Drug Register (April 2024)
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.
| NDA REGISTRATION NUMBER | LICENSE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | MANUFACTURER | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZE | REGISTRATION DATE |
|---|---|---|---|---|---|---|---|---|
| NDA/MAL/HHP/10012 | REVITAL HEALTHCARE (EPZ) LTD | REVITAL HEALTH CARE LTD | PILEENO OINTMENT | PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 28/02/2022 |
| NDA/MAL/HHP/10013 | REVITAL HEALTHCARE (EPZ) LTD | REVITAL HEALTH CARE LTD | SLIM TRIM CAPSULES. | PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER | 28/02/2022 |
| NDA/MAL/HHP/10014 | REVITAL HEALTHCARE (EPZ) LTD | REVITAL HEALTH CARE LTD | NEUROCARE | PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1X50 G TUBE | 28/02/2022 |
| NDA/MAL/HHP/10015 | REVITAL HEALTHCARE (EPZ) LTD | REVITAL HEALTH CARE LTD | DOMO CREAM. | PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 28/02/2022 |
| NDA/MAL/HHP/10016 | REVITAL HEALTHCARE (EPZ) LTD | REVITAL HEALTH CARE LTD | TOTO CARE. | PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X150.0 ML BOTTLE | 28/02/2022 |
| NDA/MAL/HHP/10017 | REVITAL HEALTHCARE (EPZ) LTD | REVITAL HEALTH CARE LTD | MARKONIL CREAM. | PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X100.0 G TUBE | 28/02/2022 |
| NDA/MAL/HHP/10019 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOMYN TABLETS | CHARAK PHARMA PRIVATE LIMITEDJAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER | 07/03/2022 |
| NDA/MAL/HHP/10024 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | LOZETS MENTHOMAX PLUS | PRINCE SUPPLICOPLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR | INDIA | ORAL SOLID ORDINARY LOZENGES | 1X50X2 LOZENGE BLISTER | 05/04/2022 |
| NDA/MAL/HHP/10026 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | NEOSILS HERBAL COUGH LOZENGES | LEAMARK HEALTHCARE PVT LTDSARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X25.0X2.0 LOZENGE STRIP | 11/04/2022 |
| NDA/MAL/HHP/10027 | BHARGAVA PHYTOLAB PVT. LTD | REDDYS PHARMA LIMITED | ACTIVATED CHARCOAL TABLETS | BHARGAVA PHYTOLAB PVT.LTDE-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X90.0 TABLET BOTTLE | 21/04/2022 |
| NDA/MAL/HHP/10411 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS ORANGE LOZENGES | LOZEN PHARMA PRIVATE LIMITEDRAGHAV 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 |
| NDA/MAL/HHP/10412 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS MENTHOL LOZENGES | LOZEN PHARMA PRIVATE LIMITEDRAGHAV 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 |
| NDA/MAL/HHP/10413 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS HONEY LEMON LOZENGES | LOZEN PHARMA PRIVATE LIMITEDRAGHAV 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 |
| 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 |
| NDA/MAL/HHP/10501 | SEGURA PHARMA PRIVATE LTD | ABACUS PHARMA (AFRICA) LIMITED | GOPAYN RUB GEL | SYNOKEM PHARMACEUTICALS LTD-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 02/12/2022 |
| NDA/MAL/HHP/10588 | CHETAN & DIPTI (C&D) PHARMA PVT LTD | KAMCARE PHARMA LIMITED | CHARCO PRO TABLET | M/S BHARGAVA PHYTOLAB PRIVATE LIMITEDE-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 |
| NDA/MAL/HHP/10780 | CONFO INTERNATIONAL LTD | DAVIMED PHARMA LIMITED | CONFO | ZHEJIANG CONBA PHARMACEUTICAL COMPANY LIMITED1ST CONBA AVENUE, LANXI, ZHEJIANG - CHINA | CHINA | | TOPICAL EXTERNAL LIQUIDS | 1.0X3.0 ML CONTAINER | 14/03/2023 |
| NDA/MAL/HHP/10899 | ARIHANT REMEDIES | DAVIMED PHARMA LIMITED | RELIEF OINTMENT | ARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X50.0 G TUBE | 27/07/2023 |
| NDA/MAL/HHP/10901 | ARIHANT REMEDIES | DAVIMED PHARMA LIMITED | RELIEF BALM | ARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X100.0 G CONTAINER | 27/07/2023 |
| NDA/MAL/HHP/10902 | ARIHANT REMEDIES | DAVIMED PHARMA LIMITED | COLD GRIP INHALER | ARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X0.5 ML CONTAINER | 27/07/2023 |
| NDA/MAL/HHP/11013 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | DEEP RUBY BALM | ARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | TOPICAL EXTERNAL OINTMENTS | 1X1X10 G BOTTLE | 13/10/2023 |
| NDA/MAL/HHP/11014 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | DEEP RUBY ROLL ON | HILTON PHARMA CHEMPLOT NO. 225, G.I.D.C, SIDHPUR - 384151, PATAN - INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1X1X10 ML BOTTLE | 13/10/2023 |
| NDA/MAL/HHP/3115 | CINCINNATI CHILDREN’S HOSPITAL | SHURIK LTD | RHINO BALM | MEHTA UNANI PHARMACY & CO LTDINDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER | 01/07/2001 |
| NDA/MAL/HHP/5500 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | APTIZOOOM SYRUP | CHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | CHARAK PHARMA PRIVATE LIMITEDJAURASI 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 |
| NDA/MAL/HHP/5502 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | GASEX | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE) | 01/07/2000 |
| NDA/MAL/HHP/5517 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | MENTAT | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0 TABLET CONTAINER | 01/07/2004 |
| NDA/MAL/HHP/5518 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | PENODEX OINTMENT | MEHTA UNANI PHARMACY & CO LTDINDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G CONTAINER | 01/07/2007 |
| 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 |
| NDA/MAL/HHP/5520 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | PILEX | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HHP/5527 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | KOFLET | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HHP/5528 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | AQUAREST | 288,SIDCO ESTATEAMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X765.0 MG SACHET | 01/07/2009 |
| NDA/MAL/HHP/5530 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | LIV.52 TABLETS | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE | 01/07/2000 |
| NDA/MAL/HHP/5531 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | RUMALAYA | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2000 |
| NDA/MAL/HHP/5532 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | ATMANANTHAN COLD RUB | META UNANI PHARMACY & CO PVTG 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI | INDIA | | NASAL TOPICAL LIQUID INHALATIONS | 1.0X12.0X1.0 G ROD | 01/07/2009 |
| NDA/MAL/HHP/5533 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | RUMALAYA | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE) | 01/07/2000 |
| NDA/MAL/HHP/5536 | ABACUS (A) PHARMA LTD | JEET PHARMACEUTICALS LIMITED | MENTHO PLUS PAIN BALM | EMAMI LTDEMAMI 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 |
| NDA/MAL/HHP/5538 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | SEPTILIN | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2000 |
| 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 |
| NDA/MAL/HHP/5547 | CINCINNATI CHILDREN’S HOSPITAL | SHURIK LTD | MENTHOSIL COUGH DROP | MEHTA HERBALS PVT LTDINDIA | INDIA | | ORAL SOLID ORDINARY LOZENGES | 1.0X35.0X2.0 LOZENGE STRIP | 01/07/2001 |
| NDA/MAL/HHP/5549 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | BONISAN LIQUID | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 01/07/2000 |
| 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 |
| NDA/MAL/HHP/5557 | BETA HEALTH CARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | NEW BETA GRIPE WATER | SYDLER REMEDIES PVT LTDM-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 |
| NDA/MAL/HHP/5559 | CINCINNATI CHILDREN’S HOSPITAL | SHURIK LTD | STAR SKIN OINTMENT | MEHTA UNANI PHARMACY & CO LTDINDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X12.0 G TUBE | 01/07/2001 |
| NDA/MAL/HHP/5563 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | CYSTONE | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HHP/5564 | AIL HEALTH CARE | VRUSHIK INVESTMENT LIMITED | FRESH HERBAL COUGH SYRUP | AIL HEALTH CARE816/1 RAKANPUR KALOL GENDHINAGAR GUJRAT | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HHP/5570 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | SITCOM | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HHP/5572 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | VIGOMAX FORTE | CHARAK PHARMA PVT LTDJAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HHP/5574 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NEW PINKOO GRIPE WATER | AJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HHP/5580 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGICA SYRUP | DHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY | VIETNAM | ORAL LIQUID ORDINARY SYRUPS | 1X60 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HHP/5583 | HIMALAYA DRUG COMPANY. | EUROPA HEALTHCARE (U) LTD | EVECARE | HIMALAYA DRUG COMPANY27256287 INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER | 01/07/2001 |
| NDA/MAL/HHP/5587 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | MANOLL SYRUP | CHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | CHARAK PHARMA PVT LTDJAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X250.0 MG BOTTLE | 01/07/2016 |
| 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 |
| NDA/MAL/HHP/5613 | DR. KIM AYURVEDIC PHARMACY | MEDVIN PHARMA LIMITED | SMOOTH COUGH DROPS | DR KIM AYURVEDIC PHARMACYINDIA | INDIA | ORAL SOLID ORDINARY LOZENGES | 1X100X2 LOZENGE STRIP | 01/07/2005 |
| NDA/MAL/HHP/5620 | UNIQUE PHARMACEUTICAL LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ZECUF COLD RUB | UNIQUE PHARMACEUTICAL LABORATORIESPLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1X20 G CONTAINER | 01/07/2009 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HHP/6848 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | KOFOL (MINT) | LEAMARK HEALTHCARE PVT LTDSARKHEJ 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 |
| NDA/MAL/HHP/7929 | WOCKHARD LTD | STAR PHARMACEUTICALS LTD | MANIX HERBAL CAPSULES | TIRUPATI LIFESCIENCESNAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2015 |
| 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 |
| NDA/MAL/HHP/7934 | STAR PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SENSUR RUBEFACIENT | GLENMARK PHARMACEUTICAL LIMITED61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 01/07/2015 |
| NDA/MAL/HHP/7936 | SQUARE HERBAL AND NUTRACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | GILOBA 60 CAPSULE | SQUARE HERBAL AND NUTRACEUTICALS LTD48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X6.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HHP/7938 | SQUARE HERBAL AND NUTRACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | SILYBIN 140 | SQUARE HERBAL AND NUTRACEUTICALS LTD 48 MOHAKHALI COMERCIAL AREA, DHAKA-1212 | BANGLADESH | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HHP/7939 | SQUARE HERBAL AND NUTRACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | GINTEX | SQUARE HERBAL AND NUTRACEUTICALS LTD48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 | BANGLADESH | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X6.0 CAPSULE STRIP | 01/07/2014 |
| NDA/MAL/HHP/7940 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SENSUR LOTION | SYDLER REMEDIESPRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA | GLENMARK PHARMACEUTICAL LIMITED61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA | | TOPICAL EXTERNAL OTHER CREAMS | 1.0X50.0 ML BOTTLE | 01/07/2015 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HHP/7966 | BHARGAVA PHYTOLAB PVT LTD | REDDYS PHARMA LIMITED | KIDFLAME | BHARGAVA PHYTOLAB PVT LTDB-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HHP/7972 | MONA LAB | VRUSHIK INVESTMENT LIMITED | STOPAIN BALM | MONA LAB20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X9.0 G JAR,1.0X5.0 G CONTAINER | 01/07/2009 |
| 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 |
| 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 |
| NDA/MAL/HHP/8379 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | M2 TONE TABLET | CHARAK PHARMA PVT LTDINDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 20/09/2017 |
| NDA/MAL/HHP/8505 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOMYN SYRUP | CHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | CHARAK PHARMA PVT LTDINDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE | 02/02/2018 |
| 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 |
| NDA/MAL/HHP/8508 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | KOFOL SF SYRUP | CHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | CHARAK PHARMA PVT LTDINDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 02/02/2018 |
| NDA/MAL/HHP/8509 | CHARAK PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EVANOVA CAPSULE | CHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER | 29/11/2017 |
| NDA/MAL/HHP/8510 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FRICKS COUGH SYRUP | BLISS GVS PHARMA LIMITEDNO.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 |
| 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 |
| 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 |
| NDA/MAL/HHP/8556 | MANKIND PHARMA LTD. | TATA UGANDA LIMITED | UNIORTHO-500 | TIRUPATI LIFESCIENCESNAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 10/11/2017 |
| NDA/MAL/HHP/8837 | PILLAR PHARMA LIMITED | PILLAR LOGISTICS LIMITED | HEPTOVIT | MILENNIUM HERBAL CARE LTD12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 07/06/2018 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HHP/9115 | REVITAL HEALTHCARE LTD | HEALTHCARE LTD. | DO-MO CAPSULES | ABARIS HEALTHCARE PVT. LTDSURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X10.0 CAPSULE BLISTER | 16/07/2019 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HHP/9182 | REVITAL HEALTHCARE LTD | HEALTHCARE LTD. | HERBICUF | ASIAN LIFECARE PVT.LTDMANJUSAR,SAVLI,VADODARA,GUJARAT, INDIA PLOT NO. 3 & 3/A,SHAH INDUSTRIAL PARK-2,NEAR LAMPDAPURA CROSSING,AT&PO | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 11/03/2020 |
| 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 |
| NDA/MAL/HHP/9332 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGICA IVY SYRUP | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 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 |
| NDA/MAL/HHP/9333 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGICA MOUTH SPRAY | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 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 |
| NDA/MAL/HHP/9570 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | BIO-SLIM ACTIVE | GAYATRI AYUPHARMA PRIVATE LIMITED234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X6X10 CAPSULE BLISTER | 22/03/2021 |
| NDA/MAL/HHP/9694 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | THROWCUF SYRUP | KESAR PHARMA PVT LTDPLOT 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 |
| NDA/MAL/HHP/9701 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | THROWCUF PLUS SYRUP | KESAR PHARMA PVT LTDPLOT 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 |
| NDA/MAL/HHP/9703 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | CURODEX OINTMENT | RAJESH PHARMACEUTICALS7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G BOTTLE | 27/08/2021 |
| NDA/MAL/HHP/9704 | GRIFFON BIOMETRIX PVT.LTD | ABACUS PHARMA (AFRICA) LIMITED | MENTHOXYL INHALER | RAJESH PHARMACEUTICALS7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | | NASAL TOPICAL LIQUID INHALATIONS | 1.0X0.5 ML INHALER | 27/08/2021 |
| 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 |
| NDA/MAL/HHP/9711 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | GINSOMIN | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 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/MAL/HHP/9923 | GAYATRI AYUPHARMA PRIVATE LIMITED | VIDA AFRICA LTD | CHARCO-PLUS | GAYATRI AYUPHARMA PRIVATE LIMITED234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 21/12/2021 |
| 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 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | SOOTHING OIL | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | UNKNOWN OILS | 1X100 ML BOTTLE, 1X250 ML BOTTLE | 01/07/2016 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NDA/MAL/HDP/0007 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROCIP SYRUP | CYPROHEPTADINE HYDROCHLORIDE | 2MG/5ML | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0012 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | PENGESIC SR | TRAMADOL HYDROCHLORIDE SR | 100MG | HOVID BHDLOT 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 |
| NDA/MAL/HDP/0013 | ORGANON SOUTH AFRICA (PTY) LTD | SURGIPHARM (U) LIMITED | IMPLANON NXT | ETONOGESTREL | 68MG | N.V. ORGANONKLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND | NETHERLANDS | | PARENTERAL RETARD IMPLANTS | 1.0X68.0 MG IMPLANT | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/0017 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | S-HYDRO | HYDROCORTISONE | 100MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X7.5 ML VIAL, 1.0X50.0X100.0 MG VIAL | 01/07/2011 |
| NDA/MAL/HDP/0021 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | QUINS | QUININE DIHYDROCHLORIDE | 300MG/ML | SAKAR HEALTHCARE PVT. LTDPLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/0022 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | QUININE SULPHATE | QUININE SULPHATE | 300MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2009 |
| NDA/MAL/HDP/0024 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMPICLOXA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| 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 |
| 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 |
| NDA/MAL/HDP/0033 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYVATE CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/0041 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RECIM | CIMETIDINE | 200MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0045 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL CAPLETS | PARACETAMOL | 500MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0056 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR QPS | DICLOFENAC | 4%W/V | TROIKAA PHARMACEUTICALS LTDTHOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | TROIKAA PHARMACEUTICALS LTDBLOCK 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 |
| NDA/MAL/HDP/0058 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | WATER FOR INJECTION B.P. | WATER FOR INJECTION | N/A | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE | 01/07/1997 |
| 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 |
| 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 SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | MERCK SERONO S.A -SUCCURSALE D'AUBONNE, ZONE INDUSTRIELLE DE L'OURIETTAZ, 1170 AUBONNE, SWITZERLAND | | ITALY | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION | 01/07/2015 |
| 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 |
| 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 SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND | | ITALY | SWITZERLAND | PARENTERAL ORDINARY CARTRIDGES | 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION | 01/07/2015 |
| NDA/MAL/HDP/0065 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | ALENDRONATE 70MG | ALENDRONATE SODIUM | 70MG | HOVID BHDLOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMOR | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/0067 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | ARTEES | ?-? ARTEETHER INJECTION | 75MG/ML | SAKAR HEALTHCARE PVT LTD -406, SILVER OAKS COMMERCIAL COMPLEX, | INDIA | PARENTERAL ORDINARY AMPOULES | 1X3.2 ML AMPOULE | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/0079 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | REVOKE 72 | LEVONORGESTREL | 750MCG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0083 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ZINNIA-F | LEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE | 150MCG + 30MCG + 75MG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER | 01/07/2014 |
| 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 LTDPLOT 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 |
| NDA/MAL/HDP/0097 | MSN LABORATORIES LTD | METRO PHARMACEUTICALS LIMITED | SAFELEVO 750 | LEVOFLOXACIN | 750MG | MSN LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0098 | MSN LABORATORIES LTD | METRO PHARMACEUTICALS LIMITED | ATOREM 10 | ATORVASTATIN | 10MG | MSN LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0101 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTETRA CAPSULES | TETRACYCLINE HYDROCHLORIDE | 250MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0102 | MSN LABORATORIES PRIVATE LIMITED, | METRO PHARMACEUTICALS LIMITED | SILMELT 100 | SILDENAFIL CITRATE | 100MG | MSN LABORATORIES LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0104 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | SILMELT 50 | SILDENAFIL CITRATE | 50MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X2.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0105 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOSPRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0110 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI 40 | TELMISARTAN | 40MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0111 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI 80 | TELMISARTAN | 80MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0112 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 5MG/160MG | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | NOVARTIS PHARMA STEIN AGH-4332 STEIN SCHAFFAUSERTRASSE | NOVARTIS FARMACEUTICA SARONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/0114 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS 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 |
| NDA/MAL/HDP/0116 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | BREATHEZY CW 5 | MONTELUKAST SODIUM | 5MG | MSN LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0118 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 750MG | CEFUROXIME SODIUM | 750MG | SANCE LABORATORIES PVT LTDVI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | ALKEM LABORATORIES LTDVILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL + 1 AMPOULE WFI | 01/07/2013 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0139 | DAWA LIMITED- | SUPER MEDIC LTD | MOXAFORTE | FLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE | 250MG + 250MG | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0157 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RECODIN | CODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE | 10MG + 4MG /5ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/0158 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | KIPEL 10 | MONTELUKAST SODIUM | 10MG | MSN LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0160 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | TIZIGESIC | TIZANIDINE HYDROCHLORIDE | 2MG | UNICHEM LABORATORIES LIMITEDC–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 |
| NDA/MAL/HDP/0161 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TRAMAREN | TRAMADOL HYDROCHLORIDE | 50MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0162 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COSYP-D LINCTUS | DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE | 10MG +4MG /5ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/0163 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PHENAREN | PROMETHAZINE HYDROCHLORIDE | 5MG/5ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/0164 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENPRESS | PROPRANOLOL | 40MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0166 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | X-PEL | MEBENDAZOLE | 100MG/5ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/0168 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | FEBUDAY | FEBUXOSTAT | 80MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| 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 |
| 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 |
| NDA/MAL/HDP/0182 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | FEBUDAY 40 | FEBUXOSTAT | 40MG | MSN LABORATORIES LTDPLOT 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0188 | AMOUN PHARMACEUTICALS LTD | BOOTS PHARMACEUTICALS LIMITED | LEVOXIN | LEVOFLOXACIN | 500MG | AMOUN PHARMACEUTICALS CO. S.A.E1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0190 | AMOUN PHARMACEUTICAL COMPANY | BOOTS PHARMACEUTICALS LIMITED | ACNE FREE CREAM | TRETINOIN | 50MG | AMOUN PHARMACEUTICALS CO. S.A.E1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | TOPICAL EXTERNAL CREAMS | , 1X30 G TUBE | 01/07/2014 |
| NDA/MAL/HDP/0191 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CLEDOMOX 228.5 | AMOXICILLIN + CLAVULANATE | 200 MG + 28.5 MG | MEDOPHARM PVT LTD.NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/0193 | MEDOPHARM, INDIA | VITACARE LIMITED | CLEDOMOX 625 | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | MEDOPHARM PVT LTD.NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET STRIP | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0203 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | SERETIDE EVOHALER 250 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG + 250MCG | GLAXO WELLCOMEPRODUCTION 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 |
| NDA/MAL/HDP/0204 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | TIVICAY | DOLUTEGRAVIR SODIUM | 50MG | GLAXOSMITHKLINE PHARMACEUTICALS SAGRUNWALDZKA 189 STREET, 60-322 POZNANA | GLAXO OPERATIONS UK LTDWARE SG120DJ UNITED KINGDOM | UNITED KINGDOM | POLAND | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/0209 | HETERO LABS LTD | AIVEEN (U) LIMITED | ABACAVIR SULPHATE ORAL SOLUTION | ABACAVIR SULPHATE | 20MG/ML | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1X240 ML BOTTLE | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/0221 | DAWA LIMITED | SUPER MEDIC LTD | AMPICLO-DAWA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0222 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | AVIR-200 | ACYCLOVIR | 200MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | LINCOLN PHARMACEUTICALS LTD .10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0230 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | COMBIART | ARTHEMETHER + LUMEFANTRINE | 20MG +120MG | UNIVERSAL CORPORATION LIMITEDPLOT NO 13777, PO BOX 1748-00902 KIKUYU CLUB RD | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0244 | SAKAR HEALTHCARE PVT LTD | ROYAL PHARMA 2011 LIMITED | HYOCIN | HYOSCINE BUTYLBROMIDE | 20MG/ML | SAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 01/07/2014 |
| NDA/MAL/HDP/0248 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PANTONEX DR-40 | PANTOPRAZOLE | 40 MG | .IPCA LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0250 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DIKON | DICLOFENAC | 1%W/W | LINCOLN PHARMACEUTICALS LTD .10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0254 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 5 | BISOPROLOL HEMIFUMARATE | 5MG | WINTHROP PHARMACEUTICALS(PTY) LTD,315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | MERCK KGAA250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | GERMANY | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0255 | BYANSI SERVICES LIMITED | AIVEEN (U) LIMITED | CAPETERO 150 | CAPECITABINE | 150MG | HETERO LABS (UNIT VI), INDIAAPIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X60 TABLET CONTAINER | 01/07/2015 |
| NDA/MAL/HDP/0256 | HETERO LABS LTD | AIVEEN (U) LIMITED | CAPETERO 500 | CAPECITABINE | 500MG | HETERO LABS (UNIT VI), INDIAAPIIC, 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 |
| 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. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON | 01/07/2001 |
| 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 |
| 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 |
| NDA/MAL/HDP/0271 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | BETT | TETANUS VACCNE ADSORBED | 40 I.U | BIOLOGICAL E LTDPLOT 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 |
| NDA/MAL/HDP/0272 | HETERO LABS LTD | AIVEEN (U) LIMITED | LEVIN 250 | LEVOFLOXACIN | 250MG | 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 | 01/07/2019 |
| NDA/MAL/HDP/0275 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | ZENTEL | ALBENDAZOLE | 400MG | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED39 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0283 | DAWA LIMITED | SUPER MEDIC LTD | AMPICLO-DAWA | AMPICILLIN + CLOXACILLIN | 125 MG + 125 MG | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/0298 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | SEFIXI-50 DRY SYRUP | CEFIXIME | 50MG | SAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 01/07/2013 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0308 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFAX-250 | CEFALEXIN | 250MG | SAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0312 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXISPA ORAL SOLUTION 125 | CLOXACILLIN | 125MG/5ML | SPARSH BIO-TECH LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0317 | YURIA PHARM LTD-UKRAINE | PHARMA VILLE LIMITED | CIPROFLOXACIN-UF | CIPROFLOXACIN | 2MG/ML | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/0322 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-5 | NEBIVOLOL HCL | 5MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/0326 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | OSTEBON | CALCIUM + COLECALCIFEROL | 250MG + 125 IU | ARISTO PHARMACEUTICALS PVT LIMITEDPLOT 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 |
| NDA/MAL/HDP/0333 | KOPRAN LIMITED | TATA UGANDA LIMITED | CLAVAMYN-625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500MG +125MG | KOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2014 |
| 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 LTDB-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/0337 | IND-SWIFT | PLANET PHARMACEUTICALS UGANDA LTD | SWAZI *500 | AZITHROMYCIN | 500MG | IND SWIFT LTDGLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER, 1.0X10.0X1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0339 | IND-SWIFT | PLANET PHARMACEUTICALS UGANDA LTD | SWAZI *250 | AZITHROMYCIN | 250MG | IND SWIFT LTDGLOBAL 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 |
| NDA/MAL/HDP/0341 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | TELSWIFT- H 40 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | IND SWIFT LTDGLOBAL 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 |
| NDA/MAL/HDP/0342 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | TELSWIFT- H 80 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | IND SWIFT LTDGLOBAL 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 |
| NDA/MAL/HDP/0348 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | XBETA | BETAMETHASONE SODIUM PHOSPHATE | 0.1%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 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 |
| NDA/MAL/HDP/0349 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | CLAXY 1.2 G | COAMOXICLAV | 1.2G | SWISS PARENTERALS (UNIT-2), PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, G.I.D.C., NR. BAVLA, DIST. AHMEDABAD- 382 220, GUJARAT, INDIA. | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL | 01/07/2013 |
| NDA/MAL/HDP/0350 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CETRIREN | CETIRIZINE HYDROCHLORIDE | 10MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/0354 | KOPRAN LIMITED | TATA UGANDA LIMITED | LEVOKOP | LEVOFLOXACIN | 500MG | KOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0355 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | BICO VITA | THIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE | 10MG + 0.1MG + 1MG + 10MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2015 |
| NDA/MAL/HDP/0358 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | STREPTOCIN | STREPTOMYCIN SULPHATE | 1GM | SWISS PARENTERALS LTD809 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 |
| NDA/MAL/HDP/0360 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 20MG | ESOMEPRAZOLE | 20MG | ASTRA ZENECA AB, SODERTALJEGARTUNAYEGEN, 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 |
| NDA/MAL/HDP/0362 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | BUPI | BUPIVACAINE | 5 MG/ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2015 |
| NDA/MAL/HDP/0363 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | AGYCIN | AZITHROMYCIN | 250MG | BLISS GVS PHARMA LIMITEDNO.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 |
| NDA/MAL/HDP/0366 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | AGYCIN 500 | AZITHROMYCIN | 500MG | BLISS GVS PHARMA LIMITEDNO.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 |
| NDA/MAL/HDP/0370 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-H | NEBIVOLOL + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/0372 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | LEZYNCET | LEVOCETIRIZINE | 5MG | UNICHEM LABORATORIES LIMITEDUNICHEM 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 |
| NDA/MAL/HDP/0376 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-D | AMLODIPINE + HYDROCHLOROTHIAZIDE | 2.5 MG + 12.5 MG | EMCURE PHARMACEUTICALS LTDLANE 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 |
| NDA/MAL/HDP/0386 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-80 | ENOXAPARIN SODIUM | 80MG/ 0.8ML | EMCURE PHARMACEUTICALS LTD PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0389 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANMOL INFUSION IV | PARACETAMOL | 1000MG/100ML | PT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0397 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-LT | AMLODIPINE + LOSARTAN POTASSIUM | 2.5 MG + 50 MG | EMCURE PHARMACEUTICALS LTDLANE 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 |
| NDA/MAL/HDP/0401 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | L MONTUS | LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | FOURRTS (INDIA) LABORATORIES (PVT) LTDFOURRTS AVENUE, VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2015 |
| 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 |
| 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 |
| NDA/MAL/HDP/0406 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | EVATOCIN | OXYTOCIN | 10 I.U./ ML | NEON LABORATORIES LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0408 | MSN LABORATORIES LTD | METRO PHARMACEUTICALS LIMITED | ALGIC - P | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | MSN LABORATORIES LTDPLOT 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0411 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | JADELLE SINE | LEVONORGESTREL | 150MG | BAYER OYPANSIONATE 47 20210 TURKU FINLAND | FINLAND | | PARENTERAL RETARD IMPLANTS | 1.0X10.0X1.0X2.0X75.0 MG IMPLANT | 01/07/2003 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0421 | MSN LABORATORIES PRIVATE LIMITED, | METRO PHARMACEUTICALS LIMITED | PREGASAFE 150 | PREGABALIN | 150MG | MSN LABORATORIES LTDPLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0422 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PARAFLAM | IBUPROFEN + PARACETAMOL | 100MG + 162.5MG /5ML | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0423 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRAM | TRAMADOL | 50MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0429 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FLEXON MR | IBUPROFEN + PARACETAMOL + CHLORZOXAZONE | 400MG + 325MG + 250MG | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT 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 |
| NDA/MAL/HDP/0430 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO ACECLO PLUS | ACECLOFENAC+PARACETAMOL | 100MG+500MG | ARISTO PHARMACEUTICALS PVT LIMITEDPLOT 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 |
| 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. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/0433 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | PROANES MCT/LCT | PROPOFOL | 1%W/V | PT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | | PARENTERAL ORDINARY I V AMPOULES | 1.0X5.0X20.0 ML AMPOULE | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0441 | AGIO PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | AGISEC | SECNIDAZOLE | 1GM | AGIO PHARMACEUTICALS LTDPLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/0449 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMINOGUARD GRANULES | CYANOCOBALAMIN | 5MCG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. 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 |
| 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 |
| NDA/MAL/HDP/0453 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMINOGUARD LIQUID | AMINO ACIDS + MULTIVITAMINS | MULTI INGREDIENTS | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. 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 |
| NDA/MAL/HDP/0454 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | LEVOCIN INFUSION | LEVOFLOXACIN HEMIHYDRATE | 500 MG | PT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0460 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 7.5MG/ML | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X15.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/0463 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TOPHEN | PHENYTOIN | 100MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0470 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVOMIX 30 FLEXPEN | INSULIN ASPART | 100I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERD | DENMARK | BRAZIL | FRANCE | PARENTERAL ORDINARY DRY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| NDA/MAL/HDP/0471 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVORAPID FLEXPEN | INSULIN ASPART | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERD | DENMARK | BRAZIL | FRANCE | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| 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 PRIVATE LIMITEDS/NO 105-110, MANJARI BUDRUK, TAL - HAVEIL, PUNE 412307 - INDIA | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL,1.0X0.5 ML VIAL | 01/07/2015 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0491 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCHLOR EYE DROPS | CHLORAMPHENICOL | 0.5% W/V | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/0493 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PRASUSAFE 10 | PRASUGREL | 10MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1X3X10 TABLET BLISTER | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0497 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | KEMOXYL DRY SUSPENSION | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | LABORATORY & ALLIED LTDPLOT 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 |
| NDA/MAL/HDP/0502 | STEDMAN PHARMACEUTICALS LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ GARGLE | IODINATED POVIDONE | 2%W/V | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. 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 |
| NDA/MAL/HDP/0507 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FILDILOL 12.5 | CARVEDILOL | 12.5 MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0509 | FOURRTS (INDIA) LABORATORIES (PVT) LTD | DELMAW ENTERPRISES LIMITED | FILDILOL 25 | CARVEDILOL | 25MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/0510 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | LIZOLID-600 | LINEZOLID | 600MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET STRIP | 01/07/2004 |
| NDA/MAL/HDP/0512 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 10 | ATORVASTATIN CALCIUM | 10MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0515 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 20 | ATORVASTATIN | 20MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0518 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CYCLOREN | ACICLOVIR | 200MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2014 |
| NDA/MAL/HDP/0520 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 40 | ATORVASTATIN CALCIUM | 40MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0521 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PAN 40 | PANTOPRAZOLE SODIUM | 40MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | ALKEM LABORATORIES LTD . VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0526 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | AMILEB- 25 | AMITRIPTYLINE | 25MG | LEBEN LABORATORIES PVT. LTDPLOT 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0542 | DAWA LIMITED | SUPER MEDIC LTD | PHENBITAL | PHENOBARBITAL | 30MG | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0543 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GLIMERYL 2 | GLIMEPIRIDE | 2MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.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 |
| NDA/MAL/HDP/0544 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0547 | NAARI LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | MISO-KARE | MISOPROSTOL | 200MCG | NAARI PHARMA PRIVATE LIMITEDPLOT 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0555 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | CARZEPIN | CARBAMAZEPINE | 200MG | HOVID BHDLOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0558 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABGENTA EYE DROPS | GENTAMICIN SULPHATE | 0.3% W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 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 |
| NDA/MAL/HDP/0559 | HOVID BHD | MEDICAL ACCESS (UGANDA) LIMITED | DIABETMIN RETARD | METFORMIN HYDROCHLORIDE | 850MG | HOVID BHDLOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/0566 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFROTIL SUSPENSION | CEFUROXIME AXETIL | 125MG/5ML | SAKAR HEALTHCARE PVT. LTDPLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0X50.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/0568 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FLUOXIREN | FLUOXETINE | 20MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0572 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | AZARGA | BRINZOLAMIDE + TIMOLOL | 10MG/ML + 5MG/ML | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 01/07/2010 |
| 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 |
| 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 |
| NDA/MAL/HDP/0576 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | 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 |
| 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 |
| NDA/MAL/HDP/0582 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ACECLO SERA | ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE | 100MG + 500MG + 15MG | ARISTO PHARMACEUTICALS PVT LTDVILLAGE: 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 |
| 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 |
| NDA/MAL/HDP/0587 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CADIGREL | CLOPIDOGREL | 75MG | CADILA PHARMACEUTICALS LIMITED1389, 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0596 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-H | TELMISARTAN/HYDROCHLOROTHIAZIDE | 40MG/12.5MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2011 |
| 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 |
| NDA/MAL/HDP/0599 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | GRAMOCEF-O-400 | CEFIXIME | 400MG | MICROLABS LIMITEDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0603 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | GROMIN SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTDPLOT 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0611 | GALPHAR LABORATORIES LTD | DAWASANA PHARMACEUTICALS LTD | GALCIPRO 500 | CIPROFLOXACIN HYDROCLORIDE|CIPROFLOXACIN HYDROCHLORIDE | 500MG | GALPHA LABORATORIES LIMITEDVILLAGE €“ THANA BADDI, TEHSIL BADDI SOLAN HIMACHAL PRADESH-173 205 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/0614 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | 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 |
| 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 |
| NDA/MAL/HDP/0619 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D10 | GLUCOSE | 10%W/V | ABACUS PARENTERAL DRUGS LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0626 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CARDIPAC-10 | AMLODIPINE BESILATE | 10MG | KPI INDUSTRIES (1996) LTDPLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/0627 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AMOXIKID | AMOXICILLIN TRIHYDRATE | 125MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDPLOT 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 |
| NDA/MAL/HDP/0633 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CIPROCIN | CIPROFLOXACIN | 0.3%W/V | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/0634 | MEDLEY PHARMACEUTICALS | EUROPA HEALTHCARE (U) LTD | TRISOLIV | ANDROGRAPHOLIDES/TRICHOLINE CITRATE | 50MCG+50MG/ML | MEDLEY PHARMACEUTICALS LTDPLOT 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 |
| NDA/MAL/HDP/0635 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-AMIN | AMINOPHYLLINE | 100MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0636 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | REVOKE-1.5 | LEVONORGESTREL | 1.5MG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0637 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | ZUDICORT | FUSIDIC ACID + BETAMETHASONE VALERATE | 20MG + 1MG/G | NABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2014 |
| NDA/MAL/HDP/0638 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABLOL-5 EYE DROPS | TIMOLOL MALEATE | 0.5% W/V | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/0639 | NEM LABORATORIES (PVT) LTD | RENE PHARMACY LTD | RHEUMATIC CREAM | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/0654 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN / METFORMIN | 50MG/500MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHRGERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/0657 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN / METFORMIN | 50MG / 850MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHRGERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0658 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN/ METFORMIN | 50MG/1000MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHRGERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/0668 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELI 40 | TELMISARTAN | 40MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0670 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FLUNAZ-200 | FLUCONAZOLE | 200MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0672 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGONOR TABLETS | NORFLOXACIN | 400MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0674 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODAPS-100 | DAPSONE | 100MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0675 | ABACUS PHARMA (A) LTD. | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL METRONIDAZOLE 400 | METRONIDAZOLE | 400MG | KOTRA PHARMA-BHD 1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/0677 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DOPAMET | METHYLDOPA | 250MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0679 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | MEFENA-250 CAPSULES | MEFENAMIC ACID | 250MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0681 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ELAXIM 40 | TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR) | 40MG/VIAL | GENNOVA BIOPHARMACEUTICALS LIMITEDBLOCK 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0688 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | HBB | HYOSCINE BUTYLBROMIDE | 10MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0689 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGONAL | NALIDIXIC ACID | 500MG | AGOG PHARMA LTDPLOT 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 |
| 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 LTDISSAPUR P.O DAPPAR 140506 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2014 |
| 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 |
| 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 |
| NDA/MAL/HDP/0693 | DAWA LIMITED | SUPER MEDIC LTD | MOXACIL -250 | AMOXYCILLIN TRIHYDRATE | 250MG | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2014 |
| NDA/MAL/HDP/0694 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DT ZINC-20 TABLETS | ZINC SULPHATE | 20MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/0696 | BYANSI SERVICES LIMITED | AIVEEN (U) LIMITED | RITONAVIR | RITONAVIR | 100MG | HETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2014 |
| NDA/MAL/HDP/0702 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEPTOCIN | STREPTOMYCIN SULPHATE | 1GM | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 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 |
| 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 |
| NDA/MAL/HDP/0704 | HETERO LABS LTD UNIT IX | AIVEEN (U) LIMITED | M-FLOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | HETERO LABS LTDUNIT II & III BADDI THE NALAGARH DIST SOLAN H.P | 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,10.0X1.0X5.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0705 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ACICLOVIR | ACICLOVIR | 5%W/W | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2011 |
| 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 |
| NDA/MAL/HDP/0707 | HETERO LABS LTD | AIVEEN (U) LIMITED | PENVIR 500 | FAMCICLOVIR | 500MG | HETERO LABS LTD(UNIT V).JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0712 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | ZENTEL | ALBENDAZOLE | 100MG/5ML | ASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSEINDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOE | FRANCE | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/0713 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 20 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 20MG | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN | 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 |
| NDA/MAL/HDP/0715 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40MG | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN | 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 |
| NDA/MAL/HDP/0718 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | GLYMET-2 | GLIMEPIRIDE+METFORMIN HYDROCHLORIDE | 2MG + 500MG | LINCOLN PHARMACEUTICALS L.T.DTRIMUL 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 |
| 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 |
| NDA/MAL/HDP/0720 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | JUSDEE 400 DROPS | COLECALCIFEROL | 400 I.U/ML | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. 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 |
| 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 |
| 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 |
| 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 LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X225.0 ML BOTTLE | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/0732 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | VOLTAMED-100 | DICLOFENAC | 100 MG | MEDICO REMEDIES PVT LIMITED8 & 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 |
| NDA/MAL/HDP/0734 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | OMMED -20 | OMEPRAZOLE | 20MG | MEDICO REMEDIES PVT LIMITED8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2015 |
| 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 |
| 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 |
| NDA/MAL/HDP/0741 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOCIPRIN | CIPROFLOXACIN | 500MG | MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 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 |
| 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, KENYARANGWE 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 |
| NDA/MAL/HDP/0748 | BAYER PHARMA | SURGIPHARM (U) LIMITED | XARELTO 15MG | RIVAROXABAN | 15MG | BAYER PHARMA AG 51368 LEVERKUSENBAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0749 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEROGRAM 1000 | MEROPENEM | 1000MG | AURONEXT PHARMA PVT LTD.A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X1 G VIAL | 01/07/2014 |
| NDA/MAL/HDP/0750 | BAYER PHARMA | SURGIPHARM (U) LIMITED | XARELTO 20MG | RIVAROXABAN | 20MG | BAYER PHARMA AG 51368 LEVERKUSENBAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0751 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN | ACECLOFENAC | 100MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0754 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TORAS DENK 10 | TORASEMIDE | 10MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/0764 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORVADIL 5 | AMLODIPINE | 5MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2011 |
| NDA/MAL/HDP/0765 | SHANGHAI DAHUA PHARMACEUTICAL CO., LTD. | UNITED HEALTHCARE DISTRIBUTORS LTD | LEVOPLANT | LEVONORGESTREL | 75MG | SHANGHAI DAHUA PHARMACEUTICAL CO. LTDCHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI | CHINA | | PARENTERAL RETARD IMPLANTS | 1.0X10.0X2.0 ROD IMPLANT | 01/07/2010 |
| 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 |
| 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 |
| NDA/MAL/HDP/0772 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA - 150 | PREGABALIN | 150MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0775 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA - 75 | PREGABALIN | 75MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/0784 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HEMOSAN | FERROUS FUMERATE | 300MG | COSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0792 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | AS-V | PHENOXYMETHYL PENICILLIN | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTDPLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP | 01/07/2010 |
| NDA/MAL/HDP/0794 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | AMYGYDEX | TOBRAMYCIN/DEXAMETHASONE | 3MG+1MG/ML | REMINGTON PHARMACEUTICALS (PVT) LTD18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN | PAKISTAN | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/0795 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPEN-250 | PHENOXYMETHYL PENICILLIN POTASSIUM | 250MG | MILAN LABORATORIES (INDIA) PVT LTD .PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0802 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE HCT 5MG/ 160MG/12.5MG | AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 5MG+ 160MG+ 12.5MG | NOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS FARMACEUTICA SARONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/0811 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN -SR | ACECLOFENAC | 200MG | MICRO LABS LTD92, 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 |
| NDA/MAL/HDP/0816 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 2 | GLIMEPIRIDE | 2MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/0821 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 3 | GLIMEPIRIDE | 3MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/0822 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXCIN-500 | CLOXACILLIN SODIUM | 500MG | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0827 | GALPHA LABORATORIES LTD | DAWASANA PHARMACEUTICALS LTD | CLANOXY 1.2 | AMOXICILLIN/CLAVULANATE|AMOXICILLIN + CLAVULANATE|CLAVUNATE POTASSIUM |AMOXYCILLIN | 1000 MG + 200 MG|1000MG/200MG|200MG|1000MG | GALPHA LABORATORIES LTDAT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL | 01/07/2015 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0835 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBIS | BISACODYL | 5MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0853 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | BRUSTAN GEL | IBUPROFEN + LEVOMENTHOL | 5% W/W+ 3%W/W | SUN PHARMACEUTICAL IND. LTDPLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X50.0 G CONTAINER | 01/07/2012 |
| NDA/MAL/HDP/0855 | HETERO LABS LTD | AIVEEN (U) LIMITED | LAZINE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | HETERO LABS LTD22-110 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 |
| NDA/MAL/HDP/0857 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID-V6 VAGINAL TABLETS | CLOTRIMAZOLE | 100MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP | 01/07/2000 |
| NDA/MAL/HDP/0858 | ASTRA ZENECA | MACNAUGHTON LIMITED | PLENDIL | FELODIPINE | 5MG | ASTRAZENECA SWEDEN OPERATIONSASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | ASTRAZENECA PHARMACEUTICAL CO LTD.NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSU | CHINA | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/0864 | HETERO LABS LTD UNIT IX | AIVEEN (U) LIMITED | PANTIN-40 | PANTOPRAZOLE SODIUM | 40 MG | HETERO LABS LIMITED UNIT VAPIIC 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 |
| NDA/MAL/HDP/0866 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | LIZOLID | LINEZOLID | 2MG/ML | AMANTA HEALTHCARE LIMITEDPLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/0868 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | VARMIKA-500 | AMIKACIN | 500MG | SAKAR HEALTH CARE PVT, LTDBLOCK 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 |
| NDA/MAL/HDP/0870 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROY-K | PHYTOMENADIONE | 10MG/ML | TROIKAA PHARMACEUTICALS LIMITEDTHOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2010 |
| NDA/MAL/HDP/0871 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | DEXA | DEXAMETHASONE SODIUM | 4MG/ML | SAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X2X6X2 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/0873 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | OXYTOCIN INJECTION | OXYTOCIN | 10I.U/ML | SAKAR HEALTH CARE PVT LTD10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | | CHINA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2009 |
| 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 |
| 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 |
| NDA/MAL/HDP/0879 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | TRIBEES FORTE FILM COATED TABLETS | THIAMINE + PYRIDOXINE + CYANOCOBALAMIN | 200MG + 50MG +1000MCG | COSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/0882 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOVANCE 500MG/2.5MG | METFORMIN + GLIBENCLAMIDE | 500MG + 2.5MG | MERCK SANTE S.A.SCENTRE 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 |
| NDA/MAL/HDP/0883 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOVANCE 500MG/5MG | METFORMIN + GLIBENCLAMIDE | 500MG + 5MG | MERCK SANTE S.A.SCENTRE 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 |
| 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 LIMITEDBLOCK 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 |
| NDA/MAL/HDP/0895 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYORTH | SODIUM HYALURONATE | 10MG/1ML | VIRCHOW BIOTECH PVT, LTDSURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0 ML PRE- FILLED SYRINGE | 01/07/2015 |
| 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 |
| 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 |
| NDA/MAL/HDP/0902 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPINE SR | NIFEDIPINE | 20MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/0911 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HEALACE | RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B | 100MCG/G | VIRCHOW BIOTECH PVT, LTDSURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2015 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0928 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | INSTACLOP 75 | CLOPIDOGREL | 75MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| NDA/MAL/HDP/0929 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | DUOQUIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG +320MG | IPCA LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0938 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | ESOMEGA 20MG | ESOMEPRAZOLE|ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS | 20MG|20 | FEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0940 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | ESOMEGA 40MG | ESOMEPRAZOLE|ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS | 40MG|40 | FEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/0941 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA | AZITHROMYCIN | 200MG/5ML | AJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/0952 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | EFECTAL | CEFTRIAXONE | 1G | NEON LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/0953 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | CIZCAN | CISPLATIN | 10MG/10ML | NEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/0954 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | ANAWIN | BUPIVACAINE | 50MG/20ML | NEON LABORATORIES LTDPLOT 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 |
| 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 LTDISAAPUR P.O DAPPAR 140056 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2012 |
| NDA/MAL/HDP/0959 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN DISPERSIBLE 20/120 | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITED PAITHANMANUFACTURING 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 |
| NDA/MAL/HDP/0969 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-2.5 | AMLODIPINE BESILATE | 2.5MG | EMCURE PHARMACEUTICALS LTD LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/0974 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEF-3 | CEFIXIME | 100MG/5ML | SQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/0978 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMBROX 75 SR CAPSULE | AMBROXOL | 75MG | SQUARE PHARMACEUTICALS LIMITEDKALIAKOIR GAZIPUR – 1750, BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2012 |
| 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 |
| NDA/MAL/HDP/0986 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CONVENTIN | GABAPENTIN | 100MG | 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 |
| NDA/MAL/HDP/0988 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CADITOR 20 | ATORVASTATIN | 20MG | CADILA PHARMACEUTICALS LIMITED1389, 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/0997 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GENUPHIL | GLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE | 375MG+375MG+300MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/1000 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROYCURIUM | ATRACURIUM | 10MG/ML | TROIKAA PHARMACEUTICALS LIMITEDTHOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.5 ML AMPOULE | 01/07/2012 |
| 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 |
| NDA/MAL/HDP/10018 | RATNAMANI HEALTHCARE PVT. LTD | VIDA AFRICA LTD | BRUMAX PLUS TABLETS | IBUPROFEN + PARACETAMOL | 400MG + 325MG | RATNAMANI HEALTHCARE PRIVATE LIMITEDSURVEY 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 | 1X1X20 TABLET BLISTER | 28/02/2022 |
| NDA/MAL/HDP/1002 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CIPROKEN 750 | CIPROFLOXACIN | 750MG | SQUARE PHARMACEUTICALS LIMITEDKALIAKOIR GAZIPUR – 1750, BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/10030 | SAKAR HEALTHCARE LIMITED - | TATA UGANDA LIMITED | NISTAN | NYSTATIN | 100,000IU | SAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1X30 ML BOTTLE | 17/05/2022 |
| NDA/MAL/HDP/10033 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | EMCAR | CARBAMAZEPINE | 200 MG | MEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER | 14/07/2022 |
| NDA/MAL/HDP/10034 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | M-FLOX | MOXIFLOXACIN HYDROCHLORIDE | 0.5 %W/V | AUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI €“ 625 020 TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 14/07/2022 |
| NDA/MAL/HDP/10036 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOL | PARACETAMOL | 500 MG | MEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER | 14/07/2022 |
| NDA/MAL/HDP/10037 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BORINI-K | LANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN | 30 MG + 500 MG + 250 MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET STRIP | 14/07/2022 |
| NDA/MAL/HDP/10038 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CLEDOMOX 312.5 MG/5 ML | AMOXILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 312.5 MG/5 ML | MEDOPHARM PVT LIMITEDNO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML CONTAINER | 14/07/2022 |
| NDA/MAL/HDP/10039 | LEGIT MEDEQ 2007 LIMITED | LEGIT MEDEQ 2007 LIMITED | ZENMIC | TRANEXAMIC ACID | 500MG/5 ML | ZEN PHARMA PVT LTD75/1, GIDC. VAPI-396 195 GUJARAT, | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0 ML AMPOULE, 1.0X1.0X10.0X5.0 ML AMPOULE | 14/07/2022 |
| 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 |
| 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 | 19/07/2022 |
| NDA/MAL/HDP/10043 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROYO-ADRENALINE | ADRENALINE ACID TARTRATE | 1 MG/ML | SANJAR PHARMACEUTICALS LIMITEDSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1X1X10X1 ML AMPOULE, | 19/07/2022 |
| NDA/MAL/HDP/10044 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TERBI RO 250 | TERBINAFINEHYDROCHLORIDE | 250 MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 19/07/2022 |
| NDA/MAL/HDP/10045 | PHARMACTIV FZCO | HEALTHCARE LTD. | SURGITEC | CEFOTAXIME SODIUM | 1 G/VIAL | SURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*5ML, WFI IN A CLEAR GLASS AMPOULE | 19/07/2022 |
| 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 | 19/07/2022 |
| NDA/MAL/HDP/10048 | JOSHPA AFRICA LTD | AAFIYA (A) LIMITED | AAFISUNATE 60 MG | ARTESUNATE | 60 MG/VIAL | SANJAR PHARMACEUTICALS LIMITEDSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X60 MG VIAL | 19/07/2022 |
| 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 | 19/07/2022 |
| 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 |
| 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 COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1X1X30 CAPSULE CONTAINER | 19/07/2022 |
| NDA/MAL/HDP/10054 | LEGIT MEDEQ 2007 LIMITED | LEGIT MEDEQ 2007 LIMITED | HEMCROZ | IRON SUCROSE COMPLEX | 20 MG/ML | ZEN PHARMA PVT LTD75/1, GIDC. VAPI-396 195 GUJARAT, | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 19/07/2022 |
| NDA/MAL/HDP/10055 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FIMABUTE-400 | CEFIXIME TRIHYDRATE | 400MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 19/07/2022 |
| 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. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1X5X1X10 CAPSULE BLISTER | 19/07/2022 |
| 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 | 19/07/2022 |
| 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 |
| NDA/MAL/HDP/10061 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | INSTACLOP PLUS | CLOPIDOGREL + ASPIRIN | 75 MG + 75 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 19/07/2022 |
| NDA/MAL/HDP/10062 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUCLOX-500 | CLOXACILLIN SODIUM | 500MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 19/07/2022 |
| NDA/MAL/HDP/10063 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | CARDIONE 25 | SPIRONOLACTONE | 25MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 19/07/2022 |
| NDA/MAL/HDP/10065 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/ 300 MG/ 300 MG | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 600 MG + 300 MG + 300 MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X90.0 TABLET BOTTLE,1.0X30.0 TABLET BOTTLE | 19/07/2022 |
| NDA/MAL/HDP/10066 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | FEMPRO | LETROZOLE | 2.5MG | CIPLA LTDUNIT 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 | 1X3X10 TABLET BLISTER | 19/07/2022 |
| NDA/MAL/HDP/10067 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRITINI | TINIDAZOLE | 500MG | TRIVENI FORMULATIONS LTDPLOT 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 | 19/07/2022 |
| NDA/MAL/HDP/10068 | LEGIT MEDEQ 2007 LIMITED | LEGIT MEDEQ 2007 LIMITED | Z- ENOX | ENOXAPARIN SODIUM | 10 MG/0.1 ML | ZEN PHARMA PVT LTD75/1, GIDC. VAPI-396 195 GUJARAT, | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.6.0 ML PRE- FILLED SYRINGE, 1.0X0.4.0 ML PRE- FILLED SYRINGE | 14/07/2022 |
| NDA/MAL/HDP/10069 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | OPELAN ODT 5 | OLANZAPINE | 5 MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 14/07/2022 |
| NDA/MAL/HDP/1007 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZINCOS DISPERSIBLE TABLETS 20MG | ZINC SULPHATE | 20MG | COSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA | KENYA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/10074 | TAURUS CHEMICALS (P) LTD. | HEALTHCARE LTD. | MAGACID SUSPENSION | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | (215 MG + 80 MG + 25 MG)/5ML | AL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | | PAKISTAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X120.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 14/07/2022 |
| 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 | 14/07/2022 |
| NDA/MAL/HDP/10080 | COMED CHEMICALS LTD. | LEGIT MEDEQ 2007 LIMITED | 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 | 14/07/2022 |
| NDA/MAL/HDP/10084 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | SEDAFOL | PROPOFOL | 10 MG/ ML | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL | 14/07/2022 |
| 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 | 14/07/2022 |
| 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 | 1X1X30 ML BOTTLE | 14/07/2022 |
| 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 |
| 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 | 1X1X30 ML BOTTLE | 14/07/2022 |
| NDA/MAL/HDP/10091 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | PG-150 | PREGABALIN | 150 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X3X10 CAPSULE BLISTER, | 14/07/2022 |
| NDA/MAL/HDP/10092 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | ROTHISTRONE 5 | NORETHISTERONE | 5 MG | SYNOKEM PHARMACEUTICALS LTD-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 14/07/2022 |
| 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 LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1X1X100 ML BOTTLE | 18/07/2022 |
| 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 | 18/07/2022 |
| 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 | 18/07/2022 |
| NDA/MAL/HDP/10097 | ALKEM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | NULOC 20 | ESOMEPRAZOLE MAGNESIUM | 20 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1X3X10 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10098 | ALKEM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | NULOC 40 | ESOMEPRAZOLE MANESIUM | 40 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1X3X10 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10099 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | GLYFERON 1000 | METFORMIN HYDROCHLORIDE | 1000 MG | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X3X10 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10100 | HETERO LABS LTD | AIVEEN (U) LIMITED | PANTIN | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40 MG/VIAL | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL | 18/07/2022 |
| NDA/MAL/HDP/10101 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | VILDARIL 50 | VILDAGLIPTIN | 50 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10102 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VILDARIL 100 | VILDAGLIPTIN | 100 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 18/07/2022 |
| 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 LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER | 18/07/2022 |
| 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 |
| 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 |
| NDA/MAL/HDP/10106 | VEERAM HEALTHCARE (U) LIMITED | VEERAM HEALTHCARE (U) LIMITED | SERAFEN | DICLOFENAC POTASSIUM + SERRATIOPEPTIDASE | 50 MG + 10 MG | KESAR PHARMA PVT LTDPLOT 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 | 14/07/2022 |
| 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 LTDPLOT 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 | 14/07/2022 |
| NDA/MAL/HDP/10108 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PIRO 20 | PIROXICAM | 20 MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 14/07/2022 |
| NDA/MAL/HDP/10110 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO TAMIC 500 | TRANEXAMIC ACID | 500 MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X10X10 TABLET BLISTER | 14/07/2022 |
| NDA/MAL/HDP/10112 | KESAR PHARMA | ABACUS PHARMA (AFRICA) LIMITED | KESKETO | KETOCONAZOLE | 2 % W/W | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 14/07/2022 |
| 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 | 1X10X10 CAPSULE BLISTER | 14/07/2022 |
| 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 |
| NDA/MAL/HDP/10117 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VENOSMIL | HIDROSMIN | 200 MG | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 06/07/2022 |
| NDA/MAL/HDP/1012 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | LOX 2% | LIDOCAINE | 2% W/V | NEON LABORATORIES LTDPLOT 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 |
| 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 IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 18/07/2022 |
| NDA/MAL/HDP/1013 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | THIOSOL | THIOPENTAL SODIUM | 500MG | NEON LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/10134 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ISONIAZID/ RIFAPENTINE COATED TABLETS 300 MG + 300 MG | ISONIAZID + RIFAPENTINE | 300MG +300MG | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X12.0 TABLET STRIP | 18/07/2022 |
| NDA/MAL/HDP/10135 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | ZEVAC SYRUP | ZINC ACETATE (AS DIHYDRATE) | 20MG/5ML | RAPTAKOS BRETT & CO.LTD1ST POKHRAN ROAD,THANE 400 606 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1X1X60 ML BOTTLE | 18/07/2022 |
| 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 | 1X1X10 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10140 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | ALDROL 5 | DONEPEZIL HYDROCHLORIDE | 5MG | UNICHEM LABORATORIES BADI-UNIT IIVILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| NDA/MAL/HDP/10141 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | ALDROL 10 | DONEPEZIL HYDROCHLORIDE | 10MG | UNICHEM LABORATORIES BADI-UNIT IIVILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/07/2022 |
| 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 LIMITEDSURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X5.0 ML AMPOULE | 06/07/2022 |
| NDA/MAL/HDP/10145 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | I-PILL | LEVONORGESTREL | 1.5MG | 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 TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 12/13/2023 |
| 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 | 1X10 G TUBE | 18/07/2022 |
| NDA/MAL/HDP/10148 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RALEF 60 | ETORICOXIB | 60MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10149 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RALEF 90 | ETORICOXIB | 90MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/1015 | DAWA LIMITED | SUPER MEDIC LTD | ORACEF | CEFALEXIN | 250MG | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE STRIP | 01/07/2013 |
| NDA/MAL/HDP/10150 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RALEF 120 | ETORICOXIB | 120MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 18/07/2022 |
| NDA/MAL/HDP/10151 | S KANT HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | FUNGARIN | MICONAZOLE | 2%W/W | S KANT HEALTHCARE LIMITED1802 – 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 |
| NDA/MAL/HDP/10152 | BIOFARMA PLASMA LIMITED LIABILITY COMPANY | ONCOPHARM (U) LTD | ALBUMIN-BIOPHARMA | HUMAN ALBUMIN | 20G/100ML | BIOPHARMA PLASMA LIMITED LIABILITY COMPANY37-V KYIVSKA ST., BILA TSERKVA, KYIV REGION, 09100 - UKRAINE | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X1X100 ML VIAL | 18/07/2022 |
| NDA/MAL/HDP/10155 | MEDIPAK LIMITED | HEALTHCARE LTD. | MEDISOL NS | SODIUM CHLORIDE | 0.9%W/V | MEDIPAK LTD132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHORE | PAKISTAN | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 02/09/2022 |
| NDA/MAL/HDP/10156 | MEDIPAK LIMITED | HEALTHCARE LTD. | MEDISOL 5% | DEXTROSE | 5%W/V | MEDIPAK LTD132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHORE | PAKISTAN | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 02/09/2022 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/10172 | SURGE LABORATORIES (PVT.) LTD. | HEALTHCARE LTD. | SURGICOMB INJECTION 2G | CEFOPRAZONE SODIUM + SULBACTUM SODIUM | (1G + 1G)/VIAL | SURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X2.0 G VIAL + 10ML WFI CLEAR GLASS AMPOULE | 09/09/2022 |
| 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 LIMITEDPLOT 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 | 09/09/2022 |
| 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 |
| NDA/MAL/HDP/10183 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | TEXAKIND | TRANEXAMIC ACID | 500MG/5ML | MANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X4.0X5.0 ML AMPOULE | 09/09/2022 |
| NDA/MAL/HDP/10185 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TURBOVAS-10 | ROSUVASTATIN CALCIUM | 10MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10186 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | AARLOFLOX OZ | OFLOXACIN + ORNIDAZOLE | 200 MG + 500 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10187 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | AARCET 5 | CETIRIZINE HYDROCHLORIDE | 5 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10188 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | AARLEFLOX 750 | LEVOFLOXACIN HEMIHYDRATE | 750 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10189 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ETRICOX 120 | ETORICOXIB | 120 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10192 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUTAXIM 1 GM | CEFOTAXIME SODIUM | 1 G/ VIAL | ZEISS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.)|INNOVA CAPTAB LIMITED 1281/1, HILLTOP INDUSTRIAL ESTATE, NEAR EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN [H.P] - INDIA | INDIA | | PARENTERAL RETARD DRY VIALS | 1.0X1.0X1.0 G VIAL | 09/09/2022 |
| 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 COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10194 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BETOLINA | BUPIVACAINE HYDROCHLORIDE | 0.5%W/V | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X5X20 ML VIAL | 03/10/2022 |
| NDA/MAL/HDP/10197 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | LEVOZINE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10199 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | GOFEN 200 | IBUPROFEN | 200 MG | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X6.0X1.0X1.0X10.0 CAPSULE BLISTER | 09/09/2022 |
| NDA/MAL/HDP/1020 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PA-12 | PARACETAMOL SUSTAINED RELEASE | 1000MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID RETARD LAYERED TABLETS | 1.0X10.0X1.0X12.0 TABLET BLISTER | 01/07/2012 |
| 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 COAL- 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 |
| NDA/MAL/HDP/10201 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | ETRICOX 60 | ETORICOXIB | 60 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/10208 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KENZOPRAZOL | ESOMEPRAZOLE SODIUM | 40MG PER VIAL | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY DRY VIALS | 1X10X40 MG VIAL | 03/10/2022 |
| 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.AC/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10210 | FDC LTD | AIVEEN (U) LIMITED | IOPROST EYE DROPS | LATANOPROST | 0.005%W/V | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 29/09/2022 |
| 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 LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10213 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | PANTAKIND-40 | PANTOPRAZOLE SODIUM | 40 MG | MANKIND PHARMA LIMITEDUNIT - 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 | 09/09/2022 |
| NDA/MAL/HDP/10214 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ILAXTEN 20 MG TABLETS | BILASTINE | 20MG | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL-VIA CAMPO DI PILE 67100 L'AQUILA (AQ) | | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10215 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ABAMOL | PARACETAMOL | 10 MG/ML | ABARIS HEALTHCARE PVT. LTDSURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML CONTAINER | 09/09/2022 |
| NDA/MAL/HDP/10216 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | LULIZOL CREAM | LULICONAZOLE | 1%W/W | CURETECH SKINCAREPLOT 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 |
| NDA/MAL/HDP/10218 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | COMIT-100 | SILDENAFIL CITRATE | 100 MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10219 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | COMIT-50 | SILDENAFIL CITRATE | 50 MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 09/09/2022 |
| 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 |
| NDA/MAL/HDP/10228 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | SEPTOPRIM 960 | TRIMETHOPRIM + SULFAMETHOXAZOLE | 160 MG + 800 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/1023 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ZINNIA P | LEVONORGESTREL + ETHINYLESTRADIOL | 150MCG + 30MCG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/10230 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | MBEN | MEBENDAZOLE | 100 MG/5 ML | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X30.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10231 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | MBEN 100 | MEBENDAZOLE | 100 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X6.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10232 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | TOPGYL | METRONIDAZOLE BENZOATE | 125 MG/5 ML | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10233 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PAINFORCE 400 | IBUPROFEN | 400 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10234 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | TERBINAFORCE 250 | TERBINAFINEHYDROCHLORIDE | 250 MG | MANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 IIB-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST) DIST. THANE 421506 | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 09/09/2022 |
| NDA/MAL/HDP/10239 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | ZITMYC | AZITHROMYCIN | 500MG | CSPC OUYI PHARMACEUTICAL CO. LTD.WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10240 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMESAR 40 | OLMESARTAN MEDOXOMIL | 40MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE 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 | 09/09/2022 |
| NDA/MAL/HDP/10241 | S K AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT FORTE | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10242 | EMCURE PHARMACEUTICALS LTD - | HARLEYS UGANDA LIMITED | INSTGRA | DOLUTEGRAVIR SODIUM | 50MG | EMCURE PHARMACEUTICALS LIMITEDPLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 09/09/2022 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/10249 | FDC LTD | AIVEEN (U) LIMITED | IOPROST – T | LATANOPROST + TIMOLOL MALEATE | (50 MCG + 5 MG)/ML | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML BOTTLE | 09/09/2022 |
| 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) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 09/09/2022 |
| 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 COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10254 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | AZICEN 500 | AZITHROMYCIN | 500MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10257 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FENTEX® | PHENYTOIN | 250MG/5ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X10X5 ML VIAL | 19/09/2022 |
| 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 COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10261 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | NTCLOT-C75 | CLOPIDOGREL BILSULFATE | 75 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10262 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROFLOX | OFLOXACIN | 0.3%W/V | AUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI €“ 625 020 TAMIL NADU INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 19/09/2022 |
| NDA/MAL/HDP/10263 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | WORMAID ORAL SUSPENSION | ALBENDAZOLE | 200 MG/5ML | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10267 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | PROTOZOX-500 | NITAZOXANIDE | 500MG | SAGA LIFESCIENCES LIMITEDSURVEY 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 | 09/09/2022 |
| NDA/MAL/HDP/10268 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | WORMAID TABLET | ALBENDAZOLE | 400 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 09/09/2022 |
| 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 OMANP.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMAN | OMAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP | 09/09/2022 |
| NDA/MAL/HDP/10280 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | ZENOXIM 500 | CEFUROXIME AXETIL | 500 MG | INDCHEMIE HEALTH SPECIALITIES PVT. LTDVILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/10282 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | MUPIWAYS | MUPIROCIN | 2.0 W/W | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 09/09/2022 |
| NDA/MAL/HDP/10283 | DAWA LIMITED- | SUPER MEDIC LTD | DAZOLE | CLOTRIMAZOLE | 100MG | DAWA LIMITEDPLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10284 | NATIONAL PHARMACEUTICAL INDUSTRIES CO. | MEDVIN PHARMA LIMITED | MACROMAX 500 | AZITHROMYCIN | 500MG | NATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMANP.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMAN | OMAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 09/09/2022 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/10286 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PERLEX 250 | CEFALEXIN MONOHYDRATE | 250 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10287 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | VILDA DENK 50 MG | VILDAGLIPTIN | 50 MG | DENK PHARMA GMBH & CO. KGGOLLSTR. 1, 84529, TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10292 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | SPASMOTRIT | DICYCLOMINE HYDROCHLORIDE + PARACETAMOL | 20MG + 500MG | SAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10294 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALTCIP | CIPROFLOXACIN | 200MG | ALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10296 | LUPIN LIMITED- | AIVEEN (U) LIMITED | RIFAMPIN, ISONIAZID, PYRAZINAMIDE, ETHAMBUTOL HYDROCHLORIDE TABLETS USP150/75/400/275MG | RIFAMPIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE | 150MG + 75MG + 400MG + 275MG | LUPIN LTDA-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X14.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10297 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 1000 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 875 MG + 125 MG | MEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10298 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | COXZOTA 90 | ETORICOXIB | 90 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10299 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | MEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 |
| NDA/MAL/HDP/10300 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 375 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 250 MG + 125 MG | MEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10303 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DAPZIN-5 | DAPAGLIFLOZIN | 5 MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10304 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DAPZIN-10 | DAPAGLIFLOZIN | 10 MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10305 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | SPASCOLIC | DICYCLOMINE HYDROCHLORIDE + MEFENAMIC ACID | 10 MG + 250 MG | SAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10307 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | DESLOZED-5 | DESLORATADINE | 5 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 |
| NDA/MAL/HDP/10310 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ZINRO INFUSION | ORNIDAZOLE | 500MG/100ML | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGA | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10311 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | LOPINAVIR AND RITONAVIR TABLETS USP | LOPINAVIR + RITONAVIR | 200MG + 50MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10313 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | LOPINAVIR AND RITONAVIR TABLETS USP | LOPINAVIR + RITONAVIR | 100MG + 25MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 09/09/2022 |
| 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 | 01/07/2008 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/1032 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ARTHFREE 20 | LEFLUNOMIDE | 20MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/10323 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XELTIN | TOFACITINIB CITRATE | 5MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10325 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | ONCET | CETIRIZINE DIHYDROCHLORIDE | 5MG/5ML | MEDLEY PHARMACEUTICALS LTDPLOT 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 | 09/09/2022 |
| NDA/MAL/HDP/10326 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | RISEOL 50 | TRAMADOL HYDROCHLORIDE | 50MG | SUNRISE INTERNATIONAL LABS LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/10338 | NEOMI PHARMACEUTICALS PVT LTD - | ROYAL PHARMA 2011 LIMITED | ROART 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X24.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10343 | DAWA LIMITED- | SUPER MEDIC LTD | KENAZOLE | KETOCONAZOLE | 2%W/W | DAWA LIMITEDPLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 09/09/2022 |
| NDA/MAL/HDP/10346 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | LACTORIV | LACTULOSE | 10 G/15 ML | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 09/09/2022 |
| 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,30.0X6.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10353 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | PAINAID | PARACETAMOL + IBUPROFEN + CAFFEINE | 400 MG + 325 MG + 40 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10355 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RIVATAS 15 | RIVAROXABAN | 15 MG | INTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/10358 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | VOLDIC - K | DICLOFENAC POTASSIUM | 50MG | PHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10361 | AFRICURE PHARMACEUTICALS (INDIA) PVT. LTD | AFRICURE PHARMACEUTICALS U LIMITED | AFRICAL | CALCIUM LACTATE | 300 MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER | 19/09/2022 |
| NDA/MAL/HDP/10363 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO - AMIKACIN | AMIKACIN SULFATE | 500 MG/2 ML | SANJAR PHARMA LLPSURVEY 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 |
| NDA/MAL/HDP/10365 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | MYLTEGA DT | DOLUTEGRAVIR SODIUM | 10MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X90.0 TABLET BOTTLE | 09/09/2022 |
| NDA/MAL/HDP/10369 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SITAPRIL 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10370 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SITAPRIL 100 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 100MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10371 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROLEXIN 250 | CEFALEXIN MONOHYDRATE | 250MG | INNOVA CAPTAB PVT. LTD1281/1, 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 |
| 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.LTDC-66/1, OKHLA INDUSTRIAL AREA, PHASE –II, NEW DELHI INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10376 | SURGE LABORATORIES (PVT.) LTD. | HEALTHCARE LTD. | SURGICOMB 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 | 09/09/2022 |
| NDA/MAL/HDP/10378 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | ESOMIZAP | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10379 | ACINO PHARMA (PTY) LTD | LABOREX UGANDA LIMITED | ORATANE® 10 MG | ISOTRETINOIN | 10MG | DOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | SWISS CAPS AG HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X4.0X15.0 CAPSULE BLISTER | 19/09/2022 |
| NDA/MAL/HDP/1038 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEF-3 | CEFIXIME TRIHYDRATE | 200MG | SQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/10380 | ACINO PHARMA (PTY) LTD | LABOREX UGANDA LIMITED | ORATANE® 20 MG | ISOTRETINOIN | 20MG | DOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | SWISS CAPS AG HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLAND | NEW ZEALAND | SWITZERLAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1X4X15 CAPSULE BLISTER | 19/09/2022 |
| NDA/MAL/HDP/10381 | ACINO PHARMA (PTY) LTD | LABOREX UGANDA LIMITED | ORATANE® 40 MG | ISOTRETINOIN | 40MG | DOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | SWISS CAPS AG HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLAND | NEW ZEALAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 19/09/2022 |
| NDA/MAL/HDP/10382 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | PINN-TRYPTILLIN | AMITRIPTYLINE HYDROCHLORIDE | 25MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/09/2022 |
| NDA/MAL/HDP/10386 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMAC 5 | OLANZAPINE | 5MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE 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 | 09/09/2022 |
| NDA/MAL/HDP/10387 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMAC 10 | OLANZAPINE | 10MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE 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 | 09/09/2022 |
| NDA/MAL/HDP/10389 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | VIREXIM INJECTION | CEFTRIAXONE SODIUM | 1G | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10ML AMPOULE OF WFI | 09/09/2022 |
| NDA/MAL/HDP/10390 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN DT 40/240 | ARTEMETHER + LUMEFANTRINE | 40MG + 240MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 09/09/2022 |
| 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,1.0X200.0 TABLET BOTTLE | 09/09/2022 |
| 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 | 09/09/2022 |
| NDA/MAL/HDP/1040 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEF-3 DS | CEFIXIME TRIHYDRATE | 400MG | SQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/10418 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA CT 100 | SILDENAFIL CITRATE | 100 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10419 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | SITAPRIL M 50/1000 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 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. LIMITEDPLOT 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 |
| NDA/MAL/HDP/10420 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | SITAPRIL M 50/500 | SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10421 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | MIOPOLOL ER 50 | METOPROLOL SUCCINATE | 50MG | INVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10422 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | MIOPOLOL ER 25 | METOPROLOL SUCCINATE | 25MG | INVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10423 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | MALAKANT DISPERSIBLE JUNIOR | SULFADOXINE + PYRIMETHAMINE | 250MG + 12.5MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X25.0X3.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10424 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | MALAKANT DISPERSIBLE | SULFADOXINE + PYRIMETHAMINE | 500MG + 25MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X25.0X3.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10425 | SUPREME PHARMA HEALTHCARE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | FLOXYPREME-500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | SAI MIRRA INNOPHARM PVT. LIMITED288 & 299 SIDCO ESTATE, AMBATTUR, CHENNAI-600098. INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10427 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CELMAC 400 | CELECOXIB | 40 MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10428 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMOXI-DENK 1000 | AMOXICILLIN TRIHYDRATE | 1000 MG | PENCEF PHARMA GMBHBREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10429 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMOXI-DENK 500 | AMOXICILLIN TRIHYDRATE | 500 MG | PENCEF PHARMA GMBHBREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 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 X)PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147, L-147/1 TO L-147/3, L-138 AND L-147/A, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE, GOA. PIN: 403722 | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X120.0 CAPSULE CONTAINER | 08/02/2023 |
| NDA/MAL/HDP/10432 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | VAMOCIN 500 | VANCOMYCIN HYDROCHLORIDE | 500MG | GUFIC BIOSCIENCES LIMITED (UNIT 2)SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X500.0 MG VIAL | 08/02/2023 |
| NDA/MAL/HDP/10433 | BIOLOGICAL E. LIMITED | GITTOES PHARMACEUTICALS LIMITED | TETANUS ANTITOXIN 1500 IU/ML BP | TETANUS ANTITOXIN | 1500 IU/ML | BIOLOGICAL E. LIMITED18/1 & 3, AZAMABAD, HYDERABAD, TELANGANA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10434 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | AZIBRU | AZITHROMYCIN DIHYDRATE | 200 MG/5 ML | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10435 | PROFARMA SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | AFEBRIL 5 MG/2.5ML | DIAZEPAM | 5MG/2.5ML | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | RECTAL SYSTEMIC OTHER SUPPOSITORIES | 1.0X5.0X1.0 ML AMPOULE,1.0X2.5 ML AMPOULE,1.0X5.0X1.0X2.5 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10436 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | PETHIDINE HYDROCHLORIDE INJECTION | PETHIDINE HYDROCHLORIDE | 50 MG/ML | YICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITEDNO. 19, DALIAN ROAD, YICHANG DEVELOPING ZONE, YICHANG, HUBEI, CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 08/02/2023 |
| NDA/MAL/HDP/10437 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | GEMCITABINE 200 MG/5ML | GEMCITABINE | 200 MG/5ML | EBEWE PHARMA GES.M.B.H. NFG.KGMONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10438 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) 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 GMBHAM PHARMAPARK, DESSAU-ROSSLAU, SACHSEN-ANHALT, 06861, GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X20.0X0.5 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10439 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) 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 GMBHAM PHARMAPARK, DESSAU-ROSSLAU, SACHSEN-ANHALT, 06861, GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X20.0X0.5 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/1044 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANGINET 80MG | VALSARTAN | 80MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.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 |
| NDA/MAL/HDP/10440 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PHENIREX | CHLORPHENAMINE MALEATE | 4 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10441 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | PREDNOVA 5 | PREDNISOLONE | 5MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10442 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECARB | CARBAMAZEPINE | 200MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10443 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | FUNGIDERM | CLOTRIMAZOLE | 1 % W/W | NANZ MED SCIENCE PHARMA PVT. LTDRAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 08/02/2023 |
| 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. LTDRAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 08/02/2023 |
| 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. LTDRAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10446 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ZITHROPLUS 500 | AZITHROMYCIN DIHYDRATE | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X1.0X3.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10447 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | TRADOSIK | TRAMADOL HYDROCHLORIDE | 50 MG/ML | PT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3)JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIA | INDONESIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X1.0X5.0X2.0 ML AMPOULE | 08/02/2023 |
| NDA/MAL/HDP/10448 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | DOLONES | LIDOCAINE + PRILOCAINE | (25 MG + 25 MG)/G | PT CAPRIFARMINDO LABORATORIES ,JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIA | INDONESIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X5.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/1045 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ZIMAX 500 | AZITHROMYCIN | 500MG | SQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/10450 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | MEFINAL 500 | MEFENAMIC ACID | 500 MG | PT CAPRIFARMINDO LABORATORIES ,JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIA | INDONESIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 08/02/2023 |
| NDA/MAL/HDP/10451 | GUANGZHOU WONDFO BIOTECH CO. LTD | METRO PHARMACEUTICALS LIMITED | WAXFREE | SODIUM BICARBONATE | 5%W/V | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | NASAL TOPICAL LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10452 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | OPTIPRED | PREDNISOLONE ACETATE | 1.0% W/V | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | SAUDI ARABIA | | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10453 | SANJAR PHARMA LLP. | NILKANTH PHARMACY LIMITED | ARTICURE 60MG | ARTESUNATE | 60MG | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 10ML OF 0.9% SODIUM CHLORIDE SOLUTION, LDPE AMPOULE + 1ML OF 5.0% SODIUM BICARBONATE SOLUTION, GLASS AMOULE | 08/02/2023 |
| NDA/MAL/HDP/10454 | PAMAJITA INTERNATIONAL LPP | NILKANTH PHARMACY LIMITED | OMEZOLE | OMEPRAZOLE SODIUM | 40MG PER VIAL | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL + 10ML OF WATER FOR INJECTION, GLASS AMPOULE | 08/02/2023 |
| 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 LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.2 ML PRE- FILLED SYRINGE | 08/02/2023 |
| 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 LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 08/02/2023 |
| 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 LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 08/02/2023 |
| 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 LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 08/02/2023 |
| NDA/MAL/HDP/10459 | UNIMED LABORATORIES | OMAB UGANDA LIMITED | PARAMED | PARACETAMOL | 1G/100ML | UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X6.0X1.0X100.0 ML BAG | 08/02/2023 |
| NDA/MAL/HDP/10460 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | AERIALLERG 5MG | DESLORATIDINE | 5 MG | PHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10461 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | AERIALLERG 0.5MG/ML | DESLORATIDINE | 0.5MG/ML | PHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X125.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10462 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TOR - LOOP 10 | ANHYDROUS TORSEMIDE | 10 MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10463 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DISFOR | METHOCARBAMOL | 500 MG | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10464 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN 4 FLU TABLETS | DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE | 12.5MG + 500MG + 22.5MG | SPECGX LLC100 LOUIS LATZER DRIVE, GREENVILLE, ILLINOIS, 62246 - UNITED STATES OF AMERICA | JOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | UNITED STATES | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X12.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10465 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ZESBINA 200 | PROGESTERONE | 200 MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10466 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | ARCELIA CEFIXIME | CEFIXIME TRIHYDRATE | 400 MG | ASSOCIATED BIOTECH-VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10467 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RABIRIV-DSR | RABEPRAZOLE SODIUM + DOMPERIDONE | 20 MG + 30 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10468 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CORTIRIV-100 | HYDROCORTISONE SODIUM SUCCINATE | 100 MG/VIAL | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL, 1.0X50.0X100.0 MG VIAL | 08/02/2023 |
| 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) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/1047 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EXOFEN 180MG | FEXOFENADINE | 180MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.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 |
| NDA/MAL/HDP/10470 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROYODOL | TRAMADOL HYDROCHLORIDE | 50MG | PSYCHOTROPICS INDIA LTDPLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10471 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CIPROSCOT-500 | CIPROFLOXACIN HYDROCHLORIDE | 500 MG | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10472 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TRAMADOL HYDROCHLORIDE INJECTION 100 MG/2ML | TRAMADOL HYDROCHLORIDE | 100 MG/2 ML | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULE | 08/02/2023 |
| NDA/MAL/HDP/10473 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | POLYMOL SUSPENSION 125MG/5ML. | PARACETAMOL | 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, 1.0X60.0ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10474 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | POLYMOL EXTRA | PARACETAMOL + CAFFEINE | 500 MG + 30 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 | 08/02/2023 |
| NDA/MAL/HDP/10475 | MARCYRL PHARMACEUTICAL INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | EVASTINE | EBASTINE | 10 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 | 08/02/2023 |
| NDA/MAL/HDP/10476 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | DEXCEN 10 | RAMIPRIL | 10 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10477 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | PENACAM | PIROXICAM | 20 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10478 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | FENTANYL SANDOZ 12 µG/H | FENTANYL | 12µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | | TRANSDERMAL PATCHES | 1.0X5.0 SACHET CARTON | 08/02/2023 |
| NDA/MAL/HDP/10479 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | FENTANYL SANDOZ 25 µG/H | FENTANYL | 25µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | | TRANSDERMAL PATCHES | 1.0X1.0X5.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10480 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | FENTANYL SANDOZ 75 µG/H | FENTANYL | 75µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | | TRANSDERMAL PATCHES | 1.0X5.0 SACHET CARTON | 08/02/2023 |
| NDA/MAL/HDP/10481 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | FENTANYL SANDOZ 50 µG/H | FENTANYL | 50µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | | TRANSDERMAL PATCHES | 1.0X5.0 SACHET CARTON | 08/02/2023 |
| NDA/MAL/HDP/10482 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | FENTANYL SANDOZ 100 µG/H | FENTANYL | 100µG/HOUR | HEXAL AG INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | | TRANSDERMAL PATCHES | 1.0X5.0 SACHET CARTON | 08/02/2023 |
| NDA/MAL/HDP/10483 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | PATIZRA | RANIBIZUMAB | 10 MG/ML | NOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONSNOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLAND | SWITZERLAND | | PARENTERAL ORDINARY VIALS | 1.0X1.0X0.23 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10484 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | TETROP | TETRACYCLINE HYDROCHLORIDE | 1%W/W | INDIANA OPHTHALMICS135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | | OPHTHALMIC OINTMENTS | 1.0X1.0X5.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10489 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | SWASTIK PHARMACEUTICAL LTD | TERBIN | TERBINAFINE HYDROCHLORIDE | 250 MG | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/1049 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVATE | BETAMETHASONE VALERATE | 0.1%W/W | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/10490 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | SWASTIK PHARMACEUTICAL LTD | BISOCARD PLUS 5MG/12.5MG | BISOPROLOL FUMARATE + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10491 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | APRETUDE 30 MG | CABOTEGRAVIR | 30 MG | GLAXO WELLCOME S.AAVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAIN | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE, SG12 ODJ | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 08/02/2023 |
| NDA/MAL/HDP/10492 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | DOLUTEGRAVIR SODIUM TABLETS 50 MG | DOLUTEGRAVIR SODIUM | 50 MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT IIPLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN - 396210 (UT) - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10493 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | ROUNOX | TRAMADOL HYDROCHLORIDE | 50 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10494 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | FORMET 1000 | METFORMIN HYDROCHLORIDE | 1000 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10495 | EGYPHAR | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HELI-CURE | CLARITHROMYCIN + OMEPRAZOLE + TINIDAZOLE | 250 MG + 20 MG + 500 MG | EGYPHAR FACTORYOBOUR CITY- INDUSTRIAL ZONE (A), BLOCK NO 13026. PIECE NO 9&0- EGYPT | EGYPT | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10496 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | IRIS SYRUP | DESLORATADINE | 0.5 MG/ML | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYAL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10497 | EGYPHAR | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZISROCIN | AZITHROMYCIN | 500MG | EGYPHAR FACTORYOBOUR CITY- INDUSTRIAL ZONE (A), BLOCK NO 13026. PIECE NO 9&0- EGYPT | EGYPT | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X3.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10499 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TIRATAM 500 MG XR | LEVETIRACETAM | 500 MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/1050 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | AMTAS-10 | AMLODIPINE | 10MG | INTAS PHARMACEUTICALS LTDPLOT 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 |
| NDA/MAL/HDP/10502 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VORIOLE 200 | VORICONAZOLE | 200MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10503 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | HI-ALFA SR 10 | ALFUZOSIN HYDROCHLORIDE | 10MG | AUROBINDO PHARMA LIMITED UNIT 3PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10504 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUROXIM 1.5 G | CEFUROXIME SODIUM | 1.5G | ZEISS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL (CLEAR GLASS VIAL) | 08/02/2023 |
| NDA/MAL/HDP/10505 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | OPTOR EYE DROPS | KETOROLAC TROMETHAMINE | 0.5%W/V | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGA | UGANDA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10506 | PHARMATHEN S.A | GOODMAN INTERNATIONAL LTD | A-CNOTREN® 10MG | ISOTRETINOIN | 10MG | PHARMATHEN S.A6, DERVENAKION STR. 15351 PALLINI ATHENS | PHARMATHEN INTERNATIONAL S.AINDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECE | GAP S.A.46 AGISSILAOU STR. 17341 AGIOS DIMITRIOS | GREECE | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10507 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | TOB - DEX | TOBRAMYCIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.3%W/V + 0.1%W/V | AUROLAB .NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10508 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FIMABUTE-100 | CEFIXIME TRIHYDRATE | 100MG/5ML | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10509 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | PANTRO INJECTION | PANTOPRAZOLE SODIUM | 40MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL + (1*1*10ML OF SODIUM CHLORIDE SOLUTION IN CLEAR GLASS AMPOULE) | 08/02/2023 |
| NDA/MAL/HDP/10510 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | NEUROZIM 75 | PREGABALIN | 75MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10511 | VRUSHIK INVESTMENT (U) LTD. | SHREEJI PHARMACEUTICALS LIMITED | METO | METOCLOPRAMIDE HYDROCHLORIDE | 10MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10512 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | FINADOL ULTRA | PARACETAMOL + CAFFEINE | 500 MG + 30 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10513 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EXITINE 0.5MG/5ML | FLUMAZENIL | 0.5MG/5ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X5X5 ML VIAL | 10/02/2023 |
| NDA/MAL/HDP/10515 | TAKEDA PHARMA A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NINLARO 2.3 MG | IXAZOMIB CITRATE | 2.3MG | HAUPT PHARMA AMAREG GMBHDONAUSTAUFER STRASSE 378, 93055 REGENSBURG | GERMANY | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X1.0X1.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10516 | TAKEDA PHARMA A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NINLARO 3.0 MG | IXAZOMIB CITRATE | 3MG | HAUPT PHARMA AMAREG GMBHDONAUSTAUFER STRASSE 378, 93055 REGENSBURG | GERMANY | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X1.0X1.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10517 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRULEXIN-250 | CEFALEXIN MONOHYDRATE | 250MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10519 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | PLASMINEX | TRANEXAMIC ACID | 500MG | PT SANBE FARMA UNIT 1JALAN INDUSTRI I NO. 9 RT. 01 RW.08, KELURAHAN UTAMA, KECAMATAN CIMAHI SELATAN, KOTA CIMAHI 40553 - INDONESIA | INDONESIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 08/02/2023 |
| 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 LTDPLOT 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 |
| NDA/MAL/HDP/10520 | ENCORE HEALTHCARE PVT. LTD. | REDDYS PHARMA LIMITED | ENCOBLOC | PROPRANOLOL HYDROCHLORIDE | 40MG | ENCORE HEALTHCARE PVT LTDD-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 08/02/2023 |
| NDA/MAL/HDP/10521 | SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., | ROYAL PHARMA 2011 LIMITED | SCOTXONE PLUS | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1000 MG + 500 MG | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1500.0 MG VIAL | 08/02/2023 |
| NDA/MAL/HDP/10522 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | CEFRIM 500 | CEFUROXIME AXETIL | 500MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10523 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | SYNRIAM DT | ARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE | 37.5 MG + 187.5 MG | SUN PHARMACEUTICAL IND. LTDPLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X3.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10524 | AGIO PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | DICLOGEN RETARD 100 | DICLOFENAC SODIUM | 100MG | AGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 08/02/2023 |
| NDA/MAL/HDP/1053 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN-125 DT | AMOXICILLIN | 125MG | MILAN LABORATORIES (INDIA) PVT LTD .PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/10530 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | COXZOTA 120 | ETORICOXIB | 120MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10531 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | ENO CALCIUM ANTACID TABLETS | CALCIUM CARBONATE | 500MG | GLAXOSMITHKLINE LIMITEDLIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI | GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC320 SOUTH BROADWAY ST. LOUIS, MISSOURI, 63102 - UNITED STATES OF AMERICA | KENYA | UNITED STATES | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10532 | ALKEM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | TAXIM-O | CEFIXIME TRIHYDRATE | 400MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10533 | CELON LABORATORIES PRIVATE LIMITED. | GOOD DAY PHARMACY LIMITED | HYPRO 200 | PROPOFOL | 200 MG/20 ML | CELON LABORATORIES PRIVATE LIMITEDPLOT NO. 2, ALEAP INDUSTRIAL ESTATE, GAJULARAMARAM, MEDCHAL - MALKAJGIRI DIST-500090, TELENGANA - INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10534 | PSYCHOTROPICS INDIA LTD- | ABACUS PHARMA (AFRICA) LIMITED | KETAMINE HYDROCHLORIDE INJECTION USP 50MG/ML | KETAMINE HYDROCHLORIDE | 50MG/ML | PSYCHOTROPICS INDIA LTDPLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10535 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGINOVAG | DEQUALINIUM CHLORIDE + TYROTHRICIN + ? -GLYCYRRHETINIC ACID (ENOXOLONE) + HYDROCORTISONE ACETATE + LIDOCAINE HYDROCHLORIDE | (100MG + 400MG + 60MG + 60MG+100MG) PER 100 ML | FERRER INTERNATIONAL, S.AC/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X10.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10536 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | MUPISOFT OINTMENT | MUPIROCIN | 2.0% W/W | CURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X5.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10537 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | NIOSOL OINTMENT | CLOBETASOL PROPIONATE | 0.05%W/W | CURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10538 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | SUDIF CREAM | FUSIDIC ACID | 2.0 %W/W | CURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10539 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZOTAMET-850 | METFORMIN HYDROCHLORIDE | 850MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/1054 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-250 | AZITHROMYCIN | 250MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER | 01/07/2011 |
| NDA/MAL/HDP/10540 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | ATAZANAVIR AND RITONAVIR TABLETS | ATAZANAVIR SULFATE + RITONAVIR | 300MG + 100MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10541 | GALENICUM HEALTH S.L. | GOODMAN INTERNATIONAL LTD | ROSUVASTATIN | ROSUVASTATIN | 20MG | BIOFARM SP. Z.O.OUL. WALBRZYSKA 13, 60-198 POZNAN - POLAND | POLAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X7.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10542 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | PACLITAXEL 6 MG /1 ML | PACLITAXEL | 300MG /50ML | EBEWE PHARMA GES.M.B.H. NFG.KGMONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10543 | ADWIA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ADWIFLAM | DICLOFENAC POTASSIUM | 75MG | SOUTH EGYPT DRUG INDUSTRIES COMPANY (SEDICO)-FIRST INDUSTRIAL ZONE, 6TH OF OCTOBER CITY - EGYPT | | EGYPT | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY STRIP | 08/02/2023 |
| NDA/MAL/HDP/10544 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | ATROP | ATROPINE SULFATE | 1%W/V | AUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA | BRAZIL | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10545 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | BRAMOL | PARACETAMOL | 10MG/ML | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10546 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | OXOFERIN | TETRACHLORODECAOXIDE | 138.0 X 10^6 PMOL/100ML | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X50.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10547 | PROFARMA SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | HALOPERIDOL SOLUTION FOR INJECTION 5MG/ML | HALOPERIDOL | 5MG/ML | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | PARENTERAL ORDINARY VIALS | 1.0X2.0X5.0X1.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10551 | SANJAR PHARMA LLP. | MOTI PHARMA (UGANDA) LIMITED | ADRENLIN | ADRENALINE ACID TARTRATE | 1MG | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 MG AMPOULE | 08/02/2023 |
| NDA/MAL/HDP/10552 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ZOPIMAC 2 | ESZOPICLONE | 2MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X100.0 TABLET CONTAINER | 08/02/2023 |
| NDA/MAL/HDP/10553 | ACINO AG. | LABOREX UGANDA LIMITED | TITANAFIL 5 | TADALAFIL | 5MG | PHARMACTIVE ILAC SAN. VE TIC. A.S.CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH. FATIH BULV. NO: 32 KAPAKLI/TEKIRDAG - 2820133250 - TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10554 | ACINO AG | LABOREX UGANDA LIMITED | TITANAFIL 20 | TADALAFIL | 20MG | PHARMACTIVE ILAC SAN. VE TIC. A.S.CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH. FATIH BULV. NO: 32 KAPAKLI/TEKIRDAG - 2820133250 - TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10556 | KESAR PHARMA | SWASTIK PHARMACEUTICAL LTD | PIADIN | POVIDONE IODINE | 5.0 W/W | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10557 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | LOFNAC-50 | DICLOFENAC SODIUM | 50MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10558 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | NEOCLEAN GEL | CLINDAMYCIN PHOSPHATE + NICOTINAMIDE | 1.0 %W/W + 4.0%W/W | CURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X10.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10559 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | NIOSALIC OINTMENT | CLOBETASOL PROPIONATE + SALICYLIC ACID | 0.05%W/W + 3.00W/W | CURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 08/02/2023 |
| 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 LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/10560 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | WHITFIELD’S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | LEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X20.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10561 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | WORIV | ALBENDAZOLE | 400MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10562 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | ACESON-P | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10563 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ENARIV-10 | ENALAPRIL MALEATE | 10MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/02/2023 |
| 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 LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10565 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | PILO | PILOCARPINE NITRATE | 2%W/V | AUROLAB .NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10566 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROCARPINE | PILOCARPINE NITRATE | 0.5%W/V | AUROLAB .NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 | INDIA | | OPHTHALMIC DROPS | 1.0X5.0X1.0 ML VIAL | 08/02/2023 |
| NDA/MAL/HDP/10567 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CELMAC 200 | CELECOXIB | 200MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10568 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMADAY PL 5/4 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 5 MG + 4 MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10569 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMADAY PL 5/8 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 5MG + 8MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| 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 |
| NDA/MAL/HDP/10570 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMADAY PL 10/4 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 10 MG + 4 MG | NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10571 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AMADAY PL 10/8 | AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE | 10MG + 8MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10572 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | NAT-B FORTE | THIAMINE MONONITRATE (VITAMIN B1) + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) + METHYLCOBALAMIN (VITAMIN B12) + FOLIC ACID + D-ALPHA-TOCOPHEROL ACETATE + VITAMIN A + VITAMIN D3 + COPPER SULPHATE ANHYDROUS + CHROMIUM PICOLINATE + ZINC AMINO ACID CHELATE | 100 MG + 200 MG + 500 MCG + 200 MCG + 200 IU + 5000 IU + 400 IU + 1.0 MG + 0.20 MG + 15.0 MG | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10575 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BINOVEN 75 | VENLAFAXINE HYDROCHLORIDE | 75MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10576 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | QUITIDE 100 | QUETIAPINE FUMARATE | 100MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/02/2023 |
| NDA/MAL/HDP/10578 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | OCORTIN | HYDROCORTISONE | 1%W/W | KREMOINT PHARMA PVT LTD. B-8, ADDITIONAL AMBERNATH M.I.D.C, OPP. ANAND NAGIAR POLICE CHECK POST, AMBERNATH (E), DIST. THANE. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 08/02/2023 |
| NDA/MAL/HDP/10579 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | BENZYL BENZOATE APPLICATION BP | BENZYL BENZOATE | 25%W/V | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE | 08/02/2023 |
| NDA/MAL/HDP/10589 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | PILECA-EZ | ATORVASTATIN + EZETIMIBE | 10 MG + 10 MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10590 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | ULCEREST 20 | ESOMEPRAZOLE MAGNESIUM | 20MG | MYLAN LABORATORIES LTD .F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10591 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | ULCEREST 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | MYLAN LABORATORIES LTD .F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10592 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | ASCARD-75 | ASPIRIN | 75MG | ATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10593 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MOMRIV | MOMETASONE FUROATE | 0.1%W/W | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10597 | MEDISEL(K) LTD | SUPER MEDIC LTD | GABANERVE | GABAPENTIN + METHYLCOBALAMIN | 300MG + 500MCG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10598 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | MIXIF | CEFIXIME TRIHYDRATE | 400MG | DAR AL DAWANA’UR – PRINCE HASHEM BIN AL-HUSSEIN STREET P.O. BOX 9364 AMMAN 11191 JORDAN | JORDAN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10599 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | BETAMET CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10600 | MEDISEL(K) LTD | AIVEEN (U) LIMITED | OSTEOCERIN | GLUCOSAMINE SULPHATE POTASSIUM CHLORIDE + METHL SULPHONYL METHANE (MSM) + DIACEREIN | 750MG + 250MG + 50MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10601 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | VORIOLE 50 | VORICONAZOLE | 50 MG | MSN LABS LTD (FORMULATION DIVISION) PLOT 42, ANRIC INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT ZIP CODE 502325, ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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 | 15/02/2023 |
| 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.KGMONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0 ML AMPOULE | 15/02/2023 |
| NDA/MAL/HDP/10604 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PIPERATAZ 4.5 | PIPERACILLIN + TAZOBACTAM | 4 G + 0.5 G | UNI MEDICOLABSUNI MEDICOLABS, PLOT NO. 21-22, PHARMACITY, SELAQUI, DEHRADUN - 248011 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL | 15/02/2023 |
| NDA/MAL/HDP/10605 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | HALOPAC | HALOPERIDOL | 5MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10606 | MEDISEL(K) LTD | AIVEEN (U) LIMITED | EMADON SYRUP | ONDANSETRON HYDROCHLORIDE | 2MG/5ML | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X30.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10607 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | DOLAC | KETOROLAC TROMETHAMINE | 10 MG | CADILA PHARMACEUTICALS LTD1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDABAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP | 15/02/2023 |
| NDA/MAL/HDP/10609 | FDC LIMITED - | AIVEEN (U) LIMITED | OCUDOR | DORZOLAMIDE HYDROCHLORIDE | 2%W/V | FDC LIMITED-WALUJ.PLOT B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 (DIST AURANGABAD) | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/1061 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BISACODYL TABLETS | BISACODYL | 5MG | NEM LABORATORIES PVT LTDPLOT 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 |
| 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 | 15/02/2023 |
| NDA/MAL/HDP/10611 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | NEWSTAR 160/10 MG | VALSARTAN + AMLODIPINE BESYLATE | 160 MG + 10 MG | PHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10612 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | NEWSTAR 160/5 MG | VALSARTAN + AMLODIPINE BESYLATE | 160 MG + 5 MG | PHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 15/02/2023 |
| 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 LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10614 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | AVIRAX | ACICLOVIR | 5% W/W | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10615 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LEVOZIN 5 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10616 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | GLYSIT 5 | DAPAGLIFLOZIN | 5MG | COSMOS LTD..RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10617 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | GLYSIT 10 | DAPAGLIFLOZIN | 10MG | COSMOS LTD..RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| 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 LIMITEDPLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE | 15/02/2023 |
