | NDA/MAL/HDP/0770 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | AMPIL-500 | AMPICILLIN | 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 | 01/07/2013 |
| 332 | NDA/MAL/HDP/0772 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA - 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 |
| 333 | NDA/MAL/HDP/0775 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA - 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 |
| 334 | 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 |
| 335 | 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 |
| 336 | NDA/MAL/HDP/0783 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | CYPOLIVE | CYPROHEPTADINE HYDROCHLORIDE | 4 MG | TRIVENI FORMULATIONS LIMITED--PLOT NO: 52,53,54, 62,63 & 64 ALEAP INDUSTRIAL ESTATE SURAMPALI VILLAGE, GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X50.0 TABLET BLISTER | 01/07/2013 |
| 337 | NDA/MAL/HDP/0784 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HEMOSAN | FERROUS FUMERATE | 300MG | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 338 | NDA/MAL/HDP/0786 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DERMA 1 | GRISEOFULVIN | 500MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 339 | NDA/MAL/HDP/0796 | HETERO LABS LTD | AIVEEN (U) 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. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 340 | NDA/MAL/HDP/0798 | HETERO LABS LTD | AIVEEN (U) 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 |
| 341 | 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 AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2015 |
| 342 | NDA/MAL/HDP/0808 | PIRAMAL HEALTHCARE LTD | TATA UGANDA LIMITED | ISOFLURANE | ISOFLURANE | 250ML | PIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2005 |
| 343 | 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 |
| 344 | NDA/MAL/HDP/0816 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 2 | GLIMEPIRIDE | 2MG | DENK PHARMA GMBH & COMPANY KG - GOLLSTR. 1, 84529 TITTMONING - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 345 | NDA/MAL/HDP/0821 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 3 | GLIMEPIRIDE | 3MG | DENK PHARMA GMBH & COMPANY KG - GOLLSTR. 1, 84529 TITTMONING - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 346 | NDA/MAL/HDP/0822 | ABACUS 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 |
| 347 | 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 |
| 348 | 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 |
| 349 | 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 |
| 350 | 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 | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2013 |
| 351 | 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 |
| 352 | 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 |
| 353 | 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 |
| 354 | 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 |
| 355 | NDA/MAL/HDP/0841 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ETHOMID | ETHIONAMIDE | 250MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2013 |
| 356 | 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 |
| 357 | NDA/MAL/HDP/0843 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | COXERIN | CYCLOSERINE | 250MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2013 |
| 358 | NDA/MAL/HDP/0845 | VIRBAC RSA (PTY) 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 |
| 359 | NDA/MAL/HDP/0846 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MOXIMAC | MOXIFLOXACIN | 400MG | MACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER | 01/07/2014 |
| 360 | NDA/MAL/HDP/0848 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MACROZIDE 500 | PYRAZINAMIDE | 500MG | MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER | 01/07/2014 |
| 361 | 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 |
| 362 | NDA/MAL/HDP/0853 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | BRUSTAN GEL | IBUPROFEN + LEVOMENTHOL | 5% W/W+ 3%W/W | SUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X50.0 G CONTAINER | 01/07/2012 |
| 363 | NDA/MAL/HDP/0855 | HETERO LABS LTD | AIVEEN (U) 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 |
| 364 | 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 |
| 365 | NDA/MAL/HDP/0858 | ASTRA ZENECA | MACNAUGHTON LIMITED | PLENDIL | FELODIPINE | 5MG | ASTRAZENECA SWEDEN OPERATIONS-ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2001 |
| 366 | NDA/MAL/HDP/0864 | HETERO LABS LTD UNIT IX | AIVEEN (U) 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 |
| 367 | NDA/MAL/HDP/0868 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | VARMIKA-500 | AMIKACIN | 500MG | 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 VIALS | 1.0X2.0X6.0X2.0 ML VIAL | 01/07/2013 |
| 368 | NDA/MAL/HDP/0869 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | 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 |
| 369 | 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 |
| 370 | NDA/MAL/HDP/0873 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | OXYTOCIN INJECTION | OXYTOCIN | 10I.U/ML | SAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2009 |
| 371 | 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 |
| 372 | 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 |
| 373 | 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 |
| 374 | 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 |
| 375 | 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 |
| 376 | 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 |
| 377 | NDA/MAL/HDP/0894 | HETERO LABS LTD | AIVEEN (U) 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 |
| 378 | 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 |
| 379 | 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 |
| 380 | 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 |
| 381 | 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 |
| 382 | NDA/MAL/HDP/0905 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | NECPOD | CEFPODOXIME PROXETIL | 200MG | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2013 |
| 383 | 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 |
| 384 | NDA/MAL/HDP/0907 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | CEFUAXIT | CEFUROXIME AXETIL | 250MG | NECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2013 |
| 385 | NDA/MAL/HDP/0909 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | FIXINECT | CEFIXIME | 100MG | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2013 |
| 386 | NDA/MAL/HDP/0911 | VIRCHOW HEALTHCARE PVT LTD | 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 |
| 387 | NDA/MAL/HDP/0914 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | OSTEOTIDE | TERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION | 250MCG/ML | VIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESH | INDIA | PARENTERAL ORDINARY VIALS | 1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN | 01/07/2015 |
| 388 | NDA/MAL/HDP/0920 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BUPITROY HEAVY | BUPIVACAINE HYDROCHLORIDE | 5MG/ML | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0X4.0 ML VIAL | 01/07/2012 |
| 389 | 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 |
| 390 | NDA/MAL/HDP/0928 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | INSTACLOP 75 | CLOPIDOGREL | 75MG | AJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 391 | NDA/MAL/HDP/0929 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | DUOQUIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG +320MG | IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER | 01/07/2012 |
| 392 | NDA/MAL/HDP/0934 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT 4 | MONTELUKAST | 4MG | CADILA HEALTHCARE LTD SARKHEJ-BAVLA 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 |
| 393 | 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 |
| 394 | 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 |
| 395 | 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 |
| 396 | 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 |
| 397 | 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 |
| 398 | 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 |
| 399 | NDA/MAL/HDP/0959 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN DISPERSIBLE 20/120 | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE 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 |
| 400 | 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 | 01/07/2005 |
| 401 | NDA/MAL/HDP/0981 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 402 | 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 |
| 403 | NDA/MAL/HDP/0990 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FUSIDERM CREAM | FUSIDIC ACID | 2%W/W | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| 404 | 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 |
| 405 | NDA/MAL/HDP/0999 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 406 | 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 |
| 407 | NDA/MAL/HDP/1001 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 408 | NDA/MAL/HDP/10030 | SAKAR HEALTHCARE LIMITED - | TATA UGANDA LIMITED | NISTAN | NYSTATIN | 100,000IU | SAKAR HEALTHCARE PVT LTD-BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 17/05/2022 |
| 409 | NDA/MAL/HDP/10031 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROFOLICK | FOLIC ACID | 5 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 410 | NDA/MAL/HDP/10032 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ACICRO-200 | ACICLOVIR | 200 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 411 | 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 | 06/07/2022 |
| 412 | NDA/MAL/HDP/10034 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | M-FLOX | MOXIFLOXACIN HYDROCHLORIDE | 0.5 %W/V | AUROLAB LIMITED-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 06/07/2022 |
| 413 | NDA/MAL/HDP/10035 | MINAPHARM PHARMACEUTICAL & CHEMICAL INDUSTRIES | SWASTIK PHARMACEUTICAL LTD | OXYTOCIN 10 IU | OXYTOCIN ACETATE | 10 IU/ AMPOULE | MINAPHARM PHARMACEUTICAL & CHEMICAL INDUSTRIES-MINA STREET, 03RD INDUSTRIAL ZONE A2-10TH OF RAMADHAN CITY EGYPT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X10.0 I.U AMPOULE | 06/07/2022 |
| 414 | 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 | 06/07/2022 |
| 415 | 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 | 06/07/2022 |
| 416 | NDA/MAL/HDP/10038 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | 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 | 06/07/2022 |
| 417 | NDA/MAL/HDP/10039 | LEGIT MEDEQ 2007 LIMITED | LEGIT MEDEQ 2007 - SMC LTD | ZENMIC | TRANEXAMIC ACID | 500MG/5 ML | ZEN PHARMA PVT LTD-75/1, GIDC. VAPI-396 195 GUJARAT, | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X5.0 ML AMPOULE | 06/07/2022 |
| 418 | NDA/MAL/HDP/10040 | NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | ROYAL PHARMA 2011 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 |
| 419 | 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 |
| 420 | NDA/MAL/HDP/10042 | GLOBELA PHARMA PVT. LTD. | SHREEJI CARE LIMITED | BACIPRO | CIPROFLOXACIN HYDROCHLORIDE | 500 MG | 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 | 06/07/2022 |
| 421 | NDA/MAL/HDP/10043 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROYO-ADRENALINE | ADRENALINE ACID TARTRATE | 1 MG/ML | SANJAR PHARMACEUTICALS LIMITED-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 06/07/2022 |
| 422 | NDA/MAL/HDP/10044 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TERBI RO 250 | TERBINAFINEHYDROCHLORIDE | 250 MG | INNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 423 | NDA/MAL/HDP/10045 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | 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 | 06/07/2022 |
| 424 | NDA/MAL/HDP/10046 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ARTEMETHER INJECTION 80 MG/ML | ARTEMETHER | 80 MG/ ML | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X6.0X1.0 ML AMPOULE | 06/07/2022 |
| 425 | NDA/MAL/HDP/10047 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS 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 |
| 426 | NDA/MAL/HDP/10048 | JOSHPA AFRICA LTD | AAFIYA (A) LIMITED | AAFISUNATE 60 MG | 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 | 1.0X60.0 MG VIAL + 1*1ML, CLEAR GLASS AMPOULE OF 5% W/V SODIUM BICARBONATE + 1*5ML CLEAR GLASS AMPOULE OF 0.9% W/V SODIUM CHLORIDE | 06/07/2022 |
| 427 | NDA/MAL/HDP/10049 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ERYTHROMYCIN ESTOLATE ORAL SUSPENSION USP 125 MG/5ML | ERYTHROMYCIN ESTOLATE | 125 MG/5ML | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 06/07/2022 |
| 428 | 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 | 06/07/2022 |
| 429 | NDA/MAL/HDP/10051 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | PENIMAX 100 | SILDENAFIL CITRATE | 100MG | UNIQUE PHARMACEUTICAL LABS LIMITED. .-215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 06/07/2022 |
| 430 | 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 | 06/07/2022 |
| 431 | NDA/MAL/HDP/10053 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | NADIMIX CREAM | NADIFLOXACIN + MICONAZOLE NITRATE + MOMETASONE FUROATE | 10 MG + 20 MG + 01 MG | WOCKHARDT LIMITED-PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X7.5 G TUBE | 06/07/2022 |
| 432 | NDA/MAL/HDP/10054 | LEGIT MEDEQ 2007 LIMITED | LEGIT MEDEQ 2007 LIMITED | HEMCROZ | IRON SUCROSE COMPLEX | 20 MG/ML | ZEN PHARMA PVT LTD-75/1, GIDC. VAPI-396 195 GUJARAT, | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 06/07/2022 |
| 433 | 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 | 06/07/2022 |
| 434 | 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 | 06/07/2022 |
| 435 | 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 |
| 436 | NDA/MAL/HDP/10058 | NEOMI PHARMACEUTICALS PVT LTD - | REDDYS PHARMA LIMITED | REDMENTIN 625 | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | CHIROS PHARMA-VILLAGE LOHARON, P.O. GHATTI, DISTT. - SOLAN, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X2.0X7.0 TABLET BLISTER | 06/07/2022 |
| 437 | NDA/MAL/HDP/10059 | SAGA LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | FULCOVER | ITRACONAZOLE | 100 MG | SAGA LABORATORIES .-198/2 & 198/3, CHACHRAWADI, VASNA NO. CLARIS LIFE SCIENCE, TA SANAND, DIST. DIST: AHMEDABAD | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X4.0 CAPSULE STRIP | 06/07/2022 |
| 438 | 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 |
| 439 | 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 | 06/07/2022 |
| 440 | NDA/MAL/HDP/10061 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) 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 | 06/07/2022 |
| 441 | NDA/MAL/HDP/10062 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUCLOX-500 | CLOXACILLIN SODIUM | 500MG | BRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 06/07/2022 |
| 442 | 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 | 06/07/2022 |
| 443 | NDA/MAL/HDP/10064 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROSUVAT 20 | ROSUVASTATIN CALCIUM | 20MG | 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 | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 444 | 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 | 06/07/2022 |
| 445 | NDA/MAL/HDP/10066 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES 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 | 06/07/2022 |
| 446 | NDA/MAL/HDP/10067 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRITINI | TINIDAZOLE | 500MG | TRIVENI FORMULATIONS LTD-PLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X25.0X4.0 TABLET BLISTER | 06/07/2022 |
| 447 | NDA/MAL/HDP/10068 | LEGIT MEDEQ 2007 LIMITED | LEGIT MEDEQ 2007 - SMC LTD | Z- ENOX | ENOXAPARIN SODIUM | 10 MG/0.1 ML | ZEN PHARMA PVT LTD-75/1, GIDC. VAPI-396 195 GUJARAT, | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.4 ML PRE- FILLED SYRINGE,1.0X0.6 ML PRE- FILLED SYRINGE | 06/07/2022 |
| 448 | 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 | 06/07/2022 |
| 449 | 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 |
| 450 | 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 |
| 451 | NDA/MAL/HDP/10071 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICAL LTD | FENAPAR | PARACETAMOL + ACECLOFENAC | 500 MG + 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 452 | 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 | 06/07/2022 |
| 453 | NDA/MAL/HDP/10073 | NATIONAL PHARMACEUTICAL INDUSTRIES CO. | HARLEYS UGANDA LIMITED | OMACILLIN 500 | AMOXICILLIN TRIHYDRATE | 500 MG | NATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMAN-P.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMAN | OMAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 06/07/2022 |
| 454 | NDA/MAL/HDP/10074 | TAURUS CHEMICALS (P) LTD. | HEALTH CARE 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 | 06/07/2022 |
| 455 | NDA/MAL/HDP/10075 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TELPER 80 | TELMISARTAN | 80 MG | GLOBELA PHARMA PVT.LTD.-357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 456 | NDA/MAL/HDP/10076 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO-CID INJ | OMEPRAZOLE SODIUM | 40MG | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 MG VIAL + 10 ML WATER FOR INJECTION AMPOULE | 06/07/2022 |
| 457 | NDA/MAL/HDP/10077 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | STREPTOMYCIN | STREPTOMYCIN SULPHATE | 1G | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL | 08/06/2022 |
| 458 | NDA/MAL/HDP/10080 | COMED CHEMICALS LTD. | LEGIT MEDEQ 2007 - SMC LTD | LYSER-D | DICLOFENAC SODIUM + SERRATIOPEPTIDASE | 50 MG + 10 MG | COMED CHEMICALS LTD (UNIT-III)-VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 06/07/2022 |
| 459 | NDA/MAL/HDP/10081 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | IO-NEPA | NEPAFENAC | 0.1%W/V | INDIANA OPHTHALMICS-135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML BOTTLE | 06/07/2022 |
| 460 | NDA/MAL/HDP/10082 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | NECIDEX EYE DROPS | NEOMYCIN SULPHATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.5%W/V + 0.1%W/V | INDIANA OPHTHALMICS-135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 06/07/2022 |
| 461 | NDA/MAL/HDP/10083 | THE SEARLE COMPANY LIMITED | HEALTHCARE LTD. | 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 | 06/07/2022 |
| 462 | NDA/MAL/HDP/10084 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | SEDAFOL | PROPOFOL | 10 MG/ ML | ASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X200.0 MG VIAL | 06/07/2022 |
| 463 | NDA/MAL/HDP/10085 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | DORZY-T | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | 2.0 % W/V + 0.5 % W/V | INDIANA OPHTHALMICS-135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 06/07/2022 |
| 464 | NDA/MAL/HDP/10086 | NEOMI PHARMACEUTICALS PVT LTD - | 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 | 06/07/2022 |
| 465 | NDA/MAL/HDP/10087 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | AZUNATE | ARTESUNATE | 60 MG/VIAL | MACLEODS PHARMACEUTICALS LTD. ..-UNIT I/UNIT II, PLOT 25-27, SR. NO. 366, PREMIER IND. ESTATE, KACHIGAM, DAMAN (U.T) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL + 1* 1ML CLEAR GLASS AMPOULE OF 5%W/V SODIUM BICARBONATE + 1*5ML CLEAR GLASS AMPOULE OF 0.9%W/V SODIUM CHLORIDE | 06/07/2022 |
| 466 | NDA/MAL/HDP/10089 | NABIQASIM INDUSTRIES (PVT) LIMITED | HEALTHCARE LTD. | CEFEXOL DS SUSPENSION | CEFIXIME TRIHYDRATE | 200 MG/5 ML | NABIQASIM INDUSTRIES (PVT) LTD .-17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE | 06/07/2022 |
| 467 | 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 |
| 468 | NDA/MAL/HDP/10090 | NABIQASIM INDUSTRIES (PVT) LIMITED | HEALTHCARE LTD. | CEFEXOL SUSPENSION | CEFIXIME TRIHYDRATE | 100 MG/5 ML | NABIQASIM INDUSTRIES (PVT) LTD .-17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE | 06/07/2022 |
| 469 | 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 | 06/07/2022 |
| 470 | NDA/MAL/HDP/10092 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROTHISTRONE 5 | NORETHISTERONE | 5 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 471 | 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 | 06/07/2022 |
| 472 | NDA/MAL/HDP/10094 | TAKEDA PHARMA A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ADCETRIS 50 MG | BRENTUXIMAB VEDOTIN | 50 MG/VIAL | BSP PHARMACEUTICALS S.P.A.-VIA APPIA KM 65, 561 LATINA SCALO (LT), 04013 | AUSTRIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X50.0 MG VIAL | 06/07/2022 |
| 473 | NDA/MAL/HDP/10095 | COMED CHEMICALS LTD. | LEGIT MEDEQ 2007 LIMITED | RAPCO -20 | RABEPRAZOLE SODIUM | 20 MG | COMED CHEMICALS LTD (UNIT-III)-VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 474 | NDA/MAL/HDP/10096 | COMED CHEMICALS LTD. | LEGIT MEDEQ 2007 LIMITED | ZACY- SR | ACECLOFENAC | 200 MG | COMED CHEMICALS LTD (UNIT-III)-VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 475 | NDA/MAL/HDP/10097 | ALKEM LABORATORIES LTD. - | ABACUS PHARMA (AFRICA) LIMITED | NULOC 20 | ESOMEPRAZOLE MAGNESIUM | 20 MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 476 | NDA/MAL/HDP/10098 | ALKEM LABORATORIES LTD. - | ABACUS PHARMA (AFRICA) LIMITED | NULOC 40 | ESOMEPRAZOLE MANESIUM | 40 MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 477 | NDA/MAL/HDP/10099 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | GLYFERON 1000 | METFORMIN HYDROCHLORIDE | 1000 MG | BILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 478 | NDA/MAL/HDP/10100 | HETERO LABS LTD | AIVEEN (U) 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 | 06/07/2022 |
| 479 | NDA/MAL/HDP/10101 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) 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 | 06/07/2022 |
| 480 | NDA/MAL/HDP/10102 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VILDARIL 100 | VILDAGLIPTIN | 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 481 | NDA/MAL/HDP/10103 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | COLDPIL | PARACETAMOL +PHENYLEPHRINE HYDROCHLORIDE + CHLORPEHNAMINE MALEATE | 650 MG + 5 MG + 2 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 | 06/07/2022 |
| 482 | 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 |
| 483 | 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 |
| 484 | NDA/MAL/HDP/10106 | VEERAM HEALTHCARE (U) LIMITED | VEERAM HEALTHCARE (U) LIMITED | SERAFEN | DICLOFENAC POTASSIUM + SERRATIOPEPTIDASE | 50 MG + 10 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,1.0X2.0X10.0 TABLET BLISTER | 06/07/2022 |
| 485 | NDA/MAL/HDP/10107 | VEERAM HEALTHCARE (U) LIMITED | VEERAM HEALTHCARE (U) LIMITED | EXPECT | AMBROXOL HYDROCHLORIDE + TERBUTALINE SULPHATE + GUAIFENESIN | (15 MG + 1.25 MG + 50 MG)/ 5 ML | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X30.0 ML BOTTLE | 06/07/2022 |
| 486 | NDA/MAL/HDP/10108 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PIRO 20 | PIROXICAM | 20 MG | INNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 06/07/2022 |
| 487 | NDA/MAL/HDP/10109 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO MIFEN 500 | MEFENAMIC ACID | 500 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 | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 488 | NDA/MAL/HDP/1011 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | DABORAL SYRUP | AMINOSIDINE | 125MG/5ML | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2012 |
| 489 | NDA/MAL/HDP/10110 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO TAMIC 500 | TRANEXAMIC ACID | 500 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 | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 490 | NDA/MAL/HDP/10111 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | NEPEXTO | ETANERCEPT | 50 MG/ML | LUPIN LIMITED (BIOTECH DIVISION)-GAT NO. 1156, GHOTAWADDE - VILLAGE, MULSHI-TALUKA, PUNE - 412 115 | INDIA | PARENTERAL ORDINARY PRE-FILLED AUTOINJECTORS | 1.0X1.0X1.0 ML PREFILLED PEN | 06/07/2022 |
| 491 | NDA/MAL/HDP/10112 | KESAR PHARMA | ABACUS PHARMA (AFRICA) 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 | 06/07/2022 |
| 492 | NDA/MAL/HDP/10113 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO-PERICEM | PIROXICAM | 20 MG | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 493 | NDA/MAL/HDP/10114 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300/300 MG | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300 MG + 300 MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 06/07/2022 |
| 494 | NDA/MAL/HDP/10115 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ASPIRIN DELAYED RELEASE TABLETS USP 75MG | ASPIRIN | 75 MG | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 495 | NDA/MAL/HDP/10116 | RATNAMANI HEALTHCARE PVT. LTD | VIDA AFRICA LTD | ZENEGRA 50 | SILDENAFIL CITRATE | 50 MG | RATNAMANI HEALTHCARE PRIVATE LIMITED-SURVEY NO. 750/1, AHMEDABAD - MEHSANA HIGHWAY, VILLAGE-INDRAD, NR. CHHATRAL G.I.D.C., TALUKA-KADI, DIST-MEHSANA, PIN-382721 (NG), GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 06/07/2022 |
| 496 | 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 |
| 497 | 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 |
| 498 | 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 | 06/07/2022 |
| 499 | 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 |
| 500 | NDA/MAL/HDP/10132 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | ATCOBETA-N | BETAMETHASONE SODIUM PHOSPHATE + NEOMYCIN SULPHATE | 0.1% W/V + 0.5% W/V | ATCO LABS LTD,-B-18, S.I.T.E, KARACHI | PAKISTAN | OPHTHALMIC DROPS | 1.0X1.0X7.5 ML BOTTLE | 06/07/2022 |
| 501 | NDA/MAL/HDP/10134 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ISONIAZID/ RIFAPENTINE COATED TABLETS 300 MG + 300 MG | ISONIAZID + RIFAPENTINE | 300MG +300MG | OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X12.0 TABLET STRIP | 06/07/2022 |
| 502 | NDA/MAL/HDP/10135 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | ZEVAC SYRUP | ZINC ACETATE (AS DIHYDRATE) | 20MG/5ML | RAPTAKOS BRETT & CO.LTD-1ST POKHRAN ROAD,THANE 400 606 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 06/07/2022 |
| 503 | NDA/MAL/HDP/10137 | UNISON PHARMACEUTICALS PVT. LTD. | HARLEYS UGANDA LIMITED | MBSON-SL | MECOBALAMIN | 1500 MCG | UNISON PHARMACEUTICALS PRIVATE LIMITED – UNIT 1-UNIT I, C/6, STEEL TOWN, OPP. NOVA PETRO, MORAIYA, TA. SANAND, DIST.: AHMEDABAD - 382213, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/07/2022 |
| 504 | NDA/MAL/HDP/10138 | NABIQASIM INDUSTRIES (PVT) LIMITED | HEALTHCARE LTD. | CLARITHRO TABLETS | CLARITHROMYCIN | 500MG | NABIQASIM INDUSTRIES (PVT) LTD .-17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 06/07/2022 |
| 505 | NDA/MAL/HDP/10139 | NABIQASIM INDUSTRIES (PVT) LIMITED | HEALTHCARE LTD. | CLARITHRO GRANULES FOR SUSPENSION | CLARITHROMYCIN | 125 MG/ 5 ML | NABIQASIM INDUSTRIES (PVT) LTD .-17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 06/07/2022 |
| 506 | 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 |
| 507 | NDA/MAL/HDP/10140 | UNICHEM LABORATORIES LIMITED? | 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 |
| 508 | NDA/MAL/HDP/10141 | UNICHEM LABORATORIES LIMITED? | 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 |
| 509 | NDA/MAL/HDP/10142 | GALENICUM HEALTH S.L. | GOODMAN INTERNATIONAL LTD | ROSUVITAE 10 MG | ROSUVASTATIN | 10MG | BIOFARM SP. Z.O.O-UL. WALBRZYSKA 13, 60-198 POZNAN - POLAND | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 06/07/2022 |
| 510 | NDA/MAL/HDP/10143 | GALENICUM HEALTH S.L. | GOODMAN INTERNATIONAL LTD | ROSUVITAE 40 MG | ROSUVASTATIN | 40MG | BIOFARM SP. Z.O.O-UL. WALBRZYSKA 13, 60-198 POZNAN - POLAND | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 06/07/2022 |
| 511 | NDA/MAL/HDP/10144 | VIRCHOW BIOTECH PVT LTD, | SURGIPHARM (U) LIMITED | CLASIPRO | BACILLUS CLAUSII SPORES | 2 X 10^9 SPORES/ 5 ML | VIRCHOW BIOTECH PRIVATE LIMITED-SURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X5.0 ML AMPOULE | 06/07/2022 |
| 512 | 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 | 06/07/2022 |
| 513 | NDA/MAL/HDP/10147 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | FLUOMIZIN | DEQUALINIUM CHLORIDE | 10MG | ROTTENDORF PHARMA GMBH-OSTENFELDER STRABE 51-61, 59320 ENNIGERLOH | GERMANY | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY BLISTER | 06/07/2022 |
| 514 | 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 | 06/07/2022 |
| 515 | 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 | 06/07/2022 |
| 516 | 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 | 06/07/2022 |
| 517 | 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 |
| 518 | NDA/MAL/HDP/10152 | BIOFARMA PLASMA LIMITED LIABILITY COMPANY | ONCOPHARM (U) LTD | ALBUMIN-BIOPHARMA | HUMAN ALBUMIN | 20G/100ML | BIOPHARMA PLASMA LIMITED LIABILITY COMPANY-37-V KYIVSKA ST., BILA TSERKVA, KYIV REGION, 09100 - UKRAINE | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML VIAL | 06/07/2022 |
| 519 | NDA/MAL/HDP/10154 | MEDIPAK LIMITED | HEALTHCARE LTD. | MEDISOL S | SODIUM CHLORIDE + DEXTROSE | 0.9%W/V + 5%W/V | MEDIPAK LTD-132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHORE | PAKISTAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 02/09/2022 |
| 520 | NDA/MAL/HDP/10155 | MEDIPAK LIMITED | HEALTHCARE LTD. | MEDISOL NS | SODIUM CHLORIDE | 0.9%W/V | MEDIPAK LTD-132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHORE | PAKISTAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 02/09/2022 |
| 521 | NDA/MAL/HDP/10156 | MEDIPAK LIMITED | HEALTHCARE LTD. | MEDISOL 5% | DEXTROSE | 5%W/V | MEDIPAK LTD-132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHORE | PAKISTAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 02/09/2022 |
| 522 | NDA/MAL/HDP/10157 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | MOXIPEN ORAL SUSPENSION | AMOXICILLIN | 125MG/5ML | XEPA-SOUL PATTINSON (MALAYSIA) SDN.BHD.-1-5 CHENG INDUSTRIAL ESTATE, 75250, MELAKA | MALAYSIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 29/08/2022 |
| 523 | NDA/MAL/HDP/10158 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | ERYSOL ORAL SUSPENSION | ERYTHROMYCIN ETHYLSUCCINATE | 200MG/5ML | XEPA-SOUL PATTINSON (MALAYSIA) SDN.BHD.-1-5 CHENG INDUSTRIAL ESTATE, 75250, MELAKA | MALAYSIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 29/08/2022 |
| 524 | NDA/MAL/HDP/10159 | MARTIN DOW MARKER LTD | HEALTHCARE LTD. | KLARIBACT | CLARITHROMYCIN | 500MG | MARTIN DOW MARKER LIMITED-7, JAIL ROAD, QUETTA - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 23/01/2023 |
| 525 | NDA/MAL/HDP/1016 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ASCORBIC ACID | ASCORBIC ACID | 200MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER | 01/07/2014 |
| 526 | NDA/MAL/HDP/10160 | MARTIN DOW MARKER LTD | HEALTHCARE LTD. | KLARIBACT | CLARITHROMYCIN | 250MG | MARTIN DOW MARKER LIMITED-7, JAIL ROAD, QUETTA - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 23/01/2023 |
| 527 | NDA/MAL/HDP/10161 | MARTIN DOW MARKER LTD | HEALTHCARE LTD. | KLARIBACT | CLARITHROMYCIN | 125MG/5ML | MARTIN DOW MARKER LIMITED-7, JAIL ROAD, QUETTA - PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 23/01/2023 |
| 528 | NDA/MAL/HDP/10162 | MARTIN DOW MARKER LTD | HEALTHCARE LTD. | LEVOMERC | LEVOFLOXACIN | 500MG | MARTIN DOW MARKER LIMITED-7, JAIL ROAD, QUETTA - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 23/01/2023 |
| 529 | 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 |
| 530 | NDA/MAL/HDP/10165 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYTETRA | TETRACYCLINE HYDROCHLORIDE | 250MG | ELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER | 02/09/2022 |
| 531 | NDA/MAL/HDP/10166 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYTETRA | TETRACYCLINE HYDROCHLORIDE | 3%W/W | ELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 02/09/2022 |
| 532 | NDA/MAL/HDP/10167 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | HEDAPAN TABLET | ASPIRIN/PARACETAMOL/CAFFEINE | 400MG/500MG/50MG | ELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 02/09/2022 |
| 533 | 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 |
| 534 | 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 |
| 535 | 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 |
| 536 | NDA/MAL/HDP/10170 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | PREDNISOLONE TABLETS | PREDNISOLONE | 5MG | ELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 02/09/2022 |
| 537 | NDA/MAL/HDP/10171 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | QUININE TABLETS | QUININE SULPHATE | 300MG | ELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 02/09/2022 |
| 538 | NDA/MAL/HDP/10172 | SURGE LABORATORIES (PVT.) LTD. | HEALTHCARE LTD. | XTRACEF 2G INJECTION | 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 | 04/10/2022 |
| 539 | NDA/MAL/HDP/10173 | APAROZA PHARMA LTD | APAROZA PHARMA LIMITED | ESCAPELLE | LEVONORGESTREL | 1.5MG | GEDEON RICHTER PLC-H-1103 BUDAPEST, GYOMROI UT 19-21 HUNGARY | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 29/09/2022 |
| 540 | NDA/MAL/HDP/10174 | STRIDES PHARMA SCIENCE LIMITED | DELMAW ENTERPRISES LIMITED | DOLUTEGRAVIR TABLETS 50 MG | DOLUTEGRAVIR SODIUM | 50 MG | STRIDES SHASUN LIMITED-NO. 36/7, SURAGAJAKKANAHALLI, INDLAVADI CROSS, ANEKAL TALUK, BENGALURU, KARNATAKA, 562106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 29/09/2022 |
| 541 | NDA/MAL/HDP/10175 | ESKAYEF PHARMACEUTICALS LTD | SWASTIK PHARMACEUTICAL LTD | LAXITOL | LACTITOL MONOHYDRATE | 10 MG | ESKAYEF BANGLADESH LTD-TONGI PLANT-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X1.0X10.0 MG SACHET | 04/10/2022 |
| 542 | NDA/MAL/HDP/10176 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CLINDAMYCIN HYDROCHLORIDE CAPSULES USP 300 MG | CLINDAMYCIN HYDROCHLORIDE | 300 MG | CIRON DRUGS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR – 401404, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/09/2022 |
| 543 | NDA/MAL/HDP/10177 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | METOCLOPRAMIDE TABLETS BP 10 MG | METOCLOPRAMIDE HYDROCHLORIDE | 10 MG | CIRON DRUGS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR – 401404, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/09/2022 |
| 544 | NDA/MAL/HDP/10178 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | BETAMET OINTMENT | BETAMETHASONE VALERATE | 0.1% W/W | ATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 29/09/2022 |
| 545 | NDA/MAL/HDP/10179 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEDOBOOK 10 | LENALIDOMIDE | 10 MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X7.0 CAPSULE BLISTER | 03/10/2022 |
| 546 | 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 |
| 547 | NDA/MAL/HDP/10180 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | POLYMOL RAPID | PARACETAMOL | 500 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 | 03/10/2022 |
| 548 | NDA/MAL/HDP/10181 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | POLYMOL ADVANCE | PARACETAMOL | 650 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 | 03/10/2022 |
| 549 | 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 | 04/10/2022 |
| 550 | 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 | 29/09/2022 |
| 551 | NDA/MAL/HDP/10184 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ROFAST 20 | ROSUVASTATIN CALCIUM | 20 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 FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/09/2022 |
| 552 | 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 | 29/09/2022 |
| 553 | 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 | 1.0X20.0X10.0 TABLET BLISTER | 29/09/2022 |
| 554 | NDA/MAL/HDP/10187 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | AARCET 5 | CETIRIZINE HYDROCHLORIDE | 5 MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/09/2022 |
| 555 | 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 | 1.0X10.0X1.0X1.0 TABLET BLISTER | 29/09/2022 |
| 556 | 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 | 29/09/2022 |
| 557 | NDA/MAL/HDP/10190 | ORCHIDIA PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TWINZOL | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | (20 MG + 5 MG)/ML | ORCHIDIA PHARMACEUTICAL INDUSTRIES-AL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPT | EGYPT | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 29/09/2022 |
| 558 | NDA/MAL/HDP/10191 | M/S HETERO LABS LIMITED | AIVEEN (U) LTD | VALSAR HT 160/25 | VALSARTAN + HYDROCHLORTHIAZIDE | 160MG + 25MG | 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 | 1.0X3.0X10.0 TABLET BLISTER | 03/10/2022 |
| 559 | NDA/MAL/HDP/10192 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUTAXIM 1 GM | CEFOTAXIME SODIUM | 1 G/ VIAL | 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 | 29/09/2022 |
| 560 | NDA/MAL/HDP/10193 | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC PLUS | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300 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 | 29/09/2022 |
| 561 | 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 |
| 562 | NDA/MAL/HDP/10195 | DEV LIFE CORPORATION | PLANET PHARMACEUTICALS UGANDA LTD | ABZODEV | ACTIVATED CHARCOAL | 250 MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 29/09/2022 |
| 563 | NDA/MAL/HDP/10196 | CONCEPT PHARMACEUTICAL LTD | QUALITY CHEMICALS LTD | PANTEC-DSR | PANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE | 40 MG + 30 MG | CONCEPT PHARMACEUTICALS LIMITED-KISHANPUR JAMALPUR ROORKEE DIST HARIDWAR -247667 UTTARAKHAND, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 29/09/2022 |
| 564 | NDA/MAL/HDP/10197 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS 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 | 29/09/2022 |
| 565 | NDA/MAL/HDP/10198 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | FORMET 500 SR | METFORMIN HYDROCHLORIDE | 500 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 | 29/09/2022 |
| 566 | 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 | 29/09/2022 |
| 567 | NDA/MAL/HDP/1020 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PA-12 | PARACETAMOL SUSTAINED RELEASE | 1000MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID RETARD LAYERED TABLETS | 1.0X10.0X1.0X12.0 TABLET BLISTER | 01/07/2012 |
| 568 | NDA/MAL/HDP/10200 | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY PLUS 5/160/12.5 MG | AMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE | 5 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 | 29/09/2022 |
| 569 | 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 | 29/09/2022 |
| 570 | NDA/MAL/HDP/10202 | ESKAYEF PHARMACEUTICALS LTD | SWASTIK PHARMACEUTICAL LTD | PRED | PREDNISOLONE ACETATE | 10 MG/ML | ESKAYEF BANGLADESH LTD-TONGI PLANT-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH | BANGLADESH | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 29/09/2022 |
| 571 | NDA/MAL/HDP/10203 | MARCYRL PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SAVIBLEED | TRANEXAMIC ACID | 500 MG | MARCYRL PHARMACEUTICAL INDUSTRIES -WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITY | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/09/2022 |
| 572 | NDA/MAL/HDP/10204 | SAGA LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | NOVACEF 100 DT | CEFIXIME TRIHYDRATE | 100 MG | SAGA LIFESCIENCES LIMITED-SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 29/09/2022 |
| 573 | NDA/MAL/HDP/10206 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD) | ROYAL PHARMA 2011 LIMITED | PRILIS 5 | LISINOPRIL DIHYDRATE | 5 MG | GLOBELA PHARMA PVT.LTD.-357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/09/2022 |
| 574 | NDA/MAL/HDP/10207 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | TACROTAS-1 | TACROLIMUS MONOHYDRARE | 1 MG | INTAS PHARMACEUTICALS LTD.-PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER | 29/09/2022 |
| 575 | 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 |
| 576 | 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 | 29/09/2022 |
| 577 | NDA/MAL/HDP/10210 | FDC LTD | AIVEEN (U) LTD | 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 | 1.0X1.0X5.0 ML BOTTLE | 29/09/2022 |
| 578 | NDA/MAL/HDP/10211 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | SPAZNOL | DICLOFENAC SODIUM + PARACETAMOL + CHLORZOXAZON | 50 MG + 325 MG + 250 MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 29/09/2022 |
| 579 | 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 | 29/09/2022 |
| 580 | NDA/MAL/HDP/10213 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | PANTAKIND-40 | PANTOPRAZOLE SODIUM | 40 MG | MANKIND PHARMA LIMITED-UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 29/09/2022 |
| 581 | 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 | 04/10/2022 |
| 582 | NDA/MAL/HDP/10215 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ABAMOL | PARACETAMOL | 10 MG/ML | ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML CONTAINER | 05/10/2022 |
| 583 | NDA/MAL/HDP/10216 | CURETECH SKINCARE | AARON PHARMACEUTICALS LIMITED | LULIZOL CREAM | LULICONAZOLE | 1%W/W | CURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 29/09/2022 |
| 584 | NDA/MAL/HDP/10217 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | MIXIF 200 | CEFIXIME TRIHYDRATE | 200 MG | DAR AL DAWA DEVELOPMENT & INVESTMENT CO. LTD -P.O.BOX 9364, AMMAN 11191, JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X8.0 CAPSULE BLISTER | 04/10/2022 |
| 585 | 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 | 29/09/2022 |
| 586 | NDA/MAL/HDP/10219 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | COMIT-50 | SILDENAFIL CITRATE | 50 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 | 29/09/2022 |
| 587 | NDA/MAL/HDP/1022 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 588 | NDA/MAL/HDP/10220 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | AZIRO-250 | AZITHROMYCIN | 250 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 29/09/2022 |
| 589 | NDA/MAL/HDP/10222 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROYALPINE-10 | AMLODIPINE BESYLATE | 10 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/09/2022 |
| 590 | NDA/MAL/HDP/10223 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROMIPHENE 50 | CLOMIPHENE CITRATE | 50 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 29/09/2022 |
| 591 | NDA/MAL/HDP/10224 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ITRO-100 | ITRACONAZOLE | 100 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/09/2022 |
| 592 | NDA/MAL/HDP/10227 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROYALPINE-5 | AMLODIPINE BESYLATE | 5 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/09/2022 |
| 593 | NDA/MAL/HDP/10228 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | SEPTOPRIM 960 | TRIMETHOPRIM + SULFAMETHOXAZOLE | 160 MG + 800 MG | 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 | 29/09/2022 |
| 594 | NDA/MAL/HDP/10229 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | SEPTOPRIM - S | TRIMETHOPRIM + SULFAMETHOXAZOLE | (40 MG + 200 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 | 29/09/2022 |
| 595 | NDA/MAL/HDP/1023 | MYLAN LABORATORIES 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 |
| 596 | NDA/MAL/HDP/10230 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | MBEN | MEBENDAZOLE | 100 MG/5 ML | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X30.0 ML BOTTLE | 29/09/2022 |
| 597 | NDA/MAL/HDP/10231 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | MBEN 100 | MEBENDAZOLE | 100 MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X6.0 TABLET BLISTER | 29/09/2022 |
| 598 | 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 | 29/09/2022 |
| 599 | NDA/MAL/HDP/10233 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PAINFORCE 400 | IBUPROFEN | 400 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 | 29/09/2022 |
| 600 | 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 | 29/09/2022 |
| 601 | 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 | 04/10/2022 |
| 602 | NDA/MAL/HDP/10236 | ESKAYEF PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | CARDOBIS 5 | BISOPROLOL FUMARATE | 5 MG | ESKAYEF BANGLADESH LTD-TONGI PLANT-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/09/2022 |
| 603 | NDA/MAL/HDP/10237 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | METHOTREXATE 500 MG/50ML | METHOTREXATE DISODIUM | 500 MG/50 ML | EBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML VIAL | 29/09/2022 |
| 604 | NDA/MAL/HDP/10238 | CCL PHARMACEUTICALS (PVT.)LTD. | HARLEYS UGANDA LIMITED | NEO-KLAR | CLARITHROMYCIN | 500MG | CCL PHARMACEUTICALS (PVT) LTD-62- INDUSTRIAL ESTATE, KOT LAKHPHAT, LAHORE- 54770, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 19/09/2022 |
| 605 | NDA/MAL/HDP/10239 | GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD | 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 | 25/01/2023 |
| 606 | NDA/MAL/HDP/10240 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMESAR 40 | OLMESARTAN MEDOXOMIL | 40MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/10/2022 |
| 607 | NDA/MAL/HDP/10241 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARIACT FORTE | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | S KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 19/09/2022 |
| 608 | 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 | 19/09/2022 |
| 609 | NDA/MAL/HDP/10243 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | OXALIPLATIN 100MG/20ML | OXALIPLATIN | 100 MG/20 ML | EBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X20.0 ML VIAL | 29/09/2022 |
| 610 | NDA/MAL/HDP/10244 | ZYDUS DISCOVERY DMCC | ABACUS PHARMA (AFRICA) LIMITED | LIPAGLYN | SAROGLITAZAR MAGNESIUM | 4MG | CADILA HEALTHCARE LTD. -PLOT NO. 417, 419 & 420, SARKHEJ-BAVLA N.H. NO. 8A, MORAIYA, TAL: SANAND, DIST. AHMEDABAD - 382210, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 19/09/2022 |
| 611 | NDA/MAL/HDP/10245 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | METHOTREXATE 5000 MG/50ML | METHOTREXATE DISODIUM | 5000 MG/50 ML | EBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML VIAL | 29/09/2022 |
| 612 | 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 |
| 613 | NDA/MAL/HDP/10247 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | MOXIKIND-CV 228.5 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 200MG/5ML + 28.5MG/5ML | COPMED PHARMACEUTICALS PVT LTD-UNIT II. ,-PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 19/09/2022 |
| 614 | NDA/MAL/HDP/10248 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVOKILZ 750 | LEVOFLOXACIN | 750MG | 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 FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 19/09/2022 |
| 615 | 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 | 19/09/2022 |
| 616 | NDA/MAL/HDP/10250 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SINUTAB SINUS PAIN EXTRA STRENGTH | CODEINE PHOSPHATE +CHLORPHENIRAMINE MALEATE +PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL | 10 MG + 2 MG + 30 MG + 500 MG | JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 19/09/2022 |
| 617 | 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 | 19/09/2022 |
| 618 | NDA/MAL/HDP/10252 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | ATCAM | LORNOXICAM | 8MG | ATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 19/09/2022 |
| 619 | NDA/MAL/HDP/10253 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | LINEZOLID DENK 2 MG/ML | LINEZOLID | 2MG/ML | PHARMACEUTICAL WORKS POLPHARMA SA (ZAKLADY FARMACEUTYCZNE POLPHARMA SA)-19 PELPLINSKA STREET, 83-200 STAROGARD GDANSKI | POLAND | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X300.0 ML BAG | 19/09/2022 |
| 620 | NDA/MAL/HDP/10254 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | AZICEN 500 | AZITHROMYCIN | 500MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 03/10/2022 |
| 621 | NDA/MAL/HDP/10255 | AKRITI PHARMACEUTICALS PVT LTD | PHARMA VILLE LIMITED | HOTGRA 100 | SILDENAFIL CITRATE | 100 MG | AKRITI PHARMACEUTICALS PVT LTD-PLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 29/09/2022 |
| 622 | NDA/MAL/HDP/10256 | AKRITI PHARMACEUTICALS PVT LTD | PHARMA VILLE LIMITED | HOTGRA 50 | SILDENAFIL CITRATE | 50 MG | AKRITI PHARMACEUTICALS PVT LTD-PLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 29/09/2022 |
| 623 | 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 |
| 624 | 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 | 19/09/2022 |
| 625 | 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 | 19/09/2022 |
| 626 | 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 | 19/09/2022 |
| 627 | NDA/MAL/HDP/10261 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | NTCLOT-C75 | CLOPIDOGREL BILSULFATE | 75 MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 29/09/2022 |
| 628 | NDA/MAL/HDP/10262 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROFLOX | OFLOXACIN | 0.3%W/V | AUROLAB LIMITED-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 19/09/2022 |
| 629 | NDA/MAL/HDP/10263 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | WORMAID ORAL SUSPENSION | ALBENDAZOLE | 200 MG/5ML | 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 | 29/09/2022 |
| 630 | NDA/MAL/HDP/10264 | RUSAN PHARMA LTD | NORVIK ENTERPRISES LIMITED | ADDTREX 765 IMPLANT | NALTREXONE | 765 MG/APPLICATOR | RUSAN PHARMA LIMITED-PLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL ECONOMIC ZONE, GANDHIDHAM KUTCH 370 230 GUJARAT | INDIA | IMPLANTS (ASEPTICALLY FILLED) | 1.0X1.0X1.0X2.0 TABLET IMPLANT (THE IMPLANTATION TABLETS ARE CONTAINED IN A 3ML SYRINGE) | 17/11/2022 |
| 631 | 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 | 19/09/2022 |
| 632 | NDA/MAL/HDP/10266 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | TELCARD H 40 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40 MG + 12.5 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 | 19/09/2022 |