| NDA/MAL/HDP/10619 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | DEXIREN | DEXKETOPROFEN TROMETAMOL | 50MG/2ML | IDOL LLAC DOLUM A.SDAVUTPASA CADDESI. CEBE ALI BEY SOK. NO. 20 34010/ DAVUTPASA - TOPKAPI / ISTANBUL | TURKEY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X6.0X2.0 ML AMPOULE | 15/02/2023 |
| NDA/MAL/HDP/1062 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | VANCONEX-CP | VANCOMYCIN | 500MG | VENUS REMEDIES LIMITEDUNIT 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 |
| NDA/MAL/HDP/10620 | RENE INDUSTRIES LIMITED | RENE PHARMACY LTD | BUSCOREN | HYOSCINE BUTYLBROMIDE | 10 MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10621 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PENIREN | PHENOXYMETHYLPENICILLIN POTASSIUM | 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10622 | CENTURION LABORATORIES PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | PANTOPRAM 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40 MG | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10623 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | STERIREN | CHLORHEXIDINE GLUCONATE | 5% W/V | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X5.0 L CONTAINER | 15/02/2023 |
| NDA/MAL/HDP/10624 | MSN LABORATORIES PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | MIBZO | BORTEZOMIB | 3.5 MG/VIAL | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X3.5 MG VIAL | 15/02/2023 |
| NDA/MAL/HDP/10625 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | ESOGRESS 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | STANFORD LABORATORIES PRIVATE LIMITED (A SUBSIDIARY COMPANY OF LA RENON HEALTHCARE PRIVATE LIMITED)8, INDUSTRIAL AREA, MEHATPUR - 174315, HIMACHAL PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10628 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | SITAGLU MET 50/500 | SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10629 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | SITAGLU MET 50/1000 | SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10630 | INNOVA CAPTAB LTD. | TATA UGANDA LIMITED | INFIXIME 400 | CEFIXIME TRIHYDRATE | 400MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10631 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | RYALTRIS | OLOPATADINE HYDROCHLORIDE + MOMETASONE FUROATE | 665 MCG/25 MCG | GLENMARK PHARMACEUTICALS LIMITED-UNIT IIIVILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIA | INDIA | | NASAL SYSTEMIC DROPS | 1.0X1.0X240.0 METERED DOSE BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10632 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD) | ROYAL PHARMA 2011 LIMITED | ROSUVAT 10 | ROSUVASTATIN CALCIUM | 10 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 | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10633 | MYLAN PHARMACEUTICAL PRIVATE LIMITED -PLOT N0. 1-A/2 | KIMSY MEDS LTD | FULPHILA | PEGFILGRASTIM | 6 MG/0.6 ML | BIOCON BIOLOGICS LIMITEDSPECIAL ECONOMIC ZONE, PLOT NO. 2, 3, 4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMASANDRA POST, BENGALURU - 560099, INDIA | INDIA | | PARENTERAL ORDINARY I V PRE-FILLED SYRINGES | 1.0X1.0X1.0X0.6 ML PRE- FILLED SYRINGE | 15/02/2023 |
| 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 | 15/02/2023 |
| NDA/MAL/HDP/10636 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | UNIPROEX ER 250 | DIVALPROEX SODIUM | 250MG | UNICHEM LABORATORIES LTDPLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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 | 15/02/2023 |
| 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 | 15/02/2023 |
| 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 | 15/02/2023 |
| NDA/MAL/HDP/10640 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DISTEM | METHOCARBAMOL + PARACETAMOL | 380 MG + 300 MG | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10642 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PACSITA 150 | CAPECITABINE | 150MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10643 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PACSITA 500 | CAPECITABINE | 500MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10645 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VINKAMINE | VANCOMYCIN HYDROCHLORIDE | 500MG | MS PHARMA - JORDANPLOT 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 | 1X1X500 MG VIAL | 06/03/2023 |
| NDA/MAL/HDP/10646 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ENZYSTAL P | PANCREAS POWDER | EQUIVALENT TO AMYLASE ACTIVITY 4200 PH. EUR UNITS, LIPASE ACTIVITY 3500 PH. EUR UNITS AND PROTEASE ACTIVITY 250 PH. EUR UNITS | TORRENT PHARMACEUTICALS LTD VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI – 173205, DIST: SOLAN, HIMACHAL PRADESH, | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10647 | LITHA PHARMA (PTY) LTD. | LABOREX UGANDA LIMITED | METHYLPHENIDATE HCL-DOUGLAS | METHYLPHENIDATE HYDROCHLORIDE | 10MG | DOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | NEW ZEALAND | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10648 | CIPLA LTD | QUALITY CHEMICALS LTD | TENVIR-AF | TENOFOVIR ALAFENAMIDE FUMARATE | 25MG | CIPLA LIMITEDPLOT 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 | 15/02/2023 |
| NDA/MAL/HDP/10649 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | ESOCID 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/1065 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SLIPIZEM-5 | DIAZEPAM | 5MG | BLISS GVS PHARMA LIMITEDNO.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 |
| 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 | 15/02/2023 |
| NDA/MAL/HDP/10652 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | Z-OFLOX 200 | OFLOXACIN | 200MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10653 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | COXZOTA-60 | ETORICOXIB | 60MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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 LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10655 | HETERO LABS LTD | AIVEEN (U) LIMITED | TENOFOVIR ALAFENAMIDE TABLETS | TENOFOVIR ALAFENAMIDE HEMIFUMARATE | 25MG | HETERO LABS LIMITED (UNIT V)SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10656 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BIOGLITA PLUS 15/500MG FC TABLETS | PIOGLITAZONE + METFORMIN HYDROCHLORIDE | 15MG + 500MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10657 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BIOGLITA PLUS 15/850MG FC TABLETS | PIOGLITAZONE + METFORMIN HYDROCHLORIDE | 15MG + 850MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10658 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATORKEY 40 | ATORVASTATIN CALCIUM TRIHYDRATE | 40MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT 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 | 15/02/2023 |
| NDA/MAL/HDP/10659 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ACENAC-P | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | MEDLEY PHARMACEUTICALS LTDLANE 03, PHASE 1, SIDCO INDUSTRIAL COMPLEX, BARI BRAHMANA JAMMU 181133 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10660 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | AZITOZ-250 | AZITHROMYCIN DIHYDRATE | 250MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10661 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | LIVOTA-750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10662 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | TOMOZA | MOSAPRIDE CITRATE DIHYDRATE | 5MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10663 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRAMAPA 37.5 MG/325 MG | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5 MG/325 MG | FERRER INTERNATIONAL, S.AC/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10664 | FDC LTD | AIVEEN (U) LIMITED | OCUDORT-T | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | (20 MG + 5 MG)/ML | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10665 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CIATUFF 10 | TADALAFIL | 10 MG | AUROBINDO PHARMA LTD, UNIT VIISY. 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 | 1.0X2.0X4.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10667 | VINS BIOPRODUCTS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VINRAB 1000 IU | EQUINE ANTIRABIES IMMUNOGLOBULIN FRAGMENTS F (AB’) 2 | NOT LESS THAN 200 IU PER ML | VINS BIOPRODUCTS LIMITEDSY. NO. 117, THIMMAPUR (V), KOTHUR MANDAL), RANGA REDDY (DIST), TELANDANA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL | 15/02/2023 |
| NDA/MAL/HDP/10668 | LUPIN LIMITED | AIVEEN (U) LIMITED | DOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMERATE 50MG/300MG/300MG | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | LUPIN LIMITED NAGPURPLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 15/02/2023 |
| NDA/MAL/HDP/10669 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CARDIOTIMIDE 20 MG | TORSEMIDE | 20 MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/1067 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | IBUPARA | IBUPROFEN+PARACETAMOL | 200MG+ 250MG/10ML | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/10670 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | DOLGINA | DEXLANSOPRAZOLE | 30MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10671 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | TRANSAMIN-S | TRANEXAMIC ACID | 1000MG/10ML | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0 ML AMPOULE | 15/02/2023 |
| NDA/MAL/HDP/10672 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | DNS | SODIUM CHLORIDE + ANHYDROUS GLUCOSE | 0.9%W/V & 5%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDSURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 | INDIA | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1.0X500.0 ML BAG | 15/02/2023 |
| NDA/MAL/HDP/10673 | EAST AFRICAN (INDIA) OVERSEAS | ROYAL PHARMA 2011 LIMITED | CETARIV | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10674 | VINS BIOPRODUCTS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | 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 LIMITEDSY. NO. 117, THIMMAPUR (V), KOTHUR MANDAL), RANGA REDDY (DIST), TELANDANA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0X10.0 ML VIAL | 15/02/2023 |
| NDA/MAL/HDP/10678 | KESAR PHARMA | ABACUS PHARMA (AFRICA) LIMITED | ARTELUM | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10679 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | PG-75 | PREGABALIN | 75 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 15/02/2023 |
| 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 & COMPANY LIMITED1ST POKHRAN ROAD, THANE 400606, MIDC, MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X1.0X15.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10681 | BIODEAL LABORATORIES LTD PLOT NO.123 | ABACUS PHARMA (AFRICA) LIMITED | PODOSAL OINTMENT | PODOPYLLUM RESIN + SALICYLIC ACID | 20%W/W + 25%W/W | BIODEAL LABOARATORIES LTD123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10682 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | RALTEGRAVIR TABLETS | RALTEGRAVIR POTASSIUM | 400 MG | HETERO LABS LIMITED (UNIT III)...22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 15/02/2023 |
| NDA/MAL/HDP/10683 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MF-DAY ER 750 | METFORMIN HYDROCHLORIDE | 750 MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10684 | GALENICUM HEALTH S.L. | GOODMAN INTERNATIONAL LTD | DUTASVITAE 0.5MG | DUTASTERIDE | 0.5MG | CYNDEA PHARMA, S.LPOLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| 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 | 15/02/2023 |
| 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 | 15/02/2023 |
| NDA/MAL/HDP/10687 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | IRNIZET 300 | IRINOTECAN HYDROCHLORIDE TRIHYDRATE | 300 MG/15ML | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X15.0 ML VIAL | 15/02/2023 |
| NDA/MAL/HDP/10688 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | UROKA | DUTASTERIDE | 0.5 MG | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10689 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | LOSARZED-100 | LOSARTAN POTASSIUM | 100 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/1069 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | K-ONE INJECTION | PHYTOMENADIONE | 10MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-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 |
| NDA/MAL/HDP/10690 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | PROTAC-40 | PANTOPRAZOLE SODIUM | 40 MG | SUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10691 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROGLOPENTIN 400 MG | GABAPENTIN | 400MG | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | | EGYPT | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10692 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROGLOPENTIN 300 MG | GABAPENTIN | 300MG | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | | EGYPT | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10693 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | GEN DEX EYE DROPS | GENTAMICIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.3% W/V + 0.1% W/V | SWISS PARENTERALS LIMITED (UNIT-1)808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10694 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | OTYCULF 500 MG | FLUCYTOSINE | 500MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X100.0 TABLET BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10695 | UNIMED TECHNOLOGIES CO., LTD | OMAB UGANDA LIMITED | GLUCOSE 5 % UNIMED | GLUCOSE ANHYDROUS | 5%W/V | UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BAG | 15/02/2023 |
| NDA/MAL/HDP/10696 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | CELEBIB CAPSULES 200MG | CELECOXIB | 200MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10697 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | ASPORELIX | CETRORELIX ACETATE | 0.25MG | BHARAT SERUM AND VACCINES LIMITEDPLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | | PARENTERAL ORDINARY I V VIALS | 1.0X0.25 MG VIAL + 1*1ML GLASS AMPOULE OF WFI | 15/02/2023 |
| NDA/MAL/HDP/10698 | EBEWE PHARMA GES.M.B.H. NFG. KG | KIMSY MEDS LTD | PACLITAXEL 6 MG /1 ML | PACLITAXEL | 6 MG /1 ML | EBEWE PHARMA GES.M.B.H. NFG.KGMONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X16.7 ML VIAL | 15/02/2023 |
| NDA/MAL/HDP/10699 | PHARMA BAVARIA INTERNACIONAL PORTUGAL | GOODMAN INTERNATIONAL LTD | RHINIZILL 50 | MOMETASONE FUROATE MONOHYDRATE | 50 ?G/ACTUATION | FARMEA10 RUE BOUCHE THOMAS, ZAC D'ORGEMONT, 49007 ANGERS CEDEX 01 | FRANCE | | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X1.0X120.0 METERED DOSE CANNISTER | 15/02/2023 |
| NDA/MAL/HDP/10702 | UNIMED LABORATORIES. | OMAB UGANDA LIMITED | VAAMOX 1G/200 MG | SODIUM AMOXICILLIN + POTASSIUM CLAVULANATE. | (1 G + 200 MG)VIAL | UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL | 15/02/2023 |
| NDA/MAL/HDP/10703 | MOTI PHARMA(U) LTD. | MOTI PHARMA (UGANDA) LIMITED | TOPSUNATE | ARTESUNATE | 60 MG | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG 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 | 15/02/2023 |
| NDA/MAL/HDP/10704 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EMEFILM-4 | ONDANSETRON HYDROCHLORIDE | 4 MG | SHILPA THERAPEUTICS PVT. LIMITEDPLOT NO. 118, PHASE-III, IDA, CHERLAPALLY, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500016, TELANGANA, INDIA | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X5.0 SACHET CARTON | 15/02/2023 |
| NDA/MAL/HDP/10705 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | SUPADOL 500 | PARACETAMOL | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10706 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | NTSUGA 500 | METFORMIN HYDROCHLORIDE | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10707 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ZOPIMAC 3 | ESZOPICLONE | 3MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X100.0 TABLET CONTAINER | 15/02/2023 |
| NDA/MAL/HDP/10708 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | CAFENOL | ACETYLSALICYLIC ACID + CAFFEINE | 375MG + 25MG | BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554, MOGADISHU ROAD INDUSTRIAL AREA, NAIROBI KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X8.0X20.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10709 | CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - | ABACUS PHARMA (AFRICA) LIMITED | VINGLYN M 50/850 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 850 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10712 | RATNAMANI HEALTHCARE PVT. LTD | VIDA AFRICA LTD | ZENEGRA 100 | SILDENAFIL CITRATE | 100MG | RATNAMANI HEALTHCARE PRIVATE LIMITEDSURVEY 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 | 1X1X4 TABLET BLISTER | 20/09/2023 |
| NDA/MAL/HDP/10713 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | IMMUNCEE 500 | ASCORBIC ACID + SODIUM ASCORBATE | 100MG + 450MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY 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 | 15/02/2023 |
| NDA/MAL/HDP/10714 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | DICLOTRIX PLUS | DICLOFENAC SODIUM + PARACETAMOL | 50MG + 500MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10715 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | VILDARIL M 50/500 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 500MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10716 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | VILDARIL M 50/850 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 850 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10717 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | VILDARIL M 50/1000 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10718 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | LIPIZAR 10 | ATORVASTATIN CALCIUM TRIHYDRATE | 10MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10719 | HETERO LABS LTD | AIVEEN (U) LIMITED | GOAB 5 | SOLIFENACIN SUCCINATE | 5 MG | M/S. ANNORA PHARMA PRIVATE LIMITEDSY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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 |
| NDA/MAL/HDP/10720 | HETERO LABS LTD | AIVEEN (U) LIMITED | GOAB 10 | SOLIFENACIN SUCCINATE | 10MG | M/S. ANNORA PHARMA PRIVATE LIMITEDSY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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 LIMITEDVILLAGE 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 | 15/02/2023 |
| NDA/MAL/HDP/10722 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEDWIN | MEDROXYPROGESTERONE ACETATE | 150MG/ML | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL | 15/02/2023 |
| 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 | | EGYPT | | PARENTERAL ORDINARY S C VIALS | 1.0X1.0X10.0 ML VIAL | 15/02/2023 |
| NDA/MAL/HDP/10724 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | VIDA AFRICA LTD | MONIZOL 3 | MICONAZOLE NITARATE | 400MG | MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | VAGINAL SUPPOSITORIES | 1X1X3 PESSARY SACHET | 20/09/2023 |
| NDA/MAL/HDP/10725 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BESICOR 2.5 | BISOPROLOL FUMARATE | 2.5MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10726 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BESICOR 5 | BISOPROLOL FUMARATE | 5MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10727 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BESICOR 10 | BISOPROLOL FUMARATE | 10MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| 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 LTD10, 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 | 15/02/2023 |
| NDA/MAL/HDP/10729 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BRISCORIL | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | (1MG + 2MG + 50MG ) PER 5ML | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10730 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICHLOR 25 | CHLORTHALIDONE | 25MG | UNICHEM LABORATORIES LIMITEDC–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10731 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICHLOR 50 | CHLORTHALIDONE | 50 MG | UNICHEM LABORATORIES LIMITEDC–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10732 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | BREAZLAX | MONTELUKAST | 4MG | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10733 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | BREAZLAX | MONTELUKAST | 5MG | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10734 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | BREAZLAX | MONTELUKAST | 10MG | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10735 | CIPLA LTD. | ABACUS PHARMA (AFRICA) 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 | 15/02/2023 |
| NDA/MAL/HDP/10736 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNIPROEX ER 500 | DIVALPROEX SODIUM | 500MG | UNICHEM LABORATORIES LTDPLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER (ALU-ALU BLISTER),1.0X3.0X10.0 TABLET BLISTER (ACLAR – PVC BLISTER) | 15/02/2023 |
| NDA/MAL/HDP/10737 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | ABACAVIR 600 MG AND LAMIVUDINE 300 MG FILM COATED TABLETS | ABACAVIR SULFATE + LAMIVUDINE | 600MG + 300MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 15/02/2023 |
| 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., LTD1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINA | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE | 15/02/2023 |
| 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 |
| NDA/MAL/HDP/10742 | CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - | ABACUS PHARMA (AFRICA) LIMITED | VINGLYN | VILDAGLIPTIN | 50 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10743 | CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - | ABACUS PHARMA (AFRICA) LIMITED | VINGLYN M 50/500 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 500 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10745 | PUNISKA HEALTHCARE PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | EBROXON | CEFTRIAXONE SODIUM | 1 G/VIAL | ZEISS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 15/02/2023 |
| NDA/MAL/HDP/10746 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | FEBLORIKA-80 | FEBUXOSTAT | 80 MG | MANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10747 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 400 MG/300 MG/300 MG | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400 MG + 300 MG + 300 MG | HETERO LABS LIMITED (UNIT V)SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 15/02/2023 |
| NDA/MAL/HDP/10748 | KESAR PHARMA | VEERAM HEALTHCARE (U) LIMITED | LULI CREAM | LULICONAZOLE | 1% W/W | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10749 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | TENOFOVIR ALAFENAMIDE TABLETS 25 MG | TENOFOVIR ALAFENAMIDE FUMARATE | 25MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10750 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN PLUS | PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE | 500 MG + 15 MG + 10 MG + 2 MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10753 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | HISTALIN 8 | BETAHISTINE DIHYDROCHLORIDE | 8 MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10754 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | HISTALIN 16 | BETAHISTINE DIHYDROCHLORIDE | 16 MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10755 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | ZADYCINE-250 | AZITHROMYCIN DIHYDRATE | 250 MG | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10756 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | DAVIGRA 100 | SILDENAFIL CITRATE | 100 MG | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10757 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | ZADYCINE-500 | AZITHROMYCIN DIHYDRATE | 500 MG | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10758 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | DAVIZOLE | ALBENDAZOLE | 400 MG | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/1076 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNICAST 4MG | MONTELUKAST SODIUM | 4MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.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 |
| NDA/MAL/HDP/10760 | TORQUE PHQRCEAUTICALS PVT LTD | SHURIK LTD | SKINNCARE | CLOBETASOL PROPIONATE + SALICYLIC ACID | 0.05% W/W+ 3.00%W/W | TORQUE PHARMACEUTICALS PVT. LTD. UNIT-1, VILLAGE- ISSAPUR, DAPPAR, POST- DAPPAR, PUNJAB- 140506 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X20.0 G TUBE | 15/02/2023 |
| NDA/MAL/HDP/10761 | WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. | GOODMAN INTERNATIONAL LTD | ZIROMIN | AZITHROMYCIN DIHYDRATE | 500MG | 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 SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10762 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LINEZOLID TABLETS 600 MG | LINEZOLID | 600 MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10763 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROCORT | TRIAMCINOLONE ACETONIDE | 40 MG/ML | AUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X5.0X1.0 ML VIAL | 15/02/2023 |
| NDA/MAL/HDP/10764 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | CLOPIVID | CLOPIDOGREL HYDROGEN SULPHATE | 75MG | HOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10765 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HEXGABALIN 75 | PREGABALIN | 75MG | GLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10766 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TRAMA-50 | TRAMADOL HYDROCHLORIDE | 50MG | CACHET PHARMACEUTICAL PVT LTD.VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10767 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ZESBINA 100 | PROGESTERONE | 100 MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10768 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NEBUNTA 5 | NEBIVOLOL HYDROCHLORIDE | 5 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10769 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN-500 | AMOXICILLIN TRIHYDRATE | 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 15/02/2023 |
| NDA/MAL/HDP/10770 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | FITIN | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML | MEDLEY PHARMACEUTICALS LTDPLOT 18 & 19 SURVEY NO. 378/7&8, 379/2&3 ZARI CAUSEWAY ROAD, KACHIGAM DAMAN-396210, INDIA | NULL | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10771 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. | HEALTHCARE LTD. | MIZICIN | AZITHROMYCIN DIHYDRATE | 250MG | AL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10773 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. | HEALTHCARE LTD. | GESIDOL | TRAMADOL HYDROCHLORIDE | 50MG | AL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10774 | PSYCHOTROPICS INDIA LTD- | BIOGEN PHARMA LIMITED | QNN 300 | QUININE DIHYDROCHLORIDE | 300MG/ML | PSYCHOTROPICS INDIA LTDPLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 15/02/2023 |
| NDA/MAL/HDP/10775 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. | HEALTHCARE LTD. | FICLO SR 100 | DICLOFENAC SODIUM | 100MG | AL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | | PAKISTAN | | ORAL SOLID RETARD CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 15/02/2023 |
| NDA/MAL/HDP/10776 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | LEEFLOX | LEVOFLOXACIN HEMIHYDRATE | 0.5%W/V | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10777 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | GLUCOTIM 0.5% | TIMOLOL MALEATE | 0.5%W/V | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/HDP/10778 | ZIM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | ZIMFIL-ODS 20 | TADALAFIL | 20MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X10.0 STRIP PACK | 15/02/2023 |
| NDA/MAL/HDP/10779 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CLAVIX AS 75 | CLOPIDOGREL BISULFATE+ ASPIRIN | 75MG + 75MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 15/02/2023 |
| NDA/MAL/HDP/1078 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT INFUSION | LEVOFLOXACIN HEMIHYDRATE | 500MG | AHLCON PARENTERALS (INDIA) LTDSP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/10783 | RUSAN PHARMA LTD | NORVIK ENTERPRISES LIMITED | BIORAN | DICLOFENAC SODIUM | 75MG/3ML | RUSAN PHARMA LIMITEDPLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL ECONOMIC ZONE, GANDHIDHAM KUTCH 370 230 GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X3.0 ML AMPOULE | 03/05/2023 |
| NDA/MAL/HDP/10785 | VINS BIOPRODUCTS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TETAVIN | TETANUS ANTITOXIN | 1500 IU/ML | VINS BIOPRODUCTS LIMITEDSY. NO. 117, THIMMAPUR (V), KOTHUR MANDAL), RANGA REDDY (DIST), TELANDANA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X10.0X1.0 ML VIAL | 03/05/2023 |
| NDA/MAL/HDP/10786 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VIATUFF 50 | SILDENAFIL CITRATE | 50MG | AUROBINDO PHARMA LTD, UNIT VIISY. 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 | 1.0X1.0X2.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10787 | PSYCHOTROPICS INDIA LIMITED. | BIOGEN PHARMA LIMITED | AZIGEN | AZITHROMYCIN DIHYDRATE | 200 MG/5 ML | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 03/05/2023 |
| NDA/MAL/HDP/10789 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | FEBLORIKA-40 | FEBUXOSTAT | 40MG | MANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/1079 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOG-QUININE SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/10792 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | NEBIMAC 5 | NEBIVOLOL HYDROCHLORIDE | 5 MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10795 | PROFARMA SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | DIAZEPAM 10MG/2ML | DIAZEPAM | 10MG/2ML | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE | 03/05/2023 |
| NDA/MAL/HDP/10796 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SECNIZOLE TABLETS | SECNIDAZOLE | 1000MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X2.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10797 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | APREZO | APREMILAST | 10MG TABLETS CO-PACKED WITH 20MG TABLETS AND 30MG TABLETS | GLENMARK PHARMACEUTICALS LIMITEDPLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 19*30MG TABLETS],1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 47*30MG TABLETS] | 03/05/2023 |
| NDA/MAL/HDP/10798 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 325 MG | STEDMAN PHARMACEUTICALS PVT LTD C-4 SIDCO PHARMACEUTICAL COMPLEX ALATHUR THIRUPORUR 603 110 TAMILNADU | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10799 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | GEFITINIB 250MG TABLETS | GEFITINIB | 250MG | CIPLA LIMITED, GOA (UNIT X)PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147, L-147/1 TO L-147/3, L-138 AND L-147/A, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE, GOA. PIN: 403722 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/1080 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 250 TABLETS | CEFUROXIME AXETIL | 250MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | ALKEM LABORATORIES LIMITED.VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/10800 | HILTON PHARMA PVT LTD | BOOTS PHARMACEUTICALS LIMITED | ROLIPEZE | ROSUVASTATIN CALCIUM + EZETIMIBE | 10 MG + 10 MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10801 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS (900 IU + 450 IU)/1.44ML | FOLLITROPIN ALFA + LUTROPIN ALFA | (900 IU + 450 IU)/1.44ML | MERCK SERONO S.P.A,.VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BA | ITALY | | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0X1.44 ML PREFILLED PEN + 14 INJECTION NEEDLES | 03/05/2023 |
| NDA/MAL/HDP/10802 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS (300 IU + 150 IU)/1.44ML | FOLLITROPIN ALFA + LUTROPIN ALFA | (300 IU + 150 IU)/1.44ML | MERCK SERONO S.P.A,.VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BA | ITALY | | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0X1.44 ML PREFILLED PEN + 5 INJECTION NEEDLES | 03/05/2023 |
| NDA/MAL/HDP/10803 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS (450 IU + 225 IU)/0.72 ML | FOLLITROPIN ALFA + LUTROPIN ALFA | (450 IU + 225 IU)/0.72ML | MERCK SERONO S.P.A,.VIA DELLE MAGNOLIE 15 (LOC FRANZIONE ZONA IDUSTRIALE) 70026, MODUGNO BA | ITALY | | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0X0.72 ML PREFILLED PEN | 03/05/2023 |
| NDA/MAL/HDP/10804 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | COLIMEX TABLETS | DICYCLOVERINE HYDROCHLORIDE + PARACETAMOL | 20MG + 500MG | WALLACE PHARMACEUTICALS PVT LTDBHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10805 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BISODAC-HF 5 | BISOPROLOL FUMARATE | 5 MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10806 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | LOSARZED-50 | LOSARTAN POTASSIUM | 50MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10807 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN PLUS | PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | (250MG + 10MG + 2MG + 5MG) PER 5ML | LINCOLN PHARMACEUTICALS LTD .,.10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARAT | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 03/05/2023 |
| NDA/MAL/HDP/10808 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ROSUNA-10 | ROSUVASTATIN CALCIUM | ROSUNA-10 | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10810 | BRAWN LABORATORIES LTD | TATA UGANDA LIMITED | BUCLAPOXIME 200 | CEFPODOXIME PROXETIL | 200 MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10812 | MICRO LABS LTD | LABOREX UGANDA LIMITED | URYSOREN-5 | SOLIFENACIN SUCCINATE | 5 MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10813 | MICRO LABS LTD | LABOREX UGANDA LIMITED | URYSOREN-10 | SOLIFENACIN SUCCINATE | 10 MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10814 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CAVIT SUSPENSION | ELEMENTAL CALCIUM (IN CALCIUM PHOSPHATE) + ELEMENTAL PHOSPHORUS (IN CALCIUM PHOSPHATE) + MAGNESIUM HYDROXIDE + ZINC GLUCONATE + VITAMIN D3 | 300 MG + 150 MG + 75 MG + 4 MG + 200 IU | CACHET PHARMACEUTICALS PVT LTD .VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X150.0 ML BOTTLE | 03/05/2023 |
| NDA/MAL/HDP/10816 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AMITRYP-25 | AMITRIPTYLINE HYDROCHLORINE | 25 MG | LINCOLN PHARMACEUTICALS LTD .,.10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10817 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | CELOFEN 100 | CELECOXIB | 100 MG | HETERO LABS LIMITED (UNIT V)SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | HETERO LABS LIMITED (UNIT III)VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10818 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LINFLOX | OFLOXACIN | 0.3 % W/V | LINCOLN PHARMACEUTICALS LTD .,.10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARAT | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 03/05/2023 |
| NDA/MAL/HDP/10819 | APPASAMY | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NASOALDO | MOMETASONE FUROATE | 50 MCG/ NASAL SPRAY | LABORATORIO ALDO-UNION, S.L3, 08950 ESPLUGUES DE LLOBREGAT (BARCELONA) | SPAIN | | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X20.0 ML BOTTLE 1*140 ACTATIONS | 03/05/2023 |
| 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 |
| NDA/MAL/HDP/10820 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OLOPAT EYE DROPS | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD .N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X15.0 ML CONTAINER | 03/05/2023 |
| NDA/MAL/HDP/10821 | PROFARMA SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | ADRENALINE 1 MG/1ML | ADRENALINE HYDROGENTARTRATE | 1 MG/1ML | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 03/05/2023 |
| NDA/MAL/HDP/10822 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACECLAV 228.5 | AMOXICILLIN TRIHYDRATE + CLAVULANIC ACID | (200MG + 28.5 MG) PER 5ML | MEDICEF PHARMANO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 03/05/2023 |
| NDA/MAL/HDP/10823 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VACODIL 12.5 | CARVEDILOL | 12.5MG | AUROBINDO PHARMA LIMITED UNIT 3PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10824 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLANGEM OD 5 | OLANZAPINE | 5MG | AUROBINDO PHARMA LTD, UNIT VIISY. 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 SOLUBLE TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10825 | NOVARTIS OVERSEAS INVESTMENT | SURGIPHARM (U) LIMITED | UPERIO 50MG | SACUBITRIL + VALSARTAN | 24.3MG + 25.7MG | NOVARTIS FARMA S.P.A.-NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10826 | NOVARTIS OVERSEAS INVESTMENT | SURGIPHARM (U) LIMITED | UPERIO 100MG | SACUBITRIL + VALSARTAN | 48.6MG +51.4MG | NOVARTIS FARMA S.P.A.-NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10827 | NOVARTIS OVERSEAS INVESTMENT | SURGIPHARM (U) LIMITED | UPERIO 200MG | SACUBITRIL + VALSARTAN | 97.2MG + 102.8MG | NOVARTIS FARMA S.P.A.-NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10828 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | FENOTOR 200 | FENOFIBRATE | 200MG | TORRENT PHARMACEUTICALS LIMITEDPLOT NO. Z104-106, DAHEJ SEZ PART II, TALUKA: VAGRA, DIST.: BHARUCH-392130, GUJARAT- INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10829 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | FENOTOR 67 | FENOFIBRATE | 67 MG | TORRENT PHARMACEUTICALS LIMITEDPLOT NO. Z104-106, DAHEJ SEZ PART II, TALUKA: VAGRA, DIST.: BHARUCH-392130, GUJARAT- INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 06/06/2023 |
| NDA/MAL/HDP/1083 | GALPHA LABORATORIES LTD | DAWASANA PHARMACEUTICALS LTD | CHOCOFER SYRUP | IRON |FOLIC ACID|IRON + FOLIC ACID | 50MG + 0.5MG /5ML|0.5MG|50MG | GALPHA LABORATORIES LIMITEDVILLAGE €“ THANA BADDI, TEHSIL BADDI SOLAN HIMACHAL PRADESH-173 205 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE, 1.0X200.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/10830 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | MUSCUREL | THIOCOLCHICOSIDE | 8 MG | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10831 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LASTAVIN 80 | VALSARTAN | 80 MG | AJANTA PHARMA LIMITEDAJANTA 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 | 19/06/2023 |
| NDA/MAL/HDP/10832 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LASTAVIN 160 | VALSARTAN | 160MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10833 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | MOLNAFLU | MOLNUPIRAVIR | 200MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | AUROBINDO PHARMA LIMITED UNIT 3PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X40.0 CAPSULE BOTTLE | 06/06/2023 |
| NDA/MAL/HDP/10834 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANSIPTIN 100 | SITAGLIPTIN HYDROCHLORIDE | 100MG | SAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10835 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANSIPTIN 50 | SITAGLIPTIN HYDROCHLORIDE | 50MG | SAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X18.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10836 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANSIPTIN 25 | SITAGLIPTIN HYDROCHLORIDE | 25MG | SAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X16.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10838 | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD | TATA UGANDA LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR SODIUM | 50MG | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINA | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 06/06/2023 |
| NDA/MAL/HDP/10839 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | ZEEDERM | ZINC OXIDE | 15%W/W | STEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 06/06/2023 |
| NDA/MAL/HDP/1084 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENIRAMINE MALEATE | 4MG | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/10840 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ THROAT SPRAY | POVIDONE IODINE | 0.45%W/V | STEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X50.0 ML CONTAINER | 06/06/2023 |
| NDA/MAL/HDP/10841 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DUTABIT PLUS 0.5/0.4 | DUTASTERIDE + TAMSULOSIN HYDROCHLORIDE | 0.5 MG + 0.4 MG | AUROBINDO PHARMA LTD, UNIT VIISY. 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 OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 06/06/2023 |
| NDA/MAL/HDP/10842 | WOCKHARDT LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EMROK | LEVONADIFLOXACIN | 800 MG / 100ML | WOCKHARDT LIMITED BIOTECH PARK, H-14/2, M.I.D.C, WALUJ, AURANGABAD - 431136, INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML VIAL | 06/06/2023 |
| NDA/MAL/HDP/10845 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TURBOVAS-20 | ROSUVASTATIN CALCIUM | 20MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10846 | ZIM LABORATORIES LTD- | REDDYS PHARMA LIMITED | CEFRAZ SUSPENSION | CEFIXIME | 100MG/5ML | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE (AMBER PET BOTTLE) | 03/05/2023 |
| NDA/MAL/HDP/10847 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | BUDESMA | BUDESONIDE | 200 MCG/ACTUATION | GLENMARK PHARMACEUTICALS LIMITED-UNIT IIIVILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIA | INDIA | | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 02/06/2023 |
| NDA/MAL/HDP/10848 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | MEFENA FORTE-500 | MEFENAMIC ACID | 500MG | AGOG PHARMA LIMITED .PLOT 33, SECTOR II THE VASAI TALUKA INDUSTIRAL COOP ESTE LTD GAURAIPADA, VASAI (E) DIST. THANE-401208 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10849 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | LIRAPYN 25 | PREGABALIN | 25MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10850 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-H | OLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE | 20MG + 12.5MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10851 | DEVA HOLDING A.S- | SHREEJI PHARMACEUTICALS LIMITED | LOSAPRES PLUS 50 MG / 12.5 MG | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50 MG + 12.5 MG | DEVA HOLDING A.S (CERKEZKOY PRODUCTION SITE)CERKEZKOY ORGANIZE SANAYI BOLGESI. KARAAGAC MAH. ATATURK CAD. NO: 32 59510 KAPAKLI/TEKIRDAG/TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10852 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INTRAM | TRAMADOL HYDROCHLORIDE | 50MG | FREDUN PHARMACEUTICALS LIMITED,14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10853 | SAVA HEALTHCARE LIMITED - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUTIAIR-S 250 | SALMETEROL + FLUTICASONE PROPIONATE | (50 MCG + 250 MCG)/CAPSULE | SAVA HEALTHCARE LIMITED.PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | | LUNG ADMINISTRATION INHALER CAPSULES | 1.0X30.0X1.0X250.0 MU CAPSULE,1.0X30.0X1.0X250.0 MCG CAPSULE | 02/06/2023 |
| NDA/MAL/HDP/10854 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | GLIMITAB 2 TABLETS | GLIMEPIRIDE | 2MG | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10855 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | TECAVIR 0.5 | ENTECAVIR MONOHYDRATE | 0.5MG | 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 | 1.0X3.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10856 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KEPAM 500MG/5ML | LEVETIRACETAM | 500MG/5ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X10.0X5.0 ML VIAL (CLEAR GLASS VIAL) | 03/05/2023 |
| NDA/MAL/HDP/10857 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANDOPOXETINE 60 MG | DAPOXETINE HYDROCHLORIDE | 60MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10858 | SYNOKEM PHARMACEUTICALS LIMITED | BIOGEN PHARMA LIMITED | DEFLAGEN | DEFLACORT | 6MG | SYNOKEM PHARMACEUTICALS LIMITEDSYNOKEM PHARMACEUTICALS LIMITED, PLOT NO. 35-36, SECTOR-6A, IIE, (SIDCUL), RANIPUR (BHEL), HARIDWAR, 249403, (UTTARAKHAND) - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10859 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PERFORMA 5% EXTRA | MINOXIDIL | 5G/100ML | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE | 03/05/2023 |
| NDA/MAL/HDP/1086 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | SYNOGEN TABLETS | DIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE | 50MG +250MG + 750MG | NEM LABORATORIES LIMITED133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA – INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/10860 | ASPIRO PHARMA LIMITED | AIVEEN (U) LIMITED | YESOM 40 | ESOMEPRAZOLE SODIUM | 40MG | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X5.0 ML VIAL (CLEAR GLASS VIAL) | 03/05/2023 |
| NDA/MAL/HDP/10862 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BIFRIL 7.5MG | ZOFENOPRIL CALCIUM | 7.5MG | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRLVIA CAMPO DI PILE 67100 L'AQUILA (AQ) | ITALY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 03/05/2023 |
| NDA/MAL/HDP/10865 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | LOREZE | LORATADINE | 10MG | MEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0X1.0X1.0X10.0 CAPSULE BLISTER | 02/06/2023 |
| NDA/MAL/HDP/10866 | LES LABORATOIRES SERVIER | HARLEYS UGANDA LIMITED | COVERSYL 10MG | PERINDOPRIL ARGININE | 10MG | SERVIER EGYPT INDUSTRIES LIMITED (SEI)PLOT NO. 37 1ST INDUSTRIAL ZONE. PLOT NO. 184 - 8 2ND INDUSTRIAL ZONE – 6TH OCTOBER CITY GIZA - EGYPT | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER (OPAQUE WHITE PLASTIC CONTAINER) | 02/06/2023 |
| NDA/MAL/HDP/10867 | LES LABORATOIRES SERVIER | HARLEYS UGANDA LIMITED | COVERSYL 5 MG | PERINDOPRIL ARGININE | 5MG | SERVIER EGYPT INDUSTRIES LIMITED (SEI)PLOT NO. 37 1ST INDUSTRIAL ZONE. PLOT NO. 184 - 8 2ND INDUSTRIAL ZONE – 6TH OCTOBER CITY GIZA - EGYPT | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER (OPAQUE WHITE PLASTIC CONTAINER) | 02/06/2023 |
| 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 |
| NDA/MAL/HDP/10873 | MARCYRL PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TORSAMOLEX 10MG | TORSEMIDE | 10 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 TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10874 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | PAN IV | PANTOPRAZOLE SODIUM | 40MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL (+ 10 ML OF 0.9%W/V SODIUM CHLORIDE INJECTION, LDPE AMPOULE) | 17/08/2023 |
| NDA/MAL/HDP/10877 | CRATUS PHARMA PVT. LTD. 7, | ABACUS PHARMA (AFRICA) LIMITED | RABEGUARD IV | RABEPRAZOLE SODIUM | 20 MG/VIAL | RATNAMANI HEALTHCARE PRIVATE LIMITEDSURVEY NO. 750/1, AHMEDABAD - MEHSANA HIGHWAY, VILLAGE-INDRAD, NR. CHHATRAL G.I.D.C., TALUKA-KADI, DIST-MEHSANA, PIN-382721 (NG), GUJARAT - INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 MG VIAL + 1*10 ML WATER FOR INJECTION IN LDPE CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10878 | LUPIN LIMITED- | AIVEEN (U) LIMITED | LINEZOID 600 MG TABLETS | LINEZOLID | 600MG | LUPIN LTD198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10879 | LUPIN LIMITED- | AIVEEN (U) LIMITED | ISONIAZID TABLETS 300MG | ISONIAZID | 300MG | LUPIN LIMITED A-28/1 MIDC CHIKALTHANA AURANGABAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/1088 | GALPHA LABORATORIES LTD | DAWASANA PHARMACEUTICALS LTD | RESTUM | CEFUROXIME FOR INJECTION |CEFUROXIME SODIUM | 750MG|750 | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL, 1.0X750.0 BLISTER VIAL | 01/07/2015 |
| NDA/MAL/HDP/10880 | TABROS PHARMA | HEALTHCARE LTD. | HEMSAMIC CAPSULE | TRANEXAMIC ACID | 500MG | TABROS PHARMAL-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTAN | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 24/07/2023 |
| NDA/MAL/HDP/10881 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR PR-750 | METFORMIN HYDROCHLORIDE | 750MG | INVENTIA HEALTHCARE LIMITEDF-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10882 | BHARAT SERUMS & VACCINES LTD. | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF 1200 IU | RECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH) | 1200IU/VIAL (MULTIDOSE) | BHARAT SERUM AND VACCINES LIMITEDPLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | | PARENTERAL ORDINARY DRY AMPOULES | 1.0X1.0 VIAL 1 PREFILLED SYRINGE OF DILUENT + 15 DISPOSABLE SYRINGES] | 17/08/2023 |
| NDA/MAL/HDP/10883 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | DAPAGLIFLOZIN TABLETS 10 MG | DAPAGLIFLOZIN PROPANEDIOL | 10MG | CIPLA LIMITEDPLOT NOS. L-139, S-103 & M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA, 403 722 - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10884 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MALOTEM 80/480MG | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | 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 | 17/08/2023 |
| NDA/MAL/HDP/10885 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | NEBIMAC 10 | NEBIVOLOL HYDROCHLORIDE | 10MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)BLOCK N1, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, HIMACHAL PRADESH -174101, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10886 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | CLOTRILIN-V | CLOTRIMAZOLE | 2%W/W | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | VAGINAL CREAMS | 1.0X1.0X15.0 G TUBE | 17/08/2023 |
| NDA/MAL/HDP/10888 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | COVIFOR | REMDESIVIR | 100MG/VIAL | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL | 17/08/2023 |
| NDA/MAL/HDP/10890 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | ZIQUANTA | PRAZIQUANTEL | 600MG | HETERO LABS LIMITED (UNIT V)SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10891 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BINAFIN | TERBINAFINE HYDROCHLORIDE | 1%W/W | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 17/08/2023 |
| NDA/MAL/HDP/10894 | REYOUNG PHARMACEUTICAL CO LTD | BIOGEN PHARMA LIMITED | FRUSOGEN | FUROSEMIDE | 20MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 17/08/2023 |
| NDA/MAL/HDP/10896 | REYOUNG PHARMACEUTICAL CO LTD | BIOGEN PHARMA LIMITED | AMPIGEN | AMPICILLIN SODIUM + CLOXACILLIN SODIUM | (250MG + 250MG)VIAL | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X0.5 G VIAL | 17/08/2023 |
| NDA/MAL/HDP/10897 | HILTON PHARMA (PVT) LTD | BOOTS PHARMACEUTICALS LIMITED | DAPA | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 5MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10898 | HILTON PHARMA (PVT) LTD | BOOTS PHARMACEUTICALS LIMITED | ROLIP EZE TABLETS | ROSUVASTATIN CALCIUM + EZETIMIBE | 20MG +10MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10900 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TRAMADOL DENK | TRAMADOL HYDROCHLORIDE | 100MG/2 ML | SOLUPHARM GMBH INDUSTRIESTRASSE 3, 34212 MELSUNGEN | GERMANY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE | 17/08/2023 |
| NDA/MAL/HDP/10903 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | BIDSIPTIN | VILDAGLIPTIN | 50MG | SAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10904 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | UROKA PLUS | DUTASTERIDE + TAMSULOSIN HYDROCHLORIDE | 0.5MG + 0.4MG | SAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10905 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | VERQUVO 2.5 MG TABLET | VERICIGUAT | 2.5MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10906 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | VERQUVO 5MG TABLET | VERICIGUAT | 5MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10907 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | VERQUVO 10 MG TABLET | VERICIGUAT | 10MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10908 | BDR PHARMACEUTICALS INTERNATIONAL PVT LTD | ONCOPHARM (U) LTD | LIVONIBE | SORAFENIB TOSYLATE | 20 MG | BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITEDR.S. NO. 578, NR, EFFLUENT CHANNEL ROAD,; VILLAGE - LUNA, TAL-PADRA; DIST - VADODARA - 391440; GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10909 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | CADZOLE | CLOTRIMAZOLE | 1% W/W | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 17/08/2023 |
| NDA/MAL/HDP/10910 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | DAVI-IBU | IBUPROFEN | 200MG | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10911 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | DAVIZOLE | ALBENDAZOLE | 200MG/5ML | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL LIQUID ORDINARY EMULSIONS | 1.0X1.0X10.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10912 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | FLUZINE | CETIRIZINE DIHYDROCHLORIDE | 10MG | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10914 | DAVIMED PHARMA LIMITED | DAVIMED PHARMA LIMITED | HI CEF 250 | CEFALEXIN MONOHYDRATE | 250 MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10915 | DAVIMED PHARMA LIMITED | DAVIMED PHARMA LIMITED | DAVICEF 1 G | CEFTRIAXONE SODIUM | 1G/VIAL | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X10.0 ML VIAL | 17/08/2023 |
| NDA/MAL/HDP/10916 | DAVIMED PHARMA LIMITED | DAVIMED PHARMA LIMITED | CEFOTEC | CEFOTAXIME SODIUM | 1G/VIAL | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | PARENTERAL RETARD DRY VIALS | 1.0X1.0X1.0 G VIAL | 17/08/2023 |
| NDA/MAL/HDP/10917 | DAVIMED PHARMA LIMITED | DAVIMED PHARMA LIMITED | CEFTRIAXONE | CEFTRIAXONE SODIUM | 1G/VIAL | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X25.0X1.0X1.0 G VIAL | 17/08/2023 |
| NDA/MAL/HDP/10918 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | ESUPRONE | ESOMEPRAZOLE SODIUM | 40 MG/VIAL | BLISS INDASI LIFESCIENCE PRIVATE LIMITEDPLOT NO. 73 TO 76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 396 210 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL + 1*10 ML, SODIUM CHLORIDE IN LDPE PACK | 17/08/2023 |
| NDA/MAL/HDP/10919 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SANFIXIME 400 | CEFIXIME TRIHYDRATE | 400MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10920 | ACINO AG. | GOODMAN INTERNATIONAL LTD | PARACONICA™ PLUS 500 MG/150 MG | PARACETAMOL + IBUPROFEN | 500 MG + 150 MG | SIGMA LABORATORIES PRIVATE LIMITED6, 7, 8 TIVIM INDUSTRIAL ESTATE, TIVIM, MAPUSA 403526, GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10921 | AVACARE GLOBAL | GOODMAN INTERNATIONAL LTD | AVAFLOX 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | 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 SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10922 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | LABCLAV 1G TABLETS | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 875MG + 125MG | LABORATORY & ALLIED LTD PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10923 | BAROQUE PHARMACEUTICALS PVT LTD | JEET PHARMACEUTICALS LIMITED | ROSUSTAR 10MG | ROSUVASTATIN CALCIUM | 10MG | BAROQUE PHARMACEUTICALS PVT. LTDPLOT 192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10924 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | METOPRIX 10 | METOCLOPRAMIDE | 10 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10925 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | HERPIRAX 200 | ACICLOVIR | 200 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10926 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACELEVO 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10927 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACELEVO 750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | BIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10928 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | FIX-A | CEFIXIME TRIHYDRATE | 100MG/5ML | THE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X75.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10930 | RATNATRIS PHARMARMACEUTICALS PVT. LTD | JEET PHARMACEUTICALS LIMITED | DIKOPAR | DICLOFENAC SODIUM + PARACETAMOL | 50MG + 500MG | RATNAMANI HEALTHCARE PRIVATE LIMITEDSURVEY 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10931 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNIDROL 10 | ALFUZOSIN HYDROCHLORIDE | 10 MG | UNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10932 | SHREEJI CARE LIMITED | SHREEJI CARE LIMITED | CALCIGLO-L | CALCIUM LACTATE | 300MG | 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,1.0X1000.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10933 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 20 MG + 160 MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X2.0X3.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10934 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | ALERCON | OLOPATADINE HYDROCHLORIDE | 1 MG/ML | THE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10935 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | SUPERPIME 1G IM/IV INJECTION | CEFEPIME HYDROCHLORIDE | 1 G/VIAL | THE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 17/08/2023 |
| NDA/MAL/HDP/10936 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | TEARLIN-0.5 % | CARMELLOSE SODIUM | 0.5% W/V | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10937 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | TEARLIN-1 % | CARMELLOSE SODIUM | 1.0% W/V | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10938 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATORKEY 80 | ATORVASTATIN CALCIUM TRIHYDRATE | 80 MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT 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 | 17/08/2023 |
| 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 |
| NDA/MAL/HDP/10940 | BRAWN LABORATORIES LTD | PLANET PHARMACEUTICALS UGANDA LTD | MASTIC-LC | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10MG + 5MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10944 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TORLEVA 500MG | LEVETIRACETAM | 500MG | TORRENT PHARMACEUTICALS LTD .,INDRAD - 382721, TAL: KADI, CITY - INDRAD, DIST. MEHSANA, GUJARAT STATE - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10945 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | XYLOPIL-2% | LIDOCAINE HYDROCHLORIDE | 20MG/ML | PSYCHOTROPICS INDIA LTDPLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X30.0 ML VIAL (CLEAR GLASS VIAL) | 17/08/2023 |
| NDA/MAL/HDP/10946 | MACLEODS PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | MONTEMAC-10 | MONTELUKAST SODIUM | 10MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE 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 | 17/08/2023 |
| NDA/MAL/HDP/10947 | MACLEODS PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | OLMESAR H | OLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE | 20 MG + 12.5 MG | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE 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 | 17/08/2023 |
| NDA/MAL/HDP/10948 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | FLUCOLD | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE | 500 MG + 10 MG + 2 MG | WALLACE PHARMACEUTICALS PVT LTDBHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10949 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | CLAMOXIN-375 TABLETS | AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE | 250MG + 125 MG | MEDOPHARM PVT LIMITEDNO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/1095 | MICRO LABS LTD | LABOREX UGANDA LIMITED | EROSTINE-20 | EBASTINE | 20MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/10950 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | DICORATE ER 500 | DIVALPROEX SODIUM | 500 MG | SUN PHARMA LABORATORIES LIMITED6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIA | INDIA | | ORAL SOLID RETARD COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10951 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC PLUS | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 25MG | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYAL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10952 | MINAPHARM PHARMACEUTICAL & CHEMICAL INDUSTRIES | SWASTIK PHARMACEUTICAL LTD | HYDROQUINE | HYDROXYCHLOROQUINE SULPHATE | 200 MG | MINAPHARM COMPANY FOR PHARMACEUTICALS AND CHEMICAL INDUSTRIESPARTS NO. 15/4; 16/4, INDUSTRIAL ZONE A2 - 10TH OF RAMADHAN CITY - EGYPT | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10953 | KOPRAN LIMITED | TATA UGANDA LIMITED | LOKIT HP | CLARITHROMYCIN + TINIDAZOLE + OMEPRAZOLE | 250 MG + 500 MG + 20 MG | KOPRAN LIMITEDVILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY COMBINATION PACK COATED TABLETS | 1.0X7.0X1.0X1.0X6.0 TABLET STRIP (EACH STRIP CONTAINS 2 TABLETS OF CLARITHROMYCIN + 2 TABLETS OF TINIDAZOLE + 2 CAPSULES OF OMEPRAZOLE) | 17/08/2023 |
| NDA/MAL/HDP/10954 | RENATA LIMITED | UHAI PHARMACY | FUROCEF® | CEFUROXIME AXETIL | 500MG | RAJENDRAPUR POTENT PRODUCT FACILITY (RPPF), RENATA LIMITEDNOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR 1700 - BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X6.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10956 | RENATA LIMITED | UHAI PHARMACY | ZITHRIN | AZITHROMYCIN | 500MG | RENATA LIMITED RAJENDRAPUR GENERAL FACILITY, NOYAPARA BHAWAL MIRZAPUR RAJENDRAPUR GAZIPUR, 1700 BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X5.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10957 | ORCHIDIA PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-AVAZIR | TOBRAMYCIN + DEXAMETHASONE | (3 MG + 1 MG)/ML | ORCHIDIA PHARMACEUTICAL INDUSTRIESAL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPT | EGYPT | | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10958 | ORCHIDIA PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ALPHANOVA | BRIMONIDINE TARTRATE | 0.15%W/V | ORCHIDIA PHARMACEUTICAL INDUSTRIESAL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPT | EGYPT | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10959 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | VALMACA 160/10 | AMLODIPINE BESYLATE + VALSARTAN | 10 MG + 160 MG | MACLEODS PHARMACEUTICALS LIMITED. .BLOCK N1, N2 & N3, VILLAGE THEDA P.O MANPURA, TEHSIL NALAGARH, DIST SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| 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 | INDIA | | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE,1.0X1.0X8.0X1.0 ML AMPOULE | 01/07/2014 |
| NDA/MAL/HDP/10960 | AXA PARENTERALS LTD | VITACARE LIMITED | AXADEX D5 | GLUCOSE ANHYDROUS | 5% W/V | AXA PARENTERALS LTDPLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10961 | ADWIA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LEPTROGINE 25MG | LAMOTRIGINE | 25 MG | ADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPT | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10962 | MYLAN LABORATORIES LIMITED- | KIMSY MEDS LTD | DARUNAVIR/RITONAVIR TABLETS 400 MG/50 MG | DARUNAVIR ETHANOLATE + RITONAVIR | 400 MG + 50 MG | MYLAN LABORATORIES LTD .F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10964 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AZIREN | AZITHROMYCIN DIHYDRATE | 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10965 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | MPHETAS-500 | MYCOPHENOLATE MOFETIL | 500MG | INTAS PHARMACEUTICALS LTD ..PLOT NO. 457-458 VILL MATODA BAVLA ROAD TA SANAND DIST AHMEDABAD PIN-382 210 GUJARART STATE | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10966 | EUGIA PHARMA SPECIALITIES LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SKYTINIB 12.5 | SUNITINIB MALATE | 12.5 MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10967 | EUGIA PHARMA SPECIALITIES LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SKYTINIB 25 | SUNITINIB MALATE | 25 MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10968 | HALEWOOD LABORATORIES PVT. LTD. | AIVEEN (U) LIMITED | ELECTRORUSH POWDER ORS BP | SODIUM CHLORIDE + POTASSIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + DEXTROSE ANHYDROUS | 2.60 G + 1.50 G + 2.90 G + 13.50 G | HALEWOOD LABORATORIES PVT. LIMITED319, PHASE - II, GIDC, VATVA, AHMEDABAD - 382445, GUJARAT | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X20.5 G SACHET | 17/08/2023 |
| NDA/MAL/HDP/10969 | FDC LTD | AIVEEN (U) LIMITED | VITCOFOL | FERROUS FUMARATE + FOLIC ACID + CYANOCOBALAMIN | (100MG + 0.5MG + 5MCG)/5ML | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10970 | UMEDICA LABORATORIES PVT LTD | VITACARE LIMITED | OLMETAN-H20/12.5 MG | OLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE | 20 MG + 12.5 MG | UMEDICA LABORATORIES PVT. LTDPLOT 221-GIDC, 2ND PHASE, VAPI 396195 GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10971 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TIRATAM 1000MG | LEVETIRACETAM | 1000MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10972 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLANGEM OD 15 | OLANZAPINE | 15MG | AUROBINDO PHARMA LTD, UNIT VIISY. 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 ORALLY DISINTEGRATING TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10973 | SWISS PARENTERALS LTD. | SHREEJI PHARMACEUTICALS LIMITED | ADRENALINE INJECTION BP 1MG/ML 1ML | ADRENALINE ACID TARTRATE | 1MG/ML | SWISS PARENTERALS LIMITED (UNIT-1)808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 17/08/2023 |
| NDA/MAL/HDP/10974 | EUGIA PHARMA SPECIALITIES LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SKYTINIB 50 | SUNITINIB MALATE | 50 MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10975 | VERVE HUMAN CARE LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | BUPIVER-H | BUPIVACAINE HYDROCHLORIDE | 5MG/ML | VERVE HUMAN CARE LABORATORIESPLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA. | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X4.0 ML AMPOULE | 17/08/2023 |
| NDA/MAL/HDP/10976 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | PARAGESIC | DICLOFENAC SODIUM + PARACETAMOL + CHLORZOXAZONE | 50 MG + 325 MG + 250 MG | SAGA LABORATORIES .198/2 & 198/3, CHACHRAWADI, VASNA NO. CLARIS LIFE SCIENCE, TA SANAND, DIST. DIST: AHMEDABAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10977 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | FIRIALTA® | FINERENONE | 10MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10978 | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANDORIVABAN | RIVAROXABAN | 10MG | AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10979 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | FIRIALTA® | FINERENONE | 20MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10980 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEFENEC PLUS | MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE | 250 MG + 20 MG | RAVIAN LIFE SCIENCE PVT. LIMITEDPLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10982 | COMED CHEMICALS LTD. | LEGIT MEDEQ 2007 LIMITED | RAPCO-DSR | RABEPRAZOLE SODIUM + DOMPERIDONE | 20 MG + 30 MG | COMED CHEMICALS LTD (UNIT-III)VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10983 | AGIO PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | ENALAPRIL-AGIO TABLET | ENALAPRIL MALEATE | 5MG | AGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10984 | AGIO PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | ENALAPRIL-AGIO TABLET | ENALAPRIL MALEATE | 10MG | AGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10985 | APEX LABORATORIES PRIVATE LIMITED | NORVIK ENTERPRISES LIMITED | ZINCOVIT DROPS | VITAMIN A (AS PALMITATE) + RRR -ALPHA-TOCOPHERYL ACETATE + COLECALCIFEROL + THIAMINE HYDROCHLORIDE + RIBOFLAVIN SODIUM PHOSPHATE + PYRIDOXINE HYDROCHLORIDE + ASCORBIC ACID + DEXPANTHENOL + NICOTINAMIDE + ZINC SULFATE HEPTAHYDRATE + LYSINE HYDROCHLORIDE | (2500.00 IU + 2.50 MG + 200.00 IU + 1.00 MG + 1.00 MG + 0.50 MG + 40.00 MG + 1.00 MG + 10.00 MG + 13.30 MG + 10.00 MG)ML | APEX LABORATORIES PRIVATE LIMITED (PLANT III)510 KUNNAM VILLAGE AND POST, THENNERI (VIA) SRIPERUMBUDUR TK KANCHEEPRURAM DISTRICT, PIN CODE: 631 604, TAMIL NADU | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X1.0X5.0 ML BOTTLE (AMBER GLASS BOTTLE) | 17/08/2023 |
| NDA/MAL/HDP/10987 | LUPIN LIMITED- | AIVEEN (U) LIMITED | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG AND 300 MG | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300 MG + 300 MG | LUPIN LTDPLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 17/08/2023 |
| NDA/MAL/HDP/10988 | Y.S.P. INDUSTRIES (M) SDN. BHD. | ROYAL PHARMA 2011 LIMITED | LACTUL | LACTULOSE | 670MG/ML | 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 | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE (AMBER PET BOTTLE) | 17/08/2023 |
| NDA/MAL/HDP/10989 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | BINFIN 5 | FINASTERIDE | 5MG | HETERO LABS LIMITED (UNIT III)...22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 17/08/2023 |
| 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 |
| NDA/MAL/HDP/10990 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BISODAC-HF 10 | BISOPROLOL FUMARATE | 10MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10991 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | IXAROLA 10 FILM-COATED TABLETS | RIVAROXABAN | 10MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10992 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | IXAROLA 20 FILM-COATED TABLETS | RIVAROXABAN | 20MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10993 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | IXAROLA 15 FILM-COATED TABLETS | RIVAROXABAN | 15MG | BAYER PHARMA AG 51368 LEVERKUSEN, | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10994 | DINLAS PHARMA EPZ LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | PARADOL | PARACETAMOL | 500MG | DINLAS PHARMA EPZ LIMITEDPLOT NO. LR 7149/121, MOMBASA ROAD, SYOKIMAU | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/10998 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | MOCIN | MOXIFLOXACIN HYDROCHLORIDE | 400MG/100ML | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGA | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/HDP/10999 | MARCYRL PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | URICODROP | FEBUXOSTAT | 80MG | 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 | 1.0X3.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/1100 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIR SKIN CREAM | ACICLOVIR | 5% W/W | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/11000 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SINUTAB SINUS PAIN NON-DROWSY | PARACETAMOL + PSEUDOEPHEDRINE HYDROCHLORIDE | 500 + 30 MG | JOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/11001 | UNISON PHARMACEUTICALS PVT. LTD. | HARLEYS UGANDA LIMITED | AKILOS-CR | ACECLOFENAC | 200MG | UNISON PHARMACEUTICALS PRIVATE LIMITED – UNIT 1UNIT I, C/6, STEEL TOWN, OPP. NOVA PETRO, MORAIYA, TA. SANAND, DIST.: AHMEDABAD - 382213, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 17/08/2023 |
| NDA/MAL/HDP/11002 | CENTAUR PHARMACEUTICALS PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | MICONA VAGINAL CREAM | MICONAZOLE NITRATE | 2%W/W | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 2)PLOT NO 39-41TIVIM INDUSTRIAL ESTATE, KARASWADA - MAPUSA, GOA-403526 | INDIA | | VAGINAL CREAMS | 1.0X1.0X40.0 G TUBE | 17/08/2023 |
| NDA/MAL/HDP/11003 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | BAROLE | RABEPRAZOLE | 20MG | NAPROD LIFE SCIENCES PVT. LTDG-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 MG VIAL | 17/08/2023 |
| NDA/MAL/HDP/11004 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | FAST 125 | PARACETAMOL | 125MG | THE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 17/08/2023 |
| NDA/MAL/HDP/11012 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | CEMET 400 | CIMETIDINE | 400MG | COSMOS LTD..RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/11015 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | HYDROCORTISONE CREAM BP | HYDROCORTISONE ACETATE | 1% W/W | CIRON DRUGS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR €“ 401404, MAHARASHTRA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11016 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEDOBOOK 15 | LENALIDOMIDE | 15MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X7.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11017 | AUROBINDO | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEDOBOOK 25 | LENALIDOMIDE | 25MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X7.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11018 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEDWIN | MEDROXYPROGESTERONE | 150MG/ML | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE | 12/13/2023 |
| NDA/MAL/HDP/11019 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEDOBOOK 5 | LENALIDOMIDE | 5MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X7.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/1102 | MATRIX UGANDA LTD | ROYAL PHARMA 2011 LIMITED | OVUREX | CLOMIPHENE | 50MG | Y.S.P INDUSTRIES (M) SDN BDH LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/11020 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | IBUPLUS | IBUPROFEN + PARACETAMOL | 100MG/125MG | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11021 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | INTAFERON | IRON SUCROSE | 100MG/5ML. | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 12/13/2023 |
| NDA/MAL/HDP/11022 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CEFIXIME QUIX DISPERSIBLE TABLETS 200MG | CEFIXIME TRIHYDRATE | 200MG | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11023 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MOXVID | AMOXICILLIN TRIHYDRATE | 125 MG/5 ML | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML CONTAINER | 12/13/2023 |
| NDA/MAL/HDP/11024 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LTD | CLONAPIN-2 | CLONAZEPAM | 2MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11025 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LTD | DYGYL | METRONIDAZOLE BENZOATE | 125MG/5ML | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11026 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LTD | TELMISIN | TELMISARTAN | 40 MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11027 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CEFIMCZ-400 | CEFIXIME | 400 MG | ZEISS PHARMA LIMITEDIGC,SIDCO, PHASE II, SAMBA, JAMMU - 184121,(J&K) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11028 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | APLENE 50 | PREGABALIN | 50MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11029 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | APLENE 75 | PREGABALIN | 75MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/1103 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIN CREAM | NEOMYCIN SULPHATE | 0.5% W/W | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/11030 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | APLENE 150 | PREGABALIN | 150MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11031 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | NIZACARD 500 | RANOLAZINE | 500MG | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE, | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11032 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | NIZACARD 1000 | RANOLAZINE | 1000MG | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11033 | KESAR PHARMA | JEET PHARMACEUTICALS LIMITED | FLUPLEX | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE ANHYDROUS | 500MG + 10MG + 2MG + 30MG | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET STRIP | 12/13/2023 |
| NDA/MAL/HDP/11034 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | ARCELIA® ESOMEPRAZOLE TABLETS 40 MG | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 40 MG | ASSOCIATED BIOTECHVILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11035 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | ARCELIA® ESOMEPRAZOLE TABLETS 20 MG | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 20 MG | ASSOCIATED BIOTECHVILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11036 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | DROCELIA | DROTAVERINE HYDROCHLORIDE | 40 MG/2 ML | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1X1X5X2X0 ML AMPOULE | 12/13/2023 |
| NDA/MAL/HDP/11037 | FERRER INTERNATIONAL, S.A. | LABOREX UGANDA LIMITED | DISLEP 25 | LEVOSULPIRIDE | 25MG | DOPPEL FARMACEUTICI SRL,VIA VOLTURNO 48-20089 QUINTO DE STAMPI, ROZZANO (MI) | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X20.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11038 | AUROBINDO | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DELOHIST 5 | DESLORATADINE | 5MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT 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 | 12/13/2023 |
| NDA/MAL/HDP/11039 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | LIGNOCAIN | LIDOCAINE | 20 MG/ML | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X30.0 ML VIAL | 12/13/2023 |
| 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 |
| NDA/MAL/HDP/11041 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | ROMYCIN | AZITHROMYCIN DIHYDRATE | 500MG | NABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X3.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11042 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | MOVFOR | MOLNUPIRAVIR | 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 RETARD OTHER CAPSULES | 1.0X40.0 CAPSULE CONTAINER, 1.0X4.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11043 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | DIAZAC 5 | DAPAGLIFLOZIN | 5MG | AJANTA PHARMA LIMITEDPLOT 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 | 12/13/2023 |
| NDA/MAL/HDP/11044 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | DIAZAC 10 | DAPAGLIFLOZIN | 10MG | AJANTA PHARMA LIMITEDPLOT 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 | 12/13/2023 |
| NDA/MAL/HDP/11047 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | MURAXAL -10 | ALFUZOSIN HYDROCHLORIDE | 10MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11048 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | APRETUDE 600 MG | CABOTEGRAVIR | 200MG/ML | GLAXO OPERATIONS UK LIMITEDHARMIRE ROAD, BARNARD CASTLE, DURHAM, DL 12 8DT - UNITED KINGDOM | UNITED KINGDOM | PARENTERAL ORDINARY VIALS | 1.0X25.0X3.0 ML VIAL, 1.0X5.0X3.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11049 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | XYM-KID | SIMETHICONE + DILL OIL + FENNEL OIL | 40MG + 0.005ML + 0.0007ML | NEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11050 | SURGE LABORATORIES (PVT) LTD, | JEET PHARMACEUTICALS LIMITED | SERGIFEX 1G | CEFTRIAXONE 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 | 12/13/2023 |
| NDA/MAL/HDP/11051 | SURGE LABORATORIES (PVT) LTD, | JEET PHARMACEUTICALS LIMITED | SERGIFEX 2G | CEFTRIAXONE SODIUM | 2 G/VIAL | SURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL | 12/13/2023 |
| NDA/MAL/HDP/11052 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AKO-PAS | ACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE | 100 MG + 325 MG + 15 MG | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11053 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | OLODINE | OLOPATADINE HYDROCHLORIDE | 0.1% W/V | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGA | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 12/13/2023 |
| NDA/MAL/HDP/11054 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | TORA | TOBRAMYCIN SULPHATE | 0.3% W/V | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGA | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 12/13/2023 |
| NDA/MAL/HDP/11055 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | TORA-D | TOBRAMYCIN SULPHATE + DEXAMETHASONE SODIUM PHOSPHATE | 0.3%W/V + 0.1%W/V | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGA | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 12/13/2023 |
| NDA/MAL/HDP/11056 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | VOLDIC ® 1% EMULGEL | DICLOFENAC DIETHYLAMINE | 1%W/W | PHARMA INTERNATIONAL COMPANY ,.AL-QASTAL AREA, AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA, 11941, AMMAN - JORDAN | JORDAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11057 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | SHELTRIZINE | CETIRIZINE HYDROCHLORIDE | 10MG | BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554, MOGADISHU ROAD INDUSTRIAL AREA, NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11058 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | EXYT-200 | ALBENDAZOLE | 200MG/5ML | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11059 | AURA LIFECARE PVT. LTD. | REDDYS PHARMA LIMITED | AURADERM-0.05 | CLOBETASOL | 0.05%W/W | AURA LIFECARE PRIVATE LIMITEDSURVEY NO. 254/14/1, JAROD-SAVLI ROAD, P.O. KARACHIYA, 391 520, TAL. SAVLI, DIST. VADODARA - INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE, 1.0X1.0X15.0 G TUBE | 12/13/2023 |
| 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 |
| NDA/MAL/HDP/11060 | WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ. | GOODMAN INTERNATIONAL LTD | ROXIPIME | CEFEPIME HYDROCHLORIDE | 1G/VIAL | PHARMAVISION SAN. VE TIC. A.S.DAVUTPASA CAD. NO: 145 ZEYTINBURNU / ISTANBUL - TURKEY | TURKEY | PARENTERAL RETARD DRY VIALS | 1.0X1.0X1.0 G VIAL | 12/13/2023 |
| NDA/MAL/HDP/11061 | MIDASCARE PHARMACEUTICALS PRIVATE LIMITED, | ABACUS PHARMA (AFRICA) LIMITED | MISTDRESS | LIDOCAINE + CETRIMIDE | 1%W/W + 0.10%W/W | MIDAS CARE PHARMACEUTICALS PVT LTD.B-16 MIDC, WALUJ AURANGABAD 431136, MAHARASHTRA, INDIA | INDIA | TOPICAL EXTERNAL SPRAYS WITHOUT GAS | 1.0X100.0 ML CANNISTER | 12/13/2023 |
| NDA/MAL/HDP/11062 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | GAVISIL | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 250MG + 250MG + 50MG | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X200.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11063 | PHARMA BAVARIA INTERNACIONAL(PBI) PORTUGUAL | GOODMAN INTERNATIONAL LTD | COMBOFUSIV | PARACETAMOL + IBUPROFEN | 10MG/ML + 3MG/ML | S.M. FARMACEUTICI S.R.LZONA INDUSTRIALE, 85050 TITO (PZ) | ITALY | PARENTERAL ORDINARY VIALS | 1.0X10.0X100.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11064 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ISONIAZID DISPERSIBLE TABLETS 100 MG | ISONIAZID | 100 MG | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP | 12/13/2023 |
| NDA/MAL/HDP/11065 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | AROX | MOXIFLOXACIN HYDROCHLORIDE | 0.5% W/V | JAMJOOM PHARMACEUTICALS COMPANYPLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIA | SAUDI ARABIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11066 | MACARTHYS LABORATORIES LTD | LABOREX UGANDA LIMITED | COLISTIMETHATE SODIUM 1 MIU | COLISTIMETHATE SODIUM | 1MU/VIAL | ALTAN PHARMACEUTICALS S.A.AVDA. DE LA CONSTITUCION 198 - 199, POLIGONO INDUSTRIAL MONTE BOYAL, CASARRUBIOS DE MONTE, 45950 TOLEDO - SPAIN | SPAIN | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 MU VIAL | 12/13/2023 |
| NDA/MAL/HDP/11067 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVAUR 250 | LEVETIRACETAM | 250MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT 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 | 12/13/2023 |
| NDA/MAL/HDP/11068 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVAUR 500 | LEVETIRACETAM | 500MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT 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 | 12/13/2023 |
| NDA/MAL/HDP/11069 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVAUR 1000 | LEVETIRACETAM | 1000MG | AUROBINDO PHARMA LIMITED, UNIT - XVPLOT 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 | 12/13/2023 |
| 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 LTD212/2 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 |
| NDA/MAL/HDP/11070 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JITRIT-5 | TOFACINIB | 5MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X15.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11071 | MYLAN PHARMACEUTICALS PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | OGIVRI„¢ 440 MG | TRASTUZUMAB | 440MG/VIAL | BIOCON BIOLOGICS LIMITEDSPECIAL ECONOMIC ZONE, PLOT NO. 2, 3, 4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMASANDRA POST, BENGALURU - 560099, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X440.0 MG VIAL | 12/13/2023 |
| NDA/MAL/HDP/11072 | MEDOPHARM | NUGEN PHARMACEUTICALS UGANDA LIMITED | NUNINE | QUININE SULFATE | 300MG | MEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11073 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PARACO-DENK 500/30 | PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE | 500 MG + 30 MG | BENE-ARZNEIMITTEL GMBHPRODUCTION AND WAREHOUSING- HERTERICHSTR. 1-3 D-81479 MUNICH GERMANY. QUALITY CONTROL LABORATORY - BAYERWALDSTR. 7-9 D-82538 GERETSRIED, GERMANY. HIGH-RACK WAREHOUSING €“ GEWERBERING 11 D-82140 OLCHING, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11074 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | FAMYTEC | MISOPROSTOL | 200MCG | MYLAN LABORATORIES LIMITEDPLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11075 | HEALTH LINK PHARMACY LTD | HEALTH LINK PHARMACY LIMITED | ROLXIN OD | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 120 MG + 960 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11076 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | G-COSPE® | SULFADOXINE + PYRIMETHAMINE | 500MG + 25MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X3.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11078 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | B-LACT | LACTULOSE | 3.35GM/5ML | FRESENIUS KABI AUSTRIA GMBHESTERMANNSTRASSE 17, A-4020 LINZ | AUSTRIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 02/02/2024 |
| NDA/MAL/HDP/11079 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | MIRAFOLIC | FOLIC ACID | 5MG | MEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER, 1.0X100.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER, 1.0X50.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11080 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-AMH | OLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE | 20MG + 5MG + 12.5MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11081 | INFUGEN PHARMA PVT. LTD. | GITTOES PHARMACEUTICALS LIMITED | INFUROXIM | CEFUROXIME SODIUM | 750MG | ZEISS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X750.0 MG VIAL | 02/02/2024 |
| NDA/MAL/HDP/11082 | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC PLUS | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150 MG + 12.5 MG | UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYAL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11083 | ASPIRO PHARMA LIMITED. | AIVEEN (U) LIMITED | CANDIVOR 200 MG/VIAL | VORICONAZOLE | 200MG | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X200.0 MG VIAL | 02/02/2024 |
| NDA/MAL/HDP/11084 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | INVEL FORTE L | METRONIDAZOLE + MICONAZOLE NITRATE + LIDOCAINE | 750 MG + 200 MG + 100 MG | BLISS GVS PHARMA LTDPLOT NO. 11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI, PALGHAR, MAHARASHTRA 401404, INDIA | INDIA | VAGINAL SUPPOSITORIES | 1.0X1.0X7.0 SUPPOSITORY STRIP, 1.0X2.0X7.0 SUPPOSITORY STRIP | 02/02/2024 |
| NDA/MAL/HDP/11085 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMITINO INJECTION | ONDANSETRON HYDROCHLORIDE | 4MG/2ML | SAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULE | 02/02/2024 |
| NDA/MAL/HDP/11086 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | ERYBRU 500 | ERYTHROMYCIN STEARATE | 500MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11087 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | AMICINE | AMIKACIN SULPHATE | 500MG/2ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X2.0 ML VIAL | 02/02/2024 |
| NDA/MAL/HDP/11088 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DARUNAVIR 400 MG | DARUNAVIR | 400MG | 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 | 1.0X1.0X60.0 TABLET BOTTLE | 02/02/2024 |
| NDA/MAL/HDP/1109 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENIRAMINE MALEATE | 2MG/5ML | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/11090 | LES LABORATOIRES SERVIER | HARLEYS UGANDA LIMITED | DIAMICRON MR 60 MG | GLICLAZIDE | 60MG | LES LABORATOIRES SERVIER INDUSTRIE (LSI)905 ROUTE DE SARAN 45520 GIDY - FRANCE | FRANCE | ORAL SOLID RETARD TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11091 | SWISS GARNIER LIFE SCIENCES. | REDDYS PHARMA LIMITED | SWIZGLIPT 100 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 100MG | SWISS GARNIER LIFE SCIENCES21-23 INDUSTRIAL AREA, MEHATPUR, UNA DIST., HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11092 | SWISS GARNIER LIFE SCIENCES. | REDDYS PHARMA LIMITED | SWIZGLIPT 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50MG | SWISS GARNIER LIFE SCIENCES21-23 INDUSTRIAL AREA, MEHATPUR, UNA DIST., HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11093 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XERATEC | IRON SUCROSE | 100MG | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X5.0X5.0 ML VIAL | 02/02/2024 |
| NDA/MAL/HDP/11094 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FETNAL 500 | CEFUROXIME AXETIL | 500MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11098 | VERVE HUMAN CARE LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | ADEVER | ADRENALINE ACID TARTRATE | 1MG/ML | VERVE HUMAN CARE LABORATORIESPLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 02/02/2024 |
| NDA/MAL/HDP/11101 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | CLARITHROMYCIN 500 MG | CLARITHROMYCIN | 500MG | SANDOZ S.R.LSTR. LIVEZENI NR. 7A 540472 TARGU-MURES ROMANIA | ROMANIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11102 | ENCORE HEALTHCARE PVT. LTD. | REDDYS PHARMA LIMITED | ONTADEX 50MG | TRAMADOL HYDROCHLORIDE | 50MG | ENCORE HEALTHCARE PVT LTDD-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11103 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | LOXIBS 50 | LOSARTAN POTASSIUM | 50MG | CACHET PHARMACEUTICAL PVT LTD.VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11104 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | ROSUCACH 10 | ROSUVASTATIN CALCIUM | 10MG | CACHET PHARMACEUTICAL PVT LTD.VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11105 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. | HEALTHCARE LTD. | TELOSIN | TAMSULOSIN HYDROCHLORIDE | 0.4MG | AL FAZAL PHARMA INDUSTRIES (PVT) LTDPLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11106 | SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., | ROYAL PHARMA 2011 LIMITED | SCOTXONE-1G | CEFTRIAXONE SODIUM | 1G | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 02/02/2024 |
| NDA/MAL/HDP/11107 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | AZITO 500 | AZITHROMYCIN DIHYDRATE | 500MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11109 | LEBEN LABORATORIES PVT. LTD | MALIX PHARMA (U) LIMITED | BETALEB-N CREAM | BETAMETHASONE VALERATE + NEOMYCIN SULPHATE | 0.1%W/W + 0.5%W/W | LEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 02/02/2024 |
| 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 LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/11110 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | GLIBEMET 500/2.5 | METFORMIN HYDROCHLORIDE + GLIBENCLAMIDE | 500 MG + 2.5 MG | SAGA LABORATORIES .198/2 & 198/3, CHACHRAWADI, VASNA NO. CLARIS LIFE SCIENCE, TA SANAND, DIST. DIST: AHMEDABAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11111 | RUSAN PHARMA LTD. | NORVIK ENTERPRISES LIMITED | ADDNOK | BUPRENORPHINE HYDROCHLORIDE | 8MG | RUSAN PHARMA LTDKHASRA NO. 122MI, CENTRAL HOPE TOWN, BEHIND PHARMA CITY, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA|RUSAN PHARMA LIMITEDPLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL ECONOMIC ZONE, GANDHIDHAM KUTCH 370 230 GUJARAT | INDIA | ORAL SOLID ORDINARY SUBLINGUAL TABLETS | 1.0X1.0X7.0 TABLET BLISTER, 1.0X4.0X7.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11112 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | BETASONE | BETAMETHASONE VALERATE | 0.1%W/W | HOVID BERHAD (IPOH SITE)121, JALAN TUNKU ABDUL RAHMAN 30010 IPOH PERAK | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 02/02/2024 |
| NDA/MAL/HDP/11113 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ATRONA-20 | ATORVASTATIN CALCIUM | 20MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11117 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | FAST 250 SUPPOSITORY | PARACETAMOL | 250MG | THE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY STRIP | 02/02/2024 |
| NDA/MAL/HDP/11118 | LUPIN LIMITED- | AIVEEN (U) LIMITED | MOXIFLOXACIN | MOXIFLOXACIN HYDROCHLORIDE | 400 MG | LUPIN LIMITEDUNIT-2, PLOT NO. M-2 & M-2-A, SPECIAL ECONOMIC ZONE, PHASE II, MISC. ZONE, APPAREL PARK, DIST. DHAR - M.P. PITHAMPUR, 454775, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11119 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ETIMICOL 10 | EZETIMIBE | 10MG | AUROBINDO PHARMA LTD, UNIT VIISY. 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 | 02/02/2024 |
| NDA/MAL/HDP/11120 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VALABIN 500 | VALACICLOVIR HYDROCHLORIDE | 500MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X7.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11128 | ATCO LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BETAMET-N | BETAMETHASONE AS VALERATE + NEOMYCIN SULPHATE | 0.1% W/W + 0.5% W/W | ATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11129 | EAST AFRICAN (INDIA) OVERSEAS | ABACUS PHARMA (AFRICA) LIMITED | PARARIV-I | IBUPROFEN + PARACETAMOL | 100 MG + 162.5 MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/1113 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ALCID-YELLOW | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS PVT LTDISAAPUR P.O DAPPAR 140056 INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/11130 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VINGLYN M 50/1000 | VILDAGLIPTIN + METFORMIN HYDROCHLORIDE | 50 MG + 1000 MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11135 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR PR-500 | METFORMIN HYDROCHLORIDE | 500MG | INVENTIA HEALTHCARE LIMITED-F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11136 | KESAR PHARMA | ABACUS PHARMA (AFRICA) LIMITED | ALZOL | ALBENDAZOLE | 400 MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11137 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | DARUNIVIR AND RITONIVIR TABLETS | DARUNAVIR ETHANOLATE + RITONAVIR | 800 MG + 100 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 FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 12/13/2023 |
| NDA/MAL/HDP/11138 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CABALIN 150 | PREGABALIN | 150 MG | CACHET PHARMACEUTICALS PVT LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11139 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS | EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 200 MG + 25 MG | LAURUS LABS LTD (UNIT 2)-PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 12/13/2023 |
| 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 LIMITED133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA – INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER | 01/07/2012 |
| NDA/MAL/HDP/11140 | SINOVAC BIOTECH CO LTD | BHL HEALTHCARE LIMITED | HEALIVE (JUNIOR USE) | INACTIVATED HEPATITIS A VIRUS ANTIGEN, TZ84 STRAIN PRODUCED IN HUMAN DIPLOID (2BS) CELLS ADSORBED ON ALUMINIUM HYDROXIDE | 250 IU/1.0 ML | SINOVAC BIOTECH COMPANY LIMITED - CHANGPING SITE-NO. 15, ZHITONG ROAD, CHANGPING DISTRICT, BEIJING, 102200 - CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X0.5 ML VIAL,1.0X1.0X0.5 ML PRE- FILLED SYRINGE | 12/13/2023 |
| NDA/MAL/HDP/11141 | SINOVAC BIOTECH CO LTD | BHL HEALTHCARE LIMITED | HEALIVE (ADULT USE) | INACTIVATED HEPATITIS A VIRUS ANTIGEN, TZ84 STRAIN PRODUCED IN HUMAN DIPLOID (2BS) CELLS ADSORBED ON ALUMINIUM HYDROXIDE | 250 IU/1.0 ML | SINOVAC BIOTECH COMPANY LIMITED - CHANGPING SITE-NO. 15, ZHITONG ROAD, CHANGPING DISTRICT, BEIJING, 102200 - CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL,1.0X1.0X1.0 ML PRE- FILLED SYRINGE | 12/13/2023 |
| NDA/MAL/HDP/11142 | PSYCHOTROPICS INDIA LTD- | BIOGEN PHARMA LIMITED | CEFTRIONE-1 | CEFTRIAXONE SODIUM | 1G/VIAL | PSYCHOTROPICS INDIA LTD-PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 12/13/2023 |
| NDA/MAL/HDP/11143 | HILTON PHARMA (PVT) LTD | BOOTS PHARMACEUTICALS LIMITED | ROLIP EZE | ROSUVASTATIN CALCIUM + EZETIMIBE | 5MG +10MG | HILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11144 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400MG + 300MG + 300 MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11145 | NEXT WAVE (INDIA) | DAVIMED PHARMA LIMITED | CADZOLE-V | CLOTRIMAZOLE | 100 MG | NEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | | INDIA | | VAGINAL TABLETS | 1.0X1.0X6.0 TABLET STRIP | 12/13/2023 |
| NDA/MAL/HDP/11147 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | MEMTIN 10 | MEMANTINE HYDROCHLORIDE | 10 MG | UNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11148 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | CONAZ CREAM | KETOCONAZOLE | 2% W/W | ATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11149 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | LICAN | LULICONAZOLE | 1% W/W | CIPLA LTD, GOA UNIT V & UNIT X-L-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11150 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | LABCLAV 625MG TABLETS | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | LABORATORY & ALLIED LTD -PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11151 | BAROQUE PHARMACEUTICALS PVT LTD | JEET PHARMACEUTICALS LIMITED | NUROQ 75 | PREGABALIN | 75 MG | BAROQUE PHARMACEUTICAL PVT LTD-192/2 & 3, SOKHADA, 388620, TA: KHAMHAT DIST. ANANT (GUJARAT) | | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11152 | BAROQUE PHARMACEUTICALS PVT LTD | JEET PHARMACEUTICALS LIMITED | COCEL | CELECOXIB | 200 MG | BAROQUE PHARMACEUTICAL PVT LTD-192/2 & 3, SOKHADA, 388620, TA: KHAMHAT DIST. ANANT (GUJARAT) | | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11153 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAFARIV 15 | RIVAROXABAN | 15 MG | MYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11154 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAFARIV 20 | RIVAROXABAN | 20 MG | MYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11155 | IDA FOUNDATYION | KIMSY MEDS LTD | BENZATHINE BENZYLPENICILLIN 1.2MIU | BENZATHINE BENZYLPENICILLIN | 1.2 MIU | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X15.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11156 | IDA FOUNDATION | KIMSY MEDS LTD | BENZATHINE BENZYLPENICILLIN 2.4MIU | BENZATHINE BENZYLPENICILLIN | 2.4 MIU | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X15.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11157 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | DOVATO 50MG/300MG | DOLUTEGRAVIR + LAMIVUDINE | 50 MG + 300 MG | GLAXOSMITHKLINE, LLC1011 NORTH ARENDELL AVENUE ZEBULON, NORTH CAROLINA 27597 | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 02/02/2024 |
| NDA/MAL/HDP/11158 | MARCYRL PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TORSAMOLEX 20MG | TORSEMIDE | 20MG | MARCYRL PHARMACEUTICAL INDUSTRIES WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITY | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11159 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | TIBAN 20 | TENEGLIPTIN HYDROBROMIDE HYDRATE | 20MG | AJANTA PHARMA LIMITEDB-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD MAHARASHTRA STATE INDIA 431 128 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11160 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ROSUNA-5 | ROSUVASTATIN CALCIUM | 5MG | ZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11161 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | EMITINO-8 INJECTION | ONDANSETRON HYDROCHLORIDE | 8MG/4ML | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X4.0 ML AMPOULE | 02/02/2024 |
| NDA/MAL/HDP/11162 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | TATA UGANDA LIMITED | RABZOL | RABEPRAZOLE SODIUM | 20MG | NAPROD LIFE SCIENCES PVT. LTDG-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 MG VIAL, 1.0X1.0X20.0 G VIAL | 02/02/2024 |
| NDA/MAL/HDP/11163 | UNIMED LABORATORIES. | OMAB UGANDA LIMITED | CIPROJECT | CIPROFLOXACIN | 200MG | UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X100.0 ML BAG | 02/02/2024 |
| NDA/MAL/HDP/11164 | IDA FOUNDATYION | KIMSY MEDS LTD | BENZATHINE BENZYLPENICILLIN 5MIU | BENZATHINE BENZYLPENICILLIN | 5 MIU | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X15.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11165 | IDA FOUNDATYION | KIMSY MEDS LTD | BENZATHINE BENZYLPENICILLIN 1MIU | BENZATHINE BENZYLPENICILLIN | 1MIU | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X15.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11166 | GLOBELA PHARMA PVT. LTD. | ROYAL PHARMA 2011 LIMITED | PYLOGLOB KIT | CLARITHROMYCIN + OMEPRAZOLE + TINIDAZOLE | 250 MG + 20 MG + 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 COMBINATION PACK COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 21/02/2024 |
| NDA/MAL/HDP/11167 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAGULANT 2.5 | APIXABAN | 2.5 MG | MYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11168 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | XAGULANT 5 | APIXABAN | 5 MG | MYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11169 | IDA FOUNDATYION | KIMSY MEDS LTD | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG/3ML | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X3.0 ML AMPOULE | 12/13/2023 |
| NDA/MAL/HDP/1117 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TETRACYCLINE EYE OINTMENT USP 1% | TETRACYCLINE | 1%W/W | NEM LABORATORIES LIMITED133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA – INDIA | INDIA | | OPHTHALMIC OINTMENTS | 1.0X20.0X3.5 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/11170 | JEVIANA HEALTH CARE LLP, | MARVIN PHARMA LIMITED | MARIPRAZOLE | OMEPRAZOLE SODIUM | 40 MG/VIAL | SANJAR PHARMACEUTICALS LIMITED-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL + 1*10 ML, WATER FOR INJECTION IN LDPE AMPOULE | 12/13/2023 |
| NDA/MAL/HDP/11171 | BIOMATRIX HEALTHCARE PVT LTD.- | MEDIWORLD PHARMA AFRICA LTD | PRIMECIP | CIPROFLOXACIN HYDROCHLORIDE | 500 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11172 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | GLANTRIM | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | 2%W/V + 0.5%W/V | ATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 02/02/2024 |
| NDA/MAL/HDP/11173 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | WINOLAP 0.1 | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | ATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 02/02/2024 |
| NDA/MAL/HDP/11174 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | WINOLAP 0.2% | OLOPATADINE HYDROCHLORIDE | 0.2%W/V | ATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | OPHTHALMIC LIQUIDS | 1.0X1.0X2.5 ML BOTTLE | 02/02/2024 |
| NDA/MAL/HDP/11175 | ADWIA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | URIPAN XR | OXYBUTYNIN HYDROCHLORIDE | 10MG | ADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11176 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BORTEBIN | BORTEZOMIB | 3.5MG | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X3.5 MG VIAL | 02/02/2024 |
| NDA/MAL/HDP/11177 | ADWIA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LEPTROGINE 200 MG | LAMOTRIGINE | 200MG | ADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/02/2024 |
| NDA/MAL/HDP/11178 | UNIMED LABORATORIES. | OMAB UGANDA LIMITED | SYNERGIC 500 | IMIPENEM + CILASTATIN | 500 MG + 500 MG | UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 ML VIAL | 02/02/2024 |
| NDA/MAL/HDP/11179 | UNIMED LABORATORIES. | OMAB UGANDA LIMITED | TAZOBACT 4G/500 MG | PIPERACILLIN SODIUM + TAZOBACTAM SODIUM | 4G + 500MG | UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL | 02/02/2024 |
| NDA/MAL/HDP/1118 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ELAXIM 52.5 | TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR), (TNK-T-PA) | 52.5 | GENNOVA BIOPHARMACEUTICALS LIMITEDBLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 | INDIA | | PARENTERAL ORDINARY I V VIALS | 1.0X52.5 MG VIAL + (1*10ML AMPOULE WFI) | 01/07/2013 |
| NDA/MAL/HDP/11180 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | CARBOPLATIN 600MG/60ML | CARBOPLATIN | 600MG | EBEWE PHARMA GES.M.B.H. NFG.KGMONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X60.0 ML VIAL | 02/02/2024 |
| NDA/MAL/HDP/11181 | SANDOZ GMBH, KUNDL | KIMSY MEDS LTD | CARBOPLATIN 450MG/45ML | CARBOPLATIN | 450MG/45ML | EBEWE PHARMA GES.M.B.H. NFG.KGMONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X45.0 ML VIAL | 02/02/2024 |
| NDA/MAL/HDP/11182 | INDIANA OPHTHALMICS | SWASTIK PHARMACEUTICAL LTD | AYZEECON | AZITHROMYCIN DIHYDRATE | 1%W/W | INDIANA OPHTHALMICS135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC OINTMENTS | 1.0X1.0X5.0 G TUBE | 02/02/2024 |
| NDA/MAL/HDP/11189 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | CLEOBACT 150 | CLINDAMYCIN HYDROCHLORIDE | 150 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11190 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ACNEX | CLINDAMYCIN PHOSPHATE | 1% W/W | NANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11191 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | FUNGIDERM | CLOTRIMAZOLE + ZINC OXIDE + DIMETHICONE | 1% W/W + 1.75% W/W + 2.50% W/W | NANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | | INDIA | | TOPICAL EXTERNAL DUSTING POWDERS | 1.0X50.0 G BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11192 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | ERINOCIN 250 | ERYTHROMYCIN STEARATE | 250 MG | BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11193 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | WELGRA 100 | SILDENAFIL CITRATE | 100 MG | AKUMS DRUGS AND PHARMACEUTICALS-19,20,21, SEC.6-A, IIE, SIDCUL, RANIPUR,HARIDWAR-249403, UTTARAKHAND, INDIAINDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11194 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | UNOKETRO | KETOROLAC TROMETHAMINE | 30 MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD ,-2,3,4,5, SECTOR 6B, SIDCUL, I.I.E, RANIPUR, HARIDWAR-249403, INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 12/13/2023 |
| NDA/MAL/HDP/11195 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | CONTR | KETOROLAC TROMETHAMINE | 60MG/2ML | THE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE | 12/13/2023 |
| NDA/MAL/HDP/11196 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | PERMIN | PERMETHRIN | 5%W/W | THE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | | BANGLADESH | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 12/13/2023 |
| NDA/MAL/HDP/11197 | LINCOLN PHARMACEUTICALS LIMITED | METRO PHARMACEUTICALS LIMITED | MYCOFIL | MYCOPHENOLATE MOFETIL | 500 MG | LINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11198 | ARCELIA LIFE SCIENCES LTD. | NOVOMED HEALTHCARE LIMITED | GENTAMICIN SULPHATE | GENTAMICIN SULPHATE | 80MG/2ML | SANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11199 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYMET-500 | METFORMIN HYDROCHLORIDE | 500 MG | BAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11200 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | HYTAN – 80 | TELMISARTAN | 80MG | BAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11201 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | HYTAN – 40 | TELMISARTAN | 40MG | BAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11202 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | IRNIZET 40 | IRINOTECAN HYDROCHLORIDE TRIHYDRATE | 20MG/ML | EUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X2.0 ML VIAL | 12/13/2023 |
| NDA/MAL/HDP/11203 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROPODOX 40 | CEFPODOXIME PROXETIL | 40MG PER 5ML | 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 | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11204 | KLM LABORATORIES PVT. LTD. | REDDYS PHARMA LIMITED | NIOFINE CREAM | TERBINAFINE HYDROCHLORIDE | 1.0% 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 | 12/13/2023 |
| NDA/MAL/HDP/11205 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | 20M | MANNITOL | 20% W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED-SURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 | | INDIA | | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X500.0 ML BOTTLE | 12/13/2023 |
| NDA/MAL/HDP/11206 | XL LABORATORIES PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | FLAMO 400 | IBUPROFEN | 400 MG | XL LABORATORIES PRIVATE LIMITED-A-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) | | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X6.0X1.0X10.0 CAPSULE BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11208 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROZMET - 500 | METFORMIN | 500 MG | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 12/13/2023 |
| NDA/MAL/HDP/11209 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | RO-VIT-K 10 | 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 | 12/13/2023 | ||
| NDA/MAL/HDP/1122 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCHLOR EAR DROPS | CHLORAMPHENICOL | 5%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | OTIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/1123 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPAR | PARACETAMOL | 500 MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER | 01/07/2012 |
| NDA/MAL/HDP/11230 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | CYVAC | R21 MALARIA VACCINE (RECOMBINANT, ADJUVANTED) | 5µG OF MALARIA ANTIGEN & 50µG OF MATRIX-M1 PER DOSE OF 0.5ML | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X0.5 ML VIAL, 1.0X50.0X1.0 ML VIAL | 22/03/2024 |
| NDA/MAL/HDP/11232 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PLERISTEM | PLERIXAFOR | 24MG/1.2ML | EUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.2.0 ML VIAL | 22/03/2024 |
| NDA/MAL/HDP/11233 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | AMCARDIA-10 | AMLODIPINE BESYLATE | 10 MG | UNIQUE PHARMACEUTICAL LABS LIMITED. .PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11234 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | MOXILEB 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | LEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104 | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11235 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | QUALITY CHEMICALS LTD | ZENTAIR 1.0MG | ENTECAVIR | 1.0MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11236 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | AURATRIM-GB | BETAMETHASONE DIPROPIONATE + CLOTRIMAZOLE + GENTAMICIN SULFATE | 0.05% W/W + 1.0% W/W + 0.1% W/W | AURA LIFECARE PRIVATE LIMITEDSURVEY NO. 254/14/1, JAROD-SAVLI ROAD, P.O. KARACHIYA, 391 520, TAL. SAVLI, DIST. VADODARA - INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE, 1.0X30.0 G TUBE | 22/03/2024 |
| NDA/MAL/HDP/11237 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PERILIN | METOCLOPRAMIDE HYDROCHLORIDE | 10MG/2ML | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 22/03/2024 |
| NDA/MAL/HDP/11238 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DESLORA-5 | DESLORATADINE | 5MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11239 | NEM LABORATORIES (PVT) LTD | RENE PHARMACY LTD | TIGBODERM -G CREAM | CLOTRIMAZOLE + GENTAMICIN SULFATE + BETAMETHASONE DIPROPIONATE | 1% W/W + 0.1% W/W + 0.05% W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE, 1.0X30.0 G TUBE | 22/03/2024 |
| NDA/MAL/HDP/1124 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO SCRUB | CHLORHEXIDINE GLUCONATE | 4%W/V | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/11241 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TERBINAFINE TABLETS USP, 250 MG | TERBINAFINE HYDROCHLORIDE | 250MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11242 | FAROMED LIFESCIENCES LLP | METRO PHARMACEUTICALS LIMITED | SITAP 50 | SITAGLIPTIN PHOSPHATE MONOHYDRATE | 50MG | ADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11243 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | ZETIRISE | ALBENDAZOLE | 200MG/5ML|200 MG/10ML | SUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE | 22/03/2024 |
| NDA/MAL/HDP/11244 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ESOPRALIN | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11245 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VALPIN-200 | SODIUM VALPROATE | 200MG | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 22/03/2024 |
| NDA/MAL/HDP/11246 | SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., | ROYAL PHARMA 2011 LIMITED | SCOFIX 400 | CEFIXIME TRIHYDRATE | 400MG | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11248 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | VIDAGLIN | VILDAGLIPTIN | 50 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11249 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ARH-L | ARTEMETHER + LUMEFANTRINE | (180 MG + 1080 MG)/ 60ML | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 22/03/2024 |
| NDA/MAL/HDP/1125 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROXONE 1000 | CEFTRIAXONE | 1000MG | AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI- R7AUROBINDO 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 |
| NDA/MAL/HDP/11250 | AUROCHEM LABORATORIES(I) PVT LTD | SUPER MEDIC LTD | DOBESIL H | CALCIUM DOBESILATE MONOHYDRATE + LIDOCAINE HYDROCHLORIDE + HYDROCORTISONE ACETATE + ZINC OXIDE | 0.5 % W/W + 3.0 %W/W + 0.25 % W/W + 5.0 % W/W | AUROCHEM LABORATORIES (I) PVT LTD8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 22/03/2024 |
| NDA/MAL/HDP/11252 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | TELMICLAR HTZ 40/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40 MG + 12.5 MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11253 | FRESENIUS KABI MANUFACTUING S.A. (PTY) LTD | SURGIPHARM (U) LIMITED | CLINDAMYCIN FRESENIUS 600MG/4ML | CLINDAMYCIN PHOSPHATE | 600MG/4ML | FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED6 GIBAUD ROAD, KORSTEN, 6020, PORT ELIZABETH, SOUTH AFRICA|LABESFAL LABORATORIOS ALMIRO, S.A ZONA INDUSTRIAL DO LAGEDO, 3465-157 SANTIAGO DE BESTEIROS | PORTUGAL|SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X4.0 ML AMPOULE | 22/03/2024 |
| NDA/MAL/HDP/11254 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ORIXO 400 | OFLOXACIN | 400MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11255 | MANKIND PHARM LTD | TATA UGANDA LIMITED | MAHACEF-200 | CEFIXIME TRIHYDRATE | 200 MG | COPMED PHARMACEUTICALS PVT LTD-UNIT II. ,PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11256 | BRAWN LABORATORIES LTD | TATA UGANDA LIMITED | MOXIBRU | MOXIFLOXACIN | 0.5% W/V | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 22/03/2024 |
| NDA/MAL/HDP/11257 | BRAWN LABORATORIES LTD | TATA UGANDA LIMITED | BRUCOXIA-90 | ETORICOXIB | 90MG | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11258 | AJANTA PHARMA LIMTED | ABACUS PHARMA (AFRICA) LIMITED | ADERAN HTZ 16/12.5 | CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE | 16 MG + 12.5 MG | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11259 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | TATA UGANDA LIMITED | MAGNILEK | GADOPENTETATE DIMEGLUMINE | 469MG/ML | UNIQUE PHARMACEUTICAL LABORATORIESPLOT NO.4, PHASE IV, GIDC, INDUSTRIAL AREA, PANOLI- 394 116, DIST: BHARUCH, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL, 1.0X10.0 ML VIAL, 1.0X15.0 ML VIAL | 22/03/2024 |
| NDA/MAL/HDP/11260 | MANKIND PHARM LTD | TATA UGANDA LIMITED | MAHACEF-100 | CEFIXIME TRIHYDRATE | 100 MG | COPMED PHARMACEUTICALS PVT LTD-UNIT II. ,PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11261 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | COLIHENZ | CITICOLINE SODIUM | 500MG | STANFORD LABORATORIES PRIVATE LIMITED (A SUBSIDIARY COMPANY OF LA RENON HEALTHCARE PRIVATE LIMITED)8, INDUSTRIAL AREA, MEHATPUR - 174315, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11262 | AMN LIFE SCIENCE PVT LTD | VITACARE LIMITED | MOXITAM 125 | AMOXICILLIN TRIHYDRATE | 125MG PER 5ML | AMN LIFE SCIENCE PVT LTD67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE | 22/03/2024 |
| NDA/MAL/HDP/11263 | ORCHIDIA PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NORMOPROST | LATANOPROST | 50MCG/ML | ORCHIDIA PHARMACEUTICAL INDUSTRIESAL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPT | EGYPT | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML BOTTLE | 22/03/2024 |
| NDA/MAL/HDP/11264 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | FLAIROF | ROFLUMILAST | 250MCG | HETERO LABS LIMITED (UNIT III)...22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X15.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11265 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | NEUTAS | RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR | 300MCG/0.5ML | INTAS PHARMACEUTICALS LTD (BIOPHARMA DIVISION)PLOT NO. 423/P/A, SARKHEJ-BAVLA HIGHWAY, MORAIYA, TALUKA SANAND, AHMEDABAD- 382213, GUJARAT | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 22/03/2024 |
| NDA/MAL/HDP/11266 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | IZ 500 | AZITHROMYCIN DIHYDRATE | 500MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11267 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CACHMAX-200 | CEFIXIME TRIHYDRATE | 200 MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11268 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PARACO-DENK 1000/60 | PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE | 1000 MG + 60 MG | BENE-ARZNEIMITTEL GMBHHERTERTICHSTR. 1-3, 81479 MUNCHEN - GERMANY | GERMANY | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 16/03/2024 |
| NDA/MAL/HDP/11269 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | DOXORUBICIN INJECTION | DOXORUBICIN | 2MG/ML | INTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X25.0 ML VIAL | 22/03/2024 |
| NDA/MAL/HDP/11270 | RUSAN PHARMA LTD. | NORVIK ENTERPRISES LIMITED | ADDNOK-N 2/0.5 | BUPRENORPHINE HYDROCHLORIDE + NALOXONE HYDROCHLORIDE | 2 MG + 0.5 MG | RUSAN PHARMA LTDKHASRA NO. 122MI, CENTRAL HOPE TOWN, BEHIND PHARMA CITY, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY SUBLINGUAL TABLETS | 1.0X3.0X10.0 TABLET BLISTER, 1.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11271 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR SODIUM 50 MG, EMTRICITABINE 200 MG AND TENOFOVIRAL AFENAMIDE 25 MG | DOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 50 MG + 200 MG + 25 MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 16/03/2024 |
| NDA/MAL/HDP/11273 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE TABLETS | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 600 MG + 50 MG + 300 MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE, 1.0X180.0 TABLET BOTTLE, 1.0X90.0 TABLET BOTTLE | 16/03/2024 |
| NDA/MAL/HDP/11274 | HILTON PHARMA (PVT) LTD | BOOTS PHARMACEUTICALS LIMITED | DAPA 10MG | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 10 MG | HILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11275 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11276 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 400/300/300 MG TABLET | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400MG + 300MG + 300MG | CIPLA LIMITEDPLOT NO. A-33, A-2 & A-37/2/2 (UNIT-I), A-42(UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRA|CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | UGANDA|INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER, 1.0X90.0 TABLET CONTAINER | 16/03/2024 |
| NDA/MAL/HDP/11277 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ANGILOCK 50 | LOSARTAN POTASSIUM | 50 MG | SQUARE PHARMACEUTICALS LIMITED - DHAKA UNITKALIAKOIR GAZIPUR | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11278 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOXIN-500 | AMOXICILLIN TRIHYDRATE | 500MG | MILAN LABORATORIES (INDIA) PVT LTD,63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X1.0X20.0 CAPSULE BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11279 | MSN LABORATORIES PRIVATE LIMITED, | GOOD DAY PHARMACY LIMITED | SILOTRIF 8 | SILODOSIN | 8MG | MSN LABORATORIES LTD. PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 16/03/2024 |
| NDA/MAL/HDP/1128 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BTC KIT | FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE | 150MG + 1G + 1G | LINCOLN PHARMACEUTICALS L.T.DTRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | | ORAL SOLID ORDINARY COMBINATION PACK TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/11280 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUGENTA EYE/EAR DROPS | GENTAMICIN SULFATE | 0.3%W/V | BRAWN LABORATORIES LTD .13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE | 16/03/2024 |
| NDA/MAL/HDP/11281 | WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ. | GOODMAN INTERNATIONAL LTD | SERTOFEN | DEXKETOPROFEN TROMETAMOL | 25MG | 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 SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11282 | WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ. | GOOD DAY PHARMACY LIMITED | CULENTO 4MG | MONTELUKAST SODIUM | 4MG | 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 SOLID ORDINARY GRANULES | 1.0X28.0 SACHET CARTON | 16/03/2024 |
| NDA/MAL/HDP/11283 | THE SEARLE COMPANY LIMITED | HEALTHCARE LTD. | VAPTOR 10MG | ROSUVASTATIN CALCIUM | 10MG | SEARLE PAKISTAN LIMITED,F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11284 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYDEKLA 60 | DACLATASVIR DIHYDROCHLORIDE | 60MG | MYLAN LABORATORIES LTD .F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET CONTAINER | 16/03/2024 |
| NDA/MAL/HDP/11285 | JSC BIOCAD, SAINT PETERSBURG | ONCOPHARM (U) LTD | BEVALAST | BEVACIZUMAB | 25 MG/ML | JSC BIOCAD NEUDORF, FACILITY 2BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515 | RUSSIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X16.0 ML VIAL, 1.0X1.0X4.0 ML VIAL, 1.0X1.0X100.0 MG VIAL, 1.0X1.0X400.0 MG VIAL | 22/03/2024 |
| NDA/MAL/HDP/11286 | JSC BIOCAD | ONCOPHARM (U) LTD | ACELLBIA | RITUXIMAB | 10 MG/ML | JSC BIOCAD NEUDORF, FACILITY 2BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515 | RUSSIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X50.0 ML VIAL, 1.0X1.0X500.0 MG VIAL | 22/03/2024 |
| NDA/MAL/HDP/11287 | LABORATÓRIOS BASI | ONCOPHARM (U) LTD | MIDAZOLAM BASI | MIDAZOLAM | 15 MG/3 ML | LABORATORIOS BASI - INDUSTRIA FARMACEUTICAPARQUE INDUSTRIAL MANUEL LOURENCO FERREIRA, LOTES 8, 15 E 16, 3450-232 MORTAGUA - PORTUGAL | PORTUGAL | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X3.0 ML AMPOULE | 22/03/2024 |
| NDA/MAL/HDP/11288 | MICRO LABS LIMITED | PHARMA VILLE LIMITED | PARACETAMOL BP 500MG TABLET | PARACETAMOL | 500MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11289 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ADCCLENA 5 | LENALIDOMIDE | 5MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11290 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ADCCLENA 10 | LENALIDOMIDE | 10MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11291 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ADCCLENA 15 | LENALIDOMIDE | 15MG|10MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BLISTER | 16/03/2024 |
| NDA/MAL/HDP/11292 | HEALTHCARE PHARMACEUTICALS LTD | MIDAS CARE (U) LIMITED | CANDINIL | FLUCONAZOLE | 50 MG/5ML | HEALTHCARE PHARMACEUTICAL LIMITEDGAZARIAPARA, RAJENDRAPUR, GAZIPUR 1703 - BANGLADESH | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X35.0 ML BOTTLE | 16/03/2024 |
| NDA/MAL/HDP/11293 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOFECON 500 | MYCOPHENOLATE MOFETIL | 500MG | CONCORD BIOTECH LIMITED297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11294 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOFECON C-250 | MYCOPHENOLATE MOFETIL | 250 MG | CONCORD BIOTECH LIMITED297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11295 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYGLI €“ 100 | SITAGLIPTIN | 100MG | BAFNA PHARMACEUTICALS LIMITED UNIT IINO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11296 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DYGLI-50 | SITAGLIPTIN | 50MG | BAFNA PHARMACEUTICALS LIMITED UNIT IINO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11297 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-AM | OLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE | 40MG + 5MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11298 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-AM | OLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE | 20MG + 5MG | MICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 22/03/2024 |
| NDA/MAL/HDP/11299 | LABORATÓRIOS VITÓRIA, S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRAUSAN | CITICOLINE SODIUM | 100MG/ML | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAIN | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X50.0 ML BOTTLE | 22/03/2024 |
| NDA/MAL/HDP/1130 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KLARO-500 | CLARITHROMYCIN TABLETS | 500MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/1131 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | XAVOR 50 | LOSARTAN | 50MG | FEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2014 |
| 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 LIMITEDNO. 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 |
| NDA/MAL/HDP/1134 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | XAVOR DIU | LOSARTAN AND HYDROCHLORTHIAZIDE | 50/12.5MG | FEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1136 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOSCAB APPLICATION | BENZYL BENZOATE | 25%W/W | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL EMULSIONS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/1138 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CALAMINE | CALAMINE | 15%W/W | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/1139 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVATE | BETAMETHASONE | 0.1%W/W | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2012 |
| 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 LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/1142 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CANDIZOL | CLOTRIMAZOLE | 1%W/W | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/1143 | LINCOLN P'CALS LTD | METRO PHARMACEUTICALS LIMITED | LOSA-H | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/1145 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | HILAC | LACTULOSE | 68%W/V | HILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/1154 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | BACQURE | IMIPENEM + CILASTATIN | 500MG + 500MG | SUN PHARMACEUTICAL INDUSTRIES LIMITEDINDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA. | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 ML VIAL | 01/07/2012 |
| 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 |
| 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 |
| NDA/MAL/HDP/1163 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | FRUSEMIDE | FUROSEMIDE | 40MG | NEM LABORATORIES PVT LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/1166 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | DOLZERO | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| 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 |
| 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 |
| NDA/MAL/HDP/1169 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | NEBI 5 | NEBIVOLOL HYDROCHLORIDE | 5MG | ARISTO PHARMACEUTCALS PVT LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/1178 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | TENOFOVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | HETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/1179 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | OVITRELLE | CHORIOGONADOTROPIN ALFA | 250MCG/0.5ML | MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY | MERCK SERONO SA-1170 AUBONNE(SWITZERLAND) | | ITALY, SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON | 01/07/2015 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1198 | THEMIS MEDICARE LTD. | STAR PHARMACEUTICALS LTD | MALITHER INJECTION | ARTEMETHER | 80MG/ML | THEMIS MEDICARE LTD SECTOR 6A ,PLOT NO. 16,17 & 18 IIE,BHEL SIDCUL,HARIDWAR UTTARAKHAND 249403 | INDIA | | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/1199 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | THEMISET 75 | PALONOSETRON HYDROCHLORIDE | 0.075MG/1.5ML | THEMIS MEDICARE LIMITEDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.5 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/1201 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | THEMISET | PALONOSETRON HYDROCHLORIDE | 0.25MG/5ML | THEMIS MEDICARE LIMITEDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.5 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/1204 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | DEXEM INJECTION | DEXMEDETOMIDINE HYDROCHLORIDE | 100 | THEMIS MEDICARE LTDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE | 01/07/2013 |
| 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 |
| 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 LTDPLOT 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 |
| NDA/MAL/HDP/1209 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-80 | TELMISARTAN | 80MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/1211 | ASTRA ZENECA | MACNAUGHTON LIMITED | BRILINTA | TICAGRELOR | 90MG | ASTRA ZENECA ABSE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/1214 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NUCLEO C.M.P FORTE | CYTIDINE+URIDINE | 5MG+3MG | FERRER INTERNACIONAL, S.AJOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 01/07/2013 |
| 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 LIMITEDNO.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 |
| NDA/MAL/HDP/1219 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | TORAS-DENK 5 | TORASEMIDE | 5MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/1220 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART | ARTEMETHER + LUMEFANTRINE | 180 MG + 1080 MG | BLISS GVS PHARMA LIMITEDNO.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 |
| 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 LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X25.0 G TUBE | 01/07/1997 |
| 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 |
| 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 |
| NDA/MAL/HDP/1242 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TOPHEN-100 | PHENYTOIN | 100MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1252 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ZOY | SILDENAFIL | 50MG | TORQUE PHAMACEAUTICALS PVT LTDVILL ISSAPUR P.O DAPPAR INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1254 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSATRIM TABLETS | CO-TRIMOXAZOLE | 480MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/1255 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | NIFELAT RETARD | NIFEDIPINE | 20MG | CIPLA LTDMIDC PATALGANGA 410 220 DIST. RAIGAD | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1259 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | CARDOZ- 6.25 | CARVEDILOL | 6.25MG | IPCA LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/1261 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | CARDOZ-12.5 | CARVEDILOL | 12.5MG | IPCA LABORATORIES LTDPLOT 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 |