| 633 | NDA/MAL/HDP/10267 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | PROTOZOX-500 | NITAZOXANIDE | 500MG | SAGA LIFESCIENCES LIMITED-SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/10/2022 |
| 634 | NDA/MAL/HDP/10268 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | WORMAID TABLET | ALBENDAZOLE | 400 MG | 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 | 29/09/2022 |
| 635 | NDA/MAL/HDP/10269 | NATIONAL PHARMACEUTICAL INDUSTRIES CO. | MEDVIN PHARMA LIMITED | DIOCLAV 625 MG | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | NATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMAN-P.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMAN | OMAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP | 19/09/2022 |
| 636 | NDA/MAL/HDP/10270 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | MALAGLEN | ATOVAQUONE + PROGUANIL HYDROCHLORIDE | 250 MG + 100 MG | GLENMARK PHARMACEUTICALS LIMITED-PLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 19/09/2022 |
| 637 | NDA/MAL/HDP/10271 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | PACLITAXEL | PACLITAXEL | 100MG PER VIAL OF 16.7ML | EBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 MG VIAL | 04/10/2022 |
| 638 | NDA/MAL/HDP/10272 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | 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 | 03/10/2022 |
| 639 | NDA/MAL/HDP/10273 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | ASPIRIN 81 MG USP | ASPIRIN | 81 MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/09/2022 |
| 640 | NDA/MAL/HDP/10274 | TAKEDA PHARMACEUTICALS U.S.A INC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VIPDOMET | ALOGLIPTIN BENZOATE + METFORMIN HYDROCHLORIDE | 12.5MG + 1000MG | TAKEDA GMBH, PLANT ORANIENBURG-PLANT ORANIENBURG, LEHNITZSTRASSE 70-98, DE – 16515, GERMANY TAKEDA IRELAND LIMITED-BRAY BUSINESS PARK, KILRUDDERY, CO. WICKLOW - IRELAND | GERMANY IRELAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X8.0X7.0 TABLET BLISTER | 19/09/2022 |
| 641 | NDA/MAL/HDP/10275 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | METFORZIDE | GLICLAZIDE + METFORMIN HYDROCHLORIDE | 80 MG + 500 MG | 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 | 29/09/2022 |
| 642 | NDA/MAL/HDP/10276 | TAKEDA PHARMACEUTICALS U.S.A INC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VIPIDIA | ALOGLIPTIN BENZOATE | 25MG | TAKEDA IRELAND LIMITED-BRAY BUSINESS PARK, KILRUDDERY, CO. WICKLOW - IRELAND | IRELAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 19/09/2022 |
| 643 | NDA/MAL/HDP/10277 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | CLOPASPRIN | CLOPIDOGREL BISULFATE + ASPIRIN | 75 MG + 75 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 | 29/09/2022 |
| 644 | NDA/MAL/HDP/10278 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROTRAMIC | TRANEXAMIC ACID | 100 MG/ML | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 04/10/2022 |
| 645 | NDA/MAL/HDP/10279 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD) | ROYAL PHARMA 2011 LIMITED | CLARIPSA | CLARITHROMYCIN | 500 MG | 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 | 19/09/2022 |
| 646 | 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 | 19/09/2022 |
| 647 | NDA/MAL/HDP/10281 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | H- CURE ES | ESOMEPRAZOLE MAGNESIUM + CLARITHROMYCIN + TINIDAZOLE | 40MG + 500MG + 500MG | FREDUN PHARMACEUTICALS LIMITED,-14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER | 29/09/2022 |
| 648 | 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 | 29/09/2022 |
| 649 | 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 | 19/09/2022 |
| 650 | NDA/MAL/HDP/10284 | NATIONAL PHARMACEUTICAL INDUSTRIES CO. | MEDVIN PHARMA LIMITED | MACROMAX 500 | AZITHROMYCIN | 500MG | NATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMAN-P.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMAN | OMAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 19/09/2022 |
| 651 | NDA/MAL/HDP/10285 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | DOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION (DISPERSIBLE TABLETS) 10MG | DOLUTEGRAVIR SODIUM | 10 MG | MACLEODS PHARMACEUTICALS LTD ,.-PHASE I & II, PLOT NO. 25-27 SURVEY NO. 366, PREMIERE INDUSTRIAL ESTATE, KACHIGAN, DAMAN-396210 | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X90.0 TABLET CONTAINER | 29/09/2022 |
| 652 | NDA/MAL/HDP/10286 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PERLEX 250 | CEFALEXIN MONOHYDRATE | 250 MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 29/09/2022 |
| 653 | NDA/MAL/HDP/10287 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | VILDA DENK 50 MG | VILDAGLIPTIN | 50 MG | DENK PHARMA GMBH & COMPANY KG - GOLLSTR. 1, 84529 TITTMONING - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 03/10/2022 |
| 654 | NDA/MAL/HDP/10288 | AGIO PHARMACEUTICALS LTD | REDDYS PHARMA LIMITED | AZIAGIO 200 | AZITHROMYCIN DIHYDRATE | 200 MG/5 ML | AGIO PHARMACEUTICALS LIMITED.-T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X15.0 ML BOTTLE | 19/09/2022 |
| 655 | NDA/MAL/HDP/10289 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | POLZIN EYE OINTMENT | POLYMYXIN B SULFATE + BACITRACIN ZINC + NEOMYCIN SULFATE | (5000 IU + 400 IU + 3400 IU)/G | INDIANA OPHTHALMICS-135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC OINTMENTS | 1.0X1.0X5.0 G TUBE | 19/09/2022 |
| 656 | 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 | 29/09/2022 |
| 657 | NDA/MAL/HDP/10291 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | CIPROCON EYE DROPS | CIPROFLOXACIN HYDROCHLORIDE | 0.3% W/V | INDIANA OPHTHALMICS-135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 19/09/2022 |
| 658 | NDA/MAL/HDP/10292 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | SPASMOTRIT | DICYCLOMINE HYDROCHLORIDE + PARACETAMOL | 20MG + 500MG | SAGA LIFESCIENCES LIMITED-SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 659 | 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 | 19/09/2022 |
| 660 | NDA/MAL/HDP/10296 | AIVEEN (U) 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 | 19/09/2022 |
| 661 | 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 | 29/09/2022 |
| 662 | 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 | 19/09/2022 |
| 663 | 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 | 29/09/2022 |
| 664 | 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 |
| 665 | 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 | 29/09/2022 |
| 666 | NDA/MAL/HDP/10301 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LETRODAY 2.5 | LETROZOLE | 2.5 MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 667 | NDA/MAL/HDP/10302 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYOTRAM-P 37.5/325 | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | AUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 668 | 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 | 19/09/2022 |
| 669 | 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 | 19/09/2022 |
| 670 | NDA/MAL/HDP/10305 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | SPASMO PONALGIC | DICYCLOMINE 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 | 1.0X1.0X10.0 TABLET BLISTER | 06/10/2022 |
| 671 | NDA/MAL/HDP/10306 | SWISS PARENTERALS LTD | SHREEJI CARE 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 | 19/09/2022 |
| 672 | 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 | 19/09/2022 |
| 673 | NDA/MAL/HDP/10308 | WALLACE PHARMACEUTICALS PVT. LTD | SURGIPHARM (U) LIMITED | ZN20 | ZINC GLUCONATE | 20MG/5ML | WALLACE PHARMACEUTICALS PVT LTD-BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 19/09/2022 |
| 674 | NDA/MAL/HDP/10309 | INDASI LIFESCIENCE PVT. LTD | ROYAL PHARMA 2011 LIMITED | OMEPRAZOLE FOR INJECTION | OMEPRAZOLE SODIUM | 40 MG | BLISS INDASI LIFESCIENCE PRIVATE LIMITED-PLOT NO. 73 TO 76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 396 210 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL | 19/09/2022 |
| 675 | NDA/MAL/HDP/1031 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MOXIFLOX | MOXIFLOXACIN | 400MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 01/07/2013 |
| 676 | 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 | 19/09/2022 |
| 677 | 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 | 19/09/2022 |
| 678 | 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 | 04/10/2022 |
| 679 | 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 | 19/09/2022 |
| 680 | NDA/MAL/HDP/10314 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | ROYAL PHARMA 2011 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 |
| 681 | NDA/MAL/HDP/10315 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | INDOMETHACIN | INDOMETHACIN | 25MG | M/S SCOTT-EDIL PHARMACIA LIMITED-56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE TIN,1.0X500.0 CAPSULE TIN, 1.0X10.0X10.0 CAPSULE BLISTER | 13/01/2023 |
| 682 | NDA/MAL/HDP/10316 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS 20 | TELMISARTAN | 20 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/09/2022 |
| 683 | NDA/MAL/HDP/10317 | Y.S.P. INDUSTRIES (M) SDN. BHD. | ROYAL PHARMA 2011 LIMITED | VOREN SUPPOSITORY 100 MG | DICLOFENAC SODIUM | 100MG | Y.S.P INDUSTRIES (M) SDN BHN.-LOT 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN PENDUSTRIAN BANDAR BARU BANGI, 43000, KAJANG, SELANGOR, MALAYSIA | MALAYSIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 03/10/2022 |
| 684 | NDA/MAL/HDP/10318 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS 40 | TELMISARTAN | 40 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/09/2022 |
| 685 | NDA/MAL/HDP/10319 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TELFOCUS 80 | TELMISARTAN | 80 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/09/2022 |
| 686 | NDA/MAL/HDP/10320 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | METROSCOT 125MG/5ML | METRONIDAZOLE BENZOATE | 125MG/5ML | M/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 03/10/2022 |
| 687 | NDA/MAL/HDP/10321 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | CYPROVIT | CYPROHEPTADINE HYDROCHLORIDE + VITAMIN A + COLECALCIFEROL (VITAMIN D3) + THIAMINE HYDROCHLORIDE + RIBOFLAVIN + CYANOCOBALAMIN + NICOTINAMIDE + CALCIUM PANTOTHENATE + ASCORBIC ACID + LYSINE HYDROCHLORIDE | 4 MG + 1500 IU + 300 IU + 2 MG + 2 MG + 5 MCG + 10 MG + 5 MG + 20 MG + 50 MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 04/10/2022 |
| 688 | NDA/MAL/HDP/10322 | CACHET PHARMACEUTICALS PVT LIMITED | ASTRA PHARMA (U) 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 | 19/09/2022 |
| 689 | 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 | 19/09/2022 |
| 690 | NDA/MAL/HDP/10325 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ONCET | CETIRIZINE DIHYDROCHLORIDE | 5MG/5ML | MEDLEY PHARMACEUTICALS LTD-PLOT 18 & 19 SURVEY NO. 378/7&8, 379/2&3 ZARI CAUSEWAY ROAD, KACHIGAM DAMAN-396210, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 19/09/2022 |
| 691 | NDA/MAL/HDP/10326 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | RISEOL 50 | TRAMADOL HYDROCHLORIDE | 50MG | SUNRISE INTERNATIONAL LABS LTD-PLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 19/09/2022 |
| 692 | NDA/MAL/HDP/10327 | ESKAYEF PHARMACEUTICALS LTD. | SWASTIK PHARMACEUTICAL LTD | DUMAX 30 | DAPOXETINE HYDROCHLORIDE | 30MG | ESKAYEF BANGLADESH LTD-TONGI PLANT-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X4.0 TABLET BLISTER | 19/09/2022 |
| 693 | NDA/MAL/HDP/10329 | ESKAYEF PHARMACEUTICALS LTD. | SWASTIK PHARMACEUTICAL LTD | TAMENOL | PARACETAMOL + TRAMADOL HYDROCHLORIDE | 325 MG + 37.5 MG | ESKAYEF BANGLADESH LTD-TONGI PLANT-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 19/09/2022 |
| 694 | 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 |
| 695 | NDA/MAL/HDP/10333 | PHARMA BAVARIA INTERNACIONAL PORTUGAL | GOODMAN INTERNATIONAL LTD | FLUCAVEX | PARACETAMOL + ASCORBIC ACID + PHENIRAMINE MALEATE | 500 MG + 25 MG + 200 MG | FARMEA-10 RUE BOUCHE THOMAS, ZAC D'ORGEMONT, 49007 ANGERS CEDEX 01 | FRANCE | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X8.0 SACHET CARTON | 03/10/2022 |
| 696 | NDA/MAL/HDP/10335 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PRIDOCAINE | LIDOCAINE + PRILOCAINE | 2.5% W/W + 2.5%W/W | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 19/09/2022 |
| 697 | 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 | 03/10/2022 |
| 698 | NDA/MAL/HDP/10338 | NEOMI PHARMACEUTICALS PVT LTD - | ROYAL PHARMA 2011 LIMITED | ROART 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X24.0 TABLET BLISTER | 19/09/2022 |
| 699 | NDA/MAL/HDP/1034 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX | AMOXICILLIN | 250MG/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 |
| 700 | NDA/MAL/HDP/10340 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KERELLA | BETAMETHASONE DIPROPIONATE + SALICYLIC ACID | (0.5 MG+ 220 MG)/G | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | TOPICAL EXTERNAL LOTIONS | 1.0X1.0X30.0 ML BOTTLE | 19/09/2022 |
| 701 | NDA/MAL/HDP/10342 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RHINOMAX | BUDESONIDE | 64MCG/ DOSE | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | JORDAN | NASAL TOPICAL METERED DOSE AEROSOLS | 1.0X120.0 METERED DOSE BOTTLE | 03/10/2022 |
| 702 | 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 | 19/09/2022 |
| 703 | NDA/MAL/HDP/10346 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | LACTORIV | LACTULOSE | 10 G/15 ML | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 19/09/2022 |
| 704 | NDA/MAL/HDP/10347 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | PENTARIV-40 | PANTOPRAZOLE SODIUM | 40MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | PARENTERAL RETARD DRY VIALS | 1.0X1.0X40.0 MG VIAL + 1*10ML LDPE AMPOULE OF NACL | 19/09/2022 |
| 705 | NDA/MAL/HDP/10349 | SHANGHAI FOSUN PHARMACEUTICAL 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 | 19/09/2022 |
| 706 | NDA/MAL/HDP/1035 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | G-CIPROX | CIPROFLOXACIN | 500MG | GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 707 | NDA/MAL/HDP/10350 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ANCOLIN-ME | PREGABALIN + METHYLCOBALAMIN | 75 MG + 750 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 03/10/2022 |
| 708 | NDA/MAL/HDP/10351 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROYALTRIM 160 MG + 800 MG | TRIMETHOPRIM + SULFAMETHOXAZOLE | 160 MG + 800 MG | SYNOKEM PHARMACEUTICALS LIMITED -PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 709 | NDA/MAL/HDP/10352 | SYNOKEM PHARMACEUTICALS 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) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 710 | NDA/MAL/HDP/10353 | CENTURION LABORATORIES PVT. LTD. | MEDIWORLD PHARMA AFRICA LTD | PAINAID | PARACETAMOL + IBUPROFEN + CAFFEINE | 400 MG + 325 MG + 40 MG | 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 | 19/09/2022 |
| 711 | NDA/MAL/HDP/10354 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | ROYAL PHARMA 2011 LIMITED | C-STOL | MISOPROSTOL | 200MCG | CORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 712 | 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 | 03/10/2022 |
| 713 | NDA/MAL/HDP/10356 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RIVATAS 20 | RIVAROXABAN | 20MG | INTAS PHARMACEUTICALS LTD.-PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X0.01 TABLET BLISTER | 03/10/2022 |
| 714 | NDA/MAL/HDP/10357 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROMOXI 125 | AMOXICILLIN TRIHYDRATE | 125 MG/5ML | PIL PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 71 & 72, SECTOR -6A, IIE, SIDCUL, HARIDWAR- 249403( UTTARAKHARD) | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 19/09/2022 |
| 715 | 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 | 19/09/2022 |
| 716 | NDA/MAL/HDP/10360 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | TERBIQUITE | TERBINAFINE HYDROCHLORIDE | 1.0% W/W | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 19/09/2022 |
| 717 | NDA/MAL/HDP/10361 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | ROYAL PHARMA 2011 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 |
| 718 | NDA/MAL/HDP/10363 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO - AMIKACIN | AMIKACIN SULFATE | 500 MG/2 ML | 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 | 19/09/2022 |
| 719 | NDA/MAL/HDP/10364 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROYO-CORT INJ | HYDROCORTISONE SODIUM SUCCINATE | 100 MG/VIAL | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X100.0 MG VIAL | 19/09/2022 |
| 720 | 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 | 19/09/2022 |
| 721 | 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 | 19/09/2022 |
| 722 | NDA/MAL/HDP/10368 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SITAPRIL 25 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 25MG | 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 | 19/09/2022 |
| 723 | NDA/MAL/HDP/10369 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) 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 | 19/09/2022 |
| 724 | NDA/MAL/HDP/10370 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) 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 | 19/09/2022 |
| 725 | NDA/MAL/HDP/10371 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROLEXIN 250 | CEFALEXIN MONOHYDRATE | 250MG | INNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 19/09/2022 |
| 726 | 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 | 19/09/2022 |
| 727 | 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 | 19/09/2022 |
| 728 | NDA/MAL/HDP/10374 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | FERLIX ®FOLIX | FERROUS SULFATE + FOLIC ACID | 200 MG + 0.4 MG | BIO NOVA PHARMACEUTICALS PVT.LTD-C-66/1, OKHLA INDUSTRIAL AREA, PHASE –II, NEW DELHI INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 729 | NDA/MAL/HDP/10375 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | ROYAL PHARMA 2011 LIMITED | AFRI-FLU | PARACETAMOL + CAFFEINE + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE | 500 MG + 15 MG + 5 MG + 2 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 |
| 730 | NDA/MAL/HDP/10376 | SURGE LABORATORIES (PVT.) LTD. | HEALTHCARE LTD. | XTRACEF 1G INJECTION | CEFOPRAZONE SODIUM + SULBACTUM SODIUM | 0.5G + 0.5G | SURGE LABORATORIES (PVT) LTD.,,-10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL + 1*5ML AMPOULE OF WFI | 21/09/2022 |
| 731 | NDA/MAL/HDP/10377 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AROXICAM 15 | MELOXICAM | 15MG | AUROBINDO PHARMA LIMITED UNIT 3-PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 732 | NDA/MAL/HDP/10378 | CENTURION LABORATORIES PVT. LTD. | VRUSHIK INVESTMENT LIMITED | ESOMIZAP | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | CENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/09/2022 |
| 733 | NDA/MAL/HDP/10379 | LITHA PHARMA (PTY) LTD. | LABOREX UGANDA LIMITED | ORATANE® 10 MG | ISOTRETINOIN | 10MG | SWISS CAPS AG-HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLAND DOUGLAS MANUFACTURING LIMITED-CORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | NEW ZEALAND SWITZERLAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X4.0X15.0 CAPSULE BLISTER | 19/09/2022 |
| 734 | NDA/MAL/HDP/10380 | LITHA PHARMA (PTY) LTD. | LABOREX UGANDA LIMITED | ORATANE® 20 MG | ISOTRETINOIN | 20MG | SWISS CAPS AG-HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLAND DOUGLAS MANUFACTURING LIMITED-CORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | NEW ZEALAND SWITZERLAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X4.0X15.0 CAPSULE BLISTER | 19/09/2022 |
| 735 | NDA/MAL/HDP/10381 | LITHA PHARMA (PTY) LTD. | LABOREX UGANDA LIMITED | ORATANE® 40 MG | ISOTRETINOIN | 40MG | SWISS CAPS AG-HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLAND DOUGLAS MANUFACTURING LIMITED-CORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | NEW ZEALAND SWITZERLAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 19/09/2022 |
| 736 | 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 | 19/09/2022 |
| 737 | NDA/MAL/HDP/10383 | AGIO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | IBUPEN PLUS SUSPENSION | IBUPROFEN + PARACETAMOL | (100MG + 162.5 MG)/ 5ML | AGIO PHARMACEUTICALS LIMITED.-T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE | 19/09/2022 |
| 738 | 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 | 19/09/2022 |
| 739 | NDA/MAL/HDP/10385 | XL LABORATORIES PRIVATE LIMITED- | ROYAL PHARMA 2011 LIMITED | SOFKOF | DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE | 10MG + 5MG + 2MG | XL LABORATORIES PRIVATE LIMITED-A-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 19/09/2022 |
| 740 | NDA/MAL/HDP/10386 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMAC 5 | OLANZAPINE | 5MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 741 | NDA/MAL/HDP/10387 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMAC 10 | OLANZAPINE | 10MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/09/2022 |
| 742 | NDA/MAL/HDP/10388 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | DEXOMETH-N CREAM | NEOMYCIN SULPHATE + DEXAMETHASONE SODIUM PHOSPHATE | (5MG + 1MG)/ G | AL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 19/09/2022 |
| 743 | NDA/MAL/HDP/10389 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | VIREXIM INJECTION | CEFTRIAXONE SODIUM | 1G | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10ML AMPOULE OF WFI | 19/09/2022 |
| 744 | 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 | 19/09/2022 |
| 745 | NDA/MAL/HDP/10391 | SANDOZ GMBH . | SURGIPHARM (U) LIMITED | HYDROXYUREA 100MG | HYDROXYCARBAMIDE | 100MG | HAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG SIEGFRIED BARBERA, S.L.-RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA, SPAIN. | GERMANY SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE,1.0X1.0X120.0 TABLET BOTTLE | 19/09/2022 |
| 746 | NDA/MAL/HDP/10392 | SANDOZ GMBH . | SURGIPHARM (U) LIMITED | HYDROXYUREA 1000MG | HYDROXYCARBAMIDE | 1000MG | HAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG SIEGFRIED BARBERA, S.L.-RONDA SANTA MARIA 158, 08210 BARBERA DEL VALLES, BARCELONA, SPAIN. | GERMANY SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 19/09/2022 |
| 747 | NDA/MAL/HDP/10393 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENDOKEY 25 | BENDAMUSTINE HYDROCHLORIDE | 25MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X25.0 MG VIAL | 19/09/2022 |
| 748 | NDA/MAL/HDP/10394 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENDOKEY 100 | BENDAMUSTINE HYDROCHLORIDE | 100MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X100.0 MG VIAL | 19/09/2022 |
| 749 | NDA/MAL/HDP/10395 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENDOKEY | BENDAMUSTINE HYDROCHLORIDE | 100MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X4.0 ML VIAL | 19/09/2022 |
| 750 | NDA/MAL/HDP/10417 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (A) LIMITED | DUONAS | AZELASTINE HYDROCHLORIDE + FLUTICASONE PROPIONATE | 137MCG/50MCG PER ACTUATION | CADILA HEALTHCARE LIMITED, PLOT NO. 417, 419, 420, SARKHEJ-BAVLA N.H. NO. 8A, VILLAGE: MORAIYA, TAL.: SANAND, DIST.: AHMEDABAD - 382 210, INDIA | INDIA | NASAL SPRAY | 1.0X1.0X30.0 ML BOTTLE | 10/02/2023 |
| 751 | NDA/MAL/HDP/10418 | AJANTA PHARMA LIMITED | ABACUS PHARMA (A) LIMITED | KAMAGRA CT 100 | SILDENAFIL CITRATE | 100 MG | AJANTA PHARMA LIMITED, B-4-5-6, MIDC INDUSTRIAL AREA PAITHAN, AURANGABAD, 431148 AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 10/02/2023 |
| 752 | NDA/MAL/HDP/10419 | AJANTA PHARMA LIMITED | ABACUS PHARMA (A) LIMITED | SITAPRIL M 50/1000 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | AJANTA PHARMA LIMITED B-4-5-6, MIDC INDUSTRIAL AREA PAITHAN, AURANGABAD, 431148 DIST: AURANGABAD MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 753 | 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 |
| 754 | NDA/MAL/HDP/10420 | AJANTA PHARMA LIMITED | ABACUS PHARMA (A) LIMITED | SITAPRIL M 50/500 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | AJANTA PHARMA LIMITED B-4-5-6, MIDC INDUSTRIAL AREA PAITHAN, AURANGABAD, 431148 DIST: AURANGABAD MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 755 | NDA/MAL/HDP/10421 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (A) LIMITED | MIOPOLOL ER 50 | METOPROLOL SUCCINATE | 50 MG | INVENTIA HEALTHCARE LIMITED F1-F1/1, F75/1 ADDITIONAL AMBERNATH M.I.D.C., AMBERNATH (EAST) - 421 506, DIST. THANE, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 756 | NDA/MAL/HDP/10422 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (A) LIMITED | MIOPOLOL ER 25 | METOPROLOL SUCCINATE | 25 MG | INVENTIA HEALTHCARE LIMITED F1-F1/1, F75/1 ADDITIONAL AMBERNATH M.I.D.C., AMBERNATH (EAST) - 421 506, DIST. THANE, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 757 | NDA/MAL/HDP/10423 | S KANT HEALTHCARE LTD | ABACUS PHARMA (A) LTD | MALAKANT DISPERSIBLE JUNIOR | SULFADOXINE + PYRIMETHAMINE | 250MG + 12.5MG | S KANT HEALTHCARE LIMITED FORMULATION BLOCK: PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI 396195. GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X25.0X3.0 TABLET BLISTER | 10/02/2023 |