| 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 |
| 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 LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/1278 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP | DIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE | 40MG +320MG | GUILIN PHARMACEUTICAL CO LTDNO.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 |
| NDA/MAL/HDP/1282 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | LOSABERG | LOSARTAN POTASSIUM | 50MG | THE MADRAS PHARMACEUTICALS..NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/1287 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANIX- DS 100 | CEFIXIME | 100MG/5ML | SANCE LABORATORIES PVT LTDVI/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 |
| NDA/MAL/HDP/1290 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANIX 400 CAP | CEFIXIME | 400MG | SANCE LABORATORIES PVT LTDVI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1291 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | ULTRAVIST-300 | IOPROMIDE | 300MG/ML | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2012 |
| 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 |
| NDA/MAL/HDP/1294 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | ULTRAVIST 370 | IOPROMIDE | 370MG/ML | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2012 |
| NDA/MAL/HDP/1295 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HARLEYS UGANDA LIMITED | ZEPAR | ALBENDAZOLE | 200MG | SHAIGAN PHARMACEUTICALS (PVT) LTD14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1299 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE PLUS-1000 | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | SANCE LABORATORIES PRIVATE LTDPB 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 |
| NDA/MAL/HDP/1302 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | HIPEN CAPSULES | AMOXYCILLIN | 250MG | SPARSH BIO-TECH PVT. LIMITEDPLOT 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1312 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SLIPIZEM- 2.5 | DIAZEPAM | 2.5MG | BLISS GVS PHARMA LIMITEDNO.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 |
| NDA/MAL/HDP/1319 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ZESTAVAL 200 F.C TABLETS | ALBENDAZOLE | 200MG | REMEDICA LTDAHARNON 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 |
| 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 |
| NDA/MAL/HDP/1328 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ENGERIX-B VACCINE | HEPATITIS B SURFACE ANTIGEN | 20MCG/ML | GLAXOSMITHKLINE BOILOGICALSS.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 |
| 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 LTDB-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 |
| NDA/MAL/HDP/1335 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | PREGATAS | PREGABALIN | 75MG | INTAS PHARMACEUTICALS LTDCAMP ROAD SELAQUI DEHRADUN | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2012 |
| 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. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| 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 |
| NDA/MAL/HDP/1345 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SWICH-200 | CEFPODOXIME | 200MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | ALKEM LABORATORIES LTDVILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/1347 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORNILOX | ORNIDAZOLE + OFLOXACIN | 500MG + 200MG | MICRO LABS LTD92, 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 |
| NDA/MAL/HDP/1348 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | VALPARIN CHRONO 500 | SODIUM VALPROATE (CONTROLLED RELEASE) | 500MG | TORRENT PHARMACEUTICAL LTDAHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2009 |
| NDA/MAL/HDP/1353 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | 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 |
| NDA/MAL/HDP/1359 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | DIFENAC-100 SR | DICLOFENAC SODIUM | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDPLOT M 444B STRETCHER ROAD NTINDA | UGANDA | | ORAL SOLID RETARD CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| NDA/MAL/HDP/1361 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 120MG | SWISS PARENTERALS LTD809 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 |
| 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 |
| NDA/MAL/HDP/1367 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1368 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D5 | GLUCOSE | 5%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 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 |
| NDA/MAL/HDP/1369 | MEDIPHARM (EA) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE CO-PACK ORANGE FLAVOUR | DT ZINC-20 + ORAL REHYDRATION SALTS (ORS) | 20G | MEDIPHARM INDUSTRIES( EA) LTDPLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | MEDICAMEN BIOTECH LTD,.SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/1370 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | STERILIZED WATER FOR INJECTION | WATER FOR INJECTION | NEUTRAL | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 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 |
| NDA/MAL/HDP/1372 | AXA PARENTERALS LTD | VITACARE LIMITED | RL | LACTIC ACID + SODIUM HYDROXIDE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE | (0.24 + 0.115 + 0.6 + 0.04 + 0.027)G/100ML | AXA PARENTERALS LTDKISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/1377 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | SUPER AMP | WATER FOR INJECTION | N/A | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0 ML AMPOULE | 01/07/2014 |
| 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 |
| NDA/MAL/HDP/1382 | HOVID BERHAD | UNITED HEALTHCARE DISTRIBUTORS LTD | INOX CAPSULES | ITRACONAZOLE | 100MG | HOVID BHDLOT 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1387 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | LAN-30 | LANSOPRAZOLE | 30MG | INTAS PHARMACEUTICALS LTDCAMP ROAD SELAQUI DEHRADUN | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0X10.0 CAPSULE STRIP | 01/07/2004 |
| NDA/MAL/HDP/1390 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN CALCIUM | 5MG | IPR PHARMACEUTICALS INC,LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/1392 | ASTRA ZENECA | MACNAUGHTON LIMITED | ZOLADEX | GOSERELIN | 3.6MG | ASTRA ZENECA UK LIMITEDASTRAZENECA 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 |
| NDA/MAL/HDP/1394 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANPIME -1000 | CEFEPIME | 1000MG | SANCE LABORATORIES PRIVATE LTDPB 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 |
| 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 |
| NDA/MAL/HDP/1397 | ASTRA ZENECA | MACNAUGHTON LIMITED | PLENDIL | FELODIPINE | 10MG | ASTRAZENECA SWEDEN OPERATIONSASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | ASTRAZENECA PHARMACEUTICAL CO LTD.NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSU | CHINA | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/1400 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR SR 500 | METFORMIN HYDROCHLORIDE | 500MG | INVENTIA HEALTHCARE LIMITEDF-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X5.0X20.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/1402 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR SR 1000 | METFORMIN HYDROCHLORIDE | 1000MG | INVENTIA HEALTHCARE LIMITEDF-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X5.0X20.0 TABLET BLISTER | 01/07/2015 |
| 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 |
| NDA/MAL/HDP/1409 | PHARMACTIV FZCO | 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 |
| NDA/MAL/HDP/1411 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | CIPIUM | CHLORPHENIRAMINE | 4MG | LEBEN LAB PVT LTDL4 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 |
| NDA/MAL/HDP/1413 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | PODINE MOUTH WASH | POVIDONE IODINE | 0.1%W/V | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL TOPICAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/1414 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN SR TABLETS | DICLOFENAC SODIUM | 100MG | UNIQUE PHARMACEUTICAL LABS LIMITED. .215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1X10X10 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/1417 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | MILICAL TABLETS | CALCIUM CITRATE + VITAMIN D3 | 1000MG +200 I.U | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/1418 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | AMINOPHYLLINE TABLETS | AMINOPHYLLINE | 100MG | NEM LABORATORIES PVT LTDPLOT 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 |
| NDA/MAL/HDP/1419 | GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIES | 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 |
| NDA/MAL/HDP/1422 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | STAMIN | CETIRIZINE DIHYDROCHLORIDE | 10MG | SHAIGAN PHARMACEUTICALS (PVT) LTD14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1427 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TENA-50 | ATENOLOL | 50MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/1433 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NORISTERAT | NORETHISTERONE ENANTATE | 200MG | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/1436 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 10 | BISOPROLOL HEMIFUMARATE | 10MG | WINTHROP PHARMACEUTICALS(PTY) LTD,315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | MERCK KGAA250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | GERMANY | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/1441 | AXA PARENTERALS LTD | VITACARE LIMITED | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9%W/V | AXA PARENTERALS LTDKISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/1445 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | AXONE 1000 | CEFTRIAXONE SODIUM | 1000MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL | 01/07/2003 |
| 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 LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2015 |
| NDA/MAL/HDP/1447 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VITONA PLUS | VITAMINS + MINERALS | MULTI-INGREDIENT | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/1449 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HARLEYS UGANDA LIMITED | ZEPAR SUSPENSION | ALBENDAZOLE | 200MG/5ML | SHAIGAN PHARMACEUTICALS (PVT) LTD14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/1450 | GLAXOSMITHKLINE LIMITED LIKONI | UNITED HEALTHCARE DISTRIBUTORS LTD | VOLTAREN EMULGEL 1% | DICLOFENAC DIETHYLAMMONIUM | 1%W/V | GSK CONSUMER HEALTH SAGSK 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 |
| NDA/MAL/HDP/1451 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN INJECTION | DICLOFENAC | 25MG/ML | NOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/1454 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PAINEX | PARACETAMOL + ASPIRIN + CAFFEINE | 500MG + 400MG + 50 MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP | 01/07/2003 |
| NDA/MAL/HDP/1456 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | SUCRAFIL O GEL | SUCRALFATE + OXETACAINE | 10MG + 0.2MG | FOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR 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 |
| NDA/MAL/HDP/1457 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | DYSEN FORTE | SECNIDAZOLE | 1000MG | NABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2006 |
| 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 |
| NDA/MAL/HDP/1460 | VENUS REMEDIES LTD | REDDYS PHARMA LIMITED | PARIN E | ENOXAPARIN | 80MG | VENUS REMEDIES LTD -UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X2.0X0.8 ML PRE- FILLED SYRINGE | 01/07/2009 |
| NDA/MAL/HDP/1463 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ARISTOZYME LIQUID | DIASTASE+PEPSIN | 50MG+10MG | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT 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 |
| 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 |
| 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. | 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 |
| NDA/MAL/HDP/1469 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX 125 | AMOXICILLIN | 125MG/5ML | VOGEN LABORATORIES LTD70, 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 |
| NDA/MAL/HDP/1474 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODIC GEL | DICLOFENAC DIETHYLAMINE | 1%W/W | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2016 |
| NDA/MAL/HDP/1476 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | SEPTOL | SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE | 1%W/W + 0.20W/W | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2016 |
| NDA/MAL/HDP/1478 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA | SILDENAFIL | 50MG | AJANTA PHARMA LIMITED PAITHANMANUFACTURING 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 |
| NDA/MAL/HDP/1482 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | STAMARIL PASTEUR | YELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED) | NLT 1000 I.U | SANOFI PASTEUR1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | SANOFI PASTEUR S.A2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) | FRANCE | | PARENTERAL ORDINARY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS | 01/07/1997 |
| NDA/MAL/HDP/1485 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DICLOFEN 25 | DICLOFENAC | 25MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.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 |
| NDA/MAL/HDP/1486 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-1 | AMPICILLIN | 1G | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL | 01/07/2011 |
| 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 |
| 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 |
| NDA/MAL/HDP/1493 | AUROBINDO PHARMA LTD UNIT VII | GITTOES PHARMACEUTICALS LIMITED | KOACT 1000 | AMOXICILLIN/CLAVULANATE POTASSIUM | 875MG/125MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID RETARD TABLETS | 1X4 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/1494 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PEITEL 0.25% | PREDNICARBATE | 0.25%W/W | FERRER INTERNACIONAL, S.AJOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/1499 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | CHINA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE | 01/07/2005 |
| NDA/MAL/HDP/1500 | MSD (PTY) LIMITED SA | SURGIPHARM (U) LIMITED | ATRIPLA | EFAVIRENZ+EMTRICITABINE + TENOFOVIR | 600MG +200MG+300MG | PATHEON INCMISSISSAUGA,ON L5N 7K9 CANADA | CANADA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2008 |
| 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 .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | TOPICAL EXTERNAL OTHER CREAMS | 1.0X20.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/1505 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | SERETIDE EVOHALER | SALMETEROL/ FLUTICASONE PROPIONATE | 25/50 MCG | GLAXO WELLCOME PRODUCTIONZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX | FRANCE | | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON | 01/07/2007 |
| NDA/MAL/HDP/1508 | DAWA LIMITED- | SUPER MEDIC LTD | WOMNIL | ALBENDAZOLE | 200MG/5ML | DAWAPLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/1514 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 100MG | SPECPHARM HOLDINGS 15TH ROAD HALFWAY HOUSE | JOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1516 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | URGENDOL P | TRAMADOL/ PARACETAMOL | 37.5MG/ 325MG | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/1523 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMPIREN | AMPICILLIN | 125MG/5ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/1524 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN | AMOXICILLIN TRIHYDRATE | 125 MG / 5 ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2008 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1529 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PROVIRON | MESTEROLONE | 25MG | BAYER WEIMAR GMBH & CO. KGDOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| 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 |
| NDA/MAL/HDP/1533 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | 5D | GLUCOSE | 50G/L | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/1535 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FORTIWIN-4 | FORTIFIED PROCAINE PENICILLIN SODIUM | 4 M.U | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | CHINA | INDIA | 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 |
| 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 |
| NDA/MAL/HDP/1544 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE HYDROCHLORIDE B.P | PROMETHAZINE HCL | 25MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/1546 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LANPRO | LANSOPRAZOLE | 30MG | UNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | UNICHEM LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/1551 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CALOSHELL-500 | CALCIUM CARBONATE + VITAMIN D3 | 1250MG + 250IU | EMCURE PHARMACEUTICALS LTDLANE 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 |
| NDA/MAL/HDP/1553 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | VIFEX | SALBUTAMOL + BROMHEXINE + GUAIFENESIN | 1MG/5ML+2MG/5ML+50MG/5ML | EMCURE PHARMACEUTICALS LTDLANE 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 |
| 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 | | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2010 |
| 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 |
| 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 BOILOGICALSS.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 |
| NDA/MAL/HDP/1563 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | 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 |
| NDA/MAL/HDP/1566 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | VITAVIT | MULTI-INGREDIENT | MULTI-INGREDIENT | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/1569 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | KALETRA | LOPINAVIR+RITONAVIR | 80MG + 20MG | AESICA PHARMACEUTICALS SRLQUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X5.0X1.0X60.0 ML BOTTLE | 01/07/2007 |
| 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 |
| NDA/MAL/HDP/1572 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ROSUVAS 20 | ROSUVASTATIN | 20MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| 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 |
| NDA/MAL/HDP/1579 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | PLASMINEX | TRANEXAMIC ACID | 100MG/ML | PT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE | 01/07/2011 |
| 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 |
| NDA/MAL/HDP/1582 | LINCON PHARMCUETICALS LIMITED | METRO PHARMACEUTICALS LIMITED | CEEPRO-500 | CIPROFLOXACIN | 500MG | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| 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 |
| NDA/MAL/HDP/1585 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | UDIHEP FORTE | URSODEOXYCHOLIC ACID | 300MG | WIN-MEDICARE PRIVATE LIMITEDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/1588 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TOZAAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | TORRENT PHARMACEUTICALS LIMITED AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER | 01/07/2005 |
| 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 LTDPLOT 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 |
| NDA/MAL/HDP/1591 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | CENTIPAR ELIXIR | PIPERAZINE CITRATE | 750ML/5ML | CENTAUR PHARMACEUTICALS PVT LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/1598 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIM 400 | CIMETIDINE | 400MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1605 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ASPIRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/1615 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APCALIS SX | TADALAFIL | 20MG | AJANTA PHARMA LIMITED PAITHANMANUFACTURING 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 |
| NDA/MAL/HDP/1616 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEZIN | CETIRIZINE | 5MG/5ML | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/1627 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID-V GEL | CLOTRIMAZOLE | 2%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | VAGINAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2004 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1635 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ORITAXIM 1000MG INJECTION | CEFOTAXIME SODIUM | 1GM | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL | 01/07/1997 |
| NDA/MAL/HDP/1636 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | VIGAMOX | MOXIFLOXACIN | 5MG/ML | S.A.ALCON COUVREUR N.VRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2013 |
| 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 |
| NDA/MAL/HDP/1639 | GLAXO SMITHLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL EXTRA WITH OPTIZORB | PARACETAMOL + CAFFEINE | 500MG + 65MG | GRANULES INDIA LIMITEDSY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA | | IRELAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON | 01/07/2003 |
| 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 LIMITEDC–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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1651 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | , 1X60 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/1652 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | VALPARIN CHRONO 300 | SODIUM VALPROATE | 300MG | TORRENT PHARMACEUTICAL LTDAHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2009 |
| NDA/MAL/HDP/1656 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | AZIGYL-500 | AZITHROMYCIN | 500MG | MEDICO REMEDIES PVT LIMITED8 & 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 |
| NDA/MAL/HDP/1660 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIM-200 | CIMEDITINE | 200MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| NDA/MAL/HDP/1663 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ALCID-PINK | ALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE | 400MG+400MG/50ML | TORQUE PHARMACEUTICALS PVT LTDISAAPUR P.O DAPPAR 140056 INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/1665 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | INDIA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1998 |
| 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. INCSUMNEYTOWN 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 |
| NDA/MAL/HDP/1676 | KOPRAN LIMITED | TATA UGANDA LIMITED | CLOXIN-250 | CLOXACILLIN | 250MG | KOPRAN LTDVILLAGE 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 |
| NDA/MAL/HDP/1678 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | 100MG/VIAL | INDASI LIFESCIENCE PRIVATE LIMITEDPLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X100.0 MG VIAL | 01/07/2007 |
| 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 |
| NDA/MAL/HDP/1680 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | H-CORT | HYDROCORTISONE | 0.1%W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/1682 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | TOFLOX-200 | OFLOXACIN | 200MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL 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 |
| NDA/MAL/HDP/1689 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | OMESK | OMEPRAZOLE | 20MG | S.KANT HEALTHCARE LTDPLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2010 |
| NDA/MAL/HDP/1690 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | FINALLERG | CETIRIZINE DIHYDROCHLORIDE | 1MG/ML | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| 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 |
| 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 |
| NDA/MAL/HDP/1697 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | FINALLERG | CETIRIZINE DIHYDROCHLORIDE | 10MG | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1698 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AZICIP 500 | AZITHROMYCIN | 500MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | CIPLA LTD.VERNA IND. ESTATE GOA 403 722 INDIA | CIPLA LTD ;VILLAGE UPPER MALPUR P.O BHUD THE NALAGARH DIST. SOLAN HIMACHAL PRADESH PIN 173205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER | 01/07/2009 |
| 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 |
| NDA/MAL/HDP/1702 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | DELOR | CLOBETASOL PROPIONATE | 0.05%W/W | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE | 01/07/2005 |
| 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 |
| 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 |
| NDA/MAL/HDP/1708 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | DENTAMOL | ACETAMINOPHEN | 500MG | LABORATORY & ALLIED LTDPLOT 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 |
| NDA/MAL/HDP/1709 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | LUCIN CREAM | HYDROCORTISONE | 1%W/W | REGAL PHARMACEUTICALS LTDBABA 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 |
| NDA/MAL/HDP/1711 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN-250 | AMOXYCILLIN | 250MG | KOPRAN LIMITEDVILLAGE- 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 |
| 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 IIPLOT 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 |
| 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 |
| NDA/MAL/HDP/1723 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT MULTIVITAMIN DROPS | MULTI-INGREDIENT | MULTI-INGREDIENT | SAKAR HEALTHCARE PVT LTDSAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/1724 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | 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 |
| NDA/MAL/HDP/1725 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | MYCORIL CREAM 1% | CLOTRIMAZOLE | 1%W/W | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2000 |
| 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 |
| 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 |
| 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 LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/1732 | MICRO LABS LTD | LABOREX UGANDA LIMITED | CEFEX-250 | CEPHALEXIN | 250MG | MICROLABS LIMITEDPLOT 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 |
| NDA/MAL/HDP/1734 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMOMINT | COMPOUND MAGNESIUM TRISILICATE | 500MG | TIL HEALTH CAREPLOT 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1747 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PRESARTAN H 50 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | IPCA LABORATORIES LTDPLOT 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 |
| NDA/MAL/HDP/1748 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-500 | AZITHROMYCIN | 500MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0 CAPSULE BLISTER | 01/07/2011 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1769 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ENGERIX-B VACCINE | HEPATITIS B SURFACE ANTIGEN | 10MCG/ML | GLAXOSMITHKLINE BOILOGICALSS.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 |
| 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 |
| 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 |
| NDA/MAL/HDP/1777 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | NUZAC 20 | FLUOXETINE | 20MG | CIPLA LTD PLOT NO. L-139, VERNA, GOA 403 722 INDIA | | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| NDA/MAL/HDP/1779 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE SOLUTION | POVIDONE IODINE | 10.0G/100ML | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTDPLOT 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 |
| NDA/MAL/HDP/1780 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI KIREKA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/1781 | ASTRAZENECA | MACNAUGHTON LIMITED | ARIMIDEX | ANASTROZOLE | 1MG | ASTRAZENECA PHARMACEUTICALS LPNEWARK, DELAWARE | UNITED STATES | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/1782 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | PER 5ML: 15MG + 90MG | AGOG PHARMA LTDPLOT 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 |
| 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 |
| 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 | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1785 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | ACTION TABLETS | ACETYL SALICYLATE + CAFFEINE + PARACETAMOL | 600MG+50MG+300MG | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1786 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGONAC TABLETS (THANE) | DICLOFENAC | 50MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/1790 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNITRIM TABLET | CO-TRIMOXAZOLE | 480MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/1792 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | LIPODAR | ATORVASTATIN | 20MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1795 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMPIK-250 | AMPICILLIN | 250MG | KOPRAN LIMITEDVILLAGE- 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 |
| NDA/MAL/HDP/1796 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA 250 | AZITHROMYCIN | 250 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/1797 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | AMPICILLIN+CLOXACILLIN | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD #14, II PHASE PIA, BANGALORE 560058 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL | 01/07/2010 |
| NDA/MAL/HDP/1799 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | SECZOL DS | SECNIDAZOLE | 1GM | INTAS PHARMACEUTICALS LTDPLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/1800 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMLONG-10 | AMLODIPINE | 10MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/1801 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | LABESTEN PESSARIES | CLOTRIMAZOLE | 100MG | LABORATORY & ALLIED LTD.--PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY STRIP | 01/07/1997 |
| NDA/MAL/HDP/1803 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 40MG | ESOMEPRAZOLE | 40MG | ASTRAZENECA AB.GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON | 01/07/2001 |
| NDA/MAL/HDP/1807 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AMPICLOX NEONATAL DROPS | AMPICILLIN + CLOXACILLIN | 60 MG / 0.6 ML + 30 MG / 0.6 ML | MEDREICH STERILAB LTD12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X8.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/1809 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIT-6 | PYRIDOXINE | 25MG | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/1810 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRI | TRIFLUOPERAZINE | 5MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/1811 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DUOVIR TABLETS | ZIDOVUDINE+ LAMIVUDINE | 300MG + 150MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/1812 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN TABLETS | QUININE SULPHATE | 300MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/1813 | DAWA LIMITED | SUPER MEDIC LTD | MOXAFORTE | AMOXICILLIN + FLUCLOXACILLIN | 125 MG + 125MG | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/1815 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | SUPIROCIN OINTMENT | MUPIROCIN | 2%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL OTHER OINTMENTS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/1816 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | DRESS UP CREAM | NEOMYCIN SULPHATE | 0.5%W/W | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/1998 |
| NDA/MAL/HDP/1820 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AZICIN-250 | AZITHROMYCIN | 250MG | 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 | 01/07/2009 |
| NDA/MAL/HDP/1821 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | MEFTAL 500 TABLETS | MEFENAMIC ACID | 500MG | BLUE CROSS LABORATORIES LTDL-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/1822 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | EPHEDRINE | EPHEDRINE HYDROCHLORIDE | 30MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/1825 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | COLDEASE SYRUP | PARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG+2MG+15MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/1827 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ALBASOL SUSPENSION | ALBENDAZOLE | 200MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/1840 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | OVA-MIT | CLOMIPHENE | 50MG | REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/1841 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | FUNGNIL CREAM | CLOTRIMAZOLE | 1%W/W | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2000 |
| NDA/MAL/HDP/1842 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | SUGAQUIN TABLETS | CHLOROQUINE PHOSPHATE | 250MG | KAMPALA PHARMACEUTICALS INDUSTIESPLOT NO M44B STRETCHER ROAD INTINDA | UGANDA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2002 |
| NDA/MAL/HDP/1843 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ECORIN-75 | ASPIRIN | 75MG | REMEDEX PHARMAB-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1844 | GUILIN PHARMACEUTICALS CO.LTD | TRIDEM PHARMA UGANDA LIMITED | SULFAMETHOXAZOLE / TRIMETHOPRIM | SULFAMETHOXAZOLE / TRIMETHOPRIM | 800MG /160MG | GUILIN PHARMACEUTICAL CO.LTD.NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/1846 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | ANTAGIT DS GEL ORANGE FLAVOUR | ALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE | 400MG + 400MG + 50MG | LEBEN LABORATORIES PVT. LTD.PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X170.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/1848 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | PARATAL | PARACETAMOL | 500MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1849 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CIFIN | CIPROFLOXACIN | 0.2%W/V | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/1850 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ALZOL TABLETS | ALBENDAZOLE | 400MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/1851 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CAPSIFENAC GEL | CAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE | 0.438 G + 0.335 G + 0.135 G + 0.918 G | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | TOPICAL EXTERNAL EMULSION GELS | 1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE | 01/07/2011 |
| NDA/MAL/HDP/1852 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | VERCEF ORAL SUSPENSION | CEFACLOR | 125MG/5ML | SUN PHARMACEUTICAL INDUSTRIES LIMITED INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/1854 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | FUROSEMIDE INJECTION | FUROSEMIDE | 10MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE | 01/07/2004 |
| NDA/MAL/HDP/1856 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PROPRANOLOL TABLETS B.P. 40MG | PROPRANOLOL HYDROCHLORIDE | 40MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/1861 | GUILIN PHARMACEUTICALS CO LTD | TRIDEM PHARMA UGANDA LIMITED | SULFAMETHOXAZOLE / TRIMETHOPRIM | SULFAMETHOXAZOLE / TRIMETHOPRIM | 400MG /80MG | GUILIN PHARMACEUTICAL CO.LTD.NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/1863 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ORACURE GEL | LIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE | 2 GM+0.1 GM | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | | EGYPT | | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/1864 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | PATANOL | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/1877 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MINT-O-COOL | DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE | 120MG + 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/1879 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPENIV | PHENOXYMETHYL PENICILLIN | 250MG | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/1880 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/1881 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX | AMOXYCILLIN | 250MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/1882 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCIL | AMPICILLIN | 250MG | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/1887 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL | PARACETAMOL | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1889 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PREDSOL | PREDNISOLONE | 5MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON | 01/07/1997 |
| NDA/MAL/HDP/1891 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LEVOMAC 500 | LEVOFLOXACIN | 500MG | MACLEODS PHARMACEUTICALS LTD PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X5.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1892 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LEVOMAC 250 | LEVOFLOXACIN | 250MG | MACLEODS PHARMACEUTICALS LTD PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X5.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/1894 | KOPRAN LIMITED | TATA UGANDA LIMITED | TRIM-480 | CO-TRIMOXAZOLE | 480MG | KOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/1895 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO (PAEDIATRIC) | CO-TRIMOXAZOLE | 100MG/20MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/1898 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | ZAPACID - 30 | LANSOPRAZOLE | 30MG | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 3.0X10.0 CAPSULE BLISTER | 01/07/2001 |
| NDA/MAL/HDP/1900 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOM 20 | OMEPRAZOLE | 20MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP | 01/07/2007 |
| NDA/MAL/HDP/1901 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | IBUMOL | IBUPROFEN + PARACETAMOL | 100MG + 162.5 MG /5ML | AJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/1902 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMODIUM | LOPERAMIDE HYDROCHLORIDE | 2MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1911 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CODEINE PHOSPHATE TABLETS BP 30 | CODEINE PHOSPHATE | 30MG | COSMOS LIMITED RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/1912 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | D-WORM | ALBENDAZOLE | 200MG | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/1914 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CHLORPHENIRAMINE | CHLORPHENIRAMINE | 4MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2003 |
| NDA/MAL/HDP/1919 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDIDERM CREAM | BECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN | 0.025%W/W+1%W/W+0.1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/1999 |
| NDA/MAL/HDP/1922 | IPCA LABORATORIES | MEDVIN PHARMA LIMITED | AZIFAST-500 | AZITHROMYCIN | 500MG | IPCA LABORATORIES LTD,PLOT NO. T-139 SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X3.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/1924 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | AMPICILLIN SODIUM | AMPICILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL | 01/07/2013 |
| NDA/MAL/HDP/1927 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | INTAPLEX TABLET | VITAMIN B COMPOUND | N/A | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1928 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX | ALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG + 250MG +250MG +250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1931 | ASTRAZENECA | MACNAUGHTON LIMITED | ZOLADEX LA | GOSERELIN ACETATE | 10.8MG | ASTRA ZENECA UK LIMITEDASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | | PARENTERAL RETARD PRE-FILLED SYRINGES | 1.0X10.8 MG IMPLANT | 01/07/2010 |
| NDA/MAL/HDP/1932 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | CANDISTAT CREAM | CLOTRIMAZOLE | 1%W/W | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | | KENYA | | ORAL TOPICAL CREAMS | 1.0X20.0 G TUBE | 01/07/2001 |
| NDA/MAL/HDP/1934 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENECHLOR SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/1937 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ | EFAVIRENZ | 600MG | AUROBINDO PHARMA LIMITED (UNIT III) AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/1938 | YURIA-PHARM LTD | PHARMA VILLE LIMITED | INFULGAN | PARACETAMOL | 10MG/ML | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/1941 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | RABELOC IV | RABEPRAZOLE | 20MG/VIAL | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL | 01/07/2005 |
| NDA/MAL/HDP/1942 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | AMCLOREN | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER | 01/07/2009 |
| NDA/MAL/HDP/1943 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | NITROCONTIN 2.6 | NITROGLYCERIN (CONTROLLED RELEASE) | 2.6MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X25.0 TABLET CONTAINER | 01/07/2009 |
| NDA/MAL/HDP/1946 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | SOLUDOL TABLETS | DICLOFENAC SODIUM | 50MG | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 10.0X10.0 TABLET STRIP | 01/07/1998 |
| NDA/MAL/HDP/1948 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 500MG | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/1949 | MACLEODS PHARMACEUTICALS LTDS LTD | VITACARE LIMITED | TRENAXA 500 | TRANEXAMIC ACID | 500MG | MACLEODS PHARMACEUTICALS PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/1951 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | CLOPI 75 | CLOPIDOGREL | 75MG | MACLEODS PHARMACEUTICALS PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | MACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/1954 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | RAPEED-20 | RABEPRAZOLE | 20MG | ALKEM LABORATORIES LTD .VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP | 01/07/2011 |
| NDA/MAL/HDP/1956 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY | AMOXYCILLIN | 250MG | MILAN LABORATORIES (INDIA) PVT LTDPLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2006 |
| NDA/MAL/HDP/1958 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY | AMOXYCILLIN | 125MG/5ML | MILAN LABORATORIES (INDIA) PVT LTDPLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/1959 | MILAN LABERATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | BETRIM 480 | CO-TRIMOXAZOLE | 480MG | MILAN LABORATORIES (INDIA) PVT LTDPLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1960 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | DIFENAC | DICLOFENAC SODIUM | 50MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2003 |
| NDA/MAL/HDP/1966 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | PARACIN | PARACETAMOL | 500MG | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1969 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SR 75MG | DICLOFENAC SODIUM | 75MG | NOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA | | ITALY | | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/1970 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | CETRAMAC | CETIRIZINE | 10MG | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1971 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMPICLOX ORAL SUSPENSION | AMPICILLIN + CLOXACILLIN | 125 MG/5ML + 125 MG/5ML | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/1974 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFROTIL | CEFUROXIME AXETIL | 500MG | SAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/1975 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BET-CODERM N | BETAMETHASONE + NEOMYCIN | 0.1 W/W + 0.5 W/W | LINCOLN PHARMACEUTICALS LTD10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/1977 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | LOSAR-H | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | UNICHEM LABORATORIES LIMITEDUNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/1984 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | CIALIS | TADALAFIL | 20MG | LILLY SA, AVDA DE LA INDUSTRIALILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID | SPAIN | | ORAL SOLID ORDINARY TABLETS | 2.0X2.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/1987 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOMYCETIN | CHLORAMPHENICOL | 250MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/1989 | FERRER INTERNACIONAL S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DERMOFIX | SERTACONAZOLE NITRATE | 2%W/W | FERRER INTERNATIONAL, S.A.C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2014 |
| NDA/MAL/HDP/1990 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TAGERA FORTE | SECNIDAZOLE | 1G | UNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | UNICHEM LABORATORIES LTD--C31 & 32 INDUSTRIAL AREA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X2.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/1997 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TENA-100 | ATENOLOL | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X1000.0 TABLET JAR (WITH STATEMENT "FOR HOSPITAL USE ONLY".) | 01/07/2011 |
| NDA/MAL/HDP/1999 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | CARBATOL 200 | CARBAMAZEPINE | 200MG | TORRENT PHARMACEUTICALS LTDINDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2000 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | CALCIGARD RETARD | NIFEDIPINE(SR) | 20MG | TORRENT PHARMACEUTICALS LTDINDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2004 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | R.B.TONE | FERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE | 200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X15.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/2005 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA-100 | SILDENAFIL CITRATE | 100MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITED PAITHANMANUFACTURING 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 | 01/07/2005 |
| NDA/MAL/HDP/2008 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID -B- CREAM | CLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM | 1%W/W + 0.025%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/2009 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZITHROX | AZITHROMYCIN | 200MG/5ML | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2012 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID -B- LOTION | CLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE | 1%W/V + 0.025%W/V | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL LOTIONS | 1.0X15.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/2014 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | CANI-MAKS | CLOTRIMAZOLE | 1%W/W | S KANT HEALTHCARE LTD1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 01/07/2009 |
| NDA/MAL/HDP/2016 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID CREAM | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2000 |
| NDA/MAL/HDP/2018 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | ORAXIN SYRUP | CYPROHEPTADINE+TRICHOLINE CITRATE | 2MG+275MG | CENTAUR PHARMACEUTICALS LTD,-KARASWADA MAPUSA GOA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2019 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOHAL | HALOPERIDOL | 10MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2020 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | QUINE | QUININE SULPHATE | 300MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2022 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | TORACTIN | CYPROHEPTADINE | 2MG/5ML | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2024 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | NEXPRO - 40 | ESOMEPRAZOLE MAGNESIUM TABLET | 40MG | TORRENT PHARMACEUTICALS LTDINDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2004 |
| NDA/MAL/HDP/2025 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | FERRO-B COMPLEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2026 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | CORAM 10MG | AMLODIPINE BESYLATE | 10MG | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTDPLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2027 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-ANGINET 160/12.5MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG + 12.5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.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 |
| NDA/MAL/HDP/2029 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CHLORAMPHENICOL PALMITATE | CHLORAMPHENICOL PALMITATE | 125MG/5ML | MEDICAMEN BIOTECH LTDSP-1192, A &B, PHASE –IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/2033 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGIZAAR-50 | LOSARTAN POTASSIUM | 50MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2009 |
| NDA/MAL/HDP/2035 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | NEOSIDAR | SULPHADOXINE + PYRIMETHAMINE | 500MG + 25MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2036 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMULIN REGULAR | HUMAN INSULIN | 100IU | LILLY FRANCE SAFRANCE | ELI LILLY & COMPANYLILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221 | FRANCE | UNITED STATES OF AMERICA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/1998 |
| NDA/MAL/HDP/2040 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2042 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BURNCURE | SILVER SULFADIAZINE | 1%W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2046 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | LORHISTINA | LORATADINE | 10MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2047 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | RITONAVIR | RITONAVIR | 100MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/2053 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-5 | AMLODIPINE BESILATE | 5MG | EMCURE PHARMACEUTICALS LTD LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2055 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARTESUN | ARTESUNATE | 120MG | GUILIN PHARMACEUTICAL CO. LTD.NO. 43 QILIDIAN ROAD, GUILIN 541004 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE | 01/07/2011 |
| NDA/MAL/HDP/2056 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | BRO-ZEDEX | TERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL | 1.25MG+ 4 MG+50 MG+2.5 MG/5 ML | NAXPAR PHARMA PRIVATE LIMITED182, VILLAGE GURUMAJRA, TEHSIL NALAGARH, BADDI, DIST. SOLAN (H.P), 174101 INDIA. | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2058 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | QUININE SULPHATE | QUININE SULPHATE | 300MG | MACLEODS PHARMACEUTICALS PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2006 |
| NDA/MAL/HDP/2061 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | ADSOCARB TABLETS | ACTIVATED CHARCOAL | 250MG | CYANO PHARMA(P)115-C IND ESTATE POLOGROUND, INDORE 452015 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2062 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCOLYN PAEDIATRIC SYRUP | DEXTROMETHORPHAN HYDROBROMIDE BP + CHLORPHENIRAMINE MALEATE BP + AMMONIUM CHLORIDE BP + PSEUDOEPHEDRINE HYDROCHLORIDE BP | (5MG + 2MG + 50MG + 10MG)/ 5ML | BETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/2063 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MICROGYNON FE | LEVONORGESTREL / ETHINYLESTRADIOL. | 0.15MG / 0.03MG | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X28.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2066 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | METHOTREXATE | METHOTREXATE | 2.5MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2067 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZYNCET | CETIRIZINE DIHYDROCHLORIDE | 10MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER | 01/07/1999 |
| NDA/MAL/HDP/2068 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | DOMADOL | TRAMADOL HYDROCHLORIDE | 50MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1999 |
| NDA/MAL/HDP/2069 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | SK DERM | BETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN | 0.05%W/W + 1%W/W + 0.1%W/W | S KANT HEALTHCARE LTDPLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE,1.0X100.0 G TUBE,1.0X100.0 G TUBE | 01/07/2010 |
| NDA/MAL/HDP/2070 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MIRENA | LEVONORGESTREL | 52MG | BAYER OYPANSIONATE 47 20210 TURKU FINLAND | FINLAND | | PARENTERAL RETARD IMPLANTS | 1.0X1.0 IMPLANT CARTON | 01/07/2009 |
| NDA/MAL/HDP/2071 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | CEFAMOR DRY SYRUP | CEFALEXIN | 125MG/5ML | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/2073 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED) | MEASLES VIRUS | NOT LESS THAN 1000CCID50/ DOSE | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION | 01/07/1997 |
| NDA/MAL/HDP/2074 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN ORAL SUSPENSION | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/2075 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPRED | PREDNISOLONE | 5MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2076 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMIDE | FUROSEMIDE | 40MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2077 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 30MG/5ML | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2083 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | BEVAC | PURIFIED HEPATITIS B SURFACE ANTIGEN | 20MCG | BIOLOGICAL E LTDPLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL) | 01/07/2015 |
| NDA/MAL/HDP/2087 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | NORVIR | RITONAVIR | 100MG | ABBVIE DEUTSCHLAND GMBH & CO. KG.KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/2089 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN XR 500MG | METFORMIN HCL EXTENDED RELEASE | 500MG | HOVID BHDLOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/2090 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CIPROREN | CIPROFLOXACIN | 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2091 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CAMSTON | CLOTRIMAZOLE | 1%W/W | KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTDPLOT M444 B STRETCHER ROAD NTINDA | UGANDA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2001 |
| NDA/MAL/HDP/2093 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TRIGAN-D TABLET | PARACETAMOL + DICYCLOMINE | 500MG + 20MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP | 01/07/1999 |
| NDA/MAL/HDP/2094 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT-750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | MICRO LABS LTD92, 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 |
| NDA/MAL/HDP/2095 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL | PARACETAMOL | 100MG | AGOG PHARMA LTDPLOT 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 | 01/07/2010 |
| NDA/MAL/HDP/2098 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO QUININE | QUININE SULPHATE | 300MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2099 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | HYDROCORTISONE 1% CREAM | HYDROCORTISONE | 1%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1998 |
| NDA/MAL/HDP/2100 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ORALCON - F | LEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE | 0.15MG + 0.03MG + 75MG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2101 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CARDISPRIN | ACETYL SALICYLIC ACID | 75MG | COSMOS LIMITEDRANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2104 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE/NEVIRAPINE /ZIDOVUDINE DISPERSIBLE TABLETS | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 30MG + 50MG + 60MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/2108 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYMOX CAPSULES 250MG | AMOXYCILLIN | 250MG | ELYS CHEMICAL INDUSTRIES LTDROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2111 | HETERO LABS LTD | AIVEEN (U) LIMITED | LOPINAVIR / RITONAVIR | LOPINAVIR / RITONAVIR | 200MG /50MG | HETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | 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 | 1.0X120.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/2112 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 200MG + 50MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER | 01/07/2008 |
| NDA/MAL/HDP/2116 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | AMLOVAS-10 | AMLODIPINE BESILATE | 10MG | MACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/2120 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEGAPIME | CEFEPIME | 1G | SANCE LABORATORIES PVT LTDVI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | ALKEM LABORATORIES LTD.VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 01/07/2011 |
| NDA/MAL/HDP/2125 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | BECLATE 100 | BECLOMETASONE | 100MCG/DOSE | CIPLA LTD.- PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2009 |
| NDA/MAL/HDP/2129 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 500MG/125MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2132 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LOPINAVIR/ RITONAVIR | LOPINAVIR/ RITONAVIR | 200MG/ 50MG | AUROBINDO PHARMA LTDUNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/2133 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ACTRAPID | HUMAN INSULIN | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PHARMANOVO ALLE | DENMARK | FRANCE | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/2136 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | SEDIPROCT SUPOSITORY | HYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN | 5MG + 5MG +10MG +10MG | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | TOPICAL EXTERNAL SUPPOSITORIES | 1.0X6.0 SUPPOSITORY STRIP | 01/07/2003 |
| NDA/MAL/HDP/2140 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | AVIRANZ | EFAVIRENZ | 600MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2006 |
| NDA/MAL/HDP/2141 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | INFLAZONE | MULTIINGREDIENT | N/A | CENTAUR PHARMACEUTICALS PVT LTD -PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2143 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GRISEOFIL | GRISEOFULVIN | 500MG | FOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2144 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICOTIL | TENOXICAM | 20MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE | 01/07/2014 |
| NDA/MAL/HDP/2145 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | METFIL 500 | METFORMIN | 500MG | FOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/2147 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | DICLOFEN -50 | DICLOFENAC | 50MG | FOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2149 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PRIMOLUT DEPOT | HYDROXYPROGESTERONE HEXANOATE | 250MG | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/2150 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMULIN MIXTURE | HUMAN INSULIN | 70/30 I.U | LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,INDIANA 46285 USA | UNITED STATES | | PARENTERAL ORDINARY S C VIALS | 1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/1997 |
| NDA/MAL/HDP/2151 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYCOMET 850 | METFORMIN | 850MG | FREDUN PHARMACEUTICALS LIMITED--14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2154 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYNASE | GLIPIZIDE | 5MG | FREDUN PHARMACEUTICALS LIMITED--14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2155 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | DOXEFIL | DOXYCYCLINE | 100MG | FOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2160 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ACEM-500 | CLARITHROMYCIN | 500MG | EMCURE PHARMACEUTICALS LTDLANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2161 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CYCLOVAX CREAM | ACICLOVIR | 5%W/W | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2170 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ALSARTAN-AM | LOSARTAN + AMLODIPINE | 50MG + 5MG | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2173 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEVO-500 | LEVOFLOXACIN | 500MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET BLISTER | 01/07/2003 |
| NDA/MAL/HDP/2176 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | RISPITAS-2 | RISPERIDONE | 2MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2178 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL CEFUROXIME-250 | CEFUROXIME AXETIL | 250MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | MALAYSIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/2181 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PHEN | PHENOXYMETHYLPENICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2185 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ROTARIX | LIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPE | NOT LESS THAN 10? CCID?? OF THE RIX4414 STRAIN | GLAXOSMITHKLINE BOILOGICALSS.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | GLAXOSMITHKLINE AUSTRALIA.GLAXOSMITHKLINE AUSTRALIA, 1061 MOUNTAIN HIGHWAY, BORONIA, VICTORIA, 3155 AUSTRALIA | BELGIUM | AUSTRALIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.5 ML TUBE (1 DOSE),1.0X50.0X1.5 ML TUBE (1 DOSE),1.0X7.5 ML TUBE (5-DOSE) FOR GAVI/UNICEF SUPPLY ONLY | 01/07/2009 |
| NDA/MAL/HDP/2186 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE | 7MG+67.5MG/5ML | KOTRA PHARMA-BHD 1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA | | MALAYSIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/2191 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | KLOXY | CLOXACILLIN | 250MG | LABORATORY & ALLIED LTD.--PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2195 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | EUDERM CREAM | UREA | 10%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X45.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2197 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | WHITFIELD'S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2199 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 50MCG | LEVOTHYROXINE SODIUM | 50MCG | MERCK KGAA - FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/2201 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CLYCIN | CLINDAMYCIN PHOSPHATE | 10MG/ML | SHAIGAN PHARMACEUTICALS (PVT) LTD14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL LOTIONS | 1.0X30.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/2208 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL CEPHALEXIN | CEPHALEXIN MONOHYDRATE | 500MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | MALAYSIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2211 | GALENTIC PHARMA (PVT)LTD | VITACARE LIMITED | BENZYL BENZOATE | BENZYL BENZOATE | 25%W/W | GALENTIC PHARMA PVT. LIMITEDR-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIA | INDIA | | TOPICAL EXTERNAL EMULSIONS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/2212 | DENK PHARMA | BENLE CONSULT LIMITED | CIPRO-DENK 500 | CIPROFLOXACIN | 500MG | ALLPHARMED PHARBIL ARZNEIMITTEL GMBH12 D377081 | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2214 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | GENTAMICIN INJECTION | GENTAMICIN SULPHATE | 40MG/ML | SCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE | 01/07/2007 |
| NDA/MAL/HDP/2216 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOCLOPRAMIDE | METOCLOPRAMIDE | 5MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2005 |
| NDA/MAL/HDP/2219 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PRIMOLUT N | NORETHISTERONE | 5MG | BAYER WEIMAR GMBH & CO. KGDOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER,1.0X2.0X15.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2223 | ROYAL PHARMA | ROYAL PHARMA 2011 LIMITED | BENZATHINE PENICILLIN INJECTION | BENZATHINE PENICILLIN | 2400000 I.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | PARENTERAL ORDINARY DRY VIALS | 1X2.4 MU VIAL | 01/07/2002 |
| NDA/MAL/HDP/2224 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX 500 | AMOXICILLIN | 500MG | VOGEN LABORATORIES LTD70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/2226 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | HEPA-MERZ GRANULES | L-ORNITHINE-L-ASPARTATE | 3G/5G | WIN-MEDICARE PRIVATE LIMITEDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X10.0X5.0 G SACHET | 01/07/2004 |
| NDA/MAL/HDP/2231 | MEDIPHARM SALES LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | PIRITEX WITH CODEINE | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDIPHARM INDUSTRIES( EA) LTDPLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2232 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNICAST | MONTELUKAST | 10MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2233 | ASTRAZENECA | MACNAUGHTON LIMITED | PULMICORT NEBULISER | BUDESONIDE | 0.25MG/ML | ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X4.0X5.0X2.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/2235 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | WOSULIN-N | INSULIN HUMAN(RECOMBINANT DNA ORIGIN) | 100IU/ML | WOCKHARDTWOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA | INDIA | | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/2006 |
| NDA/MAL/HDP/2236 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL 200 | CARBAMAZEPINE | 200MG | NOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | | ITALY | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2237 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | WOSULIN-30/70 | INSULIN HUMAN(RECOMBINANT DNA ORIGIN) | 100I.U/ML | WOCKHARDT LIMITED -WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X3.0 ML VIAL | 01/07/2006 |
| NDA/MAL/HDP/2239 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL SYRUP | CARBAMAZEPINE | 20MG/ML | DELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE | | FRANCE | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/2242 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CYCLOVAX 200 TABLETS | ACYCLOVIR | 200MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2243 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | SIMDOL TABLETS | PARACETAMOL | 500MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDPLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2245 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | X-PEL | MEBENDAZOLE | 100MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2008 |
| NDA/MAL/HDP/2248 | GALENTIC PHARMA (PVT)LTD | VITACARE LIMITED | TETRACYCLINE OPHTHALMIC | TETRACYCLINE | 1%W/W | GALENTIC PHARMA PVT. LIMITEDR-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA | | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE,1.0X5.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/2249 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | WOSULIN-R | INSULIN | 100ML | WOCKHARDT LIMITED -WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/2006 |
| NDA/MAL/HDP/2252 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 500MG | SPECPHARM HOLDINGS 15TH ROAD HALFWAY HOUSE | JOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2254 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | BURN CUR CREAM | ACRIFLAVINE/THYMOL | N/A | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1998 |
| NDA/MAL/HDP/2256 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN 457MG/5ML | AMOXICILLIN + CLAVULANIC ACID | 400 MG + 57 MG / 5 ML | GLAXO WELLCOME PRODUCTIONZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X70.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2263 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEMIN 10 PLUS | AMINO ACIDS/ELECTROLYTES | 10%W/V+10%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/2265 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | TENOFOVIR/ LAMUVIDINE | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | 300MG + 300MG | HETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | HETERO LABS LTD (UNIT-V)SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2267 | MYLAN LABORATORIES LIMITED (OTL) | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | 300MG+300MG | QUESTA CARE LIMITEDPLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. | 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 BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2269 | DAWA LIMITED | SUPER MEDIC LTD | DAWAMOX | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2271 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | ARTEMETHER 20MG/LUMEFANTRINE 120MG | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | IPCA LABORATORIES LTDPLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X10.0X4.0X6.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2272 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CLARANTA -500 | CLARITHROMYCIN | 500MG | AJANTA PHARMA LTD .B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X2.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2280 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | BETADROP-N | BETAMETHASONE + NEOMYCIN | 0.1 %W/V + 0.5 %W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD, 117 ALLAM | PAKISTAN | | OPHTHALMIC DROPS | 1.0X7.5 ML VIAL | 01/07/1999 |
| NDA/MAL/HDP/2281 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | LUMFORT | LORATADINE | 10MG | NABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2282 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROPAN | PROPRANOLOL | 40MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/2283 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII DIPHTHERIA TETANUS PERTUSIS | DIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE | >25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MG | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE) | 01/07/1997 |
| NDA/MAL/HDP/2287 | GLAXO WELLCOME (KENYA) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZINNAT | CEFUROXIME AXETIL | 250MG | GLAXOSMITHKLINE UK LTDHARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON | 01/07/1997 |
| NDA/MAL/HDP/2290 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | MYLAN LABORATORIES LTD -H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/2295 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ROZITTA 10 | ROSUVASTATIN CALCIUM | 10MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| NDA/MAL/HDP/2297 | DAWA LIMITED | SUPER MEDIC LTD | SABULIN SYRUP | SALBUTAMOL SULPHATE | 2MG/5ML | DAWA LIMITED BABA DOGO RWARAKA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/2298 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | SAFELEVO 500 | LEVOFLOXACIN | 500MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/2299 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ROZITTA 20 | ROSUVASTATIN CALCIUM | 20MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| NDA/MAL/HDP/2303 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 5/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 5 MG + 6.25 MG | MERCK KGAAFRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/2304 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 10/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 10 MG + 6.25 MG | MERCK KGAAFRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/2305 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 2.5/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 2.5 MG + 6.25 MG | MERCK KGAAFRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/2306 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MICROLUT | LEVONORGESTREL | 0.03MG | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X35.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2312 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAVOMID 625 | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2313 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAVOMID 375 | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2314 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RABEMAC-20 | RABEPRAZOLE SODIUM | 20MG | MACLEODS PHARMACEUTICALS LTD PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/2315 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-50 | CEFIXIME | 50MG/5ML | MICRO LABS LIMITED, BOMMASANDRA PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/2318 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE-4 | GLIMEPIRIDE | 4MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2319 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMOL | PARACETAMOL | 120MG/5ML | COSMOS LIMITEDRANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/2320 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ERO-125 DRY SYRUP | ERYTHROMYCIN ESTOLATE | 125MG/5ML | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/2322 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TREFLUCAN | FLUCONAZOLE | 150MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X1.0 CAPSULE STRIP | 01/07/2007 |
| NDA/MAL/HDP/2324 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSCLOXA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X7.5 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/2330 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | COARTEM | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | NOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2333 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC) | DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE | >25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MG | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE) | 01/07/1997 |
| NDA/MAL/HDP/2334 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII MEASLES MUMPS & RUBELLA | MEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUS | NLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50 | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT | 01/07/1997 |
| NDA/MAL/HDP/2335 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBEN TABLETS(THANE) | MEBENDAZOLE | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/2338 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG | GLAXO WELLCOME PRODUCTIONZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/2348 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | HEPATITIS B VACCINE(RDNA) ADULT | HEPATITIS B VACCINE(RDNA) ADULT | 20MCG/ML | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL) | 01/07/2005 |
| NDA/MAL/HDP/2350 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | PULMICORT TURBUHALER | BUDESONIDE | 200MCG | ASTRAZENECA AB,GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X100.0 DOSE CANNISTER | 01/07/2001 |
| NDA/MAL/HDP/2352 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP DAY TIME | PARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE | 500MG+30MG+30MG | REGAL PHARMACEUTICALS LIMITED PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X12.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2353 | ASTRA ZENECA | MACNAUGHTON LIMITED | NEXIUM | ESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE) | 10MG | ASTRA ZENECA ABSE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | | ORAL SOLID ORDINARY GRANULES | 1.0X28.0 SACHET CARTON | 01/07/2013 |
| NDA/MAL/HDP/2356 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | QUININE | QUININE DIHYDROCHLORIDE | 600MG/2ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA | CHINA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2005 |
| NDA/MAL/HDP/2357 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | TRABILIN- 50 CAPSULES | TRAMADOL | 50MG | MERCKLE GMBH,LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| NDA/MAL/HDP/2359 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ASPIREM 75 | ASPIRIN | 75MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X28.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2360 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | FUNGISTIN PESSARIES | NYSTATIN | 100000 IU | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | VAGINAL TABLETS | 1.0X14.0 PESSARY PACK,5.0X3.0 PESSARY STRIP,1.0X100.0 PESSARY CONTAINER | 01/07/2002 |
| NDA/MAL/HDP/2361 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAREM 500 | CLARITHROMYCIN | 500MG | REMEDICA LTDAHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2362 | GALENTIC PHARMA LTD | VITACARE LIMITED | CANDISTATIN OINTMENT | NYSTATIN | 100,000I.U | GALENTIC PHARMA PVT. LIMITED R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 01/07/2009 |
| NDA/MAL/HDP/2363 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GENTAMICIN SULPHATE | GENTAMICIN SULPHATE | 80MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2005 |
| NDA/MAL/HDP/2364 | AIVEEN (U) LIMITED | AIVEEN (U) LIMITED | VOXEL-500 | LEVOFLOXACIN | 500MG | MEDICO REMEDIES PVT LIMITED8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/2366 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | IFICIPRO INJECTION | CIPROFLOXACIN | 200MG/100ML | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)-304-308 ,GIDC , PANOLI 394116 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/2368 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DERMIDEX CREAM | MICONAZOLE NITRATE | 2%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/2369 | ARISTO PHARMACEUTICALS | NORVIK ENTERPRISES LIMITED | TRANLOK 500MG INJECTION | TRANEXAMIC ACID | 500MG/5ML | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 01/07/2010 |
| NDA/MAL/HDP/2371 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | TOPIZONE CREAM | FUSIDIC ACID + BETAMETHASONE VALERATE | 20MG/G+1MG/G | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/2375 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN 1G | AMOXICILLIN + CLAVULANIC ACID | 875 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X1.0X7.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2379 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | PUMPITOR | OMEPRAZOLE | 40MG | PT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT | 01/07/2014 |
| NDA/MAL/HDP/2384 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CLARIX 500 | CLARITHROMYCIN | 500MG | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2385 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | COZEPAM 5MG | DIAZEPAM | 5MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| NDA/MAL/HDP/2387 | DAWA LIMITED | SUPER MEDIC LTD | VERMOUT | MEBENDAZOLE | 100MG/5ML | DAWA LIMITED BABA DOGO RWARAKA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2388 | DAFRA PHARMA LTD | MULTIPHAR UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + POTASSIUM CLAVULANATE | 400MG + 57MG | BILIM ILAC SAN. VE. TIC. A.S.CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 | TURKEY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/2389 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELOCIN | ERYTHROMYCIN | 250MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/2390 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN | DIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE | 80MG /640MG | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/2391 | BIOMATRIX HEALTHCARE PVT LTD | MEDIWORLD PHARMA AFRICA LTD | HEADAID TABLETS | ASPIRIN + CAFFEINE + PARACETAMOL | 300MG + 30MG + 250MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/2394 | MERCK SHARP & DOHME BV. | SURGIPHARM (U) LIMITED | STOCRIN | EFAVIRENZ | 600MG | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA | | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/2395 | A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FASTUM GEL | KETOPROFEN | 2.5%W/W | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.LVIA SETTE SANTI 3, 50131 FIRENZE-ITALY | ITALY | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2397 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | VITAMAKS | MULTI-INGREDIENT | MULTI-INGREDIENT | S KANT HEALTH CARE LTDPLOT 1802 – 1805 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2399 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | VOLINI | MULTI INGREDIENT | MULTI INGREDIENT | SUN PHARMACEUTICAL INDUSTRIES LIMITEDKH. NO. 1335-1340, NEAR EPIP-1, VILL - BHATOLI KALAN, BADDI, DISTT. SOLAN, HIMACHAL PRADESH - 173205, INDIA | SUN PHARMACEUTICAL IND. LTDPLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2401 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | ENAT | NATURAL VITAMIN E | 400IU | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2404 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | LOSAR 50 | LOSARTAN POTASSIUM | 50MG | UNICHEM LABORATORIES LTD--VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2408 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENIRON TONIC | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/2410 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | DOXYREN | DOXYCYCLINE | 100MG | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2411 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | POVIDONE IODINE + METRONIDAZOLE | 5%W/W + 1%W/W | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE | 01/07/2010 |
| NDA/MAL/HDP/2414 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCIL | AMPICILLIN | 125MG/5ML | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/2415 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SOLINA TABLETS | DIAZEPAM | 5MG | CENTAUR PHARMACEUTICALS LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2426 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PROBEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/2427 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | CLONEM | CLOTRIMAZOLE | 1%W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2428 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | CLOTRI-DENK 1% CREAM | CLOTRIMAZOLE | 1%W/W | C.P.M. CONTRACTPHARMA GMBH & COMPANY KGFRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM | GERMANY | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1998 |
| NDA/MAL/HDP/2429 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | CLOTRI-DENK 100 VAGINAL | CLOTRIMAZOLE | 100MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | ARTESAN PHARMA GMBH & CO. KG WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | | VAGINAL TABLETS | 1.0X6.0 PESSARY CARTON | 01/07/1998 |
| NDA/MAL/HDP/2434 | STRIDES PHARMA SCIENCE LIMITED | DELMAW ENTERPRISES LIMITED | SOLCER | OMEPRAZOLE | 40MG | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/2438 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HIFENAC | ACECLOFENAC | 100MG | INTAS PHARMACEUTICALS LTDCAMP ROAD SELAQUI DEHRADUN | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2452 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | DELASED CHEST COUGH SYRUP (NON DROWSY) | GUAIFENESIN + MENTHOL | 100MG/5ML + 1.1MG/5ML | REGAL PHARMACEUTICALSPLOT 7879/18 BABA DOGO ROAD NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2458 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | PRISTINEX 2% CREAM | KETOCONAZOLE | 2%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 2.0X15.0 G TUBE | 01/07/2006 |
| NDA/MAL/HDP/2459 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | P2 | LEVONORGESTREL | 0.75MG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2462 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | HISTALIN SYRUP | CHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE | 1.0MG+ 2.5MG+5.0MG+7.5MG+90.0MG+48.0MG/ 5ML. | REGAL PHARMACEUTICALS LTD..PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 01/07/1997 |
| NDA/MAL/HDP/2471 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | OTRIVIN 0.1% NASAL DROPS | XYLOMETAZOLINE | 0.1%W/V | GSK CONSUMER HEALTH SAGSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | | NASAL SYSTEMIC DROPS | 1.0X10.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/2472 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TRAN-GEL | DICLOFENAC DIETHYLAMMONIUM | 1%W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X20.0 G TUBE | 01/07/2011 |
| NDA/MAL/HDP/2473 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NUGREL | CLOPIDOGREL | 75MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2475 | WIN-MEDICURE LTD | SURGIPHARM (U) LIMITED | URGENDOL INJECTION | TRAMADOL HYDROCHLORIDE | 50MG/ML | WIN- MEDICARE LTDMODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE | 01/07/2001 |
| NDA/MAL/HDP/2476 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | DERIVA AQUEOUS GEL | ADAPALENE | 0.1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/2478 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL PLUS | PARACETAMOL+DICLOFENAC | 500MG+50MG | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2481 | GALENTIC PHARMA (PVT)LTD | VITACARE LIMITED | NETRACORT | HYDROCORTISONE | 1%W/W | GALENTIC PHARMA PVT LIMITEDR-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X20.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2492 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | PROFIL 25 | PROMETHAZINE HYDROCHLORIDE | 25MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2502 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | PROBETA N EYE DROP | BETAMETHASONE + NEOMYCIN | 0.1%W/V+0.5%W/V | ATCO LABORATORIES PVT LTDB-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | | OPHTHALMIC DROPS | 1.0X7.5 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/2504 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN | PARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL | 500MG+ 2MG+ 2MG + 30MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET STRIP | 01/07/2008 |
| NDA/MAL/HDP/2507 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | EXERMET 1000 | METFORMIN HCL | 1000MG | CIPLA LTD ---D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL | CIPLA LIMITED ,.,.VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2509 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | OPELE LOTION | BENZYL BENZOATE | 25%W/V | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL LOTIONS | 1.0X50.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2510 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | GIRO | ORDNIDAZOLE | 500MG | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/2512 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | DICLOFENAC SODIUM INJECTABLE SOLUTION | DICLOFENAC SODIUM | 25MG/ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE | 01/07/2009 |
| NDA/MAL/HDP/2513 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIPEN DRY SYRUP | PHENOXYMETHYLPENICILLIN | 125MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2515 | AFRICURE PHARMACEUTICALS (INDIA) LTD | ROYAL PHARMA 2011 LIMITED | SIMFEN 200 TABLETS | IBUPROFEN | 200MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDPLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2521 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | MOTINORM | DOMPERIDONE | 10MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2523 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | SULPHUR OINTMENT | SULPHUR | 10%W/W | NEM LABORATORIES PVT LTD--133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2525 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DICLO-DENK 100 RETARD | DICLOFENAC SODIUM | 100MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID RETARD TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/2526 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNISTEN COMBI PACK | CLOTRIMAZOLE | 500MG & 1 %W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | VAGINAL COMBINATION PACK TABLETS | 1.0X1.0 PESSARY BLISTER + 1*20G TUBE | 01/07/2009 |
| NDA/MAL/HDP/2528 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LABESTEN | CLOTRIMAZOLE | 1%W/W | LABORATORY & ALLIED LTD.--PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2529 | B & O PHARM ZAC | TRIDEM PHARMA UGANDA LIMITED | G-CEFTRIA | CEFTRIAXONE | 1G | CHINA NATIONAL MEDICINES, GUORUI PHARMACEUTICAL CO., LTD-CAOYANG EAST ROAD, HUAINAN ECONOMICAL AND TECHNOLOGICAL DEVELOPMENT ZONE, HUAINAN CITY ANHUI PROVINCE | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML AMPOULE WFI,1.0X1.0X50.0 G VIAL,1.0X1.0 VIAL CARTON | 01/07/2012 |
| NDA/MAL/HDP/2545 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | TOBREX | TOBRAMYCIN | 0.3%W/V | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2552 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CAROFIT | VITAMIN C/ VITAMIN A/ ZINC SULPHATE | 150MG/10MG/75MG | AJANTA PHARMA LIMITEDB-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2553 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | ESOZ-20 | ESOMEPRAZOLE | 20MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP | 01/07/2003 |
| NDA/MAL/HDP/2554 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | ESOZ | ESOMEPRAZOLE | 40MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/2555 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PHENOBARBITONE TABLETS BP 30MG | PHENOBARBITONE | 30MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/2556 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | TRUVADA | EMTRICITABINE/TENOFOVIR | 200MG/300MG | PATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9 COUNTRY: CANADA | TAKEDA GMBH-16515 ORANIENBURG GERMANY | CANADA | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/2557 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | EPSITRON 25 TABLETS | CAPTOPRIL | 25MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1999 |
| NDA/MAL/HDP/2558 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MYCOREN SUSPENSION | NYSTATIN | 100000 I.U/ML | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2559 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ERYTHROREN | ERYTHROMYCIN STEARATE | 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/2562 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | TRABILIN-100 | TRAMADOL | 100MG/2ML | MERCKLE GMBH,LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE | 01/07/2005 |
| NDA/MAL/HDP/2565 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | TRAMAZAC INJECTION | TRAMADOL HYDROCHLORIDE | 50MG/ML | FARBE FIRMAPLOT NO. 1508, GIDC ANKLESHWAR - 393002, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | , 1X5X2 ML AMPOULE, 1X2 ML VIAL | NONE |
| NDA/MAL/HDP/2567 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CIPROBID-500 | CIPROFLOXACIN | 500MG | S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2568 | GLAXO WELLCOME (KENYA) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZINNAT | CEFUROXIME AXETIL | 500MG | GLAXOSMITHKLINE UK LTDHARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON | 01/07/1997 |
| NDA/MAL/HDP/2571 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | 180 MG + 1080 MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2575 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | MYTEKA | MONTELUKAST SODIUM | 10MG | HILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2576 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEQUINE TABLETS | CHLOROQUINE PHOSPHATE | 250MG | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| NDA/MAL/HDP/2578 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MAGNOMINT TABLETS | ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE | 125MG + 250MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2580 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | HEDON TABLETS | PARACETAMOL + ASPIRIN + CAFFEINE | 250 MG+ 300 MG + 30 MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | MILAN LABORATORIES (INDIA) PVT LTD - 63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP | 01/07/1998 |
| NDA/MAL/HDP/2591 | HEALTHCARE LTD. | HEALTHCARE LTD. | VITAGLOBIN SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | AL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | | PAKISTAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/2593 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ATENOLOL DENK 50 | ATENOLOL | 50MG | ARTESAN PHARMA GMBH & CO. KG WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2594 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FEF | FERROUS SULPHATE + FOLIC ACID | 200MG + 0.4MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2595 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | ZEPILEN | CEFAZOLIN | 1000MG | MEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 G VIAL | 01/07/2009 |
| NDA/MAL/HDP/2597 | E DENK OHG | BENLE CONSULT LIMITED | PARA DENK 250 | PARACETAMOL | 250MG | RUBIEPHARM ARZNEIMITTEL GMHH BRUDER-GRIMM-STRABE 62, 36396, STEINAU AN DER STRABE | BENE-ARZNEIMITTEL GMBHHERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP | 01/07/2005 |
| NDA/MAL/HDP/2600 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE-OD | CLARITHROMYCIN(EXTENTED RELEASE) | 500MG | IND-SWIFT-LTD,GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X1.0X7.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/2601 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AXETINE 750MG | CEFUROXIME | 750MG | MEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X750.0 MG VIAL | 01/07/2009 |
| NDA/MAL/HDP/2602 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM BID | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG/ 5 ML | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2604 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | SAKAR HEALTHCARE PVT LTDSAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/2612 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENIRON | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 3.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2614 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | DIALIN | LOPERAMIDE HCL | 2MG | REGAL PHARMACEUTICALS LIMITED PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2615 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | SYMBICORT TURBUHALER | BUDESONIDE+FORMOTEROL | 160MCG+4.5MCG/DOSE | ASTRAZENECA AB,GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X60.0 DOSE CANNISTER,1.0X120.0 DOSE CANNISTER | 01/07/2001 |
| NDA/MAL/HDP/2628 | MICRO LABS LTD 92 SIPCOT | LABOREX UGANDA LIMITED | AZILIDE-500 | AZITHROMYCIN | 500MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2641 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AXETINE 250MG | CEFUROXIME AXETIL | 250MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | | CYPRUS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2014 |
| NDA/MAL/HDP/2642 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOXANUM | CEFTRIAXONE | 1G | MEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML AMPOULE WFI | 01/07/2016 |
| NDA/MAL/HDP/2647 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | IBUPROFEN DENK 400MG | IBUPROFEN | 400MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2648 | E DENK OHG | BENLE CONSULT LIMITED | PARA DENK 125 | PARACETAMOL | 125MG | RUBIEPHARM ARZNEIMITTEL GMHH BRUDER-GRIMM-STRABE 62, 36396, STEINAU AN DER STRABE | BENE-ARZNEIMITTEL GMBHHERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP | 01/07/2005 |
| NDA/MAL/HDP/2650 | DENK PHARMA | BENLE CONSULT LIMITED | VIT-B-DENK | THIAMINE HCL + PYRIDOXINE HCL | 100MG + 200MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2651 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RINAVIT SYRUP | MULTIVITAMIN | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2653 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | SONADERM-GM | CLOBETASOL + MICONAZOLE + GENTAMICIN | 0.05%W/W + 2% W/W+ 0.1%W/W | BLUE CROSS LABORATORIES LTDL-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/2654 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | BEBE VIT | VITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B2 | 1500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MG | MEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/2656 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMINOPHYLLINE | AMINOPHYLLINE | 100MG | SCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/2661 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FUNGIFEN | CLOTRIMAZOLE | 1%W/W | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2671 | CIPLA LTD.. | ABACUS PHARMA (AFRICA) LIMITED | DUOLIN RESPULES | IPRATROPIUM BROMIDE & SALBUTAMOL | 500MG + 2.5 MG /2.5ML | CIPLA LTD.- PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | | LUNG ADMINISTRATION LIQUID FOR INHALATION | 4.0X5.0X2.5 ML VIAL | 01/07/2005 |
| NDA/MAL/HDP/2675 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | LIBITUS PLUS SYRUP | TERBUTALINE/ BROMHEXINE/ GUAIPHENESIN | 1.25MG/ 4MG/ 50 MG | LEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/2678 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | FORCAN-150 | FLUCONAZOLE | 150MG | CIPLA LTD PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0 CAPSULE BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2680 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMPIREN CAPSULES | AMPICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/2681 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN | AMOXICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/2683 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAMIN C | ASCORBIC ACID | 100MG | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/2685 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEDOL(SUSPENSION) | PARACETAMOL | 120MG/5ML | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2690 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-250 | AMPICILLIN | 250MG | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/2691 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-500 | AMPICILLIN | 500MG | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | CHINA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON | 01/07/2011 |
| NDA/MAL/HDP/2695 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | IDUMSTRA | PARACETAMOL + IBUPROFEN + CAFFEINE | 325MG + 200MG + 40MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2696 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | AMPHOTRET | AMPHOTERICIN B | 50MG | BHARAT SERUMS AND VACCINES LTD PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2012 |
| NDA/MAL/HDP/2697 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | LUCIN OINTMENT | HYDROCORTISONE | 1%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2698 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | AZICIN-500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2703 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT 312.50 | CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE) | 250+62.50MG/ 5ML | AUROBINDO PHARMA LTD, UNIT XII,.SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2705 | ASTRAZENECA | MACNAUGHTON LIMITED | PULMICORT NEBULISER | BUDESONIDE | 0.5MG/ML | ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X4.0X5.0X2.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/2707 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMCLOXA | CLOXACILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDPLOT M 444B STRETCHER ROAD NTINDA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/2708 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | HYPER TABLETS | PROPRANOLOL HYDROCHLORIDE | 40MG | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2710 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN BD | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2712 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | ANAWIN | BUPIVACAINE | 0.025%W/V | NEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2014 |
| NDA/MAL/HDP/2715 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE | LAMIVUDINE | 150MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 01/07/2008 |
| NDA/MAL/HDP/2717 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | OCUMYCIN EYE OINTMENT | CHLORAMPHENICOL | 1%W/W | CENTAUR PHARMA PVT. LTDPLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA | INDIA | | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE | 01/07/2000 |
| NDA/MAL/HDP/2721 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PRIMAFEN TABLET | IBUPROFEN + PARACETAMOL | 400MG + 325MG | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2722 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | NO SORES | CHOLINE SALICYLATE/LIDOCAINE | 8.7%W/W+2%W/W | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL TOPICAL GELS AND SOLS | 1.0X10.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/2723 | TABROS PHARMA | HEALTHCARE LTD. | DURAGESIC TABLET | PARACETAMOL + ORPHENADRINE | 450MG+35MG | TABROS PHARMAL-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2726 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | QUININE INJECTION | QUININE DIHYDROCHLORIDE | 600MG/2ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTDNO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/2728 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | DEXAMETHASONE INJECTION | DEXAMETHASONE | 4MG/ML | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X100.0X1.0 ML AMPOULE,1.0X100.0X1.0 ML AMPOULE (IN A 2ML AMPOULE) | 01/07/2006 |
| NDA/MAL/HDP/2734 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMLODAR-10 | AMLODIPINE BESILATE | 10MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2737 | SHAIGAN PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | SENEX FORTE | SECNIDAZOLE | 1G | SHAIGAN PHARMACEUTICALS (PVT) LTD14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET BLISTER | 07/01/2004 |
| NDA/MAL/HDP/2738 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | HEPA-MERZ INFUSION | L-ORNITHINE- L-ASPARTATE | 5G/10ML | WIN-MEDICARE PRIVATE LIMITEDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | | PARENTERAL ORDINARY I V VIALS | 1.0X5.0X10.0 ML VIAL | 01/07/2001 |
| NDA/MAL/HDP/2739 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | BISPANOL TABLET | HYOSCINE BUTYLBROMIDE | 10MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/2743 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | DUO-COTECXIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG + 320MG | KBN- ZHEJIANG PHARMACEUTICAL CO. LTDNO. 340 YUNHAI ROAD JIAXING ECONOMIC DEVELOPMENT ZONE, JIAXING CITY, ZHEJIANG PROVINCE | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER,1.0X30.0X9.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2745 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENFORMIN | METFORMIN HYDROCHLORIDE | 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/2746 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ACYCLOVIR DENK 200 | ACYCLOVIR | 200MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X25.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2753 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PRASIL | METOCLOPRAMIDE HYDROCHLORIDE | 10MG | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2754 | FDC LTD | AIVEEN (U) LIMITED | ZATHRIN 500 | AZITHROMYCIN DIHYDRATE | 500MG | FDC LIMITED PLOT NO. L121 B PHASE 111A VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/2756 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | CYTOTEC | MISOPROSTOL | 200MCG | PIRAMAL HEALTHCARE LIMITEDWALTON ROAD MORPETH NORTHUMBERLAND NE 613YA | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2760 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | DELASED DRY COUGH SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL | 14MG+6.5MG+57MG+2MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2763 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | CANDISTAT | CLOTRIMAZOLE | 100MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | VAGINAL SUPPOSITORIES | 1.0X2.0X3.0 PESSARY STRIP | 01/07/1997 |
| NDA/MAL/HDP/2773 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | BISPANOL ELIXIR | HYOSCINE-N-BUTYLBROMIDE | 5MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA, NAIROBI, KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/2774 | ACINO PHARMA AG - | LABOREX UGANDA LIMITED | BACTIFLOX NEO 500 | CIPROFLOXACIN | 500MG | ACINO PHARMA AG-BIRSWEG 2, 4253, LIESBERG - SWITZERLAND | | SWITZERLAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2776 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | TENSIMIN-100 | ATENOLOL | 100MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2777 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CO-DIOVAN 160/12.5MG TABLETS | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG + 12.5MG | NOVARTIS PHARMA AGSCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2779 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE SURGICAL SCRUB | POVIDONE IODINE | 7.5%W/V | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTDPLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/2781 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CARVETAS 6.25 | CARVEDILOL | 6.25MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2783 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 25MG | DICLOFENAC SODIUM | 25MG | DELPHARM HUNINGUE S.A.S-SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY STRIP | 01/07/2006 |
| NDA/MAL/HDP/2787 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 125 DT | AMOXICILLIN | 125MG | MEDOPHARM PVT LTD.NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/2788 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | MULTIREN | MULTIINGREDIENT | N/A | RENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2793 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TAKEDA GMBH,PLANT ORANIENBURG-LEHNITZSTRASSE 70-98,16515,ORANIENBURG-GERMANY | PATHEON YM INC. TORONTO- TORONTO, CANADA | | GERMANY | CANADA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/2796 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN SODIUM | 1,000,000I.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON | 01/07/2001 |
| NDA/MAL/HDP/2797 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | LUMAREN | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X8.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2800 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ACTRAPID FLEXPEN 100 I.U/ML | HUMAN INSULIN | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | NOVO NORDISK PHARMANOVO ALLE | DENMARK | BRAZIL | FRANCE | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN,1.0X5.0X1.5 ML PREFILLED PEN | 01/07/1997 |
| NDA/MAL/HDP/2802 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | TASOL | CLOBETASOL | 0.05%W/W | CENTAUR PHARMACEUTICALS PVT LTD -PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2805 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NIFELAT 20R TABLETS | NIFEDIPINE | 20MG | REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2807 | GUILIN PHARMACEUTICALS CO.LTD | TRIDEM PHARMA UGANDA LIMITED | ASAQ GPSC | ARTESUNATE + AMODIAQUINE | 100 MG + 270 MG | GUILIN PHARMACEUTICALS CO. LTDNO 43 QULIDIAN ROAD GUILIN GUANGXI CHINA | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/2811 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SULPHUR OINTMENT | SULPHUR PRECIPITATED | 10%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE | 01/07/2001 |
| NDA/MAL/HDP/2812 | DAFRA PHARMA LTD | MULTIPHAR UGANDA LIMITED | CO-ARTESIANE | BETA ARTEMETHER + LUMEFANTRINE | 180 MG/60ML + 1080 MG/60ML | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/2813 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | INTACYCLINE SKIN OINTMENT | TETRACYCLINE HYDROCHLORIDE | 3%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2821 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DIOLIN-M | GLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS | 5MG+500MG | LINCOLN PHARMACEUTICAL LIMITED..LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2011 |
| NDA/MAL/HDP/2826 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PIRITON SYRUP | CHLORPHENIRAMINE MALEATE | 4MG/10ML | GLAXOSMITHKLINELIKONI ROAD IND. AREA, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2835 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | SOLUDINE-M | POVIDONE IODINE / METRONIDAZOLE | 5%W/W / 1%W/W | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE,1.0X125.0 G TUBE | 01/07/2011 |
| NDA/MAL/HDP/2837 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GRAMOFIL TABLETS | NALIDIXIC ACID | 500MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2838 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | DILCONTIN XL 120 | CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE | 120MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2010 |
| NDA/MAL/HDP/2850 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DISPERCAM | PIROXICAM | 20MG | MEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X3.0X1.0 ML AMPOULE | 01/07/2007 |
| NDA/MAL/HDP/2869 | GLAXO SMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PRIORIX VACCINE | MEASLES + MUMPS + RUBELLA | 103.0CCID50 + 103.7CCID50 + 103.0CCID50 | GLAXO SMITHKLINE BIOLOGICALS S.ARUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 ML VIAL (1 DOSE) | 01/07/2010 |
| NDA/MAL/HDP/2873 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HELIGO KIT | TINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE | 500MG+ 250MG+30MG | INTAS PHARMACEUTICALS LTD .PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X7.0X6.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/2875 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | OTRIVIN 0.05% NASAL DROPS | XYLOMETAZOLINE | 0.05%W/V | GSK CONSUMER HEALTH SAGSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/2880 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CARBIMAZOLE 5 | CARBIMAZOLE | 5MG | REMEDICA LIMITED,LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2885 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | FORECOX-TRAC | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL | 150MG + 75MG+ 400MG + 275MG | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | MACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2891 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | TORVAST 20 | ATORVASTATIN | 20MG | MACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2892 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | NICARDIA-20 TABLETS | NIFEDIPINE | 20MG | UNIQUE PHARMACEUTICAL LABORATORIESPLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2893 | DAWA LIMITED | SUPER MEDIC LTD | STOPACID SUSPENSION | MAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE | 250MG/5ML + 120MG/5ML | DAWAPLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/2896 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | MCG CREAM | MICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE | 2.0%W/W + 0.05%W/W + 0.1 %W/W | KPI INDUSTRIES (1996) LTDPLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2898 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | TORVAST 10 | ATORVASTATIN | 10MG | MACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/2900 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-200 | CEFIXIME | 200MG | MICRO LABS LIMITED, BOMMASANDRA PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/2902 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MEGALIS-20 | TADALAFIL | 20MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X15.0X1.0X4.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/2905 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BRONCHOPHANE SYRUP | GUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN | 50MG+7.5MG+5MG+4.58MG | ORCHIDIA10TH STREET RAMADAN CITY, FIST INDUSTRIES ARE | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X125.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/2906 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RIFAMPICIN/ISONIAZID/ETHAMBUTOL | RIFAMPICIN+ISONIAZID+ETHAMBUTOL | 150MG+75MG+275MG | MACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/2907 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART DS | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | BLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/2908 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | PAINGO MEDICATED CREAM | METHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE OIL | 15%W/W + 1%W/W + 1.47%W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X2.0X15.0 G TUBE | 01/07/2010 |
| NDA/MAL/HDP/2910 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | TENVIR EM | TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE | 300MG+200MG | CIPLA LTD.- PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/2911 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL LORATADINE | LORATADINE | 10MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2914 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | CHLOROCIDE SUSPENSION | CHLORAMPHENICOL PALMITATE | 125MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2917 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CETAMOL TABLETS | PARACETAMOL | 500MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP,1.0X100.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2920 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | TRANSLIPO -C CREAM | CLOTRIMAZOLE | 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD -PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE | 01/07/2001 |
| NDA/MAL/HDP/2940 | CENTAUR PHARMACEUTICALS PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | BENZOX 5 GEL | BENZOYL PEROXIDE | 5%W/W | CENTAUR PHARMACEUTICALS LTD PLOT NO. 39 TIVIN IN | INDIA | | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X20.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2942 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | ARGISSEPT CREAM | CHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE | 0.2%W/W / 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD -PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X10.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/2946 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO ORAL SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/2947 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO TABLETS | CO-TRIMOXAZOLE | 480MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON | 01/07/1998 |
| NDA/MAL/HDP/2948 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | METFORMIN DENK 850 | METFORMIN HYDROCHLORIDE | 850MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2951 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART FORTE TABLETS | ARTEMETHER + LUMEFANTRINE | 40 MG + 240 MG | BLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X2.0X6.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2956 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRANLOK 500MG TABLETS | TRANEXAMIC ACID | 500MG | ARISTO PHARMACEUTICALS PVT LIMITEDPLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/2957 | MEDIPHARM SALES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEDITROL | CALCITRIOL | 0.25MCG | MEGA LIFE SCIENCES LIMITED: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X5.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/2959 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | CETAMOL SYRUP | PARACETAMOL | 120MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/2960 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 400MG/57MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY GRANULES | 1.0X70.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/2969 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | TENSIMIN-50 | ATENOLOL | 50MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,14.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/2970 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYCOMET 500 | METFORMIN | 500MG | FREDUN PHARMACEUTICALS LIMITED--14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/2971 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | LEFRA-20 TABLETS | LEFLUNOMIDE | 20MG | TORRENT PHARMACEUTICALS LTDINDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2974 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | TRAVATAN | TRAVOPROST | 4µG/ML | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X2.5 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/2979 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM N CREAM | BETAMETHASONE VALERATE + NEOMYCIN | 0.1%W/W + 0.5%W/W | ATCO LABORATORIES PVT LTDB-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/2980 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART TABLETS | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | BLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X3.0X6.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2982 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | NEURO-FORTE TABLETS | VITAMIN B1 + VITAMIN B6 + VITAMIN B12 | 200MG + 50MG + 1MG | CENTAUR PHARMACEUTICALS LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2983 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | FUCOL 200 | FLUCONAZOLE | 200MG | CIPLA LTD PLOT NO. L-139, VERNA, GOA 403 722 INDIA | CIPLA LTD KURKUMBHD-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALUKA-DAUND, PUNE, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X1.0X4.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2985 | SANOFI 410 THALES | LABOREX UGANDA LIMITED | EPILIM CHRONO | SODIUM VALPROATE PH. EUR | 500MG | SANOFI WINTHROP INDUSTRIE1,RUE DE LA VIERGE ,AMBARES ET LAGRAVE 33565,CARBON BLANC CEDEX FRANCE | FRANCE | | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2990 | MICRO LABS LTD | LABOREX UGANDA LIMITED | PULMOCEF-500 | CEFUROXIME AXETIL USP | 500MG | MICRO LABS LTD-NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/2995 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GALLOP | LOPERAMIDE HYDROCHLORIDE USP | 2MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/2997 | MEDLEY PHARMACEUTICALS | EUROPA HEALTHCARE (U) LTD | ACENAC TABLETS | ACECLOFENAC | 100 MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/2998 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | FITIN-5 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | MEDLEY PHARMACEUTICALS LTDPLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3003 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIR | ACICLOVIR | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3005 | ACINO PHARMA AG - | LABOREX UGANDA LIMITED | OLFEN-100 SR PROLONGED-RELEASE CAPSULES | DICLOFENAC SODIUM | 100MG | ACINO PHARMA AGBIRSWEG 2, 4253, LIESBERG - SWITZERLAND | SWITZERLAND | | ORAL SOLID RETARD CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3007 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | TORTAS 5 | TORSEMIDE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/3009 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | SULBACTOMAX 1.5G | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | VENUS REMEDIES LTD, UNIT II,HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/3012 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL TABLETS | DICLOFENAC SODIUM | 50MG | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/3013 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOZOLE | ALBENDAZOLE | 400MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3017 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | LIDOCAINE INJECTION | LIDOCAINE HYDROCHLORIDE | 20MG/ML | SANJAR PHARMA LLP HIMATNAGAR-VIJOPUR HIGHWAY, DEDHROTA HIMATNAGAR 383 220, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X25.0X20.0 ML VIAL,1.0X30.0 ML VIAL | 01/07/2008 |
| NDA/MAL/HDP/3021 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GLIBENCLAMIDE TABLETS | GLIBENCLAMIDE | 5MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3023 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRAX | LEVAMISOLE HYDROCHLORIDE | 40MG | AGOG PHARMA LTD.PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/3024 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 150MG + 200MG + 300MG | QUESTA CARE LIMITEDPLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | MYLAN LABORATORIES LTD -H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3029 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOZOLE SUSPENSION | ALBENDAZOLE USP | 200 MG/ 5 ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3031 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMETHASONE | DEXAMETHASONE | 0.5MG | AGOG PHARMA LTD.NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/3032 | ACINO PHARMA AG - | LABOREX UGANDA LIMITED | XYLO-ACINO 0.05% | XYLOMETAZOLINE | 0.05%W/V | MERCKLE GMBH,LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X10.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3035 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFORTE TONIC | FERRIC AMMONIUM CITRATE + FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE + VITAMIN B12 | 50MG + 0.55MG + 2.4MG + 1.2MG + 11MG + 2.5MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3037 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIT SYRUP | VITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + NIACINAMIDE + VITAMIN B12 + VITAMIN C | 1000I.U + 200I.U + 1.5MG + 1.5MG+ 10MG + 2.5MCG + 40MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3040 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODOX | DOXYCYCLINE | 100MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3046 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 400 MG + 57 MG | GLAXO WELLCOME PRODUCTIONZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3048 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO-DS TABLETS | SULFAMETHOXAZOLE/TRIMETHOPRIM | 800MG/160MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/3051 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETROZOLE | DILOXANIDE FUROATE+METRONIDAZOLE BENZOATE+SIMETHICONE | 125MG+160MG+25MG | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/3057 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | COLD-A-GO CAPSULES | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE | 400MG + 5MG + 12.5MG + 30MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3063 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODIC-50 | DICLOFENAC SODIUM | 50MG | AGOG PHARMA LTD.NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3064 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TIN-TIN TABLETS | TINIDAZOLE | 500MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER,1.0X24.0X4.0 TABLET BLISTER,25.0X4.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3067 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMAGO SYRUP | PROMETHAZINE | 5MG/5ML | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3068 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | OPTACHLOR EYE DROPS | CHLORAMPHENICOL | 0.5%W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD, 117 ALLAM | PAKISTAN | | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/1999 |
| NDA/MAL/HDP/3069 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOVE CAPSULES | PIROXICAM | 20MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/3072 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL TABLETS(THANE) | PARACETAMOL | 500 MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/3076 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS 40 | TELMISARTAN | 40MG | ARISTO PHAMACUTLAB PVT LTDPLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3077 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | UNISTEN HC CREAM | CLOTRIMAZOLE + HYDROCORTISONE | 1%W/W + 1%W/W | REGAL PHERMACUTICALS PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3078 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SINUTAB ALLERGY CONGESTION | PARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HYDROCHLORIDE | 500MG + 2MG + 30MG | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3083 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS 80 | TELMISARTAN | 80MG | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP | 01/07/2007 |
| NDA/MAL/HDP/3085 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCOLD TABLETS | PARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE | 500.MG+5.0MG+30.0MG+2.0MG | AGOG PHARMA LIMITEDPLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3090 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFODOX | CEFPODOXIME PROXETIL | 100MG/5ML | PHARMA INTERNATIONAL CO.AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/3091 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | ONDI | ONDANSETRON | 2MG/ML | SAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/3092 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | EXFORGE HCT 10MG/160MG/12.5MG | AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 10MG + 160MG +12.5MG | NOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS FARMACEUTICA SARONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/3095 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | AMPHEN SUSPENSION | CHLORAMPHENICOL PALMITATE | 125MG/5ML | LEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3098 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MOSEDIN | LORATADINE | 5MG/5ML | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/3099 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | ZONA 0.1% CREAM | HYDROCORTISONE 17-BUTYRATE | 0.1%W/W | PHARMA INTERNATIONAL CO.,AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/3101 | DAWA LIMITED | SUPER MEDIC LTD | DACOLD SYRUP | PARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE | 120MG/5ML+10MG/5ML+2MG/5ML | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/3104 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | NYSTALEB ORAL SUSPENSION | NYSTATIN | 100000IU/ML | LEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3108 | IPCA LABORATOIES LTD | MEDVIN PHARMA LIMITED | ZERODOL | ACECLOFENAC | 100MG | IPCA LABORATORIES LTD,PLOT NO. T-139 SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3111 | GLAXOSMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CALPOL | PARACETAMOL | 120MG/5ML | GLAXOSMITHKLINE LIMITED - 78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3116 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | KLOXY | CLOXACILLIN | 125MG/5ML | LABORATORY & ALLIED LTD.--PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3117 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | 100MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD #14, II PHASE PIA, BANGALORE 560058 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL | 01/07/2010 |
| NDA/MAL/HDP/3118 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LUMARTEM | ARTEMETHER /LUMEFANTRINE | 20MG /120MG | QUALITY CHEMICAL INDUSTRIES LIMITED. PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3122 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT CHEWABLE TABLETS | MULTI-INGREDIENT | MULTI-INGREDIENT | REMIDEX PHARMA PVT LTD B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058. | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2002 |
| NDA/MAL/HDP/3123 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | RECTOL 250 SUPPOSITORY | PARACETAMOL BP | 250 MG | BLISS GVS PHARMA LIMITEDPLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3125 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMLODAR 5 | AMLODIPINE BESILATE | 5MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3134 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | TOFF PLUS | PARACETAMOL+CHLORPHENIRAMINE MALEATE+ DEXTROMETHORPHAN + PHENYLEPHRINE | 500 MG + 2 MG + 15 MG + 10 MG | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3136 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3139 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | OMEDAR | OMEPRAZOLE | 20MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3141 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMLOPRESS-5 | AMLODIPINE BESYLATE | 5MG | CIPLA LTDCIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3144 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ULSEC | OMEPRAZOLE | 20MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTDPLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP | 01/07/2007 |
| NDA/MAL/HDP/3145 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AMOXICAP | AMOXYCILLIN | 500MG | HOVID BHD 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3146 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZOKAST | MONTELUKAST SODIUM | 10MG | UNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | UNICHEM LABORATORIES LTD ,.,PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/3147 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS-H 40/12.5 | TELMISARTAN/HYDROCHLOROTHIAZIDE | 40MG/12.5MG | ARISTO PHARMACEUTICALS PVT LIMITEDPLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3156 | PFIZER LABORATORIES (PTY) | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN DAYTIME FLU | PSEUDOEPHEDRINE HCL + IBUPROFEN | 30MG + 200MG | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP | 01/07/2008 |
| NDA/MAL/HDP/3159 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARTEM FORTE | ARTEMETHER + LUMEFANTRINE | 80MG + 480MG | SKANT HEALTH CARE LTD 1802-1805 GIDC PHASE III VAPI GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/3163 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 50MG | DICLOFENAC SODIUM | 50MG | DELPHARM HUNINGUE S.A.S-SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY STRIP | 01/07/2006 |
| NDA/MAL/HDP/3166 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | SEPTRIN | TRIMETHOPRIM + SULPHAMETHOXAZOLE | 40MG/5ML + 200MG/5ML | GLAXO WELLCOME EGYPT CO. S.A.ECAIRO | EGYPT | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3169 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | RANOPHAGE OD | METFORMIN HCL | 1000MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3177 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES PVT LTDB-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3178 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENDURIC TABLETS | BENDROFLUMETHIAZIDE | 5MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/3179 | GOOD DAY PHARMACY LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | SULFUR OINTMENT | SULPHUR | 10%W/W | KREMOINT PHARMA PVT LTD--B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X25.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/3181 | THEMIS MEDICARE LTD | STAR PHARMACEUTICALS LTD | EMAL | ALPHA & BETA ARTEETHER | 150MG/2ML | THEMIS MEDICARE LIMITEDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY AMPOULES | 3.0X2.0 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/3191 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERECTO -100 | SILDENAFIL CITRATE | 100 MG | CIPLA LIMITED PUNEMIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3192 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ANZAVIR-R | ATAZANAVIR + RITONAVIR | 300 MG + 100 MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/3193 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERECTO- 50 | SILDENAFIL CITRATE | 50MG | CIPLA LIMITED PUNEMIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3196 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | MOTINORM | DOMPERIDONE | 10MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/3197 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TRIAM-DENK 40 INJECTION | TRIAMCINOLONE ACETONIDE | 40 MG/ML | FISIOPHARMA S.R.L.-NUCLEOO INDUSTRIALE, 84020, PALOMONTE (SA) - ITALY | | ITALY | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2004 |
| NDA/MAL/HDP/3199 | MERCK SHARP & DOHME BV. | SURGIPHARM (U) LIMITED | ISENTRESS | RALTEGRAVIR | 400MG | ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANG | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/3200 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LETRAX | LEVAMISOLE HYDROCHLORIDE | 40MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3202 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PRESARTAN-50 | LOSARTAN | 50MG | IPCA LABORATORIES LTDPLOT 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,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3204 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | RELCER GEL | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE + LIQUORICE | 365MG/5ML + 80MG/5ML + 100MG/5ML + 400MG/5ML | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/3207 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | DILCONTIN XL 90 | CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE | 90MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2010 |
| NDA/MAL/HDP/3212 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CLOPRESS 75MG | CLOPIDOGREL BISULPHATE | 75MG | CIPLA LTD-PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | CIPLA LIMITED ,.,.VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3214 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | INDICONTIN | INDAPAMIDE | 1.5MG | MODI MUNDIPHARMA PVT. LTDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3215 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEROCORT 125 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG + 125MCG | CIPLA LTDCIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2009 |
| NDA/MAL/HDP/3219 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPHENOL ORAL SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/3220 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PYLO KIT | LANSOPRAZOLE+TINIDAZOLE+CLARITHROMYCIN | 30MG+500MG+250 MG | CIPLA LIMITED PUNEMIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) | 01/07/2005 |
| NDA/MAL/HDP/3221 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | OPTADEX-N EYE DROPS | DEXAMETHASONE/NEOMYCIN | 1MG/3MG | REMINGTON PHARMACEUTICAL INDUS. PVT LTD, 117 ALLAM | PAKISTAN | | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 01/07/1999 |
| NDA/MAL/HDP/3224 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM FLUFED ELIXIR | MULTI-INGREDIENT | MULTI-INGREDIENT | TIL HEALTHCARE PVT LIMITEDPLOT 100, WEST R-5, SOUTH, SRICITY SEZ, CHERIVE9 (VI), DISTRICT: CHITOOR 517588 ANDHRA PRADESH- | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3225 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DIFLAME | DICLOFENAC DIETHYLAMINE + LINSEED OIL + METHYL SALICYLATE MENTHOL | N/A | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/2010 |
| NDA/MAL/HDP/3231 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCOMOL | PARACETAMOL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/CHLORPHENIRAMINE MALEATE | 500MG/10MG/15MG/2MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X1.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3236 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM COTRI | CO-TRIMOXAZOLE | 480MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3237 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KONAZOL CREAM | KETOCONAZOLE | 2% W/W | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3241 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CLOTRILIN | CLOTRIMAZOLE | 1%W/W | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X15.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3243 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RAPITUS | LEVODROPROPIZINE | 30MG/5ML | MACLEODS PHARMACEUTICALS LTD BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/3245 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NYSTATIN ORAL DROPS | NYSTATIN | 100,000 I.U/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL TOPICAL DROPS | 1.0X30.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/3246 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | COMPOUND MAGNESIUM TRISILICATE | MAGNESIUM TRISILICATE | 370MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/3252 | GALENTIC PHARMA LTD | VITACARE LIMITED | PYLOOCAIN | BETAMETHASONE + PHENYLEPHRINE + LIDOCAINE | O.5 MG/G + 1 MG/G + 25 MG/G | GALENTIC PHARMA( INDIA ) PVT LTDR-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/3255 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | SATISFIL-50 | SILDENAFIL CITRATE | 50MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3259 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TIGBODERM | BETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE | 0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/W | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3261 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ | TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ | 300MG+200MG+600MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | MYLAN LABORATORIES LTD - PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | MYLAN LABORATORIES LIMITED PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3262 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEGEL | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE | 250MG + 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3263 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | TRIMEX MUCOLYTIC SYRUP | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 2MG/5ML + 4MG/5ML + 100MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3265 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMOXICILLIN | AMOXICILLIN TRIHYDRATE | 250MG | CSPC ZHONGNUO PHARMACEUTICALS (SHIJIAZHUANG) CO. LTD-SHIJIAZHUANG CITY | | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3266 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | SALIMIA LINIMENT | METHYL SALICYLATE+TURPENTINE OIL | 5ML+25ML | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3270 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4000000 IU | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON | 01/07/2001 |
| NDA/MAL/HDP/3273 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | BETASOL CREAM | BETAMETHASONE VALERATE | 0.1%W/W | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3275 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | MEFLIN-500 | MEFENAMIC ACID | 500MG | LINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3276 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | ROSUVAS 10 | ROSUVASTATIN | 10MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/3277 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | TRANSAMIN CAPSULES 500MG | TRANEXAMIC ACID | 500MG | HILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2001 |
| NDA/MAL/HDP/3279 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | HAEMOFORTE SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | BAROQUE PHARMACEUTICALS PVT LTD -S.NO.192/2 & S.NO.192/2 &3 SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3282 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | KOFF-GO | PHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN | 5MG/5ML + 2MG/5ML + 10MG/5ML | TORQUE PHARMACEUTICALS (P) LTDP.O.DAPPAR VILLISS | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3284 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | CHALEATE | CHLORPHENIRAMINE MALEATE | 4MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3285 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AMOXIL FORTE 250MG/5ML | AMOXYCILLIN | 250MG/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 |
| NDA/MAL/HDP/3288 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED CHESTY COUGHS SYRUP | DIPHENHYDRAMINE HCL BP+AMMONIUM CHLORIDE BP+SODIUM CITRATE BP+MENTHOL BP | 14MG+135MG+57MG+1.1MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3289 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID DUSTING POWDER | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL DUSTING POWDERS | 1.0X30.0 G BOTTLE,1.0X100.0 G BOTTLE | 01/07/1999 |
| NDA/MAL/HDP/3291 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | FINTOP | BUTENAFINE HCL | 1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/3292 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL | 7MG+28.5MG+0.55MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3294 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | URGENDOL CAPSULES | TRAMADOL HYDROCHLORIDE | 50 MG | WIN- MEDICARE LTDMODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3295 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEVATE | CLOBETASOL | 0.05%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3297 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | NEPIN-SR-20 | NIFEDIPINE | 20MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3300 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MUCOSOL PEDIATRIC SYRUP | CARBOCISTEINE | 125 MG/5 ML | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/3302 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMOXICILLIN ORAL SUSPENSION | AMOXICILLIN | 125MG/5ML | OKASA PVT LTD346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115 | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3312 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TIDOMET FORTE | CO-CARELDOPA | 25MG/250MG | TORRENT PHARMACEUTICALS LTD VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI €“ 173205, DIST: SOLAN, HIMACHAL PRADESH, | TORRENT PHARMACEUTICAL LTDAHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3314 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | SILVEREX | SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE | 10MG/G+10MG/G | SUN PHARMACEUTICALS IND. LTDB-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/3315 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ERO-250 TABLETS | ERYTHROMYCIN STEARATE | 250MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2003 |
| NDA/MAL/HDP/3316 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/3318 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM TABLETS | CO-TRIMOXAZOLE | 480MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| NDA/MAL/HDP/3319 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | FERROTONE CAPSULES | FERROUS FUMERATE+FOLIC ACID+VITAMIN B12 | 162MG +0.75MG +7.5MCG | MEGA LIFESCIENCES LTD.384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN | THAILAND | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3321 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DERMOLIN-GM | CLOBETASOL+GENTAMICIN+MICONAZOLE | 0.05%W/W+0.1%W/W+2%W/W | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3328 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN | 1 MU | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL | 01/07/2001 |
| NDA/MAL/HDP/3333 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | NOVACLAV-625 | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | MEDISPRAY LABORATORIES PVT LTD,UNIT II368-348 KUNDAIM INDUSTRIAL ESTATE,KUNDAIM GOA - 403115,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3334 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 375 | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/3341 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AZILIN-250 | AZITHROMYCIN | 250MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3343 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDIVEN-CREAM | BETAMETHASONE VALERATE | 0.1%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3347 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIPEN TABLETS | PHENOXYMETHYLPENICILLIN | 250MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3348 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | PIMCEF | CEFEPIME USP | 1G | VENUS REMEDIES LTD.UNIT 11 HOLL TOP INDUSTRIAL ESTATE JHARMAJRI | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 01/07/2007 |
| NDA/MAL/HDP/3354 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDIVEN OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3357 | CENTAUR PHAMACUITICALS | GITTOES PHARMACEUTICALS LIMITED | ESOREST 20 | ESOMEPRAZOLE | 20MG | CENTAUR PHARMACEUTICALS PVT L.T.D.CENTAUR HOUSE NEAR | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3359 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | ARTI | ARTEMETHER | 80MG/ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/3364 | CENTAUR PHAMACUITICALS | GITTOES PHARMACEUTICALS LIMITED | ESOREST 40 | ESOMEPRAZOLE | 40MG | CENTAUR PHARMACEUTICALS PVT L.T.D.CENTAUR HOUSE NEAR | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3367 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL SUSPENSION | PARACETAMOL | 125 MG/5ML | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/3369 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AZILIN-500 | AZITHROMYCIN | 500MG | LINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X3.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3370 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | DERMOREN 500 | GRISEOFULVIN | 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3372 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | MUCOLEX | AMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN + MENTHOL | 30 MG/5ML + 1 MG/5ML + 50 MG/5ML + 0.5 MG/5ML | S KANT HEALTHCARE LTD1802-1805 GIDC PHASE III VAPI 396 195 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/3373 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 625 | AMOXILLICIN/CLAVULANATE | 500MG/125MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/3374 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | ZITHROX 250MG | AZITHROMYCIN | 250MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3377 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMILINE | AMITRIPTYLINE | 25 MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3378 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CHLOZINE TABLETS | CHLORPROMAZINE | 100MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/3382 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFEN SUSPENSION | IBUPROFEN | 100MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/3383 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ZEPIN-200 | CARBAMAZEPINE | 200 MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3384 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PROXIMEXA 250MG | CEFUROXIME AXETIL | 250MG | GLAXOSMITHKLINE UK LTDHARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3385 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | MEFTAL-P-SUSPENSION | MEFENAMIC ACID | 100MG/5ML | BLUE CROSS LABORATORIES LTDL-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3387 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PROXIMEXA 500MG | CEFUROXIME AXETIL | 500MG | GLAXOSMITHKLINE UK LTDHARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3391 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEZIN TABLET | CETIRIZINE | 10MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/3393 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN 375MG | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 2.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3399 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LDNIL 10 | ROSUVASTATIN | 10MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/3405 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL BABY AND INFANT 120MG/5ML | PARACETAMOL | 120MG/5ML | GLAXOSMITHKLINE LIMITEDLIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3406 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | MICRONEMA | SODIUM CITRATE + SODIUM LAURYL SULPHATE + GLYCERIN | 450MG/10ML+75MG/10ML+ 90%V/V | ATCO LABORATORIES PVT LTDB-18,S.I.T.E KARACHI, PAKISTAN | PAKISTAN | | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X10.0 ML BOTTLE,1.0X20.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/3409 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | CLARITYNE | LORATADINE | 10MG | BAYER BITTERFELD GMBHORTSTEIL GREPPIN SALEGASTER CHAUSSEE 1, 06803 BITTERFELD, WOLFEN - GERMANY | NULL | | ORAL SOLID ORDINARY TABLETS | 3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/3411 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABNAL NASAL DROPS | SODIUM CHLORIDE | 0.9%W/V | ABACUS PARENTERAL DRUGS LTD.PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | NASAL SYSTEMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/3414 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 10MG/160MG | AMLODIPINE + VALSARTAN | 10 MG + 160 MG | NOVARTIS PHARMA STEIN AGH-4332 STEIN SCHAFFAUSERTRASSE | NOVARTIS FARMACEUTICA SARONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3415 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID V-1 | CLOTRIMAZOLE | 500MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | VAGINAL TABLETS | 1.0X1.0 PESSARY STRIP | 01/07/2004 |
| NDA/MAL/HDP/3423 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | AMOXICLAV-DENK 1000/125 | AMOXICILLIN TRIHYDTATE + POTASSIUM CLAVULANATE | 1000 MG + 125 MG | PENCEF PHARMA GMBHBRITENBACHSTR ASSE 13 D-13509 BERLIN | GERMANY | | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X12.0X3.0 G SACHET,1.0X8.0X3.0 G SACHET | 01/07/2011 |
| NDA/MAL/HDP/3426 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RUBEM CREAM | METHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE | 1%W/W+0.1%W/W+5%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3429 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | EZEDE | LORATADINE | 10MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/3437 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | REMYCIN 100 CAPSULES | DOXYCYCLINE HYDROCHLORIDE | 100MG | REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3439 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENECHLOR CAPSULE | CHLORAMPHENICOL | 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| NDA/MAL/HDP/3440 | ELI-LILLY EXPORT SA | LABOREX UGANDA LIMITED | HUMALOG | INSULIN LISPRO | 100IU | LILLY FRANCE SAFRANCE | FRANCE | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/2000 |
| NDA/MAL/HDP/3444 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORVADIL 10 | AMLODIPINE BESILATE | 10MG | UNICHEM LABORATORIES LIMITEDUNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2010 |
| NDA/MAL/HDP/3449 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | IMMUNOX | CEFTRIAXONE SODIUM | 1000MG | VENUS REMEDIES LIMITED ,.HILL TOP,INDUSTRIAL ESTATE,JHARMAJRI, EPIP,PHASE 1,(EXTN.) ,BHATOLI KALAN,BADDI -H.P.INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL,1.0X10.0X1.0X10.0 ML VIAL | 01/07/2008 |
| NDA/MAL/HDP/3451 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPHENOL CAPSULES (THANE0 | CHLORAMPHENICOL | 250MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/3458 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL 250MG | AMOXYCILLIN TRIHYDRATE | 250MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3460 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | MALANIL ADULT TABLETS | ATOVAQUONE + PROGUANIL HCL | 250MG + 100MG | GLAXO WELLCOME S.A ARANDAARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3464 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TARTAR CONTROL LISTERINE ANTISEPTIC | ZINC CHLORIDE + DENATURED ALCOHOL MENTHOL 95% + THYMOL | 18MG/ 20ML + 0.9ML/20ML + 12.7MG/20ML | JOHNSON&JOHNSON PTY LTD..241 MAIN ROAD RETREAT 794 | SOUTH AFRICA | | ORAL LIQUID ORDINARY OTHER LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3465 | MONDI-MUNDI PHARMA PVT LIMITED | SURGIPHARM (U) LIMITED | FECONTIN-Z | FERROUS GLYCINE SULPHATE+ZINC SULPHATE+FOLIC ACID | 100MG+61.8MG+0.5MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3466 | DAWA LIMITED | SUPER MEDIC LTD | DAWASEC | SECNIDAZOLE | 1G | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/3467 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | RONEM | MEROPENEM TRIHYDRATE | 1000MG | VENUS REMEDIES LTD -UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL | 01/07/2008 |
| NDA/MAL/HDP/3474 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMCLOREN DRY SYRUP | AMPICILLIN + CLOXACILLIN | 125MG+125MG/5ML | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3475 | VENUS REMIDIES LTD | HARLEYS UGANDA LIMITED | RONEM | MEROPENEM | 500MG | VENUS REMEDIES LTD, UNIT II,HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL | 01/07/2010 |
| NDA/MAL/HDP/3476 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | PARAFIL | PARACETAMOL | 500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3478 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | DICLOREN | DICLOFENAC SODIUM BP | 50MG | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3483 | JOHNSON&JOHNSON PTY LTD. 241 | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SINUTAB 3-WAY | IBUPROFEN + PSEUDOEPHEDRINE HCL | 200MG + 30MG | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3485 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | ERGOMETRINE | ERGOMETRINE MALEATE | 0.5MG/ML | CIRON DRUGS AND PHARMACEUTICALS PRIVATE LTDN-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE | 01/07/2007 |
| NDA/MAL/HDP/3490 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | LAXOLAC SYRUP | LACTULOSE | 67G/100ML | MEDICAL UNION PHARMACEUTICALS LTDABU SULTAN, ISMAILLIA, EGYPT | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/3492 | ACINO PHARMA AG - | LABOREX UGANDA LIMITED | OLFEN-50 GASTRO-RESISTANT TABLETS | DICLOFENAC SODIUM | 50MG | ACINO PHARMA AGBIRSWEG 2, 4253, LIESBERG - SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3494 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GAMALATE B6 SOLUTION | MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B6 | 2G + 2G + 1G +1G | FERRER INTERNATIONAL, S.A.C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X80.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/3497 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOLIN FORTE | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES LIMITED: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3500 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN 300 | IRBESARTAN | 300MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/3504 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BIFRIL | ZOFENOPRIL | 30MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.IVIA CAMPO DI PILE 67100 L'AQUILA | ITALY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X7.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/3506 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ULTANE | SEVOFLURANE | 100%W/W | AESICA QUEESNBOROUGH LTD NORTH RD. QUEENSBOROUGH KENT | ABBVIE SRLS.R. 148 PONTINA KM 52 - 04011 CAMPOVERDE DI APRILIA (LT) - ITALY | ITALY | UNITED KINGDOM | | NASAL SYSTEMIC UNIT DOSE LIQUIDS | 1.0X250.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/3507 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 250 | AMOXICILLIN | 250MG | 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,1.0X1000.0 CAPSULE CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/3512 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | LAMISIL 250MG | TERBINAFINE | 250MG | NORVATIS PHARMA PRODUKTIONS GMBH 79644 WEHR/BADEN-GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET CARTON | 01/07/1997 |
| NDA/MAL/HDP/3515 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 40/240 | ARTEMETHER + LUMEFANTRINE | 40 MG + 40 MG | AJANTA PHARMA LTD .B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO) | 01/07/2007 |
| NDA/MAL/HDP/3516 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENZHEXOL TABLETS BP 5MG | TRIHEXYPHENIDYL HYDROCHLORIDE | 5MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/3517 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TOTO ZINC | ZINC SULPHATE | 20MG | MEDICAMEN BIOTECH LTDSP-1192, A &B, PHASE €“IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/3520 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ POWDER | POVIDONE IODINE + METRONIDAZOLE | 1%W/W + 5%W/W | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | TOPICAL EXTERNAL POWDERS | 1.0X100.0 G BOTTLE,1.0X10.0 G BOTTLE,1.0X40.0 G CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/3522 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CLOXACILLIN SODIUM FOR INJECTION | CLOXACILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X10.0X500.0 MG VIAL | 01/07/2011 |
| NDA/MAL/HDP/3525 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLLIN | AMPICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/1998 |
| NDA/MAL/HDP/3527 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVOTOP-500 | LEVOFLOXACIN | 500MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3535 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | ADIFLAM-50 | DICLOFENAC SODIUM GASTRO-RESISTANT TABLETS BP | 50MG | LEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3542 | BETA HEALTH CARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | MARA MOJA | ASPIRIN + PARACETAMOL + CAFFEINE | 400MG + 200MG + 50MG | 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 | 1.0X50.0X2.0 TABLET STRIP,1.0X110.0X2.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/3545 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID MOUTH PAINT | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL TOPICAL LIQUIDS | 1.0X15.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/3546 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM D.S | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/3547 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORBIS-10 | BISOPROLOL | 10 MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2008 |
| NDA/MAL/HDP/3548 | RAJESHI PLASTICS | ABACUS PHARMA (AFRICA) LIMITED | BECORT 200 | BECLOMETASONE | 200MCG/DOSE | CIPLA LTD.- PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2009 |
| NDA/MAL/HDP/3549 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | TRIMEX PAEDIATRIC COUGH EXPECTORANT | CHLORPHENIRAMINE MALEATE+PSEUDO EPHEDRINE HCL+GUAIPHENISIN+MENTHOL | 1.0MG+15.0MG+50.0MG+0.5MG / 5ML | REGAL PHARMACEUTICALS LIMITED PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3551 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA-500MG | AZITHROMYCIN | 500MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X10.0X1.0X3.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3553 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | FALCIMON 25/67.5 B/L | ARTESUNATE+AMODIAQUINE | 25MG+67.5MG | CIPLA LTD UNIT IIA-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/3556 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | GRISACTIN-500 TABLETS | GRISEOFULVIN TABLETS | 500MG | REGAL PHARMACEUTICALS LIMITED PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3558 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEROCORT 250 | SALMETEROL+ FLUTICASONE PROPIONATE | 25MCG + 250MCG | CIPLA LTD.- PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2009 |
| NDA/MAL/HDP/3561 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCILLIN ORAL SUSPENSION | AMPICILLIN TRIHYDRATE | 125MG/5ML | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/3566 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARTESUN | ARTESUNATE | 60 MG | GUILIN PHARMACEUTICAL CO LTD-NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5% NAHCO3 + 5 ML NACL INJECTION | 01/07/2008 |
| NDA/MAL/HDP/3571 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | CADIPHEN EXPECTORANT | CHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE | 2MG//80MG/100MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3573 | VENUS REMEDIES LTD | REDDYS PHARMA LIMITED | PARIN-E | ENOXAPARIN SODIUM | 40MG/0.4ML | VENUS REMEDIES LTD -UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 01/07/2008 |
| NDA/MAL/HDP/3574 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOZ 2.5 TABLET | METOLAZONE TABLETS USP | 2.5MG | CENTAUR PHARMA PVT.LIMITED-PLANT IPLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3575 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 400 CAPSULES | CEFIXIME | 400MG | PHARMA INTERNATIONAL CO.,AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3578 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CINNARON 25 | CINNARIZINE | 25MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3580 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FEXOFEN-120 | FEXOFENADINE HYDROCHLORIDE | 120MG | ARISTO PHARMACEUTICALS PVT LTDPLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3581 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOZ 5 | METOLAZONE | 5MG | CENTAUR PHARMA PVT.LTD-PLANT IPLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3588 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FEXOFEN-180 | FEXOFENADINE | 180MG | ARISTO PHARMACEUTICALS PVT LTDPLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3590 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ALFOXAN 500 FC TABLETS | MEFENAMIC ACID | 500MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3591 | DAFRA PHARMA LTD | MULTIPHAR UGANDA LIMITED | ARTESIANE 80MG/ML | ARTEMETHER | 80MG/ML | ANFARM HELLAS S.A.61ST KM. NATIONAL ROAD, ATHENS-LAMIA, 320 09 SCHIMATARI VIOTIAS - GREECE | GREECE | | PARENTERAL ORDINARY I M AMPOULES | 1.0X5.0X1.0 ML AMPOULE | 01/07/1998 |
| NDA/MAL/HDP/3592 | FOURRTS (INDIA) LABORATORIES PUT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM DS | CO-TRIMOXAZOLE BP | 960 MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2008 |
| NDA/MAL/HDP/3594 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | STERILE QUININE DIHYDROCHLORIDE | QUININE DIHYDROCHLORIDE | 300MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LIMITEDN-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE | 01/07/2007 |
| NDA/MAL/HDP/3598 | WIN-MEDICURE LTD | SURGIPHARM (U) LIMITED | MYOSPAZ | PARACETAMOL + CHLORZOXAZONE | 500MG + 250MG | WIN- MEDICARE LTDMODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3600 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN TABLETS | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG + 320MG | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X9.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X15.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3601 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | HYDROKANT | HYDROCORTISONE ACETATE | 1%W/W | SKANT HEALTH CARE LTD 1802-1805 GIDC PHASE III VAPI GUJARAT | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| NDA/MAL/HDP/3607 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | LINOPRIL | LISINOPRIL DIHYDRATE | 20MG | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X14.0X2.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3609 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | ANTINAL | NIFUROXAZIDE | 200MG | AMOUN PHARMACEUTICALS COMPANY1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3610 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PROMETHAZINE TABLETS BP 25MG | PROMETHAZINE HYDROCHLORIDE | 25MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/3611 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | COLDRIL SYRUP | PARACETAMOL + CHLORPHENIRAMINE + PSEUDOEPHEDRINE | 120MG+1MG+10MG | BETA HEALTHCARE INTERNATIONAL LIMITED-PLOT NUMBER LR 209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA ROAD INDUSTRIAL AREA, P.O.BOX 42569-00100 NAIROBI,KENYA | | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/3612 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LOSARTAS-H 12.5 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3613 | HETERO LABS LTD | AIVEEN (U) LIMITED | ZIDOVUDINE ORAL SOLUTION | ZIDOVUDINE | 50MG/5ML | HETERO LABS LTD UNIT III22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X240.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/3614 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ERYTHROREN SUSPENSION | ERYTHROMYCIN STEARATE | 125MG/5ML | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3618 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | CLOXACILLIN SODIUM | CLOXACILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON, 1.0X10.0 VIAL CARTON | 01/07/2011 |
| NDA/MAL/HDP/3619 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | CAPTOPRIL DENK -25 | CAPTOPRIL | 25MG | DENK PHARMA, GOLLSTR.,1-D-845 529 TITTMONING GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/3620 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | HALOXEN 10 TABLETS | HALOPERIDOL BP | 10MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2004 |
| NDA/MAL/HDP/3622 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PROXIMEXA | CEFUROXIME AXETIL | 125MG/5ML | GLAXOSMITHKLINE UK LTDHARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3626 | ZYDUS LIFESCIENCES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ORIPHEX CAPSULES | CEPHALEXIN | 250MG | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | SAKAR HEALTHCARE LIMITEDBLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT – INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3628 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEMIN 5S | AMINO ACIDS/SORBITOL | 5%W/V+5%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/3630 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | UNICONTIN 600 | THEOPHYLLINE | 600MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3631 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ENA-DENK 10 | ENALAPRIL MALEATE | 10MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3634 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPLUS | PARACETAMOL+DEXTROMETHORPHAN HCL+ CHLORPHENIRAMINE+PHENYLEPHRINE HCL | 500MG+15MG+2MG+10MG | AGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3635 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIROGAN | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/3637 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | TINODERM | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X18.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3639 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL ADVANCE | PARACETAMOL | 500MG | GLAXOSMITHKLINE DUNGARAVAN LTDKNOCKBRACK DUNGARVAN CO. WATERFORD | IRELAND | | ORAL SOLID ORDINARY TABLETS | 1.0X11.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3641 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | TRD-CONTIN 100 | TRAMADOL HYDROCHLORIDE | 100MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3642 | IND-SWIFT | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE 250 | CLARITHROMYCIN | 250MG | IND-SWIFT-LTD,GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X2.0X7.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3647 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | NYSTAGO ORAL SUSPENSION | NYSTATIN | 100000 IU | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3648 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | UNICONTIN 400 | THEOPHYLLINE | 400MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3649 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | LAMISIL | TERBINAFINE | 125MG | NOVARTIS BARBERA SPAIN | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3651 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ORIPHEX SYRUP | CEPHALEXIN | 125MG/5ML | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | SAKAR HEALTHCARE LIMITEDBLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT – INDIA. | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3653 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO) | 01/07/2008 |
| NDA/MAL/HDP/3655 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | QUADRAJEL GEL | CHLORHEXIDINE+METRONIDAZOLE+LIDOCAINE | 5%W/W+1.61%W/W+2.13%W/W | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3656 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | LUMERAX | ARTEMETHER / LUMEFANTRINE | 80MG/480MG | IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3657 | DAWA LIMITED | SUPER MEDIC LTD | DAWASTIN | NYSTATIN | 100000IU/ML | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3664 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | AZZY | AZITHROMYCIN | 500MG | TORQUE PHARMACEUTICALS PVT LTDISAAPUR P.O DAPPAR 140056 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3666 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | STROM 50 | TRAMADOL HYDROCHLORIDE | 50MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3668 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN BD | AMOXICILLIN + CLAVULANIC ACID | 200 MG/ 5 ML + 28.5 MG/ 5 ML | GLAXO WELLCOME PRODUCTIONZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE,1.0X140.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/3669 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CO-TRIMOXAZOLE | SULFAMETHOXAZOLE/TRIMETHOPRIM | 200MG/40MG | MEDICAMEN BIOTECH LTD - SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/3670 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TETRAREN CAPSULES | TETRACYCLINE HYDROCHLORIDE | 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| NDA/MAL/HDP/3671 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | CLAVULIN TABLETS | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET STRIP,10.0X10.0 TABLET STRIP,1.0X20.0 TABLET STRIP | 01/07/2003 |
| NDA/MAL/HDP/3672 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | NITROCONTIN 6.4 | NITROGLYCERIN | 6.4MG | MODI MUNDIPHARMA (PVT) LTDMEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | | ORAL SOLID ORDINARY SUBLINGUAL TABLETS | 1.0X25.0 TABLET CONTAINER | 01/07/2008 |
| NDA/MAL/HDP/3673 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | PROMETHAZINE INJECTABLE SOLUTION | PROMETHAZINE HCL | 25MG/ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| NDA/MAL/HDP/3674 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | INTAMINE SYRUP | PROMETHAZINE HYDROCHLORIDE | 5MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 01/07/1997 |
| NDA/MAL/HDP/3677 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | IBUREN | IBUPROFEN | 200MG | RENE INDUSTRIES LTD680,KAMULI,KIREKA KAMPALA,UGANDA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3678 | FOURRTS LABORATORIES LTD | DELMAW ENTERPRISES LIMITED | REDINPLUS | IRON PENTACARBONYL + ZINC SULPHATE MONOHYDRATE + FOLIC ACID + SODIUM SELENITE + LYSINE HYDROCHLORIDE + HISTIDINE HYDROCHLORIDE + CHOLINE BITARTRATE | 100MG + 30MG + 7.5MG + 0.11MG + 26MG + 4.4MG + 52MG | FOURRTS (INDIA) LABS PVT LTD .VANDALUR ROAD. KELAMBAKK AM-603103 TAMIL, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X30.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3681 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEDOL | PARACETAMOL | 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| NDA/MAL/HDP/3683 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | COLD TABS FORTINSA | PARACETAMOL + PHENYLEPHRINE +CHLORPHENIRAMINE + CAFFEINE | 500MG + 5MG + 2MG + 30MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP | 01/07/2013 |
| NDA/MAL/HDP/3685 | GALPHAR LABORATORIES LTD | DAWASANA PHARMACEUTICALS LTD | ODICEF | MONTELUKAST SODIUM|CEFTRIAXONE | 1G|5 | ALKEM LABORATORIES LIMITED.VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205|INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2013 |
| NDA/MAL/HDP/3686 | ACINO PHARMA AG - | LABOREX UGANDA LIMITED | NEURORUBINE ™-FORTE 20 FILM-COATED TABLETS | MULTIVITAMIN | MULTINGREDIENT | ACINO PHARMA AGBIRSWEG 2, 4253, LIESBERG - SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3687 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-PROM | PROMETHAZINE HCL | 5MG/5ML | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/3688 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX MINT FLAVOUR | ALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG +250MG + 250MG + 250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/3698 | CADILA HEALTHCARE PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | HIPEN SYRUP | AMOXICILLIN | 125MG/5ML | SPARSH BIO-TECH LTD PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3702 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORFIT-20 | ATORVASTATIN | 20MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3703 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SONATEC | CETYLPYRIDINIUM CHLORIDE | 0.05%W/V | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL TOPICAL LIQUIDS | 1.0X250.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/3707 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | OBETAS-120 | ORLISTAT | 120MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3709 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | NIGHT & DAY -N | PARACETAMOL/ DIPHENHYDRAMINE CHLORIDE + PARACETAMOL/ PSEUDOEPHEDRINE | 500MG/ 25MG +600MG/ 90MG | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3710 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LACILLIN | AMPICILLIN | 250MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3711 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | POLY-MXB | POLYMYXIN B | 500,000 UNITS | BHARAT SERUMS AND VACCINES LIMITED,PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0 ML VIAL | 01/07/2013 |
| NDA/MAL/HDP/3712 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMLOZAAR | LOSARTAN POTASSIUM / AMLODIPINE | 50MG + 5MG | MICRO LABS LTD92,SIPCOT INDUSTRIAL COMPLEX,HOSUR-635-126(T.N)INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3714 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | ADALAT LA | NIFEDIPINE | 30MG | BAYER PHARMA AGD-51368 LEVERKUSEN, GERMANY | GERMANY | | ORAL SOLID RETARD FILM-COATED TABLETS | 2.0X14.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/3717 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEFTRIAXONE SODIUM | CEFTRIAXONE SODIUM | 1G | CSPC ZHONGNUO PHARMACEUTICALS LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY CHINA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 01/07/2011 |
| NDA/MAL/HDP/3723 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | LACILLIN | AMPICILLIN | 125MG/5ML | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 07/07/1997 |
| NDA/MAL/HDP/3724 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | EPIGAB | PREGABALIN | 150MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X14.0 CAPSULE BLISTER | 01/07/2015 |
| NDA/MAL/HDP/3725 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | NEW TUXIRIL | DEXTROMETHORPHAN HBR + PHENYLEPHRINE HCL + MENTHOL | 10MG/ML + 5MG/10ML + 5MG/10ML | MEDLEY PHARMACEUTICALS LTDPLOT 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 | 01/07/2007 |
| NDA/MAL/HDP/3728 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DICLO-DENK 50 | DICLOFENAC SODIUM | 50MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER + 1 * 10 SAMPLE | 01/07/1998 |
| NDA/MAL/HDP/3729 | MEDLEY PHARMACEUTICALS | EUROPA HEALTHCARE (U) LTD | DECIFEN-SR | DICLOFENAC SODIUM | 100MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL SOLID RETARD ENTERIC-COATED TABLETS | 1.0X10.0X20.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP | 01/07/2008 |
| NDA/MAL/HDP/3730 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 2.0X5.0 TABLET BLISTER,1.0X5.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/3732 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ALBASOL TABLETS 200MG | ALBENDAZOLE | 200MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET STRIP | 01/07/2003 |
| NDA/MAL/HDP/3734 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | ZARICORT CREAM | MICONAZOLE + HYDROCORTISONE | 2%W/W + 1%W/W | XEPA SAUL PATTINSON MALAYSIA1-5 INDUSTRIAL ESTATE 75250 MELAKA MALYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1998 |
| NDA/MAL/HDP/3736 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | RECTOL 125 SUPPOSITORY | PARACETAMOL | 125MG | BLISS GVS PHARMA LIMITEDPLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3737 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | ECOFLOX 500 TABLETS | CIPROFLOXACIN HYDROCHLORIDE | 500MG | MEDLEY PHARMACEUTICALS LTDLANE 03, PHASE 1, SIDCO INDUSTRIAL COMPLEX, BARI BRAHMANA JAMMU 181133 | MEDLEY PHARMACEUTICALS LTD..PLOT NO. 18 & 19, SURVEY NO.378/7&8, 379/2&3,ZARI CAUSEWAY ROAD, KACHIGAM,DAMAN (U.T) 396210-INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3738 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | AMPICILLIN SODIUM | AMPICILLIN SODIUM | 500MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD #14, II PHASE PIA, BANGALORE 560058 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL,1.0X50.0X500.0 MG VIAL | 01/07/2010 |
| NDA/MAL/HDP/3741 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ACTIZINE | CETIRIZINE HYDROCHLORIDE | 10MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDPLOT M 444B STRETCHER ROAD NTINDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X15.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/3744 | ABBOTT HEALTHCARE PRODUCTS B.V. | HARLEYS UGANDA LIMITED | DUPHALAC SOLUTION | LACTULOSE | 67G/100ML | ABBOTT BIOLOGICALS B.V ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLST | NETHERLANDS | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X10.0X15.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/3745 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | WINDERM CREAM | BECLOMETHASONE+MICONAZOLE+NEOMYCIN | 0.025%W/W + 2%W/W + 0.5%W/W | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/3746 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENDRO | BENDROFLUMETHIAZIDE | 5MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/3747 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ALZOL TABLETS | ALBENDAZOLE | 200MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 30.0X2.0 TABLET BLISTER | 01/07/2002 |
| NDA/MAL/HDP/3753 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | MYFORTIC 180 | MYCOPHENOLATE SODIUM | 180MG | NORVATIS PHARMA STEIN AGSCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | NORVATIS PHARMA PRODUCTIONS GMBH, WEHROEFLINGER STR. 4479664 WEHR GERMANY | SWITZERLAND | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/3754 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | SINAREST PD NASAL DROPS | OXYMETAZOLINE HYDROCHLORIDE | 0.025%W/V | CENTAUR PHARMACEUTICALS LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/3757 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNITRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3760 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | COMPOUND MAGNESIUM TRISILICATE | MAGNESIUM TRISILICATE | 370MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDPLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3761 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | RIFACOS-300 | RIFAMPICIN | 300 MG | COSMOS LIMITEDRANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3765 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ALPRIM | CO-TRIMOXAZOLE | 480MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3766 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | BUKOL TABLETS | HYOSCINE N-BUTYLBROMIDE | 10MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3767 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | AMPOXIN 500 | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER | 01/07/1999 |
| NDA/MAL/HDP/3768 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NIMOTOP 30MG | NIMODIPINE | 30MG | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3770 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XITHRONE | AZITHROMYCIN | 500 MG | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | | EGYPT | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3771 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BRONQUIDIAZINA C.R | TRIMETHOPRIM/SULFAMETHOXAZOLE/BROMHEXINE/SODIUM BENZOATE/TOLU BALSAM | 80MG/400MG/4MG/250MG/325MG | FAES FARMA, S.A MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X150.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/3772 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMULIN N NPH | HUMAN INSULIN ISOPHANE | 100IU | LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,INDIANA 46285 USA | UNITED STATES | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/2005 |
| NDA/MAL/HDP/3773 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBUTOL-4 | SALBUTAMOL SULPHATE | 4 MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3778 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XITHRONE | AZITHROMYCIN | 200MG/5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X15.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/3781 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ALZENTAL | ALBENDAZOLE | 20MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/3782 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LAE-PEN V | PHENOXYMETHYLPENICILLIN | 250MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3784 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | CIPIUM | CHLORPHENIRAMINE | 2MG/5ML | LEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/3787 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPENIV | PHENOXYMETHYLPENICILLIN | 125MG/5ML | SPARSH BIO-TECH PVT. LTD .PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/3789 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | LEVITRA | VARDENAFIL HCL | 5MG | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3790 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFLOX-P | PEFLOXACIN | 400MG | AGOG PHARMAPLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3793 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMPICILLIN | AMPICILLIN TRIHYDRATE | 250MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/3794 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMET-200 | METRONIDAZOLE | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/3798 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROTON TABLET | MULTI-INGREDIENT | N/A | AMOUN PHARMACETICAL COMPANY-1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPT | | EGYPT | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3801 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | FUNGISTIN ORAL SUSPENSION | NYSTATIN | 100000 IU/ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2002 |
| NDA/MAL/HDP/3802 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | LEVITRA 10MG | VARDENAFIL MONOHYDROCHLORIDE TRIHYDRATE | 10 MG | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3803 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | DICLODYNE SUPPOSITORY | DICLOFENAC SODIUM | 100MG | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3804 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | NEURORUBINE IM | VITAMIN B1+VITAMIN B6+VITAMIN B12 | 100MG+100MG+1MG | MERCKLE GMBH (A MEMBER OF RATIOPHARM GROUP)LUDWIG MERCKLE STR. 3, 89143 BLAUBEUREN WEILER | HAUPT PHARMA WULFING GMBH.BETHELNER LANDSTR. 18, 31028 GRONAU/LEINE | SWITZERLAND | GERMANY | PARENTERAL ORDINARY I M AMPOULES | 1.0X5.0X3.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/3806 | INDOCO REMEDIES LTD | STAR PHARMACEUTICALS LTD | NOCID GEL | ALUMINIUM HYDROXIDE + SIMETHICONE + MAGNESIUM | 400MG/5ML + 25MG/5ML + 100MG/5ML | INDOCO REMEDIES LTDB-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/3807 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ARTEMETHER INJECTION | ARTEMETHER | 80MG/ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | CHINA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/3808 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 12.5MG | DICLOFENAC SODIUM | 12.5MG | DELPHARM HUNINGUE S.A.S-SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 01/07/2006 |
| NDA/MAL/HDP/3809 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | COLDRID DAY & NIGHT | PARACETAMOL+CHLORPHENIRAMINE MALEATE+PHENYLEPRINE HYDROCHLORIDE + CAFFEINE | 500MG+2MG+5MG+15MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET STRIP | 01/07/2006 |
| NDA/MAL/HDP/3812 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | B-TONE | PHENOBARBITONE | 30MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3813 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ACTIPAR | PIPERAZINE CITRATE | 500MG/5ML | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3814 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | PETHIDINE INJECTION | PETHIDINE | 50MG/1ML | MARTINDALE PHARMACEUTICAL LIMITED BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/3817 | ROYAL PHARMA | ROYAL PHARMA 2011 LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN SODIUM | 1000000 I.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 MU VIAL | 01/07/2002 |
| NDA/MAL/HDP/3818 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN | RECOMBINANT HUMAN ERYTHROPOIETIN | 2000 I.U/0.5ML | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE | 01/07/2012 |
| NDA/MAL/HDP/3823 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | D-WORM ORAL SUSPENSION | ALBENDAZOLE | 200MG/5ML | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3827 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORFIT-10 | ATORVASTATIN | 10MG | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3829 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETACOOL | DRIED ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE /MAGNESIUM ALUMINUM SILICATE/SIMETHICANE | 300MG / 25MG / 50MG / 25MG | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X50.0 TABLET STRIP | 01/07/2006 |
| NDA/MAL/HDP/3831 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | ALUVIA | LOPINAVIR+RITONAVIR | 200MG+50MG | ABBVIE DEUTSCHLAND GMBH & CO. KG.KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X120.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/3833 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | LABSTATIN VAGINAL TABLETS | NYSTATIN | 100.000 I.U | LABORATORY & ALLIED LTD.PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | | VAGINAL TABLETS | 1.0X3.0X5.0 PESSARY STRIP (WITH APPLICATOR) | 01/07/2000 |
| NDA/MAL/HDP/3835 | GLAXOSMITHKLINE LTD | BETA HEALTHCARE UGANDA LIMITED | HEDEX CAPLETS | PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS | 200MG+400MG+50MG | SMITHKLINE BEECHAM (NAIROBI)NAIROBI, KENYA | DINLAS PHARMA EPZ LIMITEDPLOT NO. LR 7149/121, MOMBASA ROAD, SYOKIMAU | 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 | 1.0X20.0 TABLET PACK,1.0X110.0 TABLET PACK,1.0X100.0 TABLET PACK | 01/07/1997 |
| NDA/MAL/HDP/3837 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NITROFURANTOIN | NITROFURANTOIN | 100MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/3839 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLURID | ACETAMINOPHEN + PHENIRAMINE MALEATE | 500 MG + 10.5 MG | KAMPALA PHARMACEUTICALS INDUSTIESPLOT M 444B STRETCHER NTINDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/3840 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TORACTIN TABLETS | CYPROHEPTADINE | 4MG | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 2.0X50.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2000 |
| NDA/MAL/HDP/3841 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM TABLETS | CO-TRIMOXAZOLE | 480MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3844 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN RETARD | DICLOFENAC SODIUM | 100MG | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | | SWITZERLAND | ITALY | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/3845 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CARDIPAC | AMLODIPINE | 5MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTDPLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/3846 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | LEVITRA | VARDENAFIL HCL | 20 MG | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/3850 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGIZAAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3854 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LOSARTAS 50 TABLETS | LOSARTAN POTASSIUM | 50MG | INTAS PHARMACEUTICALS LTDCAMP ROAD SELAQUI DEHRADUN | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 01/07/2003 |
| NDA/MAL/HDP/3859 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | IFIMOL | PARACETAMOL | 10MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/3860 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOLAC | LACTULOSE | 3.35MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3862 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | LAMITOR 100 | LAMOTRIGINE | 100MG | TORRENT PHAMACEUTICALS LTDTORRENT PHAMACEUTICALS LTD INDRAD 382721 DIST MEHSANA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3866 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | RL | COMPOUND SODIUM LACTATE INFUSION BP | 0.6/ 0.25 /0.04 / 0.027 % W/V | ABACUS PARENTERAL DRUGS LTD.PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/3867 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES PVT LTDB-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3871 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | DOVERIN 40 | DROTAVERINE HYDROCHLORIDE | 40MG | INTAS PHARMACEUTICALS LIMITEDPLOT NO. 457 / 458 SARKHEJ-BAVLA HIGHWAY, MATODA - 382 210, TALUKA - SANAND, DISTRICT - AHMEDABAD, STATE - | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3872 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZYNCET SYRUP | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096 | | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/3873 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CHLORPROMAZINE INJECTION B.P | CHLORPROMAZINE | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/3874 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | RIDMAL 40/320 | DIHYDROARTEMISININ + PIPERAQUINE | 40MG + 320MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X8.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3875 | PHAMA INTERNATIONAL CO | OMAB UGANDA LIMITED | OPTIMAL(0.05% GEL | TRETINOIN USP | 0.25MG/1G | PHARMA INTERNATIONAL COMPANY .MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/3881 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MOXACIL | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3883 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | MYFORTIC 360 | MYCOPHENOLATE SODIUM | 360MG | NOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS PHARMA PRODUKTIONS GMBHOEFLINGER STR.4479664 WEHR GERMANY | SWITZERLAND | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/3886 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | DELOR | CLOBETASOL PROPIONATE | 0.5 MG/G | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/3888 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PYRIREN | PYRIDOXINE HYDROCHLORIDE | 25MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/3891 | PHARMATHEN S.A | GOODMAN INTERNATIONAL LTD | LADININ | CIPROFLOXACIN | 500MG | PHARMATHEN S.A-6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE | GREECE | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3892 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TETRAX | LEVAMISOLE HYDROCHLORIDE | 40MG/5ML | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3893 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | EPINEPHRINE INJECTION USP | EPINEPHRINE HCL | 1MG/ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | CHINA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/3896 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | VALCONTIN 500 | SODIUM VALPROATE (CONTROLLED RELEASE) | 500MG | MODI MUNDIPHARMA PVT. LTDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3897 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 875MG/125MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3899 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FEDATE SYRUP | SODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID | 216.87MG + 1.5MG + 7.5MCG + 1.5MG | AJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/3906 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | LEROLE | PANTOPRAZOLE | 40MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL 1*10ML 0.9%NACL AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/3913 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | VALCONTIN | SODIUM VALPROATE | 200 MG | MODI MUNDIPHARMA PVT. LTDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/3914 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | AUGMENTIN | AMOXICILLIN + CLAVULANATE POTASSIUM | 875 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X1.0X7.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/3916 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | METOCLOPRAMIDE HYDROCHLORIDE INJECTION | METOCLOPRAMIDE HYDROCHLORIDE | 5MG/ML | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/3922 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | DIAZI | DIAZEPAM | 5MG/ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/3924 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUFED | PARACETAMOL+PSEUDOEPHEDRINE HYDROCHLORIDE+TRIPOLIDINE HYDROCHLORIDE | 300MG+36MG+1.5MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3927 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL CEPHALEXIN 125 | CEPHALEXIN MONOHYDRATE | 125MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | MALAYSIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3928 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MALAREN | SULPHADOXINE + PYRIMETHAMINE | 500MG/25MG | RENE INDUSTRIES LTD .PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/3932 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIRAX TABLETS | CLIDINIUM BROMIDE + CHLORDIAZEPOXIDE | 2.5MG + 5MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2008 |
| NDA/MAL/HDP/3933 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TOZAAR-50 | LOSARTAN POTASSIUM | 50MG | TORRENT PHARMACEUTICAL LTDAHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | | ORAL SOLID ORDINARY TABLETS | 5.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/3938 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | ADRENALINE INJECTION | ADRENALINE | 1MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/3945 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | CEFONE | CEFTRIAXONE | 1G | SWISS PARENTERALS LTD, UNIT- IIPLOT NO. 402,412-414 KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, DIST: AHMEDABAD | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 01/07/2011 |
| NDA/MAL/HDP/3947 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | RABTAS-20 | RABEPRAZOLE SODIUM | 20 MG | INTAS PHARMACEUTICALS LTD .PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3948 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | TAXIM-O | CEFIXIME | 50MG/5ML | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/3949 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MAGNOMINT SUSPENSION | COMPOUND MAGNESIUM TRISILICATE | N/A | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3951 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCLOX | AMPICILLIN + CLOXACILLIN | 125MG/5ML + 125MG/5ML | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/3954 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | POWERCEF 1GM INJECTION | CEFTRIAXONE SODIUM | 1GM | ZEISS PHARMACEUTICALS PVT. LIMITEDPLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA | WOCKHARDT LIMITEDB-15/2 MIDC, WALUJ, AURANGABAD 431136, MAHARASHTRA STATE, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10ML AMPOULE OF WFI | 01/07/2001 |
| NDA/MAL/HDP/3960 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | IBUPAR | PARACETAMOL/IBUPROFEN | 325/400MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3963 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COARTEM DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | NOVARTIS URUNLERI TURKEYYENISEHIR MAHALLESI, IHLARA VADISI SOKAK, NO. 2, TR 34912, PENDIK, INSTANBUL, TURKEY. | TURKEY | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/3965 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | OROFER SYRUP | IRON(II) HYDROXIDE POLYMALTOSE COMPLEX | 50MG/5ML | EMCURE PHARMACEUTICALS LTD LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/3966 | DAWA LIMITED | SUPER MEDIC LTD | ASCORBIC ACID TABLETS | ASCORBIC ACID | 100 MG | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3967 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLOX-125 | CLOXACILLIN | 125MG/5ML | MILAN LABORATORIES (INDIA) PVT LTDPLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/3969 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FAWAR FRUIT EFFERVESCENT GRANULES | SODIUM CARBONATE + TARTARIC ACID + CITRIC ACID | 2.8G + 1.33G + 0.82G | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X6.5 G SACHET | 01/07/2002 |
| NDA/MAL/HDP/3970 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LECOTRIM | CO-TRIMOXAZOLE | 480MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/3971 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | VIRIAXONE-SL | CEFTRIAXONE + SULBACTAM | 1G+500MG | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 10 ML AMPOULE WFI | 01/07/2013 |
| NDA/MAL/HDP/3983 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | EXTRADOL | PARACETAMOL/CAFFEINE TABLETS | 500MG/65MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3985 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMYCIN SUSPENSION | ERYTHROMYCIN ESTOLATE | 125MG/5ML | AGOG PHARMAPLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/3987 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ROHISOL SYRUP | LEVAMISOLE HYDROCHLORIDE | 40MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X500.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3989 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICELIB 200 | CELECOXIB | 200MG | UNICHEM LABORATORIES LTD-PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | UNICHEM LABORATORIES LTD UNIT II ,.,VILLAGE, BHATAULI KALAN BADDI DIST. SOLAN (H.P) 173 205 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| NDA/MAL/HDP/3990 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL SYRUP | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/3991 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFULVIN | GRISEOFULVIN TABLETS | 500MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/3993 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | NEM SCAB | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/3996 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTOIN TABLETS | NITROFURANTOIN BP | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/3998 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOKOFF SYRUP | TERBUTALINE SULPHATE +GUAIFENESIN+BROMHEXINE HYDROCHLORIDE +LEVOMENTHOL | 1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/4000 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIDONE SYRUP | CHLORPHENARIMINE MALEATE/DEXAMETHASONE | 2MG/5ML + 0.5MG/5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X125.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/4001 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCOLD PLUS SYRUP | PARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE | 125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/4002 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCID | ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE | 250MG/5ML+ 250MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X170.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/4004 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ANTHEL | ALBENDAZOLE | 400MG | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/4007 | SANOFI PASTEUR. | LABOREX UGANDA LIMITED | SHANCHOL CHOLERA VACCINE | V.CHOLERA STRAINS- 01 INABA FORMALDEHYDE KILLED +01 OGAWA HEAT KILLED + 01 OGAWA FORMALDEHYDE KILLED + 01 INABA HEAT KILLED + 0139 FORMALDEHYDE KILLED | 600 + 300 +300 +300 + 600 ELISA UNITS(EU) OF LIPOPOLYSACCHARIDE (LPS) | SANOFI HEALTHCARE INDIA PRIVATE LIMITEDSURVEY NO. 247, ATHVELLI VILLAGE, MEDCHAL MANDAL - 501401, MEDCHAL - MALKAJGIRI DISTRICT, TELANGANA - INDIA | INDIA | | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X1.5 ML VIAL (1 DOSE) | 01/07/2016 |
| NDA/MAL/HDP/4010 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | PYRI | PYRIDOXINE HYDROCHLORIDE | 25MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4012 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | MESPORIN 2000 | CEFTRIAXONE | 2000MG | LABESFAL LABORATORIOS ALMIRO, S.A ,.ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROS | PORTUGAL | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X50.0 ML VIAL | 01/07/2004 |
| NDA/MAL/HDP/4015 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TAMBAC 50 | CEFPODOXIME PROXETIL | 50MG/5ML | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/4016 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | COMPOUND SODIUM LACATE INTRAVENOUS INFUSION | MULTI-INGREDIENT | MULTI-INGREDIENT | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/4023 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST LINCTUS | CHLORPHENAMINE MALEATE+DEXTROMETHORPHAN HYDROBROMIDE+MENTHOL | (4MG +10MG +3MG)/10ML | CENTAUR PHARMACEUTICALS PVT LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4030 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | XBETA- N | BETAMETHASONE + NEOMYCIN | 0.1%W/V +0.5%W/V | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/4033 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE | 7MG/5ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/4035 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | YASMIN | DROSPIRENONE + ETHINYLESTRADIOL | 3MG+0.3MG | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X21.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4038 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | PREDSONE-5 | PREDNISOLONE | 5MG | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/4042 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | S-CHLOR | CHLORAMPHENICOL | 1G | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2011 |
| NDA/MAL/HDP/4047 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | NEOGAB | GABAPENTIN | 300MG | HILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4055 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | BAYER ASPIRIN CARDIO | ACETYLSALICYLIC ACID | 100MG | BAYER PHARMA AGD-51368 LEVERKUSEN, GERMANY | GERMANY | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2006 |
| NDA/MAL/HDP/4060 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | TOBRADEX | TOBRAMYCIN/DEXAMETHASONE | 0.3%W/V+ 0.1%W/V | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4062 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | KIVEXA | ABACAVIR SULFATE + LAMIVUDINE | 600 MG + 300 MG | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE, SG12 ODJ | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/4063 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | AVOCOMB TABLET | LAMIVUDINE/ZIDOVUDINE | 150MG/300MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2003 |
| NDA/MAL/HDP/4064 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TERAFINE | TERBINAFINE | 250MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4075 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | CHERICOF COUGH FORMULAR | CHLORPHENIRAMINE/DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL | 2MG/10MG/5MG | RANBAXY LABORATORIES LTD AT: THE MADRAS PHARMACEUTICALS137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/4078 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | EPIGAB | PREGABALIN | 75MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X14.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4079 | PHARMA INTL CO.. | OMAB UGANDA LIMITED | NERVAMINE | MECOBALAMIN | 500MCG | PHARMA INTERNATIONAL CO.AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2009 |
| NDA/MAL/HDP/4086 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | KELVIN SUSPENSION | PARACETAMOL | 120MG/5ML | LEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/4091 | HILTON PHARMA PVT LTD | HEALTHCARE LTD. | MYTEKA TABLETS | MONTELUKAST SODIUM | 5MG | HILTON PHARMA PVT,LTD13 SECTOR 15,KORANG,IND.AREA,8TH FLOOR PROGRESSIVE PLAZA,BEAMONT RD,KARACHI | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/4093 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | BECLOMIN OINTMENT | BECLOMETHASONE+MICONAZOLE+NEOMYCIN | 0.025%W/W + 2%W/W + 0.5%W/W | LEBEN LAB PVT LTDL4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/4095 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | IBUT-200 | IBUPROFEN | 200MG | LEBEN LAB PVT LTDL4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4097 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | DERMOVATE | CLOBETASOL PROPIONATE | 0.05%W/W | GLAXOSMITHKLINE HARMIRE GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X30.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/4099 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEVO I.V | LEVOFLOXACIN | 500MG/100ML | AMANTA HEALTHCARE LIMITEDPLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/4100 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NORETHISTERONE | NORETHISTERONE | 5MG | REMEDICA LIMITED AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4101 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | AMLOTRUST 5 | AMLODIPINE | 5MG | CENTAUR PHARMACEUTICALS PVT LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/4103 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | POLIO SABIN - ONE AND THREE [ORAL] | LIVE ATTENUATED POLIOMYELITIS VIRUS VACCINE OF THE SABIN STRAINS TYPE 1 +TYPE 2 | 10?CCID??+10?.?CCID?? | GLAXO SMITHKLINE BIOLOGICALS S.ARUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | | ORAL LIQUID ORDINARY DROPS | 1.0X100.0X2.0 ML VIAL (20 DOSES) | 01/07/2016 |
| NDA/MAL/HDP/4104 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-PROM | PROMETHAZINE HCL | 25MG | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4113 | MICRO LABS LTD | LABOREX UGANDA LIMITED | EROSTIN 10 | EBASTINE | 10 MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/4114 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RINALIN SYRUP | CHLORPHENIRAMINE MALEATE | 2MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4115 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | PREDILONE | PREDNISOLONE | 5.0 MG | REGAL PHARMACEUICALS LTDPLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4118 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | OCUREST-AH | PHENYLEPHRINE HYDROCHLORIDE+NAPHAZOLINE HYDROCHLORIDE+CHLORPHRENIRAMINE MALEATE+MENTHOL+CAMPHOR | 0.12%+0.05%+0.1%+0.005%+0.01% | CENTAUR PHARMACEUTICALS PRIVATE LIMITEDPLOT NO.3,TIVIM INDUSTRIAL ESTATE KARASWADA MUPUSA-GOA 403 526 INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2005 |
| NDA/MAL/HDP/4126 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | UNICELIB 100 | CELECOXIB | 100MG | UNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2003 |
| NDA/MAL/HDP/4127 | SANOFI 410 THALES | LABOREX UGANDA LIMITED | EPILIM | SODIUM VALPROATE | 200MG/5ML | UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770 | | FRANCE | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X300.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/4128 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAREN SYRUP | VITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B3 | 1500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5ML | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI- KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/4134 | INDOCO REMEDIES LTD | STAR PHARMACEUTICALS LTD | CITAL | DISODIUM HYDROGEN CITRATE | 1.37G/5ML | INDOCO REMEDIES LTDB-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/4138 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYCLOX CAPSULES | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | ELYS CHEMICAL INDUSTRIES LTDROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4141 | SANOFI 410 THALES | LABOREX UGANDA LIMITED | EPILIM 200 | SODIUM VALPROATE | 200MG | FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS)RIELL, SPAIN | SPAIN | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/4143 | MODI NUNDIPHARMA PVT LTD | SURGIPHARM (U) LIMITED | TAM CONTIN 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | MODI MUNDIPHARMA PVT. LTDMEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2013 |
| NDA/MAL/HDP/4146 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMPICLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4147 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | NIFEDI-DENK 20 RETARD | NIFEDIPINE | 20MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2000 |
| NDA/MAL/HDP/4148 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | AMITRIPTYLINE TABLETS | AMITRIPTYLINE | 25MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/4150 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ANGIOPRIL-25 | CAPTOPRIL | 25MG | TORRENT PHARMACEUTICALS LTDINDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4165 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ZEFONE INJECTION | CEFTRIAXONE SODIUM | 1G | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | ZEISS PHARMACEUTICALS PVT LTD-72 EXPORT PROMOTION INDUSTRIAL PARK ,PHASE-1,JHARMAJRI, BADDI DIST:SOLAN H.P INDIA | ZYDUS HEALTHCARE LIMITED-SURVEY NO. 49/3, 51/1, 51/2 RINGANWADA VILLAGE, DAMAN (U.T) | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2001 |
| NDA/MAL/HDP/4171 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | TOREX | MULTIINGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/4172 | RENE INDUSTRIES | RENE INDUSTRIES LIMITED | KOF OFF EXPECTORANT | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIESPLOT 680 KAMULI KIREKA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X110.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/4180 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | OSMOWIN | LACTULOSE | 10G/15ML | G.S PHAMBUTOR PVT LTDG.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/4182 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST- FORTE | MULTI INGREDIENT | MULTI INGREDIENT | CENTAUR PHARMACEUTICALS LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP | 01/07/2007 |
| NDA/MAL/HDP/4187 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NORIGYNON | ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE | 5 MG+50 MG / ML | BAYER PHARMA A.GMULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/4188 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPRAZ | PRAZIQUANTEL | 600MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4209 | AUROBINDOM PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | POZINEG 1000 | CEFEPIME | 1000MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL + 1*1AMP WATER FOR INJECTION | 01/07/2008 |
| NDA/MAL/HDP/4241 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMPICILLIN SODIUM FOR INJECTION BP | AMPICILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL | 01/07/2011 |
| NDA/MAL/HDP/4275 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | AVASTIN 100MG/4ML | BEVACIZUMAB | 100 MG/ 4ML | F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL | ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY | | SWITZERLAND | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X4.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/4276 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 60MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 5 ML NACL + 1 ML SODIUM BICARBONATE | 01/07/2013 |
| NDA/MAL/HDP/4277 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | VIVIRON PLUS SYRUP | FERRIC AMMONIUM CITRATE +FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE | 50MG + 0.5MG + 2.2MG + 1.3MG +11MG | NABIQASIM INDUSTRIES (PVT) LTD-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/4280 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR SULFATE+LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 600 MG + 300 MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | MYLAN LABORATORIES LTD ,PLOT NO. 11, 12, & 13 INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III PITHAMPUR 454775, DIST DHAR – MADHYA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/4284 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | AVASTIN 400MG/4ML | BEVACIZUMAB | 400MG/4ML | | F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL | ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY | | SWITZERLAND | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X16.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/4287 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE 1000 | CEFTRIAXONE | 1000MG | SANCE LABORATORIES PVT. LTD.VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL,1.0X50.0X10.0 ML VIAL | 01/07/2010 |
| NDA/MAL/HDP/4291 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | VITAMIN B COMPLEX INJECTION | VITAMIN B COMPLEX | 10MG/2ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/4292 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | HERCEPTIN 150MG | TRASTUZUMAB | 150MG | ROCHE DIAGNOSTICS GMBH MANNHEIM-SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY. | GERMANY | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2016 |
| NDA/MAL/HDP/4303 | PFIZER LABORATORIES (PTY) | LABOREX UGANDA LIMITED | SAYANA PRESS | MEDROXYPROGESTERONE ACETATE | 104MG/0.65ML | PFIZER MANUFACTURING NV/NA, RIJKSWEG 12 2870, PUURS | BELGIUM | | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X200.0X0.65 ML PRE- FILLED SYRINGE | 01/07/2010 |
| NDA/MAL/HDP/4307 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | MIKACIN | AMIKACIN SULPHATE | 500MG/2ML | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X5.0X8.0X2.0 ML VIAL,1.0X1.0X2.0 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/4309 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | HETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | 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 | 1.0X60.0 TABLET BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/4312 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F | FOLLITROPIN ALFA | 75IU/IE | MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND | | ITALY| SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1 PRE FILLED SYRINGE OF WFI | 01/07/2016 |
| NDA/MAL/HDP/4313 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | AKUGABALIN | PREGABALIN 150MG CAPSULES | 150MG | AKUMS DRUGS & PHARMACEUTICALS LTD.2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 07/01/2016 |
| NDA/MAL/HDP/4315 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | DESLORA-DENK 5 | DESLORATIDINE | 5MG | DENK PHARMA GMBH & CO.KG GOLLSTR 1,84529 TITTMONING GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/4317 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | COLOSAR-DENK 50/12.5 | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4318 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AKUGABALIN | PREGABALIN | 75 MG | AKUMS DRUGS & PHARMACEUTICALS LTD19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 07/01/2016 |
| NDA/MAL/HDP/4320 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | ROYAL PHARMA 2011 LIMITED | HYOSCINE BUTYL BROMIDE | HYOSCINE BUTYL BROMIDE | 10MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/4324 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PRASUSAFE 5 | PRASUGREL | 5MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1X3X10 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4325 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | ACTINAC 100 | ACECLOFENAC | 100MG | AJANTA PHARMA LIMITEDPLOT NO. M-55-56-57, ISEZ, PHASE II, PITHAMPUR-454775, DISTRICT DHAR, MADHYA PRADESH STATE | AJANTA PHARMA LIMITEDB-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X2.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4329 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CPM | CHLORPHENIRAMINE MALEATE | 2MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/4330 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCLOXACILLIN CAPSULES | FLUCLOXACILLIN | 250MG | SPARSH BIO-TECH PVT. LTD.-PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP | 01/07/2016 |
| NDA/MAL/HDP/4331 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC | ACECLOFENAC | 100MG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4333 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | CARVIBERG | CARVEDILOL USP | 6.25MG | THE MADRAS PHARMACEUTICALS137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/4334 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | LOSAR-DENK 50 | LOSARTAN | 50MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4335 | DAWA LIMITED | SUPER MEDIC LTD | CURAMOL SUSPENSION | PARACETAMOL | 120MG/5ML | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/4339 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | SERETIDE 125 EVOHALER | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG/125MCG | GLAXO WELLCOME PRODUCTIONZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX | FRANCE | | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER | 01/07/2007 |
| NDA/MAL/HDP/4340 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | VITAMIN B COMPLEX | VITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM | 10MG + 1.37MG + 15MG + 1MG + 0.5MG | WUHAN FUXING BIOLOGICAL PHARMACEUTICAL COMPANY LIMITED-NO. 9 FUXING ROAD HANCHUAN ECONOMIC DEVELOPMENT DISTRICT, HUBEI PROVINCE - CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/4348 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | MEDICLOAMP SYRUP | CLOXACILLIN+AMPICILLIN | 250MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4350 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | OLFEN-75 | DICLOFENAC SODIUM | 75MG/2ML | MERCKLE GMBH,LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | HAUPT PHARMA WULFING GMBH.BETHELNER LANDSTR. 18, 31028 GRONAU/LEINE | GERMANY | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/4352 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/4356 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | FRESHEN | BISACODYL | 5 MG | ADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/4358 | A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LIOTON | HEPARIN SODIUM | 1000I.U/G | A. MENARINI MANUFACTURING LOGICTICS AND SERVICESVIA 3 SETTE SANTI FLORENCE 50131 ITALY | ITALY | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE | 01/07/2016 |
| NDA/MAL/HDP/4361 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | TAXIM-O | CEFIXIME | 200MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | ALKEM LABORATORIES LIMITED.VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4362 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LEVOMAC 750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/4365 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ACTINAC PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | AJANTA PHARMA LIMITEDPLOT NO. M-55-56-57, ISEZ, PHASE II, PITHAMPUR-454775, DISTRICT DHAR, MADHYA PRADESH STATE | AJANTA PHARMA LIMITEDB-4/5/6,MIDC AREA, PAITHAN,431 148 INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4366 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXISPA | CLOXACILLIN | 250MG | SPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2004 |
| NDA/MAL/HDP/4367 | ASTRA ZENECA | MACNAUGHTON LIMITED | ATACAND 8MG | CANDESARTAN | 8MG | ASTRA ZENECA AB, SODERTALJEGARTUNAYEGEN, SODERTALJE | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4375 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 200MG/5ML | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4379 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | SINURHON | MULTI-INGREDIENT | 5MG/ 2MG/ 500MG / 30MG | LEBEN LABORATORIES PVT. LTDPLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS). | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/4380 | GLAXO WELLCOME (KENYA) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZINNAT SUSPENSION | CEFUROXIME AXETIL- | 125MG/5ML | GLAXOSMITHKLINE UK LTDHARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/4388 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | TAZOBAK | PIPERACILLIN SODIUM + TAZOBACTAM SODIUM | 4.0G + 0.5G | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | SWISS PARENTERALS LIMITED UNIT IIPLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X4.5 G VIAL | 01/07/2016 |
| NDA/MAL/HDP/4389 | PHARMACARE LTD | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA | DARUNAVIR | 600MG | JANSSEN ORTHO LLC.-STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/4392 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | CAPLOR | CLOPIDOGREL | 75MG | IND SWIFT LTDGBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4394 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | NS | SODIUM CHLORIDE | 0.9% W/V | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/4396 | MYLAN LABORATORIES LIMITED (OTL) | KIMSY MEDS LTD | ABACAVIR SULPHATE | ABACAVIR SULFATE | 300MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/4398 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9 % W/V | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4399 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GEFIL | COMPOUND MAGNESIUM TRISILICATE | ALUMINIUM HYDROXIDE & MAGNESIUM TRISILICATE 132 & | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/4400 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ORAL REHYDRATION SALT (DTS) | ORAL REHYDRATION SALT | N/A | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET | 01/07/1997 |
| NDA/MAL/HDP/4401 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICEPHIN | CEFTRIAXONE DISODIUM | 2G | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL + 2*5 ML OF WFI GLASS AMPOULES,1.0X2.0 G VIAL + 1*10ML GLASS AMPOULE OF WFI | 01/07/2014 |
| NDA/MAL/HDP/4402 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | CLOTRILIN | CLOTRIMAZOLE | 100MG | LINCOLN PHARMACEUTICALS LTD10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA | INDIA | | VAGINAL TABLETS | 1.0X6.0 TABLET STRIP | 01/07/2014 |
| NDA/MAL/HDP/4404 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | FOLIGRAF | RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE | 75I.U/ VIAL | BHARAT SERUMS AND VACCINES LIMITED,PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2016 |
| NDA/MAL/HDP/4406 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | SATISFIL -100 | SILDENAFIL | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4408 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNISTEN CREAM | CLOTRIMAZOLE | 1%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/4411 | ASTRAZENECA AG | MACNAUGHTON LIMITED | ATACAND PLUS | CANDESARTAN + HYDROCHLOROTHIAZIDE | 16 MG + 12.5 MG | ASTRA ZENECA AB, SODERTALJEGARTUNAYEGEN, SODERTALJE | SWEDED | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4413 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICEPHIN | CEFTRIAXONE | 1G | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL (+ 1 GLASS AMPOULE OF 10ML WFI) | 01/07/2011 |
| NDA/MAL/HDP/4415 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CATAFLAM 5OMG TABLETS | DICLOFENAC POTASSIUM | 50MG | NOVARTIS--URUNLERI INSTABUL TURKEY | NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY | | ITALY |TURKEY | ORAL SOLID ORDINARY COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4417 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICEPHIN | CEFTRIAXONE SODIUM | 500MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 G VIAL + 1*5 ML OF WFI GLASS AMPOULES | 01/07/2014 |
| NDA/MAL/HDP/4418 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | VALORAN | CEFOTAXIME | 1000MG | MEDOCHEMIE LIMITED (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL - CYPRUS. | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON | 01/07/2009 |
| NDA/MAL/HDP/4419 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIGONAL 75 | HUMAN MENOPAUSAL GONADOTROPHIN | 75IU/5ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL + 1 ML AMPOULE 0.9%W/V NACL | 01/07/2010 |
| NDA/MAL/HDP/4425 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN FC | QUININE | 300MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/4480 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | KIPEL 5 | MONTELUKAST | 5MG | MSN LABORATORIES PVT. LIMITEDPLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/4483 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | WORMOL SUSPENSION | MEBENDAZOLE | 100MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE,1.0X100.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4519 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | S-AMLOSAFE 5 | AMLODIPINE BESILATE | 5MG | ARISTO PHARMACEUTICALS PVT LTDPLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4522 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | S-AMLOSAFE 2.5 | AMLODIPINE BESILATE | 2.5 MG | ARISTO PHARMACEUTICALS PVT LTDPLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4523 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | BIGOMET SR 500 | METFORMIN HYDROCHLORIDE | 500MG | ARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4526 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-500 | AZITHROMYCIN | 500MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X20.0X3.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4528 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PIOSAFE MF 15/500 | PIOGLITAZONE + METFORMIN | 15 MG + 500 MG | ARISTO PHARMACEUTICALS PVT LIMITEDPLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4546 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | CHLORAMPHENICOL INJECTION IG | CHLORAMPHENICOL SODIUM SUCCINATE | 1G | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD #14, II PHASE PIA, BANGALORE 560058 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0X1.0 G VIAL,1.0X50.0X1.0 G VIAL | 01/07/1998 |
| NDA/MAL/HDP/4553 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARTESUN | ARTESUNATE | 30MG | GUILIN PHARMACEUTICAL CO. LTD.NO. 43 QILIDIAN ROAD, GUILIN 541004 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE | 01/07/2011 |
| NDA/MAL/HDP/4556 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 375 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 250MG + 125MG | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/4559 | MSN LABORATORIES PRIVATE LIMITED, | METRO PHARMACEUTICALS LIMITED | PREGASAFE 75 | PREGABALIN | 75MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/4561 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | LORVAS SR | INDAPAMIDE | 1.5MG | TORRENT PHARMACEUTICALS LTD. AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT | TORRENT PHARMACEUTICALS LTD VILLAGE: BHUD & MAKHNU MAJRA, TEHSIL: BADDI – 173205, DIST: SOLAN, HIMACHAL PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4568 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 625 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500MG + 125MG | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/4571 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASPICLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | ASTRA LIFE CARE (INDIA) PVT.LTDPLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4575 | FDC LTD | AIVEEN (U) LIMITED | PYRICORT EYE/EAR DROPS | DEXAMETHASONE+GENTAMICIN | 0.1%+0.3%W/V | FDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/4581 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 1000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875MG + 125MG | INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/4587 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIRATRO | ATROPINE | 1MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTDN-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X1.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/4588 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCAN 200 | FLUCONAZOLE | 200MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4589 | FEROZSONS LABORATORIES LTD | HEALTHCARE LTD. | LEFOXCIN-500 | FLUOXETIN|LEVOFLOXACIN HEMIHYDRATE | 500MG|20MG | FEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4591 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | SILVER KANT | SILVER SULPHADIAZINE USP | 1%W/W | S.KANT HEALTHCARE LTD1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| NDA/MAL/HDP/4592 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PENTALINK 40 | PANTOPRAZOLE | 40MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4593 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | ERYTHROKANT-250 | ERYTHROMYCIN STEARATE | 250MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4595 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VAST-20 | ATORVASTATIN | 20MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4598 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-250 | AZITHROMYCIN | 250MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4602 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMALOG MIX 50 | INSULIN LISPRO | 100 .IU(50 I.U+50 I.U) | LILLY FRANCE SAFRANCE | FRANCE | | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/2000 |
| NDA/MAL/HDP/4603 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | HALOXEN - 5 | HALOPERIDOL | 5MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/4605 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODRYL SYRUP | BROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL | 4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/4606 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 10 | ROSUVASTATIN | 10MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4609 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELYCORT | HYDROCORTISONE | 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 |
| NDA/MAL/HDP/4611 | DAFRA PHARMA LTD | MULTIPHAR UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + POTASSIUM CLAVULANATE | 200MG + 28MG | BILIM ILAC SAN. VE. TIC. A.S.CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 | TURKEY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4614 | GALENTIC PHARMA LTD | VITACARE LIMITED | COMPOUND BENZOIC ACID OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6 %W/W + 3 %W/W | GALENTIC PHARMA( INDIA ) PVT LTDR-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE,1.0X500.0 G TUBE | 01/07/2006 |
| NDA/MAL/HDP/4617 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN | 10MG | IPR PHARMACEUTICALS INC,LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4619 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CHLORAMPHENICOL SODIUM SUCCINATE | CHLORAMPHENICOL SODIUM SUCCINATE | 1G | SCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0X1.0 G VIAL | 01/07/2009 |
| NDA/MAL/HDP/4620 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | MALANIL PAEDIATRIC TABLET | ATOVAQUONE + PROGUANIL | 62.5 MG + 25.0 MG | GLAXO WELLCOME S.A ARANDAARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4622 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | CLOXAREN | CLOXACILLIN | 250MG | RENE INDUSTRIESPLOT 680 KAMULI KIREKA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4623 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | LOPERAREN | LOPERAMIDE HYDROCHLORIDE | 2MG | RENE INDUSTRIAL LTDRENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4627 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | HYCORUM CREAM | HYDROCORTISONE | 1%W/W | LABORATORY AND ALLIED LTDPLOT 209/10349-MOMBASA ROAD NAIROBI | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/4629 | DAWA LIMITED | SUPER MEDIC LTD | ORACEF | CEFALEXIN MONOHYDRATE | 125MG/5ML | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1X100 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/4634 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | LOSAR-DENK 100 | LOSARTAN | 100MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4641 | YURIA PHARM LTD-UKRAINE | PHARMA VILLE LIMITED | RHEOSORBILACT | SORBITOL + SODIUM LACTATE + NACL + CALCIUM CHLORIDE + MAGNESIUM CHLORIDE | 6G +1.9G +0.6G + 0.01G +0.03G +0.02 | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X200.0 ML BOTTLE,1.0X400.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/4645 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN CALCIUM | 20MG | IPR PHARMACEUTICALS INC,LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4646 | YURIA PHARM LTD-UKRAINE | PHARMA VILLE LIMITED | LEFLOCIN | LEVOFLOXACIN | 5MG/ML | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X150.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/4650 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | DUOTRAV | TRAVOPROST + TIMOLOL MALEATE | 40MG/ML + 5MG/ML | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML VIAL | 01/07/2010 |
| NDA/MAL/HDP/4652 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII TETANUS TOXOID VACCINE | TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE | ? 5 LF (? 40 IU) ON ? 1.25 MG OF ALUMINIUM PHOSPHATE | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE (1 DOSE AMPOULE),1.0X10.0 ML VIAL (20 DOSE VIAL) | 01/07/1997 |
| NDA/MAL/HDP/4658 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | MEROSAN 0.5 | MEROPENEM | 0.5G | PT SANBE FARMAJI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 G VIAL | 01/07/2014 |
| NDA/MAL/HDP/4661 | YURIA PHARM LTD-UKRAINE | PHARMA VILLE LIMITED | FLUCONAZOLE-UF | FLUCONAZOLE | 2MG/ML | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/4666 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | ANTIPLEX | CLOPIDOGREL BISULFATE | 30MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4669 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC 100MG SUPPOSITORIES | DICLOFENAC SODIUM. | 100MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | TOPICAL EXTERNAL ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP | 01/07/2013 |
| NDA/MAL/HDP/4670 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 500 | AMOXICILLIN | 500MG | 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 | 01/07/2014 |
| NDA/MAL/HDP/4675 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC RETARD 100 | DICLOFENAC SODIUM | 100MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER | 01/07/2013 |
| NDA/MAL/HDP/4677 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF | CEFUROXIME | 125MG/5ML | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4678 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF-500 | CEFUROXIME AXETIL | 500MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | ALKEM LABORATORIES LIMITED.VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4694 | MERCK SHARP & DOHME INTAPHARMA | SURGIPHARM (U) LIMITED | ROTATEQ | ROTAVIRUS LIVE REASSORTANT VIRUS G1+G2+G3+G4 &P1 | 2.2M IU+2.8M IU+2.2M IU+2.0M IU | MERK & CO. INCSUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA | UNITED STATES | | ORAL LIQUID ORDINARY EMULSIONS | 1.0X10.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4697 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | SANBE CLANEKSI | AMOXICILLIN + CLAVULANIC ACID | 1000 MG + 200 MG | PT SANBE FARMAJI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA | | PARENTERAL ORDINARY VIALS | 1.0X6.0 VIAL CARTON | 01/07/2011 |
| NDA/MAL/HDP/4700 | MEDIPHARM SALES LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIZOLE | METRONIDAZOLE | 125MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTDPLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/4701 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | MEBRONE 100 TABLETS | MEBENDAZOLE | 100MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDPLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4702 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABTOL 20%W/V | MANNITOL | 200MG/ML | ABACUS PARENTERAL DRUGS LTD.PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4703 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABGYL | METRONIDAZOLE | 500MG | ABACUS PARENTERAL DRUGS LTD.PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4704 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC 12.5 | DICLOFENAC SODIUM | 12.5MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2012 |
| NDA/MAL/HDP/4705 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DICLOGESIC-50 | DICLOFENAC | 50MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2012 |
| NDA/MAL/HDP/4706 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL GEL | DICLOFENAC DIETHYLAMINE | 1.16%W/W | G,S PHARMBUTOR PVT LTD B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER | 01/07/2015 |
| NDA/MAL/HDP/4707 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL INJECTION | DICLOFENAC SODIUM | 25MG/ML | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE | 01/07/1998 |
| NDA/MAL/HDP/4710 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | MEDOPRESS TABLETS 250MG | METHYLDOPA | 250MG | COSMOS LIMITED..RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/4712 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEFINAL-500 | MEFENAMIC ACID | 500MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4715 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | MEFTAL FORTE | MEFENAMIC ACID + PARACETAMOL | 500MG + 450MG | BLUE CROSS LABORATORIES LTDL-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4717 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | MEFTAL-SPAS | MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE | 250MG + 10MG | BLUE CROSS LABORATORIES LTDL-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X3.0X10.0 TABLET BLISTER,1.0X10.0X3.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4718 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | ACNOTIN 20 | ISOTRETINOIN | 20MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4719 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | ACNOTIN 10 | ISOTRETINOIN | 10MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4721 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | MEGABAL | MECOBALAMIN | 5000MCG | PT SANBE FARMA,UNIT 1JI INDUSTRI NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVA,INDONESIA | INDONESIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 01/07/2011 |
| NDA/MAL/HDP/4723 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | MEGYL SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4725 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEGYL TABLET | METRONIDAZOLE | 200MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4726 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | ADB MIN MULTIPOWER | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X300.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4731 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | MENAFRIVAC | MENINGOCOCCAL A CONJUGATE VACCINE | 10MCG/ 0.5ML + 10-33MCG/0.5ML | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X10.0 DOSE VIAL + 1*5ML AMPOULE OF DILUENT | 01/07/2011 |
| NDA/MAL/HDP/4738 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | CILOXAN | CIPROFLOXACIN | 0.3%W/V | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4739 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | MERO | MEROPENEM | 1G | SWISS PARENTERALS LIMITED (UNIT-2) PLOT NO. 402, 412-414 KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, AHMEDABAD,382220, GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2011 |
| NDA/MAL/HDP/4744 | DAFRA PHARMA N.V/S.A | MULTIPHAR UGANDA LIMITED | MERONIA 500 | MEROPENEM | 500MG | DEMO SA21ST KM NATIONAL ROAD, ATHENS, LAMIA 14568 KRYONERI, ATHENS | GREECE | | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL | 01/07/2013 |
| NDA/MAL/HDP/4745 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PIPZO | PIPERACILLIN + TAZOBACTAM | 4.5G | ALKEM LABS LTD.-VILLAGE THANA, BADDI, THE NALAGARH, DIST SOLAN (HP) 173205 | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL + STERILIZED WATER FOR INJECTION | 01/07/2014 |
| NDA/MAL/HDP/4748 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ACICONE-S CHEWABLE TABLET | MAGALDRATE+SIMETHICONE | 720MG+25MG | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X5.0X4.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/4749 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | MEROSAN | MEROPENEM | 1G | PT SANBE FARMAJI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2012 |
| NDA/MAL/HDP/4751 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FEROL | FERROUS SULPHATE | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4757 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | METFORMIN-DENK 500 | METFORMIN | 500MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/4758 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | METFORMIN DENK 1000 | METFORMIN | 1000MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4759 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CIPRODAR | CIPROFLOXACIN | 500MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4766 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBEN SUSPENSION | MEBENDAZOLE | 100MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/4769 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBEX | MEBENDAZOLE | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4774 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FERROFOL VIT-Z | FERROUS SULPHATE+FOLIC ACID+ASCORBIC ACID+THIAMINE MONONITRATE+RIBOTLAVINE+PYRIDOXINE HCL+NICOTINAMIDE+ZINC | 150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X6.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/4775 | SKAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | CIPROKANT-500 | CIPROFLOXACIN | 500MG | S KANT HEALTH CARE LTDPLOT 1802 – 1805 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4781 | CYANO PHARMA(P) | RENE PHARMACY LTD | CYANO IRON TABLETS | FERROUS SULPHATE | 200MG | CYANO PHARMA(P)115-C IND ESTATE POLO GROUND INDORE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/4784 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D50 | GLUCOSE INTRAVENOUS INFUSION | 50%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4788 | JASSEN-CILAG (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | DAKTARIN ORAL GEL | MICONAZOLE NITRATE | 20MG/G | SPECPHARM HOLDINGS 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | | ORAL TOPICAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/4789 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN HYDROCHLORIDE | 300MG | FAREVA AMBOISE - ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP | 01/07/1997 |
| NDA/MAL/HDP/4790 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN HYDROCHLORIDE | 150MG | FAREVA AMBOISE - ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON | 01/07/1997 |
| NDA/MAL/HDP/4792 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN PHOSPHATE | 150MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NVRIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | | PARENTERAL ORDINARY VIALS | 1.0X4.0 ML VIAL,1.0X2.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/4794 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | DALADOL | DICLOFENAC SODIUM + PARACETAMOL | 50MG+500MG | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/4795 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | DAROXIME | CEFUROXIME | 500MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/4796 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DARROWS SOLUTION (HALF STRENGTH) | POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE | 0.13%+0.20%+0.30% | ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4800 | DAWA LIMITED | SUPER MEDIC LTD | DAWAVITE SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/4801 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | DAZEL KIT | FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE | 150MG + 1G + 1G | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4804 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLAVODAR | AMOXICILLIN + CLAVULANIC | 200MG + 28MG /5ML | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 01/07/2012 |
| NDA/MAL/HDP/4806 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFER | FERROUS SULPHATE+FOLIC ACID | 200MG + 0.25MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4807 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFORMIN | METFORMIN | 500MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/4809 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCORT SKIN CREAM | HYDROCORTISONE | 0.1%W/W | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/4811 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOGYL | METRONIDAZOLE | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4812 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMETROL SUSPENSION | METRONIDAZOLE BENZOATE | 125MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/4813 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMETROL TABLETS (THANE) | METRONIDAZOLE | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/4815 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | FERROLIC-LF | FERROUS SULPHATE +FOLIC ACID | 200MG+0.4MG | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/4817 | CYANO PHARMA(P) | RENE PHARMACY LTD | METOCLOPRAMIDE TABLETS | METOCLOPRAMIDE | 10MG | CYANO PHARMA(P)115-C IND ESTATE POLO GROUND INDORE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/4818 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | FERROUS SULPHATE | FERROUS SULPHATE | 200MG | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4819 | FDC LIMITED | AIVEEN (U) LIMITED | ELECTRAL 21.8G | ORAL REHYDRATION SALT | 21.8G | FDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X21.8 G SACHET | 01/07/2000 |
| NDA/MAL/HDP/4821 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | METPURE-XL 50 | METOPROLOL | 50MG | EMCURE PHARMACEUTICALS LIMITED LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4823 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | METRIS INFUSION | METRONIDAZOLE | 5MG/ML | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4826 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL DENTA GEL | METRONIDAZOLE + CHLORHEXIDINE | 1%W/W + 0.25%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/4828 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL GEL | METRONIDAZOLE | 1%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | | TOPICAL EXTERNAL EMULSION GELS | 1.0X30.0 G TUBE (ALUMINIUM TUBE),1.0X30.0 G TUBE (LAMINATED TUBE) | 01/07/2001 |
| NDA/MAL/HDP/4830 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL INJECTION | METRONIDAZOLE | 5MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTDPLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4832 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL SUSPENSION | METRONIDAZOLE | 200MG/5ML | UNIQUE PHARMACEUTICAL LABORATORIESPLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA. | J.B. CHEMICALS AND PHARMACEUTICALS LTD .128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4836 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | METRON | METRONIDAZOLE | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2009 |
| NDA/MAL/HDP/4838 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | METRONIDAZOLE | METRONIDAZOLE BENZOATE | 125MG/5ML | MEDICAMEN BIOTECH LTDSP-1192, A &B, PHASE –IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/4839 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | ANOMEX | ZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN | 5%W/W+3%W/W+0.25%W/W+0.5%W/W | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| NDA/MAL/HDP/4854 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN FC | METRONIDAZOLE | 200MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2014 |
| NDA/MAL/HDP/4855 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL EXPECTORANT | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN + MENTHOL | (2MG + 4MG + 100MG + 1MG)/10ML | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2000 |
| NDA/MAL/HDP/4856 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN | METRONIDAZOLE | 200MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/4858 | RENE INDUSTRIES | RENE INDUSTRIES LIMITED | METROREN SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/4863 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | MICONAZ ORAL GEL | MICONAZOLE | 2%W/W | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/4865 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | MICONAZ CREAM | MICONAZOLE NITRATE | 2%W/W | MEDICAL UNION PHARMA .COABU-SULTAN ISMAILIA EGYPT | EGYPT | | VAGINAL CREAMS | 1.0X20.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/4867 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | MICONA ORAL GEL | MICONAZOLE | 20MG | CENTAUR PHARMACEUTICALS PVT LTD -PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | | ORAL TOPICAL GELS AND SOLS | 1.0X40.0 G TUBE,1.0X20.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/4868 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | FLUCANIR | FLUCONAZOLE | 2MG/ML | ACULIFE HEALTHCARE PVT LTDVILLAGE SACHANA, TALUKA, VIRAMGAM, DIST. AHMEDABAD 382150, GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4872 | DAWA LIMITED | SUPER MEDIC LTD | MICLOCIN CREAM | MICONAZOLE NITRATE + CLOBETASOL PROPRIONATE + GENTAMICN | 2%W/W+0.5%W/W+0.1W/W | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/4873 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | FLUCAS | FLUCONAZOLE | 200MG | ASTRA LIFE CARE (INDIA) PVT.LTDPLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4874 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE180 RUE JEAN JAURE'S BP 94702, MAISONS-ALFORT CEDEX | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.6 ML PRE- FILLED SYRINGE | 01/07/2009 |
| NDA/MAL/HDP/4875 | MARIE STOPES UGANDA LIMITED | MARIE STOPES UGANDA LIMITED | MISOCLEAR | MISOPROSTOL | 200MCG | ACME FORMULATION PVT LTD,ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4876 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE180 RUE JEAN JAURE'S BP 94702, MAISONS-ALFORT CEDEX | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.8 ML PRE- FILLED SYRINGE | 01/07/2009 |
| NDA/MAL/HDP/4877 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE180 RUE JEAN JAURE'S BP 94702, MAISONS-ALFORT CEDEX | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.4 ML PRE- FILLED SYRINGE | 01/07/2009 |
| NDA/MAL/HDP/4880 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | MISOPROST 200 | MISOPROSTOL | 200MCG | CIPLA LTD .CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/4891 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | ASPEC TABLET | ASPIRIN+PARACETAMOL+CAFFEINE ANHYDROUS | 150MG+250MG+300MG | REGAL PHARMACEUTICALS LTDOFF BABA DOGO RD, RUARAKA, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4895 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLOMIFERT | CLOMIPHENE | 50MG | DAR AL DAWADAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4903 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CMT-TABLETS | MAGNESIUM TRISILICATE+DRIED ALUMINIUM HYDROXIDE+PEPPERMINT OIL | 250MG+120MG+0.003ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4904 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MIXTARD 30 | INSULIN HUMAN | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PHARMANOVO ALLE | DENMARK | FRANCE | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/4905 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | AVORAX CREAM | ACYCLOVIR | 5%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/4906 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | AVORAX TABLETS | ACYCLOVIR | 200MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/4907 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | AVORAX TABLETS | ACYCLOVIR | 400MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/4908 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MIXTARD 30 PENFILL | BIPHASIC ISOPHANE INSULIN (HUMAN) | 100 I.U/ML | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERD | DENMARK | BRAZIL | PARENTERAL ORDINARY CARTRIDGES | 1.0X1.5 ML FLEXPEN,1.0X5.0X3.0 ML FLEXPEN | 01/07/1997 |
| NDA/MAL/HDP/4909 | AXA PARENTERALS LTD | VITACARE LIMITED | AXAGYL | METRONIDAZOLE | 0.5%W/V | AXA PARENTERAL LIMITEDPLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/HDP/4910 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | FLUZOL | FLUCONAZOLE | 200MG | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4911 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | MOFILET-500 | MYCOPHENOLATE MOFETIL | 500MG | EMCURE PHARMACEUTICALS LIMITED LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/4915 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOGYL-S TABLETS | METRONIDAZOLE | 200MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4917 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL EVILINE FORTE SUSPENSION | MAGNESSIUM HYDROXIDE +ALUMINIUM HYDROXIDE+SIMETHICONE | 400MG/5ML+400MG/5ML+40MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/4918 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOGYL SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED VANDALUR ROAD | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4920 | LEBEN LABORATORIES LTD | MALIX PHARMA (U) LIMITED | FOLIBEN | FOLIC ACID | 5MG | LEBEN LAB PVT LTDL4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4922 | KOPRAN LIMITED | TATA UGANDA LIMITED | CIPROQUIN-500 | CIPROFLOXACIN | 500MG | KOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER | 01/07/1999 |
| NDA/MAL/HDP/4924 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | MULTIVIT TABLET | MULTIVITAMIN | MULTI-INGREDIENT | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/4926 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | FOLIC ACID | FOLIC ACID | 5MG | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4927 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | AZOPT | BRINZOLAMIDE | 10MG/ML | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/4929 | MARTINDALE AND AURUM PHARMACEUTICAL | LABOREX UGANDA LIMITED | MORPHINE INJECTION | MORPHINE | 15MG/ML | MARTINDALE PHARMACEUTICAL LIMITED BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/4932 | MARTINDALE AND AURUM PHARMACEUTICAL | LABOREX UGANDA LIMITED | MORPHINE INJECTION | MORPHINE | 10MG/ML | MARTINDALE PHARMACEUTICAL LIMITED BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/4933 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AZUDOX | DOXYCYCLINE HYDROCHLORIDE | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4936 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COMBIFEN | IBUPROFEN + PARACETAMOL | 400MG + 500MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/4937 | JASSEN-CILAG (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | MOTILIUM | DOMPERIDONE | 10MG | JANSSEN-CILAGDOMAINE DE MAIGREMONT, 27100 VAL DE REUIL - FRANCE | FRANCE | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4939 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FOLIREN | FOLIC ACID | 5MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/4940 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FOLON | FOLIC ACID | 5MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/4943 | ASTRAZENECA | MACNAUGHTON LIMITED | NOLVADEX | TAMOXIFEN | 20MG | ASTRAZENECA UK LIMITED ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/4944 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | BENA EXPECTORANT | DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE | 14MG + 135MG + 57.5MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA | MALAYSIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4946 | ESAPHARM SRL | BYAMAKA PHARMACEUTICAL COMPANY LTD | MOVATE | CLOBETASOL | 0.05%W/W | ESAPHARMA SRLVIA DE GASPERI, 13-20066 MELZO (MILAN) ITALY | ITALY | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/1999 |
| NDA/MAL/HDP/4949 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN DRY COUGH DM | DEXTROMETHORPHAN HYDROBROMIDE | 15MG/ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4951 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN ORIGINAL | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE | 12.5 MG/5ML + 125 MG/5ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4952 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WITH CODEINE | DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE | 12.5MG/5ML +125MG/5ML +10MG/5ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4953 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | NAT-B | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/4955 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | COMPOUND SODIUM LACTATE INFU. | COMPOUND SODIUM LACTATE | MULTI INGREDIENT | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/4956 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | CONTRAPAQUE 350 | IOHEXOL | 350MG | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTDPLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 01/07/2010 |
| NDA/MAL/HDP/4957 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | MUMFER | IRON (111) POLYMALTOSE COMPLEX + FOLIC ACID | 100MG + 500MCG | GLENMARK PHARMACEUTICALS LTD PLOT EPLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2004 |
| NDA/MAL/HDP/4958 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BENZOSED | MIDAZOLAM | 1MG/ML | TROIKAA PHARMACEUTICALS LTD .SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/4959 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PAEDIATRIC LINCTUS | CHLORPHENIRAMINE / PHENYLEPHRINE / DEXTROMETHORPHAN | 1MG/ 5MG/ 10MG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4962 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | BETAD | BETAMETHASONE DIPROPRIONATE | 0.05%W/W | S.KANT HEALTHCARE LTDPLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE,1.0X1.0X15.0 G TUBE | 01/07/2010 |
| NDA/MAL/HDP/4964 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PLUS PAEDIATRIC SUSPENSION | CHLORPHENAMINE+PHENYLEPHRINE+PARACETAMOL | IMG+5MG+160MG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/4965 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | BETAFEN SYRUP | IBUPROFEN | 100MG/5ML | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/4966 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS-650 | CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL | 2MG + 5MG + 650MG | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0X6.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/4968 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FRUSEMIDE INJECTION | FUROSEMIDE | 10MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2008 |
| NDA/MAL/HDP/4969 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZATHINE PENICILLIN | BENZATHINE PENICILLIN | 2.4 M.U | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.4 MU VIAL | 01/07/2001 |
| NDA/MAL/HDP/4971 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | AFRICURE PHARMACEUTICALS U LIMITED | FRUSEMIDE TABLETS | FUROSEMIDE | 40MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDPLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/4972 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | COOLMINT LISTERINE | MENTHOL + ALCOHOL 95% | 0.02% + 4.58ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 01/07/2001 |
| NDA/MAL/HDP/4973 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS | FOLLITROPIN ALFA/LUTROPIN ALFA | 150 I.U/75 I.U | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND | | ITALY| SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL + 1*1ML VIAL OF WFI | 01/07/2014 |
| NDA/MAL/HDP/4974 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | FRUSEMIDE TABLETS BP 40MG | FUROSEMIDE | 40MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/4976 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PERGLIM 2 | GLIMEPIRIDE | 2MG | INVENTIA HEALTHCARE PVT. LTD .FI – FI /1 ADDITIONAL AMBERNATH(EAST) – 421 506,MAHARASHTRA DIST. THANE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/4979 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | FUROSEMIDE | FUROSEMIDE | 10MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTDN-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| NDA/MAL/HDP/4982 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMAG TABLETS | MAGNESIUM TRISILICATE | 370MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/4983 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | PELASTIN | IMIPENEM + CILASTATIN | 500MG + 500MG | PT SANBE FARMAJI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2011 |
| NDA/MAL/HDP/4998 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | HYAN | LEVONORGESTREL | 0.03MG | MYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/4999 | UNIQUE PHARMACEUTICAL LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | PAMIDOL*370 | IOPAMIDOL | 755.3MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTDPLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 01/07/2010 |
| NDA/MAL/HDP/5001 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | GENTAMICIN INJECTION | GENTAMYCIN | 80MG/2ML | WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE | 01/07/2007 |
| NDA/MAL/HDP/5002 | ELI-LILLY EXPORT SA | LABOREX UGANDA LIMITED | HUMALOG MIX 25 | INSULIN LISPRO + INSULIN LISPRO PROTAMINE | 25I.U+75I.U | LILLY FRANCE SAFRANCE | FRANCE | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 01/07/2000 |
| NDA/MAL/HDP/5004 | GLAXOSMITHKLINE LIMITED LIKONI | BETA HEALTHCARE UGANDA LIMITED | COFTA TABLETS | MULTI-INGREDIENT | N/A | GLAXOSMITHKLINE LIMITED - 78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY LOZENGES | 1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON,1.0X150.0 TABLET CARTON | 01/07/1997 |
| NDA/MAL/HDP/5005 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | COLD GO | PARACETAMOL+PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE MALEATE+CAFFEINE | 325MG+10MG+2MG+30MG | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5008 | UNIMED INDIA | ASTRA PHARMA (U) LIMITED | COLDAFEX | MULTI-INGREDIENT | MULTI-INGREDIENT | UNIMED INDIA86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/5010 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | ZARIN CREAM | MICONAZOLE NITRATE | 2%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5011 | UNIMED INDIA | ASTRA PHARMA (U) LIMITED | COLDAFEX TABLETS | MULTI-INGREDIENT | MULTI-INGREDIENT | UNIMED INDIA86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5014 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | VERMOREX SUSPENSION | MEBENDAZOLE | 100MG/5ML | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | J.B CHEMICALS & PHARMACEUTICALS LTD128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/5015 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | COLDCAP CAPSULES | PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE | 5MG+4MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X8.0X12.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5017 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP SYRUP | PARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG/5ML + 2MG/5ML + 10MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5018 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | VENTOLIN | SALBUTAMOL | 100MCG | GLAXO WELLCOME PRODUCTION.ZONE INDUSTRIELLE NO.2 23, RUE LAVOISIER 27000 EVREUX,FRANCE. | FRANCE | | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/1997 |
| NDA/MAL/HDP/5019 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | COLOSPASMIN FORTE | MEBEVERINE | 135MG | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)-EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O) | | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5021 | BAYER SCHERING PHARMA FRANCE | SURGIPHARM (U) LIMITED | COMBINATION 3 | ETHINYL ESTRADIOL+ LEVONORGESTREL+FERROUS FUMARATE | 0.03MG+0.15MG+75MG | BAYER PHARMA AG -13353 BERLIN GERMANY | BAYER WEIMAR GMBH UND CO. KG,-WEIMAR DEBEREINERSTRASSE 20, 99427 WEIMAR GERMANY | | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X28.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5028 | THE MENTHOLATUM COMPANY LTD TWY | HARLEYS UGANDA LIMITED | DEEP HEAT SPRAY | MULTI-INGREDIENT | MULTI-INGREDIENT | COLEP LAUPHEIM GMBH & CO KG-FOCKESTRASSE 12, 88471, LAUPHEIM | | GERMANY | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X150.0 ML CANNISTER | 01/07/1997 |
| NDA/MAL/HDP/5030 | PFIZER LAB LTD | LABOREX UGANDA LIMITED | SOLU-MEDROL | METHYLPREDNISOLONE HEMISUCCINATE | 125MG/2ML | PFIZER GLOBAL MANUFACTURING BELGIUM NVRIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 ML VIAL,1.0X8.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/5031 | THE MENTHOLATUM COMPANY LTD | HARLEYS UGANDA LIMITED | DEEP HEAT RUB | MULTI-INGREDIENT | MULTI-INGREDIENT | THE MENTHOLATUM COMPANY LTD, TWYFORD,1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND | UNITED KINGDOM | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X35.0 G TUBE,1.0X67.0 G TUBE,1.0X100.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5032 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | DELASED DRY COUGH SYRUP (NON DROWSY) | DEXTROMETHORPHAN | 7.5MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/HDP/5033 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | MEBFIL TABLETS | MEBENDAZOLE | 100MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5035 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEBENDAZOLE | MEBENDAZOLE | 100MG/5ML | MEDICAMEN BIOTECH LTD - SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/5038 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-CAM TABLETS | MELOXICAM | 15MG | UNICHEM LABORATORIES LIMITEDUNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER | 01/07/2002 |
| NDA/MAL/HDP/5040 | PFIZER LABORATORIES (PTY) LTD BELGIUM | LABOREX UGANDA LIMITED | DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 40MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NVRIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL,1.0X2.0 ML VIAL,1.0X5.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/5041 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | MAXITROL | DEXAMETHASONE/NEOMYCIN/POLYMYXIN B | 0.1%W/W +0.1%W/W+6000 I.U | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5042 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSATRIM DS TABLETS | CO-TRIMOXAZOLE | 960MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/5043 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | MAXITROL | DEXAMETHASONE/NEOMYCIN/POLYMYXIN B | 0.1%W/W+3500I.U/ML+6000I.U/ML | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5044 | PFIZER LABORATORIES (PTY) LTD BELGIUM | LABOREX UGANDA LIMITED | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 150MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NVRIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | | PARENTERAL ORDINARY I M VIALS | 1.0X3.5 ML VIAL,1.0X1.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/5049 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN PLUS 300/12.5 | IRBESARTAN/HYDROCHLOROTHIAZIDE | 300MG/12.5MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2013 |