| 758 | NDA/MAL/HDP/10424 | S KANT HEALTHCARE LTD | ABACUS PHARMA (A) LTD | MALAKANT DISPERSIBLE | SULFADOXINE + PYRIMETHAMINE | 500MG + 25MG | S KANT HEALTHCARE LIMITED FORMULATION BLOCK: PLOT NO. 1802-1805, G.I.D.C., PHASE III, VAPI 396195. GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X25.0X3.0 TABLET BLISTER | 10/02/2023 |
| 759 | NDA/MAL/HDP/10425 | SUPREME PHARMA HEALTHCARE PVT. LTD | ABACUS PHARMA (U) LTD | FLOXYPREME-500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | SAI MIRRA INNOPHARM PVT. LTD. 288 & 299, SIDCO ESTATE, CHENNAI, INDIA-600 098 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 760 | NDA/MAL/HDP/10426 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA(A) LIMITED | SUPAGREL 90 | TICAGRELOR | 90 MG | MSN LABORATORIES PRIVATE LIMITED - FORMULATIONS DIVISION FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277, 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANGAREDDY DISTRICT, TELANGANA 509228, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 761 | NDA/MAL/HDP/10427 | AJANTA PHARMA LIMITED | ABACUS PHARMA(A) LIMITED | CELMAC 400 | CELECOXIB | 40 MG | AJANTA PHARMA LIMITED, B-4-5-6, MIDC INDUSTRIAL AREA PAITHAN, AURANGABAD, 431148 DIST: AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 762 | NDA/MAL/HDP/10428 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AMOXI-DENK 1000 | AMOXICILLIN TRIHYDRATE | 1000 MG | PENCEF PHARMA GMBH BREITENBACHSTR. 13-14 13509 BERLIN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 763 | NDA/MAL/HDP/10429 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AMOXI-DENK 500 | AMOXICILLIN TRIHYDRATE | 500 MG | PENCEF PHARMA GMBH BREITENBACHSTR. 13-14 13509 BERLIN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 764 | NDA/MAL/HDP/10430 | CIPLA LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | QUADRIMUNE | ABACAVIR + LAMIVUDINE + LOPINAVIR + RITONAVIR | 30 MG + 15 MG + 40 MG +10 MG | CIPLA LIMITED, GOA (UNIT VII) PLOT NO. S-103 TO S-105, S-107 TO S-112 & L-147, L-147/1 TO L-147/3, L-147/A & L-138 VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE, GOA – 403 722, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X120.0 CAPSULE CONTAINER | 10/02/2023 |
| 765 | NDA/MAL/HDP/10431 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | CLAMOXIN 375 INJECTION | AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE | 250 MG + 125 MG/VIAL | MEDOPHARM PRIVATE LIMITED NO.50, KAYARAMBEDU VILLAGE, GUDUVANCHERY CHENGALPET DISTRICT TAMILNADU-INDIA 603 202. | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1*1, GLASS VIAL + 1*20 ML WFI IN LDPE | 10/02/2023 |
| 766 | NDA/MAL/HDP/10432 | GUFIC LIFESCIENCES PRIVATE LIMITED | EUROPA HEALTHCARE (U) LTD | VAMOCIN 500 | VANCOMYCIN HYDROCHLORIDE | 500MG PER VIAL | GUFIC BIOSCIENCES LIMITED (UNIT 2) SURVEY NO. 171, N.H. NO.8, NEAR GRID KABILPORE NAVSARI – 396424 GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1*1, GLASS VIAL | 10/02/2023 |
| 767 | NDA/MAL/HDP/10433 | BIOLOGICAL E. LIMITED | GITTOES PHARMACEUTICALS LTD | TETANUS ANTITOXIN 1500 IU/ML BP | TETANUS ANTITOXIN | 1500 IU/ML | BIOLOGICAL E LIMITED,18 / 1 & 3, AZAMABAD, HYDERABAD, TELANGANA, INDIA – 500 020 | INDIA | PARENTERAL ORDINARY VIALS | 1*1*20ML CLEAR GLASS VIAL | 10/02/2023 |
| 768 | NDA/MAL/HDP/10434 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY | AZIBRU | AZITHROMYCIN DIHYDRATE | 200 MG/5 ML | BRAWN LABORATORIES LTD., 13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, (HARYANA), INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE | 10/02/2023 |
| 769 | NDA/MAL/HDP/10435 | PROFARMA SH.A | JOINT MEDICAL STORES | AFEBRIL 5 MG/2.5ML | DIAZEPAM | 5MG/2.5ML | PROFARMA SH.A.RRUGA: MYSLYM KETA TIRANA ALBANIA | ALBANIA | RECTAL SOLUTION | 1*5*1, 2.5 LDPE VIALS | 10/02/2023 |
| 770 | NDA/MAL/HDP/10436 | YICHANG HUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | PETHIDINE HYDROCHLORIDE INJECTION | PETHIDINE HYDROCHLORIDE | 50 MG/ML | YICHANG HUMANWELL PHARMACEUTICAL CO., LTD. NO. 19, DALIAN ROAD, DEVELOPMENT ZONE, YICHANG, HUBEI, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULES | 10/02/2023 |
| 771 | NDA/MAL/HDP/10437 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD. | GEMCITABINE 200 MG/5ML | GEMCITABINE | 200 MG/5ML ARTWORK TO BE PRINTED | EBEWE PHARMA GES.M.B.H. NFG.KG MONDSEESTRAßE 11 A-4866 UNTERACH AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1*1, 100 ML CLEAR GLASS VIAL | 10/02/2023 |
| 772 | NDA/MAL/HDP/10438 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (U) LIMITED | ZABDENO | ADENOVIRUS TYPE 26 ENCODING THE ZAIRE EBOLAVIRUS (EBOV) MAYINGA VARIANT GLYCOPROTEIN (GP), | NOT LESS THAN 8.75 LOG 10 INFECTIOUS UNITS (INF.U),/DOSE (0.5 ML) | IDT BIOLOGIKA GMBH AM PHARMAPARK, 06861 DESSAU-ROSSLAU GERMANY (MANUFACTURE) + JANSSEN BIOLOGICS B.V. EINSTEINWEG 101, 2333 CB LEIDEN THE NETHERLANDS ( BATCH RELEASE) | GERMANY | SUSPENSION FOR INJECTION | 1.0X20.0X0.5 ML VIAL | 10/02/2023 |
| 773 | NDA/MAL/HDP/10439 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (U) LIMITED | MVABEA | ONE DOSE (0.5 ML) CONTAINS:MODIFIED VACCINIA ANKARA BAVARIAN NORDIC VIRUS* ENCODING THE: ZAIRE EBOLAVIRUS (EBOV) MAYINGA VARIANT GLYCOPROTEIN (GP), SUDAN EBOLAVIRUS GULU VARIANT GP, TAÏ FOREST EBOLAVIRUS NUCLEOPROTEIN, MARBURG MARBURGVIRUS MUSOKE VARIANT | NOT LESS THAN 0.7 X 108 INFECTIOUS UNITS (INF.U), /DOSE (0.5 ML) | IDT BIOLOGIKA GMBH AM PHARMAPARK, 06861 DESSAU-ROSSLAU GERMANY (MANUFACTURE) + JANSSEN BIOLOGICS B.V. EINSTEINWEG 101, 2333 CB LEIDEN THE NETHERLANDS ( BATCH RELEASE) | GERMANY | SUSPENSION FOR INJECTION | 1.0X20.0X0.5 ML VIAL | 10/02/2023 |
| 774 | NDA/MAL/HDP/1044 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 775 | NDA/MAL/HDP/10440 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PHENIREX | CHLORPHENAMINE MALEATE | 4 MG | CENTURION LABORATORIES PVT. LTD, PLOT NO. P-2, SAVALI BIOTECH PARK, AT. MANJUSAR, TAL-SAVALI, CITY: MANJUSAR, DIST. - VADODARA, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 776 | NDA/MAL/HDP/10441 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PREDNOVA 5 | PREDNISOLONE | 5 MG | CENTURION LABORATORIES PVT. LTD, PLOT NO. P-2, SAVALI BIOTECH PARK, AT. MANJUSAR, TAL-SAVALI, CITY: MANJUSAR, DIST. - VADODARA, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 777 | NDA/MAL/HDP/10442 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECARB | CARBAMAZEPINE | 200 MG | CENTURION LABORATORIES PVT. LTD, PLOT NO. P-2, SAVALI BIOTECH PARK, AT. MANJUSAR, TAL-SAVALI, CITY: MANJUSAR, DIST. - VADODARA, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 778 | NDA/MAL/HDP/10443 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | FUNGIDERM | CLOTRIMAZOLE | 1 % W/W | NANZ MED SCIENCE PHARMA PVT LTD VILLAGE RAMPUR GHAT, TEHSIL PAONTA SAHIB, DIST. SIRMOUR – 173025, HIMACHAL PRADESH, INDIA. | INDIA | TOPICAL EXTERNAL CREAM | 1*1*20G, LAMI TUBE | 10/02/2023 |
| 779 | NDA/MAL/HDP/10444 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | STERODERM OINTMENT | BETAMETHASONE VALERATE | 0.1 % W/W | NANZ MED SCIENCE PHARMA PVT LTD VILLAGE RAMPUR GHAT, TEHSIL PAONTA SAHIB, DIST. SIRMOUR – 173025, HIMACHAL PRADESH, INDIA. | INDIA | TOPICAL EXTERNAL OINTMENT | 1*1*15G, LAMI TUBE | 10/02/2023 |
| 780 | NDA/MAL/HDP/10445 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | STERODERM CREAM | BETAMETHASONE VALERATE | 0.1 % W/W | NANZ MED SCIENCE PHARMA PVT LTD VILLAGE RAMPUR GHAT, TEHSIL PAONTA SAHIB, DIST. SIRMOUR – 173025, HIMACHAL PRADESH, INDIA. | INDIA | TOPICAL EXTERNAL CREAM | 1*1*15G, LAMI TUBE | 10/02/2023 |
| 781 | NDA/MAL/HDP/10446 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ZITHROPLUS 500 | AZITHROMYCIN DIHYDRATE | 500 MG | BIOMATRIX HEALTHCARE PVT LTD. SURVEY NO. 624, SARKHEJ – BAVLA HIGHWAY, VIL.: RAJODA, TAL.: BAVLA, DIST.: AHMEDABAD – 382 220, GUJARAT, INDIA | INIDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X1.0X3.0 TABLET BLISTER | 10/02/2023 |
| 782 | NDA/MAL/HDP/10447 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | TRADOSIK | TRAMADOL HYDROCHLORIDE | 50 MG/ML | PT. SANBE FARMA STERILE PREPARATION PLANT JL. INDUSTRI CIMAREME NO. 8, DESA CIMAREME, KECAMATAN NGAMPRAH, KABUPATEN BANDUNG BARAT – INDONESIA (UNIT 3) | INDONESIA | PARENTERAL ORDINARY AMPOULES | 1*2*5, CLEAR GLASS AMPOULE | 10/02/2023 |
| 783 | NDA/MAL/HDP/10448 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | DOLONES | LIDOCAINE + PRILOCAINE | (25 MG + 25 MG)/G | PT CAPRIFARMINDO LABS, JL. INDUSTRI CIMAREME NO. 8, DS. CIMAREME. KEC.PADALARANG, KABUPATEN BANDUNG BARAT, INDONESIA | INDONESIA | TOPICAL EXTERNAL CREAM | 1*1, 5 G ALUMINIUM COLLAPSIBLE TUBE | 10/02/2023 |
| 784 | NDA/MAL/HDP/10449 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | POLIDEMISIN | NEOMYCIN SULFATE + POLIMYXYN B SULFATE + DEXAMETHASONE | (3.5 MG + 6000 IU + 1 MG)ML | PT CAPRIFARMINDO LABS, JL. INDUSTRI CIMAREME NO. 8, DS. CIMAREME. KEC.PADALARANG, KABUPATEN BANDUNG BARAT, INDONESIA | INDONESIA | OPHTHALMIC SUSPENSION | 1.0X1.0X5.0 ML BOTTLE | 10/02/2023 |
| 785 | NDA/MAL/HDP/10450 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | MEFINAL 500 | MEFENAMIC ACID | 500 MG | PT CAPRIFARMINDO LABS, JL. INDUSTRI CIMAREME NO. 8, DS. CIMAREME. KEC.PADALARANG, KABUPATEN BANDUNG BARAT, INDONESIA | INDONESIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1*10*10, POLYCELLONIUM STRIP PACK | 10/02/2023 |
| 786 | NDA/MAL/HDP/10451 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LTD | WAXFREE | SODIUM BICARBONATE | 5%W/V | LINCOLN PARENTERAL LIMITED 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, GANDHINAGAR, GUJARAT, INDIA. | INDIA | NASAL DROPS | 1.0X1.0X10.0 ML BOTTLE | 10/02/2023 |
| 787 | NDA/MAL/HDP/10452 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA (U) LIMITED | OPTIPRED | PREDNISOLONE ACETATE | 1.0% W/V | JAMJOOM PHARMACEUTICALS COMPANY PLOT NO. ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267, JEDDAH-21442, KINGDOM OF SAUDI ARABIA | SAUDI ARABIA | OPHTHALMIC SUSPENSION | 1.0X1.0X5.0 ML BOTTLE | 10/02/2023 |
| 788 | NDA/MAL/HDP/10453 | SANJAR PHARMA LLP | NILKANTH PHARMACY LIMITED | ARTICURE 60MG | ARTESUNATE | 60MG PER VIAL | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHROTA, TA – HIMATNAGAR, DISTRICT SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1, GLASS VIAL + 10ML OF 0.9% SODIUM CHLORIDE SOLUTION, LDPE AMPOULE + 1ML OF 5.0% SODIUM BICARBONATE SOLUTION, GLASS AMOULE | 10/02/2023 |
| 789 | NDA/MAL/HDP/10454 | PAMAJITA INTERNATIONAL LPP | NILKANTH PHARMACY LIMITED | OMEZOLE | OMEPRAZOLE SODIUM | 40MG PER VIAL | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHROTA, TA – HIMATNAGAR, DISTRICT SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1, GLASS VIAL + 10ML OF WATER FOR INJECTION, GLASS AMPOULE | 10/02/2023 |
| 790 | NDA/MAL/HDP/10455 | UNIMED LABORATORIES | OMAB UGANDA LIMITED | ENOXAMED 2000 IU ANTI-XA /0.2 ML | ENOXAPARIN SODIUM | 2000 IU ANTI-XA /0.2 ML (EQUIVALENT TO 20 MG PER 0.2 ML) | UNIMED LABORATORIES P.O.BOX: 38, I.Z 4060 KALAA KEBIRA TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGE | 1*1*2, 0.2 ML PRE-FILLED SYRINGE | 10/02/2023 |
| 791 | NDA/MAL/HDP/10456 | UNIMED LABORATORIES | 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 4060 KALAA KEBIRA TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGE | 1*1*2, 0.4 ML PRE-FILLED SYRINGE | 10/02/2023 |
| 792 | NDA/MAL/HDP/10457 | UNIMED LABORATORIES | 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 4060 KALAA KEBIRA TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGE | 1*1*2, 0.4 ML PRE-FILLED SYRINGE | 10/02/2023 |
| 793 | NDA/MAL/HDP/10458 | UNIMED LABORATORIES | 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 4060 KALAA KEBIRA TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGE | 1*1*2, 0.4 ML PRE-FILLED SYRINGE | 10/02/2023 |
| 794 | NDA/MAL/HDP/10459 | UNIMED LABORATORIES | OMAB UGANDA LIMITED | PARAMED | PARACETAMOL | 1G/100ML | UNIMED LABORATORIES P.O.BOX: 38, I.Z 4060 KALAA KEBIRA TUNISIA | TUNISIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1*6*1*1, 100 ML MULTILAYED PLASTIC BAG IN ALUMINIUM FILM SACHETS | 10/02/2023 |
| 795 | NDA/MAL/HDP/10460 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | AERIALLERG 5MG | DESLORATIDINE | 5 MG | PHARMA INTERNATIONAL COMPANY –PIC AL QASTAL INDUSTRIAL ZONE P.O. BOX 334 AMMAN 11941 JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 796 | NDA/MAL/HDP/10461 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | AERIALLERG 0.5MG/ML | DESLORATIDINE | 0.5MG/ML | PHARMA INTERNATIONAL COMPANY –PIC AL QASTAL INDUSTRIAL ZONE P.O. BOX 334 AMMAN 11941 JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X125.0 ML BOTTLE | 10/02/2023 |
| 797 | NDA/MAL/HDP/10462 | AUROBINDO PHARMA LIMITED | PHILIPS PHARMACEUTICALS (U) LTD | TOR - LOOP 10 | ANHYDROUS TORASEMIDE | 10 MG | AUROBINDO PHARMA LIMITED (UNIT III), SURVEY NO. 313 AND 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL - MALKAJGIRI DISTRICT, TELANGANA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 798 | NDA/MAL/HDP/10463 | FAES FARMA, S.A. | PHILLIPS PHARMACEUTICALS (U) LIMITED | DISFOR | METHOCARBAMOL | 500 MG | FAES FARMA, S.A.MÁXIMO AGUIRRE,14 48940 LEIOA (VIZCAYA) SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 10/02/2023 |
| 799 | NDA/MAL/HDP/10464 | JOHNSON & JOHNSON (PTY) LTD. | PHILLIPS PHARMACEUTICALS LTD | BENYLIN 4 FLU TABLETS | DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE | 12.5MG + 500MG + 22.5MG | SPECGX LLC GREENVILLE PLANT 100 LOUIS LATZER DRIVE GREENVILLE, IL 62246 USA JANSSEN-CILAG DOMAINE DE MAIGREMONT F27100 VAL DE REUIL FRANCE JOHNSON & JOHNSON (PTY) LTD, 241 MAIN ROAD, RETREAT, 7945, SOUTH AFRICA (FPP RELEASE RESPONSIBILITY) | UNITED STATES OF AMERICA FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X12.0 TABLET BLISTER | 10/02/2023 |
| 800 | NDA/MAL/HDP/10465 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS LTD | ZESBINA 200 | PROGESTERONE | 200 MG | EUGIA PHARMA SPECIALITIES LTD, SURVEY NO. 550, 551 & 552, KOLTHUR VILLAGE, SHAMIRPET MANDAL, MEDCHAL - MALKAJGIRI,TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 801 | NDA/MAL/HDP/10466 | ARCELIA LIFE SCIENCES LTD | PLUTO PHARMACEUTICALS LIMITED | ARCELIA CEFIXIME | CEFIXIME TRIHYDRATE | 400 MG | ASSOCIATED BIOTECH VILL-KISHANPURA, GURUMAJRA ROAD, BADDI, TEH. NALAGARH, DIST. SOLAN-174 101 (H.P.) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 802 | NDA/MAL/HDP/10467 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RABIRIV-DSR | RABEPRAZOLE SODIUM + DOMPERIDONE | 20 MG + 30 MG | EAST AFRICAN (INDIA) OVERSEAS PLOT NO.1, PHARMACITY, SELAQUI DEHRADUN-248 011 UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 803 | NDA/MAL/HDP/10468 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CORTIRIV-100 | HYDROCORTISONE SODIUM SUCCINATE | 100 MG/VIAL | EAST AFRICAN (INDIA) OVERSEAS PLOT NO.1, PHARMACITY, SELAQUI DEHRADUN-248 011 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1, CLEAR GLASS AMPOULE + 5 ML WFI IN LDPE AMPOULE | 10/02/2023 |
| 804 | NDA/MAL/HDP/10469 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AZIRIV-FS KIT | FLUCONAZOLE + AZITHROMYCIN DIHYDRATE + SECNIDAZOLE | 150 MG + 1 G + 1G | EAST AFRICAN (INDIA) OVERSEAS PLOT NO.1, PHARMACITY, SELAQUI DEHRADUN-248 011 UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY COMBINATION PACK TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 10/02/2023 |
| 805 | NDA/MAL/HDP/1047 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 806 | NDA/MAL/HDP/10470 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LTD | ROYODOL | TRAMADOL HYDROCHLORIDE | 50 MG | PSYCHOTROPICS INDIA LIMITED PLOT NO.12 & 12A, INDUSTRIAL PARK-II, PHASE-I, SALEMPUR, MEHDOOD-2, HARIDWAR-249403, (UTTARAKHAND), INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 807 | NDA/MAL/HDP/10471 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LTD | CIPROFLOXACIN-500 | CIPROFLOXACIN HYDROCHLORIDE | 500 MG | SCOTT-EDIL PHARMACIA LTD. 56 EPIP, PHASE-I JHARMAJRI, BADDI, DISTT. SOLAN (HP) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 808 | NDA/MAL/HDP/10472 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LTD | TRAMADOL HYDROCHLORIDE INJECTION 100 MG/2ML | TRAMADOL HYDROCHLORIDE | 100 MG/2 ML | SCOTT-EDIL PHARMACIA LTD. 56, EPIP, PHASE-I, JHARMAJRI, BADDI-173 205, (HP), INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X 2 ML AMPOULE | 10/02/2023 |
| 809 | NDA/MAL/HDP/10473 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LTD | POLYMOL SUSPENSION 125MG/5ML. | PARACETAMOL | 125MG/5ML. | SCOTT-EDIL PHARMACIA LTD. 56, EPIP, PHASE-I, JHARMAJRI, BADDI-173 205, (HP), INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 10/02/2023 |
| 810 | NDA/MAL/HDP/10474 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LTD | POLYMOL EXTRA | PARACETAMOL + CAFFEINE | 500 MG + 30 MG | 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 | 10/02/2023 |
| 811 | NDA/MAL/HDP/10475 | MARCYRL PHARMACEUTICAL INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | EVASTINE | EBASTINE | 10 MG | MARCYRL PHARMACEUTICAL INDUSTRIES. EL OBOUR CITY, THE WESTERN EXTENSION BLOCK 20005 EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 10/02/2023 |
| 812 | NDA/MAL/HDP/10476 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LTD | DEXCEN 10 | RAMIPRIL | 10 MG | CENTURION LABORATORIES PVT. LTD. CENTURION LABORATORIES PVT. LTD. P-2, BIO-TECH PARK, MANJUSAR, SAVLI, DIST. BARODA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 813 | NDA/MAL/HDP/10477 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LTD | PENACAM | PIROXICAM | 20 MG | CENTURION LABORATORIES PVT. LTD. CENTURION LABORATORIES PVT. LTD. P-2, BIO-TECH PARK, MANJUSAR, SAVLI, DIST. BARODA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 814 | NDA/MAL/HDP/10478 | SANDOZ KENYA C/ONOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LTD | FENTANYL SANDOZ 12 µG/H | FENTANYL | 12µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN GERMANY | GERMANY | TRANSDERMAL PATCHES | 1*5, ALUMINIUM FOIL | 10/02/2023 |
| 815 | NDA/MAL/HDP/10479 | SANDOZ KENYA C/ONOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LTD | FENTANYL SANDOZ 25 µG/H | FENTANYL | 25µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN GERMANY | GERMANY | TRANSDERMAL PATCHES | 1*5, ALUMINIUM FOIL | 10/02/2023 |
| 816 | NDA/MAL/HDP/1048 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EXOFEN 120MG | FEXOFENADINE | 120MG | 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 |
| 817 | NDA/MAL/HDP/10480 | SANDOZ KENYA C/ONOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LTD | FENTANYL SANDOZ 75 µG/H | FENTANYL | 75µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN GERMANY | GERMANY | TRANSDERMAL PATCHES | 1*5, ALUMINIUM FOIL | 10/02/2023 |
| 818 | NDA/MAL/HDP/10481 | SANDOZ KENYA C/ONOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LTD | FENTANYL SANDOZ 50 µG/H | FENTANYL | 50µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN GERMANY | GERMANY | TRANSDERMAL PATCHES | 1*5, ALUMINIUM FOIL | 10/02/2023 |
| 819 | NDA/MAL/HDP/10482 | SANDOZ KENYA C/ONOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LTD | FENTANYL SANDOZ 100 µG/H | FENTANYL | 100µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN GERMANY | GERMANY | TRANSDERMAL PATCHES | 1*5, ALUMINIUM FOIL | 10/02/2023 |
| 820 | NDA/MAL/HDP/10483 | NVS KENYA LIMITED | SURGIPHARM UGANDA LIMITED | PATIZRA | RANIBIZUMAB | 10 MG/ML | NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 4332 – STEIN SWITZERLAND (MANUFACTURER)/ NOVARTIS PHARMA AG LICHTSTRASSE 35 CH-4056 (QUALITY CONTROL) | SWITZERLAND | PARENTERAL ORDINARY VIALS | 1*1, CLEAR GLASS VIAL | 10/02/2023 |
| 821 | NDA/MAL/HDP/10484 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICALS LTD | TETROP | TETRACYCLINE HYDROCHLORIDE | 1%W/W | INDIANA OPHTHALMICS 136-137 PHASE 2 GIDC, WADHWANCITY - 363035 SURENDRANAGAR GUJARAT – INDIA | INDIA | OPHTHALMIC OINTMENT | 1*1*5 G, ALUMINIUM COLLAPSIBLE TUBE | 10/02/2023 |
| 822 | NDA/MAL/HDP/10485 | ESKAYEF PHARMACEUTICALS LIMITED | SWASTIK PHARMACEUTICALS LTD | RIVAROX 15 | RIVAROXABAN | 15 MG | ESKAYEF PHARMACEUTICALS LIMITED, 400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, TONGI, GAZIPUR 1711, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 10/02/2023 |
| 823 | NDA/MAL/HDP/10486 | ESKAYEF PHARMACEUTICALS LIMITED | SWASTIK PHARMACEUTICALS LTD | RIVAROX 20 | RIVAROXABAN | 20 MG | ESKAYEF PHARMACEUTICALS LIMITED, 400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, TONGI, GAZIPUR 1711, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 10/02/2023 |
| 824 | NDA/MAL/HDP/10487 | ESKAYEF PHARMACEUTICALS LIMITED | SWASTIK PHARMACEUTICALS LTD | KETONIC 30 | KETOROLAC TROMETHAMINE | 30 MG/ AMPOULE | ESKAYEF PHARMACEUTICALS LIMITED, 400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, TONGI, GAZIPUR 1711, BANGLADESH | BANGLADESH | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X1.0 ML AMPOULE + 3 ML SYRINGE | 10/02/2023 |
| 825 | NDA/MAL/HDP/10488 | ESKAYEF PHARMACEUTICALS LIMITED | SWASTIK PHARMACEUTICALS LTD | GTN 2.6 SR | DILUTED NITROGLYCERIN | 2.6 MG | ESKAYEF PHARMACEUTICALS LIMITED, 400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, TONGI, GAZIPUR 1711, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 10/02/2023 |
| 826 | NDA/MAL/HDP/10489 | GLOBAL NAPI PHARMACEUTICALS | SWASTIK PHARMACEUTICALS LTD | TERBIN | TERBINAFINE HYDROCHLORIDE | 250 MG | GLOBAL NAPI PHARMACEUTICALS, 2ND INDUSTRIAL ZONE, ST. 18, NO. 40, 6TH OCTOBER CITY - EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 10/02/2023 |
| 827 | 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 |
| 828 | NDA/MAL/HDP/10490 | GLOBAL NAPI PHARMACEUTICALS | SWASTIK PHARMACEUTICALS LTD | BISOCARD PLUS 5MG/12.5MG | BISOPROLOL FUMARATE + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | GLOBAL NAPI PHARMACEUTICALS, 2ND INDUSTRIAL ZONE, ST. 18, NO. 40, 6TH OCTOBER CITY - EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 829 | NDA/MAL/HDP/10491 | GLAXOSMITHKLINE LIMITED | UNITED HEALTHCARE DICTRIBUTERS (UHD) LIMITED | APRETUDE 30 MG | CABOTEGRAVIR | 30 MG | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS) PRIORY STREET WARE HERTFORDSHIRE SG12 0DJ UNITED KINGDOM (MANUFACTURE) + GLAXO WELLCOME, S.A. AVDA. EXTREMADURA, 3 ARANDA DE DUERO, BURGOS 09400 SPAIN (BATCH RELEASE) | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 10/02/2023 |
| 830 | NDA/MAL/HDP/10492 | MACLEODS PHARMACEUTICALS LIMITED | VITACARE LIMITED | DOLUTEGRAVIR SODIUM TABLETS 50 MG | DOLUTEGRAVIR SODIUM | 50 MG | MACLEODS PHARMACEUTICALS LIMITED, PLOT NO. 25 – 27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN, PIN – 396210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 10/02/2023 |
| 831 | NDA/MAL/HDP/10493 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | ROUNOX | TRAMADOL HYDROCHLORIDE | 50 MG | CENTURION LABORATORIES PVT. LTD. PLOT NO.2, SAVLI BIO-TECH PARK, MANJUSAR, SAVLI, DIST. VADODARA, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 832 | NDA/MAL/HDP/10494 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | FORMET 1000 | METFORMIN HYDROCHLORIDE | 1000 MG | CENTURION LABORATORIES PVT. LTD. PLOT NO.2, SAVLI BIO-TECH PARK, MANJUSAR, SAVLI, DIST. VADODARA, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 833 | NDA/MAL/HDP/10495 | EGYPHAR | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HELI-CURE | CLARITHROMYCIN + OMEPRAZOLE + TINIDAZOLE | 250 MG + 20 MG + 500 MG | EGYPHAR, INDUSTRIAL ZONE (A), PARTS NO. 9 & 10, BLOCK 13026 – EL OBOUR CITY, EGYPT | EGYPT | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X7.0X2.0 TABLET BLISTER | 10/02/2023 |
| 834 | NDA/MAL/HDP/10496 | THE UNITED PHARMACEUTICALS MFG. CO. LTD. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | IRIS SYRUP | DESLORATADINE | 0.5 MG/ML | THE UNITED PHARMACEUTICALS MFG. CO. LTD. NUZHAT SAHAB, AL-RAQEEM- NEAR PUBLIC SECURITY HOUSING PO BOX 69 AMMAN11591JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 10/02/2023 |
| 835 | NDA/MAL/HDP/10497 | EGYPHAR | WIDE SPECTRUM ENTERPRISES (U) LTD | ZISROCIN | AZITHROMYCIN | 500MG | EGYPHAR BLOCK NO. 13026, PIECE NO. 9,10, INDUSTRIAL ZONE (A), EL-OBOUR CITY, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X3.0 CAPSULE BLISTER | 10/02/2023 |
| 836 | NDA/MAL/HDP/10498 | ADWIA CO. | WIDE SPECTRUM ENTERPRISES (U) LTD | URIPAN | OXYBUTYNIN HYDROCHLORIDE | 5MG/ML | ADWIA S.A.E. 1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY - EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 10/02/2023 |