| NDA/MAL/HDP/5050 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | MAXIDEX | DEXAMETHASONE | 0.1%W/V | ALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5053 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DERMX | ECONAZOLE/ TRIAMCINOLONE/ GENTAMYCIN | 1%/0.1%/0.1% | S KANT HEALTH CARE LTDPLOT 1802 – 1805 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2011 |
| NDA/MAL/HDP/5055 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | DERMOVATE | CLOBETASOL PROPIONATE | 0.05%W/W | GLAXOSMITHKLINE HARMIRE GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X25.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5064 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | MANNITOL INFUSION | MANNITOL | 20%W/V | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/5065 | N.V. ORGANON | SURGIPHARM (U) LIMITED | MARVELON | DESOGESTREL/ETHINYLESTRADIOL | 150MG/30MG | N.V. ORGANONKLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND | NETHERLANDS | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X1.0X28.0 TABLET BLISTER | 01/07/2015 |
| NDA/MAL/HDP/5068 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 8MG/2ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | CHINA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2010 |
| NDA/MAL/HDP/5070 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-60 | ENOXAPARIN SODIUM | 60MG/0.6ML | EMCURE PHARMACEUTICALS LTD PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 01/07/2009 |
| NDA/MAL/HDP/5071 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-40 | ENOXAPARIN SODIUM | 40MG/0.4ML | EMCURE PHARMACEUTICALS LTD PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE | 01/07/2009 |
| NDA/MAL/HDP/5073 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEXONA EYE/EAR DROP | DEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE | 0.35%W/V+0.1%W/V | AHLCON PARENTERALS (INDIA) LTDSP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5074 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEXONA INJECTION | DEXAMETHASONE DISODIUM PHOSPHATE | 4MG/ML | SAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X6.0X2.0 ML VIAL,16.0X6.0X2.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/5076 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | DEXTRACIN EYE DROPS | DEXAMETHASONE + NEOMYCIN | 0.1MG + 0.5MG | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5078 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | GLANDIN E2 VAGINAL | DINOPROSTONE | 3MG | NABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | | VAGINAL TABLETS | 1.0X1.0 TABLET STRIP | 01/07/2006 |
| NDA/MAL/HDP/5079 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEMONT CT 5 | MONTELUKAST | 5MG | GLENMARK PHARMACEUTICALS LTD .VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/5080 | GENO PHARMACEUTICALS PVT LTD | HARLEYS UGANDA LIMITED | LOBAK | DICLOFENAC/PARACETAMOL/CHLORZOXAZONE | 50MG/325MG/250MG | GENO PHARMACEUTICALS LTD-PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5086 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GLIFIL M FORT | GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE | 5MG+500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/5092 | MICRO LABS LTD 92 SIPCOT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE | GLIMEPIRIDE | 2MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5095 | MICRO LABS LTD | LABOREX UGANDA LIMITED | DIAPRIDE PLUS | GLIMEPIRIDE + METFORMIN | 1MG + 500MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/5096 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | SCABION | CROTAMITON + SULPHUR | 10 G + 2G/100G | ATCO LABS LTD,B-18, S.I.T.E, KARACHI | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X60.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/5099 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | GLUCOMET | METFORMIN | 500MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X4.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5100 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | L-GENTA | GENTAMICIN | 0.3%W/V | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL | 01/07/2005 |
| NDA/MAL/HDP/5102 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 500MG | METFORMIN | 500MG | NKUNZI PHARMACEUTICALS (PTY) LTD.259 DAVIDSON ROAD CNR PEDDIE STREET, WADEVILLE EST. 1 GERMISTON 1422 | MERCK SANTÉ2, RUE DU PRESSOIR VERT F 45400, SEMOY | FRANCE | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X6.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5103 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 1000MG | METFORMIN | 1000MG | NKUNZI PHARMACEUTICALS (PTY) LTD -259 DAVIDSON ROAD, WADEVILLE, EXT 1, GERMINSTON, SOUTH AFRICA | SOUTH AFRICA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X15.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5104 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVEMIR FLEXPEN | INSULIN DETEMIR | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERD | DENMARK | BRAZIL | FRANCE | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN | 01/07/2014 |
| NDA/MAL/HDP/5106 | ESAPHARM SRL | BYAMAKA PHARMACEUTICAL COMPANY LTD | LEMONVATE CREAM | CLOBETASOL PROPIONATE | 0.05%W/W | ESAPHARMA SRLVIA DE GASPERI, 13-20066 MELZO (MILAN) ITALY | ITALY | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2003 |
| NDA/MAL/HDP/5107 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | INDOREN CAPSULES | INDOMETHACIN | 25MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/2000 |
| NDA/MAL/HDP/5109 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | LEBASMA ORAL SOLUTION | SALBUTAMOL | 2MG/5ML | LEBEN LAB PVT LTDL4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/5110 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | GLUCOSE INFUSION BP | DEXTROSE | 5%W/V | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5111 | FREDUN PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | LAXAFRED | BISACODYL | 5MG | FREDUN PHARMACEUTICALS LIMITED,14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5112 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL SR TABLETS | DICLOFENAC SODIUM | 100MG | WIN MEDICARE PVT LIMITEDMEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/5115 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | INDOS-25 | INDOMETHACIN | 25MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| NDA/MAL/HDP/5117 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | LASTINEM | IMIPENEM + CILASTATIN | 500MG + 500MG | VENUS REMMEDIESUNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1 BHOTOLI KALA BADDI INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/5119 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | KONTRAC 200 | MISOPROSTOL | 200MCG | FOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/5120 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GLYFORMIN 500 TABLETS | METFORMIN | 500MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/1999 |
| NDA/MAL/HDP/5121 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN GEL | DICLOFENAC DIETHYLAMMONIUM | 1%W/W | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)-304-308 ,GIDC , PANOLI 394116 | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X50.0 G TUBE,1.0X20.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5122 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | KOFAREST SYRUP | SALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL | 2MG+30MG+100MG+5MG/10ML | CENTAUR PHARMACEUTICALS LTDPLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/5124 | GLAXOSMITHKLINE LTD BELGIUM | UNITED HEALTHCARE DISTRIBUTORS LTD | INFANRIX-HEXA | DIPHTHERIA TOXOID+TETANUS TOXOID+PERTUSSIS TOXOID(PT)+FILAMENTOUS HAEMAGGLUTININ(FHA)+PERTACTIN(69KDA OMP)+HBSAG PURIFIED,INACTIVATED POLIO VIRUS TYPE I+INACTIVATED POLIO VIRUS TYPE II+INACTIVATED POLIO VIRUS TYPE III+PURIFIED CAPSULAR POLYSACCHARIDE OF HIB COVALENTLY BOUND TO TETANUS TOXOID(PRP-T) | MIN 30 I.U+MIN 40 I.U+25?G+25?G+8?G+10?G,40DU+8DU+32DU+10?G | GLAXOSMITHKLINE BOILOGICALSS.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | | PARENTERAL ORDINARY COMBINATION PACK VIALS | 1.0X1.0 PACK CARTON (DTPA-HBV-IPV IN PREFILLED SYRINGE + 2 NEEDLES+FREEZE DRIED HIB IN A VIAL) | 01/07/2013 |
| NDA/MAL/HDP/5125 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | GLYGESIC FORTE RHUMETIC CREAM | MULTI INGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1998 |
| NDA/MAL/HDP/5128 | MERCK (PTY) LTD | ABACUS PHARMA (AFRICA) LIMITED | GOFEN 400 CLEARCAP | IBUPROFEN | 400MG | MEGA LIFESCIENCES LTD.384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN | THAILAND | | ORAL SOLID ORDINARY CAPSULES | 6.0X1.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/5129 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | KLEEN ENEMA | DISODIUM BISPHOSPHATE/ SODIUM PHOSPHATE | 19.2G+7.2G/ 120ML | NABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X135.0 ML BOTTLE | 01/07/2006 |
| NDA/MAL/HDP/5130 | UNIQUE PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN MS GEL | DICLOFENAC+METHYL SALICYLATE+MENTHOL | 1%W/W+10%W/W+5%W/W | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)-304-308 ,GIDC , PANOLI 394116 | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2005 |
| NDA/MAL/HDP/5131 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INSULATARD | ISOPHANE INSULIN (HUMAN) | 100 I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PHARMANOVO ALLE | DENMARK | FRANCE | | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| NDA/MAL/HDP/5133 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 900IU/1.5ML(66MCG/1.5ML) | FOLLITROPIN ALFA | 66MCG/1.5ML | MERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND | | ITALY| SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0 CARTRIDGE PREFILLED PEN + 20 NEEDLES FOR INJECTION,1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION. | 01/07/2015 |
| NDA/MAL/HDP/5134 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | GOODMORNING COUGH TABLETS | MULTIINGREDIENT | N/A | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CARTON | 01/07/1997 |
| NDA/MAL/HDP/5135 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | KETOZ | KETOCONAZOLE | 2%W/W | SK ANT HEALTHCARE LTD1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/2010 |
| NDA/MAL/HDP/5136 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | GOODMORNING LUNG TONIC | MULTIINGREDIENT | N/A | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5139 | NOVO NORDISK | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INSULATARD HM PENFILL | ISOPHANE INSULIN (HUMAN) | 100I.U/ML | NOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | NOVO NORDISK PHARMANOVO ALLE | DENMARK | BRAZIL | FRANCE | PARENTERAL ORDINARY CARTRIDGES | 1.0X5.0X3.0 ML PREFILLED PEN,1.0X5.0X1.5 ML PREFILLED PEN | 01/07/1997 |
| NDA/MAL/HDP/5140 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | DIFLUCAN | FLUCONAZOLE | 200MG | FAREVA AMBOISE - ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5142 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | INTAMINE CREAM | MEPYRAMINE MALEATE | 2%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X400.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5143 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 25MG | METOPROLOL | 25MG | ASTRA ZENECA ABGARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5146 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 100MG | METOPROLOL | 100MG | ASTRA ZENECA ABSE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/5147 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 50MG | METOPROLOL | 50MG | ASTRA ZENECA ABGARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/5150 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | KETO PLUS SHAMPOO | KETOCONAZOLE + ZINC PYRITHIONE | 2%W/W + 1%W/W | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X60.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/5154 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETASIL PAEDIATRIC SYRUP | IPECACUANHA TINCTURE | 0.5ML | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X50.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5155 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BETAVEL | MULTI-INGREDIENT | N/A | NEM LABORATORIES PVT LTD133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5157 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BETAVEL N | BETAMETHASONE+NEOMYCIN SULPHATE | 1MG+5MG | NEM LABORATORIES PVT LTD133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X3.0 G TUBE,1.0X15.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5161 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | ROYAL PHARMA 2011 LIMITED | GRISEOSIM-500 | GRISEOFULVIN | 500MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5164 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BROMSAL EXPECTORANT | SALBUTAMOL SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 1MG+2MG+50MG+0.5MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/5165 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GRISEOFULVIN 500 TABLETS | GRISEOFULVIN | 500MG | REMEDICA LIMITEDLIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER | 01/07/2003 |
| NDA/MAL/HDP/5167 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | BRUSTAN TABLETS | IBUPROFEN + PARACETAMOL | 400MG + 325MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/5169 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GVGYL SUPPOSITORY | METRONIDAZOLE BP | 500MG | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER | 01/07/2007 |
| NDA/MAL/HDP/5170 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDITRAL CAPSULE | ITRACONAZOLE | 100MG | GLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,D | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE STRIP, 1.0X10.0X1.0X4.0 CAPSULE STRIP | 01/07/2000 |
| NDA/MAL/HDP/5171 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | KETAMAX-50 | KETAMINE | 50MG/ML | TROIKAA PHARMACUETICALS LIMITEDC-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 01/07/2011 |
| NDA/MAL/HDP/5176 | BAYER AG | SURGIPHARM (U) LIMITED | CANESTEN | CLOTRIMAZOLE | 100MG | BAYER AG D-51368 LEVERKUSEN GERMANY | GERMANY | | VAGINAL TABLETS | 1.0X6.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/5177 | YURIA PHARM LTD | PHARMA VILLE LIMITED | ISONIAZID | ISONIAZID | 100MG/5ML | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/5179 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 200MG CAPSULES | CEFIXIME TRIHYDRATE | 200MG | PHARMA INTERNATIONAL CO.,AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X8.0 CAPSULE BLISTER | 01/07/2007 |
| NDA/MAL/HDP/5180 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ISORYN DROPS ( PAEDRIATRIC) | EPHEDRINE HYDROCHLORIDE | 5MG/ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5182 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ISORYN DROPS (ADULT) | EPHEDRINE HYDROCHLORIDE | 10MG/ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5183 | PHARCO B PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GYNOZOL VAGINAL CAPSULES | MICONAZOLE NITRATE | 400MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | VAGINAL SUPPOSITORIES | 1.0X3.0 CAPSULE BLISTER | 01/07/2000 |
| NDA/MAL/HDP/5184 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GYNOZOL VAGINAL CREAM | MICONAZOLE NITRATE | 2%W/W | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | VAGINAL CREAMS | 1.0X40.0 G TUBE | 01/07/2000 |
| NDA/MAL/HDP/5186 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ISOTROY 250 | ISOFLURANE | 250ML | TROIKAA PHARMACEUTICALS LTDTHOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | INDIA | | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/5187 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | HEALIT SKIN OINTMENT | BACITRACIN+POLYMYXIN B SO4+NEOMYCIN+LIDOCAINE | 500UNITS+5000UNITS+3.5MG+40MG/G | ATCO LABORATORIES PVT LTDB-18,S.I.T.E KARACHI, PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 01/07/2007 |
| NDA/MAL/HDP/5188 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ITRAZ CAPSULES | ITRACONAZOLE | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER | 01/07/2009 |
| NDA/MAL/HDP/5200 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HYDRALAZINE TABLETS B.P 25MG. | HYDRALAZINE HYDROCHLORIDE | 25MG | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1998 |
| NDA/MAL/HDP/5201 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM BENDAZOLE | MEBENDAZOLE | 100MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5205 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-VENT | SALBUTAMOL | 4MG | KAMPALA PHARMACEUTICALS INDUSTIESPLOT NO M44B STRETCHER ROAD INTINDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET JAR,1.0X500.0 TABLET JAR,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5207 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | DIGOXIN TABLETS | DIGOXIN | 0.25MG | NEM LABORATORIES PVT. LIMITED133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA - INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/5211 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DINAC GEL | DICLOFENAC | 1%W/W | S KANT HEALTHCARE LTD1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2009 |
| NDA/MAL/HDP/5214 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | NIRMET | METRONIDAZOLE | 500MG/100ML | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/5215 | J.B CHEMICALS & PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | METROGYL TABLETS | METRONIDAZOLE | 200MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD .128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | GLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X5.0X2.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/5221 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG/3ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE | 01/07/2006 |
| NDA/MAL/HDP/5222 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | EMTRICITABINE+TENOFOVIR DF | EMTRICITABINE/TENOFOVIR | 200MG/300MG | MYLAN LABORATORIES LTD-F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE | MYLAN LABORATORIES LTD ,PLOT NO. 11, 12, & 13 INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III PITHAMPUR 454775, DIST DHAR – MADHYA PRADESH | MYLAN LABORATORIES LIMITED.PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 07/07/2008 |
| NDA/MAL/HDP/5224 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | EMTRICITABINE/TENOFOVIR DISOPROXIL FUMERATE | 200MG/300MG | AUROBINDO PHARMA LTD UNIT IIIAUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2009 |
| NDA/MAL/HDP/5226 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | 200MG/300MG | HETERO LABS LTD (UNIT-V)SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO DRUGS LTDUNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2013 |
| NDA/MAL/HDP/5228 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | DICLOGENTA | DICLOFENAC SODIUM+GENTAMICIN SULPHATE | 1MG/ML+3MG/ML | CENTAUR PHARMACEUTICALS PVT LTD -PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/5231 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ENAPRIL 10 | ENALAPRIL MALEATE | 10MG | INTAS PHARMACEUTICALS LTDPLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5232 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ENAPRIL-5 | ENALAPRIL MALEATE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2006 |
| NDA/MAL/HDP/5233 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | ENVAS 10 MG TABLETS | ENALAPRIL | 10MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5234 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | ENVAS 5MG TABLETS | ENALAPRIL MALEATE | 5MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5235 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | DICLORAN DELAYED-RELEASE TABLETS | DICLOFENAC SODIUM | 50MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | GLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | | ORAL SOLID RETARD ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,5.0X2.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5243 | IND SWIFT LTD | PLANET PHARMACEUTICALS UGANDA LTD | EZO 20 | ESOMEPRAZOLE MAGNESIUM | 20MG | 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 |
| NDA/MAL/HDP/5245 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | FABUTAS-40 | FEBUXOSTAT | 40MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/5248 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-AMPI | AMPICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5249 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ENCIFER | IRON SUCROSE | 100MG/5ML | SAMRUDH PHARMACEUTICALS PVT LTDJ-174, J-168 & J-168/1, MIDC, TARAPUL, BOISAR, DIST THANE-401506 | EMCURE PHARMACEUTICALS LTD PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/5250 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCOLIN SYRUP | SALBUTAMOL + AMMONIUM CHLORIDE | 2MG/5ML +100MG/5ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/HDP/5251 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DIFLUCAN | FLUCONAZOLE | 150MG | PFIZER PGM AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE | FRANCE | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5255 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ENO LEMONFRUIT SALT | MULTI-INGREDIENT | MULTI-INGREDIENT | GLAXO SMITH KLINE LTDLIKONI RD, INDUSTRIAL AREA,NAIROBI KENYA | KENYA | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X8.0X4.5 G SACHET,1.0X10.0X4.5 G SACHET,1.0X48.0X4.5 G SACHET,1.0X4.0X4.5 G SACHET,1.0X24.0X4.5 G SACHET | 01/07/1997 |
| NDA/MAL/HDP/5260 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ERYMYCIN | ERYTHROMYCIN ESTOLATE | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5269 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | DIVAA OD 500 | DIVALPROEX | 500MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5271 | REGAL PHARMA U LIMITED | REGAL PHARMA (U) LTD | ERYTHYL SYRUP | ERYTHROMYCIN ETHYL SUCCINATE | 125MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5272 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DIX | DIGOXIN | 0.25MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/2011 |
| NDA/MAL/HDP/5279 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DOSIN | DOXAZOCIN | 2MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5281 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL | EFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 600MG +200MG + 300MG | AUROBINDO PHARMA LTD UNIT VIISEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2015 |
| NDA/MAL/HDP/5282 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DORFEN | ACECLOFENAC | 100MG | TRIVENI FORMULATIONS LIMITED -PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/5283 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX GEL | IBUPROFEN | 5%W/W | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL EMULSION GELS | 1.0X25.0 G TUBE | 01/07/2001 |
| NDA/MAL/HDP/5284 | HETERO LABS LTD | AIVEEN (U) LIMITED | EFAVIRENZ+EMTRICITABINE+TENOFOVIR | EFAVIRENZ + EMTRICITABINE + TENOFOVIR | 600MG + 200MG + 300MG | HETERO LABS LTD(UNIT V).JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2012 |
| NDA/MAL/HDP/5287 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE | 600MG + 300MG + 300MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2014 |
| NDA/MAL/HDP/5288 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX SUSPENSION | IBUPROFEN | 100MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 100.0 ML BOTTLE,60.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5291 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX TABLET | IBUPROFEN | 200MG | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5292 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DOMI 10 | DOMPERIDONE | 10MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5295 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | DOXY | DOXYCYCLINE | 100MG | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X280.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2000 |
| NDA/MAL/HDP/5298 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | ELOGYL | METRONIDAZOLE | 200MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5299 | PHARMA INTERNATIONAL.CO | OMAB UGANDA LIMITED | KENAZOLE | KETOCONAZOLE | 20MG/ML | PHARMA INTERNATIONAL COMPANY ,.AL-QASTAL INDUSTRIAL AREA/AMMAN | JORDAN | | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/5300 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DOLAC | KETOROLAC TROMETHAMINE | 30MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 01/07/2015 |
| NDA/MAL/HDP/5302 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | IBUGO-COMBI | IBUPROFEN + PARACETAMOL + CAFFEINE | 200MG + 325MG + 30MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2014 |
| NDA/MAL/HDP/5305 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | IBUGO - 200 | IBUPROFEN | 200MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/5307 | USV PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DUOTROL | GLYBURIDE + METFORMIN HYDROCHLORIDE | 5MG + 500MG | FREDUN PHARMACEUTICALS LIMITED--14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5311 | ABBOTT HEALTHCARE PRODUCTS B.V. | HARLEYS UGANDA LIMITED | DUPHASTON TABLETS | DYDROGESTERONE | 10MG | ABBOTT BIOLOGICALS B.V ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLST | NETHERLANDS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/5312 | ELYS CHEMICAL INDUSTRIES LTD | ELYS CHEMICALS INDUSTRIES UGANDA LTD | DOXYCYCLINE | DOXYCYCLINE | 100MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/5316 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR | DICLOFENAC SODIUM + PARACETAMOL | 50MG + 500MG | TROIKAA PHARMACEUTICALS LTD .SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/5317 | MACK BROWN | SHURIK LTD | DR MAC'S COUGH FORMULA | TERBUTALINE SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 2.5MG+8.0MG+100MG+5MG | TORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/HDP/5318 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR AQ (1ML) | DICLOFENAC SODIUM | 75MG/ML | TROIKAA PHARMACEUTICALS LTD .SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE | 01/07/2009 |
| NDA/MAL/HDP/5320 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | INDOL | INDOMETHACIN | 25MG | LEBEN LAB PVT LTDL4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5321 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | IBUGESIC COLD & SINUS | IBUPROFEN/PSEUDOEPHEDRINE | 200MG/30MG | DAR AL DAWANA'UR PLANT AMMAN | JORDAN | | ORAL SOLID ORDINARY GELATIN-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2012 |
| NDA/MAL/HDP/5323 | STEDMAN PHARMACEUTICALS LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | IODINATED POVIDONE + METRONIDAZOLE | 1.0% W/V + 5.0% W/V | STEDMAN PHARMACEUTICALS PVT LTD...C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML CONTAINER,1.0X30.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 01/07/2010 |
| NDA/MAL/HDP/5324 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | IBUFIL 400 | IBUPROFEN | 400MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1998 |
| NDA/MAL/HDP/5326 | UNIQUE PHARMACEUTICALS LABORATORIES | PLANET PHARMACEUTICALS UGANDA LTD | ECODAX G CREAM | ECONAZOLE NITRATE + GENTAMYCIN + BECLAMETASONE | 1%+0.1%+0.025% | UNIQUE PHARMACEUTICAL LABORATORIESPLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X100.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5327 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | IBUFIL 200 | IBUPROFEN | 200MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5330 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ-V | MICONAZOLE + METRONIDAZOLE | 2.0%W/W + 1.0%W/W | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2011 |
| NDA/MAL/HDP/5333 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | IBUFEN | IBUPROFEN | 200MG | KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTDPLOT M444 B STRETCHER ROAD NTINDA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,500.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,250.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5338 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | HYDROSIL TABLETS | ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE+SIMETHICONE | 200MG+200MG+20MG | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X20.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5341 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | HYDOPA | METHYLDOPA | 250MG | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5346 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFUTIL 500 | CEFUROXIME AXETIL | 500MG | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET CONTAINER | 01/07/2014 |
| NDA/MAL/HDP/5347 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | CEFUTIL 250 | CEFUROXIME AXETIL | 250MG | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/5348 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEPID 20 | INTRAVENOUS FAT EMULSION | 20%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/5352 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | MUMFER | IRON(111) POLYMALTOSE COMPLEX | 50MG/5ML | GLENMARK PHARMACEUTICALS LTD PLOT EPLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/5356 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | BURNNEM | MULTI-INGREDIENT | N/A | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/1997 |
| NDA/MAL/HDP/5358 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | CADISTIN EXPECTORANT | CHLORPHENIRAMINE MALEATE + GUAIFENESIN + AMMONIUM CHLORIDE + SODIUM CITRATE + LEVOMENTHOL + TERPIN HYDRATE + TOLU BALSAM + VASAKA SYRUP | (2MG + 80MG + 100MG + 44MG + 0.8MG + 4MG + 6MG + 0.133ML)/5ML | SAKAR HEALTHCARE PVT LTDSAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5361 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | CALFIC | MULTI-INGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/5362 | ASTRA ZENECA | MACNAUGHTON LIMITED | CASODEX 150MG | BICALUTAMIDE | 150MG | ASTRAZENECA MACCLESFIELDCHESHIRE | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 2.0X14.0 TABLET STRIP | 01/07/2001 |
| NDA/MAL/HDP/5363 | ASTRA ZENECA | MACNAUGHTON LIMITED | CASODEX 50MG | BICALUTAMIDE | 50MG | BULK CORDEN PHARMA GMBHOTT HAHN STRASSE ,68723 GERMANY | ASTRA ZENECA UK LIMITEDASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5366 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | CEFIM | CEFIXIME | 400MG | HILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0 CAPSULE STRIP | 01/07/2005 |
| NDA/MAL/HDP/5367 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | CEFIM | CEFIXIME | 100MG/5ML | HILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/5368 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | CEFIX 100MG/5ML DRY SUSPENSION | CEFIXIME | 100MG/5ML | PHARMA INTERNATIONAL CO.AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/5370 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HYOSCINE BUTYLBROMIDE | HYOSCINE N-BUTYLBROMIDE | 10 MG | COSMOS LIMITED RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5377 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN FOUR FLU LIQUID | DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE | 25MG/20ML + 1G/20ML + 45MG/20ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/5379 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZOLANAS-30 | LANSOPRAZOLE | 30MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2008 |
| NDA/MAL/HDP/5380 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIROZEP | DIAZEPAM | 5MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD .N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/5381 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | ADIFLAM GEL | DICLOFENAC DIETHYLAMINE | 1.16%W/W | LEBEN LABORATORIES PVT. LTDPLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS). | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2008 |
| NDA/MAL/HDP/5386 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | UDIHEP TABLETS | URSODEOXYCHOLIC ACID | 150MG | WIN- MEDICARE LTDMODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/5388 | IPCA LABORATOIES LTD | MEDVIN PHARMA LIMITED | LARINATE-60 | ARTESUNATE | 60MG | IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067 | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML SODIUM CHLORIDE INJECTION + 1*1 ML AMPOULE OF SODIUM BICARBONATE INJECTION | 01/07/2011 |
| NDA/MAL/HDP/5389 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LUMARTEM | ARTEMETHER + LUMEFANTRINE | 20MG + 120 MG | CIPLA LTD., PATALGANGA UNIT I & UNIT IIPLOT NO. A-33(UNIT-I), A-42( UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRA, INDIA | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5391 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | NITROFURANTOIN | NITROFURANTOIN | 100MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER | 01/07/2008 |
| NDA/MAL/HDP/5392 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMLO-DENK 10 | AMLODIPINE MESILATE MONOHYDRATE | 10MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/5393 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMLO-DENK 5 | AMLODIPINE MESILATE MONOHYDRATE | 5MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/5394 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FINAZOL | ALBENDAZOLE | 400MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/2007 |
| NDA/MAL/HDP/5395 | MICRO LABS LTD | LABOREX UGANDA LIMITED | OFLOX | OFLOXACIN | 200MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5400 | GLAXOSMITHKLINE TRADING SERVICES LTD, IRELAND | UNITED HEALTHCARE DISTRIBUTORS LTD | ALBEN SUSPENSION | ALBENDAZOLE | 400MG/10ML | PANACEA BIOTEC LTDMALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE | 01/07/1999 |
| NDA/MAL/HDP/5404 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HIFENAC P | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/5406 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HIFENAC SR | ACECLOFENAC | 200 MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/5407 | THEMIS PHARMACEUTICALS | STAR PHARMACEUTICALS LTD | E MAL-75 | ALPHA-BETA ARTEETHER | 75MG/ML | THEMIS MEDICARE LTDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X1.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/5410 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | UNICTAM 1500 | AMPICILLIN + SULBACTAM | 1000 MG + 500 MG | MEDICAL UNION PHARMACEUTICALS LTD - ABU SULTAN, CR 13363 ISMAILLIA, EGYPT | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2009 |
| NDA/MAL/HDP/5414 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | XYLO-ACINO 0.1% | XYLOMETAZOLINE | 0.1 % W/V | MERCKLE GMBH,LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | | NASAL TOPICAL DROPS | 1.0X1.0X10.0 ML BOTTLE | 01/07/2007 |
| NDA/MAL/HDP/5415 | CENTAUR PHARMACEUTICALS PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST | OXYMETAZOLINE | 0.05%W/V | CENTAUR PHARMACEUTICALS PVT LTD -PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/5416 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CIPROX | CIPROFLOXACIN | 0.2%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/5417 | PHARMA INTERNATIONAL.CO | OMAB UGANDA LIMITED | CIPROPHARM | CIPROFLOXACIN | 500MG | PHARMA INTERNATIONAL COMPANYMAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/5418 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | PAEDIATRIC CO-TRIMOXAZOLE | CO-TRIMOXAZOLE | 240MG/5ML | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/5419 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CPM | CHLORPHENIRAMINE | 4MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5423 | HETERO LABS LTD | AIVEEN (U) LIMITED | EFAVIRENZ+LAMIVUDINE+TENOFOVIR | EFAVIRENZ+LAMIVUDINE+TENOFOVIR | 600MG/300MG/300MG | HETERO LABS LTD. UNIT (V) .S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | HETERO DRUGS LTDUNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET JAR,1.0X100.0 TABLET JAR | 01/07/2013 |
| NDA/MAL/HDP/5427 | ACULIFE HEALTHCARE PVT LTD | ASTRA PHARMA (U) LIMITED | NIRCIP | CIPROFLOXACIN | 200MG/100MG | ACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/5428 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | CIPFIL 500 | CIPROFLOXACIN | 500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/5429 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CIPRO-500 | CIPROFLOXACIN | 500MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON | 01/07/2006 |
| NDA/MAL/HDP/5434 | MEDIPHARM (EA) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE CO-PACK | DT ZINC-20 + ORAL REHYDRATION SALTS (ORS) | 20G | MEDIPHARM INDUSTRIES( EA) LTDPLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X2.0X20.5 G SACHET + 1.0*10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/5435 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PIC | PARACETAMOL+IBUPROFEN+CAFFEINE | 500MG+200MG+30MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP | 01/07/2015 |
| NDA/MAL/HDP/5439 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENIRON SYRUP | VITAMIN B6 + FERROUS GLUCONATE + VITAMIN B1 + VITAMIN C + VITAMIN B2 | 2MG/5ML + 200MG/5ML + 2MG/5ML + 20MG/5ML + 2MG/5ML | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/5441 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL NASATAB TABLETS | PARACETAMOL+CHLORPHENIRAMINE+PSEUDOEPHEDRINE | 500MG+4MG+60MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/5442 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | CHLORAMPHENICOL OPHTHALMIC OINTMENT USP 1% | CHLORAMPHENICOL | 1%W/W | NEM LABORATORIES PVT LTD133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | | OPHTHALMIC OINTMENTS | 1.0X20.0X3.5 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/5449 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | CLOFENAC 50 | DICLOFENAC SODIUM | 50MG | HOVID BERHAD (CHEMOR SITE)-LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5457 | RAJESHI PLASTICS | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | FALCIMON 100/270 B/L | ARTESUNATE+AMODIAQUINE | 100MG+270MG | CIPLA LTD UNIT IIA-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/5458 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | FALCIMON 50/135 B/L | ARTESUNATE+AMODIAQUINE | 50MG+135MG | CIPLA LTD UNIT IIA-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER | 01/07/2014 |
| NDA/MAL/HDP/5460 | GUILIN PHARMACEUTICALS CO.LTD | TRIDEM PHARMA UGANDA LIMITED | ASAQ GPSC | ARTESUNATE+AMODIAQUINE | 50MG+135MG | GUILIN PHARMACEUTICALS CO. LTDNO 43 QULIDIAN ROAD GUILIN GUANGXI CHINA | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0X20.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5464 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/5467 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMSIDAR | SULFADOXINE/PYRIMETHAMINE | 525MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/5469 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NIMOTOP | NIMODIPINE | 0.2MG/ML | SOLUPHARM GMBH INDUSTRIESTRASSE 3, 34212 MELSUNGEN | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | PARENTERAL ORDINARY I V VIALS | 1.0X50.0 ML VIAL | 01/07/2009 |
| NDA/MAL/HDP/5471 | MICRO LABS LTD | LABOREX UGANDA LIMITED | AVAS 40 | ATORVASTATIN | 40MG | MICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/5472 | CLARIS OTSUKA LIMITED | REDDYS PHARMA LIMITED | NS | SODIUM CHLORIDE | 0.9%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTDVILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BAG | 01/07/2007 |
| NDA/MAL/HDP/5473 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TROYPOFOL | PROPOFOL | 1%W/V | TROIKAA PHARMACEUTICALS LTD .C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 01/07/2012 |
| NDA/MAL/HDP/5474 | PHARMA INTERNATIONAL.CO | OMAB UGANDA LIMITED | CEFODOX | CEFPODOXIME PROXETIL | 200MG | PHARMA INTERNATIONAL CO.AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/5476 | ACINO PHARMA AG | LABOREX UGANDA LIMITED | MESPORIN 1000MG I.V | CEFTRIAXONE | 1000MG | LABESFAL LABORATORIESALMIRO S.A ZONA INDUSTRIAL DO LAGEDO, 3465-157, SANTIAGO DE BESTERIROS PORTUGAL | PORTUGAL | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL + 10 ML WFI | 01/07/2002 |
| NDA/MAL/HDP/5478 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | BECORT 50 | BECLOMETHASONE DIPROPIONATE | 50MCG/ACTUATION | CIPLA LTD.- PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X1.0X200.0 METERED DOSE CANNISTER | 01/07/2010 |
| NDA/MAL/HDP/5479 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | RANFERON 12 CAPSULES | MULTI-INGREDIENT | MULTI-INGREDIENT | SUN PHARMACEUTICAL INDUSTRIES LIMITED,INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/5482 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-LIN | SALBUTAMOL | 2MG/5ML | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/5483 | GUILIN PHARMACEUTICALS CO.LTD | TRIDEM PHARMA UGANDA LIMITED | ASAQ GPSC | ARTESUNATE + AMODIAQUINE | 25 MG + 67.5 MG | GUILIN PHARMACEUTICALS CO. LTDNO 43 QULIDIAN ROAD GUILIN GUANGXI CHINA | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0X20.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/5486 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | FOSEAL 400 | SEVELAMER HCL | 400MG | EMCURE PHARMACEUTICALS LIMITEDPLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/5489 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORBIS-5 | BISOPROLOL | 5MG | UNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 01/07/2008 |
| NDA/MAL/HDP/5495 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCAL TABLETS | CALCIUM LACTATE | 300MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/5496 | ASTRAZENECA AG | MACNAUGHTON LIMITED | ATACAND 16MG | CANDESARTAN CILEXETIL | 16MG | ASTRA ZENECA ABSE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/5497 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | EXPEN | BENZYLPENICILLIN | 1MU | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL,1.0X100.0X1.0 MU VIAL | 01/07/2011 |
| NDA/MAL/HDP/5591 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSCILLIN | AMPICILLIN | 500MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL | 01/07/2011 |
| NDA/MAL/HDP/5619 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | RABELOC 20 | RABEPRAZOLE SODIUM | 20MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP | 01/07/2006 |
| NDA/MAL/HDP/5644 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4 MEGA UNITS | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X4.0 MU VIAL | 01/07/2001 |
| NDA/MAL/HDP/5648 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | CLOXACILLIN SODIUM | CLOXACILLIN SODIUM | 500MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD #14, II PHASE PIA, BANGALORE 560058 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL | 01/07/2010 |
| NDA/MAL/HDP/6032 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MET XL 100 | METOPROLOL SUCCINATE | 100MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6034 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN -250 DT | AMOXICILLIN TRIHYDRATE | 250 MG | MILAN LABS PVT LTD63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAI | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6036 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | OFLOTECH-O | OFLOXACIN + ORNIDAZOLE | 200MG + 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6037 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AVIT | VITAMIN A | 200,000 IU | OLIVE HEALTHCARE197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T) | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE JAR | 01/07/2017 |
| NDA/MAL/HDP/6040 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | U-TRYP | ULINASTATIN | 100,000 I.U | BHARAT SERUMS AND VACCINES LIMITED,PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2017 |
| NDA/MAL/HDP/6041 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CANDIZOL | CLOTRIMAZOLE | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP | 01/07/2017 |
| NDA/MAL/HDP/6050 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ITACARE | ITRACONAZOLE | 100MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6057 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | CORAM 5MG | AMLODIPINE BESYLATE | 5MG | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTDPLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/6059 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI CARE LIMITED | NEUROZONE | MECOBALAMIN + PREGABALIN | 750MCG + 75MG | ACME FORMULATION PVT LTD. ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6065 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PROXYREN | PIROXICAM | 20MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6067 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | DIAZEPAM | DIAZEPAM | 5MG | NEM LABORATORIES PVT LTD133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6070 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | VAZKOR | AMLODIPINE BESILATE | 10MG | DEVA HOLDING A.SCERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6071 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | VAZKOR | AMLODIPINE BESILATE | 5MG | DEVA HOLDING A.SCERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6075 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OLOHISTINE | OLOPATADINE HYDROCHLORIDE | 1MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6076 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 30MG | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*5 ML OF 0.9%W/V NACL AMPOULE + 1*1 ML OF 5%W/V NAHCO3 AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/6078 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6079 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | ALLERGEX | CHLORPHENIRAMINE MALEATE | 4MG | ADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6080 | EXPHAR SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FEBRILEX JUNIOR | PARACETAMOL+CHLORPHENIRAMINE MALEATE | 125MG+1MG/5ML | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6081 | TIANJIN MNCHIP TECHNOLOGIES CO.,LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANTALGEX T | PARACETAMOL/TRAMADOL HYDROCHLORIDE | 325MG/37.5MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6082 | EXPHAR SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CROMSOL | SODIUM CROMOGLYCATE | 2%W/V | AHLCONPARENTERALS (INDIA) LIMITEDSP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6086 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | ACEWEL-P | ACECLOFENAC+PARACETAMOL | 100MG+500MG | AKUMS DRUGS & PHARMACEUTICALS LTD19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6092 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 1000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875 MG + 125 MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6093 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 625 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500 MG + 125 MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6094 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 375 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 250 MG + 125 MG | SPARSH BIO-TECH PVT. LTDPLOT NO. 1; SURVEY NO. 242/243/244, LAKHABAVAD, JAMNAGAR-361 006, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6095 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DIPGEN | BETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE | 0.64 MG/G + 1 MG/G | S KANT HEALTHCARE LTD1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/6099 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | HARIPIL-60 | ARTESUNATE | 60MG | PSYCHOTROPICS INDIA LTD PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML OF 0.9% W/V NACL GLASS AMPOULE + 1*1 ML OF 5%W/V NAHCO3 GLASS AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/6101 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS-H 40/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6102 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS 80 | TELMISARTAN | 80MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6103 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | OZACE MD 5 | OLANZAPINE | 5MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6105 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | AZOPIL 200 | AZITHROMYCIN | 200MG/5ML | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1X15 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6106 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | TREVOX 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | SQUARE PHARMACEUTICALS LTDKALIAKOIR | BANGLADESH | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6107 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | SULPREX | IPRATROPIUM BROMIDE+SALBUTAMOL SULPHATE | 500MCG/2.5ML+2.5MG/2.5ML | SQUARE PHARMACEUTICALS LIMITEDKALIAKOIR GAZIPUR – 1750, BANGLADESH | BANGLADESH | | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X10.0 AMPOULE CARTON | 01/07/2017 |
| NDA/MAL/HDP/6110 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMBROX | AMBROXOL HYDROCHLORIDE | 15MG/5ML | SQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6114 | FDC LTD | AIVEEN (U) LIMITED | ZOXAN | CIPROFLOXACIN | 0.3% W/V | FDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/6115 | I-CARE PHARMA LTD | SUPER MEDIC LTD | TIZOL | TINIDAZOLE | 500MG | MEDICO REMEDIES PVT LTD,.8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X4 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/6117 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | GRAN-DENK | GRANISETRON HYDROCHLORIDE | 1MG/ML | SOLUPHARM GMBH INDUSTRIESTRASSE 3, 34212 MELSUNGEN | SIEGFRIED HAMELN GMBHLANGES FELD 13,31789 HAMELN | GERMANY | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE,1.0X5.0X3.0 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/6118 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | L-TRIM DS | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | LEBEN LABORATORIES PVT. LTDPLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS). | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6121 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LTD | DEXIREN | DEXKETOPROFEN TROMETAMOL | 25MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6126 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DERMOTRACIN | NEOMYCIN SULPHATE + BACITRACIN | 165,000 IU + 12,500 IU | MEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X150.0 ML CANNISTER | 01/07/2016 |
| NDA/MAL/HDP/6127 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | INTELENCE | ETRAVIRINE | 25MG | JANSSEN-CILAG S.P.A.VIA C. JANSSEN BORGO S. MICHELE 04100 LATINA | ITALY | | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6129 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | TRIUMEQ | DOLUTEGRAVIR + ABACAVIR + LAMIVUDINE | 50MG + 600MG + 300MG | GLAXOSMITHKLINE PHARMACEUTICALS SAGRUNWALDZKA 189 STREET, 60-322 POZNANA | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK | UNITED KINGDOM | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 01/07/2016 |
| NDA/MAL/HDP/6132 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | KETOVID | KETOCONAZOLE | 2%W/W | HOVID BHD 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X120.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6134 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ZAMADOL P | TRAMADOL HYDROCHLORIDE+ACETAMINOPHEN | 37.5MG+325MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6135 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TRIXONE-S | CEFTRIAXONE SODIUM+SULBACTAM | 1000MG+500MG | ZEISS PHARMA LIMITED-IGC,SIDCO, PHASE II, SAMBA, JAMMU - 184121,(J&K) | | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/6137 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | LUPRODEX | LEUPROLIDE ACETATE | 3.75MG | BHARAT SERUMS AND VACCINES LIMITED,PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA | INDIA | | PARENTERAL ORDINARY S C VIALS | 1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS | 01/07/2016 |
| NDA/MAL/HDP/6141 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | ACEWEL | ACECLOFENAC | 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6142 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCARB | ACTIVATED CHARCOAL | 0.25GM | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6143 | IESUS GROUP | SHREEJI PHARMACEUTICALS LIMITED | CONTRACTUBEX | EXTRACT CEPAE FLUID +HEPARIN SODIUM+ALLANTOIN | 10G+5000 I.U+1G/100G | MARCYRL PHARMACEUTICAL INDUSTRIES.EL OBOUR CITY CAIRO | EGYPT | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 01/07/2016 |
| NDA/MAL/HDP/6158 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DESEFIN | CEFTRIAXONE SODIUM | 1G | DEVA HOLDING A.SCERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2016 |
| NDA/MAL/HDP/6167 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AKUROSE | IRON SUCROSE | 20MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 07/01/2016 |
| NDA/MAL/HDP/6169 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | INTELENCE | ETRAVIRINE | 100MG | JANSSEN-CILAG S.P.A.VIA C. JANSSEN BORGO S. MICHELE 04100 LATINA | ITALY | | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6170 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ALACOT 0.1% EYE DROPS | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH | BANGLADESH | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 07/01/2016 |
| NDA/MAL/HDP/6176 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | G-GLUTAMIN | VITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID | 100MG+50MG+100MCG+50MG | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/6179 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ON.SETRON-DENK 4MG ODT | ONDANSENTRON | 4MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6181 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | AZINOWEL-500 | AZITHROMYCIN | 500MG | AKUMS DRUGS AND PHARMACEUTICALS LTDPLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6182 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ALARID | KETOTIFEN FUMARATE | 0.025%W/V | SQUARE PHARMACEUTICALS LTD DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6184 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 60MG | ETORICOXIB | 60MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6185 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | DOLOFORTE DENK | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6186 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 90MG F.C. TABLETS | ETORICOXIB | 90MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6187 | ALLY PHARMA OPTIONS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | FLOXCIP | CIPROFLOXACIN HYDROCHLORIDE | 500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA | | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X10X10 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6188 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | GAMA PHARMACEUTICALS (U) LIMITED | GIZLAN 150 | IRBESARTAN | 150MG | DAR AI DAWANA UR PLANT,AMMAN,JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6189 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | WORMEE-4 | ALBENDAZOLE | 400MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6190 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | D-LYTE | ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE | 2.7MG+0.52MG+0.58MG+0.30MG PER 200ML SACHET,6.75MG+1.30MG+1.45MG+0.75MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG PER 1000ML SACHET | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET | 01/07/2015 |
| NDA/MAL/HDP/6191 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KAPRON AMPOULE | TRANEXAMIC ACID | 500MG/5ML | 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 | | PARENTERAL ORDINARY AMPOULES | 1.0X6.0X5.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6201 | SPARSH BIO-TECH PVT.LTD. | ABACUS PHARMA (AFRICA) LIMITED | SPAMOXIFLOX | AMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM | 250MG + 250MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP | 01/07/2016 |
| NDA/MAL/HDP/6207 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | GO!GEL | DICLOFENAC DIETHYLAMINE+METHYL SALICYLATE | 1.16%W/W + 10%W/W | S KANT HEALTHCARE LTDPLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2016 |
| NDA/MAL/HDP/6211 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOFAINS | PARACETAMOL/DICLOFENAC SODIUM | 500MG/50MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6217 | INDIAN IMMUNOLOGICALS LTD | TATA UGANDA LIMITED | ELOVAC -B | HEPATITIS B (RDNA) | 20MCG/ML | HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LTD) RAKSHAPURAM GACHIBOWLI POST HYDERABAD 500032 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0 ML VIAL (1 DOSE VIAL) | 01/07/2016 |
| NDA/MAL/HDP/6218 | ASTRA ZENECA | MACNAUGHTON LIMITED | FORXIGA | DAPAGLIFLOZIN | 10MG | ASTRAZENECA PHARMACEUTICALS LP4601 HIGHWAY 62 EAST, MOUNT VERNON, IN 47620-1500 - UNITED STATES OF AMERICA | UNITED STATES | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6220 | SHOSAAN ASIC PACIFIC | RENE PHARMACY LTD | METHYLDOPA | METHYLDOPA | 250MG | NEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6224 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | NICLOFEN | DICLOFENAC SODIUM | 75MG/3ML | NITIN LIFESCIENCES LTD-RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025 | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1X10X5X2 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6227 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ISONIAZID | ISONIAZID | 300MG | MYLAN LABORATORIES LIMITED.PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6228 | CACHET PHAMACUITICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | ACINET | AMOXICILLIN + POTASSIUM CLAVULANATE | 500 MG + 125 MG | INDCHEMIE HEALTH SPECIALITIES PVT. LTDVILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6229 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CO-FLUAMPICIL CAPSULES BP 500MG | FLUCLOXACILLIN SODIUM + AMPICILLIN TRIHYDRATE | 250MG +250MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP | 01/07/2016 |
| NDA/MAL/HDP/6230 | CACHET PHAMACUITICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EMITINO | ONDANSENTRON | 4MG | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6231 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP DISPERSIBLE | DIHYDROARTEMISININ/PIPERAQUINE | 20MG/160MG | GUILIN PHARMACEUTICAL CO LTDNO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER,1.0X3.0X35.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6234 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP DISPERSIBLE | DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE | 40MG/320MG | GUILIN PHARMACEUTICAL CO.,LTDNO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER,1.0X3.0X25.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6235 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANGINET 160MG | VALSARTAN | 160MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6237 | HETERO LABS LTD | AIVEEN (U) LIMITED | LOPINAVIR/RITONAVIR | LOPINAVIR/ RITONAVIR | 100MG/25MG | HETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET BOTTLE,1.0X60.0 TABLET CONTAINER | 01/07/2016 |
| NDA/MAL/HDP/6238 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG -AM | NEBIVOLOL HYDROCHLORIDE + AMLODIPINE BESILATE | 5MG + 5MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6239 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE | ARTESUNATE | 60MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | BLISS GVS PHARMA LTD PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE | 01/07/2016 |
| NDA/MAL/HDP/6242 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP | DIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE | 80MG/640MG | GUILIN PHARMACEUTICAL CO LTDNO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X6.0X25.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6243 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | SURVANTA | BERACTANT | 100MG/4ML | ABBVIE NORTH CHICAGO FACILITY1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000 | UNITED STATES | | TOPICAL EXTERNAL INSTILLATION VIALS | 1.0X4.0 ML VIAL,1.0X8.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/6244 | CACHET PHAMACUITICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CABALIN | PREGABALIN | 75MG | CACHET PHARMACEUTICALS PVT LTDVILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6245 | BIOLOGICAL E. LTD | ABACUS PHARMA (AFRICA) LIMITED | COSCOPIN LINCTUS | NOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE | 7MG+2 MG+ 3.25 MG+28 MG/5 ML. | BIOLOGICAL E. LTD PLOT NO.31 & 32 PHARMA CITY SELAQUI INDUSTRIAL AREA SELAQUI DEHRADUN-248 197 UTTARAKHAND,INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6246 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | LUTHER | ARTEMETHER | 80MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT. LTDN-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIA | INDIA | | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6247 | MILAN LABORATORIES LTD (INDIA) PVT LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY 250-DT | AMOXICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6248 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | ARTEMETHER | ARTEMETHER | 80MG/ML | NITIN LIFESCIENCES LTD..RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H. | INDIA | PARENTERAL ORDINARY AMPOULES | 1X6X1 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6249 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL METRONIDAZOLE -200 TABLETS | METRONIDAZOLE | 200MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6250 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | ROCIP EYE DROPS | CIPROFLOXACIN HYDROCHLORIDE | 3MG/ML | REMINGTON PHARMACEUTICAL INDUSTRIES (PVT) LTD18 KM MULTAN ROAD LAHORE 53800 PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6256 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AZIMAX- 250 | AZITHROMYCIN DIHYDRATE | 250MG | HOVID BHDLOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6257 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | EDURANT | RILPIVIRINE | 25MG | JANSSEN CILAG S.P.AVIA C.JANSSEN, BORGO | ITALY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6264 | ACINO PHARMA AG - | LABOREX UGANDA LIMITED | PARACONICA 1000 MG IV | PARACETAMOL | 10MG/ML | S.M FARMACEUTICI SRLZONA INDUSTRIALE, 85050 TITO-POTENZA (PZ) ITALY | ITALY | | PARENTERAL ORDINARY I V VIALS | 1.0X100.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/6267 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | TRAMADOL DENK 50 | TRAMADOL HYDROCHLORIDE | 50MG | LOSAN PHARMA GMBH OTTO-HAHN-STR 13 79395 NEUENBURG | GERMANY | | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X10.0 TABLET BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6270 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | FEBUMAC 80 | FEBUXOSTAT | 80MG | MACLEODS PHARMACEUTICALS LTD - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6275 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | BENZYL BENZOATE APPLICATION BP | BENZYL BENZOATE | 25%W/V | SEV PHARMACEUTICALS LTD, PLOT 100 MASAKA ROAD ,NALUKOLONGO KAMPALA,UGANDA. | UGANDA | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE | 27/11/2018 |
| NDA/MAL/HDP/6279 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CIFF-200 DT | CEFIXIME TRIHYDRATE | 200MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET STRIP | 27/11/2018 |
| NDA/MAL/HDP/6281 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | HOMAGON | CHLORPHENAMINE MALEATE + CAFFEINE ANHYDROUS + PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL | 4MG + 30MG + 30MG + 400MG | LABORATORY AND ALLIED LTDPLOT 209/10349-MOMBASA ROAD NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 07/11/2018 |
| NDA/MAL/HDP/6282 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEBUX-40 | FEBUXOSTAT | 40MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/6283 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEBUX-80 | FEBUXOSTAT | 80 MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/6285 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | SMOFKABIVEN EMULSION FOR INFUSION INTO A CENTRAL VEIN 493ML - 550KCAL | MULTI-INGREDIENT | MULTI-INGREDIENT | FRESENIUS KABI ABRAPSGATAN 7 SE-751 74 UPPSALA SWEDEN | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X493.0 ML BAG (1*[250ML AMINO ACID SOLUTION WITH ELECTROLYTES + 149ML GLUCOSE 42% SOLUTION + 94ML LIPID EMULSION], MULTI-CHAMBER PLASTIC BAGS | 07/11/2018 |
| NDA/MAL/HDP/6286 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED - | SURGIPHARM (U) LIMITED | SMOFKABIVEN PERIPHERAL, EMULSION FOR INFUSION, 1206ML - 800KCAL | MULTI-INGREDIENT | MULTI-INGREDIENT | FRESENIUS KABI ABRAPSGATAN 7 SE-751 74 UPPSALA SWEDEN | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1206.0 ML BAG (1*[656ML GLUCOSE 13% SOLUTION + 380ML AMINO ACID SOLUTION WITH ELECTROLYTES + 170ML LIPID EMULSION], MULTI-CHAMBER PLASTIC BAG) | 27/11/2018 |
| NDA/MAL/HDP/6288 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFIX-100 DS | CEFIXIME TRIHYDRATE | 100MG/5ML | THEON PHARMACEUTICALS LIMITED. VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1X1X60 ML BOTTLE | 17/12/2018 |
| NDA/MAL/HDP/6292 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VENAXAN 250 MG | LEVOFLOXACIN HEMIHYDRATE | 250MG | SOUTH EGYPT DRUG INDUSTRIES CO-1ST INDUSTRIAL ZONE, 6 OCTOBER CITY, EGYPT. | | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 27/11/2018 |
| NDA/MAL/HDP/6293 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | NEUROGAB 150 | PREGABALIN | 150MG | "MACLEODS PHARMACEUTICALS LTD,-BLOCK N2, VILLAGE THEDA, POST OFFICE LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN, HIMACHAL PRADESH – 174101 INDIA." | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 27/11/2018 |
| NDA/MAL/HDP/6294 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | NEXAVAR | SORAFENIB TOSYLATE | 200MG | BAYER PHARMA AG 51368 LEVERKUSEN GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X28.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/6300 | GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD | TRIDEM PHARMA UGANDA LIMITED | AMOXICILLIN | AMOXICILLIN | 250MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X2.0X10.0 CAPSULE BLISTER, 1.0X10.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| NDA/MAL/HDP/6302 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | PLENOX | OFLOXACIN | 200MG | AKUMS DRUGS & PHARMACEUTICALS LTD19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6304 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | UNOSURE 72 | LEVONORGESTREL | 1.5MG | AKUMS DRUGS & PHARMACEUTICALS LTD .PLOT NO. 47, 48, SECTOR 6A, IIE, SIDCUL HARIDWAR, UTTRAKHAND – 249403, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6314 | YELURI FORMULATIONS PVT LTD | SUPER MEDIC | ELMOX-CV 625 | AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM | 500MG+125MG | YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA. | | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X5.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/6327 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENESTEN-V | CLOTRIMAZOLE | 100MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X6.0 PESSARY BLISTER | 27/11/2018 |
| NDA/MAL/HDP/6332 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN DT 250 | AMOXICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/11/2018 |
| NDA/MAL/HDP/6334 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | ENDOPROST 250MCG/1ML | CARBOPROST TROMETHAMINE | 250MCG/ML | BHARAT SERUM AND VACCINES LIMITEDPLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (EAST) INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL | 27/03/2019 |
| NDA/MAL/HDP/6338 | BIOTON S.A. | BHL HEALTHCARE LIMITED | GENSULIN M30 (30/70) | INSULIN HUMAN OF RECOMBINANT DNA ORIGIN (30% SOLUBLE INSULIN + 70% ISOPHANE INSULIN) | 100 IU/ML | BIOTON S.AMACIERZYSZ, POZNANSKA 12 STR., 05-850 OZAROW MAZOWIECKI | POLAND | | PARENTERAL ORDINARY S C VIALS | 1.0X1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 27/03/2019 |
| NDA/MAL/HDP/6339 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OXY-POL | OXYTETRACYCLINE HCL + POLYMYXIN B SULPHATE | 5MG+10000IU/G | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY – INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPT | | EGYPT | | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE | 30/05/2018 |
| NDA/MAL/HDP/6340 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | AXYLIN CAPSULES | AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM | 250MG +250 MG | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| NDA/MAL/HDP/6341 | MACLEODS PHARMACEUTICALS LTDS LTD | VITACARE LIMITED | ROSUMAC 20 | ROSUVASTATIN CALCIUM | 20MG | MACLEODS PHARMACEUTICALS LTD., NO. 25-27PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/6342 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIFENAC EYE DROPS | DICLOFENAC SODIUM SALT | 1MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT | | EGYPT | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/6343 | BIOTON S.A. | BHL HEALTHCARE LIMITED | GENSULIN N | ISOPHANE HUMAN HUMAN OF RECOMBINANT DNA ORIGIN | 100 IU/ML | BIOTON S.AMACIERZYSZ, POZNANSKA 12 STR., 05-850 OZAROW MAZOWIECKI | POLAND | | PARENTERAL ORDINARY S C VIALS | 1.0X1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 27/03/2019 |
| NDA/MAL/HDP/6344 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LACTEASE | LACTULOSE SOLUTION | 66.7% W/W | S KANT HEALTHCARE LTDPLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 26/09/2018 |
| NDA/MAL/HDP/6346 | BIOTON S.A. | BHL HEALTHCARE LIMITED | GENSULIN R | SOLUBLE HUMAN INSULIN OF RECOMBINANT DNA ORIGIN | 100 IU/ML | BIOTON S.AMACIERZYSZ, POZNANSKA 12 STR., 05-850 OZAROW MAZOWIECKI | POLAND | | PARENTERAL ORDINARY S C VIALS | 1.0X1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE | 27/03/2019 |
| NDA/MAL/HDP/6348 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP | SODIUM LACTATE SOLUTION +SODIUM CHLORIDE + CALCIUM CHLORIDE + POTASSIUM CHLORIDE | 0.533 GM +0.600 GM + 0.027G+ 0.040 GM/100ML | ABARIS HEALTHCARE PVT. LTD-PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/6349 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE -120 | ARTESUNATE | 120MG | BLISS INDASI LIFESCINCES PRIVATE LIMITED - PLOT 73-76 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN 396 210, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1*10ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1*2ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE | 26/09/2018 |
| NDA/MAL/HDP/6350 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | INVEL | METRONIDAZOLE + MICONAZOLE NITRATE | 500MG + 100MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X7.0 SUPPOSITORY STRIP | 27/03/2019 |
| NDA/MAL/HDP/6352 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | OMIPIN-20 | OMEPRAZOLE | 20MG | BRAWN LABORATORIES LTD .13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP | 28/03/2019 |
| NDA/MAL/HDP/6353 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS 50MG/300MG/300MG | DOLUTEGRAVIR+LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE TABLETS | 50MG+300MG+300MG | LAURUS LABS LIMITED, (UNIT-2) - PLOT NO:19, 20 & 21,WESTERN SECTOR, APSEZ, ATCHUTAPURAM MANDAL, VISAKHAPATNAM-DISTRICT-531011, ANDHRA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE | 07/11/2018 |
| NDA/MAL/HDP/6354 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TIMOSOL ® | TIMOLOL MALEATE | O.5%W/V | AHLCONPARENTERALS (INDIA) LIMITEDSP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6361 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSKA-P | NYSTATIN | 1,00,000 I.U/ML | S.KANT HEALTHCARE LTDPLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE | 01/07/2018 |
| NDA/MAL/HDP/6365 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | EASY PILL | LEVONORGESTREL | 1.5MG | CORONA REMEDIES PVT LTDCORONA HOUSE, C MONDEAL BUSINESS PARK, NR. GURUDWARA GOVINDDHAM LANE, SG HIGHWAY, THALTEJ, AHMEDABAD 380059, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6374 | MICRO LABS | MALIX PHARMA (U) LIMITED | PREDLEB-5 DT | PREDNISOLONE | 5MG | LEBEN LABORATORIES PVT. LTDPLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS). | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/6375 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ETHAMBUTOL DISPERSIBLE TABLETS 100 MG | ETHAMBUTOL HYDROCHLORIDE | 100MG | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | 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 | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET STRIP | 27/11/2018 |
| NDA/MAL/HDP/6377 | REGAL PHARMA U LIMITED | REGAL PHARMA U LIMITED | EPHICOL CAPSULES | CHLORPHENIRAMINE MALEATE+ PARACETAMOL+ CAFFEINE ANHYDROUS+ PHENYLEPHRINE HCL | 2MG+500 MG+30 MG+5MG | REGAL PHARMACEUTICALS LTD..PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X12.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6381 | MANKIND PHARM LTD | TATA UGANDA LIMITED | SERTAKIND | SERTACONAZOLE NITRATE | 2.0%W/W | CURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE,1.0X20.0 G TUBE | 27/03/2019 |
| NDA/MAL/HDP/6383 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EXXIB | CELECOXIB | 200MG | GRACURE PHARMACEUTICALS LIMITED E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDI | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/6385 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AMOXIKID-250 | AMOXICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET STRIP | 25/07/2018 |
| NDA/MAL/HDP/6386 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | JUSDEE 60K GRANULES | COLECALCIFEROL | 60000 IU | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X8.0X1.0 G SACHET | 30/05/2018 |
| NDA/MAL/HDP/6389 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | METRONIDAZOLE BP | METRONIDAZOLE | 0.5%W/V | ABARIS HEALTHCARE PVT. LTD-PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/6390 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ROSUMAC 10 | ROSUVASTATIN CALCIUM | 10MG | MACLEODS PHARMACEUTICALS LTD ,.PHASE I & II, PLOT NO. 25-27 SURVEY NO. 366, PREMIERE INDUSTRIAL ESTATE, KACHIGAN, DAMAN-396210 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 06/02/2019 |
| NDA/MAL/HDP/6392 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MET XL 50 | METOPROLOL SUCCINATE | 50 MG | AJANTA PHARMA LTD .B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/6395 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLOXSOL ® | NORFLOXACIN | 0.3%W/V | AHLCON PARENTERALS (INDIA) LIMITEDSP-917-918, PHASE 111, BHIWADI -301019, ALWAR, RAJASTHAN INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 28/05/2019 |
| NDA/MAL/HDP/6400 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | FENSUPP-100 | DICLOFENAC SODIUM | 100MG | MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 01/07/2017 |
| NDA/MAL/HDP/6401 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | SUPPOL 250 SUPPOSITORIES | ACETAMINOPHEN | 250MG | MERIDIAN ENTERPRISES PVT. LTDPLOT NO. 418, G.I.D.C.,KABILPORE,NAVSARI 396424 GUJARAT,INDIA | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP | 01/07/2017 |
| NDA/MAL/HDP/6404 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC GEL | ACECLOFENAC + LINSEED OIL + METHYL SALICYLATE | 1.5%W/W + 3.0W/W +10.0%W/W | STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/6405 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | CLOPRAZ | CLOPIDOGREL BISULFATE | 75MG | ZIM LABORATORIES LTDB-21/22, M.I.D.C. AREA, KALMESHWAR – 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X3X10 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6407 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | ZIMCOX 200 | CELECOXIB | 200 MG | ZIM LABORATORIES LTDB-21/22, M.I.D.C. AREA, KALMESHWAR – 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/11/2017 |
| NDA/MAL/HDP/6408 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DECOZAL | XYLOMETAZOLINE HCL | 0.1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | NASAL TOPICAL METERED DOSE AEROSOLS | 1.0X10.0 ML BOTTLE | 28/05/2019 |
| NDA/MAL/HDP/6414 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | IMATIB 100 | IMATINIB MESYLATE | 100MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6415 | CIPLA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | IMATIB 400 | IMATINIB MESYLATE | 400MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6416 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PAN-D | PANTOPRAZOLE + DOMPERIDONE | 40MG + 30MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6419 | SEGURA PHARMA PRIVATE LTD | ABACUS PHARMA (AFRICA) LIMITED | CLINICEF CV | CEFIXIME + POTASSIUM CLAVULANATE | 200MG + 125MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/6422 | INTERNATIONAL ORGANIZATION FOR MIGRATION | AIVEEN (U) LIMITED | EMADON | ONDANSETRON | 4MG | CORONA REMEDIES PVT LTD-VILLAGE JATOLI,POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. OLAN HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6423 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | CLARITEK | CLARITHROMYCIN|MOXIFLOXACIN HYDROCHLORIDE|GRISEOFULVIN|TENOFOVIR DISOPROXIL FUMARATE | 250MG|300MG|500 MG|400MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET STRIP | 25/11/2021 |
| NDA/MAL/HDP/6424 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL LS | LEVOSALBUTAMOL SULPHATE + AMBROXOL HYDROCHLORIDE + GUAIFENESIN | 1 MG + 30 MG + 100 MG | GLENMARK PHARMACEUTICALS LTD .VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 27/03/2019 |
| NDA/MAL/HDP/6426 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | SODIUM CHLORIDE INTRAVENOUS INFUSION BP | SODIUM CHLORIDE | 0.9%W/V | ABARIS HEALTHCARE PVT. LTD-PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6430 | IPCA LABORATOIES LTD | MEDVIN PHARMA LIMITED | LUMERAX DT 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | IPCA LABORATORIES LIMITED .PLOT 225/1, VILLAGE ATHAL, DANDRA AND NAGAR HAVELI UNION TERRITORY, SILVASSA-396 230 | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X30.0X1.0X6.0 TABLET BLISTER,1.0X30.0X1.0X12.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6431 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUMOX 125 | AMOXICILLIN TRIHYDRATE | 125MG/5ML | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6432 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | UMBI-GEL | CHLORHEXIDINE GLUCONATE | 4 % W/W | KAMPALA PHARMACEUTICALS INDUSTRIES (1996)LTDSTRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | TOPICAL EXTERNAL CREAMS | 1.0X50.0X1.0X5.0 G TUBE | 27/03/2019 |
| NDA/MAL/HDP/6433 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FICYC CREAM | ACICLOVIR | 5%W/W | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/6435 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FIMABUTE 200 | CEFIXIME TRIHYDRATE | 200MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6437 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | PILORECT | HYDROCORTISONE ACETATE +LIDOCAINE +ZINC OXIDE +ALLANTOIN | 0.25%W/W+3%W/W+5%W/W+0.5%W/W | MERIDIAN ENTERPRISES PVT. LTDPLOT NO. 418, G.I.D.C., KABILPORE, NAVSARI GUJARAT,INDIA | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X6.0 SUPPOSITORY STRIP | 29/11/2017 |
| NDA/MAL/HDP/6438 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL PLUS | PARACETAMOL + CAFFEINE | 500 MG + 65 MG | KAMPALA PHARMACEUTICALS INDUSTRIES (1996)LTDSTRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6439 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LIZOMAC 600 | LINEZOLID | 600MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP | 01/07/2017 |
| NDA/MAL/HDP/6440 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFIWEL 400 | CEFIXIME TRIHYDRATE | 400MG | MALIK LIFESCIENCES PRIVATE LIMITEDPLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/6441 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | OFLOXACIN INTRAVENOUS INFUSION | OFLOXACIN | 0.2%W/V | ABARIS HEALTHCARE PVT. LTD-PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X100 ML BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/6442 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | AZITO SUSPENSION | AZITHROMYCIN DIHYDRATE | 200 MG/5ML | ZIM LABORATORIES LTDB-21/22, M.I.D.C. AREA, KALMESHWAR – 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/6443 | MICRO LABS | MALIX PHARMA (U) LIMITED | SINURHON SUSPENSION | CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL | 1MG + 5MG + 125MG | LEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 27/03/2019 |
| NDA/MAL/HDP/6447 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | AZIBRU 500 | AZITHROMYCIN DIHYDRATE | 500MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6448 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIZOLONE-DEPOT 40 MG/ 1 ML VIAL | METHYLPREDNISOLONE ACETATE | 40 MG/ ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT | | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL | 25/07/2018 |
| NDA/MAL/HDP/6449 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | DESLORAT SYRUP | DESLORATIDINE | 0.5MG/ML | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6454 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MAGRILAN 20MG | FLUOXETINE HYDROCHLORIDE | 20MG | MEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 29/01/2019 |
| NDA/MAL/HDP/6455 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FICYC TABLETS | ACYCLOVIR | 200MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6456 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | GLUCOSE INTRAVENOUS INFUSION BP (5% W/V) | GLUCOSE ANHYDROUS | 5%W/V | ABARIS HEALTHCARE PVT. LTD-PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6459 | MACLEODS PHARMACEUTICALS LTDS LTD | VITACARE LIMITED | MACSUNATE AQ FORTE | ARTESUNATE + AMODIAQUINE | 100MG + 270MG | MACLEODS PHARMACEUTICALS LTD ,.PHASE I & II, PLOT NO. 25-27 SURVEY NO. 366, PREMIERE INDUSTRIAL ESTATE, KACHIGAN, DAMAN-396210 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6460 | MANKIND PHARM LTD | TATA UGANDA LIMITED | NUROKIND-OD | MECOBALAMIN | 1500MCG/ML | MANKIND PHARMA LTD.VILLAGE KISHANPURA, POAMTA SAHI DISTRICT SIRMOUR HIMACHAL PRADESH | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X4.0X1.0 ML AMPOULE | 27/03/2019 |
| NDA/MAL/HDP/6462 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | AMOXYN-500 | AMOXICILLIN TRIHYDRATE | 500MG | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 26/09/2018 |
| NDA/MAL/HDP/6465 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | NEUROGAB 75 | PREGABALIN | 75MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6468 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CIROLAZINE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE,1.0X5.0X1.0 ML AMPOULE | 30/05/2018 |
| NDA/MAL/HDP/6472 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV 375 | AMOXICILLIN TRIHYDRATE + CLAVULINIC ACID | 250MG + 125MG | MEDOCHEMIE LTD – FACTORY B-PLOT 48, IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL; AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X10.0 CAPSULE STRIP | 29/01/2019 |
| NDA/MAL/HDP/6476 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIZOLONE-DEPOT | METHYLPREDNISOLONE | 80MG/2ML | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY – INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPT | | EGYPT | | PARENTERAL RETARD VIALS | 1.0X1.0X2.0 ML VIAL | 25/07/2018 |
| NDA/MAL/HDP/6477 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOFULVIN | GRISEOFULVIN | 500 MG | MEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6482 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHROX 75MCG | LEVOTHYROXINE SODIUM | 75 MCG | MERCK KGAA-PHARMA PRODUCTION DARMSTADT FRANKFURTER STRABE 250, D-64293, DARMSTADT | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X25.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6491 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | PREGATAS ME 75 | PREGABALIN +MECOBALAMIN | 75MG+750MCG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 28/03/2018 |
| NDA/MAL/HDP/6495 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | MACROLYN® 500 MG FILM COATED TABLETS | AZITHROMYCIN DIHYDRATE | 500MG | DEVA HOLDING A. S.ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/6498 | MICRO LABS LIMITED | PHARMA VILLE LIMITED | AMOXICILLIN DISPERSIBLE TABLETS 250 MG | AMOXICILLIN TRIHYDRATE | 250MG | MICRO LABS LIMITED PLOT NO. 16, VEERASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE – 560 100. KARNATAKA, INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP | 25/07/2018 |
| NDA/MAL/HDP/6499 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | TACROZ FORTE | TACROLIMUS USP | 0.1%W/W | GLENMARK PHARMACEUTICALS LTD .PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 28/05/2019 |
| NDA/MAL/HDP/6500 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | DERIVA C GEL | ADAPLENE BP + CLINDAMYCIN PHOSPHATE USP EQUIVALENT TO CLINDAMYCIN | 1MG + 10MG | GLENMARK PHARMACEUTICALS LTD .PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE | 28/05/2019 |
| NDA/MAL/HDP/6501 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTROGYL 200 TABLET | METRONIDAZOLE | 200MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/6504 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CAPXCEL | CAPECITABINE | 500MG | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X1X10 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6506 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | ACTITOP | ETOPOSIDE | 50MG | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1X8 CAPSULE BOTTLE | 29/05/2019 |
| NDA/MAL/HDP/6507 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | ZITRAM P | ACETAMINOPHEN + TRAMADOL HYDROCHLORIDE | 325MG + 37.5MG | IPCA LABORATORIES LTDPLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6508 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | XALIPAT-100 | OXALIPLATIN | 100 MG/ 50ML (2MG/ML) | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X1X50 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6510 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | TACROZ | TACROLIMUS USP | 0.03%W/W | GLENMARK PHARMACEUTICALS LTD .PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 28/05/2019 |
| NDA/MAL/HDP/6512 | AXA PARENTERALS LTD | VITACARE LIMITED | AXACIP | CIPROFLOXACIN | 200MG/100ML | AXA PARENTERAL LIMITEDPLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA. | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/6513 | MACARTHYS LABORATORIES | LABOREX UGANDA LIMITED | GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS PER ML SOLUTION FOR INJECTION | GLYCOPYRRONIUM BROMIDE | 200MCG/ML | MACARTHYS LABORATORIES LIMITED T\A MARTINDALE PHARMABAMPTON ROAD, ROMFORD, ESSEX RM3 8UG, | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0 ML AMPOULE | 28/05/2019 |
| NDA/MAL/HDP/6514 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FEBRILEX | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE | 500MG + 5M + 2MG | MILAN LABORATORIES (INDIA) PVT LTD,63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET STRIP | 28/05/2019 |
| NDA/MAL/HDP/6515 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | WOMASTIN | CARBOPLATIN | 150MG/15ML | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X15 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6516 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | WOMASTIN | CARBOPLATIN | 150MG/15ML | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X45 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6520 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND-MD 8 | ONDASENTRON | 8MG | MANKIND PHARMA LTD-UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6521 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | KIPEL 4 | MONTELUKAST | 4MG | MSN LABORATORIES LTD. PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6522 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EPNONE 25 | EPLERENONE | 25MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6523 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLEXDOL | IBUPROFEN+METHOCARBAMOL | 200MG+500MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6524 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | RAMGIC | TRAMADOL HYDROCHLORIDE | 50MG/ML | MSN LABORATORIES LTD. PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE | 27/03/2019 |
| NDA/MAL/HDP/6525 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | DAPOXEM 30 | DAPOXETINE | 30MG | MSN LABORATORIES LTD. PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6526 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | DAPOXEM 60 | DAPOXETINE | 60MG | MSN LABORATORIES LTD. PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6527 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PULMOFIRST 62.5 | BOSENTAN MONOHYDRATE | 62.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6528 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PULMOFIRST 125 | BOSENTAN MONOHYDRATE | 125MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6532 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | BUNASE 200 | BUDESONIDE | 200MCG / ACTUATION | OXALIS LABS-VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101 INDIA | INDIA | | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON | 28/03/2018 |
| NDA/MAL/HDP/6536 | PHARMATHEN INVESTMENTS GROUP LTD | GOODMAN INTERNATIONAL LTD | OZAPEX 5MG | OLANZAPINE | 5MG | PHARMATHEN S.A6, DERVENAKION STR. 15351 PALLINI ATHENS | GREECE | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6537 | EXPHAR LTD. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CARBOSOL | CARMELLOSE SODIUM | 0.5%W/V | AHLCONPARENTERALS (INDIA) LIMITEDSP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 | INDIA | | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/6538 | PHARMATHEN INVESTMENTS GROUP LTD | GOODMAN INTERNATIONAL LTD | OZAPEX 10MG | OLANZAPINE | 10MG | PHARMATHEN S.A6, DERVENAKION STR. 15351 PALLINI ATHENS | GREECE | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6545 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | ZYTEE RB | CHOLINE SALICYLATE + BENZALKONIUM CHLORIDE | 9%W/W + 0.02% W/V | RAPTAKOS BRETT & CO.LTD1ST POKHRAN ROAD,THANE 400 606 | INDIA | | ORAL TOPICAL GELS AND SOLS | 1.0X10.0 ML TUBE | 27/03/2019 |
| NDA/MAL/HDP/6546 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | NEOPEPTINE | ALPHA AMYLASE + PAPAIN | 100MG + 50MG /5ML | RAPTAKOS BRETT & CO.LTD1ST POKHRAN ROAD,THANE 400 606 | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE | 27/03/2019 |
| NDA/MAL/HDP/6549 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PIRAV-75 | PREGABALIN | 75MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6550 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | REDCEPHIN | CEFTRIAXONE | 1 G | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 27/03/2019 |
| NDA/MAL/HDP/6551 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | NUROFEN FOR CHILDREN SUGAR FREE | IBUPROFEN | 100MG/5ML | RECKITT BENCKISER HEALTHCARE -DAMSON LANE,HULL, HUB HU8 7DS | | UNITED KINGDOM | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 27/03/2019 |
| NDA/MAL/HDP/6552 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | NUROFEN | IBUPROFEN + LYSINE | 342MG | RECKITT BENCKISER HEALTHCARE -DAMSON LANE,HULL, HUB HU8 7DS | | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6553 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENSOL SOLUTION | CHLORHEXIDINE GLUCONATE + ISOPROPYL ALCOHOL | 0.5% W/W + 70% W/W | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X5.0 L CONTAINER | 27/03/2019 |
| NDA/MAL/HDP/6554 | SEGURA PHARMA PRIVATE LTD | ABACUS PHARMA (AFRICA) LIMITED | RESPIQUIN-750 | LEVOFLOXACIN | 750MG | SAI MIRRA INNOPHARM PVT LIMITED 288&299, SIDCO ESTATE AMBTTUR, CHENNAI 600098 | INDIA | | ORAL SOLID ORDINARY TABLETS | 2.0X1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6556 | SAVA HEALTHCARE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BECLOGEN CREAM | CLOTRIMAZOLE USP, BECLOMETASONE DIPROPIONATE BP, GENTAMICIN SULPHATE BP | 1%W/W, 0.025%W/W, 0.1%W/W | SAVA HEALTHCARE LIMITED.PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 27/03/2019 |
| NDA/MAL/HDP/6562 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | ATROPINE EYE DROP BP 1 %W/V | ATROPINE SULPHATE | 1%W/V | SWISS PARENTERALS PVT LTD ..809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | OPHTHALMIC LIQUIDS | 1X1X10 ML VIAL | 28/03/2019 |
| NDA/MAL/HDP/6563 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANATAX ® 16MG | BETAHISTINE DIHYDROCHLORIDE | 16MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANYJORDAN - NUZHAT SAHAB | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6565 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | IBUPROFEN | IBUPROFEN | 200MG | TRIVENI FORMULATIONS LTDPLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 28/03/2019 |
| NDA/MAL/HDP/6568 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNADIP 50 TABLET | DICLOFENAC | 50MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6569 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MARDAGRA 50 | SILDENAFIL CITRATE | 50MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA| PSA CHEMICALS & PHARMACEUTICALS PRIVATE LIMITED - 3, SEZ-II, PITHAMPUR, DISTT. DHAR, MADHYA PRADESH - 454 774, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6572 | NTICALS LTD. | VITACARE LIMITED | METOMAC 50 | METOPROLOL SUCCINATE | 50MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/11/2018 |
| NDA/MAL/HDP/6573 | NTICALS LTD. | VITACARE LIMITED | EFAVIRENZ TABLETS USP 400MG | EFAVIRENZ | 400MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 25/07/2018 |
| NDA/MAL/HDP/6577 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | CEFIWEL-200 | CEFIXIME | 200MG | MALIK LIFESCIENCES PRIVATE LIMITEDPLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/6578 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ACINET DRY SYRUP 228.5MG/5ML | AMOXYCILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 200MG + 28.5MG PER 5ML | INDCHEMIE HEALTH SPECIALITIES PVT. LTDVILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/6579 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | PLENCOXIB 200 | CELECOXIB | 200 MG | AKUMS DRUGS AND PHARMACEUTICALS19,20,21, SEC.6-A, IIE, SIDCUL, RANIPUR,HARIDWAR-249403, UTTARAKHAND, INDIAINDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X10.0 CAPSULE BLISTER,10.0X10.0 CAPSULE BLISTER | 27/08/2019 |
| NDA/MAL/HDP/6584 | ZIFAM PINNACLE LTD | DELMAW ENTERPRISES LIMITED | ZIFLODIP 5 | AMLODIPINE BESYLATE | 5 MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/6585 | ZIFAM PINNACLE PTY. LTD. | DELMAW ENTERPRISES LIMITED | ZIFLODIP 10 | AMLODIPINE BESYLATE | 10 MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/6587 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SEDALAM | MIDAZOLAM | 1MG/ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X10X5 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6588 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SEDALAM | MIDAZOLAM | 5MG/ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X5X3 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6589 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | VANBACT | VANCOMYCIN HYDROCHLORIDE | 500MG | NABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 28/05/2019 |
| NDA/MAL/HDP/6590 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | LOPROT | OMEPRAZOLE SODIUM | 40MG | NABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHI | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 28/05/2019 |
| NDA/MAL/HDP/6593 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | TRANSIC | TRANEXAMIC ACID | 500MG | SURGE LABS (PVT) LTD10TH KM FAISALABAD ROAD, BIKHI DISTRICT SHEIKHUPURA | PAKISTAN | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0 ML AMPOULE | 28/05/2019 |
| NDA/MAL/HDP/6598 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | BREATHEZY-L (10/5) | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10MG + 5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/01/2019 |
| NDA/MAL/HDP/6600 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PROSTALEN | ALFUZOSIN HYDROCHLORIDE | 10MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6602 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CARDIURINE | CAPTOPRIL + HYDROCHLOROTHIAZIDE | 50MG + 25MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6608 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CIPROCIN 0.3% | CIPROFLOXACIN HYDROCHLORIDE | 0.3%W/W | ORCHIDIA10TH RAMADHAN CITY INDUSTRIAL AREA-B1 , P. O. BOX 149 TENTH, EGYPT | EGYPT | | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE | 28/05/2019 |
| NDA/MAL/HDP/6610 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND | ONDANSENTRON HYDROCHLORIDE | 2MG/ML | MANKIND PHARMA LTD-UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X4.0X2.0 ML AMPOULE,1.0X4.0X4.0 ML AMPOULE | 01/07/2014 |
| NDA/MAL/HDP/6611 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MARDAGRA 100 | SILDENAFIL CITRATE | 100MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | PSA CHEMICALS & PHARMACEUTICALS PRIVATE LIMITED - 3, SEZ-II, PITHAMPUR, DISTT. DHAR, MADHYA PRADESH - 454 774, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6612 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APRAZOLE PLUS-20 | OMEPRAZOLE + SODIUM BICARBONATE | 20MG/6G + 1680MG/6G | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY POWDERS | 1.0X20.0X6.0 G SACHET | 01/07/2008 |
| NDA/MAL/HDP/6613 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-40 | OLMESARTAN MEDOXOMIL | 40MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6614 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | AXETINE | CEFUROXIME SODIUM | 1.5MG | MEDOCHEMIE LIMITED (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL - CYPRUS. | CYPRUS | | PARENTERAL ORDINARY VIALS | 1.0X10.0 VIAL CARTON | 01/07/2008 |
| NDA/MAL/HDP/6616 | SHIN POONG PHARMACEUTICALS CO.LTD | AAFIYA (A) LIMITED | PYRAMAX | PYRONARIDINE TETRAPHOSPHATE + ARTESUNATE | 180MG + 60MG | SHIN POONG PHARM. CO., LTD70, SANDAN-RO, 19 BEON-GIL, DANWON-GU, ANSAN-SI, GYEONGGI-DO, REPUBLIC OF KOREA | SOUTH KOREA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X9.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6617 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APFLU | CHLOROPHENERAMINE + PARACETAMOL + VITAMIN C | 0.5MG + 120MG + 50MG | AJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/6619 | ESAPHARM SRL | BYAMAKA PHARMACEUTICAL COMPANY LTD | ORANVATE | CLOBETASOL PROPIONATE | 0.05G/100G | ESAPHARMA SRLVIA DE GASPERI, 13-20066 MELZO (MILAN) ITALY | ITALY | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 01/07/2016 |
| NDA/MAL/HDP/6620 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET 5MG | NEBIVOLOL HYDROCHLORIDE | 5MG | BERLIN-CHEMIE AGBERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLIN | GERMANY | | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6621 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | BAROLE 20 | RABEPRAZOLE | 20MG | INVENTIA HEALTHCARE LIMITEDF-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 01/07/2011 |
| NDA/MAL/HDP/6622 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFIWEL-100 DT | CEFIXIME TRIHYDRATE | 100MG | MALIK LIFESCIENCES PRIVATE LIMITEDPLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6624 | SQUARE PHARMACEUTICALS LTD.PABNA UNIT | GAMA PHARMACEUTICALS (U) LIMITED | CIPROKEN | CIPROFLOXACIN HYDROCHLORIDE | 0.3%W/V | SQUARE PHARMACEUTICALS LTD DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6625 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET PLUS 5/12.5 | NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | BERLIN-CHEMIE AG/MENARINI,GLIENICKER WEG 125, D-12489 BERLIN GERMANY | BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, ) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL) TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER (FREE MEDICAL SAMPLE) | 01/07/2016 |
| NDA/MAL/HDP/6627 | RECKITT BENCKISER HEALTHCARE INTERNATIONAL | GITTOES PHARMACEUTICALS LIMITED | STREPSILS HONEY & LEMON | MULTI-INGREDIENT | MULTI-INGREDIENT | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THALAND | THAILAND | | ORAL SOLID ORDINARY LOZENGES | 1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK,50.0X2.0 LOZENGE BLISTER,2.0X12.0 LOZENGE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/6628 | RECKITT BENCKISER HEALTHCARE INTERNATIONAL | GITTOES PHARMACEUTICALS LIMITED | STREPSILS ORIGINAL | MULTI-INGREDIENT | MULTI-INGREDIENT | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITEDRECKITT BENCKISER HEALTHCARE INTERNATIONAL-65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THALAND | THAILAND | | ORAL SOLID ORDINARY LOZENGES | 1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK,100.0X2.0 LOZENGE BLISTER,2.0X12.0 LOZENGE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/6629 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET PLUS 5/25 | NEBIVOLOL+HYDROCHLOROTHIAZIDE | 5MG+25MG | BERLIN-CHEMIE AG/MENARINIGLIENICKER WEG 125, D-12489 BERLIN GERMANY(BATCH RELEASE) | BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION)TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6631 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBURN | SILVER SULFADIAZINE | 1%W/W | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X500.0 G JAR | 01/07/2016 |
| NDA/MAL/HDP/6633 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | COLDRIL | PARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HCL | 500MG + 30MG + 2MG | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0X1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6636 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | COSAMIDE 100 | LACOSAMIDE | 100MG | MSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6638 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | COSAMIDE 50 | LACOSAMIDE | 50MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6640 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI H ( 40/ 12.5) | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6641 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | CEFTRISONE- S 1.5G | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1.0G + 0.5G | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL + 10ML WFI AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6645 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SAFETELMI H ( 80/ 12.5) | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6650 | INDUS LIFE SCIENCES PVT LIMITED | NORVIK ENTERPRISES LIMITED | INTRIAX-S-1 | CEFTRIAXONE SODIUM+SULBACTAM SODIUM | 1G+0.5G | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 01/07/2016 |
| NDA/MAL/HDP/6653 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | METSAFE 500 ER | METFORMIN HYDROCHLORIDE | 500MG | MSN LABORATORIES PVT. LIMITEDPLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. | INDIA | ORAL SOLID RETARD TABLETS | 1X3X10 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6654 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | LIVOLUK FIBRE | LACTULOSE + ISPAGHULA HUSK | 10G + 3.5G/ 15G | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X90.0 G CONTAINER | 01/07/2016 |
| NDA/MAL/HDP/6658 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEBIEM 10 | NEBIVOLOL | 10MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6662 | SAKAR HEALTHCARE PVT LTD | ROYAL PHARMA 2011 LIMITED | DIAPAM | DIAZEPAM | 5MG/ML | SAKAR HEALTHCARE PVT LIMITEDPLOT 10/13 SARKHEJ-BAVLA ROAD, AHMEDABAD, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE | 01/07/2013 |
| NDA/MAL/HDP/6663 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | SITCOM | EUPHORBIA PROSTATA DRY EXTRACT | 10MG/G | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 01/07/2013 |
| NDA/MAL/HDP/6664 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX 125 KID | AMOXICILLIN TRIHYDRATE | 125MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6665 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SALBUMOL SYRUP | SALBUTAMOL | 2MG/5ML | REGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/6666 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEBIEM 5 | NEBIVOLOL HYDROCHLORIDE | 5MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6667 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | SPARSH BIO-TECH PVT. LIMITEDPLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP | 01/07/2016 |
| NDA/MAL/HDP/6669 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SUPER WELGRA -100 | SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE | 100MG + 60MG | AKUMS DRUGS AND PHARMACEUTICALS LTDPLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6670 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | METROSIM-200 | METRONIDAZOLE | 200MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDPLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/6675 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNOSEMIDE -10 | FUROSEMIDE | 10MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6679 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | WOMIBAN TABLETS | ALBENDAZOLE | 400MG | BLUE CROSS LABORATORIES LTDL-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/HDP/6681 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | WELQUINE | LEVOFLOXACIN | 0.5%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD. PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6685 | NEON LABARATORIES LTD. | NORVIK ENTERPRISES LIMITED | EVACEF | CEFOTAXIME | 1 G | NEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2014 |
| NDA/MAL/HDP/6686 | DAWA LIMITED | SUPER MEDIC LTD | DAWASOLONE | PREDNISOLONE | 5MG | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/6688 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | CAREOCEF | CEFTRIAXONE SODIUM | 1G | NITIN LIFESCIENCES LTD..RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H. | INDIA | PARENTERAL ORDINARY VIALS | 1X50X1 G VIAL | 01/07/2016 |
| NDA/MAL/HDP/6689 | DAWA LIMITED | SUPER MEDIC LTD | EFLARON | METRONIDAZOLE | 200MG | MEDICO REMEDIES PVT LTD,.8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/1997 |
| NDA/MAL/HDP/6693 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CERTICAN1 | EVEROLIMUS | 1MG | NOVARTIS PHARMA STEIN AG.SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6694 | NOVARTIS PHARMA SERVICES INC. | SURGIPHARM (U) LIMITED | CERTICAN 0.5 | EVEROLIMUS | 0.5MG | NOVARTIS PHARMA STEIN AG.SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6695 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ORAV-OZ | OFLOXACIN + ORNIDAZOLE | 200MG + 500MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X1X10 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6699 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ATVIN-20 | ATORVASTATIN | 20MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6713 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CAMET | METOCLOPRAMIDE HYDROCHLORIDE | 10MG | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/6715 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CAZITHRO | AZITHROMYCIN | 200MG/5ML | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X15.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/6717 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CAZITHRO | AZITHROMYCIN | 500MG | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/6722 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | CILZEC 40 | TELMISARTAN | 40MG | MSN LABORATORIES PVT. LIMITEDPLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/05/2017 |
| NDA/MAL/HDP/6724 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | CILZEC 80 | TELMISARTAN | 80MG | MSN LABORATORIES PVT. LIMITEDPLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6728 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CIPROCOS-500 TABLETS | CIPROFLOXACIN | 500MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/6729 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSCOF 'C' LINCTUS | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/6732 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSCOF EXPECTORANT ORIGINAL | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/6734 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EASCOF | BROMHEXINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN + MENTHOL | (4MG + 2MG + 100MG + 1MG)/10ML | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2009 |
| NDA/MAL/HDP/6736 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | SANDOSTATIN | OCTREOTIDE ACETATE | 0.05MG | NOVARTIS PHARMA STEIN AG.SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6750 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | NYTIN | NYSTATIN | 500,000IU | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/2005 |
| NDA/MAL/HDP/6752 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | VITACEE | ASCORBIC ACID | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2000 |
| NDA/MAL/HDP/6754 | INDIAN IMMUNOLOGICALS LIMITED | TATA UGANDA LIMITED | ABHAYRAB | RABIES ANTIGEN DERIVED FROM RABIES VIRUS(L.PASTEUR 2061/VERO STRAIN) | >2.5 I.U PER VIAL | HUMAN BIOLOGICALS INSTITUTE ( A DIVISION OF INDIAN IMMUNOLOGICALS LTD) .KOZHIPANNAI PUDUMUND P.O DR. BASAVAIAH NAGAR UDHAGAMANDALAM PIN: 643007 TAMIL NADU | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.5 I.U VIAL 1*0.5ML DILUENT(0.9%W/V SODIUM CHLORIDE INJ. B.P) - 1 DOSE VIAL | 01/07/2016 |
| NDA/MAL/HDP/6758 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | ADCO-NAPAMOL | PARACETAMOL | 500MG | ADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6759 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | BETAPYN | PARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE | 450 MG+10 MG+5 MG+50 MG | ADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 2.0X9.0 TABLET BLISTER,6.0X9.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6763 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | COMPRAL HEADACHE TABLETS | PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS | 100MG+400MG+130MG | ADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X48.0X2.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/6764 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | IZRA 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | UNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2006 |
| NDA/MAL/HDP/6767 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | MEDI-KEEL A | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIESSURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN – 396 210 INDIA | INDIA | | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6769 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | MEDI-KEEL A HONEY & LEMON | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIESSURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN – 396 210 INDIA | INDIA | | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6771 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIFLUVID | FLUCONAZOLE | 150MG | HOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6772 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PIOSAFE 30 | PIOGLITAZONE HCL | 30MG | ARISTO PHARMACEUTICALS PVT LTD PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/6776 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | M-FORLIN 500 | METFORMIN | 500MG | LINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2010 |
| NDA/MAL/HDP/6778 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AXCEL IBUPROFEN | IBUPROFEN | 100MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6781 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NETAZOX-500 | NITAZOXANIDE | 500MG | IND-SWIFT LIMITEDINDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/6785 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NETAZOX DT | NITAZOXANIDE | 200MG | IND-SWIFT LIMITEDINDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/6787 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | NETAZOX | NITAZOXANIDE | 100MG/5ML | IND-SWIFT LIMITEDINDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/HDP/6788 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ROYAL VIT G | MULTI-INGREDIENTS | MULTI-INGREDIENTS | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, S" OF OCTOBER CITY, EGYPT. PO. BOX 43, OCTOBER CITY. POSTAL CODE NO.12566 | | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 01/07/2005 |
| NDA/MAL/HDP/6789 | AFRICURE PHARMACEUTICALS (INDIA) LTD | DELMAW ENTERPRISES LIMITED | AFRINAC | DICLOFENAC SODIUM | 75MG/3ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II-31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/6790 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIMZER | OMEPRAZOLE + DOMPERIDONE | 20MG + 30MG | INVENTIA HEALTHCARE PVT. LTDFI – FI /1 ADDITIONAL AMBERNATH, M.I.D.C. AMBERNATH (EAST) – 421 506, DIST. THANE, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP | 01/07/2016 |
| NDA/MAL/HDP/6792 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA | DARUNAVIR | 400MG | JANSSEN ORTHO LLC.-STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 01/07/2017 |
| NDA/MAL/HDP/6794 | HETERO LABS LTD | AIVEEN (U) LIMITED | ZOLID | LINEZOLID | 600MG | HETERO LABS LIMITED UNIT VAPIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6797 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | PETHIDINE INJECTION | PETHIDINE | 100MG/2ML | MARTINDALE PHARMACEUTICAL LIMITED BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/1997 |
| NDA/MAL/HDP/6798 | UMEDICA LABORATORIES PVT LTD | VITACARE LIMITED | PRAZIQUANTEL TABLETS USP 600MG | PRAZIQUANTEL | 600MG | UMEDICA LABORATORIES PVT. LTDPLOT 221-GIDC, 2ND PHASE, VAPI 396195 GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X8.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6808 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | GLYGEN-500 | METFORMIN HYDROCHLORIDE | 500MG | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6810 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CERVARIX | HUMAN PAPILLOMA VIRUS VACCINE (RDNA) | TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL) | GLAXOSMITHKLINE BOILOGICALSS.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) + A 25 GAUGE NEEDLE | 01/07/2007 |
| NDA/MAL/HDP/6812 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | NOFLOX | NORFLOXACIN | 0.3%W/V | ABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191 | UGANDA | | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6815 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCROM EYE DROPS | SODIUM CROMOGLYCATE | 2%W/V | ABACUS PARENTERAL DRUGS LTD.PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/6817 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | LETROZOLE DENK 2.5 | LETROZOLE | 2.5MG | HAUPT PHARMA MÜNSTER GMBHSCHLEEBRÜGGENKAMP 15 48159 MÜNSTER GERMANY | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6818 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | IMOVAX POLIO | POLIO VIRUS; (MAHONEY) TYPE 1- INACTIVE + (MEF-1) TYPE 2- INACTIVE + (SAUKETT) TYPE 3-INACTIVE | 40 D + 8D + 32 D ANTIGEN UNITS/ 0.5ML | SANOFI PASTEURMÉRIEUX 69280 MARCY L’ETOILE | FRANCE | | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/6820 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABBORI EAR DROPS | BORIC ACID | 1.83%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | OTIC DROPS | 1.0X10.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6821 | LABOREX UGANDA LIMITED | LABOREX UGANDA LIMITED | MAGNESIUM SULPHATE INJECTION | MAGNESIUM SULPHATE | 50%W/V | MARTINDALE PHARMACEUTICAL LIMITED BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X10.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6823 | LABOREX UGANDA LIMITED | LABOREX UGANDA LIMITED | EPHEDRINE HYDROCHLORIDE | EPHEDRINE HYDROCHLORIDE | 30MG/ML | MARTINDALE PHARMACEUTICALS .ROMFORD ESSEX RM3 8UG UK | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 01/07/2016 |
| NDA/MAL/HDP/6833 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ON.SENTRON-DENK 8MG ODT | ONDANSETRON | 8MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/6843 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | FYTOBACT | CEFOPERAZONE + SULBACTAM | 0.5 G + 0.5 G | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2009 |
| NDA/MAL/HDP/6845 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | FYTOBACT 2G | SULBACTAM SODIUM + CEFOPERAZONE SODIUM | 1G + 1G | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL | 01/07/2017 |
| NDA/MAL/HDP/6857 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUCIPRO TABLETS | CIPROFLOXACIN | 500MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/6859 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUVEL-500 TABLETS | LEVOFLOXACIN HEMIHYDRATE | 500MG | BRAWN LABORATORIES LTD..13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/6862 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | DITS GEL | DICLOFENAC DIETHYLAMINE | 1%W/W | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/6865 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | DITS INJECTION | DICLOFENAC SODIUM | 25MG/ML | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X3.0 ML AMPOULE | 29/11/2017 |
| NDA/MAL/HDP/6870 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | HYDROSONE 100MG | HYDROCORTISONE SODIUM SUCCINATE | 100MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON (1*100MG GLASS VIAL + 1*2ML AMP WFI),1.0X50.0 VIAL CARTON | 29/11/2017 |
| NDA/MAL/HDP/6871 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | VIVAX 100 | SILDENAFIL | 100MG | BRAWN LABORATORIES LTD..13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/6872 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | NETRACORTIL EYE/EAR SUSPENSION | OXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE | 10MG+5MG+10000I.U | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6873 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | ROXITHIN TABLETS | ROXITHROMYCIN | 150MG | BRAWN LABORATORIES LTD..13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/6874 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | CITRAX TABLETS | CETIRIZINE HYDROCHLORIDE | 10MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6875 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUMOX-250 CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER | 29/11/2017 |
| NDA/MAL/HDP/6879 | RAVIAN LIFE SCIENCE PVT. LTD | ROYAL PHARMA 2011 LIMITED | ORAV-200 | OFLOXACIN | 200MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6882 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | VORM-400 | ALBENDAZOLE | 400MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X1.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6887 | RAVIAN LIFE SCIENCE PVT. LTD | ROYAL PHARMA 2011 LIMITED | WELBEEN-L | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6897 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE GARGLE & MOUTH WASH | POVIDONE IODINE | 1G/100ML | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTDPLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | | ORAL TOPICAL LIQUIDS | 1.0X60.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6898 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | RECORMON | EPOETIN BETA | 5000I.U/0.3ML | ROCHE DIAGNOSTICS GMBH MANNHEIMSANDHOFER STRASSE 116, 68305 MANNHEIM - GERMANY | GERMANY | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0X1.0X0.3 ML PRE- FILLED SYRINGE | 28/05/2019 |
| NDA/MAL/HDP/6901 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ZINKORA KIT | [GLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + POTASSIUM CHLORIDE ] + [ZINC SULPHATE MONOHYDRATE] | [13.5G + 2.9G + 2.6G + 1.5G] + [20MG] | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY COMBINATION PACK POWDERS/GRANULES | 1.0X2.0X20.5 G SACHET + 1*10 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6905 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | NUROFEN | IBUPROFEN | 400MG | ASTRA ZENECA TURKEYNOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NOTTINGHAMSHIRE, NG90 2DB, UNITED KINGDOM | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6907 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | NUROFEN EXPRESS | IBUPROFEN | 400MG | ASTRA ZENECA TURKEYNOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NOTTINGHAMSHIRE, NG90 2DB, UNITED KINGDOM | UNITED KINGDOM | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6911 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | SCABION | CROTAMITON + SULPHUR | 10 G + 2 G | ATCO LABS LTD,B-18, S.I.T.E, KARACHI | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE | 01/07/2004 |
| NDA/MAL/HDP/6919 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MACSUNATE AQ JUNIOR | ARTESUNATE + AMODIAQUINE | 50MG + 135MG | MACLEODS PHARMACEUTICALS LTD.PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6921 | B & O PHARM ZAC | TRIDEM PHARMA UGANDA LIMITED | DUFENAC | DICLOFENAC SODIUM | 75MG | GUILIN PHARMACEUTICAL CO LTD-NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6922 | EXPHAR S.A. ZONING INDUSTRIEL DE NIVELLES SUD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUCAZOL | FLUCONAZOLE | 50 MG / 5 ML | GRACURE PHARMACEUTICALS LIMITED E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDI | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 27/11/2018 |
| NDA/MAL/HDP/6923 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MACSUNATE AQ KID | ARTESUNATE + AMODIAQUINE | 25MG + 67.5MG | MACLEODS PHARMACEUTICALS LTD ,.PHASE I & II, PLOT NO. 25-27 SURVEY NO. 366, PREMIERE INDUSTRIAL ESTATE, KACHIGAN, DAMAN-396210 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6924 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | NAC MR | DICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE | 50MG+325MG+250MG | CORONA REMEDIES PVT LIMITEDVILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/6926 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | ERYTHROKANT-ES | ERYTHROMYCIN ETHYL SUCCINATE | 125MG/5ML | S KANT HEALTHCARE LTDPLOT NO. 1805, G.I.D.C PHASE III, VAPI 396195, GUJARAT | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 29/05/2019 |
| NDA/MAL/HDP/6927 | SEGURA PHARMA PRIVATE LTD | ABACUS PHARMA (AFRICA) LIMITED | GOPAYN MR | ACECLOFENAC BP+TIZANIDINE HYDROCHLORIDE USP+PARACETAMOL BP | 100MG+2MG+500MG | SAI MIRRA INNOPHARM PVT LIMITED 288&299, SIDCO ESTATE AMBTTUR, CHENNAI 600098 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6928 | SAVA HEALTHCARE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOMENAP NS 0.05 | MOMETASONE FUROATE | 0.05%W/V | SAVA HEALTHCARE LIMITED.PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | | NASAL SYSTEMIC UNIT DOSE AEROSOLS | 1.0X1.0X12.0 ML CANNISTER | 28/05/2019 |
| NDA/MAL/HDP/6929 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RANCV1000 | RANOLAZINE | 1000MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6930 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | TAPAL 50 | TAPENTADOL | 50MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6931 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AMORIV | AMBROXOL HYDROCHLORIDE | 15MG/5ML | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/6932 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | VALATE-200 | SODIUM VALPROATE | 200 MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/6933 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | VALATE 500 | SODIUM VALPROATE BP | 500MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 25/07/2018 |
| NDA/MAL/HDP/6936 | SAVA HEALTHCARE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | RANKOF | PARACETAMOL+CAFFEINE, PHENYLEPHRINE + CHLORPHENAMINE MALEATE | 500MG+30MG+10MG+2MG | SAVA HEALTHCARE LIMITED.PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6937 | SAKAR HEALTHCARE LIMITED | ROYAL PHARMA 2011 LIMITED | CEFROTIL750 | CEFUROXIME SODIUM | 750MG | SAKAR HEALTHCARE LIMITEDBLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT – INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X10 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6939 | MSN LABORATORIES PRIVATE LIMITED | METRO PHARMACEUTICALS LIMITED | TAPAL 100 | TAPENTADOL | 100MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/6941 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLVAT 30 | TOLVAPTAN | 30MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/6942 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLVAT 15 | TOLVAPTAN | 15MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/6946 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | FEVERAL | PARACETAMOL | 1OMG/ML | SURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | | PARENTERAL ORDINARY I V VIALS | 1.0X1.0X100.0 ML VIAL | 28/05/2019 |
| NDA/MAL/HDP/6948 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | D3 MUST 60 K | CHOLECALCIFEROL | 60000IU | MANKIND PHARMA LTD-UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6949 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | MEGAFER | IRON SUCROSE | 100MG/5ML | SURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 28/05/2019 |
| NDA/MAL/HDP/6955 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SEVOTROY 250 | SEVOFLURANE | 250 | TROIKAA PHARMACEUTICALS LIMITED..SANAND - KADI ROAD, THOL, CITY: THOL - 382 728, DIST. MEHSANA, GUJARAT STATE - INDIA | INDIA | | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE | 28/05/2019 |
| NDA/MAL/HDP/6956 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | NUROTROY SR | MECOBALAMIN + FOLIC ACID + PYRIDOXINE HYDROCHLORIDE | 1500MCG + 5MG + 20MG | TROIKAA PHARMACEUTICALS LIMITED,,C-1, SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6961 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | MERROBE 1000 | MEROPENEM | 1G | ZEISS PHARMACEUTICALS PVT LTD - PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 29/05/2019 |
| NDA/MAL/HDP/6962 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROXONE- S | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1G+0.5G | ZEISS PHARMACEUTICALS PVT LTD - PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL | 28/05/2019 |
| NDA/MAL/HDP/6963 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | LANAC | LANSOPRAZOLE | 30MG | ZIM LABS LTD.B 21/22, MIDC AREA, KALMESHWAR 441501, DIST-NAGPUR | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6964 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TOXXET 200 | CEFPODOXIME PROXETIL | 200MG | ZIM LABORATORIES LTDB-21/22 MIDC, KALMESHWAR 441501 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/6967 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - | GAMA PHARMACEUTICALS (U) LIMITED | MICAZOLE | MICONAZOLE | 2%W/W | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE | 27/11/2019 |
| NDA/MAL/HDP/6970 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND ORAL SOLUTION | ONDANSETRON | 4MG/5ML | MANKIND PHARMA LTD-UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6971 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | MONTIRIV-10 | MONTELUKAST SODIUM | 10 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X3X10 TABLET BLISTER | 28/08/2019 |
| NDA/MAL/HDP/6973 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED DM SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + DEXTROMETHORPHAN | 1.25MG + 30MG + 10MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/6974 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND-MD 4 | ONDANSETRON | 4MG | MANKIND PHARMA LIMITED, UNIT-II. VILLAGE KISHANPURA, P.O JAMNIWALA, PAONTA SAHIB IN H.P. | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6978 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | DEXARIV | DEXAMETHASONE SODIUM PHOSPHATE | 4 MG/ML | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0X2.0ML VIAL, 1.0X100.0X2.0ML VIAL | 28/08/2019 |
| NDA/MAL/HDP/6980 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | KETORIV | KETOCONAZOLE | 2.0%W/W | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | NASAL TOPICAL CREAMS | 1.0X1.0X15.0 G TUBE | 28/08/2019 |
| NDA/MAL/HDP/6981 | ZIFAM PINNACLE PTY. LTD. | DELMAW ENTERPRISES LIMITED | KIT LANZ | LANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE | 30MG + 250MG + 500MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X7.0X6.0 TABLET BLISTER PACK HAS BOTH CAPSULES AND TABLETS | 27/08/2019 |
| NDA/MAL/HDP/6982 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | DEXARIV | DEXAMETHASONE SODIUM PHOSPHATE | 0.5 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/6984 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | VIREXIM-400 | CEFIXIME TRIHYDRATE | 400 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER | 27/08/2019 |
| NDA/MAL/HDP/6985 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | COLDRID SYRUP | CETIRIZINE DIHYDROCHLORIDE + PHENYLEPHRINE HCL + PARACETAMOL | 2.5MG + 5MG + 125MG | MEDLEY PHARMACEUTICALS, LTDPLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/6986 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | REPRAZ 20 TABLETS | RABEPRAZOLE SODIUM | 20MG | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/6989 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED EXPECTORANT SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + GUAIFENESIN | 1.25MG+30MG+100MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/6990 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ESORIV-40 | ESOMEPRAZOLE MAGNESIUM | 40MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6991 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ESORIV-20 | ESOMEPRAZOLE MAGNESIUM | 20MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6992 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AZIRIV-200 | AZITHROMYCIN | 200MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 28/05/2019 |
| NDA/MAL/HDP/6993 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | AZIRIV-500 | AZITHROMYCIN (AS DIHYDRATE) | 500MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/6999 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | NYSTATIN ORAL SUSPENSION | NYSTATIN | 100000 UNITS/5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1X30 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/7003 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | NAC-SP | DICLOFENAC POTASSIUM + SERRATIOPEPTIDASE | 50MG + 10MG | CORONA REMEDIES PVT LTD..VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/7004 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | DUOCETZ | PARACETAMOL+TRAMADOL HYDROCHLORIDE | 325MG+37.5MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED..515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG | THAILAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7005 | CIPLA LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE | ABACAVIR + DOLUTEGRAVIR + LAMIVUDINE | 600MG + 50MG + 300MG | CIPLA LTDUNIT 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 TABLETS | 1.0X30.0 TABLET BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7006 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | PREDNIMAX | PREDNISOLONE | 5MG | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7007 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EPNONE 50 | EPLERENONE | 50MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/11/2018 |
| NDA/MAL/HDP/7009 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DARUNAVIR TABLETS | DARUNAVIR ETHANOLATE | 600 MG | CIPLA LTD ,.PLOT NO. A-33, A-2 (UNIT 1), A42 (UNIT II), MIDC PATALGANGA, DISTRICT-RAIGAD MAHARASHTRA, 410220 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER | 27/08/2019 |
| NDA/MAL/HDP/7010 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CALCAC 300 | CALCIUM LACTATE | 300MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA.| | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/09/2019 |
| NDA/MAL/HDP/7011 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | URSOLIV 250 | URSODEOXYCHOLIC ACID | 250MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED..515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG | THAILAND | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER | 27/03/2019 |
| NDA/MAL/HDP/7012 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYHEP DVIR | DACLATASVIR + SOFOSBUVIR | 60MG + 400MG | MYLAN LABORATORIES LIMITEDF- 4 & F-12, MIDC, MALEGAON, SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/7013 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AZITHRAA 500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7014 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | ACEAAR 100 TABLET | ACECLOFENAC | 100MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP | 29/11/2017 |
| NDA/MAL/HDP/7015 | KOPRAN LIMITED | TATA UGANDA LIMITED | LOKIT | OMEPRAZOLE | 20MG | KOPRAN LTDVILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7018 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | AXYLIN | AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM | 125MG + 125MG | LABORATORY & ALLIED LTD PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | KENYA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7019 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | LECOTRIM | SULFAMETHOXAZOLE + TRIMETHOPRIM | 200MG + 40MG / 5ML | LABORATORY & ALLIED LTD PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7020 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | KEMOXYL 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | LABORATORY AND ALLIED LTD ..PLOT 209/10349, OFF MOMBASA ROAD | KENYA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7021 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNOFEC PLUS | ACECLOFENAC+PARACETAMOL | 100MG+500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7022 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNAFLAM PLUS | DICLOFENAC SODIUM+PARACETAMOL | 50MG+500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7023 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERZOL ORAL SUSPENSION | ALBENDAZOLE | 200 MG / 5 ML | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE,1.0X20.0X10.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/7024 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MICOZAL | KETOCONAZOLE | 2%W/W | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 29/11/2017 |
| NDA/MAL/HDP/7027 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | CELCOXX | CELECOXIB|ATORVASTATIN | 200MG|10MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 25/11/2021 |
| NDA/MAL/HDP/7029 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | LIPIZAR 20 | ATORVASTATIN CALCIUM (TRIHYDRATE) | 20MG | ZIM LABORATORIES LTDB-21/22, M.I.D.C. AREA, KALMESHWAR – 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X3X10 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/7037 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | O2 | OFLOXACIN + ORNIDAZOLE | 50MG + 125MG | MEDLEY PHARMACEUTICALS LTDLANE 03, PHASE 1, SIDCO INDUSTRIAL COMPLEX, BARI BRAHMANA JAMMU 181133 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7039 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | O2 | OFLOXACIN + ORNIDAZOLE | 200MG + 500MG | MEDLEY PHARMACEUTICALS LTDLANE 03, PHASE 1, SIDCO INDUSTRIAL COMPLEX, BARI BRAHMANA JAMMU 181133 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7053 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | KETOVID CREAM | KETOCONAZOLE | 2%W/W | HOVID BHD 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/7057 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VIREST CREAM 5% | ACICLOVIR | 5%W/W | HOVID BHD 121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/7058 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | NEURAN 300 MG CAPSULE | GABAPENTIN | 300MG | HOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 28/08/2019 |
| NDA/MAL/HDP/7063 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | GRISEOFULVIN 500MG FILM-COATED TABLET | GRISEOFULVIN | 500MG | HOVID BHDLOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7064 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLIMICRON 80MG TABLET | GLICLAZIDE | 80MG | HOVID BHDLOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2018 |
| NDA/MAL/HDP/7065 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | BRIMO | BRIMONIDINE TARTRATE | 2%W/V | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | OPHTHALMIC LIQUIDS | 1.0X5.0 ML BOTTLE | 02/09/2019 |
| NDA/MAL/HDP/7066 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MABRON SR | TRAMADOL HYDROCHLORIDE | 100MG | MEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | ORAL SOLID RETARD CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 BLISTER BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7067 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | SUPPOL 125 | PARACETAMOL | 125MG | MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP | 27/08/2019 |
| NDA/MAL/HDP/7070 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN 1000 MG FILM-COATED TABLET | METFORMIN HYDROCHLORIDE | 1000MG | HOVID BERHAD (CHEMOR SITE)-LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7075 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | Q-TAB-200 | QUETIAPINE FUMARATE | 200MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X1.0X8.0 TABLET BLISTER | 28/08/2019 |
| NDA/MAL/HDP/7080 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | Q-TAB-100 | QUETIAPINE FUMARATE | 100MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/08/2019 |
| NDA/MAL/HDP/7083 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | ETROBAX 90 | ETORICOXIB | 90MG | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1X3X10 TABLET BLISTER | 28/08/2019 |
| NDA/MAL/HDP/7084 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | GABA 300 | GABAPENTIN | 300MG | NABIQASIM INDUSTRIES (PVT) LTD.17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 28/08/2019 |
| NDA/MAL/HDP/7085 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | DYSEN SUSPENSION | SECNIDAZOLE | 750MG | NABIQASIM INDUSTRIES (PVT) LTD.17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7088 | PINNACLE LIFE SCIENCE PVT. LTD | METRO PHARMACEUTICALS LIMITED | PINNOX 200 | OFLOXACIN | 200MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/7089 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | ES-LOPROT | ESOMEPRAZOLE SODIUM | 40MG | NABIQASIM INDUSTRIES (PVT) LTD.17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL (+ 1*10ML AMPOULE OF 0.9% NACL) | 27/08/2019 |
| NDA/MAL/HDP/7091 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARLEFLOX 500 TABLETS | LEVOFLOXACIN HEMIHYDRATE | 500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7092 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | PATMAC | PANTOPRAZOLE SODIUM | 40MG | NABIQASIM INDUSTRIES (PVT) LTD.17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL (+ 1*10ML AMPOULE OF 0.9% NACL) | 27/08/2019 |
| NDA/MAL/HDP/7094 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | GLANDIN-E2 | DINOPROSTONE | 2MG | NABIQASIM INDUSTRIES (PVT) LTD.17/24, KORANGI INDUSTRIAL AREA, KORANGI,KARACHI -PAKISTAN | PAKISTAN | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X3.0 G PRE- FILLED SYRINGE | 27/08/2019 |
| NDA/MAL/HDP/7095 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | FREMOL EXTRA | PARACETAMOL + CAFFEINE | 500MG + 65MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X25.0X4.0 CAPLET STRIP | 21/11/2019 |
| NDA/MAL/HDP/7096 | GAMA PHARMACEUTICALS (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DEXAPHEN SYRUP | DEXAMETHASONE + CHLORPHENIRAMINE MALEATE | 10MG + 40MG/100ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7098 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ACEFORCE SP | ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE | 100MG+325MG+15MG | AKUMS DRUGS AND PHARMACEUTICALS LTDPLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7101 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ASTHAREN | SALBUTAMOL SULPHATE | 4MG | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI- KIREKA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/7102 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REPRAZINE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI- KIREKA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/7103 | MACARTHYS LABORATORIES LTD | LABOREX UGANDA LIMITED | CAFFEINE CITRATE 10MG/ ML SOLUTION FOR INJECTION | CAFFEINE CITRATE | 10MG/ML | MACARTHYS LABORATORIES LIMITED T\A MARTINDALE PHARMABAMPTON ROAD, ROMFORD, ESSEX RM3 8UG, | UNITED KINGDOM | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE | 21/11/2019 |
| NDA/MAL/HDP/7104 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPISOPT | DOROZOLAMIDE + TIMOLOL | 20MG/1ML + 5MG/1ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT | | EGYPT | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/7105 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TRAMACETAL TABLETS | ACETAMINOPHEN +TRAMADOL HYDROCHLORIDE | 325MG+37.5MG | CACHET PHARMACEUTICALS PVT LTDVILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 29/01/2019 |
| NDA/MAL/HDP/7106 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REVIVE | GLUCOSE ANHYDROUS + TRISODIUM CITRATE DIHYDRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE | 13.5G + 2.9G + 2.6G + 1.5G | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI- KIREKA | UGANDA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0 SACHET CARTON | 01/07/2016 |
| NDA/MAL/HDP/7107 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | FEBUMAC 40 | FEBUXOSTAT | 40 MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/7109 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BRUTAFLAM-60 | ETORICOXIB | 60MG | MANKIND PHARMA LTD, UNIT II ,VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7110 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED EXTRA SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + DEXTROMETHORPHAN + GUAIFENESIN | 1.25MG + 10MG + 7.5MG + 50MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7112 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | ETROBAX 60 | ETORICOXIB | 60MG | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1X3X10 TABLET BLISTER | 28/08/2019 |
| NDA/MAL/HDP/7115 | INTAS, PHARMACEUTICALS LTD | STAR BIOTECH UGANDA LTD | SARTEL 40H | TELMISARTAN +HYDROCHLOROTHIAZIDE | (40+12.5)MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/7116 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED SYRUP 120ML | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE | 1.25MG + 30MG/5ML | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7117 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNIFED TABLETS | TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE | 2.5MG+60MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7118 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BRUTAFLAM-90 | ETORICOXIB | 90MG | MANKIND PHARMA LTD, UNIT II ,VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7119 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-40 H | OLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7120 | BESINS HEALTHCARE BENELUX SA | SURGIPHARM (U) LIMITED | ANDROGEL | TESTOSTERONE | 16.2MG/G | BESINS MANUFACTURING BELGIUM (BMB)GROOT BIJGAARDENSTRAAT, 128. 1620 | BELGIUM | | TOPICAL EXTERNAL EMULSION GELS | 1.0X88.0 G CANNISTER | 21/11/2019 |
| NDA/MAL/HDP/7122 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | ATERISE-50 | ATENOLOL | 50MG | SUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/08/2019 |
| NDA/MAL/HDP/7123 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | MARTINEZ 10 | MONTELUKAST SODIUM | 10MG | AKUMS DRUGS AND PHARMACEUTICALS LTDPLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/7124 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VITAMIN E 400 MG. | VITAMIN E | 400 MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7127 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CASPOGIN 50 | CASPOFUNGIN ACETATE | 50MG | CIPLA LTDUNIT IX, M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE GOA 403 722 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 07/11/2018 |
| NDA/MAL/HDP/7128 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | COTRIKANT-960 | TRIMETHOPRIM+SULFAMETHOXAZOLE | 800MG+160MG | S KANT HEALTHCARE LTDPLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/7131 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV OS | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 125MG + 31.25MG/5ML | SPARSH BIO-TECH PVT. LTD.-PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 26/09/2018 |
| NDA/MAL/HDP/7132 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CASPOGIN 70 | CASPOFUNGIN ACETATE | 70MG | CIPLA LTDUNIT IX, M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE GOA 403 722 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 07/11/2018 |
| NDA/MAL/HDP/7133 | LIPTIS EGYPT FOR PHARMACEUTICALS AND MEDICAL PRODUCTS | HARLEYS UGANDA LIMITED | WELLNESS | DAY TABLET: PARACETAMOL + PSEUDOEPHEDRINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE | NIGHT TABLET: PARACETAMOL + PSEUDOEPHEDRINE HYDROCHLORIDE + DIPHENHYDRAMINE HYDROCHLORIDE | DAY TABLET: 325MG + 30MG + 4.5MG | NIGHT TABLET : 500MG + 30MG + 25MG | LIPTIS EGYPY FOR PHARMACEUTICALS AND MEDICAL PRODUCTSPLOT NO. 2/B, 6TH INDUSTRIAL ZONE, 6TH OF OCTOBER CITY | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER (5 DAY TABLETS + 5 NIGHT TABLETS) | 29/01/2019 |
| NDA/MAL/HDP/7135 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | CILACAR *10 | CILNIDIPINE | 10MG | UNIQUE PHARMACEUTICAL LABS LIMITED. .215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 29/08/2019 |
| NDA/MAL/HDP/7136 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | AMIKACIN 100 MG / 2ML | AMIKACIN SULPHATE | 100MG/2ML | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY – INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPT | | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.0 ML VIAL | 25/07/2018 |
| NDA/MAL/HDP/7145 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LEVOTOP 0.5% | LEVOFLOXACIN | 0.5%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD .N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 28/03/2019 |
| NDA/MAL/HDP/7147 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BIMAT | BIMATOPROST | 0.03% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML VIAL | 30/05/2018 |
| NDA/MAL/HDP/7148 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | OMEPSUN | OMEPRAZOLE | 20 MG | SUNRISE INTERNATIONAL LABS LTD.PLOT NO. 100, LANE 5, SECTOR II, PHASE II IDA CHERLAPALLY, HYDERABAD-500 051 | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 TABLET STRIP | 25/07/2018 |
| NDA/MAL/HDP/7149 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OLOPAT OD | OLOPATADINE HYDROCHLORIDE | 0.2% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML VIAL | 30/05/2018 |
| NDA/MAL/HDP/7151 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APDROPS DX | MOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE | 5MG+1MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 30/05/2018 |
| NDA/MAL/HDP/7152 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | MINOXIN PLUS | MINOXIDIL | 50MG/ML | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X6.0 ML BOTTLE WITH A DERMA ROLLER ADMINISTRATION DEVICE | 29/01/2019 |
| NDA/MAL/HDP/7154 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 2MG/ML | ABARIS HEALTHCARE PVT LTD - SURVEY NO. 1407-11, VILLAGE RAJPUR, TALUKA KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/7162 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | TEXAVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDPLOT 1-7, LUZIRA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7163 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | STODIL | LOPERAMIDE HYDROCHLORIDE | 2MG | TRIVENI FORMULATIONS LTDPLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7167 | SPARSH BIO-TECH PVT.LTD. | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV DS | AMOXICILLIN TRIHYDRATE + CLAVULANATE | 200MG + 28.5MG PER 5ML | SPARSH BIO-TECH PRIVATE LIMITED,.PLOT NO.1, SURVEY NO. 242/243/244, VILLAGE LAKHABVAD, JAMNAGAR 361006 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7172 | WOCKHARD LTD | ROYAL PHARMA 2011 LIMITED | MERIMIX | MEROPENEM TRIHYDRATE + SULBACTAM SODIUM | 1G + 0.5G | ZEISS PHARMACEUTICALS PVT LTD - PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X1 VIAL CARTON | 29/08/2019 |
| NDA/MAL/HDP/7175 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS-AM 40/5 | TELMISARTAN + AMLODIPINE BESYLATE | 40MG + 5MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/7179 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | AVONZA | TENOFOVIR DISOPROXIL FUMARATE+LAMIVUDINE+EFAVIRENZ | 300MG+300MG+400MG | MYLAN LABORATORIES LIMITEDD ,PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR-454775 DIST. DHAR, MADHYA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER | 07/11/2018 |
| NDA/MAL/HDP/7180 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | IVENTI | MOXIFLOXACIN HYDROCHLORIDE | 0.5%W/V | SQUARE PHARMACEUTICALS LIMITED - DHAKA UNITKALIAKOIR GAZIPUR | BANGLADESH | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 29/08/2019 |
| NDA/MAL/HDP/7181 | PHARMACTIV FZCO | JEET PHARMACEUTICALS LIMITED | SURGIBION | VITAMIN B1 + VITAMIN B6 + VITAMIN B12 | 100MG, + 100MG + 1000MCG | SURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN. | PAKISTAN | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0X3.0 ML AMPOULE | 27/08/2019 |
| NDA/MAL/HDP/7182 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | SUNFLAM | MELOXICAM | 7.5G | SUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/08/2019 |
| NDA/MAL/HDP/7183 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | LEVOSUN-500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | SUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7187 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | ZITHROSUN-500 | AZITHROMYCIN DEHYDRATE | 500MG | SUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X3X10 TABLET BLISTER | 29/08/2019 |
| NDA/MAL/HDP/7192 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TINAZOL | TINIDAZOLE | 500 MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/7193 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUOXINE | CIPROFLOXACIN | 500 MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/7194 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENSCRUB SOLUTION | LINEZOLID ,CHLORHEXIDINE GLUCONATE | 200 MG/100 ML ,4%W/V | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X500.0 ML BOTTLE | 29/01/2019 |
| NDA/MAL/HDP/7195 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | SMOFKABIVEN EMULSION FOR INFUSION INTO A CENTRAL VEIN, 986ML - 1100KCAL | AMINO ACID SOLUTION: [ALANINE + ARGININE + GLYCINE + HISTIDINE + HISTIDINE + ISOLEUCINE + LEUCINE + LYSINE ACETATE + METHIONINE + PHENYLALANINE + PROLINE + SERINE + TAURINE + THREONINE + TRYPTOPHAN + TYROSINE + VALINE + CALCIUM CHLORIDE DIHYDRATE + SODI | [7.0G + 6.0G + 5.5G + 1.5G + 2.5G + 3.7G + 3.3G + 2.2G + 2.6G + 5.6G + 3.2G + 0.50G + 2.2G + 1.0G + 0.2G + 3.1G + 0.28G + 2.1G + 0.6G + 2.2G + 1.7G + 0.0065G] + [42%] + [11.3G + 11.3G + 9.4G + 5.6G] | FRESENIUS KABI ABRAPSGATAN 7, UPPSALA, SE-751 74 | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X986.0 ML BAG :(1*[500ML AMINO ACID SOLUTION WITH ELECTROLYTES + 298ML GLUCOSE 42% SOLUTION + 188ML LIPID EMULSION], MULTI CHAMBER PLASTIC BAGS) | 04/02/2019 |
| NDA/MAL/HDP/7197 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | RABIVAX-S | PURIFIED RABIES ANTIGEN (RABIES VIRUS PITMAN-MOORE STRAIN 3218) | NOT LESS THAN 2.5 I.U / DOSE | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X5.0X1.0 DOSE VIAL + IML DILUENT AMPOULE | 27/08/2019 |
| NDA/MAL/HDP/7198 | UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD) | PLANET PHARMACEUTICALS UGANDA LTD | SILBECOR | SILVER SULFADIAZINE | 1%W/W | UNIQUE PHARMACEUTICAL LABS LIMITED. .215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X50.0 G TUBE | 29/08/2019 |
| NDA/MAL/HDP/7200 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | SMOFKABIVEN EMULSION FOR INFUSION INTO A CENTRAL VEIN,1477ML -1600KCAL | AMINO ACID SOLUTION: [ALANINE + ARGININE + GLYCINE + HISTIDINE + HISTIDINE + ISOLEUCINE + LEUCINE + LYSINE ACETATE + METHIONINE + PHENYLALANINE + PROLINE + SERINE + TAURINE + THREONINE + TRYPTOPHAN + TYROSINE + VALINE + CALCIUM CHLORIDE DIHYDRATE + SODI | "[10.5G + 9.0G + 8.2G + 2.2G + 3.8G + 5.6G + 5.0G + 3.2G + 3.8G + 8.4G + 4.9G + 0.75G + 3.3G + 1.5G + 0.30G + 4.6G + 0.42G + 3.1G + 0.90G + 3.4G + 2.6G + 0.0097G] + [42%W/V] + [16.9G + 16.9G + 14.1G + 8.4G ]" | FRESENIUS KABI ABRAPSGATAN 7, UPPSALA, SE-751 74 | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1477.0 ML BAG :(1*[750ML AMINO ACID SOLUTION WITH ELECTROLYTES + 446ML GLUCOSE 42% SOLUTION + 281ML LIPID EMULSION], MULTI CHAMBER PLASTIC BAGS) | 04/02/2019 |
| NDA/MAL/HDP/7201 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | MEASLES AND RUBELLA VACCINE | LIVE, ATTENUATED MEASLES VIRUS + LIVE ATTENUATED RUBELLA VIRUS | NLT 1000 CCID50 + 1000 CCID50 / DOSE | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0X10.0 DOSE VIAL + 5ML DILUENT,1.0X50.0X1.0 DOSE VIAL + 1ML DILUENT | 27/08/2019 |
| NDA/MAL/HDP/7203 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | SMOFKABIVEN EMULSION FOR INFUSION INTO A CENTRAL VEIN, 2463ML - 2700KCAL | AMINO ACID SOLUTION: [ALANINE + ARGININE + GLYCINE + HISTIDINE + HISTIDINE + ISOLEUCINE + LEUCINE + LYSINE ACETATE + METHIONINE + PHENYLALANINE + PROLINE + SERINE + TAURINE + THREONINE + TRYPTOPHAN + TYROSINE + VALINE + CALCIUM CHLORIDE DIHYDRATE + SODI | [17.5 G + 15.0 G + 13.8 G + 3.7 G + 6.2 G + 9.4 G + 8.4 G + 5.4 G + 6.4 G + 14.0 G + 8.1 G + 1.2 G + 5.4 G + 2.5 G + 0.49 G + 7.6 G + 0.69 G + 5.2 G + 1.5 G + 5.7 G + 4.2 G + 0.016 G] + [42 %] + 313 G + 28.1 G + 28.1 G + 23.4 G + 14.0 G] | FRESENIUS KABI ABRAPSGATAN 7, UPPSALA, SE-751 74 | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X2463.0 ML BAG :(1*[1250ML AMINO ACID SOLUTION WITH ELECTROLYTES + 744ML GLUCOSE 42% SOLUTION + 469ML LIPID EMULSION], MULTI CHAMBER PLASTIC BAGS) | 04/02/2019 |
| NDA/MAL/HDP/7205 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | SMOFKABIVEN EMULSION FOR INFUSION INTO A CENTRAL VEIN, 1970ML -2200KCAL | AMINO ACID SOLUTION: [ALANINE + ARGININE + GLYCINE + HISTIDINE + HISTIDINE + ISOLEUCINE + LEUCINE + LYSINE ACETATE + METHIONINE + PHENYLALANINE + PROLINE + SERINE + TAURINE + THREONINE + TRYPTOPHAN + TYROSINE + VALINE + CALCIUM CHLORIDE DIHYDRATE + SODI | [14G + 12.0G + 11.0G + 3.0G + 5.0G + 7.4G + 6.6G + 4.3G + 5.1G + 11.2G + 6.5G + 1.0G + 4.4G + 2.0G + 0.40G + 6.2G + 0.56G + 4.2G + 1.2G + 4.5G + 3.4G + 0.013G] + [42%] + [22.5G + 22.5G + 18.8G + 11.3G] | FRESENIUS KABI ABRAPSGATAN 7, UPPSALA, SE-751 74 | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1970.0 ML BAG :(1*[1000ML AMINO ACID SOLUTION WITH ELECTROLYTES + 595ML GLUCOSE 42% SOLUTION + 375ML LIPID EMULSION], MULTI CHAMBER PLASTIC BAGS) | 04/02/2019 |
| NDA/MAL/HDP/7206 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | LOS ANGIO | LOSARTAN POTASSIUM | 50MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA| PSA CHEMICALS & PHARMACEUTICALS PRIVATE LIMITED - 3, SEZ-II, PITHAMPUR, DISTT. DHAR, MADHYA PRADESH - 454 774, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 29/08/2019 |
| NDA/MAL/HDP/7207 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | TOXXET 50 | CEFPODOXIME PROXETIL | 50MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE | 29/08/2019 |
| NDA/MAL/HDP/7208 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED - | SURGIPHARM (U) LIMITED | SMOFKABIVEN PERIPHERAL EMULSION FOR INFUSION, 1448ML-1000KCAL | [GLUCOSE MONOHYDRATE] + AMINO ACID SOLUTION WITH ELECTROLYTES: [ALANINE + ARGININE + GLYCINE + HISTIDINE + ISOLEUCINE + LEUCINE + LYSINE ACETATE + METHIONINE + PHENYLALANINE + PROLINE + SERINE + TAURINE + THREONINE + TRYPTOPHAN + TYROSINE + VALINE + C | [13%] + [6.4G + 5.5G + 5.1G + 1.3G + 2.3G + 3.3G + 2.3G + 3.3G+ 3.0G + 1.9G + 2.3G + 5.1G + 3.0G + 0.46G + 2.0G + 0.91G + 0.17G + 2.9G + 0.26G + 1.9G + 0.55G + 2.0G + 1.6G + 0.006G] + [12.3G + 12.3G + 10.1G + 6.1G] | FRESENIUS KABI ABRAPSGATAN 7, UPPSALA, SE-751 74 | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1448.0 ML BAG :(1*[788ML GLUCOSE 13% + 456ML AMINO ACID SOLUTION WITH ELECTROLYTES + 204ML LIPID EMULSION], MULTI CHAMBER PLASTIC BAGS) | 04/02/2019 |
| NDA/MAL/HDP/7211 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | PYODINE GEL | POVIDONE-IODINE | 5GM/100GM | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X20.0 G TUBE | 27/03/2019 |
| NDA/MAL/HDP/7214 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED - | SURGIPHARM (U) LIMITED | SMOFKABIVEN PERIPHERAL EMULSION FOR INFUSION, 1904ML - 1300KCAL | [GLUCOSE MONOHYDRATE] + AMINO ACID SOLUTION WITH ELECTROLYTES: [ALANINE + ARGININE + GLYCINE + HISTIDINE + ISOLEUCINE + LEUCINE + LYSINE ACETATE + METHIONINE + PHENYLALANINE + PROLINE + SERINE + TAURINE + THREONINE + TRYPTOPHAN + TYROSINE + VALINE + | [13%] + [8.4G + 7.2G + 6.6G + 1.8G + 3.0G + 4.4G + 4.0G + 2.6G + 3.1G + 6.7G + 3.9G + 0.60G + 2.6G + 1.2G + 0.24G + 3.7G + 0.34G + 2.5G + 0.72G + 2.7G + 2.0G + 0.008G] + [16.1G + 16.1G + 13.4G + 8.0G] | FRESENIUS KABI ABRAPSGATAN 7, UPPSALA, SE-751 74 | SWEDEN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1904.0 ML BAG :(1*[1036ML GLUCOSE 13% + 600ML AMINO ACID SOLUTION WITH ELECTROLYTES + 268ML LIPID EMULSION], MULTI CHAMBER PLASTIC BAGS) | 04/02/2019 |
| NDA/MAL/HDP/7215 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | CELCOXX | TELMISARTAN+AMLODIPINE BESILATE|OXYTOCIN|CELECOXIB | 100MG|5IU/1ML|80MG+10MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER, 1.0X10.0 AMPOULE CARTON | 10/01/2022 |
| NDA/MAL/HDP/7216 | SHIN POONG PHARMACEUTICALS CO.LTD | AAFIYA (A) LIMITED | PYRAMAX | PYRONARIDINE TETRAPHOSPHATE + ARTESUNATE | 60MG + 20MG | SHIN POONG PHARM. CO., LTD70, SANDAN-RO, 19 BEON-GIL, DANWON-GU, ANSAN-SI, GYEONGGI-DO, REPUBLIC OF KOREA | SOUTH KOREA | | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X90.0 SACHET CARTON | 27/08/2019 |
| NDA/MAL/HDP/7217 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARPANTO 40 | PANTOPRAZOLE | 40MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/7218 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTMIN 500 | METFORMIN | 500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7219 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOXONE -1 G | CEFTRIAXONE | 1G | THEON PHARMACEUTICALS LTD.VILLAGE SAINI MAJRA, TEHSIL NALAGARH DIST, SOLAN- 174101, | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X1 G VIAL | 29/11/2017 |
| NDA/MAL/HDP/7220 | RAINBOW LIFE SCIENCES PVT.LTD. | EUROPA HEALTHCARE (U) LTD | NAPRIN | NAPROXEN | 500MG | GLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/08/2019 |
| NDA/MAL/HDP/7222 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | SAMSUNATE | ARTESUNATE | 60MG | SAMRUDH PHARMACEUTICALS PVT LTDJ-174, J-168 & J-168/1, MIDC, TARAPUL, BOISAR, DIST THANE-401506 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL OF ARTESUNATE +(1*1ML AMPOULE OF SODIUM BICARBONATE BP 5%W/V)+(1*5ML SODIUM CHLORIDE BP 0.9%W/V) | 21/11/2019 |
| NDA/MAL/HDP/7223 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DOLUTEGRAVIR | DOLUTEGRAVIR | 50MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7225 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LUMITER 80/480 | ARTEMETHER + LUMEFANTRINE | 80MG + 480MG | OXALIS LABVILLAGE THEDA, P.O. LODHIMAJRA, TEHSIL BADDI, DIST. SOLAN (HP) PIN CODE 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7229 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARCIFLOX 500 | CIPROFLOXACIN | 500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7234 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | LEVOFLOXACIN INTRAVENOUS INFUSION | LEVOFLOXACIN HEMIHYDRATE + GLUCOSE ANHYDROUS | 500MG + 5W/V% | ABARIS HEALTHCARE PVT. LTDSURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 27/08/2019 |
| NDA/MAL/HDP/7235 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | OPTIDEX-T | DEXAMETHASONE + TOBRAMYCIN | 0.1W/V + 0.3%W/V | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 27/11/2019 |
| NDA/MAL/HDP/7237 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PAEDIATRIC | CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 1MG + 2.5MG | STEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7238 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-10 | NEBIVOLOL HYDROCHLORIDE | 10MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/7239 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | GAVISCON PEPPERMINT LIQUID | SODIUM AGINATE + SODIUM BICARBONATE + CALCIUM CARBONATE | 500MG + 267MG + 160MG | RECKITT BENCKISER HEALTHCARE -DAMSON LANE,HULL, HUB HU8 7DS | | UNITED KINGDOM | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X12.0X10.0 ML SACHET,1.0X200.0 ML BOTTLE | 28/05/2019 |
| NDA/MAL/HDP/7240 | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED | GITTOES PHARMACEUTICALS LIMITED | GAVISCON DOUBLE ACTION | SODIUM AGINATE + SODIUM BICARBONATE + CALCIUM CARBONATE | 250MG + 106.5MG + 187.5MG | RECKITT BENCKISER HEALTHCARE -DAMSON LANE,HULL, HUB HU8 7DS | | UNITED KINGDOM | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X8.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/7241 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GENTASOL | GENTAMICIN SULFATE | 0.3%W/V | AHLCON PARENTERAL (I) LTD.-SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002 | INDIA | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/7242 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | AMINORICH | MULTIVITAMINS, MINERALS | NA | STEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X15.0 CAPSULE BLISTER,1.0X1.0X2.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7243 | BAL PHARMA LIMITED - | PLANET PHARMACEUTICALS UGANDA LTD | EMTRIM | TRIMETHOPRIM + SULPHAMETHOXAZOLE | 80MG+ 400MG | BAL PHARMA LTD1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7245 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | CEFAKIND-500 | CEFUROXIME AXETIL | 500MG | COPMED PHARMACEUTICALS PVT LTDUNIT-II, PLOT NO. 50, GONDPUR INDUSTRIAL AREA, TEHSIL-PAONTA SAHIB, DISTT. SIRMOUR,HIMACHAI PRADESH-173025, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 29/01/2019 |
| NDA/MAL/HDP/7246 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | DESLORAT | DESLORATIDINE | 5MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET STRIP | 01/07/2017 |
| NDA/MAL/HDP/7247 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | VITAFIL-Z | MULTIVITAMINS, MINERALS | NA | STEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7248 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | ESOMELODAN 20 | ESOMEPRAZOLE | 20MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/7249 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | ESOMELODAN 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/7250 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DOLUTEGRAVIR SODIUM, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | DOLUTEGRAVIR SODIUM +LAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7251 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | HYDROXYUREA | HYDROXYCARBAMIDE | 500MG | HAUPT PHARMA AMAREG GMBHDONAUSTAUFER STRASSE 378, 93055 REGENSBURG | GERMANY | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7253 | MANKIND PHARM LTD | TATA UGANDA LIMITED | MONTICOPE | MONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE | 10MG + 5MG | MANKIND PHARMA LTD, UNIT II ,VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7257 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PAARPIN TABLET | PARACETAMOL | 650 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7258 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | DESCOVY 200MG/10MG | EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 200MG/10MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/7259 | FERRER INTERNATIONAL, S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ENEAS 10/20 | ENALAPRIL + NITRENDIPINE | 10MG + 20MG | FERRER INTERNATIONAL S.A ..JOAN BUSCALLA, 1 - 9, 08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7260 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ESOFAG-40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7264 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MIOPAN PLUS SUSPENSION | MAGALDRATE+SIMETHICONE | 540MG + 40MG/5ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT, P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT | | EGYPT | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7267 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ESOFAG-20 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7269 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FEBRILEX SYRUP | PARACETAMOL+DEXTROMETORPHAN HYDROBROMIDE+CHLORPHENAMINE MALEATE | 125MG+5MG+1MG/5 ML | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7271 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TURBOVAS CP | ROSUVASTATIN CALCIUM + CLOPIDOGREL | 5MG + 75MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7272 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | MONTIGET | MONTELUKAST SODIUM | 10MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 25/11/2021 |
| NDA/MAL/HDP/7275 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TILYPTIN 20 | TENELIGLIPTIN HYDROBROMIDE HYDRATE | 20MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | TOPICAL EXTERNAL TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7284 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LTD | LIVERCOL 10 | ROSUVASTATIN CALCIUM | 10MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?.3. 42050 SELÇUKLU / KONYA TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/7286 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TOBRIN OPHTHALMIC OINTMENT | TOBRAMYCIN | 3MG/G | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT | | EGYPT | | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/7287 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPISTIGMIN 0.05% | NEOSTIGMINE METHYLSULPHATE | 0.05%W/V | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT | | EGYPT | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/7288 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KETESSE FILM COATED TABLETS | DEXKETOPROFEN TROMETAMOL | 25MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.IVIA CAMPO DI PILE 67100 L'AQUILA | ITALY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7292 | LEBEN LABORATORIES PVT LTD | MALIX PHARMA (U) LIMITED | IBUPLUS SUSPENSION | IBUPROFEN+.PARACETAMOL | 100MG + 125MG / 5ML | LEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7293 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LTD | ALRINAST | DESLORATADINE | 5MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7295 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | LAMIFEN | TERBINAFINE HYDROCHLORIDE | 1%W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 27/11/2019 |
| NDA/MAL/HDP/7296 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDAXONUM 2G | CEFTRIAXONE SODIUM | 2G | MEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X2.0 G VIAL | 29/01/2019 |
| NDA/MAL/HDP/7298 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-2.5 | NEBIVOLOL HYDROCHLORIDE | 2.5 MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7301 | HETERO LABS LTD | AIVEEN (U) LIMITED | PACLITERO 300 | PACLITAXEL | 60 MG/ML | HETERO LABS LIMITED UNIT-VI APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DISTRICT) ANDHRA PRADESH-509301, , INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL | 26/09/2018 |
| NDA/MAL/HDP/7302 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ACRETIN 0.025% | TRETINOIN | 0.025%W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 27/11/2019 |
| NDA/MAL/HDP/7304 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | GABAZURE | GABAPENTIN | 300 MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 26/09/2018 |
| NDA/MAL/HDP/7305 | HETERO LABS LTD | AIVEEN (U) LIMITED | PACLITERO 30 | PACLITAXEL | 6 MG/ML | HETERO LABS LIMITED UNIT-VI APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DISTRICT) ANDHRA PRADESH-509301, , INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X1X5 ML VIAL | 26/09/2018 |
| NDA/MAL/HDP/7306 | HETERO LABS LTD | AIVEEN (U) LIMITED | PACLITERO 100 | PACLITAXEL | 100 MG/16.7 ML | HETERO LABS LIMITED UNIT-VI APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DISTRICT) ANDHRA PRADESH-509301, , INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X16.7 ML VIAL | 26/09/2018 |
| NDA/MAL/HDP/7307 | EXPHAR SA. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERZOL | ALBENDAZOLE | 400 MG | GRACURE PHARMACEUTICAL LTDE-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/7310 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ACRETIN 0.05% | TRETINOIN | 0.05%W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE | 27/11/2019 |
| NDA/MAL/HDP/7311 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FLUCA OPTHALMIC SUSPENSION | FLUOROMETHOLON + SODIUM CROMOGLICATE | 1%W/V + 2%W/V | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE | 27/11/2019 |
| NDA/MAL/HDP/7312 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE OINTMENT 5%W/W | POVIDONE IODINE | 5%W/W | G.S PHAMBUTOR PVT LTD .B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X125.0 G TUBE,1.0X250.0 G JAR | 01/07/2017 |
| NDA/MAL/HDP/7317 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMITINO TABLETS 8MG | ONDANSETRON | 8MG | CACHET PHARMACEUTICAL PVT LTD. VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH - 173205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7318 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV 625 | AMOXICILLIN TRIHYDRATE + CLAVULINIC ACID | 500MG + 125MG | MEDOCHEMIE LTD – FACTORY B-PLOT 48, IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL; AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE STRIP | 29/01/2019 |
| NDA/MAL/HDP/7319 | DROGSAN ?LAÇLARI SAN. VE TIC. A.?. | BUFFALO HEALTH CARE LTD | SIPROSAN 500 | CIPROFLOXACIN HYDROCHLORIDE | 500MG | DROGSAN ?LAÇLARI SAN. VE TIC. A.?.ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X5.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/7321 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | ASCORIL-D | DEXTROMETHORPHAN HYDROBROMIDE + TRIPROLIDINE HYDROCHLORIDE + PSEUDOEPHEDRINE HYDROCHLORIDE + MENTHOL | 10MG + 1.25MG + 30MG + 1.5MG / 5ML | GLENMARK PHARMACEUTICALS LTD .PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 27/11/2019 |
| NDA/MAL/HDP/7325 | DROGSAN ?LAÇLARI SAN. VE TIC. A.?. | BUFFALO HEALTH CARE LTD | DALMAN AQ NASAL SPRAY | FLUTICASONE PROPIONATE | 0.05%W/V | DROGSAN ?LAÇLARI SAN. VE TIC. A.?. -ESENBO?A MERKEZ MAH. ÇUBUK CADDESI NO: 31 06760 ANKARA - TURKEY | TURKEY | | NASAL SYSTEMIC UNIT DOSE AEROSOLS | 1.0X1.0X120.0 METERED DOSE BOTTLE | 25/07/2018 |
| NDA/MAL/HDP/7329 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR- MR | PARACETAMOL +ACECLOFENAC+CHLORZOXAZONE | 500 MG+100 MG +375 MG | DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/7330 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | FAMY-POP | LEVONORGESTREL | 0.03MG | MYLAN LABORATORIES LIMITEDPLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X35.0 TABLET BLISTER | 27/11/2019 |
| NDA/MAL/HDP/7335 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE 5% | POVIDONE IODINE | 5%W/V | G.S PHAMBUTOR PVT LTD .B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7336 | MODI NUNDIPHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE GERMICIDE GARGLE 2% MINT | POVIDONE IODINE | 2%W/V | G.S PHAMBUTOR PVT LTDG.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | | ORAL TOPICAL LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/7337 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA 150 | DARUNAVIR | 150MG | JANSSEN ORTHO LLC.-STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X240.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7338 | LEBEN LABORATORIES PVT.LTD | MALIX PHARMA (U) LIMITED | IBUPLUS | IBUPROFEN + PARACETAMOL | 400MG + 325MG | LEBEN LABORATORIES PVT. LTDPLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS). | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X15.0X2.0X20.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7339 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ADERAN 16 | CANDESARTAN CILEXETIL | 16 MG | AJANTA PHARMA LIMITEDB-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/7340 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | HIFEN -200 | IBUPROFEN | 200MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 |KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | | INDIA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7341 | M/S.MAXHEAL PHARMACEUTICALS(INDIA) | ABACUS PHARMA (AFRICA) LIMITED | ZITHROHEAL 500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | MAXHEAL PHARMACEUTICALS INDIA LIMITEDJ-7, MIDC, TERAPUR INDUSTRIAL AREA, BOISAR 401506 MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 28/11/2019 |
| NDA/MAL/HDP/7342 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ZEALARGY | RUPATADINE FUMERATE | 10 MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7343 | WUHAN FUXING BIOLOGICAL PHARMACEUTICAL CO | KAIYUANTANG (U) LIMITED | GLEVIX | LEVOFLOXACIN + SODIUM CHLORIDE | 0.5G + 0.9G | WUHAN FUXING BIOPHARMACEUTICAL CO., LTDNO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7345 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | DELTACEF | CEFEPIME | 1G | MEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 21/11/2019 |
| NDA/MAL/HDP/7346 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REZN TABLETS | ZINC SULFATE MONOHYDRATE | 20MG | RENE INDUSTRIES LIMITEDPLOT 680 KAMULI- KIREKA | UGANDA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/7348 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | ISENTRESS 25 MG | RALTEGRAVIR POTASSIUM | 25MG | PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA | MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685 SOUTH AFRICA | | SOUTH AFRICA | UNITED STATES OF AMERICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X60.0 TABLET BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/7350 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | SULCEF | CEFOPERAZONE+ SULBACTUM | 1G+1G | MEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 ML VIAL | 27/03/2019 |
| NDA/MAL/HDP/7353 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 500MG | METFORMIN HYDROCHLORIDE | 500MG | MERCK SANTÉ S.A.S.2 RUE DU PRESSOIR VERT 45400 SEMOY FRANCE | MERCK KGAA-PHARMA PRODUCTION DARMSTADT FRANKFURTER STRABE 250, D-64293, DARMSTADT | GERMANY | FRANCE | ORAL SOLID RETARD TABLETS | 1.0X6.0X15.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/7355 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN SUSPENSION | ARTEMETHER+LUMEFANTRINE | 180MG+1080MG | AJANTA PHARMA LIMITED.B-41516, MIDC INDUSTRIAL AREA, PAITHAN, AURANGABAD-431 148 DIST: AURANGABAD MAHARASHTRA,INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/7357 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | PAMAGIN-C SYRUP | CETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL | 2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5ML | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/7359 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | INDCLAV 625 | AMOXICILLIN+CLAVULANATE POTASSIUM | 500MG+125MG | INDCHEMIE HEALTH SPECIALITIES PVT LTDVILLAGE THANA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7360 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | GAVISCON DOUBLE ACTION LIQUID | SODIUM ALGINATE + SODIUM BICARBONATE + CALCIUM CARBONATE | 500MG + 213MG + 325MG/10ML | RECKITT BENCKISER HEALTHCARE -DAMSON LANE,HULL, HUB HU8 7DS | | UNITED KINGDOM | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X150.0 ML BOTTLE,1.0X300.0 ML BOTTLE,1.0X12.0X10.0 ML SACHET | 21/11/2019 |
| NDA/MAL/HDP/7361 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | DOLUTEGRAVIR | DOLUTEGRAVIR SODIUM | 50MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7363 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | INDCLAV 228 | AMOXICILLIN+CLAVULANATE POTASSIUM | 200MG+28MG/5ML | INDCHEMIE HEALTH SPECIALITIES PVT. LTD.VILLAGE & P.O – THANA, TEHSIL – BADDI, DIST- SOLAN, HIMACHAL | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7364 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | MOKSEFEN 400 MG | MOXIFLOXACIN HYDROCHLORIDE | 400MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7365 | OCHOA LABORATORIES LIMITED - | SUPER MEDIC LTD | DOLOACT MR | PARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE | 500 MG+50 MG+250 MG | AUROCHEM PHARMACEUTICALS INDIA PRIVATE LIMITED58, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401 404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/01/2019 |
| NDA/MAL/HDP/7375 | INTAS PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | FOLISURGE 75 | FOLLITROPIN ALFA | 75IU/0.12 ML | INTAS PHARMACEUTICALS LTD (BIOPHARMA DIVISION)PLOT NO. 423/P/A, SARKHEJ-BAVLA HIGHWAY, MORAIYA, TALUKA SANAND, AHMEDABAD- 382213, GUJARAT | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.12 ML PRE- FILLED SYRINGE | 28/11/2019 |
| NDA/MAL/HDP/7381 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE ANTISEPTIC CREAM 5% | POVIDONE-IODINE | 5%W/W | G.S PHAMBUTOR PVT LTD .B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X20.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/7384 | YURIA-PHARM LTD | PHARMA VILLE LIMITED | TIVORTIN | ARGININE HYDROCHLORIDE | 42MG/ML | YURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/7389 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - | GAMA PHARMACEUTICALS (U) LIMITED | GAROPRIDE | ITOPRIDE HYDROCHLORIDE | 50MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | | EGYPT | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7391 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | TAVIN-EM | TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE | 300MG + 200MG | EMCURE PHARMACEUTICALS LTD .PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 27/11/2018 |
| NDA/MAL/HDP/7407 | HETERO LABS LTD | AIVEEN (U) LIMITED | MONAST 5 | MONTELUKAST SODIUM | 5MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | HETERO DRUGS LTD. VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, TEHSIL NALAGARH, DIST. SOLAN, HIMACHAL PRADESH PIN: 173 205 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7408 | ZIM LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | ZIFLAM 100 | ACECLOFENAC | 100MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7409 | S K AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT DISPERSIBLE | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | S KANT HEALTHCARE LTDPLOT NO. 1805, G.I.D.C PHASE III, VAPI 396195, GUJARAT | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER | 28/11/2019 |
| NDA/MAL/HDP/7410 | MEDOPHARM, INDIA | PLANET PHARMACEUTICALS UGANDA LTD | COTRIMOXAZOLE TABLETS BP 960 MG | TRIMETHOPRIM +SULPHAMETHOXAZOLE | 960MG | WATERLAND LABORATORIES34 B, INDUSTRIAL AREA, MALUR - 563160, KARNATAKA, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 26/09/2018 |
| NDA/MAL/HDP/7411 | S K AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT 180-1080 | ARTEMETHER + LUMEFANTRINE | 180MG + 1080MG /60ML | S KANT HEALTHCARE LTDPLOT NO. 1805, G.I.D.C PHASE III, VAPI 396195, GUJARAT | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 28/11/2019 |
| NDA/MAL/HDP/7413 | S K AGE EXPORTS | DAVIMED PHARMA LIMITED | LARIACT | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | S KANT HEALTHCARE LTDPLOT NO. 1805, G.I.D.C PHASE III, VAPI 396195, GUJARAT | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X24.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7414 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | RIBOREA | HYDROXYUREA | 500MG | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7415 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MAMOFEN-20 | TAMOXIFEN CITRATE | 20MG | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET STRIP | 28/11/2019 |
| NDA/MAL/HDP/7417 | INTAS PHARMACUITICALS LTD | STAR BIOTECH UGANDA LTD | SARTEL-40 | TELMISARTAN | 40MG | INTAS PHARMACEUTICALS LTD ...,CAMP ROAD, SELAQUI, DEHRADUN- 248197, UTTARKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7418 | INTAS PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | FOLISURGE 1200 | FOLLITROPIN ALFA | 1200 IU/1.92ML | INTAS PHARMACEUTICALS LTD (BIOPHARMA DIVISION)PLOT NO. 423/P/A, SARKHEJ-BAVLA HIGHWAY, MORAIYA, TALUKA SANAND, AHMEDABAD- 382213, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.92 ML VIAL | 28/11/2019 |
| NDA/MAL/HDP/7419 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | PACLITAXEL | PACLITAXEL | 6MG/ML | INTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X16.7 ML VIAL | 28/11/2019 |
| NDA/MAL/HDP/7421 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | GESIC ADL 200 | IBUPROFEN | 200MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7424 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ZINC SULFATE TABLETS USP 20MG | ZINC SULFATE MONOHYDRATE | 20MG | MACLEODS PHARMACEUTICALS LTD - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101 | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7425 | OCHOA LABORATORIES LIMITED - | AIVEEN (U) LIMITED | DOLOACT PLUS | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | AUROCHEM PHARMACEUTICALS (I)PLOT NO. 58, PTICE LTD PALGHAR 401404, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7426 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MEDOFED | GUAIFENESIN + DEXTROMETHORPHAN HYDROBROMIDE + PSEUDOEPHEDRINE HYDROCHLORIDE AND + TRIPROLIDINE HYDROCHLORIDE | 100MG + 15MG + 20MG + 1.25MG/5ML | MEDOCHEMIE ACTORY).....1-10 CONSTANTINOUPOLEOS STREET, 3011, LIMASSOL | CYPRUS | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7429 | SAKAR HEALTHCARE LIMITED | ROYAL PHARMA 2011 LIMITED | SEFIXI 1000 | CEFTRIAXONE SODIUM | 1G | SAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X50X1 G VIAL | 28/11/2019 |
| NDA/MAL/HDP/7431 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | MOVICOL | MACROGOL 3350 (POLYETHYLENE GLYCOL)+SODIUM CHLORIDE+SODIUM BICARBONATE+ POTASSIUM CHLORIDE | 13.125G+350.7MG+178.5MG+46.6MG | WIN-MEDICARE PVT. LTDMODIPURAM-250 110, UTTAR PRADESH,INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X13.81 G SACHET | 26/09/2018 |
| NDA/MAL/HDP/7432 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | MENAFRIVAC | MENINGOCOCCAL A POLYSACCHARIDE + TETANUS TOXOID | 5µG + 5µG /0.5ML | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0 ML VIAL + 1*5ML AMPOULE FOR DILUENT | 21/11/2019 |
| NDA/MAL/HDP/7435 | SQUARE FORMULATIONS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ZIMAX | AZITHROMYCIN DIHYDRATE | 200MG/5ML | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 28/11/2019 |
| NDA/MAL/HDP/7436 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEFOTIL PLUS 500 | CEFUROXIME AXETIL + CLAVULANATE | 500MG + 125MG | SQUARE CEPALOSPORINS LTD..KALIAKOIR GAZIPUR | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 28/11/2019 |
| NDA/MAL/HDP/7439 | DAWA PHARMACEUTICALS LIMITED | SUPER MEDIC LTD | LORVIC | LORATADINE | 5MG/5ML | DAWA LIMITED16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7440 | MANKIND | TATA UGANDA LIMITED | TOTACEF-1000 | CEFEPIME | 1000MG | MANKIND PHARMA LTD.VILLAGE KISHANPURA, POAMTA SAHI DISTRICT SIRMOUR HIMACHAL PRADESH | INDIA | | PARENTERAL RETARD DRY VIALS | 1.0X1000.0 MG VIAL | 28/11/2019 |
| NDA/MAL/HDP/7441 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYORTH XL | SODIUM HYALURONATE | 8MG/ML | VIRCHOW BIOTECH PVT LTDSURVEY NO. 172, PART GAGILLAPUR(P) QUTHBULLAPUR(MANDAL), R.R, DISTRICT, TELANGANA STATE, 500043.INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0 ML PRE- FILLED SYRINGE | 29/11/2017 |
| NDA/MAL/HDP/7442 | DAWA LIMITED- | SUPER MEDIC LTD | NERVILIN NT | PREGABALIN + NORTRIPTYLINE HYDROCHLORIDE | 75MG + 10MG | DAWA LIMITED16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7447 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | LORADIN 10 | LORATADINE | 10MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7448 | OCHOA LABORATORIES LIMITED - | SUPER MEDIC LTD | SORID OINTMENT | CALCIPOTRIOL MONOHYDRATE + BETAMETHASONE DIPROPIONATE | 50MCG +0.5MG | AUROCHEM LABORATORIES (I) PVT LTD8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE | 29/11/2017 |
| NDA/MAL/HDP/7450 | OCHOA LABORATORIES | SUPER MEDIC LTD | DOLOACT GEL | KETOPROFEN + CAPSICUM OLEORESIN | 2.50%W/W + 0.25%W/W | AUROCHEM LABORATORIES (I) PVT LTD-8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE | 29/11/2017 |
| NDA/MAL/HDP/7454 | MEDISEL(K) LTD | AIVEEN (U) LIMITED | GIT | ITOPRIDE HYDROCHLORIDE | 150MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 CAPSULE BLISTER | 28/11/2019 |
| NDA/MAL/HDP/7456 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUTRAX | CEFTRIAXONE SODIUM | 1G | VENUS REMEDIES LIMITED ,.HILL TOP, INDUSTRIAL ESTATE, JHARMAJRI, EPIP, PHASE 1, EXT. BBATOLI KALAN, BADDI-SOLAN HIMACHAL PRADESH, INDIA PIN 173205 | M/S ZEISS PHARMACEUTICALS PVT LTD,,PLOT 72, EPIP PHASE 1, JHARMAJRI BADDI, DIST: SOLAN HP-INDIA | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 21/11/2019 |
| NDA/MAL/HDP/7460 | INVENTIA HEALTHCARE PVT LTD | EUROPA HEALTHCARE (U) LTD | SEGABIN SR 75 | PREGABALIN | 75MG | INVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7461 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | WOMAZOL | ANASTROZOLE | 1MG | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X10 TABLET BLISTER | 29/05/2019 |
| NDA/MAL/HDP/7463 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ACURON | ATRACURIUM BESYLATE | 10MG/ML | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 27/08/2019 |
| NDA/MAL/HDP/7464 | INVENTIA HEALTHCARE PVT LTD | EUROPA HEALTHCARE (U) LTD | SEGABIN M 75 | PREGABALIN + METHYCOBALAMIN | 75MG + 1500MCG | INVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7465 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN TS | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 120MG + 960MG | M/S BLISS GVS PHARMA LIMITED PLOT 10, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE PALGHAR, DIST. THANE - 401404 | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7467 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | TEZOLE CREAM | KETOCONAZOLE | 20 MG | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 27/08/2019 |
| NDA/MAL/HDP/7468 | AKRITI PHARMACEUTICALS PVT LTD | PHARMA VILLE LIMITED | GYNO PLUS | AMPICILLIN SODIUM|METRONIDAZOLE + MICONAZOLE NITRATE | 100MG + 100MG|0.5G | AKRITI PHARMACEUTICALS PVT LTDPLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA | INDIA | VAGINAL TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/11/2019 |
| NDA/MAL/HDP/7469 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ECZEMUS 0.03% OINTMENT | TACROLIMUS MONOHYDRATE | 0.03%W/W | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE | 25/07/2018 |
| NDA/MAL/HDP/7473 | INVENTIA HEALTHCARE PVT LTD | EUROPA HEALTHCARE (U) LTD | AFLODOR 16 | ACECLOFENAC + THIOCOLCHICOSIDE | 200MG + 16MG | INVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X5.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7474 | INVENTIA HEALTHCARE PVT LTD | EUROPA HEALTHCARE (U) LTD | AFLODOR 8 | ACECLOFENAC + THIOCOLCHICOSIDE | 200 MG + 8 MG | INVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X5.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7477 | CHEPLAPHARM ARZNEIMITTEL GMBH | LABOREX UGANDA LIMITED | ROHYPNOL | FLUNITRAZEPAM | 1 MG | CENEXI S.A.S52, RUE MARCEL ET JACQUES GAUCHER 94120 FONTENAY-SOUS-BOIS- FRANCE | FRANCE | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/7480 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | AMOKLAVIN BID | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 200MG + 28.5MG/5ML | DEVA HOLDING A.SCERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7481 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | INTAGRA 100 | SILDENAFIL CIRATE | 100MG | INTAS PHARMACEUTICALS LTD .PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7483 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APISOPT PLUS | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | 2%W/V + 0.5%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | OPHTHALMIC LIQUIDS | 1.0X5.0 ML VIAL | 21/11/2019 |
| NDA/MAL/HDP/7487 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | BETASALIC | BETAMETHASONE DIPROPIONATE + SALICYLIC ACID | 0.05%W/W + 3%W/W | ATCO LABS LTD,B-18, S.I.T.E, KARACHI | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE | 21/11/2019 |
| NDA/MAL/HDP/7488 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | FINTAS 5 | FINASTERIDE | 5MG | INTAS PHARMACEUTICALS LTD .PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7489 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | DOLUTEGRAVIR + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIA | MACLEODS PHARMACEUTICALS LTD BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | MACLEODS PHARMACEUTICALS LTD ,.PHASE I & II, PLOT NO. 25-27 SURVEY NO. 366, PREMIERE INDUSTRIAL ESTATE, KACHIGAN, DAMAN-396210 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X100.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7490 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | INTAGRA 50 | SILDENAFIL CITRATE | 50MG | INTAS PHARMACEUTICALS LTD .PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7491 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | CIPRO-DENK 750 | CIPROFLOXACIN HYDROCHLORIDE | 750MG | ALLPHAMED PHARBIL ARZNEIMITTEL GMBH. HILDEBRANDSTRABE 12 37081 GOTTINGEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7493 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | CEFRAZ 200 | CEFIXIME TRIHYDRATE | 200 MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X10 TABLET BLISTER | 27/11/2019 |
| NDA/MAL/HDP/7504 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | IMATINATE 400 | IMATINIB MESYLATE | 400MG | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X1X10 CAPSULE BLISTER | 26/09/2018 |
| NDA/MAL/HDP/7505 | DEV LIFE CORPORATION | PLANET PHARMACEUTICALS UGANDA LTD | EPIRYTE 300 | SODIUM VALPOATE | 300 MG | SWISS GARNIER LIFE SCIENCES21-23 INDUSTRIAL AREA, MEHATPUR, UNA DIST., HIMACHAL PRADESH - INDIA | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1X10X10 TABLET STRIP | 27/11/2019 |
| NDA/MAL/HDP/7506 | DEV LIFE CORPORATION | PLANET PHARMACEUTICALS UGANDA LTD | EPIRYTE 500 | SODIUM VALPOATE | 500 MG | SWISS GARNIER LIFE SCIENCES21-23 INDUSTRIAL AREA, MEHATPUR, UNA DIST., HIMACHAL PRADESH - INDIA | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1X3X10 TABLET BLISTER | 27/11/2019 |
| NDA/MAL/HDP/7507 | ZIM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | FINEVIT-D3 2000 | CHOLECALCIFEROL (VITAMIN D3) | 2000 IU | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET STRIP | 27/11/2019 |
| NDA/MAL/HDP/7510 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | IMAVIR EYE OINTMENT | ACYCLOVIR | 3% | AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN, JORDAN MMAN, JORDAN | | JORDAN | | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE | 28/05/2019 |
| NDA/MAL/HDP/7514 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | ILFLOX 500 | LEVOFLOXACIN HEMIHYDRATE | 500 MG | ILKO ILAC SANAYI VE TICARET A.S3.ORGANIZE SANAYI BOLGESI, BUYUK KAYACIK MAH. KUDDISI CAD.23 SOKAKNO. 1 42050 SELCUKLU, KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7515 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | HEPBEST | PREGABALIN + NORTRIPTYLINE (AS HYDROCHLORIDE) | 75MG + 10MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 21/11/2019 |
| NDA/MAL/HDP/7516 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | ILFLOX 750 | LEVOFLOXACIN HEMIHYDRATE | 750 MG | ILKO ILAC SANAYI VE TICARET A.S3.ORGANIZE SANAYI BOLGESI, BUYUK KAYACIK MAH. KUDDISI CAD.23 SOKAKNO. 1 42050 SELCUKLU, KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7517 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI CARE LIMITED | LEVOCET-M | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | RESONANT PHARMACEUTICALS PRIVATE LIMITED - PLOT NO – 430-1-A NEAR SAFFRO MELLOW COLOUR FACTORY, VILLAGE, NAVAGAM, DISTRICT KHEDA, GUJARAT - 387540, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7518 | RESONANT PHARMACEUTICALS | SHREEJI CARE LIMITED | LEVOCET-M SUSPENSION | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 2.5MG / 5ML + 4MG / 5ML | CENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/7519 | MACLEODS PHARMACEUTICALS LTDS LTD | VITACARE LIMITED | LEVOFLOXACIN | LEVOFLOXACIN HEMIHYDRATE | 250 MG | MACLEODS PHARMACEUTICALS LTD BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 27/11/2019 |
| NDA/MAL/HDP/7520 | DAWA LIMITED | SUPER MEDIC LTD | LEVOXCIN | LEVOFLOXACIN HEMIHYDRATE | 750 MG | DAWA LIMITED 16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7523 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | LEVOFLOX-DENK 5 MG/ML | LEVOFLOXACIN HEMIHYDRATE | 5MG/ML | SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH-INDUSTRIESTR. 3 34212 MELSUNGEN GERMANY | GERMANY | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML VIAL | 01/07/2017 |
| NDA/MAL/HDP/7524 | AMMAN PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LOPROSTAN | LATANOPROST + TIMOLOL MALEATE | 0.005% W/V + 0.5%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | OPHTHALMIC LIQUIDS | 1.0X2.5 ML VIAL | 21/11/2019 |
| NDA/MAL/HDP/7525 | DAWA LIMITED | SUPER MEDIC LTD | LORVIC | LORATADINE | 10 MG | DAWA LIMITED16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7526 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | MANIGRA 100 | SILDENAFIL CITRATE | 100 MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 27/11/2019 |
| NDA/MAL/HDP/7529 | FDC LTD | AIVEEN (U) LIMITED | MOSI EYE DROPS | MOXIFLOXACIN HYDROCHLORIDE | 5 MG/ML | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | | OPHTHALMIC LIQUIDS | 1.0X1.0X5.0 ML VIAL | 21/11/2019 |
| NDA/MAL/HDP/7530 | HETERO LABS LTD | AIVEEN (U) LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR | 50MG | HETERO LABS LTD UNIT III22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 07/11/2018 |
| NDA/MAL/HDP/7535 | ACME FORMULATION PVT. LTD. | MARIE STOPES UGANDA LIMITED | MARIPRIST | MIFEPRISTONE + MISOPROSTOL | 200MG + 200MCG | ACME FORMULATION PVT. LTDROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X1.0X4.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/7536 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | SPINESIA-D | BUPIVACAINE HYDROCHLORIDE + DEXTROSE | 5MG + 80MG /ML | UNIQUE PHARMACEUTICAL LABORATORIESPLOT NO.4, PHASE IV, GIDC, INDUSTRIAL AREA, PANOLI- 394 116, DIST: BHARUCH, INDIA | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X10.0X4.0 ML AMPOULE,1.0X10.0X4.0 ML AMPOULE,1.0X1.0X5.0X5.0X4.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/7539 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | COUGH LINCTUS | CHLORPHENIRAMINE | 2MG/5ML | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1000.0 ML JERRYCAN,1.0X200.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/7541 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | CHLORHEXIDINE SCRUB | CHLORHEXIDINE GLUCONATE | 4%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1000.0 ML JERRYCAN | 01/07/2012 |
| NDA/MAL/HDP/7544 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | GLYCERIN OF BORAX | GLYCERINE+BORAX | 12%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X22.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/7546 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | HYDROGEN PEROXIDE | HYDROGEN PEROXIDE | 6%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 01/07/2012 |
| NDA/MAL/HDP/7548 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | IODINE TINCTURE | IODINE + POTASSIUM IODIDE | 2.5%W/V+2.5%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X22.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/7552 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | MAGNESIUM TRISILICATE MIXTURE | MAGNESIUM TRISILICATE + LIGHT MAGNESIUM CARBONATE + SODIUM BICARBONATE | 250MG + 250MG + 250MG/5ML | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/7554 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | POVIDONE IODINE BP | POVIDONE IODINE | 10%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN | 01/07/2013 |
| NDA/MAL/HDP/7556 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | SEVASTAT | CETRIMIDE + CHLORHEXIDINE | 3%W/V+0.3%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L BOTTLE | 01/07/2012 |
| NDA/MAL/HDP/7559 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | SURGICAL SPIRIT | METHYL SALICYLATE | 0.5%V/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL SPIRITS | 1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/HDP/7560 | SEV PHARMACEUTICALS LIMITED | SEV PHARMACEUTICALS LIMITED | VIOLGENT | CRYSTAL VIOLET | 0.5%W/V | SEV PHARMACEUTICALS LIMITEDPLOT 100 NALUKOLONGO | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X25.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/HDP/7571 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | NEUROVIT FILM-COATED TABLET | THIAMINE MONONITRATE + PYRIDOXINE HCL + CYANOCOBALAMINE | 97MG + 50MG + 100MG | HOVID BHDLOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/7586 | OCHOA LABORATORIES | SUPER MEDIC LTD | CLEAR-T GEL | CLINDAMYCIN PHOSPHATE + TRETINOIN | 1.0%W/W + 0.025%W/W | AUROCHEM LABORATORIES LTD PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 29/11/2017 |
| NDA/MAL/HDP/7587 | DAWA LIMITED | SUPER MEDIC LTD | NERVILIN 75 | PREGABALIN | 75 MG | DAWA LIMITED16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7588 | OCHOA LABORATORIES LIMITED - | SUPER MEDIC LTD | EXEVATE-MF OINTMENT | BETAMETHASONE DIPROPIONATE + SALICYLIC ACID + UREA + LACTIC ACID + SODIUM LACTATE SOLUTION | 0.05 % W/W + 3.0 % W/W + 10.0 % W/W + 3.0 % W/W + 2.0 % W/W | AUROCHEM LABORATORIES (I) PVT LTD8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404 | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE | 29/11/2017 |
| NDA/MAL/HDP/7589 | OCHOA LABORATORIES | SUPER MEDIC LTD | LACX SYRUP | LACTULOSE | 10G/15ML | AUROCHEM LABORATORIES (I) PVT LTD-8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/7590 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | MONTIGET | MONTELUKAST SODIUM | 5MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER | 25/11/2021 |
| NDA/MAL/HDP/7595 | AMMAN PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LOPROST | LATANOPROST | 0.005% W/V | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | OPHTHALMIC VIALS | 1.0X2.5 ML VIAL | 21/11/2019 |
| NDA/MAL/HDP/7598 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | RABEFLUX-DSR | RABEPRAZOLE SODIUM + DOMPERIDONE | 20MG + 30MG | STEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7605 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | STRIPOLE | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40 MG | GUFIC BIOSCIENCES LIMITED (UNIT 2)SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 27/11/2019 |
| NDA/MAL/HDP/7607 | FDC LTD | AIVEEN (U) LIMITED | TEARMAX EYE DROPS | CARMELLOSE SODIUM | 5MG/ML | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML VIAL | 21/11/2019 |
| NDA/MAL/HDP/7610 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | TERBIDERM FORTE | TERBINAFINE HYDROCHLORIDE | 250 MG | ATCO LABS LTD,B-18, S.I.T.E, KARACHI | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7611 | FERRING GMBH | MACNAUGHTON LIMITED | PABAL | CARBETOCIN | 100MCG/ML | FERRING GMBH.11, WITTLAND | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X5.0X1.0 ML VIAL | 01/07/2017 |
| NDA/MAL/HDP/7615 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | AIVCLAV-625 | AMOXICILLIN + CLAVULANIC ACID | 500MG + 125MG | AMN LIFE SCIENCE PVT LTD-67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | MEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/7622 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | MONTELAIR 5 | MONTELUKAST SODIUM | 5MG | HOVID BHDLOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2018 |
| NDA/MAL/HDP/7652 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | JANUVIA 100 | SITAGLIPTIN | 100MG | MSD PTY LTD117 16TH ROAD, HALFWAY HOUSE 1685 | SOUTH AFRICA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7653 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | JANUVIA 50 | SITAGLIPTIN | 50MG | MSD PTY LTD117 16TH ROAD, HALFWAY HOUSE 1685 | SOUTH AFRICA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7656 | A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SPASMOMEN | OTILONIUM BROMIDE | 40MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.LVIA CAMPO DI PILE, L’AQUILA (AQ), ITALY | ITALY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER (FREE PHYSICIAN'S SAMPLE, NOT FOR SALE ) | 01/07/2017 |
| NDA/MAL/HDP/7674 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABLEVOX | LEVOFLOXACIN HEMIHYDRATE | 5G/L | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7681 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEECEL 200 | CELECOXIB | 200MG | THE MADRAS PHARMACEUTICALS..NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7682 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AB-TETRA-250 | TETRACYCLINE | 250MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | CHINA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7686 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OPTIGENT EYE/EAR DROPS | GENTAMICIN SULPHATE | 0.3W/V | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7687 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DI - QUIN | DIHYDROARTEMISININ+PIPERAQUINE PHOSPHATE | 40MG + 320MG | SKANT HEALTH CARE LTD 1802-1805 GIDC PHASE III VAPI GUJARAT | CHINA | ORAL SOLID ORDINARY TABLETS | 1X9 TABLET BLISTER, | 09/07/1905 |
| NDA/MAL/HDP/7688 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 850MG TABLET | METFORMIN HYDROCHLORIDE | 850MG | NKUNZI PHARMACEUTICALS259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA | SOUTH AFRICA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X300.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER,1.0X4.0X15.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7695 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | CORTUM 500 | CEFUROXIME AXETIL | 500MG | MALIK LIFESCIENCES PRIVATE LIMITEDPLOT NO. 16, NH 58, VARDHMAN INDUTRIAL ESTATE, VILLAGE BAHADARPUR SAINI HARIDWAR, UTTARAKHAND-247667 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7706 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACEF 200 | CEFPODOXIME PROXETIL | 200MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | ALKEM LABORATORIES LIMITED VILLAGE- THANA BADDI, YEH NALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7709 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 8MG/2ML | NITIN LIFESCIENCES LTD-RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025 | INDIA | PARENTERAL ORDINARY AMPOULES | 1X50X2 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/7714 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ROXONE 1GM | CEFTRIAXONE SODIUM | 1 G | ZEISS PHARMACEUTICALS PVT LTD - PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | M/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 07/11/2018 |
| NDA/MAL/HDP/7715 | JANSSEN-CILAG INTERNATIONAL NV | LABOREX UGANDA LIMITED | SIRTURO | BEDAQUILINE FUMARATE | 100MG | RECIPHARM PHARMACEUTICALS PVT LTD34TH KM, TUMKUR ROAD, T-BEGUR, NELAMANGALA TALUK BENGALURU, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X188.0 TABLET BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/7716 | CORE ACCESS LIMITED | CORE ACCESS LTD | ALRINAST 2.5 MG / 5 ML SYRUP | DESLORATIDINE | 2.5 MG / 5 ML | NOBEL ?LAÇ SAN. VE TIC. A.?SANCAKLAR, DÜZCE, 81100 | TURKEY | | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/7726 | NTICALS LTD. | VITACARE LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 100MG + 25MG | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7735 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IBUMOL 400 | PARACETAMOL + IBUPROFEN | 325MG + 400MG | AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7745 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | TAZOGARD | PIPERACILLIN +TAZOBACTAM | 4G + 0.5G | AKUMS DRUGS & PHARMACEUTICALS LTD.2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X4.5 G VIAL ,2X10ML LDPE AMPOULES OF WFI | 01/07/2017 |
| NDA/MAL/HDP/7747 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | THERMODOL | PARACETAMOL | 1.0%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD.2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7751 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNODEX COUGH SYRUP | BROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE | 8MG + 10MG + 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT IIPLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7760 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | OZACE MD 10 | OLANZAPINE | 10MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | PSYCHOTROPICS INDIA LTD PLOT-NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/7784 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | LORATOL | LORATADINE | 5MG/5ML | NOBEL ILAC DUZCESANAYIINVE TICARET A.S SANCAKLAR 81100 DUZCE | TURKEY | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/7903 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MELMET-1000SR | METFORMIN HYDROCHLORIDE | 1000MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID RETARD COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2009 |
| NDA/MAL/HDP/7905 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | ACEFYL | ACEFYLINE PIPERAZINE + DIPHENHYDRAMINE HYDROCHLORIDE | 45MG +8MG | NABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/7907 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | HUCOG 5000 HP | CHORIONIC GONADOTROPHIN | 5000 I.U/ VIAL | BHARAT SERUMS & VACCINES LIMITED PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (E) MAHARASHTRA STATE 421501 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/8015 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | D-FEN | DICLOFENAC SODIUM | 25MG/ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X3.0 ML AMPOULE,1.0X10.0X1.0X10.0X3.0 ML AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/8023 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMOXICLAV-DENK 500/62.5 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 62.5 MG | PENCEF PHARMA GMBHBRITENBACHSTR ASSE 13 D-13509 BERLIN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X8.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/HDP/8043 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | RABEZOL | RABEPRAZOLE SODIUM | 20MG | B?L?M PHARMACEUTICALSGOSB 41480 GEBZE-KOCAEL?/TURKE | TURKEY | | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8073 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TRILEPTAL | OXCARBAZEPINE | 300MG | NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY | | ITALY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X50.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/8085 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CIPROL-500 | CIPROFLOXACIN | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/8089 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-AMOXY | AMOXYCILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/8091 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEGEL SUSPENSION | ALUMINIUM HYDROXIDE+MAGNESIUM TRISILICATE | 120MG+250MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/HDP/8092 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | KEMOXYL 250MG | AMOXYCILLIN | 250MG | LABORATORY & ALLIED LTDPLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER | 01/07/1997 |
| NDA/MAL/HDP/8095 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | COLOSAR-DENK 100/12.5 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 100MG + 12.5MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/8096 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | BENZALIN | BENZATHINE BENZYLPENICILLIN SODIUM | 2.4MEGA/ VIAL | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON,1.0X100.0X2.4 VIAL CARTON,1.0X10.0X2.4 VIAL CARTON | 01/07/2011 |
| NDA/MAL/HDP/8097 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN 5000 | ERYTHROPOIETIN | 5000IU/ 0.5ML | SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0X0.5 ML PRE- FILLED SYRINGE | 01/07/2016 |
| NDA/MAL/HDP/8103 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | WELQUINE 500 | LEVOFLOXACIN | 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD.PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/8104 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS 40 | TELMISARTAN | 40MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8105 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | XERIN | LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | AKUMS DRUGS AND PHARMACEUTICALS LTDPLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8107 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | WELRAB 20 | RABEPRAZOLE SODIUM | 20MG | AKUMS DRUGS & PHARMACEUTICALS LTD -19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8108 | MEDIPHARM SALES LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | ORS | GLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE | 6.75G + 1.45G + 1.3G + 0.75G | MEDIPHARM INDUSTRIES LTDPLOT 65, KAKAJJO ROAD, BWEYOGERERE POSTAL ADDRESS : P.O.BOX 5917, KAMPALA. | UGANDA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X25.0 G SACHET | 01/07/2017 |
| NDA/MAL/HDP/8109 | ABACUS (A) PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | IRON FOLATE | FERROUS SULPHATE + FOLIC ACI | 200MG + 0.4MG | MEDICAMEN BIOTECH LTDSP-1192, A &B, PHASE –IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET JAR | 01/07/2017 |
| NDA/MAL/HDP/8110 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | R.B.TONE SYRUP | MULTI-INGREDIENT | N/A | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X200.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8112 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV | AMOXICILLIN + CLAVULANIC ACID | 156.25MG/5ML | MEDOCHEMIE LTD – FACTORY B-PLOT 48, IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL; AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | | CYPRUS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/8113 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | MOXICLAV FORTE | AMOXICILLIN + CLAVULANIC ACID | 312.5MG/5ML | MEDOCHEMIE LIMITED (FACTORY B - ORAL FACILITY)-PLOT 48, LAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 41101 AGIOS ATHANASSIOS, LIMASSOL - CYPRUS | CYPRUS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/HDP/8114 | MEDOCHEMIE LTD | LABOREX UGANDA LIMITED | RUPAN | IBUPROFEN | 400MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | | CYPRUS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/8115 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LAMIVUDINE | LAMIVUDINE | 150MG | MACLEODS PHARMACEUTICALS LTD.PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8118 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 200MG + 50MG | MACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/8119 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | 50MG/ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/8121 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSQUINE | QUININE | 300MG/ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 01/07/2011 |
| NDA/MAL/HDP/8127 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% W/V | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X30.0 ML VIAL | 01/07/2016 |
| NDA/MAL/HDP/8130 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DEGRA 100 | SILDENAFIL CITRATE | 100MG | DEVA HOLDING A. S.ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/8131 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DEGRA | SILDENAFIL CITRATE | 50MG | DEVA HOLDING A. S.ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8133 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYHEP | SOFOSBUVIR | 400MG | MYLAN LABORATORIES LIMITEDD ,F-4 & F-12,MIDC, MALEGAON,SIRRRRAR, NASHIK -422113 MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8135 | BAL PHARMA LIMITED - | PLANET PHARMACEUTICALS UGANDA LTD | REGAMOL | PARACETAMOL | 500MG | BAL PHARMA LTD1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8142 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | XARELTO | RIVAROXABAN | 2.5MG | BAYER PHARMA AG 51368 LEVERKUSENBAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8143 | NAARI LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | LYDIA POSTPIL | LEVONORGESTREL | 1.5MG | NAARI PHARMA PRIVATE LIMITEDPLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER | 01/07/2013 |
| NDA/MAL/HDP/8144 | NAARI LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | MA KARE | MIFEPRISTONE + MISOPROSTOL | 200MG+ 200MCG | NAARI PHARMA PRIVATE LIMITEDPLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8145 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR 10 | MONTELUKAST SODIUM | 10MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8146 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR JUNIOR 4 | MONTELUKAST SODIUM | 4MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8147 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR JUNIOR 5 | MONTELUKAST SODIUM | 5 MG | DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONING | GERMANY | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8148 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCLOXACILLIN | FLUCLOXACILLIN | 500MG | SPARSH BIO-TECH PVT. LTD.-PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8150 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 20MG | NOVARTIS PHARMA STEIN AGCH. 4002 STEIN, SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8151 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-C | VITAMIN C | 100MG | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP | 01/07/2005 |
| NDA/MAL/HDP/8152 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 15MG | NOVARTIS PHARMA STEIN AG.SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8154 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOGCORT | HYDROCORTISONE ACETATE | 1%W/W | AGOG PHARMA LTDPLOT 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 |
| NDA/MAL/HDP/8155 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 5MG | NOVARTIS PHARMA STEIN AG.SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8156 | TATA UGANDA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE | DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE | 25 LF (? 30 IU)+5.5 LF (? 40 IU)+16 IOU (? 4.0 IU)+12.5MCG+11MCG | BIOLOGICAL E LTDPLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | | PARENTERAL ORDINARY I M VIALS | 1.0X48.0X0.5 ML VIAL (1 DOSE VIAL),1.0X24.0X5.0 ML VIAL (10 DOSE VIAL) | 01/07/2014 |
| NDA/MAL/HDP/8157 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | D LYTE- PLAIN | ANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE | 13.50G + 2.60G + 2.90G +1.50G/ 1L | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X20.5 G SACHET | 01/07/2016 |
| NDA/MAL/HDP/8159 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 100MG + 25MG | AUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8160 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID (CHERRY FLAVOUR) | ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE | 200MG+250MG+250MG+250MG+125MG/15ML | STEDMAN PHARMACEUTICALS PVT LTD...C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8162 | BHARAT SERUMS AND VACCINES LTD | ABACUS PHARMA (AFRICA) LIMITED | HUMOG 75 HP | HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U | 75 IU + 75 IU/ 150 I.U VIAL | BHARAT SERUMS AND VACCINES LTD PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL | 01/07/2017 |
| NDA/MAL/HDP/8163 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE SURGICAL SCRUB | POVIDONE-IODINE | 7.5%W/W | G,S PHARMBUTOR PVT LTD B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN | INDIA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 26/09/2018 |
| NDA/MAL/HDP/8167 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE STANDARDISED MICROBICIDAL SOLUTION 10% W/V | POVIDONE-IODINE | 10%W/W | G,S PHARMBUTOR PVT LTD B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN | INDIA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/HDP/8170 | PRISMA PHARMA FZE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID (PINEAPPLE FLAVOUR) | ALGINIC + MAGNESIUM HYDROXIDE +DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE | 200MG+250MG+250MG+250MG+125MG/15ML | STEDMAN PHARMACEUTICALS PVT LTD...C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8177 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | CILZEC PLUS | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES PVT. LIMITEDPLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2016 |
| NDA/MAL/HDP/8178 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | NYSTAGO TABLETS | NYSTATIN | 500,000I.U | AGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/8185 | AFRICURE PHARMACEUTICALS (INDIA) LTD | AFRICURE PHARMACEUTICALS U LIMITED | INDOSIM | INDOMETHACIN | 25MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER | 01/07/1997 |
| NDA/MAL/HDP/8194 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | SOLONEX-100 | ISONIAZID | 100MG | OXALIS LAB-VILLAGE THEDA, P.O. LODHIMAJRA, TEHSIL BADDI, DIST. SOLAN (HP) PIN CODE 174101 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X24.0X28.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/8195 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RH-COM | RIFAMPICIN & ISONIAZID | 150MG +75MG | MACLEODS PHARMACEUTICALS LTD-BLOCK N3, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X24.0X28.0 TABLET BLISTER,1.0X3.0X28.0 TABLET BLISTER | 01/07/2005 |
| NDA/MAL/HDP/8197 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | AMIKACIN | AMIKACIN SULPHATE | 500MG/2ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X2.0 ML VIAL | 01/07/2017 |
| NDA/MAL/HDP/8198 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | XYMEX DROPS | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE | 01/07/1999 |
| NDA/MAL/HDP/8199 | MEDLEY PHARMACEUTICALS LTD | EUROPA HEALTHCARE (U) LTD | XYMEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTDPLOT 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 | 01/07/2000 |
| NDA/MAL/HDP/8200 | MEDIPHARM SALES LIMITED | MEDIPHARM INDUSTRIES (E.A) LTD | ORS ORANGE | GLUCOSE ANHYDROUS + TRISODIUM CITRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE | 6.75G + 1.45G + 1.3G + 0.75G / SACHET | MEDIPHARM INDUSTRIES( EA) LTDPLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.4 G SACHET | 01/07/2017 |
| NDA/MAL/HDP/8201 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CENTROZINE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8202 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | ISONIAZID | ISONIAZID | 300MG | OXALIS LABS-VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101 INDIA | MACLEODS PHARMACEUTICALS LTD.PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8206 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRULEXIN | CEFALEXIN MONOHYDRATE | 125MG/5ML | BRAWN LABORATORIES LTD.13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE | 01/07/2018 |
| NDA/MAL/HDP/8207 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | ZOMETA | ZOLEDRONIC ACID | 4MG/5ML | NOVARTIS PHARMA STEIN AG ;SCHAFFHAUSERSTRASSE CH 4332 STEIN-SWITZERLAND | SWITZERLAND | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X5.0 ML VIAL | 01/07/2017 |
| NDA/MAL/HDP/8210 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP | HYDROCORTISONE | 100MG | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X100.0 MG VIAL | 01/07/2007 |
| NDA/MAL/HDP/8211 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCO-ASTHALIN SYRUP | SALBUTAMOL + BROMHEXINE | 2MG/5ML + 4MG/5ML | BETA HEALTHCARE INTERNATIONAL LTD - PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/HDP/8212 | FDC LIMITED - | AIVEEN (U) LIMITED | BACTIGEN EYE/EAR DROPS | GENTAMICIN | 0.3%W/V | FDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | | OPHTHALMIC VIALS | 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/1998 |
| NDA/MAL/HDP/8213 | FDC LTD | AIVEEN (U) LIMITED | ZOCON 200 | FLUCONAZOLE | 200MG | FDC LTD.L-56/L-57,PHASE II-D, VERNA INDUSTRIAL ESTATE,VERNA-403722, SALCETE,GOA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/HDP/8216 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | SEFOTAX | CEFOTAXIME SODIUM | 1G | SWISS PARENTERALS LTD, UNIT- IIPLOT NO. 402,412-414 KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAVLA, DIST: AHMEDABAD | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 01/07/2017 |
| NDA/MAL/HDP/8224 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OPTIGENT OINTMENT | GENTAMICIN SULFATE | 0.3%W/W | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT | | EGYPT | | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE | 01/07/2017 |
| NDA/MAL/HDP/8226 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | SALRES | SALBUTAMOL SULPHATE | 120.5MCG/SPRAY | DEVA HOLDING A. S.ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER | 01/07/2017 |
| NDA/MAL/HDP/8228 | AFRICURE PHARMACEUTICALS (INDIA) LTD | AFRICURE PHARMACEUTICALS U LIMITED | VITAMIN B-COMPLEX (BEEKO) | VITAMINS B1 + B2 + B6 + NIACINAMIDE | 1MG +1MG +1MG +15MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8235 | DAWA LIMITED- | SUPER MEDIC LTD | ACEPAR | ACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL | 100MG + 15MG + 500MG | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8243 | OCHOA LABORATORIES LIMITED - | SUPER MEDIC LTD | TX-MF | TRANEXAMIC ACID + MEFENAMIC ACID | 500MG + 250MG | AUROCHEM PHARMACEUTICALS INDIA PRIVATE LIMITED58, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401 404 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 01/07/2017 |
| NDA/MAL/HDP/8252 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | PARACETAMOL FRESENIUS | PARACETAMOL | 10MG/ML | FRESENIUS KABI DEUTSCHLAND GMBHFRESENIUSSTRASSE 1, D-61169, FRIEDBERG | | GERMANY | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X10.0X50.0 ML VIAL,1.0X10.0X100.0 ML VIAL | 01/07/2017 |
| NDA/MAL/HDP/8253 | REYOUNG PHARMACEUTICAL CO LTD | ROYAL PHARMA 2011 LIMITED | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG/ML | REYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 10X10X3 ML AMPOULE | 01/07/2017 |
| NDA/MAL/HDP/8254 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-CV | CEFIXIME TRIHYDRATE + CLAVULANIC ACID | 200MG + 125MG | MICRO LABS LIMITED, BOMMASANDRA PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP | 01/07/2017 |
| NDA/MAL/HDP/8264 | CACHET PHARMA PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | EMITINO ORAL SOLUTION | ONDANSETRON | 2MG/5ML | CACHET PHARMACEUTICALS PVT LTD THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8274 | HETERO LABS LTD | AIVEEN (U) LIMITED | BICATERO 50 | BICALUTAMIDE | 50MG | HETERO LABS LTD (UNIT-VI)"SY.NO. 439, 440 & 458,APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/8275 | HETERO LABS LTD | AIVEEN (U) LIMITED | LETERO | LETROZOLE | 2.5MG | HETERO LABS LTD (UNIT-VI)"SY.NO. 439, 440 & 458,APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/8276 | HETERO LABS LTD | AIVEEN (U) LIMITED | GEMTERO 1G | GEMCITABINE | 1G | HETERO LABS (UNIT VI), INDIAAPIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL | 01/07/2013 |
| NDA/MAL/HDP/8277 | HETERO LABS LTD | AIVEEN (U) LIMITED | GEMTERO 200MG | GEMCITABINE | 200MG | HETERO LABS (UNIT VI), INDIAAPIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X200.0 MG VIAL | 01/07/2013 |
| NDA/MAL/HDP/8278 | HETERO LABS LTD | AIVEEN (U) LIMITED | ANATERO | ANASTROZOLE | 1MG | HETERO LABS LTD, UNIT VI, INDIAAPIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X30 TABLET BOTTLE | 01/07/2013 |
| NDA/MAL/HDP/8279 | SAKAR HEALTHCARE PVT LTD | ROYAL PHARMA 2011 LIMITED | GENTACIN | GENTAMICIN SULPHATE | 80MG/2ML | SAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X6.0X2.0 ML AMPOULE IN BLISTERS | 01/07/2013 |
| NDA/MAL/HDP/8299 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | DICLOFENAC TABLETS BP | DICLOFENAC SODIUM | 50MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2007 |
| NDA/MAL/HDP/8307 | NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | METFORMIN 500 | METFORMIN | 500MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/8308 | NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITED | AFRICURE PHARMACEUTICALS U LIMITED | PREDNISOLONE 5MG | PREDNISOLONE | 5MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 01/07/2008 |
| NDA/MAL/HDP/8312 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TRICORT 40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL | 29/11/2017 |
| NDA/MAL/HDP/8315 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA 75 | DARUNAVIR | 75MG | JANSSEN ORTHO LLC.-STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X480.0 TABLET BOTTLE | 01/07/2017 |
| NDA/MAL/HDP/8316 | AUROBINDOM PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DOLUTEGRAVIR 50 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | AUROBINDO PHARMA LTD, UNIT XNO. 16, APIIC MULTI PRODUCTS SEZ, MENAKUR VILLAGE, NAIDUPETA MANDAL, SPSR, NELLORE DISTRICT, ANDHRA PRADESH, PIN 524421 | "AUROBINDO PHARMA LIMITEDUNIT –VII, SEZ, TSIIC, PLOT NO. SI,S. NO.’S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT -509 302 TELANGANA STATE, INDIA" | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8319 | KOPRAN LIMITED | TATA UGANDA LIMITED | ERYKO-250 | ERYTHROMYCIN STEARATE TABLETS BP | 250MG | KOPRAN LTDVILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER | 29/11/2017 |
| NDA/MAL/HDP/8321 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PROSTAR- 200 CAPSULES | PROGESTERONE | 200 MG | AKUMS DRUGS & PHARMACEUTICALS LTD .PLOT NO. 47, 48, SECTOR 6A, IIE, SIDCUL HARIDWAR, UTTRAKHAND – 249403, INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| NDA/MAL/HDP/8322 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEMONT L | MONTELUKAST SODIUM+LEVOCETIRIZINE DIHYDROCHLORIDE | 10 MG + 5 MG | GLENMARK PHARMACEUTICALS LIMITED-UNIT IIIVILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/8324 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LOOBID TABLETS | OFLOXACIN + ORNIDAZOLE | 200MG + 500 MG | CACHET PHARMACEUTICAL PVT LTD. HIMACHALTHANA, BADDI, HIMACHAL PRADESH-173 205, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8326 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | MEDOMOX 250 DT | AMOXICILLIN | 250MG | MEDOPHARM PVT LTD.NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER (EMBOSSED WITH "GOU NOT FOR SALE" & NON-EMBOSSED) | 29/11/2017 |
| NDA/MAL/HDP/8331 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TORSINEX-20 | TORSEMIDE | 20MG | MICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8332 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | AZITRO 500 MG | AZITHROMYCIN | 500MG | DEVA HOLDING A. S.ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8333 | MICRO LABS LTD 92 SIPCOT INDUSTRIAL | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AVAS-20 | ATORVASTATIN | 20MG | MICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8335 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIVAMOX | AMOXICILLIN TRIHYDRATE | 500MG | RIVA PHARMA FREE ZONENASR CITY CAIRO EGYPT | EGYPT | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER | 31/01/2018 |
| NDA/MAL/HDP/8337 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ARTESUNATE 120 MG | ARTESUNATE | 120 MG | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | BLISS INDAS LIFESCIENCE P. LTD..PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1*2 ML AMPOULE OF SODIUM BICARBONATE + 1*10 ML VIAL OF 0.9%W/V SODIUM CHLORIDE | 29/11/2017 |
| NDA/MAL/HDP/8340 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MONTEMAC 5 | MONTELUKAST SODIUM | 5 MG | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8341 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | GENVOYA | ELVITEGRAVIR+COBICISTAT+EMTRICISTABINE+TENOFOVIR ALAFENAMIDE | 150MG + 150MG + 200MG + 10MG | PATHEON INC.-TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/8343 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XYKAA EXTEND 1000 | PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE) | 325MG+675MG | TROIKAA PHARMACEUTICALS LTD .SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8344 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CELZA DRY SYRUP | CEFUROXIME AXETIL USP | 125 MG/5 ML | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/8345 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CELZA 500 | CEFUROXIME AXETIL USP | 500 MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8346 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ADERAN 8 | CANDESARTAN CILEXETIL | 8MG | AJANTA PHARMA LIMITEDB-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 | 29/11/2017 |
| NDA/MAL/HDP/8347 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | FENTWELL 0.05MG/ML | FENTANYL CITRATE | 0.05MG/ML | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0 ML AMPOULE | 30/05/2018 |
| NDA/MAL/HDP/8348 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | IRBECOR PLUS 300MG/12.5MG | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8350 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | FENTWELL 0.05MG/ML | FENTANYL CITRATE | 0.05MG/ML | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINA | CHINA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 30/05/2018 |
| NDA/MAL/HDP/8352 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KETESSE | DEXKETOPROFEN TROMETAMOL | 50MG/2ML | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.LVIA SETTE SANTI 3, 50131 FIRENZE | ITALY | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 AMPOULE CARTON,1.0X6.0 AMPOULE CARTON,1.0X20.0 AMPOULE CARTON,1.0X5.0 AMPOULE CARTON | 21/11/2019 |
| NDA/MAL/HDP/8353 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FEDATE CAPSULES | CARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE | 100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8354 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | ZORUXA | ZOLEDRONIC ACID | 5MG/100ML | GLAND PHARMA LIMITTED 143-148D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/HDP/8356 | UNOSOURCE PHARMA LTD | MEDVIN PHARMA LIMITED | LORFACT-D | DESLORATIDINE | 5MG, | AKUMS DRUGS & PHARMACEUTICALS LTD19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8357 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | FRESENIUS PROPOVEN 1% | PROPOFOL | 1% W/V | FRESENIUS KABI AB PLANT UPPSALARAPSGATAN 7S-75174 UPPSALA SWEDEN | SWEDEN | | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X10.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL,1.0X10.0X100.0 ML VIAL | 29/11/2017 |
| NDA/MAL/HDP/8392 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | IRBECOR PLUS 150MG/12.5MG | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1 SELÇUKLU / KONYA | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8394 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RIFAMPICIN 75 MG ISONIAZID 50 MG AND PYRAZINAMIDE 150 MG DISPERSIBLE TABLETS | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE | 75MG + 50MG + 150MG | MACLEODS PHARMACEUTICALS LTD., NO. 25-27PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X3.0X28.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8395 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | RIFAMPICIN 75 MG ISONIAZID 50 MG DISPERSABLE TABLETS | RIFAMPICIN + ISONIAZID | 75MG + 50MG | OXALIS LABVILLAGE THEDA, P.O. LODHIMAJRA, TEHSIL BADDI, DIST. SOLAN (HP) PIN CODE 174101 | MACLEODS PHARMACEUTICALS LTD., NO. 25-27PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X3.0X28.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8396 | MARIE STOPES INTERNATIONAL | MARIE STOPES UGANDA LIMITED | BACK-UP | LEVONORGESTREL | 1.5MG | ACME FORMULATION PVT LTD. ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8407 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | TORTAS 20 | TORSEMIDE | 20MG | INTAS PHARMACEUTICALS LTD CAMP ROAD, SELAQUI – 248 197 DEHRADUN (UK) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/HDP/8411 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | RHEUMAC GEL | DICLOFENAC | 1%W/W | LABORATORY & ALLIED LTD-PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE | 29/11/2017 |
| NDA/MAL/HDP/8419 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | VB COMPLEX | VIT B1+ VIT B2 +VIT B3 + NICOTINAMIDE+PANTOTHENOL | 10MG +1MG +1MG +16MG +0.5MG | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE | 01/07/2018 |
| NDA/MAL/HDP/8434 | DAWA LIMITED | SUPER MEDIC LTD | DACINAZOLE | MICONAZOLE NITRATE | 2%W/W | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 01/07/2009 |
| NDA/MAL/HDP/8468 | THEON PHARMACEUTICALS LIMITTED | AIVEEN (U) LIMITED | THEOMOX-500 | AMOXICILLIN | 500 MG | THEON PHARMACEUTICALS LIMITED. VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 31/01/2018 |
| NDA/MAL/HDP/8477 | WOCKHARDT LTD | ABACUS PHARMA (AFRICA) LIMITED | GLARITUS 100IU/ML | INSULIN GLARGINE | 100IU/ML | WOCKHARDT LIMITED -WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY CARTRIDGES | 1.0X10.0 ML VIAL | 31/01/2018 |
| NDA/MAL/HDP/8485 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CACHMAX-400 | CEFIXIME | 400MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/8487 | BAL PHARMA LIMITED - | PLANET PHARMACEUTICALS UGANDA LTD | EMTRIM FORTE | SULFAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | BAL PHARMA LTD1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/01/2018 |
| NDA/MAL/HDP/8489 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | MEDOL | TRAMADOL HYDROCHLORIDE | 100 MG / 2 ML | SWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE | 31/01/2018 |
| NDA/MAL/HDP/8490 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9% W/V | ALTHEA PHARMA PVT LTD -PLOT NO. 374 SHED NO. E,.ALPHA INDUSTRIAL PARK , ATHIYAWAD DABHEL ,NANI DAMAN (U.T) 396210, INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/8491 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CETROTIDE 0.25MG | CETRORELIX | 0.25MG | PIERRE FABRE MEDICAMENT AQUITAINE PHARM INTERNATIONAL SITE 1 | ABBOTT BIOLOGICALS B.V VEERWEG 12,NL-8121 AA OLST THE NETHERLANDS | FRANCE | | PARENTERAL ORDINARY COMBINATION PACK VIALS | 1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON | 31/01/2018 |
| NDA/MAL/HDP/8493 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | DESCOVY 200MG/25MG | EMTRICITABINE/TENOFOVIR ALAFENAMIDE | 200MG + 25 MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | | CANADA | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 31/01/2018 |
| NDA/MAL/HDP/8499 | YELURI FORMULATIONS PVT LTD | SUPER MEDIC | SOLOCEF 1000 MG | CEFTRIAXONE SODIUM | 1000MG | YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA. | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL | 31/01/2018 |
| NDA/MAL/HDP/8522 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | DAYPENAM | MEROPENEM | 500MG | ZEISS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) - INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL | 07/01/2017 |
| NDA/MAL/HDP/8566 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | AZINOWEL | AZITHROMYCIN | 200MG/5ML | AKUMS DRUGS & PHARMACEUTICALS LTDPLANT II, PLOT NO. 22, SECTOR- 6A, IIE, SIDCUL, RANIPUR, DISTT.: HARIDWAR, UTTARAKHAND | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/8569 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | TERBINOL® | TERBINAFINE HYDROCHLORIDE | 1%W/W | NOBEL ?LAÇ SAN. VE TIC. A.?SANCAKLAR, DÜZCE, 81100 | TURKEY | | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE | 21/11/2019 |
| NDA/MAL/HDP/8602 | KIMSY MEDS LTD | KIMSY MEDS LTD | KOFLIN COUGH FLU LINCTUS | CHLOPHENIRAMINE | 2MG | MAVID PHARMACEUTICAL INDUSTRIES LIMITEDPLOT 490 BIRONGO, KITIIKO | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/8603 | KIMSY MEDS LTD | KIMSY MEDS LTD | MAAGA | SODIUM BICARBONATE + LIGHT MAGNESIUM CARBONATE + MAGNESIUM | 250 MG + 250 MG + 250 MG | MAVID PHARMACEUTICAL INDUSTRIES LIMITEDPLOT 490 BIRONGO, KITIIKO | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/HDP/8637 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | AGYCIN | AZITHROMYCIN DIHYDRATE | 40MG/ML | BLISS GVS PHARMA LTDPLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X15.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/8639 | MSD (PTY) LTD | SURGIPHARM (U) LIMITED | ISENTRESS 100MG | RALTEGRAVIR POTASSIUM | 100MG | PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA |MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685 SOUTH AFRICA | | SOUTH AFRICA | UNITED STATES OF AMERICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X60.0 TABLET BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/8641 | CADILA PHARMACEUTICALS LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | TELI H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | CADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/8643 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | ARTESUNATE 60MG | ARTESUNATE | 60MG | M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA | BLISS INDAS LIFESCIENCE P. LTD..PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL + 1*1*5ML AMPOULE OF 0.9%W/V NACL + 1*1*1ML AMPOULE OF 5%W/V NAHCO3 | 28/03/2018 |
| NDA/MAL/HDP/8648 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNODEX PLUS | TERBUTALINE SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 2.5MG + 8MG + 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT IIPLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/8649 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | CEFCARE | CEFTRIAXONE SODIUM | 1G | INJECTCARE PARENTERALS PVT. LTD.PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 31/01/2018 |
| NDA/MAL/HDP/8650 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | CEFDIA 400MG | CEFIXIME TRIHYDRATE | 400MG | NOBEL ?LAÇ SAN. VE TIC. A.?.81100 SANCAKLAR, DÜZCE-TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER,1.0X2.0X1.0X5.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/8655 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 1000MG | METFORMIN HYDROCHLORIDE | 1000MG | MERCK SANTÉ S.A.S.2 RUE DU PRESSOIR VERT 45400 SEMOY FRANCE | MERCK KGAA-PHARMA PRODUCTION DARMSTADT FRANKFURTER STRABE 250, D-64293, DARMSTADT | GERMANY | FRANCE | ORAL SOLID RETARD TABLETS | 1.0X4.0X15.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/8660 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | VEMLIDY | TENOFOVIR ALAFENAMIDE | 25MG | PATHEON INC.-TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/8661 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR SODIUM | 50MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIICPLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/8662 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | AMOXIREN-DS | AMOXICILLIN TRIHYDRATE | 250MG/5ML | RENE INDUSTRIES LTD .PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/HDP/8665 | CACHET PHARMACEUTICALS PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | PAMAGIN-C | CETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE | 5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MG | CACHET PHARMACEUTICALS PVT LTDVILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 28/03/2018 |
| NDA/MAL/HDP/8684 | TENTH OF RAMADAN FOR PHARMACEUTICALS INDUSTRIES AND DIAGNOSTICS REAGENTS(RAMEDA) | GAMA PHARMACEUTICALS (U) LIMITED | MEGAFEN N | PRAZIQUANTEL USP|IBUPROFEN | 100MG/5ML|600 MG | TENTH OF RAMADAN FOR PHARMACEUTICAL INDUSTRIES & DIAGNOSTIC REAGENTS (RAMEDA)SECOND INDUSTRIAL ZONE, PLOT NO.5 SIXTH OF OCTOBER- EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE, 1.0X100.0 TABLET BOTTLE | 26/11/2019 |
| NDA/MAL/HDP/8685 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | RANCV 500 | RANOLAZINE | 500 MG | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/8688 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DURART 600 | DARUNAVIR | 600 MG | MYLAN LABORATORIES LTD -H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8689 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DURART 800 | DARUNAVIR | 800 MG | MYLAN LABORATORIES LTD -H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8691 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | QUETRA 1000 | LEVETIRACETAM | 1000MG | REMEDICA LTD.AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUS | CYPRUS | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/8694 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ERBITUX | CETUXIMAB | 5MG/ML | MERCK KGAA-250 FRANKFURTERSTRASSE, D-6100 DARMSTADT | | GERMANY | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X20.0 ML VIAL | 07/11/2018 |
| NDA/MAL/HDP/8699 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ACETAZOLAMIDE | ACETAZOLAMIDE | 250 MG | REMEDICA LTD.AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUS | CYPRUS | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/8778 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | AIVCEF-250 | CEFUROXIME AXETIL|OXALIPLATIN | 250MG|5MG/ML | ASSOCIATED BIOTECHKRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER, 1.0X10.0 ML VIAL | 26/11/2019 |
| NDA/MAL/HDP/8779 | M/S HETERO LABS LIMITED | AIVEEN (U) LIMITED | STATINOR 20 | ROSUVASTATIN | 20MG | HETERO LABS LIMITED UNIT VTSIIC FORMULATION SEZ, S.NO 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DIST) –509301, TELANGANA INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 28/05/2019 |
| NDA/MAL/HDP/8780 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | STATINOR 10 | ROSUVASTATIN CALCIUM | 10 MG | HETERO LABS LIMITED UNIT VTSIIC FORMULATION SEZ, S.NO 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DIST) –509301, TELANGANA INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/HDP/8783 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | AIVCLAV-375 | AMOXICILLIN + CLAVULANIC ACID | 250MG + 125MG | AMN LIFE SCIENCE PVT LTD-67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT | MEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) | | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/8786 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | AIVXIM | ARTEMETHER + LUMEFANTRINE|CEFIXIME TRIHYDRATE | 100MG|20MG + 120MG | ASSOCIATED BIOTECHKRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X12.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER, 1.0X6.0 TABLET BLISTER | 26/11/2019 |
| NDA/MAL/HDP/8795 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 60/360 | ARTEMETHER + LUMEFANTRINE | 60MG + 360MG | AJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | AJANTA PHARMA LIMITEDB-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD MAHARASHTRA STATE INDIA 431 128 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X1.0X6.0 TABLET BLISTER | 26/11/2019 |
| NDA/MAL/HDP/8796 | PSYCHOTROPICS INDIA LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | AMITRIP-25 | AMITRIPTYLINE HYDROCHLORIDE | 25MG | PSYCHOTROPICS INDIA LTDPLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/8797 | TENTH OF RAMADAN FOR PHARMACEUTICALS INDUSTRIES AND DIAGNOSTICS REAGENTS(RAMEDA) | GAMA PHARMACEUTICALS (U) LIMITED | COLONA | DOMPERIDONE |MEBEVERINE HYDROCHLORIDE + SULPIRIDE|RABEPRAZOLE SODIUM | 100MG + 25MG|30MG|20MG | TENTH OF RAMADAN FOR PHARMACEUTICAL INDUSTRIES & DIAGNOSTIC REAGENTS (RAMEDA)SECOND INDUSTRIAL ZONE, PLOT NO.5 SIXTH OF OCTOBER- EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 CAPSULE BLISTER | 26/11/2019 |
| NDA/MAL/HDP/8803 | SQUARE PHARMACEUTICALS LTD.(CHEMICALS DIVISION) | GAMA PHARMACEUTICALS (U) LIMITED | SYNERGEX 625MG | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500MG + 125MG | SQUARE PHARMACEUTICALS LIMITED.SQUARE ROAD, SALGARIA, PABNA | BANGLADESH | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X6.0 TABLET BLISTER, 1.0X5.0X6.0 TABLET BLISTER | 26/11/2019 |
| NDA/MAL/HDP/8814 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ACRIPTEGA | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | MYLAN LABORATORIES LIMITEDD ,PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR-454775 DIST. DHAR, MADHYA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE,1.0X180.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8815 | ZIM LABORATORIES LTD | REDDYS PHARMA LIMITED | ZIMAGRA – ODS 50 | SLIDENAFIL CITRATE | 50 MG | ZIM LABORATORIES LTDB-21/22, M.I.D.C. AREA, KALMESHWAR – 441501, DIST. NAGPUR, MAHARASHTRA, | INDIA | | OTHER SYSTEMIC SPECIAL SOLIDS | 1.0X1.0X10.0 SACHET CARTON | 30/05/2018 |
| NDA/MAL/HDP/8816 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABPARA | PARACETAMOL | 1%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1.0X100.0 ML BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8817 | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | MEDISOLONE-15 | PREDNISOLONE SODIUM PHOSPHATE | 15MG/5ML | MEDIPHARM INDUSTRIES( EA) LTDPLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X5.0 ML BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8818 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVOTOP-PF | LEVOFLOXACIN HEMIHYDRATE | 1.5%W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 30/05/2018 |
| NDA/MAL/HDP/8819 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LORFACT-D SYRUP | DESLORATADINE | 5MG/5ML | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT IIPLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8820 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | T-DOL P RAPID | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | TROIKAA PHARMACEUTICALS LTD .C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 30/05/2018 |
| NDA/MAL/HDP/8823 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | EPCLUSA | SOFOSBUVIR + VELPATASIR | 400MG + 100MG | PATHEON INC.-TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8824 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NEPAFLAM | NEPAFENAC | 0.1% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML VIAL | 30/05/2018 |
| NDA/MAL/HDP/8826 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | ABACAVIR SULFATE AND LAMIVUDINE TABLETS FOR ORAL SUSPENSION 120/60 MG | ABACAVIR SULFATE + LAMIVUDINE | 120MG + 60MG | CIPLA LIMITED PLOT NO A – 33, A – 2 (UNIT – I), MIDC PATALGANGA, DISTRICT RAIGAD, 410 220 MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X1.0X60.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8827 | HETERO LABS LTD | AIVEEN (U) LIMITED | SOFGEN | SOFOSBUVIR | 400 MG | HETERO LABS LIMITED UNIT-VI -APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR DIST -509301, TELANGANA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 30/05/2018 |
| NDA/MAL/HDP/8829 | HETERO LABS LTD | AIVEEN (U) LIMITED | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | M/S. ANNORA PHARMA PRIVATE LIMITEDSY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | 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 | 1X90 TABLET BOTTLE | 20/12/2018 |
| NDA/MAL/HDP/8830 | HETERO LABS LTD | AIVEEN (U) LIMITED | IRBIS-HT | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/8831 | HETERO LABS LTD | AIVEEN (U) LIMITED | PREGA 75 | PREGABALIN | 75MG | HETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | HETERO LABS LIMITED (UNIT I)VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE 173205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X3X10 CAPSULE BLISTER | 26/11/2019 |
| NDA/MAL/HDP/8836 | EXPHAR S.A. ZONING INDUSTRIEL DE NIVELLES SUD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GASTRICID | FAMOTIDINE BP + MAGNESIUM HYDROXIDE BP + CALCIUM CARBONATE BP | 10 MG + 165 MG + 800 MG | MILAN LABORATORIES (INDIA ) PVT LTDPLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X4.0 TABLET STRIP | 07/11/2018 |
| NDA/MAL/HDP/8839 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | HEALTH RICH | FERRIC AMMONIUM CITRATE + FOLIC ACID + VITAMIN B1 HCL + VITAMIN B6 HCL + NICOTINAMIDE + VITAMIN B12 | 900MG + 10MG + 20MG + 40MG + 200MG + 360MG /5ML | TORQUE PHARMACEUTICALS PVT LTD VILL. ISSAPUR, P.O. DAPPAR, PUNJAB-140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1X100 ML BOTTLE, 1X1X100 ML BOTTLE | 26/11/2019 |
| NDA/MAL/HDP/8844 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VENAXAN 500 MG | LEVOFLOXACIN HEMIHYDRATE | 500 MG | SOUTH EGYPT DRUG INDUSTRIES CO-1ST INDUSTRIAL ZONE, 6 OCTOBER CITY, EGYPT. | | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER | 07/11/2018 |
| NDA/MAL/HDP/8845 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | FUROSEMIDE | FUROSEMIDE | 10MG/ML | SWISS PARENTERALS PVT LTD ..809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 21/11/2019 |
| NDA/MAL/HDP/8914 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PEFLOREN 400 | PEFLOXACIN MESILATE DIHYDRATE | 400 MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8915 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 120 MG | ETORICOXIB | 120 MG | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD-P.O. BOX 69 AMMAN 11591 - AL-RAGEEM SAHAB - JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8916 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | TAMSUMAC 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | MACLEODS PHARMACEUTICALS LIMITED BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA | INDIA | | ORAL SOLID RETARD CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8920 | MERCK | UNITED HEALTHCARE DISTRIBUTORS LTD | CRINONE 8% GEL | PROGESTERONE | 90MG/APPLICATOR | DENDRON BRANDS LIMITED94 RICKMANSWORTH ROAD,WATFORD , WD18 7JJ, UNITED KINGDOM | UNITED KINGDOM | | VAGINAL GELS AND SOLS | 1.0X1.0X15.0 POUCH CARTON | 25/07/2018 |
| NDA/MAL/HDP/8926 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLUSIS 1000 ER | METFORMIN HYDROCHLORIDE | 1000 MG | MSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION) - PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1X3X10 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8927 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | DIPHTHERIA AND TETANUS VACCINE (ADSORBED REDUCED ANTIGEN(S) CONTENT) | DIPHTHERIA TOXOID + TETANUS TOXOID | 2 LF ( NOT LESS THAN 2 IU) + 8.8 LF (NOT LESS THAN 20 IU)/ 0.5ML | BIOLOGICAL E. LIMITED-PLOT NO.1 SHAPOORJI PALLONJI BIOTECH PARK PHASE II, KOLTHUR VILLAGE, SHAMEERPET, MANDAL, R.R. DISTRICT, ANDRA PRADESH 500078, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X24.0X1.0X10.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL | 25/07/2018 |
| NDA/MAL/HDP/8929 | OCTAPHARMA AG | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ALBUNORM | HUMAN ALBUMIN | 20%W/V | OCTAPHARMA PRODUKTIONSGESELLSCHAFT DEUTSCHLAND MBH-WOLFGANG-MARGUERRE-ALLEE 1 31832 SPRINGE GERMANY | GERMANY | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 25/07/2018 |
| NDA/MAL/HDP/8933 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | Q-TIB | SULFAMETHOXAZOLE + TRIMETHOPRIM + ISONIAZID + PYRIDOXINE HYDROCHLORIDE | 800MG + 160MG + 300MG +25MG | CIPLA LTD ,.PLOT NO. A-33, A-2 (UNIT 1), A42 (UNIT II), MIDC PATALGANGA, DISTRICT-RAIGAD MAHARASHTRA, 410220 INDIA | CIPLA LIMITED>A-33, A-37/2/2 & A-2, M.I.D.C, PATALANGA 410 220, DISTRICT RAIGAD, M.S, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 25/07/2018 |
| NDA/MAL/HDP/8934 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CYCLO P EYE DROPS | CYCLOPENTOLATE HYDROCHLORIDE | 1.0%W/V | ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL | 25/07/2018 |
| NDA/MAL/HDP/8936 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | ESOFOLE | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN | | PAKISTAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8940 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | RABIZA 20MG | RABEPRAZOLE SODIUM | 20MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?.3. 42050 SELÇUKLU / KONYA TURKEY | TURKEY | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8941 | ?LKO ?LAÇ SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | LIVERCOL 20MG | ROSUVASTATIN CALCIUM | 20MG | ?LKO ?LAÇ SANAYI VE TICARET A. ?.3. 42050 SELÇUKLU / KONYA TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8943 | HETERO LABS LTD | AIVEEN (U) LIMITED | IRBIS-HT 150/12.5 | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/8944 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | GAMOK 625MG | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500MG + 125MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8946 | B & O PHARM ZAC | TRIDEM PHARMA UGANDA LIMITED | GAMOK 0.6G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 500MG + 100MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X0.6 G VIAL | 25/07/2018 |
| NDA/MAL/HDP/8947 | B & O PHARM ZAC | TRIDEM PHARMA UGANDA LIMITED | GAMOK 1.2G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 1G + 0.2G | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.2 G VIAL | 25/07/2018 |
| NDA/MAL/HDP/8949 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CETAL SUPOSITORIES | PARACETAMOL | 120MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT | | EGYPT | | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8952 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFLEX -500 | CEFALEXIN MONOHYDRATE | 500 MG | THEON PHARMACEUTICALS LIMITED. VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1X10X10 CAPSULE BLISTER | 25/07/2018 |
| NDA/MAL/HDP/8953 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN CHILDREN'S WET COUGH | GUAIFENESIN | 100MG PER 10ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 25/07/2018 |
| NDA/MAL/HDP/8954 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WET COUGH | GUAIFENESIN | 200MG PER 10ML | JOHNSON&JOHNSON PTY LTD.EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 25/07/2018 |
| NDA/MAL/HDP/9053 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | MABTHERA® 100MG/10ML | RITUXIMAB | 100MG/10ML | ROCHE DIAGNOSTICS GMBH MANNHEIM-SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY. | GERMANY | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X2.0X10.0 ML VIAL | 26/09/2018 |
| NDA/MAL/HDP/9054 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | MABTHERA® 500MG/50ML | RITUXIMAB | 500MG/50ML | ROCHE DIAGNOSTICS GMBH MANNHEIM-SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY. | GERMANY | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML VIAL | 26/09/2018 |
| NDA/MAL/HDP/9057 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP® | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 60MG + 480MG | GUILIN PHARMACEUTICAL CO LTD-NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X6.0X25.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9058 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | D-ARTEPP® DISPERSIBLE | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 30MG + 240MG | GUILIN PHARMACEUTICAL CO LTD-NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER,1.0X3.0X25.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9059 | CRATUS PHARMA PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | CLASSMOX DROPS | AMOXICILLIN TRIHYDRATE | 125MG/ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTARAKHAND | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X10.0 ML BOTTLE | 26/09/2018 |
| NDA/MAL/HDP/9062 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ADERAN 32 | CANDESARTAN CILEXETIL | 32 MG | AJANTA PHARMA LIMITEDB-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9063 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | TENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MG | TENOFOVIR DISOPROXIL FUMARATE | 300 MG | LAURUS LABS LIMITED, (UNIT-2) - PLOT NO:19, 20 & 21,WESTERN SECTOR, APSEZ, ATCHUTAPURAM MANDAL, VISAKHAPATNAM-DISTRICT-531011, ANDHRA PRADESH, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 26/09/2018 |
| NDA/MAL/HDP/9064 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOMOX-250 | AMOXICILLIN TRIHYDRATE | 250 MG | THEON PHARMACEUTICALS LIMITED. VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9065 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFLEX -250 | CEFALEXIN MONOHYDRATE | 250 MG | THEON PHARMACEUTICALS LIMITED. VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X10X10 CAPSULE BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9066 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFIX-200 | CEFIXIME TRIHYDRATE | 200 MG | THEON PHARMACEUTICALS LIMITED. VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X2X10 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9067 | MEDISEL(K) LTD | AIVEEN (U) LIMITED | BRONCHOWIN | DOXOFYLLINE | 400 MG | CORONA REMEDIES PVT LIMITEDVILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9068 | MEDISEL(K) LTD | AIVEEN (U) LIMITED | MOXIDOC TABLET | MOXIFLOXACIN HYDROCHLORIDE | 400 MG | CORONA REMEDIES PVT LIMITEDVILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X10 TABLET BLISTER | 26/09/2018 |
| NDA/MAL/HDP/9129 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LOXAMOX | LEVOFLOXACIN HEMIHYDRATES | 250MG/50ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | | PARENTERAL ORDINARY INFUSION BAGS | 1.0X50.0 ML BAG | 21/11/2019 |
| NDA/MAL/HDP/9137 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | DOM R | RABEPRAZOLE SODIUM + DOMPERIDONE SR | 20MG + 30MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9140 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9141 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | RABZOLE | RABEPRAZOLE SODIUM + LEVOSULPIRIDE | 20MG + 75MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9142 | THEON PHARMACEUTICALS LIMITTED | AIVEEN (U) LIMITED | THEOFIX -50 DS | CEFIXIME TRIHYDRATE | 50MG/5ML | THEON PHARMACEUTICALS LTD ,VILLAGE SAINI MAJRA, TEHSIL, NALAGARH, DIST. SOLAN HP | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1X60 ML BOTTLE | 26/11/2019 |
| NDA/MAL/HDP/9146 | MICRO LABS LTD | PHARMA VILLE LIMITED | ISONIAZID | ISONIAZID | 300MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER,1.0X1000.0 TABLET BOTTLE | 21/11/2019 |
| NDA/MAL/HDP/9147 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | HUMAN ROTAVIRUS REASSORTANT | LIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT [G1, G2, G3, G4 AND G9] | ?105.6 FFU / SEROTYPE | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.5 ML VIAL (1DOSE),1.0X1.0X5.0 ML VIAL (2 DOSES) | 21/11/2019 |
| NDA/MAL/HDP/9165 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | VAGID-100 | CLOTRIMAZOLE | 100 MG | M/S BLISS GVS PHARMA LIMITED PLOT 10, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE PALGHAR, DIST. THANE - 401404 | INDIA | | VAGINAL SUPPOSITORIES | 1.0X1.0X7.0 PESSARY BLISTER,1.0X1.0X6.0 PESSARY BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9166 | HETERO LABS LTD | AIVEEN (U) LIMITED | VIRDAC 30 | DACLATASVIR DIHYDROCHLORIDE | 30 MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BOTTLE | 27/11/2019 |
| NDA/MAL/HDP/9172 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | DOXYDERMA | DOXYCYCLINE MONOHYDRATE | 100MG | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/9173 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | PRODEXA-T | DEXAMETHASONE | 0.5MG | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 27/08/2019 |
| NDA/MAL/HDP/9174 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | ULCOZOL 20MG | OMEPRAZOLE | 20MG | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9175 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | ERITROMICINE | ERYTHROMYCIN ESTOLATE | 250MG | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9176 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | PIROCUTAN | PIROXICAM | 20MG | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9177 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | TETRA | TETRACYCLINE HYDROCHLORIDE | 1%W/V | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE | 21/11/2019 |
| NDA/MAL/HDP/9178 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | LORADE | LORATIDINE,LORATIDINE | 10MG,10MG | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 21/11/2019 |
| NDA/MAL/HDP/9189 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | ESOFLUX 40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | SAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 28/09/2020 |
| NDA/MAL/HDP/9190 | SAKAR HEALTHCARE LIMITED | TATA UGANDA LIMITED | RABEKAR | RABEPRAZOLE SODIUM | 20MG | SAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 MG VIAL + 1*5ML WFI IN LDPE | 15/02/2023 |
| NDA/MAL/HDP/9191 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANDOX-DS 50 | CEFPODOXIME PROXETIL | 50 MG/5ML | SANCE LABORATORIES PVT LTDVI/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 | 08/09/2020 |
| NDA/MAL/HDP/9192 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANDOX- 200 | CEFPODOXIME PROXETIL | 200 MG | SANCE LABORATORIES PVT LTDVI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9193 | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD | TATA UGANDA LIMITED | LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MG | LAMIVUDINE + ZIDOVUDINE | 150 MG + 300 MG | SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD1479 ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE SHANGHAI, CHINA | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9194 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MAGNABIOTIC | AMOXICILLINTRIHYDRATE + POTASSIUM CLAVULANATE | 875 MG + 125 MG | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, 6 OCTOVER CITY, P.O. BOX 43 | | EGYPT | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9195 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SOBISIS | SODIUM BICARBONATE | 500 MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9196 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SOBISIS FORTE | SODIUM BICARBONATE | 1000 MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9197 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SEVLAREN 400 | SEVELAMER CARBONATE | 400 MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9198 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | PBREN 75 | PREGABALIN | 75 MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9199 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | KCHEK | CALCIUM POLYSTYRENE SULPHONATE | 15 MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X15.0 G SACHET | 08/09/2020 |
| NDA/MAL/HDP/9200 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | LEVIGRESS 250 | LEVETIRACETAM | 250 MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9201 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | LEVIGRESS 500 | LEVETIRACETAM | 500MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9202 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | ESCIGRESS 5 | ESCITALOPRAM OXALATE | 5MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9203 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | ESCIGRESS 10 | ESCITALOPRAM OXALATE | 10MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9204 | SUN PHARMACEUTICAL INDUSTRIES LTD | STAR PHARMACEUTICALS LTD | CHERIFLU PLUS WITH VITAMIN C | CHLORPHENAMINE MALEATE + PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE +VITAMIN C | 4 MG + 650 MG + 10 MG + 30 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9210 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC | IRBESARTAN | 300 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9211 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 10000 IU | CHOLECALCIFEROL | 10,000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X30.0 CAPSULE CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9212 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 50000 IU | CHOLECALCIFEROL | 50,000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X8.0 CAPSULE CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9213 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | COMBIART SUSPENSION | ARTEMETHER + LUMEFANTRINE | 15 MG + 90 MG/5ML | MADRAS PHARMACEUTICALS 137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI – 600 096, INDIA | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9214 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 2000 IU | CHOLECALCIFEROL | 2000IU | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1.0X30.0 CAPSULE CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9215 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HI DEE 2000 IU/5 DROPS | CHOLECALCIFEROL | 2000IU/ 5 DROPS | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL LIQUID ORDINARY DROPS | 1.0X1.0X10.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9217 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE TABLETS | ABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE | 600 MG + 50 MG + 300 MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9219 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TESS | TRIAMCINOLONE ACETONIDE | 0.1% W/W | TROIKAA PHARMACEUTICALS LTDBLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE | INDIA | | TOPICAL EXTERNAL PASTES | 1.0X1.0X5.0 G TUBE | 08/09/2020 |