| 837 | NDA/MAL/HDP/10499 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDESPECTRUM ENTERPRISES (U) LTD. | TIRATAM 500 MG XR | LEVETIRACETAM | 500 MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES, PART NO. 7/6, 6TH INDUSTRIAL AREA, 6TH OF OCTOBER CITY, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 10/02/2023 |
| 838 | NDA/MAL/HDP/1050 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | AMTAS-10 | AMLODIPINE | 10MG | INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 839 | NDA/MAL/HDP/10502 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (U) LTD | VORIOLE 200 | VORICONAZOLE | 200 MG | MSN LABORATORIES PRIVATE LIMITED - FORMULATIONS DIVISION PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 840 | NDA/MAL/HDP/10503 | AUROBINDO PHARMA LIMITED | PHILIPS PHARMACEUTICALS (U) LTD | HI-ALFA SR 10 | ALFUZOSIN HYDROCHLORIDE | 10 MG | AUROBINDO PHARMA LIMITED (UNIT-III), SURVEY NO. 313 & 314, BACHUPALLY VILLAGE, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE. ZIP CODE: 500090, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 841 | NDA/MAL/HDP/10504 | INFUGEN PHARMA PVT LTD | TATA UGANDA LILITED | INFUROXIM 1.5 G | CEFUROXIME SODIUM | 1.5 G/VIAL | ZEISS PHARMACEUTICALS PVT. LTD. 72, EPIP, PHASE-I, JHARMAJRI, BADDI, 173205, DIST. SOLAN, H.P, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL | 10/02/2023 |
| 842 | NDA/MAL/HDP/10505 | ABACUS PARENTERAL DRUGS LTD | ABACUS PARENTERAL DRUGS LTD | OPTOR EYE DROPS | KETOROLAC TROMETHAMINE | 0.5 %W/V | ABACUS PARENTERAL DRUGS LTD (APDL). BLOCK 191, PLOT 114, KINGA MUKONO. P.O.BOX 31376, KAMPALA, UGANDA | UGANDA | OPHTHALMIC SOLUTION | 1.0X1.0X10.0 ML BOTTLE | 10/02/2023 |
| 843 | NDA/MAL/HDP/10506 | PHARMATHEN S.A | GOODMAN INTERNATIONAL LIMITED | A-CNOTREN® 10MG | ISOTRETINOIN | 10 MG | PHARMATHEN S.A., DERVENAKION 6, 15351 PALLINI, ATTIKI, GREECE | GREECE | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 844 | NDA/MAL/HDP/10507 | AUROLAB | SWASTIK PHARMACEUTICALS LIMITED | TOB - DEX | TOBRAMYCIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.3%W/V + 0.1%W/V | AUROLAB NO 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI – 625020, TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 10/02/2023 |
| 845 | NDA/MAL/HDP/10508 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY | FIMABUTE-100 | CEFIXIME TRIHYDRATE | 100 MG/5 ML | BRAWN LABORATORIES LTD., 13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, (HARYANA), INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 10/02/2023 |
| 846 | NDA/MAL/HDP/10509 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY | PANTRO INJECTION | PANTOPRAZOLE SODIUM | 40 MG | BRAWN LABORATORIES LTD. 13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1*40 MG, CLEAR GLASS VIAL + 1*1*10ML OF SODIUM CHLORIDE SOLUTION IN CLEAR GLASS AMPOULE | 10/02/2023 |
| 847 | NDA/MAL/HDP/10510 | ZIM LABORATORIES LIMITED | GITTOES PHARMACEUTICALS LIMITED | NEUROZIM 75 | PREGABALIN | 75 MG | ZIM LABORATORIES LIMITED, B-21/22, M.I.D.C. AREA, KALMESHWAR, NAGPUR 441501, MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 848 | NDA/MAL/HDP/10511 | VRUSHIK INVESTMENT (U) LTD | SHREEJI PHARMACEUTICALS LIMITED | METO | METOCLOPRAMIDE HYDROCHLORIDE | 10 MG | CENTURION LABORATORIES PVT. LTD. PLOT NO.2, SAVLI BIO-TECH PARK, MANJUSAR, SAVLI, DIST. VADODARA, 391775, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 849 | NDA/MAL/HDP/10512 | VRUSHIK INVESTMENT (U) LTD | SHREEJI PHARMACEUTICALS LIMITED | FINADOL ULTRA | PARACETAMOL + CAFFEINE | 500 MG + 30 MG | CENTURION LABORATORIES PVT. LTD. PLOT NO.2, SAVLI BIO-TECH PARK, MANJUSAR, SAVLI, DIST. VADODARA, 391775, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 850 | 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 - KING ABDULLAH II INDUSTRIAL ESTATE P.O. BOX 34 SAHAB 11512 AMMAN – JORDAN | JORDAN | SOLUTION OF INJECTION | 1*5*5 ML CLEAR GLASS VIAL | 10/02/2023 |
| 851 | NDA/MAL/HDP/10514 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICALS LTD | ORITA-100 | SILDENAFIL CITRATE | 100 MG | ARTURA PHARMACEUTICALS PVT LTD NO. 1505 PORTIA ROAD, SRI CITY SEZ, SATYAVEDU MANDAL CHITTOOR DIST.- 517 588, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 10/02/2023 |
| 852 | NDA/MAL/HDP/10515 | TAKEDA PHARMA A/S | PHILIPS PHARMACEUTICALS (U) LTD | NINLARO 2.3 MG | IXAZOMIB CITRATE | 2.3 MG | HAUPT PHARMA AMAREG GMBH DONAUSTAUFER STRAßE 378 93055 REGENSBURG GERMANY (MANUFACTURER) TAKEDA PHARMA A/S DYBENDAL ALLE 10 2630 TAASTRUP DENMARK (BATCH RELEASER) | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X1.0X1.0 CAPSULE BLISTER | 10/02/2023 |
| 853 | NDA/MAL/HDP/10516 | TAKEDA PHARMA A/S | PHILIPS PHARMACEUTICALS (U) LTD | NINLARO 3.0 MG | IXAZOMIB CITRATE | 3.0 MG | HAUPT PHARMA AMAREG GMBH DONAUSTAUFER STRAßE 378 93055 REGENSBURG GERMANY (MANUFACTURER) TAKEDA PHARMA A/S DYBENDAL ALLE 10 2630 TAASTRUP DENMARK (BATCH RELEASER) | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X1.0X1.0 CAPSULE BLISTER | 10/02/2023 |
| 854 | NDA/MAL/HDP/10517 | BRAWN LABORATORIES LTD | GOOOD DAY PHARMACY | BRULEXIN-250 | CEFALEXIN MONOHYDRATE | 250 MG | BRAWN LABORATORIES LTD. 13, N.I.T. INDUSTRIAL AREA, FARIDABAD-121 001, (HARYANA), INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 855 | NDA/MAL/HDP/10518 | ARTURA PHARMACEUTICALS PVT LTD | SWASTIK PHARMACEUTICALS LTD | GLYCOFORM 500 | METFORMIN HYDROCHLORIDE | 500 MG | ARTURA PHARMACEUTICALS PVT LTD NO. 1505 PORTIA ROAD, SRI CITY SEZ, SATYAVEDU MANDAL CHITTOOR DIST.- 517 588, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 856 | NDA/MAL/HDP/10519 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | PLASMINEX | TRANEXAMIC ACID | 500 MG | PT. SANBE FARMA UNIT 1, JL. INDUSTRI I NO. 9 RT.01 RW.08, KELURAHAN UTAMA, KECAMATAN CIMAHI SELATAN, CIMAHI, INDONESIA | INDONESIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 857 | 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 |
| 858 | NDA/MAL/HDP/10520 | ENCORE HEALTHCARE PVT. LTD. | REDDY'S PHARMA LIMITED | ENCOBLOC | PROPRANOLOL HYDROCHLORIDE | 40 MG | ENCORE HEALTHCARE PVT. LTD D-5, M.I.D.C. AREA, PAITHAN, 431148 DIST. AURANGABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 859 | NDA/MAL/HDP/10521 | SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD | ROYAL PHARMA LIMITED | SCOTXONE PLUS | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1000 MG + 500 MG | SCOTT – EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD. HILL TOP INDUSTRIAL AREA, BHATOLI KALAN, BADDI-173205, (H.P.) INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1*1500MG, CLEAR GLASS VIAL | 10/02/2023 |
| 860 | NDA/MAL/HDP/10522 | ZIM LABORATORIES LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEFRIM 500 | CEFUROXIME AXETIL | 500 MG | ZIM LABORATORIES LIMITED, B-21/22, MIDC AREA, KALMESHWAR, NAGPUR 441501, MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 861 | NDA/MAL/HDP/10523 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LIMITED | SYNRIAM DT | ARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE | 37.5 MG + 187.5 MG | SUN PHARMACEUTICAL INDUSTRIES LTD, PLOT NO. B-2 MADKAI INDUSTRIAL ESTATE, PONDA, GOA - 403404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X3.0 TABLET BLISTER | 10/02/2023 |
| 862 | NDA/MAL/HDP/10524 | AGIO PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | DICLOGEN RETARD 100 | DICLOFENAC SODIUM | 100 MG | AGIO PHARMACEUTICALS LTD T-82, MIDC, BHOSARI, PUN, 411026, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 863 | NDA/MAL/HDP/10525 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (A) LIMITED | PRELYNCA 50 MG | PREGABALIN | 50 MG | 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 | 10/02/2023 |
| 864 | NDA/MAL/HDP/10526 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (A) LIMITED | PRELYNCA 75 MG | PREGABALIN | 75 MG | 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 | 10/02/2023 |
| 865 | NDA/MAL/HDP/10527 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (A) LIMITED | PRELYNCA 150 MG | PREGABALIN | 150 MG | 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 | 10/02/2023 |
| 866 | NDA/MAL/HDP/10528 | THE SEARLE COMPANY LIMITED | HEALTHCARE LIMITED | EZIUM 20 MG | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20 MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E, KARACHI PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 10/02/2023 |
| 867 | NDA/MAL/HDP/10529 | THE SEARLE COMPANY LIMITED | HEALTHCARE LIMITED | EZIUM 40 MG | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | THE SEARLE COMPANY LIMITED, F-319, S.I.T.E, KARACHI PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 10/02/2023 |
| 868 | NDA/MAL/HDP/10530 | ZOTA HEALTHCARE LTD | HARLEY'S (U) LTD | COXZOTA 120 | ETORICOXIB | 120 MG | ZOTA HEALTHCARE LTD. PLOT NO: 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT-394 230, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 869 | NDA/MAL/HDP/10531 | GLAXOSMITHKLINE LIMITED | UNITED HEALTHCARE DICTRIBUTERS (UHD) LIMITED | ENO CALCIUM ANTACID TABLETS | CALCIUM CARBONATE | 500 MG | GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC 320 SOUTH BROADWAY ST. LOUIS, MISSOURI 63102 USA (MANUFACTURE OF BULK) GLAXOSMITHKLINE LIMITED LIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, NAIROBI KENYA (PACKAGING AND RELEASE) | USA + KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER 1.0X2.0X10.0 TABLET BLISTER | 10/02/2023 |
| 870 | NDA/MAL/HDP/10532 | ALKEM LABORATORIES LTD | ABACUS PHARMA (U) LTD | TAXIM-O | CEFIXIME TRIHYDRATE | 400 MG | EAST AFRICAN (INDIA) OVERSEAS, PLOT N. 1, PHARMACITY, SELAQUI, DEHRADUN (INDIA)- 248011 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0 CAPSULE BLISTER | 10/02/2023 |
| 871 | NDA/MAL/HDP/10533 | CELON LABORATORIES PRIVATE LIMITED | GENERAL ANESTHETIC | HYPRO 200 | PROPOFOL | V | CELON LABORATORIES PRIVATE LIMITED PLOT NO.2, ALEAP INDUSTRIAL ESTATE, GAJULARAMARAM, RANGA REDDY, MEDCHAL DISTRICT - 500090, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1*1*20 ML, CLEAR GLASS VIAL | 10/02/2023 |
| 872 | NDA/MAL/HDP/10534 | PSYCHOTROPICS INDIA LTD. | ABACUS PHARMA (U) LTD | KETAMINE HYDROCHLORIDE INJECTION USP 50MG/ML | KETAMINE HYDROCHLORIDE | 50MG/ML | PSYCHOTROPICS INDIA LIMITED PLOT NO.12 & 12A, INDUSTRIAL PARK-II, PHASE-I, SALEMPUR, MEHDOOD-2, HARIDWAR-249403, (UTTARAKHAND), INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL | 10/02/2023 |
| 873 | NDA/MAL/HDP/10535 | FERRER INTERNACIONAL | PHILLIPS PHARMACEUTICALS (U) LIMITED | ANGINOVAG | DEQUALINIUM CHLORIDE + TYROTHRICIN + ? - GLYCYRRHETINIC ACID (ENOXOLONE) + HYDROCORTISONE ACETATE + LIDOCAINE HYDROCHLORIDE | 100MG + 400MG + 60MG + 60MG+100MG) PER 100 ML | FERRER INTERNACIONAL, S.A. JOAN BUSCALLÀ 1-9 08173-SANT CUGAT DEL VALLÈS (BARCELONA) SPAIN | SPAIN | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X10.0 ML BOTTLE | 10/02/2023 |
| 874 | NDA/MAL/HDP/10536 | KLM LABORATORIES PVT. LTD. | REDDY'S PHARMA LIMITED | MUPISOFT OINTMENT | MUPIROCIN | 2.0% W/W | CURETECH SKINCARE PLOT NO-33 & 34, PHASE-IV, BHATOLI KALAN, BADDI, DISTT.- SOLAN (HP) INDIA | INDIA | TOPICAL EXTERNAL OINTMENT | 1*1*5 G, LAMI TUBE | 10/02/2023 |
| 875 | NDA/MAL/HDP/10537 | KLM LABORATORIES PVT. LTD. | REDDY'S PHARMA LIMITED | NIOSOL OINTMENT | CLOBETASOL PROPIONATE | 0.05%W/W | CURETECH SKINCARE PLOT NO-33 & 34, PHASE-IV, BHATOLI KALAN, BADDI, DISTT.- SOLAN (HP) INDIA | INDIA | TOPICAL EXTERNAL OINTMENT | 1*1*30 G, LAMI TUBE | 10/02/2023 |
| 876 | NDA/MAL/HDP/10538 | KLM LABORATORIES PVT. LTD. | REDDY'S PHARMA LIMITED | SUDIF CREAM | FUSIDIC ACID | 2.0 %W/W | CURETECH SKINCARE PLOT NO-33 & 34, PHASE-IV, BHATOLI KALAN, BADDI, DISTT.- SOLAN (HP) INDIA | INDIA | TOPICAL EXTERNAL CREAM | 1.0X1.0X10.0 GTUBE | 10/02/2023 |
| 877 | NDA/MAL/HDP/10539 | ZOTA HEALTHCARE LTD | REDDY'S PHARMA LIMITED | ZOTAMET-850 | METFORMIN HYDROCHLORIDE | 850 MG | ZOTA HEALTHCARE LTD., PLOT NO: 169, SURAT SPECIAL ECONOMIC ZONE, , SACHIN, SURAT-394 230, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 878 | NDA/MAL/HDP/10540 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ATAZANAVIR AND RITONAVIR TABLETS | ATAZANAVIR SULFATE + RITONAVIR | 300MG + 100MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED VILLAGE: GANGUWALA, PAONTA SAHIB, DISTRICT SIRMOUR – 173025, HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE, 1.0X1.0X90.0 TABLET BOTTLE | 10/02/2023 |
| 879 | NDA/MAL/HDP/10541 | GALENICUM HEALTH S.L. | GOODMAN INTERNATIONAL UGANDA LTD | ROSUVASTATIN | ROSUVASTATIN | 20MG | BIOFARM SP.Z O.O WALBRZYSKA 13, 60-198 POZNAN POLAND | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X7.0 TABLET BLISTER | 10/02/2023 |
| 880 | NDA/MAL/HDP/10542 | SANDOZ GMBH, KUNDL | KIMSY MEDS LIMITED | PACLITAXEL 6 MG /1 ML | PACLITAXEL | 300MG /50ML | EBEWE PHARMA GESMBH NFG.KG MONDSEESTRASSE 11 4866 UNTERACH AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1*1*50 ML, CLEAR GLASS VIAL | 10/02/2023 |
| 881 | NDA/MAL/HDP/10543 | ADWIA CO. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ADWIFLAM | DICLOFENAC POTASSIUM | 75 MG | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO.) PART NO. 44-A/11- FIRST INDUSTRIAL ZONE – 6TH OF OCTOBER CITY, EGYPT | EGYPT | RECTAL SUPPOSITORIES | 1*1*5, PVC/PVC STRIP PACK | 10/02/2023 |
| 882 | NDA/MAL/HDP/10544 | AUROLAB | SWASTIK PHARMACEUTICALS LIMITED | ATROP | ATROPINE SULFATE | 1%W/V | AUROLAB NO 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI – 625020, TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 10/02/2023 |
| 883 | NDA/MAL/HDP/10545 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEY'S (U) LTD | BRAMOL | PARACETAMOL | 10 MG/ML | BROOKES PHARMA (PRIVATE) LIMITED 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTAN | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML VIAL | 10/02/2023 |
| 884 | NDA/MAL/HDP/10546 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEY'S (U) LTD | OXOFERIN | TETRACHLORODECAOXIDE | 100ML OF TCDO FORMING “REACTION PRODUCT” HAS A BIOLOGICAL ACTIVITY: 138.0 X 10^6 PMOL | BROOKES PHARMA (PRIVATE) LIMITED 58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTAN | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1*1*50 ML, LDPE CONATINER | 10/02/2023 |
| 885 | NDA/MAL/HDP/10547 | PROFARMA SH.A | JOINT MEDICAL STORES | HALOPERIDOL SOLUTION FOR INJECTION 5MG/ML | HALOPERIDOL | 5MG/ML | PROFARMA SH.A. RRUGA : MYSLYM KETA TIRANË - ALBANIA | ALBANIA | PARENTERAL ORDINARY VIALS | 1*2*5*1ML, AMBER GLASS VIAL | 10/02/2023 |
| 886 | NDA/MAL/HDP/1055 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ROZITTA 40 | ROSUVASTATIN CALCIUM | 40MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| 887 | NDA/MAL/HDP/10550 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (U) LTD | AZADUAL 100 | AZACITIDINE | 100 MG/VIAL | MSN LABORATORIES PRIVATE LIMITED FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277, 1319 TO 1324, NANDIGAMA (VILLAGE& MANDAL), RANGAREDDY DISTRICT, TELANGANA 509228, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100 MG VIAL | 10/02/2023 |
| 888 | NDA/MAL/HDP/10551 | SANJAR PHARMA LLP | MOTI PHARMA (U) LTD | ADRENLIN | ADRENALINE ACID TARTRATE | 1 MG/VIAL | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, DEDHROTA, HIMATNAGAR, DIST-SABARKANTHA, GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULES | 10/02/2023 |
| 889 | NDA/MAL/HDP/10552 | MACLEODS PHARMACEUTICALS LIMITED | VITACARE LIMITED | ZOPIMAC 2 | ESZOPICLONE | 2MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK NO.: 2, VILLAGE THEDA P.O. LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN, HIMACHAL PRADESH, 174101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X100.0 TABLET BOTTLE | 10/02/2023 |
| 890 | NDA/MAL/HDP/10553 | ACINO AG | GOODMAN INTERNATIONAL LIMITED | TITANAFIL 5 | TADALAFIL | 5 MG | PHARMACTIVE ?LAÇ SAN. VE TIC. A.?. ÇERKEZKÖY ORGANIZE SANAYI BÖLGESI KARAA?AÇ MAH. FATIH BULV. NO:32 KAPAKLI / TEKIRDA? TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 10/02/2023 |
| 891 | NDA/MAL/HDP/10554 | ACINO AG | GOODMAN INTERNATIONAL LIMITED | TITANAFIL 20 | TADALAFIL | 20 MG | PHARMACTIVE ?LAÇ SAN. VE TIC. A.?. ÇERKEZKÖY ORGANIZE SANAYI BÖLGESI KARAA?AÇ MAH. FATIH BULV. NO:32 KAPAKLI / TEKIRDA? TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 10/02/2023 |
| 892 | NDA/MAL/HDP/10555 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS LTD | ZESBINA 200 | PROGESTERONE | 200 MG | EUGIA PHARMA SPECIALITIES LTD, SURVEY NO. 550, 551 & 552, KOLTHUR VILLAGE, SHAMIRPET MANDAL, MEDCHAL - MALKAJGIRI, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 893 | NDA/MAL/HDP/10556 | KESAR PHARMA (P) LIMITED | SWASTIK PHARMACEUTICALS LIMITED | PIADIN | POVIDONE IODINE | 5.0 W/W | KESAR PHARMA (P) LIMITED. PLT NO.50-P/2, AT VILLAGE, BILESHWARPURA. PO CHHATRAL-382729. TAL. KALOL, DIST. GANDHINAGAR, GUJARAT INDIA | INDIA | TOPICAL EXTERNAL OINTMENT | 1.0X1.0X10.0 GTUBE | 10/02/2023 |
| 894 | NDA/MAL/HDP/10557 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | LOFNAC-50 | DICLOFENAC SODIUM | 50 MG | BLISS GVS PHARMA LIMITED, 10, DEWAN UDYOG NAGAR, ALIYALI, PALGHAR, DISTRICT THANE 401404, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 895 | NDA/MAL/HDP/10558 | KLM LABORATORIES PVT. LTD. | REDDY'S PHARMA LIMITED | NEOCLEAN GEL | CLINDAMYCIN PHOSPHATE + NICOTINAMIDE | 1.0 %W/W + 4.0%W/W | CURETECH SKINCARE PLOT NO-33 & 34, PHASE-IV, BHATOLI KALAN, BADDI 173205 , DISTT.- SOLAN (HP) INDIA | INDIA | TOPICAL EXTERNAL GEL | 1.0X1.0X10.0 GTUBE | 10/02/2023 |
| 896 | NDA/MAL/HDP/10559 | KLM LABORATORIES PVT. LTD. | REDDY'S PHARMA LIMITED | NIOSALIC OINTMENT | CLOBETASOL PROPIONATE + SALICYLIC ACID | 0.05%W/W + 3.00W/W | CURETECH SKINCARE PLOT NO-33 & 34, PHASE-IV, BHATOLI KALAN, BADDI 173205 , DISTT.- SOLAN (HP) INDIA | INDIA | TOPICAL EXTERNAL OINTMENT | 1*1*30 G, LAMINATED TUBE | 10/02/2023 |
| 897 | 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 |
| 898 | NDA/MAL/HDP/10560 | LEBEN LABORATORIES PVT. LTD. | MALIX PHARMA (U) LTD | WHITFIELD’S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | LEBEN LABORATORIES LTD. PLOT NO. L-4 & L-15, PHASE-III, MIDC, AKOLA– 444 104 (MS). | INDIA | TOPICAL EXTERNAL OINTMENT | 1*1*20G, LAMINATED TUBE | 10/02/2023 |
| 899 | NDA/MAL/HDP/10561 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA II LTD | WORIV | ALBENDAZOLE | 400 MG | EAST AFRICAN (INDIA) OVERSEAS, PLOT N. 1, PHARMACITY, SELAQUI, DEHRADUN - 248011 - INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 10/02/2023 |
| 900 | NDA/MAL/HDP/10562 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 11 LIMITED | ACESON-P | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | EAST AFRICAN (INDIA) OVERSEAS, PLOT N. 1, PHARMACITY, SELAQUI, DEHRADUN - 248011 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 10/02/2023 |
| 901 | NDA/MAL/HDP/10563 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ENARIV-10 | ENALAPRIL MALEATE | 10 MG | EAST AFRICAN (INDIA) OVERSEAS, PLOT N. 1, PHARMACITY, SELAQUI, DEHRADUN - 248011 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 10/02/2023 |
| 902 | 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 LIMITED, PLOT NO. 11,12 AND 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 | 1.0X1.0X10.0 TABLET BLISTER + 1.0X1.0X30.0 TABLET CONTAINER | 10/02/2023 |
| 903 | NDA/MAL/HDP/10565 | AUROLAB | SWASTIK PHARMACEUTICALS LIMITED | PILO | PILOCARPINE NITRATE | 2%W/V | AUROLAB NO 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI – 625020, TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 10/02/2023 |
| 904 | NDA/MAL/HDP/10566 | AUROLAB | SWASTIK PHARMACEUTICALS LIMITED | AUROCARPINE | PILOCARPINE NITRATE | 0.5 % W/V | AUROLAB NO 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI – 625020, TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1*5*1 ML, AMBER GLASS VIAL | 10/02/2023 |
| 905 | NDA/MAL/HDP/10567 | AJANTA PHARMA LIMITED | ABACUS PHARMA (A) LIMITED | CELMAC 200 | CELECOXIB | 200 MG | AJANTA PHARMA LIMITED B-4-5-6, MIDC INDUSTRIAL AREA PAITHAN, AURANGABAD, 431148, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 906 | NDA/MAL/HDP/10568 | AJANTA PHARMA LIMITED | ABACUS PHARMA (U) LTD | AMADAY PL 5/4 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 5 MG + 4 MG | AJANTA PHARMA LTD. MIRZA - PALASHBARI ROAD VILLAGE: KOKJHAR DIST: KAMPUR, GUWAHATI ASSAM-781128 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 907 | NDA/MAL/HDP/10569 | AJANTA PHARMA LIMITED | ABACUS PHARMA (U) LTD | AMADAY PL 5/8 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 5 MG + 8 MG | AJANTA PHARMA LTD. MIRZA - PALASHBARI ROAD VILLAGE: KOKJHAR DIST: KAMPUR, GUWAHATI ASSAM-781128 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 908 | NDA/MAL/HDP/1057 | NECTAR LIFESCIENCES LTD | SUPER MEDIC LTD | FIXINECT-200MG | CEFIXIME | 200MG | NECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL. NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2013 |
| 909 | NDA/MAL/HDP/10570 | AJANTA PHARMA LIMITED | ABACUS PHARMA (U) LTD | AMADAY PL 10/4 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 10 MG + 4 MG | AJANTA PHARMA LTD. MIRZA - PALASHBARI ROAD VILLAGE: KOKJHAR DIST: KAMPUR, GUWAHATI ASSAM-781128 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 910 | NDA/MAL/HDP/10571 | AJANTA PHARMA LIMITED | ABACUS PHARMA (U) LTD | AMADAY PL 10/8 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 10 MG + 8 MG | AJANTA PHARMA LTD. MIRZA - PALASHBARI ROAD VILLAGE: KOKJHAR DIST: KAMPUR, GUWAHATI ASSAM-781128 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 911 | NDA/MAL/HDP/10572 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | ABACUS PHARMA (U) LTD | 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 + 153.84 MG + 200 IU + 13.33 MG + 5000 IU + 0.4 MG + 400 IU + 2.512 MG + 1.0 MG +1.609 MG + 0.20 MG + 75.0 MG + 15.0 MG | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 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 | 10/02/2023 |
| 912 | NDA/MAL/HDP/10573 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (U) LTD | DABIFIB 110 | DABIGATRAN ETEXILATE | 110 MG | MSN LABORATORIES PRIVATE LIMITED - FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277, 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANGA REDDY DISTRICT, TELANGANA 509228, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 913 | NDA/MAL/HDP/10574 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (U) LTD | DABIFIB 150 | DABIGATRAN ETEXILATE | 150 MG | MSN LABORATORIES PRIVATE LIMITED - FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277, 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANGA REDDY DISTRICT, TELANGANA 509228, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 10/02/2023 |
| 914 | NDA/MAL/HDP/10575 | AUROBINDO PHARMA LIMITED | PHILIPS PHARMACEUTICALS (U) LTD | BINOVEN 75 | VENLAFAXINE HYDROCHLORIDE | 75 MG | AUROBINDO PHARMA LIMITED (UNIT III), SURVEY NO. 313 AND 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL - MALKAJGIRI DISTRICT, TELANGANA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 10/02/2023 |
| 915 | NDA/MAL/HDP/10576 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS LTD | QUITIDE 100 | QUETIAPINE FUMARATE | 100MG | AUROBINDO PHARMA LIMITED (UNIT III), SURVEY NO. 313 AND 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL - MALKAJGIRI DISTRICT, TELANGANA STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 10/02/2023 |
| 916 | NDA/MAL/HDP/10577 | ARCELIA LIFE SCIENCES LTD | PLUTO PHARMACEUTICALS LIMITED | ARCELIA MEROPENEM | MEROPENEM TRIHYDRATE | 1G/VIAL | REYOUNG PHARMACEUTICAL CO., LTD. NO. 1, RUIYANG ROAD, YIYUAN COUNTY, SHANDONG PROVINCE, CHINA. POST CODE: 256100 | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1*1,CLEAR GLASS VIAL | 10/02/2023 |
| 917 | NDA/MAL/HDP/10578 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | OCORTIN | HYDROCORTISONE | 1%W/W | KREMOINT PHARMA PVT.LTD. B-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH INDIA | INDIA | TOPICAL EXTERNAL CREAM | 1*1*30G, LAMI TUBE | 10/02/2023 |
| 918 | NDA/MAL/HDP/10579 | RENE INDUSTRIES LTD | RENE INDUSTRIES LTD | BENZYL BENZOATE APPLICATION BP | BENZYL BENZOATE | 25%W/V | RENE INDUSTRIES LTD. PO BOX 6034, PLOT NO.680, KAMULI, KIREKA, KAMPALA, UGANDA | UGANDA | TOPICAL EXTERNAL EMULSION | 1.0X1.0X100.0 ML BOTTLE | 10/02/2023 |
| 919 | NDA/MAL/HDP/10580 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LTD | ASHIVER FORTE | IVERMECTIN + CLORSULON | (10MG + 100MG)/ML | ASHISH LIFE SCIENCE PVT LIMITED J-137, M.I.D.C., TARAPUR, BOISAR - 401501, TAL & DIST – PALGHAR, MAHARASHTRA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML BOTTLE, 1.0X1.0X250.0 ML BOTTLE | 10/02/2023 |
| 920 | NDA/MAL/HDP/10581 | NEOGEN CHEMICALS UGANDA LIMITED | NEOGEN CHEMICALS UGANDA LIMITED | OXY-GEN® | OXYTETRACYCLINE HYDROCHLORIDE | 3.15%W/V | HEBEI NEW CENTURY PHARMACEUTICAL CO., LTD NO. 189 TAIHANG STREET., SHIJIAZHUANG, HEBEI CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML BOTTLE, 1.0X1.0X250.0 ML BOTTLE, 1.0X1.0X500.0 ML BOTTLE | 10/02/2023 |