| NDA/MAL/HDP/9222 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | DARUNAVIR TABLETS | DARUNAVIR | 800 MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9223 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | LAXIWAL | LACTULOSE | 10 G/15 ML | WALLACE PHARMACEUTICALS PVT LTDBHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9225 | ZIM LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | ZIMADOL 50 | TRAMADOL HYDROCHLORIDE | 50 MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9228 | LIFEWAY PHARMACEUTICAL INDUSTRIES LIMITED | LIFEWAY PHARMACEUTICAL INDUSTRIES LIMITED | SUREDOL | PARACETAMOL | 500MG | LIFEWAY PHARMACEUTICAL INDUSTRIES LIMITED-BLOCK 198, PLOT 478, | | UGANDA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9229 | UNOSOURCE PHARMA LTD. | MEDVIN PHARMA LIMITED | TRADMIN | TRAMADOL HYDROCHLORIDE | 50MG | AKUMS DRUGS & PHARMACEUTICALS LTD19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9237 | DENK PHARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AZITHRO-DENK 250 MG | AZITHROMYCIN MONOHYDRATE | 250MG | ARTESAN PHARMA GMBH & CO. KGWENDLANDSTR.1, 29439, LUCHOW | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9238 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | AZITHRO-DENK 500 MG | AZITHROMYCIN MONOHYDRATE | 500MG | ARTESAN PHARMA GMBH & CO. KGWENDLANDSTR.1, 29439, LUCHOW | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9241 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | LEXAR | LEVOFLOXACIN HEMIHYDRATE | 500MG | HIGGS HEALTHCARE PVT. LIMITED KHASRA NO. 480/1, BHATOLIKALAN BADDI, DIST SOLAN, (H.P) - INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9246 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | CLAMOXIN | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 125 MG | MEDOPHARM PVT LIMITEDNO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER | 19/02/2021 |
| NDA/MAL/HDP/9248 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ESOFAG-D | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE + DOMPERIDONE | 40MG + 30MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP | 08/09/2020 |
| NDA/MAL/HDP/9251 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIBOFAN | TIROFIBAN HYDROCHLORIDE | 12.5 MG/50ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X1X50 ML VIAL | 28/09/2020 |
| NDA/MAL/HDP/9252 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | FLUCO-BKRS | FLUCONAZOLE | 0.2% W/V | HIGGS HEALTHCARE PVT. LIMITED KHASRA NO. 480/1, BHATOLIKALAN BADDI, DIST SOLAN, (H.P) - INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9262 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | DOMIPAN | PANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE | 40 MG + 30 MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9263 | FREDUN PHARMACEUTICALS LTD | REDDYS PHARMA LIMITED | ETCOX-90 | ETORICOXIB | 90MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9264 | MSN LABORATORIES PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APRITANT IV | FOSAPRIPITANT DIMEGLUMINE | 150 MG/VIAL | MSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISIONPLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL VIAL | 08/09/2020 |
| NDA/MAL/HDP/9266 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR (AS SULFATE) / LAMIVUDINE DISPERSIBLE TABLETS | ABACAVIR SULFATE + LAMIVUDINE | 120 MG + 60 MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | MYLAN LABORATORIES LIMITEDNO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9275 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | GENTACIN | GENTAMICIN SULPHATE | 0.3% W/V | NITIN LIFE SCIENCES LIMITED.RAMPUR ROAD, PAONTA SAHIB, SIRMOUR-173025, H.P, | INDIA | OPHTHALMIC LIQUIDS | 1X1X10 ML BOTTLE | 28/09/2020 |
| NDA/MAL/HDP/9276 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZYLODINE | LIDOCAINE HYDROCHLORIDE | 20MG/ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X25X50 ML VIAL | 28/09/2020 |
| NDA/MAL/HDP/9278 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | CANDIFORCE-100 | ITRACONAZOLE | 100 MG | RA CHEM PHARMA LTDPLOT NO. A-19/C, ROAD NO. 18, IDA NACHARAM, HYDERABAD-500076, TELENGANA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9279 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | SILVIRIN | SILVER SULFADIAZINE | 1% W/W | RAPTAKOS BRETT & CO.LTD1ST POKHRAN ROAD,THANE 400 606 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 08/09/2020 |
| NDA/MAL/HDP/9280 | RAPTAKOS, BRETT & CO. LTD. | EUROPA HEALTHCARE (U) LTD | NORASH | DIMETHICONE + ZINC OXIDE + CALAMINE + CETRIMIDE | 20% W/W + 7.5% W/W + 1.5% W/W + 1.125% W/W | RAPTAKOS BRETT & CO.LTD1ST POKHRAN ROAD,THANE 400 606 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE | 08/09/2020 |
| NDA/MAL/HDP/9286 | GALENTIC PHARMA LTD | VITACARE LIMITED | SELDRUF | SELENIUM SULFIDE | 2.5% W/V | GALENTIC PHARMA (INDIA) LTD .R-673, MIDC, TTC, RABALE, THANE-BELAPUR ROAD, NAVI MUMBAI | INDIA | | TOPICAL EXTERNAL SUSPENSIONS | 1.0X100.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9287 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CANDID-V3 | CLOTRIMAZOLE | 200MG | GLENMARK PHARMACEUTICALS LTD .PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | | VAGINAL TABLETS | 1.0X1.0X3.0 TABLET STRIP | 08/09/2020 |
| NDA/MAL/HDP/9288 | HETERO DRUGS LTD | AIVEEN (U) LIMITED | VIRDAC 60 | DACLATASVIR DIHYDROCHLORIDE | 60 MG | HETERO LABS LIMITED (UNIT V)SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE | 28/09/2020 |
| NDA/MAL/HDP/9290 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFIXIME 200 | CEFIXIME TRIHYDRATE | 200MG | INNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9291 | INTAS PHARMACEUTICALS LIMITED | STAR BIOTECH UGANDA LTD | SARTEL-80 LH | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80 MG + 12.5 MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9294 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WET COUGH MENTHOL | GUAIFENESIN | 200 MG/10 ML | JOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/HDP/9295 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | TRIMIC | METRONIDAZOLE + MICONAZOLE NITRATE | 500 MG + 100 MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | VAGINAL SUPPOSITORIES | 1.0X2.0X7.0 SUPPOSITORY STRIP | 25/09/2020 |
| NDA/MAL/HDP/9296 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | VAGID-CL | CLINDAMYCIN + CLOTRIMAZOLE | 100 MG + 200 MG | BLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | | VAGINAL SUPPOSITORIES | 1.0X1.0X3.0 SUPPOSITORY STRIP | 08/09/2020 |
| NDA/MAL/HDP/9305 | KOPRAN LIMITED | TATA UGANDA LIMITED | CELEKOP-200 | CELECOXIB | 200MG | KOPRAN LIMITEDVILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9306 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | FUNBACT-A | CLOTRIMAZOLE + BETAMETHASONE DIPROPIONATE + NEOMYCIN SULFATE | 1.0 % W/W + 0.05 % W/W + 0.5 % W/W | KREMOINT PHARMA PVT LTD. B-8, ADDITIONAL AMBERNATH M.I.D.C, OPP. ANAND NAGIAR POLICE CHECK POST, AMBERNATH (E), DIST. THANE. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 08/09/2020 |
| NDA/MAL/HDP/9313 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE-30 | ARTESUNATE | 30 MG/VIAL | BLISS INDAS LIFESCIENCE P. LTD..PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON + 0.5 ML OF 5.0 %W/V SODIUM BICARBONATE VIAL + 2.5 ML OF 0.9% W/V SODIUM CHLORIDE VIAL | 08/09/2020 |
| NDA/MAL/HDP/9315 | CENTAUR PHARMACEUTICALS PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | ACETAMOX | ACETAZOLAMIDE | 250 MG | CENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9316 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | TERBIDERM | TERBINAFINE HYDROCHLORIDE | 1% W/W | ATCO LABS LTD,B-18, S.I.T.E, KARACHI | PAKISTAN | | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE | 08/09/2020 |
| NDA/MAL/HDP/9322 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 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 | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9324 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | PROP PLUS | IBUPROFEN + PARACETAMOL | 400 MG + 325 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER | 08/09/2020 |
| NDA/MAL/HDP/9325 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | OESTROGEL | ESTRADIOL HEMIHYDRATE | 0.06W/W | BESINS MANUFACTURING BELGIUM (BMB)GROOT BIJGAARDENSTRAAT, 128. 1620 | BELGIUM | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X80.0 G CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9327 | ATCO LABORATORIES LIMITED | HARLEYS UGANDA LIMITED | OXCIN-D | MOXIFLOXACIN + DEXAMETHASONE SODIUM PHOSPHATE | 0.5%W/V + 0.1% W/V | ATCO LABS LTD,B-18, S.I.T.E, KARACHI | PAKISTAN | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML CONTAINER | 08/09/2020 |
| NDA/MAL/HDP/9331 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | PARA-BKRS | PARACETAMOL | 1.0%W/V | HIGGS HEALTHCARE PVT. LIMITEDKHASRA NO. 480/1, BHATOLIKALAN BADDI, DISTT SOLAN, (H.P) - INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 26/10/2020 |
| NDA/MAL/HDP/9345 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | FLUCONAZOLE INJECTION USP (2MG/ML) | FLUCONAZOLE | 2MG/ML | ABARIS HEALTHCARE PVT. LTDSURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X100 ML BOTTLE | 22/12/2020 |
| NDA/MAL/HDP/9350 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GITTOES PHARMACEUTICALS LIMITED | NUROFEN | IBUPROFEN LYSINE | 684MG | ASTRA ZENECA TURKEYNOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NOTTINGHAMSHIRE, NG90 2DB, UNITED KINGDOM | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9352 | HEALTHCARE LTD. | HEALTHCARE LTD. | NEFZONE-S | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1000MG + 500MG | NITIN LIFE SCIENCES LIMITED.RAMPUR ROAD, PAONTA SAHIB, SIRMOUR-173025, H.P, | INDIA | PARENTERAL ORDINARY DRY VIALS | 1X1X1.5 G VIAL | 22/12/2020 |
| NDA/MAL/HDP/9353 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | LUMITER DT | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,30.0X1.0X12.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9355 | KHANDELWAL LABORATORIES PVT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | PLATINEX | CISPLATIN | 1MG/ML | KHANDELWAL LABORATORIES PVT. LTDB-1, WAGLE INDUSTRIAL ESTATE, THANE – 400 604 INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X1X10 ML VIAL | 22/12/2020 |
| NDA/MAL/HDP/9356 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | IRIS | DESLORATADINE | 5MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9365 | HETERO BIOPHARMA LIMITED, | AIVEEN (U) LIMITED | BEVAAS 100 | BEVACIZUMAB | 100MG/4ML | HETERO BIOPHARMA LIMITEDSY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT – 509 301, TELANGANA STATE, INDIA. | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X4.0 ML VIAL | 09/12/2020 |
| NDA/MAL/HDP/9366 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TOBRASON | TOBRAMYCIN + DEXAMETHASONE | 3 MG + 1 MG/1G | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | OPHTHALMIC OINTMENTS | 1.0X1.0X5.0 MG TUBE | 09/12/2020 |
| NDA/MAL/HDP/9367 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XENAMEX | TRANEXAMIC ACID | 100MG/ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X10.0X5.0 ML VIAL | 09/12/2020 |
| NDA/MAL/HDP/9368 | HETERO BIOPHARMA LIMITED, | AIVEEN (U) LIMITED | BEVAAS 400 | BEVACIZUMAB | 400MG/16ML | HETERO BIOPHARMA LIMITEDSY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT – 509 301, TELANGANA STATE, INDIA. | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X16.0 ML VIAL | 09/12/2020 |
| NDA/MAL/HDP/9370 | RAINBOW LIFE SCIENCES PVT.LTD. | EUROPA HEALTHCARE (U) LTD | MONTLIV | MONTELUKAST + LEVOCETIRIZINE DIHYDROCHLORIDE | 10 MG+ 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 FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9371 | MEDINOVATION ENTERPRISES LTD | MEDINOVATION ENTERPRISES LTD | MEDSUNATE- 60 | ARTESUNATE | 60MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | BLISS INDASI LIFESCIENCE PRIVATE LIMITEDPLOT NO. 73 TO 76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 396 210 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + (1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML AMPOULE OF 5%W/V NAHCO3) | 09/12/2020 |
| NDA/MAL/HDP/9376 | KOPRAN LIMITED | TATA UGANDA LIMITED | AZ-1 500 | AZITHROMYCIN DIHYDRATE | 500 MG | KOPRAN LIMITEDVILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9377 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN DT 250 | AMOXICLLIN TRIHYDRATE | 250 MG | KOPRAN LIMITEDVILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0X15.0 TABLET STRIP,10.0X10.0 TABLET STRIP | 09/12/2020 |
| NDA/MAL/HDP/9379 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN DT 125 | AMOXICILLIN TRIHYDRATE | 125 MG | KOPRAN LIMITEDVILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0X15.0 TABLET STRIP,10.0X10.0 TABLET STRIP | 09/12/2020 |
| NDA/MAL/HDP/9381 | POPULATION SERVICES INTERNATIONAL, UGANDA (PSIU) | POPULATION SERVICES INTERNATIONAL - UGANDA | PRONTA 1 | LEVONORGESTREL | 1.5 MG | MYLAN LABORATORIES LIMITEDPLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X1.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9383 | SUN PHARMACEUTICAL INDUSTRIES LTD | STAR PHARMACEUTICALS LTD | DOLUTEGRAVIR, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50 MG + 300 MG + 300 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X1.0X90.0 TABLET CONTAINER | 09/12/2020 |
| NDA/MAL/HDP/9385 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BRUZOLIN | XYLOMETAZOLINE HYDROCHLORIDE | 0.05% W/V | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | NASAL SYSTEMIC DROPS | 1.0X1.0X15.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/HDP/9387 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | DIPHTHERIA AND TETENUS VACCINE ADSORBED FOR ADULTS AND ADOLESCENTS | DIPHTHERIA + TETANUS + ALUMINIUM PHOSPHATE | ? 5 LF (? 2 IU) + ? 5 LF (? 40 IU) + ? 1.25 MG/DOSE | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0X10.0 DOSE VIAL,1.0X5.0X10.0X1.0 DOSE AMPOULE | 09/12/2020 |
| NDA/MAL/HDP/9389 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | DIPHTHERIA, TETANUS, PERTUSSIS, HEPATITIS B AND HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE ADSORBED | DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE + ALUMINIUM PHOSPHATE | ? 25 LF (? 30 IU) + ? 2.5 LF (? 40 IU) + ? 16 OU (? 4.0 IU) + ? 10 MCG + ? 10 MCG + ? 1.25 MG/DOSE | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0X10.0 DOSE VIAL | 09/12/2020 |
| NDA/MAL/HDP/9393 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | LESS-K | CALCIUM POLYSTYRENE SULFONATE | 5 GM/SACKET | MEGA LIFESCIENCES PUBLIC COMPANY LTDPLANT 2; 515/1 MOO 4, SOI 8 BANGPOO INDUSTRIAL ESTATE PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280, THAILAND | THAILAND | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0X5.0 G SACHET | 09/12/2020 |
| NDA/MAL/HDP/9394 | HETERO LABS LTD | AIVEEN (U) LIMITED | TEMOTERO 100 | TEMOZOLOMIDE | 100MG | HETERO LABS LIMITED (UNIT VI)APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X1X5 CAPSULE BOTTLE | 22/12/2020 |
| NDA/MAL/HDP/9395 | HETERO LABS LTD | AIVEEN (U) LIMITED | TEMOTERO 250 | TEMOZOLOMIDE | 250MG | HETERO LABS LIMITED (UNIT VI)APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X1X5 CAPSULE BOTTLE | 22/12/2020 |
| NDA/MAL/HDP/9401 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | UTROGESTAN | PROGESTERONE | 100 MG | CYNDEA PHARMA, S.LPOLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9403 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARTEM | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9404 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SOFTDROPS | CARBOXYMETHYLCELLULOSE SODIUM + GLYCERIN | 0.5% W/V + 0.5% W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD .N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/HDP/9408 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | ZIRIN | CETIRIZINE DIHYDROCHLORIDE | 10 MG | MEGA LIFESCIENCES PUBLIC COMPANY LTDPLANT 2; 515/1 MOO 4, SOI 8 BANGPOO INDUSTRIAL ESTATE PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280, THAILAND | THAILAND | | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9409 | HETERO LABS LTD | AIVEEN (U) LIMITED | STAVANCE 500 | VANCOMYCIN HYDROCHLORIDE | 500 MG/VIAL | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X500.0 MG VIAL | 09/12/2020 |
| NDA/MAL/HDP/9410 | HETERO LABS LTD | AIVEEN (U) LIMITED | STAVANCE 1 | VANCOMYCIN HYDROCHLORIDE | 1G/VIAL | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 09/12/2020 |
| NDA/MAL/HDP/9411 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 5 +5 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 5MG + 5MG | EGIS PHARMACEUTICALS PLCBOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9412 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | EBASTO - 10 | EBASTINE | 10 MG | SAGA LIFESCIENCES LIMITEDSURVEY 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 | 09/12/2020 |
| NDA/MAL/HDP/9413 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 10 + 5 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 10MG + 5MG | EGIS PHARMACEUTICALS PLCBOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9415 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 10 + 10 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 10MG + 10MG | EGIS PHARMACEUTICALS PLCBOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9416 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR AMLO 5 + 10 | BISOPROLOL FUMARATE + AMLODIPINE BESILATE | 5MG + 10MG | EGIS PHARMACEUTICALS PLCBOKENYFOLDI UT 118-120, 1165 BUDAPEST | HUNGARY | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9418 | LAURUS LABS LIMITED - | BEYOND LOGISTICS LTD | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 400 MG + 300 MG + 300 MG | LAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER | 09/12/2020 |
| NDA/MAL/HDP/9421 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MUCOSIL AM | TERBUTALINE SULFATE + GUAIFENESIN + AMBROXOL HYDROCHLORIDE + MENTHOL | 1.25 MG + 50 MG + 15 MG + 2.5 MG/5 ML | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/HDP/9424 | PHARCO B INTERNATIONAL, | GAMA PHARMACEUTICALS (U) LIMITED | CEFAXONE 1G I.V. | CEFTRIAXONE SODIUM HYDRATE | 1G | PHARCO-B INTERNATIONAL PHARMACEUTICALSBORG EL-ARAB 3D INDUSTRIAL ZONE, BLOCK 18 AREA, 10, 11, ALEXANDRIA EGYPT | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 09/12/2020 |
| NDA/MAL/HDP/9426 | PHARCO B INTERNATIONAL, | GAMA PHARMACEUTICALS (U) LIMITED | CEFAXONE 2G I.V. | CEFTRIAXONE SODIUM HYDRATE | 2G | PHARCO-B INTERNATIONAL PHARMACEUTICALSBORG EL-ARAB 3D INDUSTRIAL ZONE, BLOCK 18 AREA, 10, 11, ALEXANDRIA EGYPT | EGYPT | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL | 09/12/2020 |
| NDA/MAL/HDP/9428 | LUPIN LIMITED | AIVEEN (U) LIMITED | RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS | RIFAMPIN + ISONIAZID | 75 MG + 50 MG | LUPIN LIMITED A-28/1 MIDC CHIKALTHANA AURANGABAD | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X14.0X6.0 TABLET STRIP | 09/12/2020 |
| NDA/MAL/HDP/9430 | SAGA LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | VALK PLUS SP | ACECLOFENAC + PARACETAMOL+ SERRATIOPEPTIDASE | 100 MG + 500 MG +10 MG | SAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9431 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | NALTRAS 50 | NALTREXONE HYDROCHLORIDE | 50 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 | 1.0X2.0X14.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9432 | MEDISEL(K) LTD | SUPER MEDIC LTD | ECOFREE 120 | ETORICOXIB | 120MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 22/12/2020 |
| NDA/MAL/HDP/9433 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ADACIN | ADAPALENE + CLINDAMYCIN PHOSPHATE | 0.1 %W/W + 1.0% W/W | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X15.0 G TUBE | 09/12/2020 |
| NDA/MAL/HDP/9434 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | LAVAGEM | BISACODYL | 5MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9436 | SAKAR HEALTHCARE PVT LTD | TATA UGANDA LIMITED | SEFIXI-200 | CEFIXIME TRIHYDRATE | 200MG | SAKAR HEALTHCARE PVT LIMITEDPLOT 10/13 SARKHEJ-BAVLA ROAD, AHMEDABAD, GUJARAT, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9439 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | HYFRESH | SODIUM HYALURONATE | 0.2% W/V | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 18/12/2020 |
| NDA/MAL/HDP/9440 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | XOLAMOL | DORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE | 2%W/V + 0.5%W/V/ML | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/HDP/9441 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PARAVIN | PARACETAMOL | 10MG/ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X12.0X100.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 09/12/2020 |
| NDA/MAL/HDP/9442 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VOMIRAN | ONDANSETRON HYDROCHLORIDE | 2MG/ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X5X2 ML VIAL | 22/12/2020 |
| NDA/MAL/HDP/9445 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | SURECURE GEL | ADAPALENE | 0.1% W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | TOPICAL EXTERNAL GELS AND SOLS | 1X1X30 G TUBE | 18/12/2020 |
| NDA/MAL/HDP/9446 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FUSIBACT | SODIUM FUSIDATE | 2%W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 18/12/2020 |
| NDA/MAL/HDP/9447 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FUSIBACT-B | FUSIDIC ACID + BETAMETHASONE VALERATE | 2% W/W + 0.1% W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 09/12/2020 |
| NDA/MAL/HDP/9448 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ELICA | MOMETASONE FUROATE | 0.1%W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 18/12/2020 |
| NDA/MAL/HDP/9449 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | ELICASAL | MOMETASONE FUROATE + SALICYLIC ACID | 0.1% W/W + 5.0% W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE | 18/12/2020 |
| NDA/MAL/HDP/9452 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BNOXIPARIN 40 | ENOXAPARIN SODIUM | 40 MG/0.4 ML | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.4 ML PRE- FILLED SYRINGE | 09/12/2020 |
| NDA/MAL/HDP/9453 | BRAWN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BNOXIPARIN 60 | ENOXAPARIN SODIUM | 60 MG/0.6 ML | BRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.6 ML PRE- FILLED SYRINGE | 09/12/2020 |
| NDA/MAL/HDP/9455 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | BISPEC-5 | SOLIFENACIN SUCCINATE | 5MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9456 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | BISPEC-10 | SOLIFENACIN SUCCINATE | 10MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 09/12/2020 |
| NDA/MAL/HDP/9481 | BKRS PHARMA PVT. LTD. | VEERAM HEALTHCARE (U) LIMITED | OFLO-BKRS | OFLOXACIN | 0.2% W/V | HIGGS HEALTHCARE PVT. LIMITED KHASRA NO. 480/1, BHATOLIKALAN BADDI, DIST SOLAN, (H.P) - INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/HDP/9490 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | IPEN-CIL | IMIPENEM + CILASTATIN | 500 MG + 500 MG/VIAL | ZEISS PHARMACEUTICALS PVT LTD - PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON | 09/12/2020 |
| NDA/MAL/HDP/9494 | ZIM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | ONDANSET ODS 8 | ONDANSETRON HYDROCHLORIDE | 8 MG/STRIP | ZIM LABS LTD.B 21/22, MIDC AREA, KALMESHWAR 441501, DIST-NAGPUR | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0X1.0 TABLET STRIP | 24/02/2021 |
| NDA/MAL/HDP/9500 | POPULATION SERVICES INTERNATIONAL, UGANDA (PSIU) | POPULATION SERVICES INTERNATIONAL - UGANDA | MEURI | DESOGESTREL + ETHINYLESTRADIOL | 150MCG + 30MCG | MYLAN LABORATORIES LIMITEDPLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X28.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9501 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | UTROGESTAN VAGINAL 100 MG | PROGESTERONE | 100 MG | CYNDEA PHARMA, S.LPOLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9502 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | UTROGESTAN VAGINAL 200 MG | PROGESTERONE | 200 MG | CYNDEA PHARMA, S.LPOLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | | VAGINAL CAPSULES | 1.0X1.0X7.0X1.0X8.0 CAPSULE BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9503 | BESINS HEALTHCARE SA | SURGIPHARM (U) LIMITED | UTROGESTAN 200 MG SOFT CAPSULES | PROGESTERONE | 200 MG | CYNDEA PHARMA, S.LPOLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X8.0X3.0X7.0 CAPSULE BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9504 | BETA HEALTHCARE INTERNATIONAL LIMITED | BETA HEALTHCARE UGANDA LIMITED | BETA COOL DOUBLE ACTION ANTACID SUSPENSION | SODIUM ALGINATE + SODIUM BICARBONATE | (500 MG + 267 MG)/10 ML | BETA HEALTHCARE INTERNATIONAL LTD PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE | 24/02/2021 |
| NDA/MAL/HDP/9505 | CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT-LC | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST | 5 MG + 10 MG | RAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9506 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TROFENTYL | FENTANYL CITRATE | 50 MCG/ML | TROIKAA PHARMACEUTICALS LIMITED,,C-1, SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE | 24/02/2021 |
| NDA/MAL/HDP/9511 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPASNIL FORTE TABLET | MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE | 250 MG + 10 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9513 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | METRONIDAZOLE INFUSION BP | METRONIDAZOLE | 0.5% W/V | ALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 24/02/2021 |
| NDA/MAL/HDP/9514 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BACTAFUZ | FUSIDIC ACID | 2% W/W | ENCUBE ETHICALS PVT LTDPLOT C-1, MADKAIM INDUSTRIAL ESTATE, MADKAIM, POST: MARDOL, PONDA GOA-403404 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 24/02/2021 |
| NDA/MAL/HDP/9515 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BACTAFUZ-B | FUSIDIC ACID + BETAMETHASONE VALERATE | 2% W/W + 0.1%W/W | ENCUBE ETHICALS PVT LTDPLOT C-1, MADKAIM INDUSTRIAL ESTATE, MADKAIM, POST: MARDOL, PONDA GOA-403404 | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 24/02/2021 |
| NDA/MAL/HDP/9525 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | SPAQ-CO DISP | (SULFADOXINE + PYRIMETHAMINE) + AMODIAQUINE HYDROCHLORIDE | (250 MG + 12.5 MG) +76.5 MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER, 1.0X25.0X1.0X12.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9526 | SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | SPAQ-CO DISP | (SULFADOXINE + PYRIMETHAMINE) + AMODIAQUINE HYDROCHLORIDE | (500 MG + 25 MG) +153 MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9533 | LUPIN LTD | AIVEEN (U) LIMITED | ISONIAZID TABLETS BP 100MG | ISONIAZID | 100 MG | LUPIN LTDA-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9534 | B&O PHARM | TRIDEM PHARMA UGANDA LIMITED | PHLORO-G | PHLOROGLUCINOL DIHYDRATE | 80MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9535 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO DURATAZ INJECTION 4.5 G | PIPERACILLIN + TAZOBACTAM | (4 G + 0.5 G)/VIAL | ARISTO PHARMACEUTICALS PVT LTDPLOT 208, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP 462046 DIST. RAISEN (MP) | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL | 24/02/2021 |
| NDA/MAL/HDP/9537 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | SENSOCAIN SPINAL 0.5% INJECTION | BUPIVACAINE HYDROCHLORIDE | 5MG/ML | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X4.0 ML AMPOULE | 24/02/2021 |
| NDA/MAL/HDP/9538 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ECZEMUS 0.1 % OINTMENT | TACROLIMUS MONOHYDRATE | 0.1% W/W | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 24/02/2021 |
| NDA/MAL/HDP/9541 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERLOCIP 25 | ERLOTINIB HYDROCHLORIDE | 25MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9542 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERLOCIP 100 | ERLOTINIB HYDROCHLORIDE | 100MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9543 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERLOCIP 150 | ERLOTINIB HYDROCHLORIDE | 150MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9549 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | DUOSKIN | ISOCONAZOLE NITRATE + DIFLUCORTOLONE VALERATE | 1% W/W + 0.1% W/W | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 04/03/2021 |
| NDA/MAL/HDP/9550 | OCTOBER PHARMA- | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BRONCHOPRO | AMBROXOL HYDROCHLORIDE | 7.5MG/ML | OCTOBER PHARMA1ST INDUSTRIAL ZONE, STREET 25 PLOT 190, 6TH OCTOBER CITY CAIRO, ARAB REPUBLIC OF EGYPT | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X30.0 ML BOTTLE | 24/02/2021 |
| NDA/MAL/HDP/9551 | DEVA HOLDING A.S- | SHREEJI PHARMACEUTICALS LIMITED | LUXAT | MONTELUKAST SODIUM | 10MG | DEVA HOLDING A.SCERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC MAH., ATATURK CAD., NO.: 32 KAPAKLI TEKIRDAG | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 24/02/2021 |
| NDA/MAL/HDP/9552 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | HOPEIN 1000 MG | MEROPENEM TRIHYDRATE | 1000MG | ZEISS PHARMACEUTICALS PVT LTD - PLOT 72, EPIP, PHASE 1, JHARMAJRI BADDI, 173205, DIST: SOLAN HIMACHAL PRADESH, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL | 24/02/2021 |
| NDA/MAL/HDP/9557 | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIACTIN | CYPROHEPTADINE HYDROCHLORIDE | 2 MG/5 ML | MEDIPHARM INDUSTRIES (E.A.) LTDPLOT 65 KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1X60 ML BOTTLE | 04/03/2021 |
| NDA/MAL/HDP/9576 | SAVA HEALTHCARE LIMITED - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUTIAIR | FLUTICASONE PROPIONATE | 0.05%W/V | SAVA HEALTHCARE LIMITED.PLOT NO 507B -512, G.I.D.C. ESTATE, WADHWANCITY-363 035 SURENDRANAGAR, GUJARAT, INDIA | INDIA | | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X10.0 ML VIAL | 24/02/2021 |
| NDA/MAL/HDP/9586 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMVA DENK 5/160 MG | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | BALKANPHARMA-DUPNITSA AD3, SAMOKOVSKO SHOSSE STR. 2600 DUPNITSA | BULGARIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9588 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMVA DENK 10/160 MG | AMLODIPINE BESILATE + VALSARTAN | 10 MG + 160 MG | BALKANPHARMA-DUPNITSA AD3, SAMOKOVSKO SHOSSE STR. 2600 DUPNITSA | BULGARIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9589 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | CLOFAZIMINE TABLETS 100MG | CLOFAZIMINE | 100 MG | OXALIS LABVILLAGE THEDA, P.O. LODHIMAJRA, TEHSIL BADDI, DIST. SOLAN (HP) PIN CODE 174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP | 02/06/2021 |
| NDA/MAL/HDP/9590 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | AMVA DENK 5/80 MG | AMLODIPINE BESILATE + VALSARTAN | 5 MG + 80 MG | BALKANPHARMA-DUPNITSA AD3, SAMOKOVSKO SHOSSE STR. 2600 DUPNITSA | BULGARIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9591 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | AZITOZ-500 | AZITHROMYCIN DIHYDRATE | 500 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X3 TABLET BLISTER | 04/06/2021 |
| NDA/MAL/HDP/9594 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | ROSUVASTATIN DENK 10 MG | ROSUVASTATIN CALCIUM | 10 MG | PHARMACEUTICAL WORKS POLPHARMA SA (ZAKLADY FARMACEUTYCZNE POLPHARMA SA)-19 PELPLINSKA STREET, 83-200 STAROGARD GDANSKI | | POLAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9595 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | ROSUVASTATIN DENK 20 MG | ROSUVASTATIN CALCIUM | 20 MG | PHARMACEUTICAL WORKS POLPHARMA SA (ZAKLADY FARMACEUTYCZNE POLPHARMA SA)-19 PELPLINSKA STREET, 83-200 STAROGARD GDANSKI | | POLAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9596 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | ROSUVASTATIN DENK 5 MG | ROSUVASTATIN CALCIUM | 5 MG | PHARMACEUTICAL WORKS POLPHARMA SA (ZAKLADY FARMACEUTYCZNE POLPHARMA SA)-19 PELPLINSKA STREET, 83-200 STAROGARD GDANSKI | | POLAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9597 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | MALACURE | SULFADOXINE + PYRIMETHAMINE | 500 MG + 25 MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER | 03/06/2021 |
| NDA/MAL/HDP/9600 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIVAZAC 150 MG | IRBESARTAN | 150 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9601 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY 5/160MG | AMLODIPINE BESYLATE + VALSARTAN | 5 MG + 160 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9602 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SENERGY 10/160MG | AMLODIPINE BESYLATE + VALSARTAN | 10 MG + 160 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9603 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | KOCITAF | DOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE FUMARATE | 50 MG + 200 MG + 25 MG | MYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9609 | ZIM LABORATORIES LTD | ABACUS PHARMA (AFRICA) LIMITED | CETRIZIM L ODS | LEVOCETIRIZINE DIHYDROCHLORIDE | 5 MG | ZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET STRIP | 02/06/2021 |
| NDA/MAL/HDP/9610 | REDDYS PHARMA LIMITED | REDDYS PHARMA LIMITED | LASOFLOX-O | OFLOXACIN + ORNIDAZOLE | 200 MG + 500 MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9611 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ESOMAC-40 MUPS | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 40 MG | CIPLA LIMITED.PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9612 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | ESOMAC-20 MUPS | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 20 MG | CIPLA LIMITED.PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9613 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | IVABEAT 5 | IVABRADINE HYDROCHLORIDE | 5 MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9614 | CIPLA LTD | ABACUS PHARMA (AFRICA) LIMITED | IVABEAT 7.5 | IVABRADINE HYDROCHLORIDE | 7.5 MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9615 | ARTEPHARM CO., LTD., | BHL HEALTHCARE LIMITED | ARTEQUICK | ARTEMISININ + PIPERAQUINE | 62.5 MG + 375 MG | ARTEPHARM CO. LTD4 ROAD STREET AVENUE ECONOMY DEVELOPMENT ZONE OF FENGSHUN COUNTY MEIZHOU CITY GUANGDONG PRONVINCE | CHINA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9620 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | DOLUTEGRAVIR TABLETS | DOLUTEGRAVIR SODIUM | 50 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9621 | FDC LIMITED - | AIVEEN (U) LIMITED | ELECTRAL-Z KIT | ZINC SULPHATE MONOHYDRATE + (SODIUM CHLORIDE + POTASSIUM CHLORIDE + SODIUM CITRATE + ANHYDROUS GLUCOSE) | 20 MG + (2.6 G + 1.5 G + 2.9 G + 13.5 G)/SACHET | FDC LTD.L-56&L-57, PHASE II- D, VERNA INDUSTRIAL ESTATE, VERNA-403 722, SALCETE, GOA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X21.8 G SACHET COMBIPACK | 02/06/2021 |
| NDA/MAL/HDP/9624 | ADCOCK INGRAM LIMITED | SURGIPHARM (U) LIMITED | ADCO-IBUPROFEN 400 MG | IBUPROFEN | 400 MG | ADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA | INDIA | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9625 | ACME FORMULATION PVT. LTD. | POPULATION SERVICES INTERNATIONAL - UGANDA | AVERTISO | MISOPROSTOL | 200 MCG | ACME FORMULATION PVT. LTDROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X4.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9626 | GILEAD SCIENCES INC | MEDICAL ACCESS (UGANDA) LIMITED | BIKTARVY | BICTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 50 MG + 200 MG + 25 MG | GILEAD SCIENCES IRELAND UC,CORKIDA BUSINESS & TECHNOLOGY PARK, CARRIGTOHILL, COUNTY CORK, | IRELAND | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9627 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIMEXA | ROCURONIUM BROMIDE | 50 MG/5ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X10X5 ML VIAL | 03/06/2021 |
| NDA/MAL/HDP/9628 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | MPLIFY 20 | TADALAFIL | 20 MG | UNICHEM LABORATORIES LTDPLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | UNICHEM LABORATORIES BADI-UNIT IIVILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X1.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9629 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DECOZAL | XYLOMETAZOLINE HYDROCHLORIDE | 0.5 MG/ML | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9631 | DAWA LIMITED | SUPER MEDIC LTD | DAWASOLONE | PREDNISOLONE SODIUM PHOSPHATE | 5 MG/5 ML | DAWA LIMITEDPLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X60.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9632 | AGIO PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | CANISON VAGINAL 100 | CLOTRIMAZOLE | 100 MG | AGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | | VAGINAL TABLETS | 1.0X1.0X6.0 TABLET STRIP | 02/06/2021 |
| NDA/MAL/HDP/9633 | AGIO PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | AGILAX | LACTULOSE SOLUTION | 3.35G/5ML | AGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9634 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | RABISHIELD - 100 | RABIES HUMAN MONOCLONAL ANTIBODY (RDNA) | 40 IU/ ML | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.5 ML VIAL | 02/06/2021 |
| NDA/MAL/HDP/9636 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALTHEMOL | PARACETAMOL | 1.0 % W/V (1G/100 ML) | ALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9637 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE | PNEUMOCOCCAL SACCHARIDE FOR SEROTYPE 1, 5, 6A, 7F, 9V, 14, 19A, 19F AND 23F + SACCHARIDE FOR SEROTYPE 6B | (2 MCG OF PNEUMOCOCCAL SACCHARIDE FOR SEROTYPE 1, 5, 6A, 7F, 9V, 14, 19A, 19F AND 23F + 4 MCG OF SACCHARIDE FOR SEROTYPE 6B)/ DOSE | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0X1.0 DOSE VIAL,1.0X50.0X5.0 DOSE VIAL | 02/06/2021 |
| NDA/MAL/HDP/9638 | LUPIN LIMITED- | AIVEEN (U) LIMITED | RIFAMPICIN AND ISONIAZID TABLETS | RIFAMPICIN + ISONIAZID | 150 MG + 75 MG | LUPIN LTDA-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9639 | ZOTA HEALTHCARE LTD | HARLEYS UGANDA LIMITED | ZOMEP-ES-40 | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1X3X10 TABLET BLISTER | 03/06/2021 |
| NDA/MAL/HDP/9640 | BERLIN-CHEMIE AG - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PRILIGY 30 MG | DAPOXETINE HYDROCHLORIDE | 30 MG | MENARINI - VON HEYDEN GMBHLEIPZIGER STRABE 7-13, 01097 DRESDEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9641 | BERLIN-CHEMIE AG - | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PRILIGY 60 MG | DAPOXETINE HYDROCHLORIDE | 60 MG | MENARINI - VON HEYDEN GMBHLEIPZIGER STRABE 7-13, 01097 DRESDEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9642 | GLENMARK PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | OFLOMIL | AMOROLFINE HYDROCHLORIDE | 5% W/V | GLENMARK PHARMACEUTICALS LTD .PLOT E-37, 39, D ROAD, MIDC, SATPUR, NASHIK 422007, MAHARASHTRA STATE | INDIA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X2.5 ML VIAL + 1*12, ISOPROPYL ALCOHOL 70% SWAB SACHETS | 03/06/2021 |
| NDA/MAL/HDP/9643 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ABACAVIR (AS SULFATE) AND LAMIVUDINE TABLETS | ABACAVIR SULFATE + LAMIVUDINE | 600MG + 300 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X90.0 TABLET CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9645 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | HALOPERIDOL INJECTION BP 5 MG/ML | HALOPERIDOL | 5 MG/ML | SWISS PARENTERALS PVT LTD ..809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE | 02/06/2021 |
| NDA/MAL/HDP/9648 | JAMJOOM PHARMACEUTICALS COMPANY | MU PHARMA CO -SMC LIMITED | FUSIBACT CREAM | FUSIDIC ACID | 2%W/W | JAMJOOM PHARMACEUTICALS CO.PLOT NO. ME 1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 JEEDAH | SAUDI ARABIA | TOPICAL EXTERNAL CREAMS | 1X1X15 G TUBE | 04/06/2021 |
| NDA/MAL/HDP/9651 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANTOCYN | OXYTOCIN | 10 IU/ML | PT SANBE FARMA UNIT 3.JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNG | INDONESIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE | 02/06/2021 |
| NDA/MAL/HDP/9652 | SUN PHARMACEUTICAL INDUSTRIES LIMITED - | STAR PHARMACEUTICALS LTD | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 300 MG/300 MG TABLETS | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300 MG + 300 MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9653 | LABORATE PHARMACEUTICALS INDIA LIMITED | HEALTHCARE LTD. | FERROUS SULPHATE WITH FOLIC ACID TABLETS | FERROUS SULPHATE + FOLIC ACID | 60 MG + 0.6 MG | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9655 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | METOCLOPRAMIDE INJECTION BP 5 MG/ML | METOCLOPRAMIDE HYDROCHLORIDE | 5 MG/ML | PSYCHOTROPICS INDIA LTDPLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 02/06/2021 |
| NDA/MAL/HDP/9663 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | POVIREN | POVIDONE + IODINE | 10% W/V | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9665 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYNAC-SP | ACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE | 100 MG + 325 MG + 15 MG | RAVIAN LIFE SCIENCE PVT. LIMITEDPLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHAND | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9666 | SCOTT-EDIL PHARMACIA LTD., | ROYAL PHARMA 2011 LIMITED | VOLIGESIC-GEL | DICLOFENAC DIETHYLAMINE | 1.0 % W/W | SCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE | 04/06/2021 |
| NDA/MAL/HDP/9667 | NATIONAL PHARMACEUTICAL INDUSTRIES CO. | MEDVIN PHARMA LIMITED | SPECTROMAX 500 | CLARITHROMYCIN | 500MG | NATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMANP.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMAN | OMAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X2X7 TABLET BLISTER | 04/06/2021 |
| NDA/MAL/HDP/9668 | LABORATE PHARMACEUTICALS INDIA LIMITED | HEALTHCARE LTD. | AZILAB-200 | AZITHROMYCIN DIHYDRATE | 200MG/5ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML CONTAINER + 30 ML WFI IN LDPE CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9669 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZOCOLD | PARACETAMOL + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE | 500 MG + 2 MG + 5 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1X25X4 TABLET STRIP | 04/06/2021 |
| NDA/MAL/HDP/9670 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | CDGREL-75 | CLOPIDOGREL BISULFATE | 75MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X3X10 TABLET BLISTER | 04/06/2021 |
| NDA/MAL/HDP/9672 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NASO B12 | METHYLCOBALAMIN | 250 MCG/ACTUATION | TROIKAA PHARMACEUTICALS LIMITED..SANAND - KADI ROAD, THOL, CITY: THOL - 382 728, DIST. MEHSANA, GUJARAT STATE - INDIA | INDIA | | NASAL SYSTEMIC UNIT DOSE AEROSOLS | 1.0X1.0X2.3 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9678 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AXABAN-DENK 2.5 MG | APIXABAN | 2.5 MG | COMBINO PHARM (MALTA) LIMITEDHF60 HAL FAR INDUSTRIAL ESTATE BBG3000 | MALTA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9679 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | AXABAN-DENK 5 MG | APIXABAN | 5MG | COMBINO PHARM (MALTA) LIMITEDHF60 HAL FAR INDUSTRIAL ESTATE BBG3000 | MALTA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 02/06/2021 |
| NDA/MAL/HDP/9681 | SYNOKEM PHARMACEUTICALS LIMITED | ROYAL PHARMA 2011 LIMITED | MISSROL-200 | MISOPROSTOL | 200MCG | SYNOKEM PHARMACEUTICALS LTD-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,10.0X1.0X10.0 TABLET BLISTER | 02/06/2021 |
| NDA/MAL/HDP/9683 | GLOBELA PHARMA PVT. LTD. | ROYAL PHARMA 2011 LIMITED | CAPTOGLO | CAPTOPRIL | 25 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 | 1X10X10 TABLET STRIP, | 23/06/2021 |
| NDA/MAL/HDP/9712 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | QUININE DIHYDROCHLORIDE INJECTION | QUININE DIHYDROCHLORIDE | 600MG/2ML | SCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE | 13/09/2021 |
| NDA/MAL/HDP/9713 | I CARE PHARMA LIMITED | SUPER MEDIC LTD | AZOL 400 | ALBENDAZOLE | 400MG | MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | | INDIA | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X1.0 TABLET BLISTER | 15/09/2021 |
| NDA/MAL/HDP/9714 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | ROVISTA | ROSUVASTATIN | 20MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9721 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | MONTIGET | MONTELUKAST SODIUM | 4MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY GRANULES | 1.0X14.0 SACHET CARTON | 29/09/2021 |
| NDA/MAL/HDP/9722 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | SEKROL 30 MG/5 ML | AMBROXOL HYDROCHLORIDE | 30 MG/5 ML | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X150.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/HDP/9723 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | SEKROL 15MG/5 ML | AMBROXOL HYDROCHLORIDE | 15MG/5ML | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 05/10/2021 |
| NDA/MAL/HDP/9725 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | MOCIN | MOXIFLOXACIN HYDROCHLORIDE | 0.5%W/V | ABACUS PARENTERAL DRUGS LTD (APDL)PLOT 114, BLOCK 191, KINGA - MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 05/10/2021 |
| NDA/MAL/HDP/9726 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ABLEPT – 300 | GABAPENTIN | 300MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9728 | ENCORE HEALTHCARE PVT. LTD. | REDDYS PHARMA LIMITED | ATONL 100 | ATENOLOL | 100MG | ENCORE HEALTHCARE PVT LTDD-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER, | 12/10/2021 |
| NDA/MAL/HDP/9729 | ENCORE HEALTHCARE PVT. LTD. | REDDYS PHARMA LIMITED | ATONL 50 | ATENOLOL | 50MG | ENCORE HEALTHCARE PVT LTDD-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER, | 12/10/2021 |
| NDA/MAL/HDP/9731 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MELANOV-M | GLICLAZIDE + METFORMIN HYDROCHLORIDE | 80MG + 500MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9747 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 60 MG | ARTESUNATE | 60MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE | 05/10/2021 |
| NDA/MAL/HDP/9748 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 30 MG | ARTESUNATE | 30MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X30.0 MG VIAL 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE | 05/10/2021 |
| NDA/MAL/HDP/9749 | SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD | TRIDEM PHARMA UGANDA LIMITED | ARGESUN 120 MG | ARTESUNATE | 120MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X120.0 MG VIAL 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE | 05/10/2021 |
| NDA/MAL/HDP/9754 | PROFARMA .SH.A | JOINT MEDICAL STORE (UPMB - UCMB) | LUMINAL | PHENOBARBITAL SODIUM | 200 MG/2 ML | PROFARMA SH.AMYSLYM KETA,TIRANA | ALBANIA | | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE | 05/10/2021 |
| NDA/MAL/HDP/9755 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORILAM ODT-100 | LAMOTRIGINE | 100MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9756 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORILAM ODT-25 | LAMOTRIGINE | 25MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9757 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | GLYFERON 850 | METFORMIN HYDROCHLORIDE | 850MG | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9758 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SKUDEXA | TRAMADOL HYDROCHLORIDE + DEXKETOPROFEN | 75MG + 25MG | MENARINI - VON HEYDEN GMBHLEIPZIGER STRABE 7-13, 01097 DRESDEN | GERMANY | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 12/10/2021 |
| NDA/MAL/HDP/9759 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | EZITA | EZETIMIBE | 10MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9760 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | ADVANT | CANDESARTAN | 16MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1X2X7 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9761 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | LOPICARD 10MG | AMLODIPINE BESILATE | 10MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9762 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | ADVANTEC | CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE | 16MG + 12.5MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9763 | RAINE INDUSTRIES | HEALTH LINK PHARMACY LIMITED | ROLXIN 40/320 | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40 MG + 320 MG | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X9.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9765 | PANACEA BIOTEC LTD | VITACARE LIMITED | LIVOLUK | LACTULOSE | 10.0 G/15 ML | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE, 1.0X450.0 ML BOTTLE | 05/10/2021 |
| NDA/MAL/HDP/9766 | S KANT HEALTHCARE LTD - | ABACUS PHARMA (AFRICA) LIMITED | NEOMYCIN SULFATE CREAM USP | NEOMYCIN SULPHATE | 0.5%W/W | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE | 05/10/2021 |
| NDA/MAL/HDP/9767 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | PREZEL 75 | PREGABALIN | 75MG | IND-SWIFT LIMITED ,.PHASE 1, INDUSTRIAL GROWTH CENTRE, SAMBA-184121, JAMMU & KASHMIR | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9768 | LABORATE PHARMACEUTICALS INDIA LIMITED | HEALTHCARE LTD. | MALAREST | QUININE DIHYDROCHLORIDE | 600MG/2ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | FRANCE | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULE | 05/10/2021 |
| NDA/MAL/HDP/9769 | FERRING INTERNATIONAL CENTER SA | MACNAUGHTON LIMITED | CARBETOCIN FERRING, 100 µG/ML | CARBETOCIN | 100 µG/ML | M/S STERIL-GENE LIFE SCIENCES (P) LTD45, MAIN ROAD, MANGALAM VILLAGE, VILLIANUR COMMUNE, PUDUCHERRY-605110 | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 05/10/2021 |
| NDA/MAL/HDP/9773 | GLOBELA PHARMA PVT. LTD. | SHREEJI CARE LIMITED | LOPERAGLOBE | LOPERAMIDE HYDROCHLORIDE | 2MG | GLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 11/10/2021 |
| NDA/MAL/HDP/9774 | I-CARE PHARMA LTD | AIVEEN (U) LIMITED | DOLOFIT | PARACETAMOL + DICLOFENAC SODIUM | 500MG + 50MG | MEDICO REMEDIES PVT LTD,.8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9775 | LABORATOIRE AGUETTANT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PHENYLEPHRINE AGUETTANT | PHENYLEPHRINE HYDROCHLORIDE | 500µG/10ML | LABORATOIRE AGUETTANT1 RUE ALEXANDER FLEMING 69007, LYON - FRANCE | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X10.0 ML PRE- FILLED SYRINGE | 05/10/2021 |
| NDA/MAL/HDP/9776 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEFAL DROPS | DEFLAZACORT | 22.75MG/ML | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X13.0 ML BOTTLE | 05/10/2021 |
| NDA/MAL/HDP/9777 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEFAL 30 MG | DEFLAZACORT | 30MG | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9778 | FAES FARMA S.A | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DEFAL 6MG | DEFLAZACORT | 6 MG | FAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9779 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | EYLEA | AFLIBERCEPT | 40 MG/ML | BAYER AG, BERLINMULLERSTRABE 178, 13353 BERLIN - GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL | 05/10/2021 |
| NDA/MAL/HDP/9780 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE DS 125 | CLARITHROMYCIN | 125 MG/5 ML | IND-SWIFT LIMITED ,.PHASE 1, INDUSTRIAL GROWTH CENTRE, SAMBA-184121, JAMMU & KASHMIR | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE | 12/10/2021 |
| NDA/MAL/HDP/9781 | IND SWIFT LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CLARIE DS 250 | CLARITHROMYCIN | 250 MG/5 ML | IND-SWIFT LIMITED ,.PHASE 1, INDUSTRIAL GROWTH CENTRE, SAMBA-184121, JAMMU & KASHMIR | INDIA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE | 12/10/2021 |
| NDA/MAL/HDP/9782 | LUPIN LIMITED- | AIVEEN (U) LIMITED | ATAZANAVIR SULFATE AND RITONAVIR TABLETS 300 MG AND 100 MG | ATAZANAVIR SULFATE + RITONAVIR | 300 MG + 100 MG | LUPIN LTDPLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 05/10/2021 |
| NDA/MAL/HDP/9785 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VAROXA-10 | RIVAROXABAN | 10MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9786 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VAROXA-20 | RIVAROXABAN | 20MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9790 | PANACEA BIOTEC PHARMA LTD | VITACARE LIMITED | WILLGO CR | ACECLOFENAC | 200MG | PANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA | | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9791 | IMPACT RH360 | UNITED HEALTHCARE DISTRIBUTORS LTD | AVIBELA | LEVONORGESTREL | 52 MG/ SYSTEM | ODYSSEA PHARMA SPRLRUE DU TRAVAIL 16, 4460 GRACE-HOLLOGNE | BELGIUM | | VAGINAL INTRA UTERINE DEVICES | 1.0X1.0X52.0 MG DEVICE | 05/10/2021 |
| NDA/MAL/HDP/9792 | ACINO AG | LABOREX UGANDA LIMITED | NBAXO 500 G IV | MEROPENEM TRIHYDRATE | 500MG/VIAL | DEMO SA21ST KM NATIONAL ROAD, ATHENS, LAMIA 14568 KRYONERI, ATHENS | GREECE | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X500.0 MG VIAL | 05/10/2021 |
| NDA/MAL/HDP/9793 | ACINO AG | LABOREX UGANDA LIMITED | NBAXO 1000 G IV | MEROPENEM TRIHYDRATE | 1000MG/VIAL | DEMO SA21ST KM NATIONAL ROAD, ATHENS, LAMIA 14568 KRYONERI, ATHENS | GREECE | | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X1.0X1000.0 MG VIAL | 05/10/2021 |
| NDA/MAL/HDP/9794 | VERVE HUMAN CARE LABORATORIES | ABACUS PHARMA (AFRICA) LIMITED | VERMOR-10 | MORPHINE SULPHATE | 10MG/ML | VERVE HUMAN CARE LABORATORIESPLOT 15A, PHARMACY, SELAQUI DEHRADUN-248011, UTTARAKHAND | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X1.0 ML AMPOULE | 05/10/2021 |
| NDA/MAL/HDP/9796 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APDROPS | MOXIFLOXACIN HYDROCHLORIDE | 0.5%W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE | 05/10/2021 |
| NDA/MAL/HDP/9797 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | TRAMASURE-100 | TRAMADOL HYDROCHLORIDE | 100 MG/2ML | MANKIND PHARMA LTD.VILLAGE KISHANPURA, POAMTA SAHI DISTRICT SIRMOUR HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1X1X4X2 ML AMPOULE | 12/10/2021 |
| NDA/MAL/HDP/9799 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VOMIRAN 8 MG/ 4ML | ONDANSETRON HYDROCHLORIDE DIHYDRATE | 8MG/4ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X5X4 ML VIAL | 12/10/2021 |
| NDA/MAL/HDP/9801 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LENOSIDE 10 | LENALIDOMIDE | 10MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9802 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LENOSIDE 15 | LENALIDOMIDE | 15MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9803 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | LENOSIDE 25 | LENALIDOMIDE | 25MG | CIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA | INDIA | | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9804 | LABORATOIRE AGUETTANT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATROPINE SULFATE AGUETTANT | ATROPINE SULFATE | 0.5MG/5ML | LABORATOIRE AGUETTANT1 RUE ALEXANDER FLEMING 69007, LYON - FRANCE | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X5.0 ML PRE- FILLED SYRINGE | 05/10/2021 |
| NDA/MAL/HDP/9807 | LABORATOIRE AGUETTANT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EPHEDRINE AGUETTANT | EPHEDRINE HYDROCHLORIDE | 30MG/10ML | LABORATOIRE AGUETTANT1 RUE ALEXANDER FLEMING 69007, LYON - FRANCE | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X10.0 ML PRE- FILLED SYRINGE | 05/10/2021 |
| NDA/MAL/HDP/9809 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | REVENTA | ALENDRONATE SODIUM | 70MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9810 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | MONTIGET | MONTELUKAST SODIUM | 4MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X1.0X7.0X2.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9815 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | ADVANT | CANDESARTAN | 8MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1X2X10 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9816 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | LOPICARD 5MG | AMLODIPINE | 5MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9817 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | LARINEX | DESLORATIDINE | 5MG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1X1X10 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9818 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | CYTOPAN | DICLOFENAC / MISOPROSTOL | 75MG/200MCG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9819 | GETZ PHARMA PVT LIMITED | MU PHARMA CO -SMC LIMITED | CYTOPAN | DICLOFENAC SODIUM + MISOPROSTOL | 50MG + 200MCG | GETZ PHARMA (PVT) LIMITED29, 30, SECTOR 27, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER | 29/09/2021 |
| NDA/MAL/HDP/9820 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | PHENYTOIN INJECTION BP 50 MG/ML, 5 ML | PHENYTOIN SODIUM | 50 MG/ML | SWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NR. BAVLA DIST. AHMEDABAD-380220 GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X5.0 ML AMPOULE | 05/10/2021 |
| NDA/MAL/HDP/9821 | JERUSALEM PHARMACEUTICALS CO. LIMITED | GAMA PHARMACEUTICALS (U) LIMITED | FRINASE NASAL SPRAY | FLUTICASONE PROPIONATE | 50 MCG/0.1 ML (ONE ACTUATION) | JERUSALEM PHARMACEUTICALS CO. LTDAL-BIREH RAMALLAH INDUSTRIAL ZONE, AL-BIREH NABLUS ROAD, P.O. BOX: 3570 PALESTINE | PALESTINE | | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X1.0X120.0 DOSE CONTAINER | 05/10/2021 |
| NDA/MAL/HDP/9823 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | HEDON PLUS | PARACETAMOL + ASPIRIN + ANHYDROUS CAFFEINE | 500 MG + 500 MG + 50 MG | RATNAMANI HEALTHCARE PRIVATE LIMITEDSURVEY 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 TABLETS | 1.0X50.0X1.0X2.0 TABLET STRIP | 05/10/2021 |
| NDA/MAL/HDP/9827 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CAPEMAX 500 | CAPECITABINE | 500MG | 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 | 11/10/2021 |
| NDA/MAL/HDP/9828 | SWISS PARENTERALS LTD | SHREEJI PHARMACEUTICALS LIMITED | OXYTOCIN INJECTION BP 10 IU/ML | OXYTOCIN | 10 IU/ML | SWISS PARENTERALS PVT LTD ..809, KERALA INDUSTRIAL ESTAE, GIDC NEAR BAVLA, AHMEDABAD 382220, GUJARAT | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X1.0 ML AMPOULE | 05/10/2021 |
| NDA/MAL/HDP/9829 | RENATA LIMITED | MARIE STOPES UGANDA LIMITED | WELL-PLAN | LEVONORGESTREL + ETHINYLESTRADIOL | 0.15MG + 0.03 MG | RAJENDRAPUR POTENT PRODUCT FACILITY (RPPF), RENATA LIMITEDNOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR 1700 - BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X28.0 TABLET BLISTER | 05/10/2021 |
| NDA/MAL/HDP/9831 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | ABACAVIR (AS SULFATE) AND LAMIVUDINE DISPERSIBLE TABLETS 120/60 MG | ABACAVIR SULFATE + LAMIVUDINE | 120 MG + 60 MG | CIPLA LTD ,.PLOT NO. A-33, A-2 (UNIT 1), A42 (UNIT II), MIDC PATALGANGA, DISTRICT-RAIGAD MAHARASHTRA, 410220 INDIA | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X30.0 TABLET BOTTLE | 05/10/2021 |
| NDA/MAL/HDP/9834 | ABACUS PARENTERAL DRUGS LTD (APDL) | ABACUS PARENTERAL DRUGS LIMITED | TFEN | KETOTIFEN FUMARATE | 0.025%W/V | ABACUS PARENTERAL DRUGS LTD (APDL)PLOT 114, BLOCK 191, KINGA - MUKONO | UGANDA | | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL | 08/12/2021 |
| NDA/MAL/HDP/9835 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | METAPROMIDE | METOCLOPRAMIDE HYDROCHLORIDE | 10 MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9836 | WALLACE PHARMACEUTICALS PVT. LTD | STAR PHARMACEUTICALS LTD | DIOVOL FORTE SUSPENSION | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 300MG + 250MG + 40MG | WALLACE PHARMACEUTICALS PVT LTDBHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X170.0 ML BOTTLE | 19/01/2022 |
| NDA/MAL/HDP/9839 | CIPLA LTD. | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DOLUTEGRAVIR AND LAMIVUDINE TABLETS 50 MG / 300 MG | DOLUTEGRAVIR SODIUM + LAMIVUDINE | 50 MG + 300 MG | CIPLA LTDUNIT 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 | 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER | 16/12/2021 |
| NDA/MAL/HDP/9842 | LABORATOIRE AGUETTANT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ADRENALINE AGUETTANT | ADRENALINE TARTRATE | 1MG/10ML | LABORATOIRE AGUETTANT1 RUE ALEXANDER FLEMING 69007, LYON - FRANCE | FRANCE | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X10.0 ML SYRINGE | 16/12/2021 |
| NDA/MAL/HDP/9843 | DAFRA PHARMA GMBH | MULTIPHAR UGANDA LIMITED | HACTOSEC | LEVODROPROPIZINE | 30MG/5ML | BILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X150.0 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9845 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | ALTLEVO | LEVOFLOXACIN HEMIHYDRATE | 500MG/100ML | ALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9846 | GLOBELA PHARMA PVT. LTD. | TATA UGANDA LIMITED | SQUAM | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 400MG + 320MG | 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 | 1X1X9 TABLET BLISTER, | 16/12/2021 |
| NDA/MAL/HDP/9848 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | STERILIZED WATER FOR INJECTION | WATER FOR INJECTION | N/A | ALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0 ML AMPOULE | 08/12/2021 |
| NDA/MAL/HDP/9849 | HETERO BIOPHARMA LIMITED, | AIVEEN (U) LIMITED | PAMERA 40 | ADALIMUMAB (R-DNA ORIGIN) | 40MG/ SYRINGE | HETERO BIOPHARMA LIMITEDSY. NO. 458 (PART), TSIIC-FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT – 509 301, TELANGANA STATE, INDIA. | INDIA | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X0.8 ML SYRINGE | 08/12/2021 |
| NDA/MAL/HDP/9850 | ZOTA HEALTHCARE LTD | REDDYS PHARMA LIMITED | ZEDGRA 50 | SILDENAFIL CITRATE | 50 MG | ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X4 TABLET BLISTER | 16/12/2021 |
| NDA/MAL/HDP/9853 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | MYCOREN V | NYSTATIN | 100,000 IU | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | PESSARIES | 1.0X1.0X15.0 PESSARY BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9854 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FLUZOLE | FLUCONAZOLE | 200MG | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X4.0 CAPSULE STRIP | 08/12/2021 |
| NDA/MAL/HDP/9855 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TRADOX | TRAMADOL HYDROCHLORIDE | 10 MG/2 ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X5.0X2.0 ML VIAL | 08/12/2021 |
| NDA/MAL/HDP/9856 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LARTEM DISPERSIBLE | ARTEMETHER + LUMEFANTRINE | 20MG +120MG | S KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X6.0 TABLET BLISTER | 16/12/2021 |
| NDA/MAL/HDP/9858 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | TIVICAY 25MG | DOLUTEGRAVIR SODIUM | 25MG | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE, SG12 ODJ | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 08/12/2021 |
| NDA/MAL/HDP/9859 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | TIVICAY 10MG | DOLUTEGRAVIR SODIUM | 10MG | GLAXO WELLCOME S.AAVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAIN | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE, SG12 ODJ | SPAIN | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 08/12/2021 |
| NDA/MAL/HDP/9860 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CLINDACIN 300 MG | CLINDAMYCIN HYDROCHLORIDE | 300 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X8.0 CAPSULE BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9864 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS, 400 MG / 300 MG / 300 MG | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | 400MG+300MG+300MG | MACLEODS PHARMACEUTICALS LTD BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X90.0 TABLET BOTTLE,1.0X30.0 TABLET BOTTLE | 21/12/2021 |
| NDA/MAL/HDP/9865 | PINNACLE LIFE SCIENCE PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | PINFOL | FOLIC ACID | 5MG | PINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1X10X10 TABLET BLISTER | 21/12/2021 |
| NDA/MAL/HDP/9866 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | JULUCA 50MG/25MG | DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE | 50MG + 25MG | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE, SG12 ODJ | UNITED KINGDOM | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET CONTAINER | 08/12/2021 |
| NDA/MAL/HDP/9867 | ASTRA PHARMA UGANDA LTD | ASTRA PHARMA (U) LIMITED | CEFTRIAXONE | CEFTRIAXONE SODIUM | 1G | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | CSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTDNO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, (WORKSHOP 402)CHINA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL | 21/12/2021 |
| NDA/MAL/HDP/9871 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RETALEX | ATRACURIUM BESYLATE | 50MG/5ML | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS | 1X5X5 ML VIAL | 21/12/2021 |
| NDA/MAL/HDP/9872 | SAGA LIFESCIENCES LTD | ABACUS PHARMA (AFRICA) LIMITED | COL-COL | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE USP + CAFFEINE ANHYDROUS | 500MG + 5MG + 2MG + 15MG | SAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9873 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OMISEC | OMEPRAZOLE SODIUM | 40MG/VIAL | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL,1.0X5.0X40.0 MG VIAL | 08/12/2021 |
| NDA/MAL/HDP/9874 | OCTAPHARMA AG | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OCTANATE 500 IU | HUMAN COAGULATION FACTOR VIII | 500IU PER VIAL | OCTAPHARMA DESSAU GMBHOTTO-REUTER-STR.3 06847 DESSAU, ROSSLAU | GERMANY | PARENTERAL ORDINARY DRY VIALS | 1X500 I.U VIAL | 21/12/2021 |
| NDA/MAL/HDP/9875 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | TALIMUS 0.1% | TACROLIMUS | 0.1% W/W | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE | 08/12/2021 |
| NDA/MAL/HDP/9876 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | LENIOL | PARACETAMOL | 1000MG/100 ML | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDSURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BAG,1.0X100.0 ML BOTTLE (GLASS BOTTLE),1.0X100.0 ML BOTTLE (NIPPLE HEAD PLASTIC BOTTLE),1.0X100.0 ML BOTTLE (EURO HEAD PLASTIC BOTTLE) | 08/12/2021 |
| NDA/MAL/HDP/9877 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LACOMA-T | LATANOPROST + TIMOLOL MALEATE | (50MCG + 5MG)/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTD .N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9878 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LACOMA | LATANOPROST | 0.005%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD .N-118, 118/1, 119, 119/1, 119/2, 113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, MAHARASHTRA STATE | INDIA | | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9879 | LABORATE PHARMACEUTICALS INDIA LIMITED | HEALTHCARE LTD. | AMILAB-500 | AMIKACIN SULFATE | 500MG/2 ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.0 ML VIAL | 08/12/2021 |
| NDA/MAL/HDP/9881 | HETERO LABS LTD | AIVEEN (U) LIMITED | DOLUTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS 50MG/200MG/25MG | DOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE HEMIFUMARATE | 50MG+200MG+25MG | HETERO LABS LIMITED (UNIT III)...22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9882 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA CT 50 | SILDENAFIL CITRATE | 50MG | AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9884 | LABORATE PHARMACEUTICALS INDIA LIMITED | HEALTHCARE LTD. | FOLILAB | FOLIC ACID, | 5MG | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9885 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BECLOCORT | BECLOMETHASONE DIPROPIONATE | 50MCG/METERED DOSE | AMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN | | JORDAN | | NASAL TOPICAL METERED-DOSE LIQUIDS | 1.0X1.0X30.0 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9888 | GLOBELA PHARMA PVT. LTD. | SHREEJI CARE LIMITED | GLOMET 200 | METRONIDAZOLE | 200MG | GLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 08/12/2021 |
| NDA/MAL/HDP/9889 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MOMADERM | MOMETASONE FUROATE | 0.1%W/W | AJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE | 08/12/2021 |
| NDA/MAL/HDP/9897 | MEDOPHARM | PLANET PHARMACEUTICALS UGANDA LTD | CO-TRIMOXAZOLE TABLETS BP | TRIMETHOPRIM + SULPHAMETHOXAZOLE | 400MG + 80MG | MEDOPHARM PVT LTD. 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY VILLAGE, 603 203 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER | 11/12/2021 |
| NDA/MAL/HDP/9899 | MEDICAL UNION PHARMACEUTICALS. | KARURI PHARMACEUTICALS LTD. | MUCOSOL ADULT SYRUP | CARBOCYSTEINE | 250MG/5ML | MEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9902 | LA RENON HEALTHCARE PRIVATE LIMITED | AIVEEN (U) LIMITED | SEVLAREN 800 | SEVELAMER CARBONATE | 800MG | STANFORD LABORATORIES PVT LIMITED8,INDUSTRIAL AREA,MEHATPUR-174 315, HIMACHAL PRADESH. | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9903 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | MEDICLOAMP 500MG | AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM | 250MG + 250MG | REGAL PHARMACEUTICALS LTD PLOT NO. 7879/18, OFF BABA DOGO ROAD, RUARAKA - NAIROBI | KENYA | | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9904 | MEDOPHARM PRIVATE LIMITED | VITACARE LIMITED | CLEDOMOX 228.5 DT | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 200 MG + 28.5 MG | MEDOPHARM PVT LTD. 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY VILLAGE, 603 203 | INDIA | | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X2.0X10.0 TABLET STRIP | 11/12/2021 |
| NDA/MAL/HDP/9906 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | NEBTAS-5 | NEBIVOLOL HYDROCHLORIDE | 5MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9911 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BISOPROL® 5 | BISOPROLOL FUMARATE | 5MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9912 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | IBUREN SUSPENSION | IBUPROFEN | 100MG/5ML | RENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9913 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | BRUTAFLAM-120 | ETORICOXIB | 120MG | MANKIND PHARMA LTD, UNIT II ,VILLAGE-KISHANPURA, PAONTA SAHIB, DIST. SIRMOUR, HP | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 08/12/2021 |
| NDA/MAL/HDP/9920 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | CIS-CURON | CIS-ATRACURIUMBESYLATE | 10MG/5ML | BROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 08/12/2021 |
| NDA/MAL/HDP/9921 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | SONATEC MOUTHWASH MENTHOL BREEZE | CETYLPYRIDINIUM CHLORIDE | 0.05%W/V | REGAL PHARMACEUTICALS LTD PLOT NO. 7879/18, OFF BABA DOGO ROAD, RUARAKA - NAIROBI | KENYA | | ORAL TOPICAL LIQUIDS | 1.0X250.0 ML BOTTLE | 08/12/2021 |
| NDA/MAL/HDP/9922 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PALONOSETRON HYDROCHLORIDE INJECTION | PALONOSETRON HYDROCHLORIDE | 0.25MG/5ML | CIPLA LIMITED.PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL | 08/12/2021 |
| NDA/MAL/HDP/9924 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | OPTIZOLINE EYE DROPS | TETRAHYDROZOLINE HYDROCHLORIDE | 0.5%W/V | XEPA-SOUL PATTINSON (MALAYSIA) SDN.BHD.1-5 CHENG INDUSTRIAL ESTATE, 75250, MELAKA | MALAYSIA | | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL | 17/01/2022 |
| NDA/MAL/HDP/9925 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | TUSSIDEX LINCTUS | DEXTROMETHORPHAN | 10MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN.BHD.1-5 CHENG INDUSTRIAL ESTATE, 75250, MELAKA | MALAYSIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE | 17/01/2022 |
| NDA/MAL/HDP/9931 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | CLOSUPP 100 | CLOTRIMAZOLE | 100MG | MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY STRIP | 08/12/2021 |
| NDA/MAL/HDP/9932 | INFUGEN PHARMA PVT. LTD. | TATA UGANDA LIMITED | INFUDEXA | DEXAMETHASONE | 0.5MG | FREDUN PHARMACEUTICALS LIMITED14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9933 | THE UNITED PHARMACEUTICALS MFG, CO. LTD, | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BISOPROL® 10 | BISOPROLOL FUMARATE | 10MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANYJORDAN - NUZHAT SAHAB | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| NDA/MAL/HDP/9936 | GUFIC BIOSCIENCES LTD | EUROPA HEALTHCARE (U) LTD | VAMOCIN 1GM | VANCOMYCINHYDROCHLORIDE | 1G/VIAL | GUFIC BIOSCIENCES LIMITED (UNIT 2)SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 31/03/2022 |
| NDA/MAL/HDP/9941 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | STERILIZED WATER FOR INJECTION | WATER FOR INJECTION | WATER FOR INJECTION | ALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X20.0X5.0X5.0 ML AMPOULE | 24/03/2022 |
| NDA/MAL/HDP/9942 | FOSUN PHARMACEUTICAL DISTRIBUTION JIANGSU CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1X1X6 TABLET BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9943 | FOSUN PHARMACEUTICAL DISTRIBUTION JIANGSU CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 40MG + 240MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1X1X6 TABLET BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9944 | FOSUN PHARMACEUTICAL DISTRIBUTION JIANGSU CO. LTD | TRIDEM PHARMA UGANDA LIMITED | GLUMAC DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 60MG + 360MG | GUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1X1X6 TABLET BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9948 | BLISS GVS PHARMA LIMITED | MEDVIN PHARMA LIMITED | SANTRIAX-1000 | CEFTRIAXONE SODIUM | 1000MG/VIAL | INJECT CARE PARENTERALS PVT LTDPLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X25.0X1000.0 MG VIAL,1.0X10.0 ML VIAL | 24/03/2022 |
| NDA/MAL/HDP/9949 | LABORATE PHARMACEUTICALS INDIA LIMITED | HEALTHCARE LTD. | GENTAM | GENTAMICIN SULPHATE | 80MG/2ML | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | INDIA | | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE | 24/03/2022 |
| NDA/MAL/HDP/9950 | XL LABORATORIES PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | RETOVIT | VITAMIN A | 200000 IU | XL LABORATORIES PRIVATE LIMITEDA-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X3X10 CAPSULE BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9951 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | ARCELIA ARTESUNATE FOR INJECTION | ARTESUNATE | 60MG/VIAL | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDASI LIFESCIENCE PRIVATE LIMITEDPLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL + 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE + 1 CLEAR GLASS AMPOULE OF SODIUM CHLORIDE | 31/03/2022 |
| NDA/MAL/HDP/9952 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 MG/ML | DEXAMETHASONE SODIUM PHOSPHATE | 8MG/2ML | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0X2.0 ML VIAL | 31/03/2022 |
| NDA/MAL/HDP/9954 | MARVIN PHARMA LTD (BURUNDI) | MARVIN PHARMA LIMITED | MARISUNATE 30MG | ARTESUNATE | 30MG/VIAL | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X30.0 MG VIAL + 1 CLEAR GLASS AMPOULE OF SODIUM BICARBONATE + 1 CLEAR GLASS AMPOULE OF SODIUM CHLORIDE | 31/03/2022 |
| NDA/MAL/HDP/9955 | VEERAM HEALTHCARE (U) LIMITED | VEERAM HEALTHCARE (U) LIMITED | DICLONI | DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL | 1.16%W/W+ 1.0% W/W+3.0%W/W+ 10%W/W+2.0% W/W | KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X15.0 G TUBE, 1.0X1.0X30.0 G TUBE | 31/03/2022 |
| NDA/MAL/HDP/9956 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | ARCELIA OMEPRAZOLE FOR INJECTION | OMEPRAZOLE SODIUM | 40 MG/VIAL | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X40.0 MG VIAL +10ML GLASS AMPOULE OF WATER FOR INJECTION | 31/03/2022 |
| NDA/MAL/HDP/9957 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | TERBICON CREAM | TERBINAFINE HYDROCHLORIDE | 1.0%W/W | INDCHEMIE HEALTH SPECIALITIES PVT. LTDVILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE | 24/03/2022 |
| NDA/MAL/HDP/9958 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | NUMED STORES SMC LIMITED | MUPRICON | MUPIROCIN | 2.0%W/W | INDCHEMIE HEALTH SPECIALITIES PVT. LTDVILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X5.0 G TUBE | 24/03/2022 |
| NDA/MAL/HDP/9959 | MARVIN PHARMA LTD (BURUNDI) | MARVIN PHARMA LIMITED | MARISUNATE 60MG | ARTESUNATE | 60MG/VIAL | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1, CLEAR GLASS AMPOULE OF SODIUM BICARBONATE + 1 CLEAR GLASS AMPOULE SODIUM CHLORIDE | 31/03/2022 |
| NDA/MAL/HDP/9960 | MARVIN PHARMA LTD (BURUNDI) | MARVIN PHARMA LIMITED | MARISUNATE 120MG | ARTESUNATE | 120MG/VIAL | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1, CLEAR GLASS AMPOULE OF SODIUM BICARBONATE + 1 CLEAR GLASS AMPOULE SODIUM CHLORIDE | 31/03/2022 |
| NDA/MAL/HDP/9961 | FDC LIMITED - | AIVEEN (U) LIMITED | ALLERCROM EYE DROPS | SODIUM CROMOGLICATE | 2%W/V | FDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | | OPHTHALMIC LIQUIDS | 1.0X1.0X10.0 ML BOTTLE | 31/03/2022 |
| NDA/MAL/HDP/9962 | ARCELIA LIFE SCIENCES LTD. | PLUTO PHARMACEUTICALS LIMITED | ARTEMETHER INJECTION 80 MG/ML | ARTEMETHER | 80MG/ML | SANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | EAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0X3.0X1.0 ML AMPOULE | 31/03/2022 |
| NDA/MAL/HDP/9964 | VIIV HEALTHCARE UK LTD- | UNITED HEALTHCARE DISTRIBUTORS LTD | TIVICAY 5 MG | DOLUTEGRAVIR SODIUM | 5MG | GLAXO WELLCOME S.AAVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAIN | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)PRIORY STREET, WARE, SG12 ODJ | SPAIN | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X60.0 TABLET CONTAINER | 31/03/2022 |
| NDA/MAL/HDP/9967 | MACLEODS PDHARMACEUTICALS LT | VITACARE LIMITED | VENTOMAC 100 | SALBUTAMOL SULFATE | 100MCG PER ACTUATION | OXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA | | LUNG ADMINISTRATION METERED-DOSE LIQUIDS | 1.0X1.0X200.0 METERED DOSE CANNISTER | 24/03/2022 |
| NDA/MAL/HDP/9968 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | MAXICEF | CEFEPIME HYDROCHLORIDE | 1G | ARISTO PHARMACEUTICALS PVT LTD .PLOT 208, NEW INDUSTRIAL AREA, NO. II, MANDIDEEP 462046 DIST-RAISEN, RAISEN, MADHYA PRADESH | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL | 24/03/2022 |
| NDA/MAL/HDP/9972 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | OLMESAR 20 | OLMESARTAN MEDOXOMIL | 20MG | MACLEODS PHARMACEUTICALS LTD BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9973 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL 80 H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | MICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126 | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| NDA/MAL/HDP/9974 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | NEBTAS-H | NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE | 5MG + 12.5 MG | INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| NDA/MAL/HDP/9975 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | RENERVE-P | PREGABALIN + MECOBALAMIN | 75MG + 750MG | CORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X3X10 CAPSULE BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9976 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EZIFLO | TAMSULOSIN HYDROCHLORIDE | 0.4 MG | UNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDAN | JORDAN | | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 24/03/2022 |
| NDA/MAL/HDP/9978 | ASPIRO PHARMA LIMITED | AIVEEN (U) LIMITED | PALOX | PALONOSETRON HYDROCHLORIDE | 0.25MG/5ML | ASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X0.25 MG VIAL | 31/03/2022 |
| NDA/MAL/HDP/9981 | MS PHARMA JORDAN CO.LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VELOCE | LORNOXICAM | 8MG PER VIAL | MS PHARMA - JORDANPLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY DRY VIALS | 1X1 VIAL CARTON | 31/03/2022 |
| NDA/MAL/HDP/9983 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 25 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 25MG + 1000MG | CIPLA LIMITED.PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| NDA/MAL/HDP/9984 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 12.5 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 12.5MG + 1000MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| NDA/MAL/HDP/9985 | CIPLA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 5 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 5MG + 1000MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| NDA/MAL/HDP/9986 | CIPLA LTD. | ABACUS PHARMA (AFRICA) LIMITED | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 10 MG/1000 MG | EMPAGLIFLOZIN + METFORMIN HYDROCHLORIDE | 10MG + 1000MG | CIPLA LTD, GOA UNIT V & UNIT XL-139, S-103&M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X60.0 TABLET BOTTLE | 24/03/2022 |
| NDA/MAL/HDP/9987 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SACROFER | IRON SUCROSE | 100MG/5ML | AMOUN PHARMACEUTICAL COMPANY...-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, CAIRO | | EGYPT | | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE | 24/03/2022 |
| NDA/MAL/HDP/9991 | CACHET PHARMACEUTICALS PVT LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EASCOF-LS | LEVOSALBUTAMOL SULPHATE + AMBROXOL HYDROCHLORIDE + GUAIPHENESIN | 1MG + 30MG + 50 MG | CACHET PHARMACEUTICALS PVT LTD .VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE | 24/03/2022 |
| NDA/MAL/HDP/9992 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | ASPEC EXTRA | ASPIRIN + PARACETAMOL + CAFFEINE ANHYDROUS | 300MG + 250MG + 30MG | REGAL PHARMACEUTICALS LTD PLOT NO. 7879/18, OFF BABA DOGO ROAD, RUARAKA - NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP | 24/03/2022 |
| NDA/MAL/HDP/9995 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | LYDIA FINE TABLET | LEVONORGESTREL + ETHINYLESTRADIOL | 0.15 MG + 0.03MG | RAJENDRAPUR POTENT PRODUCT FACILITY (RPPF), RENATA LIMITEDNOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR 1700 - BANGLADESH | BANGLADESH | | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1.0X28.0 TABLET BLISTER | 24/03/2022 |
| NDA/MAL/HDP/9996 | MACLEODS PHARMACEUTICALS LTD | VITACARE LIMITED | MONTEMAC 4 | MONTELUKAST SODIUM | 4MG | MACLEODS PHARMACEUTICALS LTD BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | INDIA | | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER | 31/03/2022 |
| NDA/MAL/HDP/9997 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RIVATAS 10 | RIVAROXABAN | 10MG | 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 | 24/03/2022 |
| NDA/MAL/HDP/9998 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DERMOCIN | MUPIROCIN | 2.0%W/W | LINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE | 24/03/2022 |
| NDA/MAL/HDP/9999 | SERUM INSTITUTE OF INDIA PVT LTD | NORVIK ENTERPRISES LIMITED | POLIOMYELITIS VACCINE (ORAL), BIVALENT TYPES 1 AND 3. | POLIO VIRUS (SABIN) | TYPE - I ?106.0 CCID50 TYPE - III ?105.8 CCID50 | SERUM INSTITUTE OF INDIA PVT LTD .212/2, HADAPSAR, PUNE- 411028, INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0X2.0 ML VIAL (20DOSES) | 31/03/2022 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| NDA/MAL/VDP/10003 | JUBAILI AGROTEC LIMITED | JUBAILI AGROTEC LIMITED | INFLANOR | DEXAMETHASONE SODIUM PHOSPHATE | 2 MG/ML | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 31/03/2022 |
| NDA/MAL/VDP/10004 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS SG 9R | LIVE, SALMONELLA GALLINARUM ORGANISMS, STRAIN 9R | 2 X 10^7 - 2 X 10^8 CFU PER DOSE | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL | 24/03/2022 |
| NDA/MAL/VDP/10005 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | MURTRYP PLUS | DIMINAZENE DIACETURATE + PHENAZONE + VITAMIN B6 + VITAMIN B12 | (444.3 MG + 555.3 MG + 0.8 MG 0.4 MG)/G | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X10.0X2.37 G SACHET,1.0X10.0X23.7 G SACHET | 24/03/2022 |
| NDA/MAL/VDP/10007 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | AMOXICOLINOR WSP | AMOXICILLIN TRIHYDRATE + COLISTIN SULFATE | (200MG + 1000000 IU) PER G | HEBEI KEXING PHARMACEUTICALS CO. LTDNO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X100.0 G SACHET | 31/03/2022 |
| NDA/MAL/VDP/10008 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | AMPRONOR 300MG® | AMPROLIUM HYDROCHLORIDE | 300MG/G | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X1.0 KG SACHET,1.0X50.0 G SACHET,1.0X100.0 G SACHET | 31/03/2022 |
| NDA/MAL/VDP/10009 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | D.COLINOR EXTRA | DOXYCYCLINE HYDROCHLORIDE + COLISTIN SULFATE + AMBROXOL HYDROCHLORIDE | (400MG + 800000 IU + 10MG)/G | HEBEI KEXING PHARMACEUTICALS CO. LTDNO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | | ORAL SOLID ORDINARY UNIT DOSE POWDERS | 1.0X100.0 G SACHET,1.0X50.0 G SACHET,1.0X1.0 KG SACHET | 31/03/2022 |
| NDA/MAL/VDP/10010 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | POULVAC®IB QX | LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN L1148 | 10^3.0 - 10^5.0 EID50/DOSE | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.LCTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2000.0 DOSE VIAL | 31/03/2022 |
| NDA/MAL/VDP/10120 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | ERYCONOR® | COLISTIN SULPHATE + ERYTHROMYCIN THIOCYANATE | (600,000 IU + 200MG) PER G | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 14/07/2022 |
| NDA/MAL/VDP/10121 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | TETRANOR® 25% WSP | OXYTETRACYCLINE HYDROCHLORIDE | 25%W/W | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 14/07/2022 |
| NDA/MAL/VDP/10122 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | VITRANOR-EGG FORMULA® WSP | OXYTETRACYCLINE HYDROCHLORIDE+ NEOMYCIN SULPHATE + VITAMIN A+VITAMIN D3+VITAMIN E+VITAMIN B1+VITAMIN B2+VITAMIN B6+VITAMIN B12+VITAMIN C+CALCIUM PANTOTHENATE+VITAMIN K3+NICOTINAMIDE+FOLIC ACID+METHIONINE+LYSINE+COPPER SULPHATE | (60MG + 40MG + 7500IU + 1750IU + 35MG + 1MG + 3MG + 2MG + 7.5 MCG + 25MG + 7.5MG + 5MG + +15MG + 0.3MG + 30MG + 50MG + 12.25MG) PER G | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 14/07/2022 |
| NDA/MAL/VDP/10123 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | PARAMECTIN | IVERMECTIN | 10MG/ML | PHARMA SWEDE - EGYPT10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 | EGYPT | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 06/07/2022 |
| NDA/MAL/VDP/10124 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | PARAMECTIN SUPER | IVERMECTIN + CLORSULON | (10MG + 100MG) PER ML | PHARMA SWEDE - EGYPT10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 | EGYPT | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 06/07/2022 |
| NDA/MAL/VDP/10125 | INTRACIN PHARMACEUTICAL PVT LTD? | VEERAM HEALTHCARE (U) LIMITED | MELOXIN-I | MELOXICAM | 5MG/ML | INTRACIN PHARMACEUTICAL PVT. LTD.C-1B/53, G.I.D.C. ESTATE, NADIAD 387 001, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X15.0 ML VIAL,1.0X30.0 ML VIAL,1.0X100.0 ML VIAL | 06/07/2022 |
| NDA/MAL/VDP/10128 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | NOBILIS® RISMAVAC+CA126 | LIVE, CHICKEN HERPES VIRUS, STRAIN CVI-988 (SEROTYPE I) + LIVE, TURKEY HERPES VIRUS, STRAIN FC-126 (SEROTYPE 3) | (? 3.0 LOG10 PFU + ? 3.0 LOG10 PFU) PER BIRD DOSE | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | PARENTERAL ORDINARY AMPOULES | 1.0X1000.0 DOSE AMPOULE,1.0X2000.0 DOSE AMPOULE | 14/07/2022 |
| NDA/MAL/VDP/10130 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY 10% LA | OXYTETRACYLINE DIHYDRATE | 100MG/ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 14/07/2022 |
| NDA/MAL/VDP/10131 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY 20% LA | OXYTETRACYCLINE DIHYDRATE | 200MG/ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 14/07/2022 |
| NDA/MAL/VDP/10133 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIENRO 10% | ENROFLOXACIN | 100MG/ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 14/07/2022 |
| NDA/MAL/VDP/10337 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | GENTAVET 10% INJ | GENTAMICIN SULPHATE | 10%W/V | THE ARAB PESTICIDES & VETERINARY DRUGS MANUFACTURING CO.AL HASSAN INDUSTRIAL ESTATE, IRBID, P.O. BOOX 45, IRIBID, 21467 | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 29/09/2022 |
| NDA/MAL/VDP/10339 | VAPCO VETERINARY AND AGRICULTURAL PRODUCTS CO LTD | GOODMAN INTERNATIONAL LTD | TYLOXIN | TYLOSIN TARTRATE + DOXYCYCLINE HYDROCHLORIDE | (200MG + 200MG ) PER GRAM | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 29/09/2022 |
| NDA/MAL/VDP/10341 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | AVISAN MULTI | INACTIVATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN H52 + INACTIVATED NEWCASTLE DISEASE VIRUS, LASOTA STRAIN + INACTIVATED EGG DROP SYNDROME ‘76 VIRUS, STRAIN 127 | 26 – 28 HAI1 + 24 – 26 HAI2 + 27 – 29 HAI1 | LABORATORIOS HIPRA, S.A. AVDA LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | PARENTERAL ORDINARY I V VIALS | 1.0X1.0X1000.0 DOSE BOTTLE | 04/10/2022 |
| NDA/MAL/VDP/10344 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | LEVANOR 200MG | LEVAMISOLE HYDROCHLORIDE | 200MG PER GRAM | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X50.0 G SACHET,1.0X100.0 G SACHET | 09/09/2022 |
| NDA/MAL/VDP/10345 | NEOGEN CHEMICALS(U) LTD | NEOGEN CHEMICALS (U) LTD | MULTIGEN | VITAMIN A + VITAMIN D3 +VITAMIN B1 + VITAMIN B6 + VITAMIN B2 + VITAMIN B12 + VITAMIN E ACETATE + NICOTINAMIDE + D-PANTOTHENOL + D-BIOTIN | (2000 IU + 2000 IU + 10 MG + 5 MG + 1MG + 10 MCG + 4 MG + 10 MG + 1MG + 10 MCG) PER ML | HEBEI NEW CENTURY PHARMACEUTICAL CO., LTD.N0. 189 TAIHANG STREET, SHIJIAZHUANG CITY, HEBEI, CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 09/09/2022 |
| NDA/MAL/VDP/10348 | ADWIA | GAMA PHARMACEUTICALS (U) LIMITED | OXYJECT 20 L.A. INJECTION | OXYTETRACYCLINE DIHYDRATE | 20%W/V | ADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPT | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X30.0 ML VIAL, 1.0X1.0X100.0 ML VIAL | 29/09/2022 |
| NDA/MAL/VDP/10397 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVIZURIL LIQUID | DICLAZURIL | 10 MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 09/09/2022 |
| NDA/MAL/VDP/10401 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | LIMOVIT WS | OXYTETRACYCLINE HYDROCHLORIDE + VITAMIN A (RETINOL ACETATE) + VITAMIN D3 (CHOLECALCIFEROL) + VITAMIN E (?-TOCOPHEROL ACETATE) + VITAMIN B1 (THIAMINE HYDROCHLORIDE) + VITAMIN B2 (RIBOFLAVIN) + VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) + VITAMIN B12 (CYANOCOBAL | (55MG + 5000IU + 1750IU + 3.5MG + 0.5MG + 3MG + 0.3MG + 2.5?G + 12MG + 3MG + 5.6MG + 15MG + 0.3MG + 12MG) PER GRAM | INTERCHEMIE WERKEN "DE ADEKAAR" BVMETAALWEG 85804 CG VENRY | NETHERLANDS | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 09/09/2022 |
| NDA/MAL/VDP/10402 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTERFLOX-100 | ENROFLOXACIN | 100MG/ML | INTERCHEMIE WERKEN "DE ADEKAAR" BVMETAALWEG 85804 CG VENRY | NETHERLANDS | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 09/09/2022 |
| NDA/MAL/VDP/10404 | NEOGEN CHEMICALS(U) LTD | NEOGEN CHEMICALS (U) LTD | OXY-GEN® LA | OXYTETRACYCLINE HYDROCHLORIDE | 20%W/V | HEBEI NEW CENTURY PHARMACEUTICAL CO., LTD.N0. 189 TAIHANG STREET, SHIJIAZHUANG CITY, HEBEI, CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X1.0X250.0 ML VIAL,1.0X1.0X500.0 ML VIAL | 09/09/2022 |
| NDA/MAL/VDP/10405 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVIMEC | IVERMECTIN | 1%W/V | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL,1.0X1.0X250.0 ML VIAL | 09/09/2022 |
| NDA/MAL/VDP/10414 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-MVIT | VITAMIN A + VITAMIN D3 + VITAMIN E + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + NICOTINAMIDE + D-PANTHENOL + VITAMIN B12 + D- BIOTIN | (3000IU + 2000IU + 4MG + 10MG + 1 MG + 5 MG + 12.5 MG + 10MG + 10MCG + 10MCG) PER ML | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X1.0X250.0 ML VIAL,1.0X1.0X500.0 ML VIAL | 09/09/2022 |
| NDA/MAL/VDP/10415 | INTERCHEMIE | VET CENTRE UGANDA LIMITED | LIMOXIN WS | OXYTETRACYCLINE HYDROCHLORIDE | 1000 MG/G | INTERCHEMIE WERKEN "DE ADEKAAR" BVMETAALWEG 85804 CG VENRY | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G JAR | 08/02/2023 |
| NDA/MAL/VDP/10416 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOTRIM | SULPHADIAZINE SODIUM + TRIMETHOPRIM | (200MG + 40MG) PER ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 08/02/2023 |
| NDA/MAL/VDP/10580 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIVER FORTE | IVERMECTIN + CLORSULON | (10MG + 100MG)/ML | ASHISHI LIFE SCIENCE PVT LTDJ-137, MIDC, TARAPUR, BOISAR 401501 DIST. THANE, MAHARASHTRA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL | 10/02/2023 |
| NDA/MAL/VDP/10582 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | POULVAC MAREK CVI + HVT (RISPENS-HVT) FROZEN | MAREK’S DISEASE CHICKEN HERPES VIRUS-INFECTED CELL SUSPENSION (CVI 988 STRAIN) + MAREK’S DISEASE TURKEY HERPES VIRUS-INFECTED CELL SUSPENSION (FC #126 STRAIN) | (?1,046 PFU + ?992 PFU)/ DOSE | ZOETIS2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | | PARENTERAL ORDINARY DRY AMPOULES | 1.0X5.0X1000.0 DOSE AMPOULE + (1*200ML OF DILUENT IN GLASS VIALS OR PLASTIC BAGS) | 10/02/2023 |
| NDA/MAL/VDP/10594 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | VECTONOR® | SULPHAMONOMETHOXINE SODIUM + TRIMETHOPRIM | 20% W/V + 4% W/V | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 08/02/2023 |
| NDA/MAL/VDP/10595 | LABORATORIOS HIPRA, S.A | ERAM UGANDA LIMITED | GUMBOHATCH | LIVE ATTENUATED, INFECTIOUS BURSAL DISEASE (GUMBORO DISEASE) VIRUS, STRAIN 1052 | 10^1.48 -10^2.63 PU* PER DOSE *PU= POTENCY UNITS | LABORATORIOS HIPRA, S.A. AVDA LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL + 1*10*200 ML OF SOLVENT,1.0X10.0X2000.0 DOSE VIAL + 1*10*400 ML OF SOLVENT,1.0X10.0X2500.0 DOSE VIAL + 1*10*500 ML OF SOLVENT,1.0X10.0X4000.0 DOSE VIAL + 1*10*800 ML OF SOLVENT,1.0X10.0X5000.0 DOSE VIAL + 1*10*1000 ML OF SOLVENT | 15/02/2023 |
| NDA/MAL/VDP/10596 | LABORATORIOS HIPRA, S.A | ERAM UGANDA LIMITED | HIPRAVIAR TRT | INACTIVATED, TURKEY RHINOTRACHEITIS VIRUS (TRTV), STRAIN 1062 | ELISA ? 196* *ELISA: ANTIBODY AGAINST TRTV TITRE EXPRESSED IN ELISA UNITS. | LABORATORIOS HIPRA, S.A. AVDA LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X500.0 ML CONTAINER (1000 DOSES) | 15/02/2023 |
| NDA/MAL/VDP/10739 | NEOGEN CHEMICALS(U) LTD | NEOGEN CHEMICALS (U) LTD | BUPARGEN | BUPARVAQUONE | 5%W/V | HEBEI NEW CENTURY PHARMACEUTICAL CO., LTD.N0. 189 TAIHANG STREET, SHIJIAZHUANG CITY, HEBEI, CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL,1.0X1.0X50.0 ML VIAL | 15/02/2023 |
| NDA/MAL/VDP/10740 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | COMBAT SHAMPOO | PERMETHRIN + CETRIMIDE | 0.05%W/V + 1%W/V | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X1.0X200.0 ML BOTTLE | 15/02/2023 |
| NDA/MAL/VDP/10741 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCO DIGEST | SODIUM PROPIONATE + MAGNESIUM SULPHATE + IRON II SULPHATE + ZINC SULPHATE + MANGANESE SULPHATE + COPPER SULPHATE + COBALT CHLORIDE + SODIUM SELENITE | 600 MG + 125 MG + 0.40 MG + 0.10 MG + 0.20 MG + 0.45 MG + 0.40 MG + 0.10 MG | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X200.0 G SACHET | 15/02/2023 |
| NDA/MAL/VDP/10781 | PT MEDION FARMA JAYA | AMAZON IMMUNO- CHEM LTD | MEDIVAC ND LASOTA | LIVE NEWCASTLE DISEASE VIRUS, LA SOTA STRAIN. | AT LEAST 10^7 EID50 PER DOSE | PT MEDION FARMA JAYA (PLANT) ..JALAN RAYA BATUJAJAR NO. 29, CIMAREME, NGAMPRAH, BANDUNG BARAT - INDONESIA | INDONESIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 DOSE VIAL,1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL | 03/05/2023 |
| NDA/MAL/VDP/10782 | PT MEDION FARMA JAYA | AMAZON IMMUNO- CHEM LTD | MEDIVAC ND-IB | LIVE NEWCASTLE DISEASE VIRUS, CLONE 45 STRAIN + LIVE INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS, H-120 STRAIN | ((? 10^7 EID50 + ? 10^3.5 EID50) PER DOSE | PT MEDION FARMA JAYA (PLANT) ..JALAN RAYA BATUJAJAR NO. 29, CIMAREME, NGAMPRAH, BANDUNG BARAT - INDONESIA | INDONESIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL | 03/05/2023 |
| NDA/MAL/VDP/10843 | PT MEDION FARMA JAYA | AMAZON IMMUNO- CHEM LTD | TOLTRADEX® | TOLTRAZURIL | (150MG + 500MG) PER GRAM | PT MEDION FARMA JAYA (PLANT) ..JALAN RAYA BATUJAJAR NO. 29, CIMAREME, NGAMPRAH, BANDUNG BARAT - INDONESIA | INDONESIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X20.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1000.0 ML CONTAINER | 06/06/2023 |
| NDA/MAL/VDP/10844 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | P. STREPNOR EXTRA® WSP | STREPTOMYCIN SULPHATE + PROCAINE PENICILLIN G + PANTOTHENIC ACID + NICOTINAMIDE + FOLIC ACID + VITAMIN A + VITAMIN B2 + VITAMIN B6 + VITAMIN B12 + VITAMIN D3 + VITAMIN E + VITAMIN K3 | 133 MG + 45 MG + 5850MG + 16600MG + 410MG + 6600IU + 1740MCG + 2550MCG + 52.5 MCG, + 1660IU + 2550MCG + 2550MCG | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X50.0 G SACHET | 08/06/2023 |
| NDA/MAL/VDP/10861 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | NEWCASTLE-BRONCHITIS VACCINE | NEWCASTLE DISEASE VIRUS, B1 TYPE, LASOTA STRAIN + AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS SEROTYPE, STRAIN #1263 | (? 10^6.0 EID50/DOSE + ? 10^3.8 EID50) PER DOSE | ZOETIS2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | | LYOPHILISATES (ASEPTICALLY FILLED) | 1.0X10.0X1000.0 DOSE VIAL | 03/05/2023 |
| NDA/MAL/VDP/10870 | PT MEDION FARMA JAYA | AMAZON IMMUNO- CHEM LTD | MEDIVAC GUMBORO B | LIVE INFECTIOUS BURSAL DISEASE VIRUS, D22 STRAIN | 10^3.5TCID50 PER DOSE | PT MEDION FARMA JAYA (PLANT) ..JALAN RAYA BATUJAJAR NO. 29, CIMAREME, NGAMPRAH, BANDUNG BARAT - INDONESIA | INDONESIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 DOSE VIAL,1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 02/06/2023 |
| NDA/MAL/VDP/10872 | ASHISH LIFE SCIENCE PVT LIMITED | ASHISH LIFE SCIENCE UGANDA LIMITED | CATACURE | BUTAPHOSPHAN + CYANOCOBALAMIN E | 100 MG + 50 MCG | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 17/08/2023 |
| NDA/MAL/VDP/10995 | VMD NV HOGE MAUW | ERAM UGANDA LIMITED | DOXYVETO-CITRIX 500 MG/G | DOXYCYCLINE HYCLATE | 500 MG/G | LABORATORIES BIOVE' -3, RUE DE LORRAINE, F-62510 ARQUES | VMD NV -HOGE MUW 900, 2370, ARENDONK | | FRANCE | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G JAR,1.0X1000.0 G JAR | 17/08/2023 |
| NDA/MAL/VDP/10996 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ZEROKRIM® CH | PRAZIQUANTEL + PYRANTEL PAMOATE + FENBENDAZOLE | 50.00 MG + 144.00 MG + 500.00 MG | ASHISH LIFE SCIENCE PVT. LTDJ-137, MIDC,TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X10.0 TABLET STRIP | 17/08/2023 |
| NDA/MAL/VDP/11005 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ALBECTIN SUSPENSION | ALBENDAZOLE + IVERMECTIN | (100MG +2 MG) PER ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 17/08/2023 |
| NDA/MAL/VDP/11006 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIENRO® - BH | ENROFLOXACIN + BROMHEXINE HYDROCHLORIDE | (200MG + 15MG) PER ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 17/08/2023 |
| NDA/MAL/VDP/11007 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO. | GLOBAL VET (U) LIMITED | ALBEMEC | ALBENDAZOLE + IVERMECTIN | (50MG +10 MG) PER ML | THE ARAB PESTICIDES & VETERINARY DRUGS MANUFACTURING CO.AL HASSAN INDUSTRIAL ESTATE, IRBID, P.O. BOOX 45, IRIBID, 21467 | JORDAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 ML CONTAINER | 17/08/2023 |
| NDA/MAL/VDP/11099 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CHLORAZIN | CHLORPHENIRAMINE MALEATE INJECTION | 10MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED-PLOT NO. F-1/1, SECTOR 6 B, IIE, SIDCUL, HARIDWAR-249403, UTTARAKHAND (INDIA) | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 12/13/2023 |
| NDA/MAL/VDP/11100 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | INTERTRIM-480 WS | SULFADIAZINE SODIUM + TRIMETHOPRIM | (400MG + 80MG)/G | INTERCHEMIE WERKEN DE ADELAAR BV-METAALWEG 8 5804 (G VENRA) | | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 12/13/2023 |
| NDA/MAL/VDP/11122 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BIOTRIM | SULFADIAZINE + TRIMETHOPRIM | (400MG + 80MG)/G | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED-PLOT NO. F-1/1, SECTOR 6 B, IIE, SIDCUL, HARIDWAR-249403, UTTARAKHAND (INDIA) | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 12/13/2023 |
| NDA/MAL/VDP/11123 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | ALBEX PLUS® | ALBENDAZOLE | 100MG/G | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD-AL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | | JORDAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 12/13/2023 |
| NDA/MAL/VDP/11124 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MARBODAC | MARBOFLOXACIN | 100 MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED-PLOT NO. F-1/1, SECTOR 6 B, IIE, SIDCUL, HARIDWAR-249403, UTTARAKHAND (INDIA) | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 12/13/2023 |
| NDA/MAL/VDP/11125 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | COXIWIN 5% | TOLTRAZURIL | 50 MG/ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED-PLOT NO. F-1/1, SECTOR 6 B, IIE, SIDCUL, HARIDWAR-249403, UTTARAKHAND (INDIA) | | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 12/13/2023 |
| NDA/MAL/VDP/11126 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | CLOTIN 1% | IVERMECTIN | 10 MG/ML | INTRACIN PHARMACEUTICALS PVT LTD ,.,.-C-1, B-53, GIDC ESTATE, NADIAD-387001 | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 12/13/2023 |
| NDA/MAL/VDP/11127 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | FLASIN | TYLOSIN | 200 MG/ML | INTRACIN PHARMACEUTICALS PVT LTD ,.,.-C-1, B-53, GIDC ESTATE, NADIAD-387001 | | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 12/13/2023 |
| NDA/MAL/VDP/11185 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | NEFLUK 2.5% | ALBENDAZOLE | 2.5% W/V | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML CONTAINER | 02/02/2024 |
| NDA/MAL/VDP/11186 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | DECTOMAX® INJECTABLE SOLUTION | DORAMECTIN | 10MG/ML | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.LCTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL | 02/02/2024 |
| NDA/MAL/VDP/11187 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | INJECTIPHOS | BUTAPHOSPHAN + CYANOCOBALAMIN | (100MG + 0.05MG) PER ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITEDPLOT NO. F-1/1, SECTOR 6 B, IIE, SIDCUL, HARIDWAR-249403, UTTARAKHAND (INDIA) | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 02/02/2024 |
| NDA/MAL/VDP/11188 | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BIOTRIM IV INJECTION (VET) | SULFADIAZINE + TRIMETHOPRIM | (200MG + 40MG) PER ML | ZENEX ANIMAL HEALTH INDIA PRIVATE LIMITEDPLOT NO. F-1/1, SECTOR 6 B, IIE, SIDCUL, HARIDWAR-249403, UTTARAKHAND (INDIA) | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 02/02/2024 |
| NDA/MAL/VDP/1536 | NORBROOK KENYA LTD | NORBROOK (U) LTD | LEVAFAS X-TRA | LEVAMISOLE +OXYCLOZANIDE | 7.5% W/V +15% W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X40.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 01/07/2014 |
| NDA/MAL/VDP/1617 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | EVACIDE | OXYCLOZANIDE + LEVAMISOLE HYDROCHLORIDE | 30MG + 15MG /ML | HEBEI YUANZHENG PHARMACEUTICAL CO., LTD INDUSTRIAL AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE. P.R. CHINA. | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X1.0 L CONTAINER | 01/07/2013 |
| NDA/MAL/VDP/1619 | MEDISEL(K) LTD | SUPER MEDIC LTD | TRIMOXOL-VET ORAL POWDER | TRIMETHOPRIM+SULFAMETHOXAZOLE | 2.0%W/W+10%W/W | MEDISEL KENYA LTD - LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | DAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X30.0 G SACHET, 1.0X100.0 G SACHET | 07/01/2015 |
| NDA/MAL/VDP/1621 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | IVERMECTIN | IVERMECTIN | 1%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY S C VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/1644 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | DIMINAZENE PLUS | DIMINAZENE DIACETURATE + ANTIPYRINE + VITAMIN B12 | 1.05G + 1.31G +1MG/ 2.36G | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | OTHER SYSTEMIC POWDER | 1.0X23.6 G SACHET,1.0X2.36 G SACHET | 01/07/2014 |
| NDA/MAL/VDP/1667 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTRAFER 100 B12 | IRON DEXTRAN + CYANOCOBALAMIN | 100MG + 0.1MG / ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/2443 | MEDISEL(K) LTD | SUPER MEDIC LTD | DABENDAZOLE 2.5%W/V | ALBENDAZOLE | 2.5%W/V | MEDISEL KENYA LTD - LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE, 1.0X5000.0 ML BOTTLE, 1.0X1000.0 ML BOTTLE, 1.0X500.0 ML BOTTLE | 07/01/2009 |
| NDA/MAL/VDP/2520 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | IMIVET | IMIDOCARB DIPROPIONATE | 120MG/ML | INTRACIN PHARMACEUTICALS PVT LTDC-1, B-53, GIDC ESTATE NADAID-387 001(GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/VDP/2550 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | INTERMECTIN SUPER | IVERMECTIN + CLORSULON | 10MG + 100MG | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X500.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/2551 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | INTRACOX ORAL | TOLTRAZURIL | 45MG/ML | INTERCHEMIE WERKEN DE ADELAAREESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAA | ESTONIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/2590 | LAPROVET S.A.S | EVERVICTORY LIMITED | TETRACOLIVIT | OXYTETRACYCLINE+COLISTIN | 10G/100G+7MUI/100G | LABORATOIRES BIOVE SAS3 RUE DE LORRAINE, BP 45 62510 ARQUES FRANCE | FRANCE | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1000.0 G CONTAINER,1.0X100.0 G SACHET | 01/07/2012 |
| NDA/MAL/VDP/2623 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | IMOCHEM 120 | IMIDOCARB DIPROPIONATE | 120MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL (STERILE PRODUCT) | 01/07/2014 |
| NDA/MAL/VDP/2630 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | HIPRAVIAR CLON | ATTENUATED LIVE NEWCASTLE VIRUS CL/79 CLON | 10??? - 10???? EID??/ DOSE (0.03ML) | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X2500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X5000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/2633 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | HIPRAVIAR B1/H120 | LIVE NEWCASTLE DISEASE VIRUS, B1 STRAIN + LIVE AVIAN INFECTIOUS BRONCHITIS VIRUS, MASS H120 STRAIN | LIVE NEWCASTLE DISEASE VIRUS - 10??? -10??? EID??/DOSE + LIVE AVIAN INFECTIOUS BROCHITIS VIRUS - 10³-10?EID??/DOSE | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 DOSE VIAL, 1.0X10.0X2500.0 DOSE VIAL | 01/07/2015 |
| NDA/MAL/VDP/2634 | LABORATORIES HIPRA SA | ERAM UGANDA LIMITED | HIPRAGUMBORO CH/80 | CLONED LIVE INFECTIOUS BURSAL DISEASE VIRUS, CH/80 CLON | 10³?? TCID??/DOSE | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/2635 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | HIPRAGUMBORO-GM97 | LIVE INFECTIOUS BURSAL DISEASE VIRUS, STRAIN GM97 | 10² - 10³ EID??/ DOSE | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL | 01/07/2015 |
| NDA/MAL/VDP/2637 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | HIPRAVIAR S | ATTENUATED LIVE NEWCASTLE DISEASE VIRUS, LASOTA STRAIN | 10??? - 10???EID??/ DOSE (0.03ML) | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | OTHER SYSTEMIC SPECIAL SOLIDS | 1.0X2500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X10.0X500.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/2638 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | HIPRAVIAR CLON/ H120 | LIVE NEWCASTLE DISEASE VIRUS CL/79 CLON + LIVE INFECTIOUS BRONCHITIS VIRUS, MASS H120 STRAIN | LIVE NEWCASTLE DISEASE VIRUS, CL/79 - ?10???EID??/DOSE + LIVE INFECTIOUS BROCHITIS VIRUS - ?10³EID??/DOSE | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 DOSE VIAL, 1.0X10.0X2500.0 DOSE VIAL | 01/07/2015 |
| NDA/MAL/VDP/2839 | MEDISEL(K) LTD | SUPER MEDIC LTD | EGOCIN 20 % | OXYTETRACYCLINE | 200MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD.NO. 16, LIUYUAN ROAD, CHANGAN DISTRICT, SHIJIAZHUANG, HEBEI, | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 07/01/2011 |
| NDA/MAL/VDP/2845 | ALIVIRA ANIMAL HEALTH | ERAM UGANDA LIMITED | SEMIDIUM | ISOMETAMIDIUM | 1000MG | ALIVIRA ANIMAL HEALTH LIMITED A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIA | INDIA | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X1000.0 MG SACHET | 01/07/2013 |
| NDA/MAL/VDP/2847 | NILE SERVICES LTD | NILE SERVICES LTD | STARMECTIN 1% | IVERMECTIN | 10MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/2856 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOGENT-10% | GENTAMICIN | 10%W/V | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDAN | JORDAN | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/2866 | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD | EVERVICTORY LIMITED | EVALBEN-2.5 | ALBENDAZOLE | 2.5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L JERRYCAN | 01/07/2012 |
| NDA/MAL/VDP/2871 | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD | EVERVICTORY LIMITED | EVALBEN-10 | ALBENDAZOLE | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L JERRYCAN,1.0X1000.0 ML CONTAINER | 01/07/2012 |
| NDA/MAL/VDP/4157 | NILE SERVICES LTD | NILE SERVICES LTD | MULTISTAR | VIT( A + D3 + E + B1 + B2 + B6 +B12) + NICOTINAMIDE + PANTOTHENOL | 15000 IU + 1000 IU + 20MG + 10MG + 5MG + 3MG + 50MG + 35MG + 25MG | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/4189 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | IPLUS | IVERMECTIN + CLORSULON | 1%W/V + 10%W/V | ELANCO KOREA, BANWOL PLANT14, NEUNGAN-RO, DANWON-GU, ANSAN-SI, GYEONGGI-DO, 15427, REPUBLIC OF SOUTH KOREA | SOUTH KOREA | PARENTERAL ORDINARY S C VIALS | 1.0X500.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/4214 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | IROFLOX | ENROFLOXACIN | 10%W/V | INTRACIN PHARMACEUTICAL PVT LTD C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIA | INDIA | | PARENTERAL ORDINARY OTHER VIALS | 1.0X100.0 ML BOTTLE,1.0X50.0ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/4240 | NORBROOK KENYA LTD | NORBROOK (U) LTD | ALBAFAS 2.5% | ALBENDAZOLE | 25MG/ML | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 01/07/2009 |
| NDA/MAL/VDP/4258 | VAPCO | GOODMAN INTERNATIONAL LTD | LEVOZAN | LEVAMIZOLE HCL +OXYCLOZANIDE | 30MG/ML+60MG/ML | VAPCODHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1000.0 ML BOTTLE,250.0 ML BOTTLE,100.0 ML BOTTLE,500.0 ML BOTTLE | 01/07/2008 |
| NDA/MAL/VDP/4262 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIDOX-N | DOXYCYCLINE+NEOMYCIN | 100MG+100MG/G | ASHISH LIFE SCIENCE PVT. LTD. .AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 01/07/2013 |
| NDA/MAL/VDP/4265 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIALBEN 300 | ALBENDAZOLE | 300MG | ASHISH LIFE SCIENCE PVT. LTDJ-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X11.0X5.0 BOLUS BLISTER | 01/07/2013 |
| NDA/MAL/VDP/4270 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | ZANIDE | LEVAMISOLE/OXYCLOZANIDE | 15MG/30MG | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTDAL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITY | JORDAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/4424 | ALIVIRA ANIMAL HEALTH | ERAM UGANDA LIMITED | SEQUZENE PLUS | DIMINAZENEDIACETURATE,CYANOCOBALAMIN | 0.5G,0.01G | ALIVIRA ANIMAL HEALTH LIMITED A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIA | INDIA | | ORAL SOLID ORDINARY GRANULES | 1.0X1.0X10.0X23.6 G SACHET,1.0X1.0X10.0X2.36 G SACHET | 01/07/2011 |
| NDA/MAL/VDP/4427 | NORBROOK KENYA LTD | NORBROOK (U) LTD | ALBAFAS 10% | ALBENDAZOLE | 10%W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 01/07/2008 |
| NDA/MAL/VDP/4435 | V.M.D.N.V | ERAM UGANDA LIMITED | ENROVETO-20 | ENROFLOXACIN | 200MG/ML | VMD NV HOGE MAUW--HOGE MUW 900-B2370, ARENDONK | | BELGIUM | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/VDP/4437 | NORBROOK KENYA | NORBROOK (U) LTD | SYPERTIX 10% EC | ALPHACYPERMETHRIN | 10%W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | TOPICAL EXTERNAL EMULSION GELS | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN | 01/07/2009 |
| NDA/MAL/VDP/4443 | V.M.D.N.V | ERAM UGANDA LIMITED | IVERVETO-1 | IVERMECTIN | 10MG/ML | VMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONK | | BELGIUM | | PARENTERAL ORDINARY S C VIALS | 1.0X1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2010 |
| NDA/MAL/VDP/4445 | MEDISEL(K) LTD | SUPER MEDIC LTD | FASOVERM DS SUSPENSION | OXYCLOZANIDE + LEVAMISOLE HCL + COBALT SULPHATE | 6%W/V + 3%W/V + 0.704%W/V | MEDISEL KENYA LTD - LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN, 1.0X1.0 L BOTTLE, 1.0X150.0 ML BOTTLE, 1.0X500.0 ML JERRYCAN | 07/01/2010 |
| NDA/MAL/VDP/4449 | COSMOS LTD | ERAM UGANDA LIMITED | COSVITA | MULTIVITAMIN | N/A | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 10.0X30.0 G SACHET | 01/07/2010 |
| NDA/MAL/VDP/4452 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY 20% | OXYTETRACYCLINE HYDROCHLORIDE | 100G | ASHISH LIFE SCIENCE PVT. LTD. .AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 01/07/2010 |
| NDA/MAL/VDP/4476 | VMD NV HOGE MAUW | ERAM UGANDA LIMITED | DOXYVET-50S | DOXYCYCLINE | 500MG/G | VMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONK | | BELGIUM | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G BOTTLE,1.0X1.0 KG JAR | 01/07/2005 |
| NDA/MAL/VDP/4478 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIALBEN 10% | ALBENDAZOLE | 500MG/5ML | ASHISH LIFE SCIENCE PVT. LIMITEDJ-137, MIDC, TARAPUR, BOISAR, THANE 401 501, MAHARASTRA INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X250.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/4479 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZ-PENSTREPTO 20/20 SUSPENSION | PENICILLIN G/DIHYDROSTREPTOMYCIN SUPHATE | 200MG/ML+200MG/ML | HEBEI YUANZHENG PHARM.CO.LTDNO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/2012 |
| NDA/MAL/VDP/4502 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHOXY CHICK FORMULA | OXYTETRACYCLINE+ VIT A+ D3 + E + K3 + B2 +B12 + CALCIUM + NICOTINAMIDE | 6G + 0.4G +0.09MG +0.147MG 72MG + 260MG +200MCG + 465MG +1.2MG | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X25.0 G SACHET | 01/07/2012 |
| NDA/MAL/VDP/4512 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTROVIT | VITAMINS/ AMINO ACIDS | MULTI-INGREDIENT | INTERCHEMIE WERKEN “DE ADELAAR” B.V - METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 ML BOTTLE | 01/07/1999 |
| NDA/MAL/VDP/4649 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | TOLTRACOX | TOLTRAZURIL | 50MG/ML | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X15.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/4653 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ALBECTIN | ALBENDAZOLE+IVERMECTIN | 3000MG+100MG | ASHISH LIFE SCIENCE PVT. LTDJ-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X1.0 BOLUS BLISTER | 01/07/2014 |
| NDA/MAL/VDP/4659 | INTRACINE PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | I- TIN | IVERMECTIN | 1% W/V | INTRACIN PHARMACEUTICAL PVT LTD C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/4664 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | IMOLY 10% | OXYTETRACYCLINE | 10% W/V | INTRACIN PHARMACEUTICAL PVT. LTDC-1 B/53, G.I.D.C ESTATE, NADIAD-387001 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/4667 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | PHENYLJECT | PHENYLBUTAZONE | 200MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/4668 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | OXYNAL 20 LA | OXYTETRACYCLINE | 200MG/ML | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTDAL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITY | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/4673 | NILE SERVICES LTD | NILE SERVICES LTD | DIMINASTAR | DIMINAZENE DIACETURATE | 1.05G | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X2.36 G SACHET,1.0X10.0X23.6 G SACHET | 01/07/2014 |
| NDA/MAL/VDP/4676 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | INTERMECTIN | IVERMECTIN | 10MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY OTHER VIALS | 1.0X50.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/4689 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | GENTA 100 | GENTAMYCIN | 100MG/ ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/4691 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | INTERFLOX ORAL | ENROFLOXACIN | 100MG/ML | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/4699 | NILE SERVICES LTD | NILE SERVICES LTD | TETRASTAR 130 | OXYTETRACYCLINE | 13%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5637 | MEDISEL(K) LTD | SUPER MEDIC LTD | DASCARNIL WORM POWDER | PIPERAZINE CITRATE B.P | 0.35G/G | MEDISEL KENYA LTD - LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | DAWA LIMITED BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 5.0X30.0 G SACHET, 1.0X100.0 G SACHET | 08/01/2013 |
| NDA/MAL/VDP/5645 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVACIDE POULTRY | LEVAMISOLE HYDROCHLORIDE | 7.5%W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 01/07/1998 |
| NDA/MAL/VDP/5646 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVACIDE WORM DRENCH | LEVAMISOLE HYDROCHLORIDE | 15MG/ML | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L JERRYCAN,1.0X2.5 L JERRYCAN,1.0X5.0 L JERRYCAN,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5649 | NILE SERVICES LTD | NILE SERVICES LTD | ALBENDASTAR 10% | ALBENDAZOLE | 10%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | NON-HUMAN USE LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L JERRYCAN | 01/07/2013 |
| NDA/MAL/VDP/5651 | NILE SERVICES LTD | NILE SERVICES LTD | ALBENDASTAR 2.5% | ALBENDAZOLE | 25MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L JERRYCAN | 01/07/2014 |
| NDA/MAL/VDP/5652 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVAFAS DIAMOND | LEVAMISOLE+OXYCLOZANIDE | 30G+60G | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X5.0 L JERRYCAN,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5653 | VAPCO | GOODMAN INTERNATIONAL LTD | PIROPLASMIN | DIMINAZENE ACETURATE + ANTIPYRINE + VITAMIN B12 | 75 MG + 250 MG + 0.04 MCG | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/5654 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVAFAS FLUKE & WORM DRENCH | LEVAMISOLE HCL+OXYCLOZANIDE | 15G+30G | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5657 | COSMOS LTD | ERAM UGANDA LIMITED | POLTRICIN CHICK FORMU | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 5.0X25.0 G SACHET | 01/07/1998 |
| NDA/MAL/VDP/5659 | COSMOS LTD | ERAM UGANDA LIMITED | POLTRICIN MAYAI FORMULA | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 5.0X25.0 G SACHET | 01/07/1998 |
| NDA/MAL/VDP/5660 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID 150 TABLETS | LEVAMISOLE HYDROCHLORIDE | 150MG | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER | 01/07/1997 |
| NDA/MAL/VDP/5661 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | ALBENOL-100 ORAL | ALBENDAZOLE | 100MG/ML | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 01/07/2004 |
| NDA/MAL/VDP/5662 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID 1G BOLUS | LEVAMISOLE HYDROCHLORIDE | 1G | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X30.0 BOLUS CARTON | 01/07/1997 |
| NDA/MAL/VDP/5663 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID LIQUID DEWORMER | LEVAMISOLE HYDROCHLORIDE | 1.5W/V | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5665 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID PLUS-O | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE+CALCIUM SULFATE | 1.5W/V+3%W/V+0.382%W/V | MEDISEL (K) LTDPLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/VDP/5668 | COSMOS LTD | ERAM UGANDA LIMITED | WORMITA SUSPENSION | ALBENDAZOLE | 2.5%W/V | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5676 | VMD NV | ERAM UGANDA LIMITED | DIAZIPRIM 48% | SULPHADIAZINE + TRIMETHOPRIM | 400 MG + 80 MG | VMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONK | | BELGIUM | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 01/07/2000 |
| NDA/MAL/VDP/5677 | LABORATOIRES LAPROVET | EVERVICTORY LIMITED | LEVALAP | LEVAMISOLE | 20%W/W | LABORATOIRES BIOVE 3 RUE DE LORRAINE BP 45 62510 ARQUES | FRANCE | | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X10.0X100.0 G SACHET,1.0X1000.0 G SACHET | 01/07/2014 |
| NDA/MAL/VDP/5680 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | LEVAMISOLE | LEVAMISOLE | 75MG/ML | HEBEI YUANZHENG PHARMACEUTICALS COMPANYNO.16 LIUYUAN ROAD CHANG’AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2012 |
| NDA/MAL/VDP/5681 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | LEVAMISOLE | LEVAMISOLE | 100MG/ML | HEBEI YUANZHENG PHARMACEUTICALS COMPANYNO.16 LIUYUAN ROAD CHANG’AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2012 |
| NDA/MAL/VDP/5682 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | DIMINACIN | DIMINAZENE ACETERATE | 7%W/V | INTRACIN PHARMACEUTICAL PVT. LTDC-1 B/53, G.I.D.C ESTATE, NADIAD-387001 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/5688 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | LIMOXIN-200 LA | OXYTETRACYCLINE | 200MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5690 | VET CENTRE LTD | VET CENTRE UGANDA LIMITED | MACROLAN-200 | TYLOSIN | 200MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5692 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | MACROLAN WS | TYLOSIN TARTRATE | 1000MG | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 01/07/2015 |
| NDA/MAL/VDP/5695 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | DIMINAZENE DIACETURATE | DIMINAZENE DIACETURATE | 2.36G/ SACHET, 23.6G/ SACHET | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | OTHER SYSTEMIC POWDER | 10.0X2.36 G SACHET | 01/07/2014 |
| NDA/MAL/VDP/5696 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | MILBITRAZ | AMITRAZ | 12.5% W/V | BAYER (PTY) LTD5TH AVENUE, VOSTERSKROON, EXT. 3 | SOUTH AFRICA | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN | 01/07/1998 |
| NDA/MAL/VDP/5702 | COSMOS LTD | ERAM UGANDA LIMITED | DISEPTOPRIM BOLUS | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X10.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/VDP/5703 | ALFASAN INTERNATIONAL BV | NILE SERVICES LTD | ALFAPOR | ALPHACYPERMETHRIN | 5%W/V | CHIMAC S.ARUE DE RENORY, 26/2,B-4102 OUGREE BELGIUM | BELGIUM | | TOPICAL EXTERNAL EMULSIONS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2002 |
| NDA/MAL/VDP/5705 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | PIPERIN WS | PIPERAZINE CITRATE | 1000MG | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X30.0 G SACHET | 01/07/2015 |
| NDA/MAL/VDP/5706 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | DOXIN 200 WS | DOXYCYCLINE HYCLATE+TYLOSIN TARTRATE | 100MG+100MG | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, ? HOLLAND | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER,1.0X30.0 G SACHET | 01/07/2015 |
| NDA/MAL/VDP/5719 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | TYLOVAP | TYLOSIN | 200MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE, 1.0X50.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/5722 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCODIMIDINE | SULPHADIMIDINE | 33%W/V | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5723 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | DUOFAST INTRAMAMMARY SUSPENSION | TRIMETHOPRIM + SULFADIAZINE | 40MG+200MG IN 8G SYRINGE | NORBROOK LABERATORIES LTD STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOM | IRELAND | | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X8.0 G SYRINGE | 01/07/2004 |
| NDA/MAL/VDP/5726 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | DUOTECH DRENCH | OXFENDAZOLE+CLOSANTEL | 25MG/ML + 50MG/ML | NORBROOK LABERATORIES LTD OLD LIMURU RD NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5000.0 ML CONTAINER,1.0X60.0 ML CONTAINER | 01/07/2005 |
| NDA/MAL/VDP/5727 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOZIN | AMITRAZ | 125MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5730 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAZURIL | TOLTRAZURIL | 2.5%W/V | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDAN | JORDAN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN | 01/07/2013 |
| NDA/MAL/VDP/5731 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VERMECTIN | IVERMECTIN | 1%W/V | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) AL-HALABAT STREET NO. 5 DHELEIL ZARKA GOVERNERATE, JORDAN | JORDAN | | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2011 |
| NDA/MAL/VDP/5732 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VERMECTIN-PLUS | IVERMECTIN+CLORSULON | 10MG/ML+100MG/ML | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDAN | JORDAN | | PARENTERAL ORDINARY OTHER VIALS | 1.0X1.0X100.0 ML VIAL,1.0X1.0X50.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5734 | VAPCO | GOODMAN INTERNATIONAL LTD | ENROSOL-S | ENROFLOXACIN | 10%W/V | VAPCODHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X500.0 ML JAR | 01/07/2005 |
| NDA/MAL/VDP/5738 | VAPCO | GOODMAN INTERNATIONAL LTD | ERYTHROMYCIN THIOCYANATE | ERYTHROMYCIN THIOCYANATE | 20%W/W | VAPCODHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 01/07/2009 |
| NDA/MAL/VDP/5741 | INTERVET SA (PTY) LTD | ERAM UGANDA LIMITED | ESTRUMATE | CLOPROSTENOL SODIUM | 0.263MG/ML | VET PHARMA FRIESOYTHE GMBH ,.SEDELSBERGER STRABE 2, 26169, FRIESOYTHE | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/5742 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | PENSTREP-400 | DIHYDROSTREPTOMYCIN + PENICILLIN | 200MG+200MG | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/1999 |
| NDA/MAL/VDP/5748 | LAPROVET | EVERVICTORY LIMITED | ETHIDIUM | HOMIDIUM BROMIDE | 250MG | CEVA SANTE ANIMALEZI TRES LE BOIS - BP 372-22603 LOUDEAC CEDEX | FRANCE | | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X20.0 TABLET BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5750 | NILE SERVICES LTD | NILE SERVICES LTD | PENSTAR | PENICILLIN G PROCAINE + DIHYDROSTREPTOMYCIN SULPHATE | 200,000IU/ML + 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5753 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | PEN & STREP | DIHYDROSTREPTOMYCIN SULPHATE + PENICILLIN G MONOHYDRATE | 250MG + 250MG | NORBROOK LABARATORIES LIMITEDSTAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UK | UNITED KINGDOM | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/5754 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | ALISERYL WS | ERYTHROMYCIN + OXYTETRACYCLINE +STREPTOMYCIN + COLISTIN + VITAMINS (A + D3 + B1 + B2 + B6 + B12 + C) + CALCIUM + VIT K3 + NICOTINAMIDE + INOSITOL | 35MG +50MG + 35MG + 200 0001U + 3000 IU + 1500 IU + 2MG + 2MG + 4MG + 2MG + 10MCG + 20MG + 10MG + 2MG + 20MG +1MG | INTERCHEMIE WERKEN “DE ADELAAR” B.V - METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X30.0 G SACHET,1.0X1.0 KG JAR | 01/07/2015 |
| NDA/MAL/VDP/5756 | INTRACIN PHARMACEUTICAL PVT LTD? | VEERAM HEALTHCARE (U) LIMITED | PAVEX | PARVAQUONE | 150MG/ML | INTRACIN PHARMACEUTICALS PVT LTDC-1, B-53, GIDC ESTATE NADAID-387 001(GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL | 01/07/2015 |
| NDA/MAL/VDP/5757 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | EVACIDE PLUS | OXYCLOZANIDE + LEVAMISOLE HYDROCHLORIDE | 60MG + 30MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/5776 | VAPCO | GOODMAN INTERNATIONAL LTD | OXYVITAMIN | OXYTETRACYCLINE HCL+VIT A+VIT D3+VIT E+VIT C+FERROUS SO4+MAGNESIUM SO4+ZINC SO4+COPPER SO4+COBALT CH | 250G+2,500,000IU+500,000IU+1,000IU+10,000MG+500MG+400MG+150MG+40MG+10MG / 1000G | VAPCODHULIEL ARA, KING HUSSEIN STREET HALLOBAT | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G SACHET | 01/07/2007 |
| NDA/MAL/VDP/5777 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | FLUCONIX 340 | NITROXINIL | 340MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/5778 | VMD NV | ERAM UGANDA LIMITED | OXYVETO 50 S POWDER | OXYTETRACYCLINE HCL | 500MG/G | VMD NV-HOGE MAUW 900-B2370, ARENDOK | | BELGIUM | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G SACHET | 01/07/2000 |
| NDA/MAL/VDP/5779 | MEDISEL(K) LTD | SUPER MEDIC LTD | AMIDIOSTAT-PLUS | AMPROLIUM HCL +SULFAQUINOXALINE SODIUM + VITAMIN K3 + VITAMIN A | 200MG +150MG +5MG + 15000 IU/ G | MEDISEL KENYA LTD - LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X30.0 G SACHET | 09/01/2015 |
| NDA/MAL/VDP/5784 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZ-PENSTREPTO 20/25 SUSPENSION | PENICILLIN G/DIHYDROSTREPTOMYCIN | 200MG/ML+250MG/ML | HEBEI YUANZHENG PHARMACEUTICALS COMPANYNO.16 LIUYUAN ROAD CHANG’AN DISTRICT SHIJIAZHUANG CITY-050041, HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/VDP/5787 | ALFASAN INTERNATIONAL BV | NILE SERVICES LTD | AMITIX | AMITRAZ | 12.5%W/V | CHIMAC S.ARUE DE RENORY, 26/2,B-4102 OUGREE BELGIUM | BELGIUM | | TOPICAL EXTERNAL EMULSIONS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2001 |
| NDA/MAL/VDP/5789 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | OXYTOCIN-10 | OXYTOCIN | 10 IU/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/5791 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | AMPROCOX WS | AMPROLIUM HYDROCHLORIDE + SULFAQUINOXALINE + VITAMIN A + VITAMIN K3 | 200MG +150MG +15 000 IU + 5MG | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G SACHET | 01/07/2015 |
| NDA/MAL/VDP/5793 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 30% | OXYTETRACYCLINE HCL | 30%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2009 |
| NDA/MAL/VDP/5795 | VAPCO | GOODMAN INTERNATIONAL LTD | OXYTETRACYCLINE | OXYTETRACYCLINE | 25%W/W | VAPCO -DHULIEIL PROVINCE, KING HUSSEIN STREET NO. IT 1 IZARKA, JORDAN | JORDAN | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 01/07/2009 |
| NDA/MAL/VDP/5796 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 20% | OXYTETRACYCLINE DIHYDRATE | 20%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/2009 |
| NDA/MAL/VDP/5797 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 12.5% | OXYTETRACYCLINE HCL | 12.5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2009 |
| NDA/MAL/VDP/5800 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | YZOXYTETRA 10% | OXYTETRACYCLINE HCL | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 01/07/2009 |
| NDA/MAL/VDP/5811 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | AMPROLIN-300 WS | AMPROLIUM | 30%W/W | INTERCHEMIE WERKEN “DE ADELAAR” B.V - METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1.0 KG JAR | 01/07/2004 |
| NDA/MAL/VDP/5813 | VMD NV | ERAM UGANDA LIMITED | AMPROLIUM-20S | AMPROLIUM HYDROCHLORIDE | 200MG/G | VMD NV-HOGE MAUW 900-B2370, ARENDOK | | BELGIUM | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 01/07/2000 |
| NDA/MAL/VDP/5815 | LABORATORIES HIPRA SA | ERAM UGANDA LIMITED | GENTAMOX | AMOXYCILLIN + GENTAMICIN | 150 MG + 40 MG | LABORATORIES HIPRA SAAVDA LASELVA 135-17170, AME | SPAIN | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5818 | NILE SERVICES LTD | NILE SERVICES LTD | OXYSTAR 10% | OXYTETRACYCLINE | 100MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5820 | NILE SERVICES LTD | NILE SERVICES LTD | OXYSTAR 20% | OXYTETRACYCLINE | 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5826 | VMD NV | ERAM UGANDA LIMITED | GENTAVETO -5 | GENTAMYCIN SULPHATE | 50MG/ML | VMD NV-HOGE MAUW 900-B2370, ARENDOK | | BELGIUM | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/VDP/5827 | LAPROVET S.A.S | EVERVICTORY LIMITED | ANTICOX | SULFADIMIDINE SODIUM + DIAVERIDINE | 80%W/W + 8%W/W | BIOVE LABORATORY3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCE | FRANCE | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X30.0 G SACHET,1.0X10.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 01/07/2013 |
| NDA/MAL/VDP/5830 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | GLUCORTIN 20 | DEXAMETHASONE | 2MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/5831 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASAMPRO | AMPROLIUM | 20%W/W | ASHISH LIFE SCIENCE PVT. LTDJ-137, MIDC,TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 01/07/2011 |