| 921 | NDA/MAL/HDP/10582 | ZOETIS BELGIUM SA | ERAM UGANDA LTD | 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 INC. 2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616, USA | UNITED STATES OF AMERICA | PARENTERAL ORDINARY DRY AMPOULES | 1*5*1000 DOSES, GLASS AMPOULES + 1*200ML OF DILUENT IN GLASS VIALS OR PLASTIC BAGS | 10/02/2023 |
| 922 | NDA/MAL/HDP/10583 | VETCARE KENYA LTD | VETCARE UGANDA LTD | TYLODOXY 200 | TYLOSIN TARTRATE + DOXYCYCLINE HYCLATE | (100MG + 100MG)/ GRAM | VETCARE KENYA LTD UNITS 7 AND 8, PLOT NO.336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI, KENYA. | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X10.0X25.0 G SACHET, 1.0X12.0X100.0 G SACHET, 1.0X1.0X1000.0 G JAR | 10/02/2023 |
| 923 | NDA/MAL/HDP/10584 | VETCARE KENYA LTD | VETCARE UGANDA LTD | WORMIFAS DRENCH | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT (II) CARBONATE | (15MG + 30MG + 1.5MG) PER ML | VETCARE KENYA LTD UNITS 7 AND 8, PLOT NO.336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI, KENYA. | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X150.0 ML BOTTLE, 1.0X1.0X500.0 ML BOTTLE, 1.0X1.0X1000.0 ML BOTTLE | 10/02/2023 |
| 924 | NDA/MAL/HDP/10585 | VETCARE KENYA LTD | VETCARE UGANDA LTD | WORMIFAS MZITO SUSPENSION | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT (II) CARBONATE + SODIUM SELENITE | (30MG + 60MG + 3.0MG + 0.32MG) PER ML | VETCARE KENYA LTD UNITS 7 AND 8, PLOT NO.336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI, KENYA. | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X125.0 ML BOTTLE, 1.0X1.0X500.0 ML BOTTLE, 1.0X1.0X1000.0 ML BOTTLE | 10/02/2023 |
| 925 | NDA/MAL/HDP/10586 | VETCARE KENYA LTD | VETCARE UGANDA LTD | WORMITREX 7.5 POULTRY | LEVAMISOLE HYDROCHLORIDE | 7.5%W/V | VETCARE KENYA LTD UNITS 7 AND 8, PLOT NO.336/202, WINSFORD PARK, BABA DOGO ROAD, RUARAKA, NAIROBI, KENYA. | KENYA | ORAL LIQUID ORDINARY SOLUTION | 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 | 10/02/2023 |
| 926 | NDA/MAL/HDP/10587 | INTERCHEMIE WERKEN ‘DE ADELAAR’ B.V. | VET CENTRE (U) LTD | XYLA | XYLAZINE HYDROCHLORIDE | 20MG/ML | INTERCHEMIE WERKEN ‘DE ADELAAR’ B.V., METAALWEG 8, 5804 CG VENRAY, THE NETHERLANDS | THE NETHERLANDS | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML BOTTLE | 10/02/2023 |
| 927 | 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 | 06/03/2023 |
| 928 | 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 | 06/03/2023 |
| 929 | 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 | 06/03/2023 |
| 930 | 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 | 06/03/2023 |
| 931 | NDA/MAL/HDP/10593 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MOMRIV | MOMETASONE FUROATE | 0.1%W/W | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 06/03/2023 |
| 932 | NDA/MAL/HDP/10597 | MEDISEL (K) LTD | AIVEEN (UGANDA) LIMITED | GABANERVE | GABAPENTIN + METHYLCOBALAMIN | 300MG + 500MCG | CORONA REMEDIES PVT LTD VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 20/02/2023 |
| 933 | NDA/MAL/HDP/10598 | DAR AL DAWA DEVELOPMENT & INVESTMENT CO. LTD | KIMSY MEDS LTD | MIXIF | CEFIXIME TRIHYDRATE | 400MG | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD (DAD) PRINCE HASHEM BIN AL-HUSSEIN STREET, NA’UR AMMAN 11191 JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X5.0 CAPSULE BLISTER | 20/02/2023 |
| 934 | NDA/MAL/HDP/10599 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | BETAMET CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 06/03/2023 |
| 935 | NDA/MAL/HDP/10600 | MEDISEL (K) LTD | AIVEEN (U) LTD | OSTEOCERIN | GLUCOSAMINE SULPHATE POTASSIUM CHLORIDE + METHL SULPHONYL METHANE (MSM) + DIACEREIN | 750MG + 250MG + 50MG | CORONA REMEDIES PVT LTD VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 20/02/2023 |
| 936 | NDA/MAL/HDP/10601 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA(A) LTD | VORIOLE 50 | VORICONAZOLE | 50 MG | MSN LABORATORIES PRIVATE LIMITED – FORMULATIONS DIVISION PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, TELANGANA - 502 325, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 20/02/2023 |
| 937 | NDA/MAL/HDP/10602 | WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. | GOODMAN INTERNATIONAL LTD | ZIROMIN 200 MG/5 ML | AZITHROMYCIN DIHYDRATE | 200 MG/5 ML | WORLD MEDICINE ILAC SAN VE TIC A.S.-15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEY | TURKEY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE | 06/03/2023 |
| 938 | NDA/MAL/HDP/10603 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | ETOPOSIDE 200 MG/10ML | ETOPOSIDE | 200 MG/10ML | EBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0 ML AMPOULE | 06/03/2023 |
| 939 | NDA/MAL/HDP/10604 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PIPERATAZ 4.5 | PIPERACILLIN + TAZOBACTAM | 4 G + 0.5 G | UNI MEDICOLABS-UNI MEDICOLABS, PLOT NO. 21-22, PHARMACITY, SELAQUI, DEHRADUN - 248011 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL | 06/03/2023 |
| 940 | NDA/MAL/HDP/10605 | PSYCHOTROPICS INDIA LTD. | ABACUS PHARMA (A) LTD | HALOPAC | HALOPERIDOL | 5MG | PSYCHOTROPICS INDIA LTD. PLOT NO.46 & 49, SECTOR-6A, IIE, SIIDCUL, HARIDWAR- 249403 (UTTARAKHAND), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 20/02/2023 |
| 941 | NDA/MAL/HDP/10606 | MEDISEL (K) LTD | ALVEEN (U) LIMITED | EMADON SYRUP | ONDANSETRON HYDROCHLORIDE | 2MG/5ML | CORONA REMEDIES PVT LTD VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X30.0 ML BOTTLE | 20/02/2023 |
| 942 | NDA/MAL/HDP/10607 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD | DOLAC | KETOROLAC TROMETHAMINE | 10 MG | CADILA PHARMACEUTICALS LIMITED 1389, TRASAD ROAD, DHOLKA – 382225, DIST:AHMEDABAD GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 20/02/2023 |
| 943 | NDA/MAL/HDP/10608 | WILSHIRE LABORATORIES (PVT) LTD | HEALTHCARE LIMITED | QOSMET 500/50 | METFORMIN HYDROCHLORIDE+ SITAGLIPTIN MONOHYDRATE PHOSPHATE | 500MG + 50MG | WILSHIRE LABORATORIES (PVT) LTD, 124/1, INDUSTRIAL ESTATE, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0 TABLET BLISTER | 20/02/2023 |
| 944 | NDA/MAL/HDP/10609 | FDC LIMITED | AIVEEN UGANDA LIMITED | OCUDOR | DORZOLAMIDE HYDROCHLORIDE | 2%W/V | FDC LIMITED B-8, MIDC INDUSTRIAL AREA , WALUJ , AURANGABAD 431136 MAHARASHTRA , INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 20/02/2023 |
| 945 | 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 |
| 946 | NDA/MAL/HDP/10610 | WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. | GOODMAN INTERNATIONAL LTD | ESLOTIN | DESLORATADINE | 2.5 MG/5ML | WORLD MEDICINE ILAC SAN VE TIC A.S.-15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEY | TURKEY | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 06/03/2023 |
| 947 | 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 | 06/03/2023 |
| 948 | 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 | 06/03/2023 |
| 949 | NDA/MAL/HDP/10613 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | SYNER-CEF 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 |
| 950 | 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 | 1.0X1.0X10.0 G TUBE | 06/03/2023 |
| 951 | 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 | 06/03/2023 |
| 952 | 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 | 06/03/2023 |
| 953 | 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 | 06/03/2023 |
| 954 | 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 | 06/03/2023 |
| 955 | NDA/MAL/HDP/10619 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | DEXIREN | DEXKETOPROFEN TROMETAMOL | 50MG/2ML | IDOL ILAC SAN. VE TIC A.S, 34010 TOPKAPI, ISTANBUL, TURKEY | TURKEY | PARENTERAL ORDINARY AMPOULES | 1*1*6*2 ML, AMBER GLASS AMPOULES | 20/02/2023 |
| 956 | 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 |
| 957 | NDA/MAL/HDP/10620 | RENE INDUSTRIES LTD | RENE INDUSTRIES LTD | BUSCOREN | HYOSCINE BUTYLBROMIDE | 10 MG | RENE INDUSTRIES LTD. P.O BOX 6034, PLOT NO 680, KAMULI, KIREKA, KAMPALA, UGANDA | UGANDA | ORAL SOLID ORDINARY SUGAR-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 20/02/2023 |
| 958 | NDA/MAL/HDP/10621 | RENE INDUSTRIES LTD | RENE INDUSTRIES LTD. | PENIREN | PHENOXYMETHYLPENICILLIN POTASSIUM | 250MG | RENE INDUSTRIES LTD. PLOT NO 680, PO BOX 6034, KAMULI, KIREKA, KAMPALA, UGANDA. | UGANDA. | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 20/02/2023 |
| 959 | NDA/MAL/HDP/10622 | CENTURION LABORATORIES PVT. LTD | SHREEJI PHARMACEUTICALS LTD | PANTOPRAM 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40 MG | CENTURION LABORATORIES PVT. LTD. P-2, BIO-TECH PARK, MANJUSAR, SAVLI, DIST. BARODA, INDIA. | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 960 | NDA/MAL/HDP/10623 | RENE INDUSTRIES LTD | RENE INDUSTRIES LTD | STERIREN | CHLORHEXIDINE GLUCONATE | 5% W/V | RENE INDUSTRIES LTD. PO BOX 6034, PLOT NO.680, KAMULI, KIREKA, KAMPALA, UGANDA | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1*5 L, HDPE CONTAINER | 20/02/2023 |
| 961 | NDA/MAL/HDP/10624 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (U) LTD | MIBZO | BORTEZOMIB | 3.5 MG/VIAL | MSN LABORATORIES PRIVATE LIMITED - FORMULATIONS DIVISION, FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277, 1319 TO 1324, NANDIGAMA (VILLAGE & MANDAL), RANGAREDDY DISTRICT, TELANGANA 509216, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1*3.5 MG, CLEAR GLASS VIAL | 20/02/2023 |
| 962 | NDA/MAL/HDP/10625 | LA RENON HEALTHCARE PVT. LTD | AIVEEN (U) LTD | 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 | 20/02/2023 |
| 963 | NDA/MAL/HDP/10626 | GAMA PHARMACEUTICALS (U) LTD | GAMA PHARMACEUTICALS (U) LTD | XAPRINE 5 | CYCLOBENZAPRINE HYDROCHLORIDE | 5 MG | BEIT JALA PHARMACEUTICAL CO. 81, AL-MADARESS STREET, P.O. BOX 58, BEIT JALA-PALESTINE | PALESTINE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 20/02/2023 |
| 964 | NDA/MAL/HDP/10627 | GAMA PHARMACEUTICALS (U) LTD | GAMA PHARMACEUTICALS (U) LTD | XAPRINE 10 | CYCLOBENZAPRINE HYDROCHLORIDE | 10 MG | BEIT JALA PHARMACEUTICAL CO. 81, AL-MADARESS STREET, P.O. BOX 58, BEIT JALA-PALESTINE | PALESTINE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 20/02/2023 |
| 965 | NDA/MAL/HDP/10628 | HILTON PHARMA (PVT.) LTD. | ASTRA PHARMA (U) LTD | SITAGLU MET 50/500 | SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | HILTON PHARMA (PVT.) LTD. PLOT NO.13-14, SECTOR 15, KORANGI INDUSTRIAL AREA KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 20/02/2023 |
| 966 | NDA/MAL/HDP/10629 | HILTON PHARMA (PVT.) LTD. | ASTRA PHARMA (U) LTD | SITAGLU MET 50/500 | SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | HILTON PHARMA (PVT.) LTD. PLOT NO.13-14, SECTOR 15, KORANGI INDUSTRIAL AREA KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 20/02/2023 |
| 967 | NDA/MAL/HDP/10630 | INNOVA CAPTAB PVT. LTD | TATA UGANDA LTD | INFIXIME 400 | CEFIXIME TRIHYDRATE | 400MG | INNOVA CAPTAB PVT. LTD 1281/1, HILLTOP INDUSTRIAL ESTATE, NEAR EPIP, PHASE-I, JHARMAJARI, BADDI, DIST. SOLAN (H.P.) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 20/02/2023 |
| 968 | NDA/MAL/HDP/10631 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LIMITED | RYALTRIS | OLOPATADINE HYDROCHLORIDE + MOMETASONE FUROATE | 665 MCG/25 MCG | GLENMARK PHARMACEUTICALS LIMITED (UNIT III), VILLAGE KISHANPURA, BADDI- NALAGARH ROAD, TEHSIL BADDI, DISTT. SOLAN HIMACHAL PRADESH-173205, INDIA | INDIA | NASAL TOPICAL SPRAYS WITHOUT GAS | HDPE BOTTLE | 20/02/2023 |
| 969 | NDA/MAL/HDP/10632 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD.) | ROYAL PHARMA 2011 LTD | ROSUVAT 10 | ROSUVASTATIN CALCIUM | 10 MG | GLOBELA PHARMA PVT. LTD., 357, G.I.D.C., SACHIN, SURAT 394 230, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 970 | NDA/MAL/HDP/10633 | MYLAN PHARMACEUTICAL PRIVATE LIMITED | KIMSY MEDS LTD | FULPHILA | PEGFILGRASTIM | 6 MG/0.6 ML | BIOCON LIMITED SPECIAL ECONOMIC ZONE PLOT NO: 2, 3, 4, 5, PHASE – IV BOMMASANDRA JIGANI LINK ROAD BOMMASANDRA POST BANGALORE KARNATAKA, 560099 INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1*1*1, 0.6 ML SINGLE DOSE PREFILLED SYRINGE | 20/02/2023 |
| 971 | NDA/MAL/HDP/10634 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | FLUSCOT | PARACETAMOL + CAFFEINE + CHLORPHENIRAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 500MG + 30MG + 2MG + 10MG | M/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 06/03/2023 |
| 972 | NDA/MAL/HDP/10636 | UNICHEM LABORATORIES LIMITED? | 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 | 06/03/2023 |
| 973 | NDA/MAL/HDP/10637 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | SETRIZIN | CETIRIZINE | 10MG | M/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/03/2023 |
| 974 | NDA/MAL/HDP/10638 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CLOTRIMAZOLE, BETAMETHASONE DIPROPIONATE, GENTAMICIN SULPHATE CREAM | CLOTRIMAZOLE + BETAMETHASONE DIPROPIONATE + GENTAMICIN SULPHATE | (10 MG + 0.5 MG + 1 MG)/G | 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 | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 06/03/2023 |
| 975 | NDA/MAL/HDP/10639 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CIROVIR | ACICLOVIR | 5%W/W | 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 | TOPICAL EXTERNAL CREAMS | 1.0X1.0X5.0 G TUBE | 06/03/2023 |
| 976 | 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 | 06/03/2023 |
| 977 | NDA/MAL/HDP/10641 | BHARAT BIOTECH INTERNATIONAL LIMITED. | REDDYS PHARMA LIMITED | TYPBAR TCV | S. TYPHI TY 2 CONJUGATED TO TETANUS TOXOID | 25 ?CG/0.5ML | BHARAT BIOTECH INTERNATIONAL LTD-GENOME VALLEY, SHAMEERPET MANDAL, RANGAREDDY, TELANGANA STATE-500078 INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 PREFILLED SYRINGE CARTON | 06/03/2023 |
| 978 | NDA/MAL/HDP/10642 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PACSITA 150 | CAPECITABINE | 150MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 06/03/2023 |
| 979 | NDA/MAL/HDP/10643 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PACSITA 500 | CAPECITABINE | 500MG | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 06/03/2023 |
| 980 | NDA/MAL/HDP/10644 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | LORATYN 10 | LORATADINE | 10MG | HOVID BERHAD (IPOH SITE)-121, JALAN TUNKU ABDUL RAHMAN 30010 IPOH PERAK | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/03/2023 |
| 981 | 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 |
| 982 | 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 | 06/03/2023 |
| 983 | NDA/MAL/HDP/10648 | CIPLA LTD | QUALITY CHEMICALS LTD | TENVIR-AF | TENOFOVIR ALAFENAMIDE FUMARATE | 25MG | CIPLA LIMITED-PLOT NO. A-33, A-2 & A-37/2/2 (UNIT-I), A-42(UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 06/03/2023 |
| 984 | NDA/MAL/HDP/10649 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | ESOCID 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/03/2023 |
| 985 | 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 |
| 986 | 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 | 06/03/2023 |
| 987 | 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 |
| 988 | 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 | 06/03/2023 |
| 989 | 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 | 06/03/2023 |
| 990 | 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 | 06/03/2023 |
| 991 | 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 | 06/03/2023 |
| 992 | NDA/MAL/HDP/10658 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATORKEY 40 | ATORVASTATIN CALCIUM TRIHYDRATE | 40MG | AUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/03/2023 |
| 993 | NDA/MAL/HDP/10659 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ACENAC-P | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | MEDLEY PHARMACEUTICALS LTD-LANE 03, PHASE 1, SIDCO INDUSTRIAL COMPLEX, BARI BRAHMANA JAMMU 181133 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/03/2023 |
| 994 | 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 | 06/03/2023 |
| 995 | 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 | 06/03/2023 |
| 996 | 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 | 06/03/2023 |
| 997 | NDA/MAL/HDP/10663 | FERRER INTERNATIONAL,SA | PHILIPS PHARMACEUTICALS (U) LTD | TRAMAPA 37.5 MG/325 MG | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5 MG/325 MG | FERRER INTERNACIONAL, S.A C/JOAN BUSCALLA, 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 20/02/2023 |
| 998 | NDA/MAL/HDP/10664 | FDC LIMITED | AIVEEN UGANDA LTD | OCUDORT-T | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | (20 MG + 5 MG)/ML | FDC LTD. B-8, MIDC INDUSTRIAL AREA, WALUJ, AURANGABAD 431136 MAHARASHTRA, INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 20/02/2023 |
| 999 | NDA/MAL/HDP/10665 | AUROBINDO PHARMA LIMITED | PHILIPS PHARMACEUTICALS (UGANDA) LIMITED | CIATUFF 10 | TADALAFIL | 10 MG | AUROBINDO PHARMA LIMITED, UNIT-VII, SEZ, TSIIC, PLOT NO. S1, SURVEY NO’S: 411/P, 425/P, 434/P, 435/P & 458/P, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, TELANGANA STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X4.0 TABLET BLISTER | 20/02/2023 |
| 1000 | NDA/MAL/HDP/10666 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LTD | VANCOLIN-500 | VANCOMYCIN HYDROCHLORIDE | 500 MG | LINCOLN PARENTERAL LIMITED, 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*10*500 MG CLEAR GLASS VIALS | 20/02/2023 |
| 1001 | NDA/MAL/HDP/10667 | VINS BIOPRODUCTS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LTD | VINRAB 1000 IU | EQUINE ANTIRABIES IMMUNOGLOBULIN FRAGMENTS F (AB’) 2 | NOT LESS THAN 200 IU PER ML | VINS BIOPRODUCTS LIMITED, SURVEY NO.117, THIMMAPUR (V) KOTHUR MANDAL, RANGA REDDY-DIST., TELANGANA., INDIA 509325 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*1*5 ML, CLEAR GLASS VIAL | 20/02/2023 |
| 1002 | NDA/MAL/HDP/10668 | LUPIN LIMITED | AIVEEN UGANDA LIMITED | DOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMERATE 50MG/300MG/300MG | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXI | 50 MG + 300 MG + 300 MG | LUPIN LIMITED PLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIA. (BLOCK 1). | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET BOTTLE | 20/02/2023 |
| 1003 | NDA/MAL/HDP/10669 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LTD | CARDIOTIMIDE 20 MG | TORSEMIDE | 20 MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES ADDRESS: PART NO. 7/6, 6TH INDUSTRIAL AREA, 6TH OF OCTOBER CITY, EGYPT. | EGYPT | ORAL SOLID ORDINARY TABLETS | AL/OPAQUE(PVC/PVDC | 20/02/2023 |
| 1004 | 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 |
| 1005 | NDA/MAL/HDP/10670 | HILTON PHARMA (PVT.) LTD. | HEALTHCARE LIMITED | DOLGINA | DEXLANSOPRAZOLE | 30 MG | HILTON PHARMA (PVT.) LTD. PLOT NO.13-14, SECTOR 15, KORANGI INDUSTRIAL AREA KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 20/02/2023 |
| 1006 | NDA/MAL/HDP/10671 | HILTON PHARMA (PVT.) LTD. | HEALTHCARE LIMITED | TRANSAMIN-S | TRANEXAMIC ACID | 1000MG/10ML | HILTON PHARMA (PVT.) LTD. PLOT NO.13-14, SECTOR 15, KORANGI INDUSTRIAL AREA KARACHI, PAKISTAN | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1*2*5, CLEAR GLASS AMPOULES | 20/02/2023 |
| 1007 | NDA/MAL/HDP/10672 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDY'S PHARMA LTD | DNS | SODIUM CHLORIDE + ANHYDROUS GLUCOSE | 0.9%W/V & 5%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED, VILLAGE; VASANA – CHACHARWADI,TAL:SANAND, DIST;AHMEDABAD, 382 213, INDIA | INDIA | SOLUTION FOR INTRAVENOUS INFUSION | 1*1*500ML, LDPE BOTTLE | 20/02/2023 |
| 1008 | NDA/MAL/HDP/10673 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | CETARIV | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 06/03/2023 |
| 1009 | NDA/MAL/HDP/10674 | VINS BIO PRODUCTS LIMITED | PHILLIPS PHARMACEUTICALS (U) LTD | AFRIVEN-10 | NAJA MELANOLEUCA+ NAJA NIGRICOLLIS + NAJA HAJE + DENDROASPIS POLYLEPIS + DENDROASPIS VIRIDIS + DENDROASPIS JAMESONI + BITIS GABONICA + BITIS ARIETANS + ECHIS LEUCOGASTER + ECHIS OCELLATUS | NOT LESS THAN 22 LD50 + 22 LD50 + 27.5 LD50 + 27.5 LD50 + 27.5 LD50 + 27.5 LD50 + 27.5 LD50 + 27.5 LD50 + 27.5 LD50 + 27.5 LD50 | VINS BIOPRODUCTS LIMITED, SURVEY NO.117, THIMMAPUR (V) KOTHUR MANDAL, RANGA REDDY-DIST., TELANGANA., INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*5, 10 ML CLEAR GLASS VIAL | 20/02/2023 |
| 1010 | NDA/MAL/HDP/10675 | THE SEARLE COMPANY LIMITED | HEALTHCARE LIMITED | JENTIN 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50 MG | THE SEARLE COMPANY LIMITED, F-319, S. I.T.E. KARACHI PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1*2*7,ALU/ALU BLISTER PACK | 20/02/2023 |
| 1011 | NDA/MAL/HDP/10676 | THE SEARLE COMPANY LIMITED | HEALTHCARE LIMITED | JENTIN 100 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 100 MG | THE SEARLE COMPANY LIMITED, F-319, S. I.T.E. KARACHI PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1*2*7,ALU/ALU BLISTER PACK | 20/02/2023 |
| 1012 | NDA/MAL/HDP/10677 | MEDOCHEMIE LTD | SHREEJI PHARMACEUTICALS LTD | MEDOCRIPTINE 2.5 MG | BROMOCRIPTINE MESILATE | 2.5 MG | MEDOCHEMIE LTD. (CENTRAL FACTORY), 1-10 CONSTANTINOUPOLEOS STREET, 3011 LIMASSOL, CYPRUS | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1013 | NDA/MAL/HDP/10678 | KESAR PHARMA (P) LIMITED, | ABACUS PHARMA (A) LIMITED | ARTELUM | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | KESAR PHARMA (P) LIMITED, PLOT SURVEY NO.50-P/2, VILLAGE, BILESHWARPURA, PO CHHATRAL-382729. TAL.KALOL, DIST. GANDHINAGAR, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1*1*24 ALU/PVC BLISTER PACK | 20/02/2023 |
| 1014 | NDA/MAL/HDP/10679 | ZOTA HEALTHCARE LTD | REDDY`S PHARMA LTD, | PG-75 | PREGABALIN | 75 MG | ZOTA HEALTHCARE LTD., PLOT NO: 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT-394 230, GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 20/02/2023 |
| 1015 | NDA/MAL/HDP/10680 | RAPTAKOS, BRETT & CO. LTD | EUROPA HEALTHCARE (U) LTD | NEOPEPTINE PLUS DROPS | ALPHA AMYLASE (BACTERIAL 1:800) + PAPAIN | (20MG + 10MG) PER ML | RAPTAKOS, BRETT & CO LTD 1ST POKHRAN ROAD, SHASTRI NAGAR, THANE 400606, INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X1.0X5.0 ML BOTTLE | 20/02/2023 |
| 1016 | NDA/MAL/HDP/10681 | BIODEAL LABORATORIES LTD | ABACUS PHARMA (U) LTD | PODOSAL OINTMENT | PODOPYLLUM RESIN + SALICYLIC ACID | 20%W/W + 25%W/W | BIODEAL LABORATORIES LTD, PLOT NO.123, LUNGA LUNGA ROAD, P.O BOX 32040-00600, NAIROBI KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1*1*10 GM , ALLUMINIUM COLLAPSIBLE TUBE | 20/02/2023 |
| 1017 | NDA/MAL/HDP/10682 | HETERO LABS LIMITED | AIVEEN (U) LTD | RALTEGRAVIR TABLETS | RALTEGRAVIR POTASSIUM | 400 MG | HETERO LABS LIMITED UNIT – III (FORMULATIONS), 22 – 110, I.D.A JEEDIMETLA, HYDERABAD, TELANGANA, INDIA. PIN CODE 500 055 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1*60, HDPE CONTAINER | 20/02/2023 |
| 1018 | NDA/MAL/HDP/10683 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS LTD | MF-DAY ER 750 | METFORMIN HYDROCHLORIDE | 750 MG | AUROBINDO PHARMA LIMITED (UNIT III) SURVEY NO. 313 & 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, TELANGANA STATE, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1019 | NDA/MAL/HDP/10684 | GALENICUM HEALTH S.L. | GOODMAN INTERNATIONAL LTD | DUTASVITAE 0.5MG | DUTASTERIDE | 0.5MG | CYNDEA PHARMA, S.L-POLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 06/03/2023 |
| 1020 | NDA/MAL/HDP/10685 | AVACARE GLOBAL | GOODMAN INTERNATIONAL LTD | DEMOX | MOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE PHOSPHATE | (5MG + 1MG)/ML | WORLD MEDICINE ILAC SAN VE TIC A.S.-15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEY | TURKEY | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 06/03/2023 |
| 1021 | NDA/MAL/HDP/10686 | HETERO LABS LTD | AIVEEN (U) 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 | 06/03/2023 |
| 1022 | NDA/MAL/HDP/10687 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | IRNIZET 300 | IRINOTECAN HYDROCHLORIDE TRIHYDRATE | 300 MG/15ML | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X15.0 ML VIAL | 06/03/2023 |
| 1023 | NDA/MAL/HDP/10688 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, | ABACUS PHARMA (A) LTD | UROKA | DUTASTERIDE | 0.5 MG | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKAN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 20/02/2023 |
| 1024 | NDA/MAL/HDP/10689 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LTD | LOSARZED-100 | LOSARTAN POTASSIUM | 100 MG | ZOTA HEALTHCARE LTD., PLOT NO: 169, SURAT SPECIAL ECONOMY ZONE, NR. SACHIN RAILWAY STATION, SACHIN, SURAT-394 230, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1025 | 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 |
| 1026 | NDA/MAL/HDP/10690 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LTD | PROTAC-40 | PANTOPRAZOLE SODIUM | 40 MG | SUNRISE INTERNATIONAL LABS LTD. PLOT NO. 100, LANE-5, SECTOR-II, PHASE II, IDA CHERLAPALLY, HYDERABAD 500051 INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1027 | NDA/MAL/HDP/10691 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROGLOPENTIN 400 MG | GABAPENTIN | 400 MG | GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, 6TH OCTOBER CITY, GIZA, EGYPT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 20/02/2023 |