| NDA/MAL/VDP/5832 | COSMOS LTD | ERAM UGANDA LIMITED | ASCAREX WORM POWDER | PIPERAZINE CITRATE | 360MG/G | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X30.0 G SACHET | 01/07/1997 |
| NDA/MAL/VDP/5833 | COSMOS LTD | ERAM UGANDA LIMITED | ASCATEN-P | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 10.0X6.0 TABLET BLISTER | 01/07/2001 |
| NDA/MAL/VDP/5834 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | ASCAZINE | PIPERAZINE CITRATE | 360MG/G | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDAN | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1000.0 G SACHET,1.0X100.0 G SACHET | 01/07/2007 |
| NDA/MAL/VDP/5835 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIALBEN 2500 | ALBENDAZOLE | 2500MG | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 TABLET BLISTER | 01/07/2011 |
| NDA/MAL/VDP/5837 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | GRENADE EC | CYHALOTRIN | 5%W/V | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 01/07/1997 |
| NDA/MAL/VDP/5846 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHIENRO 10% | ENROFLOXACIN | 100MG/ML | ASHISH LIFE SCIENCE PVT. LTDJ-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/VDP/5849 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NOROMECTIN INJECTION | IVERMECTIN | 1%W/V | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL,1.0X20.0 ML VIAL | 01/07/2000 |
| NDA/MAL/VDP/5851 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NOROTRAZ | AMITRAZ | 12.5%W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X1.0 L JERRYCAN | 01/07/1997 |
| NDA/MAL/VDP/5861 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | HI-TET | OXYTETRACYCLINE DIHYDRATE | 120MG/ML | PHARMA-Q (PTY) LTD 50 COMMANDO ROAD, INDUSTRIA WES | SOUTH AFRICA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5863 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NORODINE 24 | SULFADIAZINE + TRIMETHOPRIM | 200MG + 40MG | NORBROOK LABARATORIES LIMITEDSTAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UK | UNITED KINGDOM | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/5865 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHPIRAZINE | PIPERAZINE CITRATE | 1000MG/G | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 01/07/2015 |
| NDA/MAL/VDP/5869 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NOROCILLIN LA | BENZATHINE+PROCAINE PENICILLIN | 159MG+112MG/ML | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2003 |
| NDA/MAL/VDP/5871 | INTERVET SA (PTY) LTD | ERAM UGANDA LIMITED | IMIZOL | IMIDOCARB | 12%W/V | VET PHARMA FRIESOYTHE GMBHGERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X40.0 ML VIAL,1.0X10.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/5873 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | NORBROOK MILKING SALVE | DICHLOREPHEN/LANOLIN | 0.55%W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X250.0 G CONTAINER,1.0X100.0 G CONTAINER,1.0X500.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X2.0 KG CONTAINER | 01/07/1998 |
| NDA/MAL/VDP/5874 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHTYL | TYLOSIN | 20%W/W | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1.0 KG CONTAINER,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 01/07/2013 |
| NDA/MAL/VDP/5877 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | NITRODOX | NITROXYNIL ETHYL GLUCAMINE | 34%W/V | CHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDBANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY S C VIALS | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5878 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | NILZASH S FORTE | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE | 30MG/ML+60MG/ML | ASHISH LIFE SCIENCE PVT. LTDJ-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/VDP/5879 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASHULPHA 5 | SULPHADIMIDINE | 5G | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 BOLUS BLISTER | 01/07/2014 |
| NDA/MAL/VDP/5880 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | NILZAN BOLUS | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE | 1G + 1.4G | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X20.0X1.0 TABLET STRIP | 01/07/1997 |
| NDA/MAL/VDP/5881 | ASHISH LIFE SCIENCE PVT. LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | ASTRISUL 480 | SULPHADIAZINE+TRIMETHOPRIM | 400MG+80MG | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET | 01/07/2013 |
| NDA/MAL/VDP/5882 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | NILZAN PLUS | LEVAMISOLE HYDROCHLORIDE+ OXYCLOZANIDE | 15MG+30MG | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X150.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5884 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | MULTIVITAMIN INJECTION | VIT A + VIT B2 +VIT B6 + VIT B12 +VIT D3 | 15,000 IU + 10MG +3MG +60 MCG + 7500 IU | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X250.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5885 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTERTRIM | SULFAMETHOXAZOLE + TRIMETHOPRIM | 200MG + 40MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5886 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | AVISAN SECURE | INACTIVATED SALMONELLA ENTERITIDIS PT-4 FAGOTYPE MAT + INACTIVATED SALMONELLA TYPHIMURIUM, DT-4 FAGOTYPE MAT | INACTIVATED SALMONELLA ENTERITIDIS ? 1/13 + INACTIVATED SALMONELLA TYPHIMURIUM ? 1/40 | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL | 01/07/2015 |
| NDA/MAL/VDP/5887 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | MULTIVITAMIN INJECTION | VITAMIN A + B1 + B2 +B6 +B12 + D3 + E + DEXPANTHENOL + FOLIC | 15,000 IU + 10MG + 5MG +3MG + 25MCG + 1000IU +20MG + 25MG | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/5889 | NILE SERVICES LTD | NILE SERVICES LTD | BACLEAN | SULFAMONOMETHOXINE SODIUM + TRIMETHOPRIM | 50MG +10MG /ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 01/07/2015 |
| NDA/MAL/VDP/5891 | ASHISH LIFE SCIENCE PVT LTD | ASHISH LIFE SCIENCE UGANDA LIMITED | MURTRYP | DIMINAZENE DIACETURATE + PHENAZONE | 1.05G + 1.31G /2.36G | ASHISH LIFE SCIENCE PVT. LTD.AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA | INDIA | | NON-HUMAN USE POWDERS | 1.0X10.0X2.36 G SACHET,1.0X23.6 G SACHET | 01/07/2013 |
| NDA/MAL/VDP/5895 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | BAYTICOL2% | FLUMETHRIN | 2 % W/V | BAYER (PTY) LTD5TH AVENUE, VOSTERSKROON, EXT. 3 | SOUTH AFRICA | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2001 |
| NDA/MAL/VDP/5896 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | INTRADINE POULTRY | SULPHADIMIDINE SODIUM | 33.3%W/V | NORBROOK LABERATORIES LTD OLD LIMURU RD NAIROBI | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/1998 |
| NDA/MAL/VDP/5899 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | BAYTICOL POUR-ON | FLUMETHRIN | 1 % W/V | BAYER (PTY) LTD5TH AVENUE, VOSTERSKROON, EXT. 3 | SOUTH AFRICA | | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5900 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | OPTICLOX EYE OINTMENT | CLOXACILLIN BENZATHINE | 835MG/5G | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | | NON-HUMAN USE PASTES | 1.0X5.0 G PRE- FILLED SYRINGE | 01/07/1997 |
| NDA/MAL/VDP/5904 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | INTROVIT A+ WS | VITAMINS A + D3 + E + B1 + B2 + B6 + B12 +C) + CA + VIT K3 + NICOTINAMIDE + FOLATE + BIOTIN + CL + FESO4 +MNSO4 + ZNSO4 + NACL | 20000 IU + 6000 IU + 60MG + 6MG +12MG +8MG +60 MCG + 20MG + 20MG +4MG + 80MG +2MG + 300MCG + 5MG + 12MG + 12MG +12MG + 12MG + 100MG | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, ? HOLLAND | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 SACHET CARTON | 01/07/2015 |
| NDA/MAL/VDP/5912 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | BETAMOX LA | AMOXYCILLIN TRIHYDRATE | 150MG/ML | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2007 |
| NDA/MAL/VDP/5913 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | BILOSIN | TYLOSIN TARTRATE | 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTDBANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING| HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/5916 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | BIMECTIN DS | IVERMECTIN | 2%W/W | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTDBANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | CHINA | | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/VDP/5918 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | BIMECTIN PLUS | IVERMECTIN+CLORSULON | 10MG/ML+100MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTDBANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | CHINA | | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/5920 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | BIOGENTA | AMOXYCILLIN TRIHYDRATE + GENTAMYCIN SULPHATE | 150MG + 40MG/ ML | INTERCHEMIE WERKEN DE ADELAAR EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAA | ESTONIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5931 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | TRYPASHISH | ISOMETAMIDIUM HYDROCHLORIDE | 1G/SACHET | ASHISH LIFE SCIENCE PVT. LIMITED. J-137, MIDC, TARAPUR, BOISAR, THANE, INDIA | INDIA | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X1.0 G SACHET,1.0X10.0X125.0 MG SACHET | 01/07/2013 |
| NDA/MAL/VDP/5932 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | MULTIJECT IMM | NEOMYCIN SULPHATE + PREDNISOLONE PROCAINE PENICILLIN G MONOHYDRATE | 20MG + 2MG | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X5.0 G PRE- FILLED SYRINGE | 01/07/1997 |
| NDA/MAL/VDP/5938 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | LEVA 200 | LEVAMISOLE HYDROCHLORIDE | 200MG | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, ? HOLLAND | NETHERLANDS | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G CONTAINER | 01/07/2015 |
| NDA/MAL/VDP/5941 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | LEVACIDE INJECTION | LEVAMISOLE HYDROCHLORIDE | 75MG/ML | NORBROOK LABERATORIES LTD STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOM | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5942 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | NEMOVIT WS (EGG FORMULA) | OXYTETRACYCLINE + NEOMYCIN + VITAMINS( A + D3 + E + B1 + B2 + B6 + B12 +C) + CALCIUM + VIT K3 + NICOTINAMIDE + FOLATE + METHIONINE + LYSINE | 60MG + 40MG + 7500 I.U + 1500I.U + 5MG + 1MG + 2MG + 7.5MCG + 25MG + 7.5MG + 5MG + 15MG + 30MG +0.3MG +30MG +50MG | INTERCHEMIE WERKENS DE ADELAAR B.VMETAALWEG 8, 5804 VENARY, NETHERLANDS | NETHERLANDS | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X1000.0 G JAR | 01/07/2015 |
| NDA/MAL/VDP/5950 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | BRONIPRA 1 | ATTENUATED LIVE INFECTIOUS BRONCHITIS VIRUS , STRAIN H120 | ?10³ EID??/DOSE (0.03ML) | LABORATORIOS HIPRA, S.AAVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN | SPAIN | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X5000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/5953 | SEQUENT SCIENTIFIC LTD | ERAM UGANDA LIMITED | SEQUZENE | DIMINAZENE DIACETURATE / PHENAZONE | 1.05G + 1.31G PER 2.36G | ALIVIRA ANIMAL HEALTH LIMITED A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIA | INDIA | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET | 01/07/2011 |
| NDA/MAL/VDP/5959 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | BOVACLOX DC | AMPICILLIN + CLOXACILLIN | 250 MG + 500 MG | NORBROOK LABARATORIES LIMITEDSTAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UK | IRELAND | | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X4.5 G PRE- FILLED SYRINGE | 01/07/1997 |
| NDA/MAL/VDP/5960 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | BOVITRAZ | AMITRAZ | 12.5 % W/V | BAYER (PTY) LTD5TH AVENUE, VOSTERSKROON, EXT. 3 | SOUTH AFRICA | | TOPICAL EXTERNAL EMULSIONS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1998 |
| NDA/MAL/VDP/5961 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | BUPACIN | BUPARVAQUONE | 50MG/ML | INTRACIN PHARMACEUTICAL PVT LTD C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIA | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5962 | INTERVET SA (PTY) LTD | ERAM UGANDA LIMITED | TAKTIC | AMITRAZ | 125G/L | CKL AFRICA LTD - MASHIARA PARK, KAPTAGAT ROAD, LORESHO P.O. BOX 40596 00100 NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X20.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X40.0 ML BOTTLE,1.0X500.0 ML JAR | 01/07/1997 |
| NDA/MAL/VDP/5963 | DAWA LIMITED | SUPER MEDIC LTD | BUPALEX | BUPARVAQUONE | 50MG/ML | HEBEI YUANZHENG PHARMACEUTICALS CO LTDWUQI INTERSECTION SHIZHENG ROAD SHIJIAZHUANG PROVINCE,CHINA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML VIAL | 07/01/2013 |
| NDA/MAL/VDP/5967 | NORBROOK KENYA LTD | NORBROOK (U) LTD | BUPANOR INJECTION | BUPARVAQUONE | 50MG/ML | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | UNITED KINGDOM | | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL,1.0X50.0 ML BOTTLE | 01/07/2014 |
| NDA/MAL/VDP/5970 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | BUTACHEM-50 | BUPARVAQUONE | 50MG/ML | INTERCHEMIE WERKEN DE ADELLAR EESTI ASVANAPERE TEE 14, PUUNSI VILLAGE, 74013, VIIMSI, HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 2.0X50.0 ML VIAL,1.0X20.0 ML VIAL (STERILE PRODUCT) | 01/07/2011 |
| NDA/MAL/VDP/5973 | INTERVET SA (PTY) LTD | ERAM UGANDA LIMITED | BUTALEX | BUPARVAQUONE | 5%W/V | VET PHARMAFRIESOYTHE SEDELSBERGE 26169,GERMANY | GERMANY | | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML VIAL,1.0X20.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/5974 | ZOETIS BELGIUM SA | ERAM UGANDA LIMITED | SUPONA EXTRA | CHLORPHENVINPHOS | 1000G | ZOETIS MANUFACTURING ITALIA S.R.LVIA F. GORGONE, SNC., 95121, CATANIA | ITALY | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5977 | NILE SERVICES LTD | NILE SERVICES LTD | BUTARSTAR | BUPARVAQUONE | 50 MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X30.0 ML VIAL,1.0X20.0 ML VIAL | 01/07/2013 |
| NDA/MAL/VDP/5982 | ZOETIS BELGIUM SA | ERAM UGANDA LIMITED | PROTAID | CHLORFENVINPHOS+ALPHACYPERMETHRIN | 30%W/V+3%W/V | ZOETIS MANUFACTURING ITALIA S.R.L.,VIA FRANCO GORGONE S.N.C., 95121 CATANIA, ITALY | ITALY | | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2004 |
| NDA/MAL/VDP/5983 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | CALCIJECT | BORIC ACID+CALCIUM GLUBIONATE | 6.84G+33.3G | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X400.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5986 | COSMOS LTD | ERAM UGANDA LIMITED | S-DIME 16% SOLUTION | SULPHADIMIDINE | 16%W/V | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5987 | COSMOS LTD | ERAM UGANDA LIMITED | S-DIME 5G BOLUS | SULPHADIMIDINE | 5G | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 BOLUS BLISTER,1.0X10.0 BOLUS BLISTER | 01/07/1997 |
| NDA/MAL/VDP/5988 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | CALCIJECT LV | CALCIUM GLUCONATE+BORIC ACID | 388.5MG/ML+73.4MG/ML | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/VDP/5994 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | CEFTIONEL 50 | CEFTIOFUR | 50MG/ML | INTERCHEMIE WERKEN DE ADELAAR EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAA | ESTONIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/5998 | VAPCO | GOODMAN INTERNATIONAL LTD | CHOLIVIT-AM | MULTI-INGREDIENT | N/A | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G CONTAINER,1.0X5.0 KG CONTAINER | 01/07/2008 |
| NDA/MAL/VDP/6003 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | CLOSAMECTIN | IVERMECTIN+CLOSANTEL | 5MG/ML+125MG/ML | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY S C VIALS | 1.0X20.0 ML VIAL,1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2004 |
| NDA/MAL/VDP/6008 | COSMOS LTD | ERAM UGANDA LIMITED | COCCID GRANULES | AMPROLIUM HYDROCHLORIDE | 20%W/W | MEDISEL (K) LTDPLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | COSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | | ORAL SOLID ORDINARY GRANULES | 10.0X30.0 G SACHET | 01/07/1997 |
| NDA/MAL/VDP/6010 | VMD NV HOGE MAUW | ERAM UGANDA LIMITED | COLIVETO-4800 | COLISTINE SULPHATE | 4.8 MILLION I.U/G | VMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONK | | BELGIUM | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G CONTAINER,1.0X1.0 KG JAR | 01/07/2005 |
| NDA/MAL/VDP/6011 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | COLVASONE INJECTION | DEXAMETHASONE SODIUM PHOSPHATE | 0.2%W/V | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 01/07/2000 |
| NDA/MAL/VDP/6014 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | CKL MILKING SALVE | DICLOROPHEN/LANOLIN | 0.55 % W/W / 2.00%W/W | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | TOPICAL EXTERNAL CREAMS | 1.0X100.0 G CONTAINER,1.0X250.0 G CONTAINER,1.0X400.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X2.0 KG CONTAINER,1.0X50.0 G CONTAINER | 01/07/2005 |
| NDA/MAL/VDP/6018 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | ALAMYCIN 10 | OXYTETRACYCLINE HYDROCHLORIDE | 10%W/V | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/6022 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | ALAMYCIN LA 20 | OXYTETRACYCLINE HYDROCHLORIDE | 20%W/V | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/6023 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | ALAMYCIN LA 300 | OXYTETRACYCLINE HYDROCHLORIDE | 30%W/V | NORBROOK LABORATORIES LTDSTATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UK | IRELAND | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/6026 | ELANCO ANIMAL HEALTH (PTY) LTD | KWEWAYO (U) VET PHARMACY LIMITED | CURAMYCIN | OXYTETRACYCLINE DIHYDRATE | 123MG/ML | PHARMA-Q (PTY) LTD 50 COMMANDO ROAD, INDUSTRIA WES | SOUTH AFRICA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X500.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/6028 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | CYPERMETHRIN-10 EC | CYPERMETHRIN | 10%W/V | VAPCO.DHULIEIL ARA, KING HUSSEIN STREET 120/ZARKA HALLOBAT | JORDAN | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/VDP/6029 | MEDISEL(K) LTD | SUPER MEDIC LTD | DABENDAZOLE 10% | ALBENDAZOLE | 10%W/V | MEDISEL KENYA LTD - LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | DAWA LTDBABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X40.0 ML BOTTLE, 1.0X1000.0 ML BOTTLE, 1.0X500.0 ML BOTTLE, 1.0X120.0 ML BOTTLE, 1.0X5.0 L JERRYCAN | 08/01/2010 |
| NDA/MAL/VDP/6083 | INTERCHEMIE WERKEM DE ADELAAR B.V | VET CENTRE UGANDA LIMITED | LIMOXIN-400 WS | OXYTETRACYCLINE HYDROCHLORIDE | 400MG/G | INTERCHEMIE WERKEN “DE ADELAAR” B.V - METAALWEG 8,5804 CG,VENRAY,HOLLAND | NETHERLANDS | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 01/07/2016 |
| NDA/MAL/VDP/6084 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | VAPCOTRIM BOLUS | TRIMETHOPRIM + SULFADIAZINE | 200MG + 1000MG | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 BOLUS BLISTER | 01/07/2017 |
| NDA/MAL/VDP/6087 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | TECTIN | IVERMECTIN | 1%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/6255 | CKL AFRICA LIMITED | CKL UGANDA LIMITED | NEFLUK | ALBENDAZOLE | 10%W/V | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2016 |
| NDA/MAL/VDP/6258 | HEBEI YUANZHENG PHARMACEUTICAL CO., LTD | ERAM UGANDA LIMITED | OXYTET-10% | OXYTETRACYCLINE HYDROCHLORIDE | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/6260 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | ERAM UGANDA LIMITED | OXYTET-30% | OXYTETRACYCLINE HYDROCHLORIDE | 30%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/6262 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | INTROMIDIUM | ISOMETAMIDIUM HYDROCHLORIDE | 1G/SACHET | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, ? HOLLAND | NETHERLANDS | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X1.0 G SACHET,1.0X125.0 MG SACHET | 01/07/2016 |
| NDA/MAL/VDP/6265 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | INTERZAN GOLD ORAL | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE | 30MG+60MG/ML | INTERCHEMIE WERKEN "DE ADEKAAR" BVMETAALWEG 85804 CG VENRY | NETHERLANDS | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/VDP/6266 | VET CENTRE UGANDA LIMITED | VET CENTRE UGANDA LIMITED | COLEXIL ORAL | COLISTIN/ENROFLOXACIN | 1200000IU+100MG/ML | INTERCHIEME WENKEN "DE ADELAAR" B.V.HORSTERWEG 26A 5811 AC CASTENERY HOLLAND | NETHERLANDS | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML CONTAINER | 01/07/2016 |
| NDA/MAL/VDP/6822 | CEVA SANTE ANIMALE | VERI BRANDS U LTD | PRID DELTA | PROGESTERONE | 1.55G | CEVA SANTE ANIMALE .ZI TRES LE BIOS 22600 LOUDEAC | FRANCE | | VAGINAL INTRA UTERINE DEVICES | 1.0X10.0 DEVICE CARTON,1.0X100.0 DEVICE SACHET | 01/07/2016 |
| NDA/MAL/VDP/6827 | NORBROOK LABORATORIES LTD | NORBROOK (U) LTD | HEXASOLLA | OXYTETRACYCLINE+FLUNIXIN | 300MG+20MG | NORBROOK LABERATORIES LTD STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOM | UNITED KINGDOM | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2003 |
| NDA/MAL/VDP/6849 | BIMEDA UGANDA LIMITED | BIMEDA UGANDA LIMITED | TETROXY 12.5% | OXYTETRACYCLINE | 125MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHONGQING FANGTONG ANIMALBANGQIAO INDUSTRIAL PARK | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/6889 | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD | ERAM UGANDA LIMITED | OXYTET- 12.5% | OXYTETRACYCLINE HYDROCHLORIDE | 12.5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/6892 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | BUTEX | BUPARVAQUONE | 5%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML VIAL | 01/07/2010 |
| NDA/MAL/VDP/6893 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | OXYTETRAVET 20% | OXYTETRACYCLINE | 20%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE €“IRBID | JORDAN | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2010 |
| NDA/MAL/VDP/6894 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO. | GLOBAL VET (U) LIMITED | PRIMOVET | SULPHADIAZINE + TRIMETHOPRIM | 400MG + 80MG | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 01/07/2010 |
| NDA/MAL/VDP/6899 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO. | GLOBAL VET (U) LIMITED | OXYTETRAVET 30% | OXYTETRACYCLINE | 30%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE €“IRBID | JORDAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/VDP/6900 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO. | GLOBAL VET (U) LIMITED | DEXAROIDE | DEXAMETHASONE SODIUM PHOSPHATE | 4MG/ML | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE | 01/07/2016 |
| NDA/MAL/VDP/6908 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO. | GLOBAL VET (U) LIMITED | TECTIN SUPER | IVERMECTIN + CLORSULON | 10MG + 100MG/ ML | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/7032 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | BUPARVANOR | BUPARVAQUONE | 5 % W/V | HEBEI HOPE HARMONY PHARMACEUTICAL CO. LTD-INDUSTRIAL AREA, YUANSHI TOWN, SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA |HEBEI KEXING PHARMACEUTICALS CO. LTD - NO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI CHINA | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/VDP/7034 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | IVANOR | IVERMECTIN | 1% W/V | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL + 10ML VIAL AND 5ML SYRINGE,1.0X50.0 ML VIAL + 5ML VIAL AND 5ML SYRINGE,1.0X250.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/VDP/7036 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | DIMINOR PLUS | DIMINAZENE DIACETURATE + ANTIPYRINE + VITAMIN B12 | 10.5G + 13.1G + 10MG / SACHET OF 23.6G, 1.05G + 1.31G + 1MG / SACHET OF 2.36G | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET | 27/11/2018 |
| NDA/MAL/VDP/7038 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | VBNOR | VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + NICOTINAMIDE + D-PANTHENOL | 25MG + 2MG + 2.5MG + 50MG + 5MG /10ML | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | PARENTERAL ORDINARY I M VIALS | 1.0X1.0X100.0 ML VIAL,1.0X50.0X10.0 ML VIAL | 27/11/2018 |
| NDA/MAL/VDP/7040 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | DIMINAL | DIMINAZINE DIACETURATE + PHENAZONE | 445MG + 555MG / 1G | EAGLE VET TECH. CO. LTD235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | SOUTH KOREA | | OTHER SYSTEMIC POWDER | 1.0X2.36 G SACHET | 27/03/2019 |
| NDA/MAL/VDP/7043 | ASIATIC AGRICULTURAL INDUSTRIES PTE LTD | NANDINI PHARMACEUTICALS LIMITED | AWARD | CYPERMETHRIN | 10%W/V | ASIATIC AGRICULTURAL IND. PTE LTD 150 GUL CIRCLE SINGAPOLE 629607 | SINGAPORE | | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 29/01/2019 |
| NDA/MAL/VDP/7045 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-DOXYTYLOSIN | TYLOSIN + DOXYCYCLINE | 200MG + 200MG | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 29/11/2017 |
| NDA/MAL/VDP/7048 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-ALBEN 1500 | ALBENDAZOLE | 1500MG | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/VDP/7049 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-ALBEN 2500 | ALBENDAZOLE | 2500MG | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 TABLET BLISTER | 27/03/2019 |
| NDA/MAL/VDP/7062 | ALIVIRA ANIMAL HEALTH LTD | ERAM UGANDA LIMITED | SELVO ORAL | LEVOFLOXACIN | 10%W/V | ALIVIRA ANIMAL HEALTH LTDA-68, MIDC INDUSTRIAL AREA, ADDITIONAL AMBERNATH; THANE, MAHARASHTRA-INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 28/05/2019 |
| NDA/MAL/VDP/7176 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD(VAPCO) | GOODMAN INTERNATIONAL LTD | ERYXIN | ERYTHROMYCIN THIOCYNATE + BROMHEXINE HYDROCHLORIDE | 350MG + 10MG/G | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G SACHET | 29/01/2019 |
| NDA/MAL/VDP/7262 | INTRACIN PHARMACEUTICALS PVT LTD | VEERAM HEALTHCARE (U) LIMITED | BUPACIN PLUS | BUPARVAQUONE + FUROSEMIDE | 50MG + 55MG / ML | INTRACIN PHARMACEUTICAL PVT. LTD.C-1B/53, G.I.D.C. ESTATE, NADIAD 387 001, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL, 1.0X1.0X20.0 ML VIAL | 27/11/2018 |
| NDA/MAL/VDP/7265 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | V-MULTINOR | VITAMINS (A+D3 + E+ B12 + C + B1 + B6 +B2 ) + NIACINAMIDE + D-PANTHENOL + D- BIOTIN | 3000 I.U + 2000 I.U + 4MG + 10MCG + 1 MG + 10MG + 5MG + 1MG + 12.5MG + 10MG + 10MCG | HEBEI KEXING PHARMACEUTICALS CO. LTD -NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL + 5ML SYRINGE AS A MEASURING DEVICE,1.0X50.0 ML VIAL + 5ML SYRINGE AS A MEASURING DEVICE,1.0X250.0 ML VIAL + 5ML SYRINGE,1.0X250.0 ML VIAL ( WITH A 10ML SYRINGE),1.0X500.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/7276 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-OXY | OXYTETRACYCLINE HCL | 100MG/ML | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/7279 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-OXYLA | OXYTETRACYCLINE | 200MG/ML | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/VDP/7280 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-OXYLA 30% | OXYTETRACYCLINE | 300MG/ML | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/7281 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-IVERMEC | IVERMECTIN | 10MG/ML | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/7282 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-IVERCLO | IVERMECTIN+ CLORSULON | 10MG/ML + 100MG/ML | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 31/01/2018 |
| NDA/MAL/VDP/7285 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | DEXANOR | DEXAMETHASONE SODIUM PHOSPHATE | 4MG/ML | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/VDP/7399 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | OXYVET-10% | OXYTETRACYCLINE HYDROCHLORIDE | 100MG/ML | EAGLE VET TECH. CO. LTD235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | SOUTH KOREA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7402 | MEDISEL(K) LTD | SUPER MEDIC LTD | DAWAFER INJECTABLE SOLUTION | IRON DEXTRAN | 100G/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL | 07/01/2017 |
| NDA/MAL/VDP/7540 | LABORATOIRES LAPROVET | EVERVICTORY LIMITED | SECURIDIUM | ISOMETAMIDIUM CHLORHYDRATE | 125MG /SACHET | CEVA SANTE ANIMALE ZONE INDUSTRIELLETRES LE BOIS 22600 LOUDEAC | FRANCE | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 1.0X10.0X6.2 G SACHET,1.0X10.0X775.0 MG SACHET | 01/07/2016 |
| NDA/MAL/VDP/7542 | LABORATOIRES LAPROVET | EVERVICTORY LIMITED | SURVIDIM | DIMINAZENE DIACETURATE + VIT B12 + VIT B6 | 10.5G + 10MG + 50MG/ SACHET | CEVA SANTE ANIMALE ZONE INDUSTRIELLETRES LE BOIS 22600 LOUDEAC | FRANCE | | OTHER SYSTEMIC OTHER POWDERS/GRANULES | 2.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET | 01/07/2016 |
| NDA/MAL/VDP/7543 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | AVIAN INFECTIOUS BRONCHITIS VACCINE | LIVE AVIAN INFECTIOUS BRONCHITIS VACCINE (MILD MASS TYPE STRAIN) | ?10³??EID??/DOSE. | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7545 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE , AVIAN INFECTIOUS BRONCHITIS AND AVIAN REOVIRUS VACCINE, INACTIVATED | INFECTIOUS BURSAL DISEASE (STANDARD TYPE 1 STRAIN, VARIANT DELAWARE 1084A STRAIN, & MAY LAND STRAIN); NEWCASTLE DISEASE (LASOTA STRAIN); AVIAN INFECTIOUS BRONCHITIS (MASS &ARK TYPE STRAINS) AND AVIAN REOVIRUS ( 1133 & 1733 STRAINS) | MULTIPLE STRAINS/ DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 01/07/2017 |
| NDA/MAL/VDP/7547 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE AND AVIAN INFECTIOUS BRONCHITIS VACCINE, INACTIVATED. | INFECTIOUS BURSAL DISEASE (STANDARD TYPE 1 STRAIN); NEWCASTLE DISEASE (LASOTA STRAIN) AND AVIAN INFECTIOUS BRONCHITIS (MASS TYPE STRAIN) | INFECTIOUS BURSAL DISEASE VIRUS - ?10??²TCID??/DOSE; NEW CASTLE DISEASE VIRUS - ?10?EID??/DOSE AND AVAIN INFECTIOUS BROCHITIS VIRUS - ?10???EID??/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 01/07/2017 |
| NDA/MAL/VDP/7549 | LAPROVET S.A.S | EVERVICTORY LIMITED | DICLACOX | DICLAZURIL | 1G/100ML | BIOVE LABORATORY3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCE | FRANCE | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L BOTTLE | 01/07/2016 |
| NDA/MAL/VDP/7550 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | EVAMIDIUM | ISOMETAMIDIUM | 1G/ SACHET & 125MG SACHET | HEBEI YUANZHENG PHARM.CO.LTDNO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | | OTHER SYSTEMIC POWDER | 1.0X10.0X1.0 G SACHET,10.0X1.0X125.0 MG SACHET | 01/07/2016 |
| NDA/MAL/VDP/7551 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | FOWL POX VACCINE, LIVE | FOWL POX VACCINE (FOWL POX STRAIN) | ?10² TCID??FP VIRUS/DOSE. | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL,1.0X10.0X500.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7553 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE VACCINE | INFECTIOUS BURSAL DISEASE VACCINE, LIVE (INTERMEDIATE STRAIN) | ?10³ EID??IBD VIRUS/DOSE. | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X10.0X200.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7555 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE VACCINE | INFECTIOUS BURSAL DISEASE VACCINE ,LIVE (INTERMEDIATE INVASIVE STRAIN) | ?10³ EID??IBD VIRUS/DOSE. | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7557 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS BURSAL DISEASE VACCINE INACTIVATED | INFECTIOUS BURSAL DISEASE VACCINE , INACTIVATED (STANDARD TYPE 1 STRAIN) | ?10??²TCID??IBD VIRUS/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 01/07/2016 |
| NDA/MAL/VDP/7558 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | INFECTIOUS CORYZA INACTIVATED VACCINE | INFECTIOUS CORYZA VACCINE, INACTIVATED (HAEMOPHILUS PARAGALLINARUM SEROTYPES A, B & C) | ?10?CFU/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 01/07/2016 |
| NDA/MAL/VDP/7561 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | MAREK'S DISEASE VACCINE | MAREK'S DISEASE VACCINE, LIVE (HVT FC126 STRAIN) | ?10³ PFU/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7570 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | DOXY TYLOVET PLUS | DOXYCYCLINE HYCLATE+TYLOSIN TARTRATE+VITAMIN A ACETATE+ CHOLECALCIFEROL+VITAMIN E +RIBOFLAVIN + CYANOCOBALAMIN + CALCIUM PANTHOTHENATE +NICOTINAMIDE +VITAMIN K3 + ASCORBIC ACID +THIAMINE HYDROCHLORIDE +PYRIDOXINE HYDROCHLORIDE | 200MG +100MG + 750I.U + 300I.U + 3MG + 6MG + 0.015MG + 15MG + 30MG + 3MG + 30MG + 3MG + 3MG | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-BUILDING NO.:150, KING ABDELLAHA II ST.AMMAN-JORDAN | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET | 31/01/2018 |
| NDA/MAL/VDP/7572 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE & AVIAN INFECTIOUS BRONCHITIS VACCINE | NEWCASTLE DISEASE & AVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (B1 & MILD MASS TYPE STRAINS) | NEW CASTLE DISEASE VIRUS - ?10?EID??/DOSE & AVAIN INFECTIOUS BROCHITIS VIRUS - ?10³??EID??/DOSE. | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X200.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7574 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE & AVIAN INFECTIOUS BRONCHITIS VACCINE | NEWCASTLE DISEASE & AVIAN INFECTIOUS BRONCHITIS VACCINE , LIVE (LASOTA + MASS TYPE STRAINS) | NEW CASTLE DISEASE VIRUS - ?10?EID??/DOSE & AVAIN INFECTIOUS BROCHITIS VIRUS - ?10³??EID??/DOSE. | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7576 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE DISEASE VACCINE | NEWCASTLE DISEASE VACCINE , LIVE (LASOTA STRAIN) | ?10?EID??ND VIRUS/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL,1.0X10.0X500.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7577 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE DISEASE VACCINE | NEWCASTLE DISEASE , VACCINE (B1 STRAIN) | ?10?EID??ND VIRUS/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X500.0 DOSE VIAL,1.0X200.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 01/07/2016 |
| NDA/MAL/VDP/7578 | INTRACIN PHARMACEUTICAL PVT LTD? | VEERAM HEALTHCARE (U) LIMITED | CLOTIN FORTE | IVERMECTIN + CLORSULON | 10MG +100MG/ML | INTRACIN PHARMACEUTICAL PVT. LTDC-1 B/53, G.I.D.C ESTATE, NADIAD-387001 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/7579 | HESTER BIOSCIENCES LTD | EVERVICTORY LIMITED | NEWCASTLE DISEASE VACCINE INACTIVATED | NEWCASTLE DISEASE VACCINE, INACTIVATED (LASOTA STRAIN) | ?10???EID??ND VIRUS/DOSE | HESTER BIOSCIENCES LIMITEDMERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE VIAL (500ML) | 01/07/2016 |
| NDA/MAL/VDP/7581 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | NITROXYNIL-34 | NITROXYNIL | 34%W/V | HEBEI YUANZHENG PHARM.CO.LTDNO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | | PARENTERAL ORDINARY S C VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7582 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | ZANIDE SUPER | LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE | 30MG+60MG/ML | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTDAL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITY | JORDAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X5.0 L BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/7584 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | PARVAQUONE -15 | PARVAQUONE | 150MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7665 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | BOVAR | BUPARVAQUONE | 50MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7669 | MEDISEL(K) LTD | SUPER MEDIC LTD | DEXAJET | DEXAMETHASONE SODIUM PHOSPHATE | 2MG/ML | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 07/01/2017 |
| NDA/MAL/VDP/7676 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | IVANOR PLUS | IVERMECTIN + CLOSANTEL SODIUM | 1%W/V + 10%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7679 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | TYLONOR 20 | TYLOSIN TARTRATE | 20%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7680 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | TYLOSIN 20% | TYLOSIN | 20%W/V | HEBEI YUANZHENG PHARM.CO.LTDNO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/7684 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | OCCTAN-D | OXYTETRACYCLINE HYDROCHLORIDE + VIT ( A + D3 +E + K3 +B2 + B6 + B12)+CALCIUM PANTOTHENATE + NIACINAMIDE | 60G +2,250,000 I.U + 450,000IU + 660IU + 880MG + 3000MG + 2000MG +2200µG +4650MG + 14000MG/KG | EAGLE VET TECH. CO. LTD235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | SOUTH KOREA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 G SACHET,1.0X100.0 G SACHET | 01/07/2017 |
| NDA/MAL/VDP/7690 | INTERCHIEME WENKEN "DE ADELAAR" B.V | VET CENTRE UGANDA LIMITED | TRYPONIL | DIMINAZENE ACETURATE + PHENAZONE | 1.05G +1.31G/ 2.36G | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | ORAL SOLID ORDINARY GRANULES | 1.0X10.0X2.36 G SACHET | 01/07/2017 |
| NDA/MAL/VDP/7691 | MEDISEL(K) LTD | SUPER MEDIC LTD | VETGENTA | GENTAMICIN SULPHATE | 10%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO. LTD.NO. 16, LIUYUAN ROAD, CHANGAN DISTRICT, SHIJIAZHUANG, HEBEI, | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 07/01/2017 |
| NDA/MAL/VDP/7693 | INTERCHEMIE WENKEN "DE ADELAAR" B.V. | VET CENTRE UGANDA LIMITED | LIMOXIN 25 SPRAY | OXYTETRACYCLINE HYDROCHLORIDE | 25MG/ML | INTERCHEMIE WERKEN “DE ADELAAR” B.VMETAALWEG 8, 5804 CG, VENRAY, HOLLAND | NETHERLANDS | | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X200.0 ML CANNISTER | 01/07/2017 |
| NDA/MAL/VDP/7696 | INTERVET SA (PTY) LTD. | CKL UGANDA LIMITED | NILZAN SUPER | LEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT SULPHATE HEPTAHYDRATE + SODIUM SELENATE | 3.0%W/V + 6.0%W/V + 0.764%W/V+ 0.0766%W/V | CKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/7700 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | ERAM UGANDA LIMITED | OXYTET- 20% | OXYTETRACYCLINE HYDROCHLORIDE | 20%W/V | HEBEI YUANZHENG PHARM.CO.LTDNO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X500.0 ML VIAL | 01/07/2016 |
| NDA/MAL/VDP/7717 | NILE SERVICES LTD | NILE SERVICES LTD | PARVASTAR | PARVAQUONE | 150MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 28/05/2019 |
| NDA/MAL/VDP/7718 | NILE SERVICES LTD | NILE SERVICES LTD | SAMOSTAR | ISOMETAMIDIUM CHLORIDE HYDROCHLORIDE | 125MG/DOSE | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | NON-HUMAN USE POWDERS | 1.0X10.0X1.0 DOSE SACHET,1.0X10.0X8.0 DOSE SACHET | 28/05/2019 |
| NDA/MAL/VDP/7720 | NILE SERVICES LTD | NILE SERVICES LTD | TYLOSTAR | TYLOSIN TARTRATE | 20% W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE | 28/05/2019 |
| NDA/MAL/VDP/7725 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-DIC | DICLAZURIL | 0.5% W/W | HEBEI KEXING PHARMACEUTICALS CO. LTDNO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 27/08/2019 |
| NDA/MAL/VDP/8033 | COSMOS LTD | ERAM UGANDA LIMITED | WORMICID PLUS - O BOLUS | MULTI-INGREDIENT | N/A | COSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X2.0X15.0 BOLUS STRIP | 01/07/2004 |
| NDA/MAL/VDP/8214 | LAPROVET S.A.S | EVERVICTORY LIMITED | OXYTETRACYCLINE | OXYTETRACYCLINE | 50%W/W | LABOTOIRES BIOVE3 RUE DE LORRAINE F-6251O ARQUES | FRANCE | | ORAL SOLID ORDINARY POWDERS | 1.0X10.0X100.0 G SACHET,1.0X1.0 KG SACHET | 01/07/2017 |
| NDA/MAL/VDP/8256 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 2500 | ALBENDAZOLE | 2500MG | HEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCE | | CHINA | | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X20.0 BOLUS BLISTER | 28/03/2018 |
| NDA/MAL/VDP/8258 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | ALBENDA 10% SOL | ALBENDAZOLE | 100G/1L | EAGLE VET TECH CO. LTD.235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DO | SOUTH KOREA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L CONTAINER,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 28/03/2018 |
| NDA/MAL/VDP/8260 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | TETRANOR 10 | OXYTETRACYCLINE HYDROCHLORIDE | 10%W/V | HEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCE | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X250.0 ML VIAL,1.0X500.0 ML VIAL,1.0X100.0 ML VIAL | 28/03/2018 |
| NDA/MAL/VDP/8261 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | P-STREPNOR | PROCAINE PENICILLIN + DIHYDROSTREPTOMYCIN SULPHATE | 200MG + 250MG/ML | HEBEI HOPE HARMONY PHARMACEUTICAL CO.,LTD -INDUSTRY AREA,YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 28/03/2018 |
| NDA/MAL/VDP/8266 | ALIVIRA ANIMAL HEALTH | ERAM UGANDA LIMITED | SEQUENRO ORAL | ENROFLOXACIN | 10%W/V | ALIVIRA ANIMAL HEALTH LTDA-68, MIDC INDUSTRIAL AREA, ADDITIONAL AMBERNATH; THANE, MAHARASHTRA-INDIA | INDIA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE | 01/07/2017 |
| NDA/MAL/VDP/8267 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-ALBENDAZOLE | ALBENDAZOLE | 10%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN | 01/07/2017 |
| NDA/MAL/VDP/8268 | GOODMAN INTERNATIONAL LTD | GOODMAN INTERNATIONAL LTD | OXYTETRACYCLINE HYDROCHLORIDE | OXYTETRACYCLINE HYDROCHLORIDE | 50%W/W | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDAN | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET | 01/07/2017 |
| NDA/MAL/VDP/8269 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 2.5% | ALBENDAZOLE | 2.5%W/V | HEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCE | | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L CONTAINER, 1.0X125ML CONTAINER | 28/03/2018 |
| NDA/MAL/VDP/8270 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | TETRANOR 20 L.A | OXYTETRACYCLINE DIHYDRATE | 20%W/V | HEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCE | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X250.0 ML VIAL,1.0X100.0 ML VIAL,1.0X500.0 ML VIAL | 28/03/2018 |
| NDA/MAL/VDP/8271 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | TETRANOR 30 L.A | OXYTETRACYCLINE HYDROCHLORIDE | 30%W/V | HEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCE | HEBEI KEXING PHARMACEUTICALS CO. LTD - NO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 28/03/2018 |
| NDA/MAL/VDP/8272 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | BUPAQUONE | BUPARVAQUONE | 50MG/ML | EAGLE VET TECH. CO. LTD235-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN CHUNGCHEONGNAM-DO, KOREA | SOUTH KOREA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL | 01/07/2017 |
| NDA/MAL/VDP/8298 | NORBROOK LABORATORIES | NORBROOK (U) LTD | NOROMECTIN ORAL DRENCH | IVERMECTIN | 0.08%W/V | NORBROOK KENYA LTDOLD KIMURU RD- KARURI | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,2.5 L JERRYCAN,1.0X1.0 L JERRYCAN,1.0X5000.0 ML JERRYCAN | 01/07/2000 |
| NDA/MAL/VDP/8360 | FATRO S.P.A | GLOBAL VET (U) LIMITED | VAIOL-VAC | LIVE ATTENUATED AVIAN FOWLPOX VIRUS, HP-2 STRAIN-2 | ?10?EID??/DOSE | FATRO S.P.AVIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | | ORAL LIQUID ORDINARY DROPS | 1.0X10.0X1000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8361 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | FLOXINOR | ENROFLOXACIN | 200MG/ML | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/VDP/8362 | FATRO S.P.A | GLOBAL VET (U) LIMITED | S.E.T-VAC | INACTIVATED CULTURE OF SALMONELLA ENTERITIDIS + INACTIVATED CULTURE OF SALMONELLA TYPHIMURIUM | 1,000,000,000CFU/DOSE + 1,000,000,000CFU/DOSE | FATRO S.P.A.-VIA EMILIA 285, OZZANO EMILIA (BO, ITALY) | FATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | | ITALY | | PARENTERAL ORDINARY VIALS | 1.0X500.0 DOSE VIAL (250ML),1.0X1000.0 DOSE VIAL (500ML) | 31/01/2018 |
| NDA/MAL/VDP/8364 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BIO–VAC ND–IB | HITCHNER B1 STRAIN + MASSACHUSETTS H-120 | HITCHNER B1 STRAIN - ?10??? EID??/DOSE+ MASSACHUSETTS H-120 - ?10³?? EID??/DOSE | FATRO S.P.AFATRO S.P.A VIA MOLINO EMILI, 225030 MACLODIO (BS) ITALY | ITALY | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1000.0 DOSE VIAL | 29/11/2017 |
| NDA/MAL/VDP/8365 | LAPROVET S.A.S | EVERVICTORY LIMITED | SANIMIX | DIMINAZENE DIACETURATE + LEVIMISOLE | 1.05G + 1.5G | CEVA SANTE ANIMALE ZONE INDUSTRIELLETRES LE BOIS 22600 LOUDEAC | FRANCE | | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X10.0X4.9 G SACHET,1.0X10.0X49.0 G SACHET | 29/11/2017 |
| NDA/MAL/VDP/8366 | EAGLE VET TECH CO., LTD | EAGLEVET UGANDA LIMITED | COLLIE- AM | AMPICILLIN TRIHYDRATE + COLLISTIN SULPHATE | 100G + 25,000,000IU | EAGLE VET TECH CO. LTD.235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DO | SOUTH KOREA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET | 29/11/2017 |
| NDA/MAL/VDP/8367 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | V.H. + H-120 COMBINED VACCINE, NEWCASTLE DISEASE | NEWCASTLE DISEASE VIRUS (V.H STRAIN) + INFECTIOUS BRONCHITIS VIRUS (H-120 STRAIN) | NOT LESS THAN 10^6.0 EID50 + NOT LESS THAN 10^3.5 EID50 PER DOSE | ABIC BIOLOGICAL LABORATORIES LTD.3 HAMELACHA ST.WEST INDUSTRIAL ZONE,BEIT SHEMESH,ISRAEL | ISRAEL | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X10.0X2000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL | 26/09/2018 |
| NDA/MAL/VDP/8368 | FATRO S.P.A | GLOBAL VET (U) LIMITED | IBA-VAC | LIVE ATTENUATED VIRUS OR GUMBORO DISEASE, 1/65PV STRAIN | ?10³EID??/DOSE | FATRO S.P.AVIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8369 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-OXYWSP | OXYTETRACYCLINE | 25 % W/W | HEBEI KEXING PHARMACEUTICALS CO. LTDNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET | 29/11/2017 |
| NDA/MAL/VDP/8370 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BI-VAC 1º | AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS H120 STRAIN VACCINE(FREEZE DRIED ) | ? 10^4 EID50/DOSE | FATRO S.P.AVIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8371 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BIO-VAC LA SOTA | NEWCASTLE DISEASE VIRUS (STRAIN LA SOTA) | 10^6.5 EID50/DOSE | FATRO S.P.AVIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X1000.0 DOSE VIAL,1.0X1.0X2500.0 DOSE VIAL,1.0X1.0X500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8372 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BIO-MAREK HVT | FREEZE DRIED FC 126 STRAIN OF HERPES VIRUS OF TURKEY (HVT) | 1500 PLAQUE FORMING UNITS/ DOSE | FATRO S.P.AVIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8374 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | ND+IB+VP2 | INACTIVATED, NEWCASTLE DISEASE VIRUS (V.H STRAIN) + INACTIVATED, INFECTIOUS BRONCHITIS VIRUS (M41 STRAIN) + INFECTIOUS BURSAL DISEASE VIRUS (ISRAELI STRAIN VP2 PROTEIN) | INACTIVATED, ND VIRUS (V.H STRAIN) ?10???EID??/DOSE + INACTIVATED, IB VIRUS (M41 STRAIN) ?10??¹EID??/DOSE + IBD VIRUS, VP2 PROTEIN - 25 µG/DOS | ABIC BIOLOGICAL LABORATORIESWESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAEL | ISRAEL | | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X1000.0 DOSE BOTTLE (500ML) | 29/11/2017 |
| NDA/MAL/VDP/8375 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | IC- QUADRO INACTIVATED VACCINE | INFECTIOUS CORYZA (AVIBACTERIUM PARAGALLINARUM) VACCINE, INACTIVATED | 221 STRAIN -10???CFU/DOSE, SPROSS STRAIN - 10???CFU/DOSE - MODESTO STRAIN - 10???CFU/DOSE & AKKO STRAIN - 10???CFU/DOSE. | ABIC BIOLOGICAL LABORATORIESWESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAEL | ISRAEL | | PARENTERAL ORDINARY VIALS | 1.0X1000.0 DOSE BOTTLE (300ML),1.0X2000.0 DOSE BOTTLE (600ML) | 29/11/2017 |
| NDA/MAL/VDP/8376 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | NECTIV FORTE | INACTIVATED, NEWCASTLE DISEASE VIRUS (V.H STRAIN | ?10??¹EID??/DOSE 90.1 ML) | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X5000.0 DOSE BOTTLE (500ML) | 29/11/2017 |
| NDA/MAL/VDP/8377 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | V.H. LIVE VACCINE | ND VIRUS, LIVE (V.H. STRAIN) | ND VIRUS, V.H STRAIN (LYOPHILIZED) ?10? EID??/DOSE | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | ORAL LIQUID ORDINARY DROPS | 1.0X1000.0 DOSE VIAL | 29/11/2017 |
| NDA/MAL/VDP/8378 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | TABIC IB VAR VACCINE | AVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (233A STRAIN) | IB VIRUS (233A STRAIN) ?10³?²EID??/DOSE | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X1.0X10.0 TABLET BLISTER (10,000 DOSES) | 29/11/2017 |
| NDA/MAL/VDP/8380 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | TABIC V.H. LIVE VIRUS VACCINE | LIVE ATTENUATED NEWCASTLE DISEASE VIRUS, V.H. STRAIN | 10? - 10???EID??/DOSE | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X1.0X10.0 TABLET BLISTER (100 DOSES),1.0X1.0X10.0 TABLET BLISTER (500 DOSES),1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X1.0X10.0 TABLET BLISTER (10,000 DOSES) | 29/11/2017 |
| NDA/MAL/VDP/8381 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | TABIC MB LIVE VIRUS VACCINE | INFECTIOUS BURSAL DISEASE (IBD) VACCINE, LIVE (M.B STRAIN) | INFECTIOUS BURSAL DISEASE VIRUS,M.B STRAIN : 10²?? - 10³?¹EID??/DOSE | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X1.0X10.0 TABLET BLISTER (500 DOSES),1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES) | 29/11/2017 |
| NDA/MAL/VDP/8384 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | SALMABIC | INACTIVATED SALMONELLA ENTERITIDIS (C8, B3) AND SALMONELLA TYPHIMURIUM [2(+4)] STRAINS | S. ENTERITIDIS (PT C8 - 1X10? CFU/DOSE & PT B3 - 1X10? CFU/DOSE)+ S. TYPHIMURIUM - PT 2(4+) -1X10? CFU/DOSE | ABIC BIOLOGICAL LABORATORIESWESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAEL | ISRAEL | | PARENTERAL ORDINARY S C VIALS | 1.0X500.0 DOSE BOTTLE (250ML),1.0X1000.0 DOSE BOTTLE (500ML) | 29/11/2017 |
| NDA/MAL/VDP/8386 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-AMP WSP | AMPROLIUM HYDROCHLORIDE | 20% W/W | HEBEI KEXING PHARMACEUTICALS CO. LTDNO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET | 27/08/2019 |
| NDA/MAL/VDP/8387 | FATRO S.P.A | GLOBAL VET (U) LIMITED | BI-VAC 2º | ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS H-52 STRAIN | ?10?EID??/DOSE | FATRO S.P.AVIA MOLINO EMILI 2, MACLODIO (BS, ITALY) | ITALY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8397 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-OXY | OXYTETRACYCLINE | 12.5% W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD -NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL | 29/11/2017 |
| NDA/MAL/VDP/8398 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 300 | ALBENDAZOLE | 300MG | HEBEI HOPE HARMONY PHARMACEUTICAL CO.,LTD -INDUSTRY AREA,YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA | | CHINA | | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER | 29/11/2017 |
| NDA/MAL/VDP/8400 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | ALBENOR 10 | ALBENDAZOLE | 100MG/ML | HEBEI HOPE HARMONY PHARMACEUTICAL CO.,LTD -INDUSTRY AREA,YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA | | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN,1.0X125.0 ML BOTTLE | 29/11/2017 |
| NDA/MAL/VDP/8435 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | BRONCHIN | INACTIVATED NDV, V.H. STRAIN + INACTIVATED IBV, M-41 STRAIN | INACTIVATED NDV, V.H. STRAIN ?10???EID??/DOSE + INACTIVATED IBV, M-41 STRAIN?10???EID??/DOSE | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | OTHER SYSTEMIC LIQUIDS | 1.0X1000.0 DOSE BOTTLE (500ML) | 29/11/2017 |
| NDA/MAL/VDP/8479 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-IRONDEX | IRON DEXTRAN | 10%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD -NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 31/01/2018 |
| NDA/MAL/VDP/8482 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-GENTAMY | GENTAMYCIN SULPHATE | 10%W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD -NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 31/01/2018 |
| NDA/MAL/VDP/8486 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX - TYLOSIN | TYLOSIN TARTRATE | 20 % W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD -NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE | 31/01/2018 |
| NDA/MAL/VDP/8492 | ABIC BIOLOGICAL LABORATORIES LTD | BIMEDA UGANDA LIMITED | MB (GUMBORO) VACCINE | LIVE ATTENUATED IBD VIRUS M.B. | 10²?? - 10³?¹EID??/DOSE | ABIC BIOLOGICAL LABORATORIES LTDP.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAEL | ISRAEL | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL | 31/01/2018 |
| NDA/MAL/VDP/8532 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | TYLORATE | TYLOSIN | 20%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 01/07/2011 |
| NDA/MAL/VDP/8533 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | OXYTETRAVET 25% | OXYTETRACYCLINE | 25%W/W | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE €“IRBID | JORDAN | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 G SACHET, 1.0X500.0 G SACHET, 1.0X1.0 KG SACHET | 01/07/2011 |
| NDA/MAL/VDP/8535 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | MULTIVITAMIN INJ | VITAMINS A + D3 +E + B1 + B2 +B6 + B12 + NICOTINAMIDE + PANTOTHENOL | 15,000IU + 1000IU + 20MG + 10MG + 5MG + 3MG + 50MCG + 35MG + 25MG | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/8536 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | GENTAVET | GENTAMICIN | 5%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2011 |
| NDA/MAL/VDP/8537 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | ENROCURE | ENROFLOXACIN | 10%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/8663 | : LAPROVET S.A.S | EVERVICTORY LIMITED | INOMIDIUM® | ISOMETAMIDIUM CHLORIDE HYDROCHLORIDE | 1 G | CEVA SANTE ANIMALE - Z.I. TRES LE BOIS, B.P. 372, 22603 LOUDEAC CEDEX, FRANCE | FRANCE | | OTHER SYSTEMIC POWDER | 1.0X10.0 SACHET CARTON | 28/03/2018 |
| NDA/MAL/VDP/8664 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-TOLTRA | TOLTRAZURIL | 2.5% W/V | HEBEI KEXING PHARMACEUTICALS CO. LTD -NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. | CHINA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE | 28/03/2018 |
| NDA/MAL/VDP/8701 | HEBEI YUANZHENG PHARMACEUTICAL CO LTD | EVERVICTORY LIMITED | BUPARVAQUONE-5 | BUPARVAQUONE INJECTION | 5%W/V | HEBEI YUANZHENG PHARMACEUTICAL CO LTD-NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCE | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 30/05/2018 |
| NDA/MAL/VDP/8702 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | IMICARB | IMIDOCARB | 12%W/V | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X40.0 ML BOTTLE | 01/07/2011 |
| NDA/MAL/VDP/8703 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | PIPERAMENTIC | PIPERAZINE | 36%W/W | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET | 01/07/2011 |
| NDA/MAL/VDP/8707 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | HEXAVET LA | FLUNIXIN + OXYTETRACYCLINE | 20MG + 300MG /ML | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML VIAL | 01/07/2014 |
| NDA/MAL/VDP/8708 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | OXYTETRAVET | OXYTETRACYCLINE HYDROCHLORIDE | 5G/200ML | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.AL HASSAN INDUSTRIAL ESTATE –IRBID | JORDAN | | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X200.0 ML CANNISTER | 01/07/2015 |
| NDA/MAL/VDP/9116 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | NANDINI PHARMACEUTICALS LIMITED | KX-ENRO | ENROFLOXACIN | 20% W/V | HEBEI KEXING PHARMACEUTICALS CO. LTDNO. 114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG | CHINA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML SACHET | 27/08/2019 |
| NDA/MAL/VDP/9117 | CEVA-PHYLAXIA VETERINARY BIOLOGICALS CO. LTD | VERI BRANDS U LTD | CEVAC® NEW L | NEWCASTLE DISEASE VIRUS, LASOTA STRAIN | NLT 10^5.5 EID50 / DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | OTHER SYSTEMIC DROPS | 1.0X1000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL | 27/08/2019 |
| NDA/MAL/VDP/9118 | CEVA-PHYLAXIA VETERINARY BIOLOGICALS CO. LTD | VERI BRANDS U LTD | CEVAC® BI L | INFECTIOUS BRONCHITIS DISEASE VIRUS, MASSACHUSETTS TYPE, B-48 STRAIN + NEWCASTLE DISEASE VIRUS, HITCHNER B1 STRAIN | NLT 10^3.0 EID50 + NLT 10^5.5 EID50 / DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | OTHER SYSTEMIC DROPS | 1.0X2500.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL | 27/08/2019 |
| NDA/MAL/VDP/9152 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | FLUKENOR | OXYCLOZANIDE + LEVAMISOLE + COBALT SULPHATE | 3.5%W/V + 2%W/V + 0.4%W/V | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE | 21/11/2019 |
| NDA/MAL/VDP/9153 | HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD | JUBAILI AGROTEC LIMITED | I.D-NOR PLUS | IRON DEXTRAN + VITAMIN B12 | 100MG + 100MCG/ML | HEBEI HOPE HARMONY PHARMACEUTICAL CO LTD-INDUSTRY DEVELOPMENT AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE - PEOPLE'S REPUBLIC OF CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE | 21/11/2019 |
| NDA/MAL/VDP/9154 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS®IB 4-91 | LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN 4-91 | AT LEAST LOG10^3.6 EID50 / DOSE | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS | 1.0X1000.0 DOSE VIAL | 21/11/2019 |
| NDA/MAL/VDP/9155 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS® GUMBORO D78 | LIVE,ATTENUATED, INFECTIOUS BURSAL DISEASE (GUMBORO DISEASE) VIRUS, STRAIN D78 | AT LEAST 4.0 LOG10 TCID50 OF INFECTIOUS BURSAL DISEASE (GUMBORO) VIRUS STRAIN D78 (OR ?10^4.0 TCID50/DOSE) | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS | 1.0X10.0X1000.0 DOSE VIAL | 21/11/2019 |
| NDA/MAL/VDP/9156 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS® IB MA5 | LIVE INFECTIOUS BRONCHITIS VIRUS, STRAIN MA5 (SEROTYPE MASSACHUSETTS) | ATLEAST 103.0 EID50 OFINFECTIOUS BRONCHITIS VIRUS, STRAIN MA5, SEROTYPE MASSACHUSETTS I.E. ? 103.0 EID50 /DOSE | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS | 1.0X1000.0 DOSE VIAL | 21/11/2019 |
| NDA/MAL/VDP/9157 | ASIATIC AGRICULTURAL INDUSTRIES PTE LTD | NANDINI PHARMACEUTICALS LIMITED | VIZAC | ALPHA-CYPERMETHRIN | 50G/L | ASIATIC AGRICULTURAL INDUSTRIES PTE LTD150 GUL CIRCLE, SINGAPORE 629607 | SINGAPORE | | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1.0 L CONTAINER | 21/11/2019 |
| NDA/MAL/VDP/9158 | VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD - VET | DO-CARB | IMIDOCARB DIPROPIONATE | 120MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL,1.0X1.0X50.0 ML VIAL | 21/11/2019 |
| NDA/MAL/VDP/9221 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD - VET | PROTEIN 100 | PROTEIN HYDROLYSATE | 98 GM/100 GM | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1X250 G SACHET | 28/09/2020 |
| NDA/MAL/VDP/9227 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | POULVAC IB PRIMER | LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN H120 + LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, STRAIN D274 CLONE | 10^3.0 - 10^5.4 EID50 + 10^3.0 - 10^5.4 EID50/DOSE | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.LCTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2500.0 DOSE VIAL | 15/02/2023 |
| NDA/MAL/VDP/9240 | CEVA-PHYLAXIA VETERINARY BIOLOGICALS CO. LTD | VERI BRANDS U LTD | CEVAC TRANSMUNE | LIVE, AVIAN INFECTIOUS BURSAL DISEASE VIRUS, WINTERFIELD 2512 G-61 STRAIN + IBD ANTIBODIES | MIN 0.1 CID50/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0X2000.0 DOSE VIAL | 08/09/2020 |
| NDA/MAL/VDP/9282 | CEVA-PHYLAXIA VETERINARY BIOLOGICALS CO. LTD | VERI BRANDS U LTD | CEVAC GUMBO L | LIVE AVIAN NFECTIOUS BURSAL DISEASE VIRUS, LIBDV STRAIN | NOT LESS THAN 10^3.0TCID50/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X20.0X1000.0 DOSE VIAL,1.0X20.0X2500.0 DOSE VIAL,1.0X20.0X5000.0 DOSE VIAL | 08/09/2020 |
| NDA/MAL/VDP/9283 | CEVA-PHYLAXIA VETERINARY BIOLOGICALS CO. LTD | VERI BRANDS U LTD | CEVAC IBD L | LIVE AVIAN INFECTIOUS BURSAL DISEASE VIRUS, WINTERFIELD 2512 G-61 STRAIN | NOT LESS THAN 10^2.0 EID50/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X20.0X1000.0 DOSE VIAL,1.0X20.0X2500.0 DOSE VIAL | 08/09/2020 |
| NDA/MAL/VDP/9292 | INTERVET SA (PTY) LTD. | ERAM UGANDA LIMITED | NOBILIS GUMBORO 228E | LIVE AVIAN INFECTIOUS GUMBORO DISEASE VIRUS STRAIN 228E | NLT 2.0 LOG10EID50/DOSE | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X1000.0 DOSE VIAL | 08/09/2020 |
| NDA/MAL/VDP/9293 | INTRACIN PHARMACEUTICAL PVT LTD? | VEERAM HEALTHCARE (U) LIMITED | CRAMINE | CHLORPHENAMINE MALEATE | 10 MG/ML | INTRACIN PHARMACEUTICAL PVT. LTD.C-1B/53, G.I.D.C. ESTATE, NADIAD 387 001, GUJARAT | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL, 1.0X30.0 ML VIAL, 1.0X50.0 ML VIAL | 28/09/2020 |
| NDA/MAL/VDP/9300 | EAGLEVET UGANDA LIMITED | EAGLEVET UGANDA LIMITED | 9R-VAC | SALMONELLA GALLINARUM 9 ROUGH LIVE STRAIN | NLT 2X10^7 CFU/DOSE | KOMIPHARM INTERNATIONAL CO. LTD17, GYEONGJE-RO, SIHEUNG-SI, GYEONGGI-DO | SOUTH KOREA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1X10X1000 DOSE VIAL | 28/09/2020 |
| NDA/MAL/VDP/9301 | EAGLEVET UGANDA LIMITED | EAGLEVET UGANDA LIMITED | PRO-VAC ND LASOTA | NEWCASTLE DISEASE VIRUS (NDV : LASOTA STRAIN) | NLT 10^5.0 EID50/DOSE | KOMIPHARM INTERNATIONAL CO. LTD17, GYEONGJE-RO, SIHEUNG-SI, GYEONGGI-DO | SOUTH KOREA | NON-HUMAN USE SOLUBLE POWDERS | 1X10X500 DOSE VIAL | 28/09/2020 |
| NDA/MAL/VDP/9302 | EAGLEVET UGANDA LIMITED | EAGLEVET UGANDA LIMITED | PRO-VAC ND-IB | NEW CASTLE DISEASE VIRUS, (NDV: B1 STRAIN) + INFECTIOUS BRONCHITIS VIRUS, (BV: KH-120 STRAIN) | NLT 10^5.0 EID50/DOSE + NLT 10^2.5 EID50/DOSE | KOMIPHARM INTERNATIONAL CO. LTD17, GYEONGJE-RO, SIHEUNG-SI, GYEONGGI-DO | SOUTH KOREA | NON-HUMAN USE SOLUBLE POWDERS | 1X10X500 DOSE VIAL | 28/09/2020 |
| NDA/MAL/VDP/9303 | EAGLEVET UGANDA LIMITED | EAGLEVET UGANDA LIMITED | PRO-VAC IBD | INFECTIOUS BURSAL DISEASE VIRUS (IBDV: KOMI 40 STRAIN) | NLT 10^2.0 EID50/DOSE | KOMIPHARM INTERNATIONAL CO. LTD17, GYEONGJE-RO, SIHEUNG-SI, GYEONGGI-DO | SOUTH KOREA | NON-HUMAN USE SOLUBLE POWDERS | 1X20X500 DOSE VIAL | 28/09/2020 |
| NDA/MAL/VDP/9304 | EAGLEVET UGANDA LIMITED | EAGLEVET UGANDA LIMITED | PRO-VAC CRDF | MYCOPLASMA GALLISEPTICUM CULTURE (F STRAIN) | NLT 10^5.0 CCU/DOSE | KOMIPHARM INTERNATIONAL CO. LTD17, GYEONGJE-RO, SIHEUNG-SI, GYEONGGI-DO | SOUTH KOREA | OPHTHALMIC DRY VIALS | 1X10X1000 DOSE VIAL | 28/09/2020 |
| NDA/MAL/VDP/9309 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | SELECTAN | FLORFENICOL | 300MG/ML | LABORATORIOS HIPRA S.A ,AVDA. LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | PARENTERAL ORDINARY VIALS | 1.0X3.0X50.0 ML BOTTLE,1.0X2.0X100.0 ML BOTTLE,1.0X1.0X250.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/VDP/9310 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | EFICUR | CEFTIOFUR | 50MG/ML | LABORATORIOS HIPRA S.A ,AVDA. LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | PARENTERAL ORDINARY VIALS | 1.0X3.0X50.0 ML BOTTLE,1.0X10.0X100.0 ML BOTTLE,1.0X1.0X250.0 ML BOTTLE | 08/09/2020 |
| NDA/MAL/VDP/9311 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | STARTVAC | E. COLI J5 INACTIVATED + S. AUREUS CP8 STRAIN SP 140 INACTIVATED | 50RED60 + 50RED80/ DOSE | LABORATORIOS HIPRA S.A ,AVDA. LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | PARENTERAL ORDINARY VIALS | 1.0X10.0X50.0 ML BOTTLE (50ML BOTTLE HAS 25 DOSES),1.0X10.0X10.0 ML BOTTLE (10ML BOTTLE HAS 5 DOSES),1.0X10.0X2.0 ML BOTTLE (2ML BOTTLE HAS 1 DOSE) | 08/09/2020 |
| NDA/MAL/VDP/9312 | LABORATORIOS HIPRA S.A | ERAM UGANDA LIMITED | EVALON | "EIMERIA ACERVULINA, STRAIN 003 + EIMERIA BRUNETTI, STRAIN 034 + EIMERIA MAXIMA, STRAIN 013 + EIMERIA NECATRIX, STRAIN 033 + EIMERIA TENELLA, STRAIN 004" | 332-450 + 213-288 + 196-265 + 340-460 + 276-374 /DOSE | LABORATORIOS HIPRA S.A ,AVDA. LA SELVA, 135, 17170 AMER (GIRONA) | SPAIN | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X1000.0 DOSE VIAL,1.0X1.0X5000.0 DOSE VIAL | 08/09/2020 |
| NDA/MAL/VDP/9458 | LAPROVET-HUNGARY VETERINARY PHARMACEUTICALS LTD | EVERVICTORY LIMITED | AVI IBD PLUS | INFECTIOUS BURSAL DISEASE VIRUS (GUMBORO VIRUS), STRAIN WINTERFIELD 2512 G-61, LIVE | NLT 10^2.0 EID50/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X20.0X1000.0 DOSE VIAL | 08/09/2020 |
| NDA/MAL/VDP/9459 | LAPROVET-HUNGARY VETERINARY PHARMACEUTICALS LTD | EVERVICTORY LIMITED | ITA ND + IB+EDS | NEWCASTLE DISEASE VIRUS, STRAIN LASOTA + INFECTIOUS BRONCHITIS VIRUS, STRAIN M-41 + EGG DROP SYNDROME, STRAIN B8/78 | MIN. 50 PD50 + MIN 6 LOG2 HI + MIN. 7 LOG2 HI/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML VIAL (1000 DOSES) | 09/12/2020 |
| NDA/MAL/VDP/9460 | LAPROVET-HUNGARY VETERINARY PHARMACEUTICALS LTD | EVERVICTORY LIMITED | ITA – NEW (ND) | NEWCASTLE DISEASE VIRUS, LASOTA STRAIN | NLT 50 PD50/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | PARENTERAL ORDINARY VIALS | 1.0X500.0 ML VIAL (1000 DOSES) | 09/12/2020 |
| NDA/MAL/VDP/9464 | LAPROVET-HUNGARY VETERINARY PHARMACEUTICALS LTD | EVERVICTORY LIMITED | AVI ND LASOTA+ IB | LIVE, NEWCASTLE DISEASE VIRUS, LASOTA STRAIN + AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS B48 STRAIN | NOT LESS THAN 10^5.5 EID50 + NOT LESS THAN 10^2.6EID50 /DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X20.0X1000.0 DOSE VIAL | 09/12/2020 |
| NDA/MAL/VDP/9465 | LAPROVET-HUNGARY VETERINARY PHARMACEUTICALS LTD | EVERVICTORY LIMITED | AVI ND LASOTA | LIVE, NEWCASTLE DISEASE VIRUS, LASOTA STRAIN | NOT LESS THAN 10^5.5 EID50/DOSE | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X20.0X1000.0 DOSE VIAL | 09/12/2020 |
| NDA/MAL/VDP/9468 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | NEROCIN | METHYLCOBALAMIN + PYRIDOXINE HYDROCHLORIDE + NICOTINAMIDE | (500 MCG + 50 MG + 50 MG)/ML | INTRACIN PHARMACEUTICALS PVT LTD ,.,C-1, B-53, GIDC ESTATE, NADIAD-387001 | INDIA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X100.0 ML VIAL | 09/12/2020 |
| NDA/MAL/VDP/9477 | NORBROOK KENYA LTD | NORBROOK (U) LTD | BENDAMEC | ALBENDAZOLE + IVERMECTIN | 10%W/V + 0.2%W/V | NORBROOK KENYA LTDOLD LIMURU ROAD, KARURI, NAIROBI | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X40.0 ML CONTAINER,1.0X120.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1.0 L CONTAINER,1.0X5.0 L CONTAINER | 09/12/2020 |
| NDA/MAL/VDP/9478 | NILE SERVICES LTD | NILE SERVICES LTD | OXYTETRACYCLINE WSP 20% | OXYTETRACYCLINE HYDROCHLORIDE | 200 MG/G | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 G SACHET,1.0X10.0X5.0 G SACHET | 09/12/2020 |
| NDA/MAL/VDP/9479 | NILE SERVICES LTD | NILE SERVICES LTD | STARMECTIN PLUS | IVERMECTIN + CLORSULON | 1%W/V | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL | 09/12/2020 |
| NDA/MAL/VDP/9520 | MEDISEL(K) LTD | SUPER MEDIC LTD | TYLO-DOX POWDER | DOXYCYCLINE HYCLATE + TYLOSIN TARTRATE | (200 MG + 200 MG)/G | MEDISEL (K) LTDPLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | KENYA | ORAL SOLID ORDINARY POWDERS | 1.0X30.0 G SACHET, 1.0X100.0 G SACHET, 1.0X500.0 G CONTAINER, 1.0X1.0 KG CONTAINER | 03/04/2021 |
| NDA/MAL/VDP/9521 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | THEIL-CURE | BUPARVAQUONE | 50MG/ML | ORCHIDIA10TH RAMADHAN CITY INDUSTRIAL AREA-B1 , P. O. BOX 149 TENTH, EGYPT | EGYPT | | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML VIAL,1.0X1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 24/02/2021 |
| NDA/MAL/VDP/9522 | BIMEDA AMEA LIMITED | BIMEDA UGANDA LIMITED | AMPROMED | AMPROLIUM HYDROCHLORIDE | 20% W/W | CHONGQING FANTONG ANIMAL PHARMACEUTICALSBANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING | CHINA | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X30.0 G SACHET,1.0X100.0 G SACHET | 24/02/2021 |
| NDA/MAL/VDP/9531 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | COCCIDIOPAN | SULPHAQUINOXALINE SODIUM + SULPHADIMIDINE SODIUM + SULPHADIAZINE SODIUM + VITAMIN K3 + VITAMIN A | (150 MG + 70 MG + 70 MG + 2 MG + 8000 I.U)/G | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X100.0 G SACHET,1.0X200.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET | 24/02/2021 |
| NDA/MAL/VDP/9532 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | BACTECLEAN 50% | DOXYCYCLINE HYCLATE | 500 MG/G | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X200.0 G SACHET,1.0X500.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X100.0 G SACHET | 24/02/2021 |
| NDA/MAL/VDP/9553 | CEVA SANTE ANIMALE | VERI BRANDS U LTD | VERIBEN B12 HC | DIMINAZENE DIACETURATE + CYANOCOBALAMIN | (1.05 G + 0.0012 G)/ 2.36 G | CEVA SANTE ANIMALEZI TRES LE BOIS - BP 372-22603 LOUDEAC CEDEX | FRANCE | | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X2.36 G SACHET,1.0X23.6 G SACHET | 04/03/2021 |
| NDA/MAL/VDP/9554 | INTERVET SOUTH AFRICA (PTY) LTD | ERAM UGANDA LIMITED | NOBILIS MA5+CLONE 30 | AVIAN INFECTIOUS BRONCHITIS + NEW CASTLE DISEASE VACCINE, LIVE. | AT LEAST 3.0 LOG10 EID50 + AT LEAST 6.0 LOG10 EID50/DOSE | INTERVET INTERNATIONAL BVWIM DE KORVERSTARAAT 35, 5831 AN BOXMEER | NETHERLANDS | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X2500.0 DOSE VIAL + 1*80ML DILUENT IN HDPE CONTAINER,1.0X10.0X1000.0 DOSE VIAL + 1*80ML DILUENT IN HDPE CONTAINER | 24/02/2021 |
| NDA/MAL/VDP/9560 | THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO | GLOBAL VET (U) LIMITED | ENROTRILL | ENROFLOXACIN | 200 MG/ML | THE ARAB PESTICIDES & VETERINARY DRUGS MANUFACTURING CO.AL HASSAN INDUSTRIAL ESTATE, IRBID, P.O. BOOX 45, IRIBID, 21467 | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE, 1.0X1.0 L BOTTLE | 04/03/2021 |
| NDA/MAL/VDP/9564 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | MEDACOX | TOLTRAZURIL | 25MG/ML | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTDAL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | JORDAN | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 24/02/2021 |
| NDA/MAL/VDP/9565 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVITRYL 10% | ENROFLOXACIN | 100 MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 24/02/2021 |
| NDA/MAL/VDP/9566 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | AVIMEC SUPER | IVERMECTIN + CLORSULON | 10MG + 100MG/ML | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | | PARENTERAL ORDINARY VIALS | 1.0X1.0X20.0 ML BOTTLE,1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X1.0X250.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/VDP/9567 | ARAB VETERINARY INDUSTRIAL CO. | K.S. VET PHARMACY LIMITED | ERYTHROMYCIN – AVICO 25% | ERYTHROMYCIN THIOCYANATE | 330 MG/G | ARAB VETERINARY INDUSTRIAL COMPANY AVICOALQUDS ST- NAUR, AMMAN JORDAN, P.O BOX 150906 | JORDAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1X500 G SACHET, 1X1 KG SACHET | 04/03/2021 |
| NDA/MAL/VDP/9578 | VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) | GOODMAN INTERNATIONAL LTD | THEILACIDE | BUPARVAQUONE | 50 MG/ML | VAPCO (VETERINARY & AGRICULTURAL PRODUCTS MFG. CO. LTD)KING HUSSEIN STREET NO. 120, DHULAIL PROVINCE, ZARQUA'A | JORDAN | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE | 09/12/2020 |
| NDA/MAL/VDP/9579 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | PRO VAC® 4 | INACTIVATED INFECTIOUS BURSAL DISEASE VIRUS-BEARING FLUIDS (LUKERT STRAIN) + INACTIVATED NEWCASTLE DISEASE VIRUS-BEARING FLUIDS (KIMBER STRAIN) | ?10^5.2 TCID50 + ?10^7.7 EID50 + ? 10^6.9 EID50 + ?10^6.2 TCID50 + ?10^6.2 TCID50/DOSE | ZOETIS2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | | PARENTERAL ORDINARY OTHER VIALS | 1.0X100.0 ML CONTAINER (1000 DOSES) | 02/06/2021 |
| NDA/MAL/VDP/9580 | PHARMA SWEDE - | KWEWAYO (U) VET PHARMACY LIMITED | LEVAPAN LIQUID | LEVAMISOLE HYDROCHLORIDE | 118 MG/ML | PHARMA SWEDE - EGYPT10TH OF RAMADAN CITY - INDUSTRIAL ZONE B3 | EGYPT | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1000.0 ML CONTAINER,1.0X100.0 ML BOTTLE | 02/06/2021 |
| NDA/MAL/VDP/9582 | HEBEI KEXING PHARMACEUTICAL CO., LTD. | JUBAILI AGROTEC LIMITED | PIPERANOR | PIPERAZINE CITRATE | 360 MG/G | HEBEI KEXING PHARMACEUTICALSNO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI | CHINA | | POWDERS/ GRANULES IN SACHETS | 1.0X100.0 G SACHET,1.0X50.0 G SACHET | 02/06/2021 |
| NDA/MAL/VDP/9697 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | TRI-REO® | AVIAN REOVIRUS VACCINE, (STRAIN NO. 1133 + STRAIN NO.2408 + STRAIN NO. 3005) | (? 10^5.9 TCID50 + ? 10^6.0 TCID50 + ? 104.8 TCID50) PER DOSE | ZOETIS2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X500.0 ML CONTAINER (1000 DOSES) | 02/06/2021 |
| NDA/MAL/VDP/9737 | ASIATIC AGRICULTURAL INDUSTRIES PTE LTD | NANDINI PHARMACEUTICALS LIMITED | DEL-Z | DELTAMETHRIN | 5% W/V | ASIATIC AGRICULTURAL IND. PTE LTD 150 GUL CIRCLE SINGAPOLE 629607 | SINGAPORE | | TOPICAL EXTERNAL EMULSIONS | 1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 05/10/2021 |
| NDA/MAL/VDP/9738 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | MG-BAC® | MYCOPLASMA GALLISEPTICUM BACTERIN, STRAIN R-980 | ?1000 MGCFU/DOSE | ZOETIS2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | | PARENTERAL ORDINARY OTHER VIALS | 1.0X500.0 ML CONTAINER (1000 DOSES) | 05/10/2021 |
| NDA/MAL/VDP/9739 | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD. | KWEWAYO (U) VET PHARMACY LIMITED | TETRAMED | OXYTETRACYCLINE HYDROCHLORIDE | TETRAMED | MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTDAL HUSSUN ST. OPPOSITE AL-ASSER SUITE COMPANY, AL RUMTHA /AL HASSAN INDUSTRIAL CITY, JORDAN. | JORDAN | | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET | 05/10/2021 |
| NDA/MAL/VDP/9740 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | MELOXICASH | MELOXICAM | 5MG/ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE | 05/10/2021 |
| NDA/MAL/VDP/9743 | LAPROVET-HUNGARY VETERINARY PHARMACEUTICALS LTD | EVERVICTORY LIMITED | AVI ND HB1 + IB | NEWCASTLE DISEASE VIRUS (HITCHNER B1 STRAIN) + AVIAN INFECTIOUS BRONCHITIS VIRUS (MASSACHUSETTS TYPE B-48 STRAIN), LIVE | NOT LESS THAN 10^5.5 EID50 + NOT LESS THAN 10^3.0 EID50 | CEVA- PHYLAXIA VETERINARY BIOLOGICALS CO. LTDSZALLAS UTCA 5, BUDAPEST, 1107 - HUNGARY | HUNGARY | | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0X1000.0 DOSE VIAL | 05/10/2021 |
| NDA/MAL/VDP/9744 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | BURSINE®-2 | LIVE, INFECTIOUS BURSAL DISEASE VIRUS (LUKERT STRAIN) | NOT LESS THAN 10^3.6 TCI D50 AT RELEASE/DOSE | ZOETIS2000 ROCKFORD ROAD, CHARLES CITY, IOWA 50616-9101 | UNITED STATES | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL | 05/10/2021 |
| NDA/MAL/VDP/9890 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | BURSINE® PLUS | LIVE, INFECTIOUS BURSAL DISEASE VIRUS (LUKERT STRAIN) | NOT LESS THAN 10^2.4 TCID50 AT EXPIRATION/DOSE (0.005ML) | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.LCTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1000.0 DOSE VIAL | 05/10/2021 |
| NDA/MAL/VDP/9891 | ZOETIS BELGIUM SA | VET CENTRE UGANDA LIMITED | MD-VAC® CFL | MAREK’S DISEASE VACCINE, SEROTYPE 3, LIVE VIRUS | NOT LESS THAN 1500 PFU /DOSE (AT RELEASE) | ZOETIS MANUFACTURING AND RESEARCH SPAIN, S.LCTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA | SPAIN | | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 DOSE VIAL + 1*200ML OF DILUENT, GLASS BOTTLE | 08/12/2021 |
| NDA/MAL/VDP/9892 | ASHISH LIFE SCIENCE PVT. LTD. | ASHISH LIFE SCIENCE UGANDA LIMITED | FENACURE 10% | FENBENDAZOLE | 100MG/ML | ASHISH LIFE SCIENCES PVT LTDJ-137, MIDC TARAPUR, BOISAR 40150, DIST. THANE MAHARASHTRA INDIA | INDIA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER | 21/12/2021 |
| NDA/MAL/VDP/2881 | NORBROOK KENYA LTD | NORBROOK (U) LTD | DUODIP 50:5 % | CHLORPYRIFOS + CYPERMETHRIN | 50%W/V + 5%W/V | NORBROOK KENYA LIMITED.P.O BOX 1287,00606 OLD LIMURU ROAD KARURI NAIROBI,KENYA(REPACKAGING) | KENYA | | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X50.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/2013 |
| NDA/MAL/VDP/5701 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | DIPEN | DIHYDROSTREPTOMYCIN/ BENZYL PENICILLIN | 200MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | | CHINA | | NON-HUMAN USE LIQUIDS | 1.0X100.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5733 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | ENDOSPEC 10% | ALBENDAZOLE | 100MG/ML | MEDISEL (K) LTD-PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X5.0 L JERRYCAN | 01/07/1997 |
| NDA/MAL/VDP/5752 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | TETROXY INJECTION | OXYTETRACYCLINE HYDROCHLORIDE | 100MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHONGOING FANGTONG ANIMAL PHARMACEUTICALS CO. LTDBANQIAO INDUSTRIAL PARK, RONGCHANG, CHONGOING, CHINA | | BULGARIA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5755 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | TETROXY LA | OXYTETRACYCLINE HYDROCHLORIDE | 200MG/ML | CHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | CHINA | | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5761 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | PARVEXON INJECTION | PARVAQUONE | 150MG/ML | BIOVET JOINT STOCK COMPANY -FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550 | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY COMPANY LIMITED 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | BULGARIA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/1997 |
| NDA/MAL/VDP/5763 | BIMEDA CHEMICAL EXPORT | BIMEDA UGANDA LIMITED | PARVEXON PLUS | PARVAQUONE + FRUSEMIDE | 150MG + 55MG/ML | BIOVET JOINT STOCK COMPANY -FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550 | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY COMPANY LIMITED 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | BULGARIA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/2000 |
| NDA/MAL/VDP/5898 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | MULTIVITAMIN INJECTION | MULTIVITAMIN | MULTI-INGREDIENT | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO. LTDNO.80 EAST PART OF CHANGZHOU ROAD BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA | | BULGARIA | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/1997 |
| NDA/MAL/VDP/5915 | BIMEDA UGANDA LIMITED | BIMEDA UGANDA LIMITED | BIMATRAZ | AMITRAZ | 12.5% W/V | IMPACT CHEMICALS LIMITEDKC ARORA COMPLEX, MOMBASA ROAD, | CHONGQING FANTONG ANIMAL PHARMACEUTICALSBANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING | | CHINA | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L CONTAINER,1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER | 01/07/1999 |
| NDA/MAL/VDP/5917 | BIMEDA UGANDA LIMITED | BIMEDA UGANDA LIMITED | BIMECTIN INJECTION | IVERMECTIN | 10MG/ML | CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY COMPANY LIMITED 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | CHINA | | PARENTERAL ORDINARY S C VIALS | 1.0X500.0 ML VIAL,1.0X50.0 ML VIAL,1.0X20.0 ML VIAL,1.0X100.0 ML VIAL | 01/07/1998 |
| NDA/MAL/VDP/5945 | CEVA SANTE ANIMALE | VERI BRANDS U LTD | VERIBEN | DIAMINAZENE DIACETURATE | 445MG/G | CEVA SANTE ANIMALE .ZI-TRES LE BOIS 22600-LOUDEAC | FRANCE | | OTHER SYSTEMIC SPECIAL SOLIDS | 1.0X2.36 G SACHET | 01/07/1997 |
| NDA/MAL/VDP/5948 | CEVA SANTE ANIMALE | VERI BRANDS U LTD | VERIDIUM | ISOMETAMIDIUM HCL | 125MG,1G | CEVA SANTE ANIMALE .ZI-TRES LE BOIS 22600-LOUDEAC | FRANCE | | OTHER SYSTEMIC POWDER | 1.0X10.0X125.0 MG SACHET,1.0X10.0X1.0 G SACHET | 01/07/1997 |
| NDA/MAL/VDP/5968 | UNIVET LTD | BIMEDA UGANDA LIMITED | TRAMAZOLE | ALBENDAZOLE | 10%W/V | MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X5.0 L JERRYCAN,1.0X2.5 L JERRYCAN,1.0X120.0 ML BOTTLE,1.0X1.0 L JERRYCAN | 01/07/2000 |
| NDA/MAL/VDP/5969 | BIMEDA CHEMICAL EXPORTS LTD | BIMEDA UGANDA LIMITED | BUPARVEX | BUPARVAQUONE | 50MG/ML | HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO. LIMITEDNO. 60 GANJIANG ROAD, SHIJIAZHUANG ECONOMIC AND TECHNOLOGY DEVELOPMENT ZONE, CHINA | BIOVET JOINT STOCK COMPANY FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550 | | BULGARIA | CHINA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X50.0 ML BOTTLE | 01/07/2005 |
| NDA/MAL/VDP/7056 | NORBROOK KENYA LTD | NORBROOK (U) LTD | EPRIZERO | EPRINOMECTIN | 5MG/ML | NORBROOK LABS LTDFACTORY 4, CARNBANE INDUSTRIAL ESTATE, NEWRY BT35 6QQ, CO DOWN, NORBROOK LABS LTD FACTORY 3, 105 ARMAGH ROAD, NEWRY, BT35 6PU CO.; / | UNITED KINGDOM | | TOPICAL EXTERNAL LIQUIDS | 1.0X5.0 L CONTAINER,1.0X0.25 L CONTAINER,1.0X2.5 L CONTAINER,1.0X1.0 L CONTAINER,1.0X1.0 L CONTAINER,1.0X2.5 L CONTAINER | 27/03/2019 |
| NDA/MAL/VDP/8181 | UNIVET LTD | BIMEDA UGANDA LIMITED | CURAFLUKE | FENBENDAZOLE+RAFOXANIDE | 5%W/V+5%W/V | MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYA | | KENYA | | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0 L JERRYCAN | 01/07/2017 |
| NDA/MAL/VDP/8399 | BIMEDA CHEMICAL EXPORTS | BIMEDA UGANDA LIMITED | AMINOVITAL | MULTIVITAMIN | MULTI-INGREDIENT | MEDISEL (K) LTD-PLOT NO. 4953/1209, GENERAL KAGO ROAD, THIKA | | KENYA | | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X500.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X1.0 L BOTTLE | 01/07/1998 |
| S/N | REG NUMBER | LICENCE HOLDER | LOCAL TECHNICAL REPRESENTATIVE | NAME OF DRUG | MANUFACTURER | COUNTRY OF MANUFACTURE | DOSAGE FORM | PACK SIZES | DATE OF REGISTRATION |
|---|---|---|---|---|---|---|---|---|---|
| 1 | HDA094 | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA HERBAL SOAP | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA,TEL: 0414 271 214 | UGANDA | SOAP | 100GM & 120GM | 29/08/2017 |
| 2 | HDA095 | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA | SAMONA HERBAL JELLY | SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA,TEL: 0414 271 214 | UGANDA | OINTMENT | 50GM,100GM,150GM,250GM,& 500GM | 29/08/2017 |
| 3 | HDA129/02/16 | NSIMYE HERBAL MEDICINE RESEARCHERS | NSIMYE HERBAL MEDICINE RESEARCHERS | KABUUTI HERBAL SYRUP | NSIMYE HERBAL MEDICINE RESEARCHERS,KIKUUBO ZONE IV,KANYANYA PARISH,KAWEMPE DIV,TEL: 0782 457 919/0708 457 919 | UGANDA | SYRUP | 1*100ML HDPE BOTTLE IN A CARTON | 25/01/2022 |
| 4 | THA 1020 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELO-ENJO | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA ELOIPHARM@GMAIL.COM | UGANDA | LIQUID | 200 MLS | 27/02/2023 |
| 5 | THA 346 | NANA HERBAL PRODUCTS (U) LTD MENGO HILL ROAD, KAMPALA-UGANDA | NANA HERBAL PRODUCTS (U) LTD MENGO HILL ROAD, KAMPALA-UGANDA | NANA HERBAL MOUTHWASH | NANA HERBAL PRODUCTS (U) LTD MENGO HILL ROAD, KAMPALA-UGANDA | UGANDA | SPRAY | 60ML BOTTLE | 03/10/2017 |
| 6 | THA 582 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | CARMILEX DIGESTIVE TONIC | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | LIQUID | 1*100ML. AMBER PET BOTTLE | 07/05/2019 |
| 7 | THA 585 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | PAIN NIL HERBAL CREAM | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | CREAM | 1*25GWHITE PET BOTTLE | 02/10/2019 |
| 8 | THA 819 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD, P.O. BOX 36766, KAMPALA, UGANDA 0758329111 | ELOLAX | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA ELOIPHARM@GMAIL.COM | UGANDA | LIQUID | 100 MLS | 27/02/2023 |
| 9 | THA018 | KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE | KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE | KIPO HERBAL SKIN OINTMENT | KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE P.O.BOX 25562, KAMPALA 0782351873/0753-807748 | UGANDA | OINTMENT | 1*50 & 100G IN PET JAR | 03/03/2018 |
| 10 | THA1000 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | COFFVOP HERBAL MIXTURE | VAX ORGANIC PRODUCTS BULOBA ALONG MITYANA ROAD ,WAKISO DISTRICT TEL:0775827379/0755540110 | UGANDA | LIQUID | 200ML PET BOTTLE | 27/02/2023 |
| 11 | THA1001 | KATEREGGA HUSSEIN TEL: 0701466596 | KATEREGGA HUSSEIN TEL: 0701466596 | AFRI BALM | KATEREGGA PHYSIOTHERAPY SERVICES KIBULI DIPPO TEL: 0781466596/0700414277/0701466596 | UGANDA | OINTMENT | 20 AND 80G PET CONTAINER | 27/02/2023 |
| 12 | THA1002 | EARTH NATURAL LIFE LTD, MAWANDA ROAD,NEAR YUDESI PRIMARY SCHOOL,KAMPALA | EARTH NATURAL LIFE LTD, MAWANDA ROAD,NEAR YUDESI PRIMARY SCHOOL,KAMPALA | INFLA | EARTH NATURAL LIFE LTD, MAWANDA ROAD,NEAR YUDESI PRIMARY SCHOOL,KAMPALA,UGANDA TEL: 0779412612/0758 654620 EMAIL: EARTHNATURALLIFE@GMAIL.COM | UGANDA | LIQUID | 1*500ML WHITE HDPE BOTTLE | 07/09/2022 |
| 13 | THA1007 | BAMAKOOLA HERBAL PRODUCTS NEAR MENGO POST OFFICE TEL: +256(0)712406847 | BAMAKOOLA HERBAL PRODUCTS NEAR MENGO POST OFFICE TEL: +25690)712406847 | ZUUKUKA HERBL POWDER | BAMAKOOLA HERBAL PRODUCTS NEAR MENGO POST OFFICE TEL: +25690)712406847 | UGANDA | POWDER | 100GM HDPE CONTAINER | 07/09/2022 |
| 14 | THA1008 | MUHUMUZA JAMES TEL: 0772460171/0755460171 E-MAIL: TROALOELDS1@GMAIL.COM | MUHUMUZA JAMES TEL: 0772460171/0755460171 E-MAIL: TROALOELDS1@GMAIL.COM | AHACOD-II HERBAL SYRUP | TROPICAL ALOELANDS FOUNDATION TEL: +256772460171,+256755460171 E-MAIL: TROALOELDS1@GMAIL.COM KAMPLALA,UGANDA | UGANDA | SYRUP | 1*200ML PLASTIC BOTTLE | 26/05/2023 |
| 15 | THA1013 | ZAMURI HAIR ESSENTIALS SMS LTD MUTUNDWE KAMPALA ROAD UGANDA TEL:0200926769/0755108006 | ZAMURI HAIR ESSENTIALS SMS LTD MUTUNDWE KAMPALA ROAD UGANDA TEL:0200926769/0755108006 | ZAMURI ORGANIC POWDERED SHAMPOO | ZAMURI HAIR ESSENTIALS SMS LTD MUTUNDWE KAMPALA ROAD UGANDA TEL:0200926769/0755108006 | UGANDA | POWDER | 100GM ALU/ALU SACHET | 09/02/2022 |
| 16 | THA1014 | NGOBI MUKADASI, PEARL HERBALS (U) LIMITED | NGOBI MUKADASI, PEARL HERBALS (U) LIMITED | BANUTWE FLU & COUGH HERBAL SYRUP | PEARL HERBALS (U) LIMITED, KAYUNGA DISTRICT,KAYONZA SUB COUNTY,KANYWERO PARISH TEL:0752837021,0782837021 | UGANDA | LIQUID | 200ML HDPE BOTTLE | 07/09/2022 |
| 17 | THA1017 | MR TAYEBWA WYCLIFF, KASHASHA CELL, ITOJO PARISH, RUHAMA SUBCOUNTY, NTUNGAMO | SAUDA HEALTHY PRODUCT (U) LTD | SAUDA HERBAL SYRUP | SAUDA HEALTHY PRODUCT (U) LTD KASHASHA CELL-ITOJO PARISH, RUHAMA SUBCOUNTY, NTUNGAMO DISTRICT | UGANDA | LIQUID | 100ML | 04/05/2023 |
| 18 | THA1021 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOCID MIXTURE | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA ELOIPHARM@GMAIL.COM | UGANDA | LIQUID | 200 MLS | 16/12/2022 |
| 19 | THA1038 | MR.AMBROSE OGWANG AMBROSOLI HERBAL PRODUCTS AMOLATADISTRICT AMIRIMIRI WARD TEL:0773312693 | MR.AMBROSE OGWANG AMBROSOLI HERBAL PRODUCTS AMOLATADISTRICT AMIRIMIRI WARD TEL:0773312693 | DIAPUTEX | MR.AMBROSE OGWANG AMBROSOLI HERBAL PRODUCTS AMOLATAR DISTRICT AMIRI MIRI WARD TEL:0773312693 | UGANDA | POWDER | 1*250GM IN A TRANSPARENT PLASTIC JAR | 07/09/2022 |
| 20 | THA1044 | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI, KIREKA, P.O BOX 6034, KAMPALA, UGANDA | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI, KIREKA, P.O BOX 6034, KAMPALA, UGANDA | PAINEX BALM | RENE INDUSTRIES LIMITED, PLOT 680, KAMULI, KIREKA, P.O BOX 6034, KAMPALA, UGANDA TEL:+256414236595 E-MAIL: INFO@RENE.CO.UG | UGANDA | BALM | 9G GLASS JAR | 27/01/2023 |
| 21 | THA1045 | UGANICS REPELLENTS LTD TEL: +256(0)702100900 +256(0)777211055 +256(0)752315007 | UGANICS REPELLENTS LTD TEL: +256(0)702100900 +256(0)777211055 +256(0)752315007 | CLEANMATE MOSQUITO REPELLENT CREAM | UGANICS REPELLENTS LTD,NSOZIBILYE,PLOT 61,KABASANDA, P.O.BOX 102330,KAMPALA ,UGANDA | UGANDA | CREAM | 90ML HDPE BOTTLE | 27/05/2022 |
| 22 | THA1050 | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | SIBMOS MOSQUITO REPELLANT SPRAY | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE P.O.BOX 12889,KAMPALA +256761670543 | UGANDA | AEROSOL | 60ML SPRAY | 07/09/2022 |
| 23 | THA1051 | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE | LUNAKOFF | SIBPHARM LTD PLOT 1830 SSENYONGA ROAD GOODWILL ZONE MAKINDYE P.O.BOX 12889,KAMPALA +256761670543 | UGANDA | LIQUID | 200ML AND 100ML PET AMBER BOTTLE | 07/09/2022 |
| 24 | THA1073 | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD | BIGGI SINA SYRUP | BIGGI HERBAL CLINIC P.O. BOX 10479 KAMPALA, PLOT 5176 BLOCK 383 BWEYA ENTEBBE ROAD TEL 0772484882 0705484882 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 04/08/2023 |
| 25 | THA1079 | AHHUU BARINTUMYE HERBAL CLINICAL RESEARCH LTD 0772392795/0756438883 | AHHUU BARINTUMYE HERBAL CLINICAL RESEARCH LTD 0772392795/0756438883 | AHHUU STAMINA DRINK | AHHUU BARINTUMYE HERBAL CLINICAL RESEARCH LIMITED KIKUMBI-KANSOLEETI PLOT 104,BUSINZIGGO ROAD – MITYANA TEL: 0754392795/0772392795 | UGANDA | LIQUID | 300ML IN AMBER COLOURED PLASTIC BOTTLE | 26/05/2023 |
| 26 | THA1081 | KAZIRE HEALTH PRODUCTS LTD PLOT 178, KABALE RD P.O.BOX 1802 MBARARA CITY TEL 0782801622 | KAZIRE HEALTH PRODUCTS LTD PLOT 178, KABALE RD P.O.BOX 1802 MBARARA CITY TEL 0782801622 | ALSATON | KAZIRE HEALTH PRODUCTS LTD PLOT 178, KABALE RD P.O.BOX 1802 MBARARA CITY TEL 0782801622 | UGANDA | LIQUID | 200ML PET BOTTLE | 07/09/2022 |
| 27 | THA1083 | KASTEL HERBALS LIMITED KAZIMOTO STEVEN 1 KM OFF NANSANA-NNABWERU ROAD WAKISO DISTRICT | KASTEL HERBALS LIMITED KAZIMOTO STEVEN 1 KM OFF NANSANA-NNABWERU ROAD WAKISO DISTRICT | KASTEL COUGH MIXTURE | KASTEL HERBALS LIMITED NANSANA-KABUMBI ROAD BUJAGALI WAKISO UGANDA TEL:+25674195201/07877741684 KASTELHERBALSLTD@GMAIL.COM | UGANDA | LIQUID | 200ML PET BOTTLE | 27/02/2023 |
| 28 | THA1087 | BUSITEMA UNIVERSITY NATURAL PRODUCTS AND DRUGS RESEARCH GROUP (BUNAPREG) | BUSITEMA UNIVERSITY NATURAL PRODUCTS AND DRUGS RESEARCH GROUP (BUNAPREG) | TAZCOV SYRUP | BUSITEMA UNIVERSITY NATURAL PRODUCTS AND DRUGS RESEARCH GROUP (BUNAPREG), TEL; +256704946479/+256785466337 | UGANDA | LIQUID | 100ML PET BOTTLE | 07/09/2022 |
| 29 | THA1093 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA, | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA, | KIRUNGI KAZI BOOSTER | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | LIQUID | 270ML | 04/05/2023 |
| 30 | THA1094 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | KAZI BOOSTER MULONDO EXTRA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | LIQUID | 270ML | 26/05/2023 |
| 31 | THA1097 | BAMU INTERNATIONAL GROUP OF RESEARCHERS. | BAMU INTERNATIONAL GROUP OF RESEARCHERS. | BAMU HERBAL COUGH SYRUP | BAMU INTERNATIONAL GROUP OF RESEARCHERS. KIREKA-KAMULI ROAD St.GONZAGA GONZA CATHOLIC PARISH0776992091/0755992091 | UGANDA | LIQUID | 1*2OOML AMBER PLASTIC BOTTLE | 25/07/2023 |
| 32 | THA1104 | SSENDEGE ISMAIL NSAMBYA 0761099626 | SSENDEGE ISMAIL NSAMBYA 0761099626 | MUQ CHARCOAL TOOTH PASTE | MUQ HABO PRODUCTS KAMPALA UGANDA NEAR KATWE PRIMARY SCHOOL TEL: +256761099626 +256755206349 | UGANDA | GEL | 50GM | 27/01/2023 |
| 33 | THA1110 | PHARMA FLEX LIMITED | PHARMA FLEX LIMITED | ULCEFLEX HERBAL POWDER | PHARMA FLEX LIMITED, NAMUGONGO BULOOLI ,WABUSAANA ,KIRA MUNICIPALITY , WAKISO DISTRICT , UGANDA, 0771756555 | UGANDA | POWDER | 1*3 SACHETS EACH 5G IN A CARTON | 04/05/2023 |
| 34 | THA1122 | KABATERINE EDMAND, 0787870908 EDMANDKABZ@GMAIL.COM NANTABULIRWA, GOMA, MUKONO DISTRICT | KABATERINE EDMAND, 0787870908 EDMANDKABZ@GMAIL.COM NANTABULIRWA, GOMA, MUKONO DISTRICT | ZERO BYTE MOSQUITO REPELLENT BATHING BAR | KAKIE ORGANICS AND NUTRACEUTICALS LTD, WANDEGEYA,KAMPALA-UGANDA 0787 870908/0757 613026 | UGANDA | SOAP | 60GMS IN A BOX CARTON | 25/07/2023 |
| 35 | THA1136 | MUKWAYA JAMIR LUTAKOME, 0772538794/0702538794, NDEEBA OPP. TOTAL PETROL STATION | MUKWAYA JAMIR LUTAKOME, 0772538794/0702538794, NDEEBA OPP. TOTAL PETROL STATION | ZAMZAM HERBAL COUGH MIXTURE | BWAKEDDE MPULIRA TRADITIONAL MEDICINES NDEEBA OPP TOTAL PETROL STATION | UGANDA | LIQUID | 238ML PET BOTTLE | 27/02/2023 |
| 36 | THA1139 | MWEYUNDO HEALTH PRODUCTS LTD PLOT 4, RIVERSIDE ROAD, CENTRAL DIVISION | MWEYUNDO HEALTH PRODUCTS LTD PLOT 4, RIVERSIDE ROAD, CENTRAL DIVISION | MWECODEX | MWEYUNDO HEALTH PRODUCTS LTD PLOT 4, RIVERSIDE ROAD, CENTRAL DIVISION P.O.BOX 390051, FORT PORTAL TEL: +256752852051 +256786746493 | UGANDA | LIQUID | 200ML PET AMBER BOTTLE | 11/09/2023 |
| 37 | THA1172 | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | OMUKAMA MOSQUITO REPELLANT JELLY | OMUKAMA NATURALS, KIGO LUNYA NDEJJE WARD MAKINDYE SSABAGABO-WAKISO TEL: 0756586146 | UGANDA | JELLY | 50GMS ,60GMS,120GMS AND 200GMS PLASTIC JAR | 25/07/2023 |
| 38 | THA1176 | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | BACTOFLEX | KATEREGGA ISMAEL,NAMUGONGO BULOOLI KIRA WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | UGANDA | CREAM | 10G AND 60 G COLLAPSIBLE PLASTIC TUBE | 17/11/2023 |
| 39 | THA1177 | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | KATEREGGA ISMAEL,NAMUGONGO BULOOLI, KIRA ,WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | CUREFLEX HERBAL CREAM CREAM | KATEREGGA ISMAEL,NAMUGONGO BULOOLI KIRA WAKISO DISTRICT 0771756555 PHARMAFLEX LTD | UGANDA | CREAM | 10G AND 60 G COLLAPSIBLE PLASTIC TUBE | 17/11/2023 |
| 40 | THA1184 | NANA HERBAL PRODUCTS UGANDA LTD. P.O.BOX 10815,BULOBA OFF MITYANA ROAD 0392081170 | NANA HERBAL PRODUCTS UGANDA LTD. P.O.BOX 10815,BULOBA OFF MITYANA ROAD 0392081170 | CHOCOMEL | NANA HERBAL PRODUCTS UGANDA LTD. P.O.BOX 10815,BULOBA OFF MITYANA ROAD | UGANDA | LIQUID | 250ML PET BOTTLE | 15/07/2023 |
| 41 | THA137 | DEI NATURAL PRODUCTS INTERNATIONAL LTD | DEI NATURAL PRODUCTS INTERNATIONAL LTD | ARTAVOL | DEI NATURAL PRODUCTS INTERNATIONAL LTD,PLOT 5685-KABAGAMBE CLOSE-MUYENGA P.O.BOX 35854,KAMPALA UGANDA TEL: +256 414-660-519 MOB: +256-752- | UGANDA | POWDER | 1*100GM IN A METALLIC TIN | 17/06/2019 |
| 42 | THA171 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | DARACUF HERBAL COUGH MIXTURE | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | UGANDA | LIQUID | 120ML PET BOTTLE WITH PRINTED LABEL AND SEALED WITH A WHITE LDPE CAP | 01/10/2021 |
| 43 | THA183 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | KWESIIMA COUGH MIXTURE | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | UGANDA | SUSPENSION | 1*200ML PET BOTTL | 03/02/2020 |
| 44 | THA197 | NAKAGWA HENRICA,KISAASI,KAMPALA | NAKAGWA HENRICA,KISAASI,KAMPALA | PALANS COUGH MIXTURE | NAKAGWA HENRICA,KISAASI,KAMPALA,Tel 0700 665917/0782 007752 | UGANDA | SYRUP | 1*100ML,PET BOTTLE | 28/08/2021 |
| 45 | THA198 | AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA | AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA | STILE HERBAL SOLUTION | AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA +256782361761/ +256753361761 EMAIL: AMANSMICHEAL@GMAIL.COM | UGANDA | LIQUID | 1*500ML PET BOTTLE | 17/07/2018 |
| 46 | THA206 | GREEN PHARMACY | GREEN PHARMACY | AGNUS CACTUS | Green Pharmacy 11 Pokino Luzige Road Kirumba A Masaka,Tel: 0779 829914 | UGANDA | ORAL SOLUTION | 1*100ML AMBER PET BOTTLE | 06/02/2017 |
| 47 | THA207 | GREEN PHARMACY | GREEN PHARMACY | CALENDULA | GREEN PHARMACY 11 POKINO LUZIGE ROAD, KIRUMBA “A” MASAKA,Tel:0779 829914 | UGANDA | OINTMENT | 50GRAMS | 28/08/2021 |
| 48 | THA209 | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA ‘A’ MASAKA P.O BOX 886, MASAKA. TEL:0779829914 | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA ‘A’ MASAKA P.O BOX 886, MASAKA. TEL:0779829914 | BODY REJUVENATING TONIC | GREEN PHARMACY 11 POKINO LUZIGE ROAD KIRUMBA ‘A’ MASAKA P.O BOX 886, MASAKA. TEL:0779829914 | UGANDA | LIQUID | 100ML HDPE BOTTLE | 09/11/2020 |
| 49 | THA210 | GREEN PHARMACY | GREEN PHARMACY | AMBER PAIN STOP | GREEN PHARMACY 11 POKINO LUZIGE ROAD, KIRUMBA “A” MASAKA Tel: 0779 829914 | UGANDA | OINTMENT | 50GRAMS | 28/08/201 |
| 50 | THA211 | GREEN PHARMACY | GREEN PHARMACY | BLOOD CLEANSER AND DETOXIFIER | Green Pharmacy 11 Pokino Luzige Road Kirumba A Masaka,Tel: 0779 829914 | UGANDA | ORAL LIQUID | 100ML PET BOTTLE | 06/02/2017 |
| 51 | THA212 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | TEEMAC A4 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 40GMS AND 18GMS | 06/04/2018 |
| 52 | THA213 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | MONITEEMAC BA4 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 18GMS AND 32 GMS | 06/04/2018 |
| 53 | THA214 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | TEEMONI B4 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 50GMS & 35GMS | 06/04/2018 |
| 54 | THA215 | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, | TEEBUO | AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780 | UGANDA | POWDER | 15GMS & 6GMS | 06/04/2018 |
| 55 | THA226 | MBUNDA HEALTH PRODUCTS | MBUNDA HEALTH PRODUCTS | MBUNDA HERBAL COUGH SYRUP | MBUNDA HEALTH PRODUCTS 0771-448469/ 0758-555876/0700-507258 KATEMBWA, BUNYANGABO, KASESE DISTRICT | UGANDA | SYRUP | 100MLS IN A WHITE BOTTLE | 26/04/2019 |
| 56 | THA229/01/16 | CREST NATURAL HEALTH CENTRE | CREST NATURAL HEALTH CENTRE | PROST TINCTURE | CREST NATURAL HEALTH CENTRE A.K PLAZA OPPOSITE ALOYSIUS COMPLEX KALERWE, ,Dr.Lutwaama George TEL: 0770 704 880/ 0750 185 580 | UGANDA | SOLUTION | 1*20ML HDPE | 31/05/2016 |
| 57 | THA247 | YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD | YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD | YECO COUGH DOCTOR | YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD, Tel: +256 705 454951 | UGANDA | SYRUP | 1*120ML HDPE AMBER BOTTLE | 06/02/2017 |
| 58 | THA271 | MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748 | MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748 | MATIA SSETUTEMBA HERBAL REMEDIES | MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748 | UGANDA | LIQUID | 5 L HDPE CAN | |
| 59 | THA284 | RUTEDA HERBAL PRODUCTS, NTUNGAMO,RUBAARE 0772369781/0752 369 781 RUTEDAPRODUCTS@YAHOO.COM | RUTEDA HERBAL PRODUCTS, NTUNGAMO,RUBAARE 0772369781/0752 369 781 RUTEDAPRODUCTS@YAHOO.COM | RUTEDA LADY’S MANTLE | RUTEDA HERBAL PRODUCTS, NTUNGAMO,RUBAARE 0772369781/0752 369 781 RUTEDAPRODUCTS@YAHOO.COM | UGANDA | LIQUID | 1*400ML AND 1*800ML PET BOTTLE | 01/10/2021 |
| 60 | THA289 | PIPAX LTD | PIPAX LTD | DERMACOL | PIPAX LTD,PLOT 20 BUZIGA RING ROAD KAMPALA, MR.EGUMAH PIE,TEL:0754 618691 | UGANDA | ORAL SUSPENSION | 100ML AMBER PET BOTTLE | 06/02/2017 |
| 61 | THA290 | JONITA INVESTMENTS,MUTUNDWE, MIREMBE ZONE | JONITA INVESTMENTS,MUTUNDWE, MIREMBE ZONE | SAVANAH HERBAL SYRUP | JONITA INVESTMENTS,MUTUNDWE, MIREMBE ZONE TEL: 0756 636262/0784908004EMAIL: tjohnbosco56@gmail.com | UGANDA | SYRUP | 1*100ML PLASTIC AMBER BOTTLE | 25/01/2019 |
| 62 | THA291 | DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338 | DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338 | DAMALEO VERA TABLETS | DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338 | UGANDA | TABLETS | 1*5*10 ALU-PVC BLISTERS | 12/03/2018 |
| 63 | THA292 | GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD | GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD | GABOGOLA SYRUP | GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD,TEL:0772 532353,EMAIL:GABOGOLAAGENCIES@GMAIL.COM | UGANDA | SYRUP | 300ML GLASS BOTTLE | 29/03/2018 |
| 64 | THA294 | KIWANUKA AND SONS HERBAL SERVICES | KIWANUKA AND SONS HERBAL SERVICES | LUCAS SYRUP | KIWANUKA AND SONS HERBAL SERVICES,BWEYOGERERE NTEBETEBE ZONE,P.O.BOX 9263,KAMPALA-UGANDA TEL: 0772 511153/0754 280 718 | UGANDA | SYRUP | 1*100ML AMBER GLASS BOTTLE | 14/11/2018 |
| 65 | THA295 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL COUGH SYRUP | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | UGANDA | SYRUP | 100ML &200ML PET BOTTLE | 10/10/2017 |
| 66 | THA296 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI ULCER HERBAL MEDICINE | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | UGANDA | SYRUP | 100ML &200ML PET BOTTLE | 10/10/2017 |
| 67 | THA297 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | BIGGI HERBAL MALARIA SYRUP | BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882 | UGANDA | SYRUP | 100ML &200ML PET BOTTLE | 10/10/2017 |
| 68 | THA301 | MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA | MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA | MALARID | MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA | UGANDA | SYRUP | 1*60ML PET BOTTLE | 29/08/2017 |
| 69 | THA302 | BANGI BALISIMA UNITED AFRICAN MEDICINE INDUSTRY AND PHARMACY RESEARCH CENTRE, NAKASEKE,SEMUTO | BANGI BALISIMA UNITED AFRICAN MEDICINE INDUSTRY AND PHARMACY RESEARCH CENTRE, NAKASEKE,SEMUTO | SUPER MULABE | BANGI BALISIMA UNITED AFRICAN MEDICINE INDUSTRY AND PHARMACY RESEARCH CENTRE,NAKASEKE,SEMUTO +256 75000580 | UGANDA | LIQUID | 300ML HDPE BOTTLE | 09/11/2020 |
| 70 | THA331 | AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115 | AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115 | BAYAN HERBAL SYRUP | AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115 | UGANDA | SYRUP | 50ML AMBER PLASTIC BOTTLE | 08/11/2017 |
| 71 | THA333 | MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT | MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT | MAMULA COUGH MIXTURE | MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT | UGANDA | LIQUID | 400ML BOTTLE | 27/02/2018 |
| 72 | THA342 | ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA | ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA | ROPER FREE MOSQUITO REPELLENT | ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA,TEL:+256 770838356/+256 772 421235, ROPERFREE@JKASUMBAS.COM | UGANDA | EMULSION | 1*100 ML & 1* 60 ML HDPE BOTTLE | 23/01/2018 |
| 73 | THA344 | SSEKANDI HAKIM HASHA PRODUCT (U) LTD, 0751110866/0703110866 HKINDUSTRIES@GMAIL.COM | SSEKANDI HAKIM HASHA PRODUCT (U) LTD, 0751110866/0703110866 HKINDUSTRIES@GMAIL.COM | HASHA HERBAL COUGH MIXTURE | HASHA PRODUCT (U) LTD,KAMPALA,NSANGI,KYENGERA,MASAKA ROAD,UGANDA | UGANDA | LIQUID | 1*60ML PET BOTTLE | 07/09/2022 |
| 74 | THA347 | RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO | RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO | DEFENDER TONIC | RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO | UGANDA | POWDER | 1*100G BOTTLE | 20/09/2017 |
| 75 | THA354 | GWOWONYA EGGERE HERBAL SERVICES | GWOWONYA EGGERE HERBAL SERVICES | HEG HERBAL MOUTHWASH | GWOWONYA EGGERE HERBAL SERVICES 0704578355 EZEESHADIA@GMAIL.COM P. O. BOX 30982 KAMPALA UGANDA | UGANDA | SOLUTION | 200ML PET BOTTLE | 27/02/2018 |
| 76 | THA355 | ZURI HOMEOPATHICS | ZURI HOMEOPATHICS | TYPHO-CURUM | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 zurimedicine@gmail.com | UGANDA | SYRUP | 1*60ml Amber PET bottle | 08/11/2017 |
| 77 | THA357 | VISIONARY HEALTH LINK KAMPALA UGANDA 0751501406 | VISIONARY HEALTH LINK KAMPALA UGANDA 0751501406 | BREMOXI | VISIONARY HEALTH LINK KAMPALA UGANDA 0751501406 | UGANDA | SYRUP | 1*100ML PET BOTTLE | 14/11/2018 |
| 78 | THA359 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | MZAVA | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | UGANDA | POWDER | 150GM POWDER | 02/12/2022 |
| 79 | THA361 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | SIMMA HERBAL COUGH SYRUP | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | UGANDA | SYRUP | 1*120ML IN AMBER LDPE BOTTLE | 21/05/2019 |
| 80 | THA362 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | HERBEM NATURAL MOUTHWASH | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | UGANDA | SOLUTION | 120ML IN LDPE BOTTLE | 21/05/2019 |
| 81 | THA363 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | RUMATI | MADAME HERBALS KIREKA KAMULI – NAALYA ROAD ,P.O BOX 8224 KAMPALA ,UGANDA 0782-559123 | UGANDA | OINTMENT | 1*30G IN LDPE JAR | 21/05/2019 |
| 82 | THA364 | TAYEBWA HEALTH PRODUCTS LTD | TAYEBWA HEALTH PRODUCTS LTD | TAYEBWA HERBAL COUGH SYRUP | TAYEBWA HEALTH PRODUCTS LTD KASHASHA CELL – ITOJO PARISH RUHAMA SUBCOUNTY, NTUNGAMO DISTRICT 0772-927206 | UGANDA | SYRUP | 1*100ML AMBER PET BOTTLE | 01/12/2017 |
| 83 | THA366 | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION | TESOCOKO “B” | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION SABAGABO-MAKINDYE MUNICIPALITY WAKISO DISTRICT 0779071321/0704510148 | UGANDA | POWDER | 1*100G IN A CLEAR PET JAR | 20/09/2017 |
| 84 | THA367 | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION | TESOCOKO “G” | RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION SABAGABO-MAKINDYE MUNICIPALITY WAKISO DISTRICT 0779071321/0704510148 | UGANDA | POWDER | 1*100G IN A CLEAR PET JAR | 20/09/2017 |
| 85 | THA368 | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA | HEG HERBAL COUGH MIXTURE | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 0700 3134484 | UGANDA | LIQUID | 200ML | 06/04/2018 |
| 86 | THA369 | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448 | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448 | HEG HERBAL ULCER SOLUTION | GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448 | UGANDA | SOLUTION | 500ML IN AN HDPE BOTTLE | 31/01/2018 |
| 87 | THA371 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | MUCURA HERBAL MEDICINE | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 88 | THA372 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | WAMPEMBE SYRUP | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 89 | THA373 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | GANYANA HERBAL MEDICINE | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 90 | THA374 | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN | MWAMBALA HERBAL MEDICINE | SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181 | UGANDA | SYRUP | 1*250ML IN AN HDPE BOTTLE | 31/01/2018 |
| 91 | THA377 | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM | MUWEREZA HERBAL COUGH REMEDIES | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM | UGANDA | SYRUP | 1*200ML IN AN HDPE BOTTLE | 31/01/2018 |
| 92 | THA378 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | MUWEBWA INTESTINAL CLEANSER | KWESIMA HERBAL MEDICINES LTD P.O BOX 813, MASAKA 0705518257/0772661257/0751794315 | UGANDA | POWDER | 1*10G SACCHET | 03/02/2020 |
| 93 | THA380 | SKY HEALTH CARE LTD BUGOBA ZONE SEETA-MUKONO DISTRICT | SKY HEALTH CARE LTD BUGOBA ZONE SEETA-MUKONO DISTRICT | ZYLAM HERBAL MIXTURE | SKY HEALTH CARE LTD BUGOBA ZONE SEETA-MUKONO DISTRICT. KAMPALA OFFICE: PT. 7 MARKET STREET OFF SUITE A2 1ST FLOOR TEL:0781492638 | UGANDA | LIQUID | 200ML AMBER PET BOTTLE IN A CARTON | 19/03/2021 |
| 94 | THA381 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | GASTUM HERBAL MIXTURE | SKY HEALTHCARE LTD,BUGOBA ZONE SEETA,GOMA DIVISION MUKONO TEL: 0781492638 | UGANDA | LIQUID | 120ML PET BOTTLE WITH PRINTED LABEL AND SEALED WITH A WHITE LDPE CAP | 01/10/2021 |
| 95 | THA382 | TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA | TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA | KKATALEMWA HERBAL COUGH MIXTURE | TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA 0703678484/ 0774464843 | UGANDA | LIQUID | *200ML WHITE PET BOTTLE AND 1*100ML WHITE PET BOTTLE. | 04/06/2018 |
| 96 | THA383 | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM | REZA LIN FOR ULCER | MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM | UGANDA | SYRUP | 200ML AND 500ML IN HDPE BOTTLES | 31/01/2018 |
| 97 | THA384 | HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492 | HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492 | MABIRA HERBAL TEA SPICE | HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492 | UGANDA | POWDER | 100GMS IN A TRANSPARENT PLASTIC JAR | 31/01/2018 |
| 98 | THA385 | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | N’ZURI DEWORMER | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 ZURIMEDICINE@GMAIL.COM | UGANDA | SOLUTION | 60ML AND 100ML PET BOTTLE | 12/03/2018 |
| 99 | THA386 | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD | GUT REPLENISHER | ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 ZURIMEDICINE@GMAIL.COM | UGANDA | SOLUTION | 100ML PET BOTTLE | 12/03/2018 |
| 100 | THA387 | SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA | SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA | RENA ULCER SOLUTION | SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA +256-775-199-750/ +256-703-830-538 | UGANDA | SOLUTION | 1*500ML PET BOTTLE | 06/04/2018 |
| 101 | THA388 | JAGGWE MARIAM MARIAMJAGWE.MJ@GMAIL.COM HAJJAT MASITUULAH HERBAL PRODUCTS LTD | JAGGWE MARIAM MARIAMJAGWE.MJ@GMAIL.COM HAJJAT MASITUULAH HERBAL PRODUCTS LTD | SUPER ROCK | JAGGWE MARIAM MARIAMJAGWE.MJ@GMAIL.COM HAJJAT MASITUULAH HERBAL PRODUCTS LTD SALAAMA ROAD, KULEKAANA STAGE 0773303330/0701400412/0751303330 | UGANDA | POWDER | 1*200G IN A TRANSPARENT HDPE JAR | 17/06/2019 |
| 102 | THA389 | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD | SACCO SYRUP | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD P.O.BOX 7876 PLOT 17, TULA ROAD, KIYANJA ZONE, MPERERWE, KAMPALA, UGANDA 0704356951/0776290548 | UGANDA | SYRUP | 1*110ML PET AMBER BOTTLE | 07/03/2018 |
| 103 | THA390 | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE | REVITAL | ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE P.O.BOX 7876 KAMPALA,PLOT 17 0752940747/0414692983 | UGANDA | SOLUTION | 1*720ML HDPE BOTTLE | 16/01/2018 |
| 104 | THA393 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | WATER FORM | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | UGANDA | LIQUID | 500MLS | 20/08/2019 |
| 105 | THA394 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | RED LIQUID | MR.SADAM RASHID LUKWAGO,WAKALIGA OPP.VETERAN MARKET,EL:0772512372 | UGANDA | LIQUID | 500MLS | 20/08/2019 |
| 106 | THA398 | MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249 | MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249 | POMADAT | MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249 | UGANDA | OINTMENT | 1*50G HDPE JAR | 13/02/2018 |
| 107 | THA399 | RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM | RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM | HIBISC HERBAL MIXTURE | RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM | UGANDA | SOLUTION | 1*500ML HDPE BOTTLE | 13/02/2018 |
| 108 | THA400 | RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM 0785374627 | RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM 0785374627 | RWEHIDI DETOXER | RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM 0785374627 | UGANDA | SOLUTION | 1*500MLS IN A PET BOTTLE | 23/01/2018 |
| 109 | THA405 | DAMA MEDICINAL HERBS. | DAMA MEDICINAL HERBS. SEROMA SHOPPERS STOP PLAZA 1ST FLOOR, ROOM A/F/11 P.O.BOX 25216 KLA,UG | DAMA TOOTH GEL | DAMA MEDICINAL HERBS. SEROMA SHOPPERS STOP PLAZA 1ST FLOOR, ROOM A/F/11 P.O.BOX 25216 KLA,UG 0758684274/0772684274 SADAKA2003@YAHOO.COM | UGANDA | GEL | 1*50ML TUBE | 06/04/2018 |
| 110 | THA407 | DOCTOR’S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:INFO@DOCTORSCHOICE.AFRICA | DOCTOR’S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:INFO@DOCTORSCHOICE.AFRICA | REPLENISH+ | DOCTOR’S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:INFO@DOCTORSCHOICE.AFRICA | UGANDA | CAPSULES | 1*90 IN AN HDPE BOTTLE,1*10 AND 1*3*10 BLISTERS | 19/09/2018 |
| 111 | THA410 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | KIRUNGI AYI AYI | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | OINTMENT | 20GMS HDPE JAR | 26/05/2023 |
| 112 | THA411 | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA | KIRUNGI HERBAL MOUTHWASH | JASBO AGRIBUSINESS LTD, BLOCK 212,PLOT 1138,KYEBANDO-KITABULIKI, KAMPALA,UGANDA TEL.0702475090, 0772475090 | UGANDA | LIQUID | 50ML HDPE BOTTLE | 26/05/2023 |
| 113 | THA413 | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | TOWA BUTWA | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | UGANDA | POWDER | 150G | 18/03/2020 |
| 114 | THA414 | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | ROZE POWDER | MR.KAMYUFU.AUGUSTINE MANYA OBULAMU BWO. 0772-380194/0751553405KIBOGA TOWN-KIGANZI ROAD. | UGANDA | POWDER | 150G | 18/03/2020 |
| 115 | THA415 | EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299. | EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299. | CLEDARI HERBAL HYDRO GEL | EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299. | UGANDA | OINTMENT | 200GMS AND 50GMS | 16/01/2018 |
| 116 | THA416 | RASHID SADAM LUKWAGO,WAKALIGA NATEETETEL: 0772 512372 | RASHID SADAM LUKWAGO,WAKALIGA NATEETETEL: 0772 512372 | SHID COUGH SYRUP | RASHID SADAM LUKWAGO,WAKALIGA NATEETETEL: 0772 512372 | UGANDA | LIQUID | 1*250ML PLASTIC BOTTLE | 25/01/2019 |
| 117 | THA417 | UGANDAN WISDOM HERBAL RESEARCH CENTRE, SAZA ROAD, IGANGA TOWN- UGANDA | UGANDAN WISDOM HERBAL RESEARCH CENTRE, SAZA ROAD, IGANGA TOWN- UGANDA | FUNGUA | UGANDAN WISDOM HERBAL RESEARCH CENTRE, SAZA ROAD, IGANGA TOWN- UGANDA 0782196350/0752196350 | UGANDA | SUSPENSION | 1*500ML IN LDPE BOTTLE | 09/09/2019 |
| 118 | THA419 | ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, UNICAREHERBS@YAHOO.COM 0703062799 | ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, UNICAREHERBS@YAHOO.COM 0703062799 | USHA HERBAL ULCER SYRUP | ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, UNICAREHERBS@YAHOO.COM 0703062799 | UGANDA | LIQUID | 500MLS PET BOTTLE | 07/03/2018 |
| 119 | THA425 | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWATTE 7 MILES OFF GAYAZA ROAD 0773219404/0705005896 | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWATTE 7 MILES OFF GAYAZA ROAD 0773219404/0705005896 | SMCU HERBAL TONIC | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWATTE 7 MILES OFF GAYAZA ROAD 0773219404/0705005896 | UGANDA | POWDER | 170G IN POLYTHENE IN A UNIT CARTON | 19/02/2021 |
| 120 | THA426 | SMCU HERBAL RESEARCH CENTRE,KUNGU,DUWAATE,KIRA MUNICIPALITY | SMCU HERBAL RESEARCH CENTRE,KUNGU,DUWAATE,KIRA MUNICIPALITY | BURN MASTER L | SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWAATE,KIRA MUNICIPALITY 0773219404/0705005896 | UGANDA | OINTMENT | 250G PET JAR | 29/03/2018 |
| 121 | THA427 | HEALTH LIVING HERBAL RESEARCH ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718 | HEALTH LIVING HERBAL RESEARCH ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718 | FOCUS HERBAL COUGH SYRUP | HEALTH LIVING HERBAL RESEARCH LTD ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718 | UGANDA | LIQUID | 100ML | 17/09/2018 |
| 122 | THA428 | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | PRIKINO | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. TEL:0757 577692/0782 577692 | UGANDA | TABLETS | 1*180 IN A PET JAR | 17/06/2019 |
| 123 | THA429 | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. | TASANO | KUTUUSA NOAH KYENZIGE TRANDING CENTRE KAGADI DISTRICT 5KM ON KAGADI-HOIMA ROAD. TEL:0757 577692/0782 577692 | UGANDA | TABLETS | 1*180 IN A PET JAR | 17/06/2019 |
| 124 | THA436 | RUSIGWA E SIMON BUSEGA KAMPALA | RUSIGWA E SIMON BUSEGA KAMPALA | NOURISH | RUSIGWA E SIMON BUSEGA KAMPALA P.O. BOX 1189 BUSEGA (PETRO CITY) 0758444222 | UGANDA | POWDER | 1*150G PET JAR | 07/01/2019 |
| 125 | THA438 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | SIGWA ONE | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL:0758444222/0781222271 | UGANDA | POWDER | 150GM POWDER | 02/12/2022 |
| 126 | THA439 | RUSIGWA E SIMON 0758444222 BUSEGA | RUSIGWA E SIMON 0758444222 BUSEGA | KRG | SIGWA HERBAL CLINIC P.O.BOX 1189 BUSEGA-KAMPALA TEL: 0758444222/0781222271 | UGANDA | POWDER | 150GM PET BOTTLE | 04/11/2022 |
| 127 | THA446 | NIVIKA ORGANIC | NIVIKA ORGANIC | DW LIQUID | NIVIKA ORGANIC,PLOT 33,SHAMBA COMPLEX,NAKIVUBO ROAD,OPP KISEKA MARKET, TEL: 0754 674010/0701627712 EMAIL:NIVIKAORGANIC@GMAIL.COM | UGANDA | LIQUID | 1*500ML PET BOTTLE | 18/02/2019 |
| 128 | THA449 | ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. | ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. | ROPER FREE AROMETHERAPHY | ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. TEL:+256772489739, +256773782977 EMAIL: ROPERFREE@KASUMBAS.COM | UGANDA | LIQUID | 60ML &100 ML HDPE BOTTLE | 25/04/2018 |
| 129 | THA450 | JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR | JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR | JOYVA COUGH MIXTURE | JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR 0755 878 779 0712 878 779 | UGANDA | LIQUID | 200 ML PET BOTTLE | 07/05/2018 |
| 130 | THA451 | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | KATS MANTOPS | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. TEL.0759100200 0758651913 0785151891 | UGANDA | LIQUID | 1*750ML PET BOTTLE | 23/10/2019 |
| 131 | THA452 | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. | VIGOR MEN PLUS | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD. TEL.0759100200 0758651913 0785151891 | UGANDA | LIQUID | 1*750ML PET BOTTLE | 23/10/2019 |
| 132 | THA455 | CHAMUKA PHARMACEUTICAL RESEARCH HALF A MILE, LUTEEYE, GAYAZA ROAD | CHAMUKA PHARMACEUTICAL RESEARCH HALF A MILE, LUTEEYE, GAYAZA ROAD | CHAM DETOX | CHAMUKA PHARMACEUTICAL RESEARCH HALF A MILE, LUTEEYE, GAYAZA ROAD EMAIL: ROFON2005@YAHOO.CO.UK TEL: +256-782-054723 / +256-759-481 793 | UGANDA | POWDER | 64.3 GRAMS | 21/05/2019 |
| 133 | THA458 | SSEWANKAMBO MARTIN NAMUNGOONA STAGE,KAMPALA,UGANDA TEL: 0700247264 | SSEWANKAMBO MARTIN NAMUNGOONA STAGE,KAMPALA,UGANDA TEL: 0700247264 | MARTIN HERBAL JELLY | SSEWANKAMBO MARTIN NAMUNGOONA STAGE,KAMPALA,UGANDA TEL: 0700247264 | UGANDA | OINTMENT | 1*100GM IN HDPE JAR | 19/03/2021 |
| 134 | THA465 | ALINYIKIRA ECO-INVESTMENTS LTD, KABAAWO ZONE NALUKOLONGO OFF MASAKA TEL 0701121873 /0782121873 | ALINYIKIRA ECO-INVESTMENTS LTD, KABAAWO ZONE NALUKOLONGO OFF MASAKA TEL 0701121873 /0782121873 | AHP 10+ | ALINYIKIRA ECO-INVESTMENTS LTD, KABAAWO ZONE NALUKOLONGO OFF MASAKA TEL 0701121873 /0782121873 | UGANDA | POWDER | 1*150GMS | 14/11/2019 |
| 135 | THA470 | BULAMU NATURAL ORGANIC HERBAL PRODUCTS, BULENGA ,NAKUWADDE. | BULAMU NATURAL ORGANIC HERBAL PRODUCTS, BULENGA ,NAKUWADDE. | COUGH &FLUE MIXTURE | SSEKAMWA PETER AND MUKISA PAUL BULAMU NATURAL ORGANIC HERBAL PRODUCTS, BULENGA ,NAKUWADDE. TEL: 0752772600 , 0751200946 | UGANDA | MIXTURE | 100ML AMBER COLOURED PET BOTTLE WITH A GREEN HDPE LID | 08/08/2019 |
| 136 | THA471 | YAKUBU LUKWAGO, SHANA GENITAL SOLUTION, UGANDA. TEL:+256772444221/+256392964961 | YAKUBU LUKWAGO, SHANA GENITAL SOLUTION, UGANDA. TEL:+256772444221/+392964961 | SHANA HERBAL GENTLE WASH | YAKUBU LUKWAGO, SHANA GENITAL SOLUTION, UGANDA. TEL:+256772444221/+256392964961 | UGANDA | SOLUTION | 1*100ML PET TRANSPARENT BOTTLE | 29/03/2019 |
| 137 | THA474 | KATONDA YA AWONYA HERBAL MEDICINES | KATONDA YA AWONYA HERBAL MEDICINES | ACACIA NICOTICA | MUGISHA MUHAMMAD. KATONDA YA AWONYA HERBAL MEDICINES, WILLIAM STREET GAZA LAND PLAZA, LEVEL 5, ROOM 743, KAMPALA. TEL: 0782408819 / 0702408819 | UGANDA | LIQUID | 1 LITRE IN A WHITE PLASTIC OPAQUE BOTTLE | 20/08/2019 |
| 138 | THA475 | KATONDA YA AWONYA HERBAL MEDICINES | KATONDA YA AWONYA HERBAL MEDICINES | KIGERIA AFRICANA | MUGISHA MUHAMMAD. KATONDA YA AWONYA HERBAL MEDICINES, WILLIAM STREET GAZA LAND PLAZA, LEVEL 5, ROOM 743, KAMPALA. TEL: 0782408819 / 0702408819 | UGANDA | LIQUID | 1 LITRE IN A WHITE PLASTIC OPAQUE BOTTLE | 20/08/2019 |
| 139 | THA477 | KATONDA YA AWONYA HERBAL MEDICINES | KATONDA YA AWONYA HERBAL MEDICINES | KIFUULA | MUGISHA MUHAMMAD. KATONDA YA AWONYA HERBAL MEDICINES, WILLIAM STREET GAZA LAND PLAZA, LEVEL 5, ROOM 743, KAMPALA. TEL: 0782408819 / 0702408819 | UGANDA | LIQUID | 1 LITRE IN A WHITE PLASTIC OPAQUE BOTTLE | 20/08/2019 |
| 140 | THA478 | UGANDA JOINT HERBAL RESEARCH CLINIC, BUSABALA VALLEY CLINIC, TEL: 0772 327111/0701 327111 | UGANDA JOINT HERBAL RESEARCH CLINIC, BUSABALA VALLEY CLINIC, TEL: 0772 327111/0701 327111 | IMMUNE BOOSTER | UGANDA JOINT HERBAL RESEARCH CLINIC, BUSABALA VALLEY CLINIC, TEL: 0772 327111/0701 327111 | UGANDA | LIQUID | 1 LITRE IN A PET BOTTLE | 15/01/2019 |
| 141 | THA479 | DR.ODOCH PASCAL 0774783006/0789-866-534,P.O BOX 79, PLOT 3,GREENSTAR BUILDING,NYARAVUR-NEBBI | DR.ODOCH PASCAL 0774783006/0789-866-534 | MAISHA | DR.ODOCH PASCAL 0774783006/0789-866-534,P.O BOX 79, PLOT 3,GREENSTAR BUILDING,NYARAVUR-NEBBI | UGANDA | POWDER | 100GMS | 20/08/2019 |
| 142 | THA482 | JENA HERBALS LTD | JENA HERBALS LTD | JENACID | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD PLOT 232 WALNUT AVENUE, HOUSE NO. 11 0700412666/0785374967 | UGANDA | SYRUP | 1*100ML,200ML AND 1 L PET BOTTLE | 15/12/2021 |
| 143 | THA484 | JENA HERBALS LTD | JENA HERBALS LTD | JenaCof DS | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD PLOT 232 WALNUT AVENUE, HOUSE NO. 11 0700412666/0785374967 | UGANDA | SYRUP | 1*100ML AND 200ML PET BOTTLE | 15/12/2021 |
| 144 | THA488 | JUROSE ORGANIC EQUATORIAL MALL ROOM 125, TEL: +256 779707047 | JUROSE ORGANIC EQUATORIAL MALL ROOM 125, TEL: +256 779707047 | LIVALIS DETOXIFIER | JUROSE ORGANIC EQUATORIAL MALL ROOM 125, TEL: +256 779707047 | UGANDA | POWDER | 1*125GM IN LDPE JAR | 17/06/2019 |
| 145 | THA489 | STEMAR AROMATIC OIL DISTILLERS 0751-569009,0782-432534,0705-780688 | STEMAR AROMATIC OIL DISTILLERS 0751-569009,0782-432534,0705-780688 | STEMAR ORGANIC MOSQUITO REPELLANT | STEMAR AROMATIC OIL DISTILLERS 0751-569009,0782-432534,0705-780688 | UGANDA | OINTMENT | 30G AND 50G IN TRANSPARENT HDPE JAR | 17/06/2019 |
| 146 | THA490 | ELOIPHARM (U) LTD | ELOIPHARM (U) LTD | ELOCOF HERBAL COUGH MIXTURE | ELOIPHARM (U) LTD. KYEBANDO,CENTRAL ZONE,KAWEMPE DIVISION P.O.BOX 36766,KAMPALA, +256 758329 111 | UGANDA | SYRUP | 1*200 ML PET BOTTLE IN A UNIT CARTON | 18/02/2019 |
| 147 | THA507 | ABL HERBAL PRODUCTS. KATWE OPP QUALITY CHEMICALS, TEL; 0782447722 | ABL HERBAL PRODUCTS. KATWE OPP QUALITY CHEMICALS, TEL; 0782447722 | VITAL LADY | ABL HERBAL PRODUCTS. KATWE OPP QUALITY CHEMICALS, TEL; 0782447722 | UGANDA | POWDER | 200G TIN | 20/08/2019 |
| 148 | THA508 | ABL HERBAL PRODUCTS | ABL HERBAL PRODUCTS, KATWE OPPOSITE QUALITY CHEMICAL LTD. | WITCH HAZEL | ABL HERBAL PRODUCTS, KATWE OPPOSITE QUALITY CHEMICAL LTD. 0782447722. | UGANDA | LIQUID | 100ML | 07/01/2019 |
| 149 | THA510 | FRIENDS DRUG SHOP AND COSMETICS, 0755922605/0704310191/0772310191 KYENGERA, MASAKA ROAD | FRIENDS DRUG SHOP AND COSMETICS, 0755922605/0704310191/0772310191 KYENGERA, MASAKA ROAD | FRIENDS HERBAL JELLY | FRIENDS DRUG SHOP AND COSMETICS, 0755922605/0704310191/0772310191 KYENGERA, MASAKA ROAD | UGANDA | OINTMENT | 120G/60G | 26/04/2019 |
| 150 | THA511 | DR. ISSA MABIRIZI MAGERE, GAYAZA 070124945 | DR. ISSA MABIRIZI MAGERE, GAYAZA 070124945 | ZED SYRUP | DR. ISSA MABIRIZI MAGERE, GAYAZA 070124945 | UGANDA | SOLUTION | 500ML HDPE BOTTLE | 19/02/2021 |
| 151 | THA516 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | TUM SOLUTION | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | UGANDA | LIQUID | 1*250ML HDPE RED BOTTLE WITH GREEN HDPE LID. | 19/02/2020 |
| 152 | THA518 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | HEAL HERBAL COUGH MIXTURE | HEAL NATURAL REMEDIES AND COSMETICS KAJJANSI. TEL; 0772- 499992; 0701-834960; 0778-298063 | UGANDA | LIQUID | 1*500MLS IN HDPE BOTTLE | 19/02/2020 |
| 153 | THA522 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | RENA HERBAL JELLY | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA TEL: +256782518060 EMAIL;HERBSUG@GMAIL.COM | UGANDA | OINTMENT | 1*100G IN WHITE PET JAR | 15/10/2019 |
| 154 | THA523 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA | RENA HERBAL CREAM | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272-BUSIA-UGANDA TEL: +256782518060 EMAIL;HERBSUG@GMAIL.COM | UGANDA | CREAM | 1*100G IN WHITE PET JAR | 15/10/2019 |
| 155 | THA524 | RUDII INTERNATIONAL CO LTD.P.O.BOX 637 TORORO, UGANDA | RUDII INTERNATIONAL CO LTD.P.O.BOX 637 TORORO, UGANDA | RUDII DETOX DRINK | RUDII INTERNATIONAL CO LTD.P.O.BOX 637 TORORO, UGANDA. +2656782371007 OR +256701371371 EMAIL:rudiicoltd@gmail.com | UGANDA | SUSPENSION | 1L,500ML,250ML,& 200ML | 18/02/2019 |
| 156 | THA525 | AKATUSIIMA PEACE MITI HERBAL COMPANY LTD KAWEMPE | AKATUSIIMA PEACE MITI HERBAL COMPANY LTD KAWEMPE | MITI HERBAL COUGH SYRUP | AKATUSIIMA PEACE MITI HERBAL COMPANY LTD KAWEMPE 5MILES ALONG BOMBO ROAD TEL:0704218078 | UGANDA | SYRUP | 1*100ML AND 60ML PET BOTTLE | 18/02/2019 |
| 157 | THA534 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272, BUSIA, TEL: 0712 002220 | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272, BUSIA, TEL: 0712 002220 | GEKASA ORGANIC POWDER | UGANDA HERBS AND RESEARCH CENTRE P.O.BOX 272, BUSIA, TEL: 0712 002220 | UGANDA | POWDER | 1*125GMS | 14/11/2019 |
| 158 | THA535 | MUHAMMAD LUTAAYA 0776-835780 MAKERERE,KAVULE, | MUHAMMAD LUTAAYA 0776-835780 MAKERERE,KAVULE, | EASY WAY BLACK SEED OIL | MUHAMMAD LUTAAYA 0776-835780 MAKERERE,KAVULE, | UGANDA | LIQUID | 1*50MLS,100MLS, 300MLS AND 500MLS | 15/10/2019 |
| 159 | THA543 | MS. SSENDYOSE MASITULLAH TEL; 0700-570125 P.O BOX 282 KAMPALA WANDEGEYA, ANNEX S.A BUILDING | MS. SSENDYOSE MASITULLAH TEL; 0700-570125 P.O BOX 282 KAMPALA WANDEGEYA, ANNEX S.A BUILDING | HEWO COUGH DOCTOR | MS. SSENDYOSE MASITULLAH TEL; 0700-570125 P.O BOX 282 KAMPALA WANDEGEYA, ANNEX S.A BUILDING | UGANDA | LIQUID | 1*120MLS IN PET BOTTLE | 27/01/2020 |
| 160 | THA544 | YECO ORGANIC MANAGEMENT LTD KAGOMA - KAWEMPE TEL; 0705 454951; 0781505806 | YECO ORGANIC MANAGEMENT LTD KAGOMA - KAWEMPE TEL; 0705 454951; 0781505806 | YECO ANTI-ULCER HERBAL SYRUP | YECO ORGANIC MANAGEMENT LTD KAGOMA - KAWEMPE TEL; 0705 454951; 0781505806 | UGANDA | SYRUP | 1*200ML PET BOTTLE IN A UNIT CARTON | 01/08/2019 |
| 161 | THA545 | NALONGO MUSANA HERBAL CLINIC GAYAZA OPP. FISH FACTORY | NALONGO MUSANA HERBAL CLINIC GAYAZA OPP. FISH FACTORY | NALONGO MUSANA ORAL HERBAL SUSPENSION | NALONGO MUSANA HERBAL CLINIC GAYAZA OPP. FISH FACTORY TEL; 0701-693848; 0781-544591 | UGANDA | SOLUTION | 1*750ML IN AN HDPE BOTTLE | 17/06/2019 |
| 162 | THA546 | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI HERBAL CREAM | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA ABABIRI, ENTEBBE ROAD, KITUBULU OPPOSITE SESE GATEWAY P.O.BOX 74 0752524060/0782524060 | UGANDA | CREAM | 1*100G PET JAR | 07/01/2019 |
| 163 | THA547 | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA | KSOVITI HERBAL JELLY | KSOVITI INTERNATIONAL HOLDING LIMITED ABAYITA ABABIRI, ENTEBBE ROAD, KITUBULU OPPOSITE SESE GATEWAY P.O.BOX 74 0752524060/0782524060 | UGANDA | OINTMENT | 1*100G PET JAR | 07/01/2019 |
| 164 | THA548 | KSOVITI INTERNATIONAL HOLDING LIMITED, | KSOVITI INTERNATIONAL HOLDING LIMITED, | PSIDIUM COUGH MIXTURE | KSOVITI INTERNATIONAL HOLDING LIMITED, ABAYITA ABABIRI, ENTEBBE ROAD, KITUBULU OPPOSITE SESE GATEWAY 0752524060 | UGANDA | SOLUTION | 1*200ML IN LDPE IN A CARTON | 03/09/2019 |
| 165 | THA552 | MAMA POWER LIMITED KAWAALA KAMPALA, UGANDA | MAMA POWER LIMITED KAWAALA KAMPALA, UGANDA | MAMA POWER NATURAL POWER | MAMA POWER LIMITED KAWAALA KAMPALA, UGANDA MAMAPOWER256U@GMAIL.COM +256 771266692 | UGANDA | POWDER | 1*200G IN A POLYTHENE IN A UNIT CARTON | 17/06/2019 |
| 166 | THA553 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS HAND SANITIZER GEL | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | GEL | 1*500ML IN A TRANSPARENT PET BOTTLE | 20/03/2019 |
| 167 | THA554 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PAIN BALM | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | OINTMENT | 1*20GM IN A PET JAR | 20/03/2019 |
| 168 | THA555 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS ALOE LIP BALM | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | OINTMENT | 1*20GM IN A PET JAR | 20/03/2019 |
| 169 | THA556 | PHYTO HERBALS LTD,KAGOMA-BOMBO ROAD | PHYTO HERBALS LTD,KAGOMA-BOMBO ROAD | PHYCOF COUGH SYRUP | PHYTO HERBALS LTD,KAGOMA-BOMBO ROAD TEL: +256 783 811801/+256 752 540 140 | UGANDA | SYRUP | 1*100ML IN AMBER PET BOTTLE IN A UNIT CARTON | 20/03/2019 |
| 170 | THA563 | MS KAYANJA GORRETH 0752842145/ 0776842145 MASAKA(GRAMMER) KYENGERA | MS KAYANJA GORRETH 0752842145/ 0776842145 MASAKA(GRAMMER) KYENGERA | HOME EASY BALM | MS KAYANJA GORRETH 0752842145/ 0776842145 MASAKA(GRAMMER) KYENGERA | UGANDA | CREAM | 60G IN A PLASTIC CONTAINER | 20/08/2019 |
| 171 | THA565 | HAJJAT JEMEWO HERBAL CENTRE NATEETE 0701499579 | HAJJAT JEMEWO HERBAL CENTRE NATEETE 0701499579 | P21 | HAJJAT JEMEWO HERBAL CENTRE NATEETE 0701499579 | UGANDA | SOLUTION | 1*1 LITER PLASTIC JERRYCAN | 17/06/2019 |
| 172 | THA566 | KISA KYAMUZADDE GENERAL AGENCIES NALUKOLONGO INDUSTRIAL AREA, MASAKA ROAD. | KISA KYAMUZADDE GENERAL AGENCIES NALUKOLONGO INDUSTRIAL AREA, MASAKA ROAD. | KISA KYAMUZADDE ORIGINAL HERBAL | KISA KYAMUZADDE GENERAL AGENCIES NALUKOLONGO INDUSTRIAL AREA, MASAKA ROAD. REG NO. 127581 MOB: 0712 831375/ 0772 335874 | UGANDA | LIQUID | 200MLS LDPE BOTTLE. | 09/11/2020 |
| 173 | THA574 | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | MUBEEZE HERBAL SOLUTION | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | UGANDA | SOLUTION | 1*750ML PLASTIC BOTTLE | 19/02/2021 |
| 174 | THA575 | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD | RP HERBAL LIQUID | NALONGO MUSANA LEVINATA, KANYANYA, ALONG GAYAZA ROAD OPPOSITE THE FISH FACTORY TEL:0701693848 | UGANDA | LIQUID | 750 ML HDPE BOTTLE | 19/02/2021 |
| 175 | THA580 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | KOFNIL COUGH SYRUP | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | LIQUID | 1*100ML. AMBER PET BOTTLE | 16/04/2019 |
| 176 | THA581 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | ACINIL ANTACID SYRUP | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | LIQUID | 1*100ML AMBER PET BOTTLE | 16/04/2019 |
| 177 | THA583 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | Q-DENT | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | LIQUID | 20ML PET BOTTLE | 16/04/2019 |
| 178 | THA584 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | AKE OFF HERBAL CREAM | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | CREAM | 1*25GM WHITE PET BOTTLE | 02/10/2019 |
| 179 | THA587 | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA | Q-DERM HERBAL CREAM | QAMARI PRODUCTS LTD. P.O.BOX 11953,KAMPALA, PLOT 601,BUSIRO,WAKISO,UGANDA ghqamari@hotmail.com,Tel: 0776856931 | UGANDA | CREAM | 20GM PET BOTTLE | 02/10/2019 |
| 180 | THA588 | SURE DEAL BEAUTY CENTRE MUTUNDWE OPPOSITE SERENE HOTEL | SURE DEAL BEAUTY CENTRE MUTUNDWE OPPOSITE SERENE HOTEL | SURE DEAL SENNA SOLUTION | SURE DEAL BEAUTY CENTRE MUTUNDWE OPPOSITE SERENE HOTEL +256 772 329181/+256 701 863001 | UGANDA | SOLUTION | 500ML HDPE | 20/08/2019 |
| 181 | THA591 | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | SURE DEAL MANGIFERA SOLUTION | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD 0701 863001/0772 329181 | UGANDA | SOLUTION | 1*500ML IN LDPE BOTTLE | 17/06/2019 |
| 182 | THA592 | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD | BIDEN MIXTURE | SURE DEAL BEAUTY CENTER, PLOT NO 2127 SENANA PLAZA,BUGANDA ROAD 0701 863001/0772 329181 | UGANDA | SOLUTION | 1*500ML IN LDPE BOTTLE | 17/06/2019 |
| 183 | THA595 | SEREEYI HERBAL RESEARCH CLINIC,LWEZA,KAJJANZI 0781 020 108/0200-904 813 | SEREEYI HERBAL RESEARCH CLINIC,LWEZA,KAJJANZI 0781 020 108/0200-904 813 | SONSOMOLA | SEREEYI HERBAL RESEARCH CLINIC,LWEZA,KAJJANZI 0781 020 108/0200-904 813 | UGANDA | LIQUID | 250ML | 09/11/2020 |
| 184 | THA596 | TINEX LOGISTICS LTD, P.O BOX 37030, ZONE II,KASUBI-KAWALA ROAD KAMPALA,UGANDA | TINEX LOGISTICS LTD, P.O BOX 37030, ZONE II,KASUBI-KAWALA ROAD KAMPALA,UGANDA | TINEX HERBALMOUTHWASH | TINEX LOGISTICS LTD, P.O BOX 37030, ZONE II,KASUBI-KAWALA ROAD KAMPALA,UGANDA TINEXLOGISTICS6@GMAIL.COM 0782 992 257/0200-904 813 | UGANDA | SOLUTION | 1*50ML PET BOTTLE | 17/06/2019 |
| 185 | THA602 | MULABIKIRWA HERBAL, NSAMBIA, ARUA TEL: 0772740186 | MULABIKIRWA HERBAL, NSAMBIA, ARUA TEL: 0772740186 | SSENGA MULABIKIRWA HERBAL MEDICINE | MULABIKIRWA HERBAL, NSAMBIA, ARUA TEL: 0772740186 | UGANDA | POWDER | 1*100GM IN A PLASTIC TIN | 27/01/2020 |
| 186 | THA603 | RASHID LUKWAGO HERBAL GROUP. KYENGERA OFF MASAKA ROAD. TEL: 0782413626 | RASHID LUKWAGO HERBAL GROUP. KYENGERA OFF MASAKA ROAD. TEL: 0782413626 | LUK COUGH SYRUP | RASHID LUKWAGO HERBAL GROUP. KYENGERA OFF MASAKA ROAD. TEL: 0782413626 | UGANDA | SYRUP | 1*500ML AMBER COLORED PET BOTTLE | 27/01/2020 |
| 187 | THA604 | RASHID LUKWAGO HERBAL GROUP 0782413626. Kyengera off Masaka road | RASHID LUKWAGO HERBAL GROUP 0782413626. Kyengera off Masaka road | NEOMORBUS | RASHID LUKWAGO HERBAL GROUP 0782413626. Kyengera off Masaka road | UGANDA | LIQUID | 500ML | 09/11/2020 |
| 188 | THA606 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | AMBA LIQUID | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | UGANDA | LIQUID | 1*500ML PLASTIC BOTTLE | 19/02/2021 |
| 189 | THA607 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | BYANSI COUGH MIXTURE | BYANSI HERBAL RESEARCH CLINIC, KIBUYE, ENTEBBE ROAD TEL: 0772861974 /0702522250 /0752522250 | UGANDA | LIQUID | 1*200ML PLASTIC BOTTLE | 19/02/2021 |
| 190 | THA608 | KALASO HERBAL PRODUCTS.NATEETE NEAR BOOM HOTEL | KALASO HERBAL PRODUCTS.NATEETE NEAR BOOM HOTEL | KALASO KOKOLILOKO EXTRA | KALASO HERBAL PRODUCTS.NATEETE NEAR BOOM HOTEL 075399073 0752048389 | UGANDA | LIQUID | 1*500ML YELLOW PET BOTTLE. | 04/10/2019 |
| 191 | THA611 | SSENGA PROSSY NABUKEERA, KATWE I, MUWONGE ZONE, NEAR MUSA BODY MACHINERY | SSENGA PROSSY NABUKEERA, KATWE I, MUWONGE ZONE, NEAR MUSA BODY MACHINERY | LUWAWU | SSENGA PROSSY NABUKEERA, KATWE I, MUWONGE ZONE, NEAR MUSA BODY MACHINERY, TEL: 0700505780/0780525090 prossynabukeera@gmail.com | UGANDA