| 1028 | NDA/MAL/HDP/10692 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROGLOPENTIN 300 MG | GABAPENTIN | 300 MG | GLOBAL NAPI PHARMACEUTICALS 2ND INDUSTRIAL ZONE, 6TH OCTOBER CITY, GIZA, EGYPT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 20/02/2023 |
| 1029 | NDA/MAL/HDP/10693 | SWISS PARENTERALS LTD | SHREEJI CARE LTD | GEN DEX EYE DROPS | GENTAMICIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.3% W/V + 0.1% W/V | SWISS PARENTERALS LTD. 808, 809, 810 KERALA INDUSTRIAL ESTATE, NR. BAVLA, DIST. AHMEDABAD - 382 220 GUJARAT, INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 20/02/2023 |
| 1030 | 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 | 06/03/2023 |
| 1031 | NDA/MAL/HDP/10695 | UNIMED LABORATORIES | OMAB UGANDA LTD | GLUCOSE 5 % UNIMED | GLUCOSE ANHYDROUS | 5%W/V | UNIMED LABORATORIES P.O BOX: 38, I.Z 4060 KALAA KEBIRA TUNISIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1*100 ML, POLYOLEFIN BAG | 20/02/2023 |
| 1032 | NDA/MAL/HDP/10696 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | CELEBIB CAPSULES 200MG | CELECOXIB | 200MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 06/03/2023 |
| 1033 | 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 | 06/03/2023 |
| 1034 | NDA/MAL/HDP/10698 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | PACLITAXEL 6 MG /1 ML | PACLITAXEL | 6 MG /1 ML | EBEWE PHARMA GES.M.B.H. NFG. KG MONDSEESTRASSE 11 4866 UNTERACH AM ATTERSEE AUSTRIA. | AUSTRIA. | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | EBEWE PHARMA GES.M.B.H. NFG. KG MONDSEESTRASSE 11 4866 UNTERACH AM ATTERSEE AUSTRIA. | 20/02/2023 |
| 1035 | NDA/MAL/HDP/10699 | PHARMA BAVARIA INTERNACIONAL (PBI) | GOODMAN INTERNATIONAL LTD | RHINIZILL 50 | MOMETASONE FUROATE MONOHYDRATE | 50 ?G/ACTUATION | FARMEA 10, RUE BOUCHÉ THOMAS Z.A.C D’ORGEMONT 49000 ANGERS FRANCE | FRANCE | NASAL TOPICAL SPRAYS WITHOUT GAS | 1*1, HDPE BOTTLE WITH 120 OR 140 ACTUATIONS, GLASS CONTAINER | 20/02/2023 |
| 1036 | NDA/MAL/HDP/10700 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | NEPEXTO 50 MG | ETANERCEPT (RDNA ORIGIN) | 50 MG/ML | LUPIN LIMITED (BIOTECH DIVISION)-GAT NO. 1156, GHOTAWADDE - VILLAGE, MULSHI-TALUKA, PUNE - 412 115 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE | 06/03/2023 |
| 1037 | NDA/MAL/HDP/10701 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | NEPEXTO 25 MG | ETANERCEPT | 25MG/0.5ML | LUPIN LIMITED (BIOTECH DIVISION)-GAT NO. 1156, GHOTAWADDE - VILLAGE, MULSHI-TALUKA, PUNE - 412 115 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X0.5 ML PRE- FILLED SYRINGE | 06/03/2023 |
| 1038 | NDA/MAL/HDP/10702 | UNIMED LABORATORIES | OMAB UGANDA LIMITED | VAAMOX 1G/200 MG | SODIUM AMOXICILLIN + POTASSIUM CLAVULANATE. | (1 G + 200 MG)VIAL | UNIMED LABORATORIES I.Z KALAA KEBIRA P.O BOX 38 4060 TUNISIA | TUNISIA | PARENTERAL ORDINARY DRY VIALS | 1*1, CLEAR GLASS VIAL | 20/02/2023 |
| 1039 | NDA/MAL/HDP/10703 | MOTI PHARMA (U) LTD | MOTI PHARMA(U) LTD. | TOPSUNATE | TOPSUNATE | 60 MG | SANJAR PHARMA LLP SURVEY NO. 622/2/1/4, HIMATNAGAR - VIJAPUR HIGHWAY, DEDHROTA, HIMATNAGAR - 383 220, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1*[1, CLEAR GLASS VIAL + 5ML OF 0.9%W/V SODIUM CHLORIDE SOLUTION IN A CLEAR GLASS AMPOULE + 1ML OF 5%W/V SODIUM BICARBONATE SOLUTION IN A CLEAR GLASS AMPOULE] | 20/02/2023 |
| 1040 | NDA/MAL/HDP/10704 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LTD | EMEFILM-4 | ONDANSETRON HYDROCHLORIDE | 4 MG | SHILPA THERAPEUTICS PRIVATE LIMITED (FORMERLY M/S NU THERAPEUTICS PVT. LTD.) PLOT NO. 118, PHASE III, IDA, CHERLAPALLY HYDERABAD-500 051, INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1*5, ALU/ALU STRIP PACK | 20/02/2023 |
| 1041 | NDA/MAL/HDP/10705 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | SUPADOL 500 | PARACETAMOL | 500 MG | BIOMATRIX HEALTHCARE PVT LTD. SURVEY NO. 624, SARKHEJ – BAVLA HIGHWAY, VIL.: RAJODA, TAL.: BAVLA, DIST.: AHMEDABAD – 382 220, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1042 | NDA/MAL/HDP/10706 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | NTSUGA 500 | METFORMIN HYDROCHLORIDE | 500 MG | BIOMATRIX HEALTHCARE PVT LTD. SURVEY NO. 624, SARKHEJ, BAVLA HIGHWAY, VIL.: RAJODA, TAL.: BAVLA, DIST.: AHMEDABAD, 382 220, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1043 | NDA/MAL/HDP/10707 | MACLEODS PHARMACEUTICALS LIMITEDAST, MUMBAI 400059 INDIA | VITACARE LIMITED | ZOPIMAC 3 | ESZOPICLONE | 3MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK NO.: 2, VILLAGE THEDA P.O. LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN, HIMACHAL PRADESH, 174101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1*1*100, HDPE CONTAINER | 20/02/2023 |
| 1044 | NDA/MAL/HDP/10708 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | CAFENOL | ACETYLSALICYLIC ACID + CAFFEINE | 375MG + 25MG | BETA HEALTHCARE INTERNATIONAL LIMITED PLOT NO. LR 209/6554, MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1*8*20, ALU-PVC BLISTER PACK | 20/02/2023 |
| 1045 | NDA/MAL/HDP/10709 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (A) LTD | VINGLYN M 50/850 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 850 MG | EAST AFRICAN (INDIA) OVERSEAS, PLOT NO. 1, PHARMACITY, SELAQUI DEHRADUN – 248011, UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 20/02/2023 |
| 1046 | NDA/MAL/HDP/1071 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-ANGINET 160/25MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 160 MG + 25 MG | 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 |
| 1047 | NDA/MAL/HDP/10710 | CADILA HEALTHCARE LIMITED; | ABACUS PHARMA (AFRICA) LIMITED | OXALGIN GEL | DICLOFENAC DIETHYLAMINE+ METHYL SALICYLATE + VIRGIN LINSEED OIL + CAPSAICIN + RACEMENTHOL | 1.0%W/W + 10.0%W/W + 3.0%W/W + 0.05%W/W + 5.0%W/W | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 06/03/2023 |
| 1048 | NDA/MAL/HDP/10711 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | VIREXIM-DS | CEFIXIME TRIHYDRATE | 100MG/5ML | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 06/03/2023 |
| 1049 | NDA/MAL/HDP/10713 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | IMMUNCEE 500 | ASCORBIC ACID + SODIUM ASCORBATE | 100MG + 450MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 06/03/2023 |
| 1050 | 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 | 06/03/2023 |
| 1051 | NDA/MAL/HDP/10715 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) 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 | 06/03/2023 |
| 1052 | NDA/MAL/HDP/10716 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) 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 | 06/03/2023 |
| 1053 | NDA/MAL/HDP/10717 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) 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 | 06/03/2023 |
| 1054 | NDA/MAL/HDP/10719 | HETERO LABS LTD | AIVEEN (U) 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 | 06/03/2023 |
| 1055 | NDA/MAL/HDP/1072 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 1056 | NDA/MAL/HDP/10720 | HETERO LABS LTD | AIVEEN (U) 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 | 06/03/2023 |
| 1057 | NDA/MAL/HDP/10721 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | FLEXABENZ GEL | DICLOFENAC DIETHYLMAINE + LINSEED OIL + METHYL SALICYLATE + MENTHOL + CYCLOBENZAPRINE HYDROCHLORIDE | 1.0%W/W + 3.0%W/W + 10.0%W/W + 5.0%W/W + 2.0%W/W | OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 06/03/2023 |
| 1058 | NDA/MAL/HDP/10722 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEDWIN | MEDROXYPROGESTERONE ACETATE | 150MG/ML | EUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL | 06/03/2023 |
| 1059 | NDA/MAL/HDP/10723 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | INSULIN H MIX | RECOMBINANT HUMAN INSULIN + RECOMBINANT PROTAMINE -HUMAN INSULIN | (30IU + 70IU)/ML | SOUTH EGYPT DRUG INDUSTRIES COMPANY (SEDICO)-FIRST INDUSTRIAL ZONE, 6TH OF OCTOBER CITY - EGYPT | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X1.0X10.0 ML VIAL | 06/03/2023 |
| 1060 | NDA/MAL/HDP/10725 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) 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 | 06/03/2023 |
| 1061 | NDA/MAL/HDP/10726 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) 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 | 06/03/2023 |
| 1062 | NDA/MAL/HDP/10727 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) 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 | 06/03/2023 |
| 1063 | NDA/MAL/HDP/10728 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RAPI-COOL | CHOLINE SALICYLATE + LIDOCAINE HYDROCHLORIDE | 8.70% W/W + 2.00% W/W | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X10.0 G TUBE | 06/03/2023 |
| 1064 | 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 | 06/03/2023 |
| 1065 | 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 | 06/03/2023 |
| 1066 | NDA/MAL/HDP/10731 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICHLOR 50 | 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 | 06/03/2023 | ||
| 1067 | NDA/MAL/HDP/10732 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | BREAZLAX | MONTELUKAST | 4MG | BILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 06/03/2023 |
| 1068 | NDA/MAL/HDP/10733 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | BREAZLAX | MONTELUKAST | 5MG | BILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 06/03/2023 |
| 1069 | NDA/MAL/HDP/10734 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | BREAZLAX | MONTELUKAST | 10MG | BILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 06/03/2023 |
| 1070 | NDA/MAL/HDP/10735 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLADON PLUS | PARACETAMOL + DOXYLAMINE SUCCINATE + CAFFEINE + CODEINE PHOSPHATE | 450MG + 5MG + 30MG + 10MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X4.0X10.0 TABLET BLISTER | 06/03/2023 |
| 1071 | 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) | 06/03/2023 |
| 1072 | 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 | 06/03/2023 |
| 1073 | 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 | 06/03/2023 |
| 1074 | NDA/MAL/HDP/1074 | NECTAR LIFESCIENCES LTD | SUPER MEDIC LTD | CEFUAXIT | CEFUROXIME | 500MG | NECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL. NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2013 |
| 1075 | NDA/MAL/HDP/1075 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | NECPIME | CEFEPIME | 1000MG | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION | 01/07/2013 |
| 1076 | NDA/MAL/HDP/1076 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 1077 | NDA/MAL/HDP/1077 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | NECTRAM | CEFTRIAXONE | 1G | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE | 01/07/2013 |
| 1078 | 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 |
| 1079 | 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 |
| 1080 | NDA/MAL/HDP/1080 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 250 TABLETS | CEFUROXIME AXETIL | 250MG | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2009 |
| 1081 | 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 |
| 1082 | 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 |
| 1083 | 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 |
| 1084 | NDA/MAL/HDP/1087 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCYCLINE | TETRACYCLINE | 3%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 |
| 1085 | NDA/MAL/HDP/1093 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE | 200MG+300MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| 1086 | 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 |
| 1087 | 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 |
| 1088 | NDA/MAL/HDP/1096 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ARTEMETHER | ARTEMETHER | 80MG/ML | SANJAR PHARMA LLP HIMATNAGAR-VIJOPUR HIGHWAY, DEDHROTA HIMATNAGAR 383 220, GUJARAT INDIA | CHINA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE,1.0X1.0X8.0X1.0 ML AMPOULE | 01/07/2014 |
| 1089 | 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 |
| 1090 | 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 |
| 1091 | NDA/MAL/HDP/1103 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIN CREAM | NEOMYCIN SULPHATE | 0.5% 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 | 1.0X15.0 G TUBE | 01/07/2014 |
| 1092 | NDA/MAL/HDP/1104 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | LIPIDUCE 10 | ATORVASTATIN | 10MG | HOVID BERHAD,-LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0 TABLET BLISTER | 01/07/2014 |
| 1093 | NDA/MAL/HDP/1106 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 1094 | NDA/MAL/HDP/1107 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | HEPATITIS B VACCINE(RDNA) (PAEDIATRIC)) | HEPATITIS B VACCINE(RDNA) | 10MCG /0.5ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE) | 01/07/2005 |
| 1095 | NDA/MAL/HDP/1109 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENIRAMINE MALEATE | 2MG/5ML | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2014 |
| 1096 | NDA/MAL/HDP/1111 | DAWA LIMITED | SUPER MEDIC LTD | FAST-ACT GEL | DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS | 1.16%W/W + 10%W/W + 3%W/W + 5%W/W | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2013 |
| 1097 | NDA/MAL/HDP/1113 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ALCID-YELLOW | MULTI-INGREDIENT | MULTI-INGREDIENT | 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 | 01/07/1997 |
| 1098 | NDA/MAL/HDP/1114 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TRANGEL ULTRA | DICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN | 10MG/80MG/60MG/0.15MG | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA – INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER | 01/07/2012 |
| 1099 | NDA/MAL/HDP/1117 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TETRACYCLINE EYE OINTMENT USP 1% | TETRACYCLINE | 1%W/W | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA – INDIA | INDIA | OPHTHALMIC OINTMENTS | 1.0X20.0X3.5 G TUBE | 01/07/2013 |
| 1100 | NDA/MAL/HDP/1124 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO SCRUB | CHLORHEXIDINE GLUCONATE | 4%W/V | 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 LIQUIDS | 1.0X1.0X500.0 ML BOTTLE | 01/07/2013 |
| 1101 | NDA/MAL/HDP/1125 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROXONE 1000 | CEFTRIAXONE | 1000MG | AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI- R7-AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI SY.NO.329/39 & 329/47 CHITKUL(V) PATANCHERU MANDAL, SANGA REDDY DISTTELANGANA502307 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2009 |
| 1102 | 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 |
| 1103 | NDA/MAL/HDP/1130 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KLARO-500 | CLARITHROMYCIN TABLETS | 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 | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1104 | 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 |
| 1105 | 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 |
| 1106 | 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 |
| 1107 | 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 |
| 1108 | 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 |
| 1109 | 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 | 01/07/2013 |
| 1110 | NDA/MAL/HDP/1143 | LINCOLN P'CALS LTD | METRO PHARMACEUTICALS LIMITED | LOSA-H | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | 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 | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1111 | NDA/MAL/HDP/1149 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | NEUROBA | GABAPENTIN | 300MG | UNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2015 |
| 1112 | 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 |
| 1113 | 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 |
| 1114 | 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 |
| 1115 | NDA/MAL/HDP/1160 | DAFRA PHARMA LTD | MULTIPHAR UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + CLAVULANIC ACID | 875MG+125MG | BILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0 TABLET BLISTER | 01/07/2011 |
| 1116 | NDA/MAL/HDP/1162 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | WINKLOT | CLOPIDOGREL | 75MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1117 | 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 |
| 1118 | 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 |
| 1119 | 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 |
| 1120 | 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 |
| 1121 | 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 |
| 1122 | 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 |
| 1123 | NDA/MAL/HDP/1170 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO MEGANEURON | METHYLCOBALAMIN | 500MCG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/2013 |
| 1124 | 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 | 1.0X20.0 ML VIAL,1.0X30.0 ML VIAL | 01/07/2010 |
| 1125 | NDA/MAL/HDP/1176 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS 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 |
| 1126 | 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 |
| 1127 | NDA/MAL/HDP/1179 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | OVITRELLE | CHORIOGONADOTROPIN ALFA | 250MCG/0.5ML | MERCK SERONO SA-1170 AUBONNE(SWITZERLAND) MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON | 01/07/2015 |
| 1128 | NDA/MAL/HDP/1182 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ASTHATOR 5 | MONTELUKAST SODIUM | 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 |
| 1129 | NDA/MAL/HDP/1184 | DAWA LIMITED | SUPER MEDIC LTD | DACOF MUCOLYTIC | SALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL | 2.0MG + 4.0MG +100MG + 1.0MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 1130 | 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 |
| 1131 | 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 |
| 1132 | 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 |
| 1133 | 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 |
| 1134 | NDA/MAL/HDP/1194 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | PISA | PIPERACILLIN + TAZOBACTAM | 4000MG/VIAL + 500MG/VIAL | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X30.0 ML VIAL | 01/07/2009 |
| 1135 | NDA/MAL/HDP/1195 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | ALTRINE | CETIRIZINE | 5MG/5ML | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2013 |
| 1136 | NDA/MAL/HDP/1196 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | ACNESOL | TRETINOIN | 0.05%W/W | UNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE | 01/07/2012 |
| 1137 | NDA/MAL/HDP/1205 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | EFAVIRENZ | EFAVIRENZ | 600MG | 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 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2008 |
| 1138 | 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 |
| 1139 | 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 |
| 1140 | 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 |
| 1141 | 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 |
| 1142 | 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 |
| 1143 | 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 |
| 1144 | NDA/MAL/HDP/1219 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | TORAS-DENK 5 | TORASEMIDE | 5MG | DENK PHARMA GMBH & COMPANY KG - GOLLSTR. 1, 84529 TITTMONING - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1145 | 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 |
| 1146 | 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 |
| 1147 | NDA/MAL/HDP/1226 | AFRICURE PHARMACEUTICALS (INDIA) LTD | ROYAL PHARMA 2011 LIMITED | SALBUTAMOL | SALBUTAMOL | 4MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1148 | NDA/MAL/HDP/1227 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS 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 |
| 1149 | NDA/MAL/HDP/1230 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | LOXAMP | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 1150 | NDA/MAL/HDP/1231 | NORVIK ENTERPRISES LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 125 | AMOXYCILLIN | 125MG/5ML | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2012 |
| 1151 | NDA/MAL/HDP/1234 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | BISACODYL TABLETS BP | BISACODYL | 5MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2007 |
| 1152 | 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 | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2013 |
| 1153 | NDA/MAL/HDP/1243 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | LEVO DENK 250 | LEVOFLOXACIN HEMIHYDRATE | 250MG | ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1154 | 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 |
| 1155 | NDA/MAL/HDP/1245 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | FLEXILOR P8 | LORNOXICAM + PARACETAMOL | 8MG + 500MG | GLENMARK PHARMACEUTICALS LTD .-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1156 | 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 |
| 1157 | 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 |
| 1158 | NDA/MAL/HDP/1255 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | NIFELAT RETARD | NIFEDIPINE | 20MG | CIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| 1159 | NDA/MAL/HDP/1259 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | CARDOZ- 6.25 | CARVEDILOL | 6.25MG | IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2013 |
| 1160 | NDA/MAL/HDP/1261 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | CARDOZ-12.5 | CARVEDILOL | 12.5MG | IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2013 |
| 1161 | 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 |
| 1162 | 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 |
| 1163 | 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 |
| 1164 | NDA/MAL/HDP/1278 | SHANGHAI FOSUN PHARMACEUTICAL 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 |
| 1165 | 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 |
| 1166 | 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 |
| 1167 | 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 | 01/07/2013 |
| 1168 | 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 |
| 1169 | 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 | 1.0X4.0 TABLET BLISTER | 01/07/2016 |
| 1170 | 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 |
| 1171 | NDA/MAL/HDP/1295 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HARLEYS UGANDA LIMITED | ZEPAR | ALBENDAZOLE | 200MG | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/1997 |
| 1172 | NDA/MAL/HDP/1298 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | NEUROVIT FORTE | THIAMINE MONONITRATE/ PYRIDOXINE/ CYANOCOBALAMIN | 245.5MG/ 250MG/ 1.4MG | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1173 | NDA/MAL/HDP/1299 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE PLUS-1000 | CEFTRIAXONE+SULBACTAM | 1000MG+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 |
| 1174 | 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. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 1175 | NDA/MAL/HDP/1303 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FIBRAL | FINOFIBRATE | 200MG | MICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 1176 | 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 |
| 1177 | 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 |
| 1178 | 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 |
| 1179 | NDA/MAL/HDP/1319 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ZESTAVAL 200 F.C TABLETS | ALBENDAZOLE | 200MG | REMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER | 01/07/1997 |
| 1180 | 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 |
| 1181 | NDA/MAL/HDP/1328 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | 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 |
| 1182 | NDA/MAL/HDP/1330 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | RAPICLAV-625 | AMOXYCILLIN+CLAVULANIC ACID | 500MG+125MG | IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP | 01/07/2003 |
| 1183 | 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 |
| 1184 | NDA/MAL/HDP/1335 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES 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 |
| 1185 | 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 |
| 1186 | 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 |
| 1187 | NDA/MAL/HDP/1341 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | G-FLOX | GATIFLOXACIN SESQUIHYDRATE | 0.3%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC LIQUIDS | 1.0X5.0 ML VIAL | 01/07/2016 |
| 1188 | NDA/MAL/HDP/1343 | MICRO LABS LTD | PHARMA VILLE LIMITED | PRAZIQUANTEL | PRAZIQUANTEL | 600MG | MICRO LABS LIMITED .,-92, SIPCOT, HOSUR 635126 MICRO LABS LIMITED, BOMMASANDRA (ML07),-PLOT 121-124, IV PHASE KIADB, BOMMASANDRA IND. AREA, JIGNI LINK ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER | 01/07/2009 |
| 1189 | NDA/MAL/HDP/1345 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SWICH-200 | CEFPODOXIME | 200MG | ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| 1190 | 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 |
| 1191 | 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 |
| 1192 | NDA/MAL/HDP/1351 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ATORIN | ATORVASTATIN CALCIUM | 20MG | MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 1193 | NDA/MAL/HDP/1352 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | PLATFREE | CLOPIDOGREL | 75MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1194 | NDA/MAL/HDP/1353 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | KITPYLO - C | LANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN | 30MG +500MG + 250MG | MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) | 01/07/2015 |
| 1195 | NDA/MAL/HDP/1355 | PIRAMAL HEALTHCARE LTD | MEDIWORLD PHARMA AFRICA LTD | SEVOFLURANE | SEVOFLURANE | 100% V/V | PIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE | 01/07/2010 |
| 1196 | 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 |
| 1197 | NDA/MAL/HDP/1361 | SWISS PARENTERALS LTD | SHREEJI CARE 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 |
| 1198 | 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 |
| 1199 | NDA/MAL/HDP/1366 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | HERCEPTIN 440MG | TRASTUZUMAB | 440MG | F. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGST | SWITZERLAND | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT | 01/07/2016 |
| 1200 | 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 |
| 1201 | 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 |
| 1202 | 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 |
| 1203 | 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 |
| 1204 | 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 |
| 1205 | NDA/MAL/HDP/1382 | HOVID BERHAD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 1206 | NDA/MAL/HDP/1383 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS 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 |
| 1207 | NDA/MAL/HDP/1384 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LAMIVUDINE AND ZIDOVUDINE TABLETS | LAMIVUDINE + ZIDOVUDINE | 30MG + 60MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2013 |
| 1208 | NDA/MAL/HDP/1387 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES 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 |
| 1209 | NDA/MAL/HDP/1391 | UNIVERSAL CORPORATION LTD | PHARMA VILLE LIMITED | UNIVIR 5% | ACYCLOVIR | 5%W/W | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 01/07/2010 |
| 1210 | 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 |
| 1211 | 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 |
| 1212 | 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 | 1.0X15.0 ML VIAL | 01/07/2010 |
| 1213 | 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 |
| 1214 | NDA/MAL/HDP/1397 | ASTRA ZENECA | MACNAUGHTON LIMITED | PLENDIL | FELODIPINE | 10MG | ASTRAZENECA SWEDEN OPERATIONS-ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2001 |
| 1215 | NDA/MAL/HDP/1399 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES 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 |
| 1216 | NDA/MAL/HDP/1400 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR SR 500 | METFORMIN HYDROCHLORIDE | 500MG | INVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID RETARD TABLETS | 1.0X5.0X20.0 TABLET BLISTER | 01/07/2015 |
| 1217 | NDA/MAL/HDP/1402 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR SR 1000 | METFORMIN HYDROCHLORIDE | 1000MG | INVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID RETARD TABLETS | 1.0X5.0X20.0 TABLET BLISTER | 01/07/2015 |
| 1218 | 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 |
| 1219 | NDA/MAL/HDP/1409 | SURGE LAB (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | ROMYCIN | AZITHROMYCIN | 200MG/5ML | NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X15.0 ML BOTTLE | 01/07/2007 |
| 1220 | 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 |
| 1221 | NDA/MAL/HDP/1415 | ASTRA ZENECA | MACNAUGHTON LIMITED | ATACAND | CANDESARTAN | 32MG | ASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| 1222 | 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 |
| 1223 | 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 |
| 1224 | NDA/MAL/HDP/1419 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SINOPRIL 10 | LISINOPRIL | 10MG | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1225 | NDA/MAL/HDP/1422 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | STAMIN | CETIRIZINE DIHYDROCHLORIDE | 10MG | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| 1226 | NDA/MAL/HDP/1425 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) 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 |
| 1227 | NDA/MAL/HDP/1426 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) 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 |
| 1228 | 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 |
| 1229 | NDA/MAL/HDP/1431 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | TORTAS 10 | TORSEMIDE | 10MG | INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 1230 | 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 |
| 1231 | NDA/MAL/HDP/1436 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 10 | BISOPROLOL HEMIFUMARATE | 10MG | MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1232 | 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 |
| 1233 | 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 |
| 1234 | NDA/MAL/HDP/1449 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HARLEYS UGANDA LIMITED | ZEPAR SUSPENSION | ALBENDAZOLE | 200MG/5ML | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2000 |
| 1235 | 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 |
| 1236 | NDA/MAL/HDP/1451 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN INJECTION | DICLOFENAC | 25MG/ML | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE | 01/07/1997 |
| 1237 | 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 |
| 1238 | 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 |
| 1239 | 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 |
| 1240 | NDA/MAL/HDP/1458 | STRIDES PHARMA SCIENCE LIMITED | DELMAW ENTERPRISES LIMITED | CLAVICIN INJECTION | AMOXICILLIN + POTASSIUM CLAVULANATE | 1.2G | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL | 01/07/2013 |
| 1241 | NDA/MAL/HDP/1459 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | TASIGNA 200 | NILOTINIB | 200MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 01/07/2014 |
| 1242 | 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 |
| 1243 | NDA/MAL/HDP/1464 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ORNIDA | ORNIDAZOLE | 500MG | 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 | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 1244 | NDA/MAL/HDP/1465 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTFAST 50MG | DICLOFENAC POTASSIUM | 50MG | MIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY. | ITALY | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X3.0 SACHET CARTON,9.0X1.0X3.0X3.0 SACHET CARTON | 01/07/2014 |
| 1245 | NDA/MAL/HDP/1468 | CADILA HEALTHCARE LTD | 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. CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID RETARD CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/1998 |
| 1246 | 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 |
| 1247 | 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 |
| 1248 | 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 | 01/07/2016 |
| 1249 | NDA/MAL/HDP/1478 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA | SILDENAFIL | 50MG | AJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2001 |
| 1250 | NDA/MAL/HDP/1484 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CLYCIN.V | CLINDAMYCIN | 2%W/W | SHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OTHER CREAMS | 1.0X40.0 G TUBE + APPLICATOR | 01/07/2004 |
| 1251 | NDA/MAL/HDP/1485 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | 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 |
| 1252 | 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 | 10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP | 01/07/2000 |
| 1253 | NDA/MAL/HDP/1492 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DICLO-DENK 75 INJECTION | DICLOFENAC SODIUM | 25MG/ML | HAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X3.0 ML AMPOULE | 01/07/1998 |
| 1254 | 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 |
| 1255 | NDA/MAL/HDP/1495 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | PELOX-400 | PEFLOXACIN | 400MG | WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP | 01/07/1997 |
| 1256 | NDA/MAL/HDP/1497 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA 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 |
| 1257 | NDA/MAL/HDP/1499 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II-31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE | 01/07/2005 |
| 1258 | NDA/MAL/HDP/1500 | MSD (PTY) LIMITED SA | SURGIPHARM (U) LIMITED | ATRIPLA | EFAVIRENZ+EMTRICITABINE + TENOFOVIR | 600MG +200MG+300MG | PATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2008 |
| 1259 | 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 |
| 1260 | NDA/MAL/HDP/1505 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA 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 |
| 1261 | 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 |
| 1262 | NDA/MAL/HDP/1509 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | FEVEREX | PARACETAMOL | 500MG | BETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100, | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| 1263 | NDA/MAL/HDP/1514 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 100MG | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/1997 |
| 1264 | 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 |
| 1265 | NDA/MAL/HDP/1517 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | VEST MENTAMU BALM | COMPOUND METHYLSALICYLATE | MULTI INGREDIENT | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1998 |
| 1266 | 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 |
| 1267 | 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 |
| 1268 | NDA/MAL/HDP/1525 | CIPLA LIMITED. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | BENDEX | ALBENDAZOLE | 20MG/5ML | CIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2007 |
| 1269 | 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 |
| 1270 | NDA/MAL/HDP/1527 | MICRO LABS LTD | LABOREX UGANDA LIMITED | BACTOCLAV | AMOXICILLIN + CLAVULANATE POTASSIUM | 200MG + 28.5MG/ 5ML | MICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2012 |
| 1271 | 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 |
| 1272 | 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 | 01/07/1997 |
| 1273 | NDA/MAL/HDP/1532 | BF BIOSCIENCES LTD | HARLEYS UGANDA LIMITED | NOVAPRESSIN | TERLIPRESSIN | 1MG/VIAL | BF BIOSCIENCES LTD. -RAIWIND,PAKISTAN | PAKISTAN | PARENTERAL ORDINARY VIALS | 1.0X1.0 MG VIAL | 01/07/2014 |
| 1274 | 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 |
| 1275 | NDA/MAL/HDP/1535 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FORTIWIN-4 | FORTIFIED PROCAINE PENICILLIN SODIUM | 4 M.U | 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 | 1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL | 01/07/2011 |
| 1276 | NDA/MAL/HDP/1537 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYZOLE | ALBENDAZOLE | 200MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X2.0 TABLET BLISTER | 01/07/2005 |
| 1277 | 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 |
| 1278 | 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 |
| 1279 | 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 |
| 1280 | 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 |
| 1281 | 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 |
| 1282 | 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 |
| 1283 | 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 |
| 1284 | NDA/MAL/HDP/1556 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | VOMISTAT | ONDASENTRON | 2MG/ML | LINCOLN PARENTERAL LTD-11, 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 |
| 1285 | NDA/MAL/HDP/1557 | GLAXOSMITHKLINE | 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 |
| 1286 | NDA/MAL/HDP/1561 | LINCOLN P'CALS LTD | METRO PHARMACEUTICALS LIMITED | NEOVAG | NYSTATIN | 10000IU | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA | INDIA | VAGINAL TABLETS | 1.0X14.0 PESSARY STRIP | 01/07/2004 |
| 1287 | NDA/MAL/HDP/1563 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | AMOXIL | AMOXYCILLIN | 125MG/5ML | GLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1288 | 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 | NULL | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2009 |
| 1289 | 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 |
| 1290 | 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 | 01/07/2011 |
| 1291 | NDA/MAL/HDP/1574 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES 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 |
| 1292 | NDA/MAL/HDP/1579 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | 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 |
| 1293 | 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 |
| 1294 | NDA/MAL/HDP/1584 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | UCLOX | CLOXACILLIN SODIUM | 500MG | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL | 01/07/2015 |
| 1295 | 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 |
| 1296 | 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 |
| 1297 | 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 |
| 1298 | 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 |
| 1299 | 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 |
| 1300 | NDA/MAL/HDP/1615 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APCALIS SX | TADALAFIL | 20MG | AJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X2.0 TABLET BLISTER | 01/07/2005 |
| 1301 | 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 |
| 1302 | 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 |
| 1303 | 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 |
| 1304 | 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 |
| 1305 | NDA/MAL/HDP/1632 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 1.2G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 1000MG +200MG | ALKEM LABS LTD.-VILLAGE THANA, BADDI, THE NALAGARH, DIST SOLAN (HP) 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1 AMPOULE OF WFI | 01/07/2005 |
| 1306 | 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 |
| 1307 | NDA/MAL/HDP/1636 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA 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 |
| 1308 | 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 |
| 1309 | NDA/MAL/HDP/1639 | GLAXO SMITHLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL EXTRA WITH OPTIZORB | PARACETAMOL + CAFFEINE | 500MG + 65MG | GLAXOSMITHKLINE DUNGARAVAN LTD-KNOCKBRACK DUNGARVAN CO. WATERFORD GRANULES INDIA LIMITED-SY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA | 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 |
| 1310 | 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 |
| 1311 | NDA/MAL/HDP/1642 | UMEDICA LABORATORIES PVT LTD | VITACARE LIMITED | EUCHLOR-1000 | CHLORAMPHENICOL SODIUM SUCCINNATE B.P | 1G | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL | 01/07/2004 |
| 1312 | NDA/MAL/HDP/1646 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | BETROZOLE TABLETS | METRONIDAZOLE+DILOXANIDE | 200MG+250MG | 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 | 1.0X30.0 TABLET BLISTER | 01/07/2002 |
| 1313 | 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 |
| 1314 | NDA/MAL/HDP/1651 | FOURTS(INDIA) LABORATORIES PVT LTD | SUPER MEDIC LTD | MEGATRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| 1315 | 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 |
| 1316 | 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 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/2015 |
| 1317 | 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 |
| 1318 | NDA/MAL/HDP/1661 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | ALUVIA 100/25 | LOPINAVIR/ RITONAVIR | 100MG/25MG | ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2007 |
| 1319 | 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 |
| 1320 | NDA/MAL/HDP/1665 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1998 |
| 1321 | 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 |
| 1322 | 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 |
| 1323 | 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 |
| 1324 | 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 |
| 1325 | NDA/MAL/HDP/1682 | VIRBAC RSA (PTY) 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 |
| 1326 | NDA/MAL/HDP/1690 | PHARMA INTERNATIONAL CO | OMAB UGANDA 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 |
| 1327 | NDA/MAL/HDP/1691 | WIDE SPECTRUM ENTERPRISES (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZITHRORIV | AZITHROMYCIN | 500MG | RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0 CAPSULE BLISTER | 01/07/2011 |
| 1328 | 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 |
| 1329 | 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 |
| 1330 | NDA/MAL/HDP/1697 | PHARMA INTERNATIONAL CO | OMAB UGANDA 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 |
| 1331 | NDA/MAL/HDP/1698 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | AZICIP 500 | AZITHROMYCIN | 500MG | CIPLA LTD ;-VILLAGE UPPER MALPUR P.O BHUD THE NALAGARH DIST. SOLAN HIMACHAL PRADESH PIN 173205 CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIA CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER | 01/07/2009 |
| 1332 | 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 |
| 1333 | 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 |
| 1334 | NDA/MAL/HDP/1704 | DAFRA PHARMA LTD | MULTIPHAR UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + POTASSIUM CLAVULANATE | 500MG + 125MG | BILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X5.0 TABLET BLISTER | 01/07/2011 |
| 1335 | 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 |
| 1336 | NDA/MAL/HDP/1708 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA 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 |
| 1337 | 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 |
| 1338 | 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 |
| 1339 | NDA/MAL/HDP/1713 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LUMITER | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH MACLEODS PHARMACEUTICALS LIMITED, UNIT II-PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN - 396210 (UT) - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER | 01/07/2007 |
| 1340 | 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 |
| 1341 | 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 | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2011 |
| 1342 | 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 |
| 1343 | NDA/MAL/HDP/1724 | GLAXOSMITHKLINE 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 | UNITED KINGDOM | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2009 |
| 1344 | 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 |
| 1345 | 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 |
| 1346 | 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 |
| 1347 | 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 |
| 1348 | 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 |
| 1349 | 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 |
| 1350 | 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 |
| 1351 | NDA/MAL/HDP/1738 | ALCON PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | TEARS NATURALE II | NATURAL TEARS | 15ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM ALCON SINGAPORE MANUFACTURING PTE. LIMITED-19 TUAS SOUTH AVENUE 14 - SINGAPORE | BELGIUM | OPHTHALMIC DROPS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| 1352 | NDA/MAL/HDP/1739 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MELOX | MELOXICAM | 15MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2009 |
| 1353 | NDA/MAL/HDP/1741 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEOPRED-P | PREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B | 5MG/ML +5MG/ML + 1M I.U/ML | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1354 | 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 |
| 1355 | NDA/MAL/HDP/1745 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIGEN | GENTAMYCIN SULPHATE | 0.3%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1356 | NDA/MAL/HDP/1747 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PRESARTAN H 50 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| 1357 | NDA/MAL/HDP/1750 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIFLOX | NORFLOXACIN | 0.3%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1358 | NDA/MAL/HDP/1751 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OPTIFUCIN | FUSIDIC ACID | 1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X5.0 ML AMPOULE | 01/07/2005 |
| 1359 | NDA/MAL/HDP/1753 | PHARMATEC PAKISTAN PVT LTD | HEALTHCARE LTD. | FLU-GONE-P. PLUS SYRUP | PARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE | 120MG/5ML + 15MG/5ML + 1MG/5ML | PHARMATEC PKISTAN (PVT) LTD-D-86/A, S.I.T.E., KARACHI - 75700, PAKISTAN | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 01/07/2013 |
| 1360 | NDA/MAL/HDP/1754 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIMOL | TIMOLOL MALEATE | 0.5%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 01/07/2005 |
| 1361 | NDA/MAL/HDP/1756 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APICROM 2% | SODIUM CROMOGLYCATE | 2%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1362 | NDA/MAL/HDP/1758 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APICORT | PREDNISOLONE ACETATE | 0.12%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1363 | NDA/MAL/HDP/1759 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | AMLOPIN | AMLODIPINE | 5MG | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 07/01/2004 |
| 1364 | NDA/MAL/HDP/1760 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEODEX | NEOMYCIN +DEXAMETHASONE | 0.5%W/V + 0.1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OTIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1365 | NDA/MAL/HDP/1761 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ATAZOR-R | ATAZANAVIR + RITONAVIR | 300 MG + 100 MG | EMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2014 |
| 1366 | NDA/MAL/HDP/1762 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APITROPIN | ATROPINE | 1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 01/07/2005 |
| 1367 | NDA/MAL/HDP/1763 | LABORATORY&ALLIED LTD | HARLEYS UGANDA 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 |
| 1368 | NDA/MAL/HDP/1764 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FRESH BURST LISTERINE | ALCOHOL + THYMOL | 95 % W/V + 12 MG | JOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794 | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 01/07/2006 |
| 1369 | NDA/MAL/HDP/1765 | UMEDICA LABORATORIES PVT LTD | VITACARE LIMITED | RILIF PLUS | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| 1370 | 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 |
| 1371 | NDA/MAL/HDP/1769 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | 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 |
| 1372 | 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 |
| 1373 | 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 |
| 1374 | NDA/MAL/HDP/1777 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | NUZAC 20 | FLUOXETINE | 20MG | CIPLA LTD ..-PLOT NO. 910 & 15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH 454775 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 |
| 1375 | 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 |
| 1376 | 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 |
| 1377 | NDA/MAL/HDP/1781 | ASTRAZENECA | MACNAUGHTON LIMITED | ARIMIDEX | ANASTROZOLE | 1MG | ASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2000 |
| 1378 | 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 |
| 1379 | NDA/MAL/HDP/1783 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA 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 |
| 1380 | NDA/MAL/HDP/1784 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | AZICURE-500 | AZITHROMYCIN | 500MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |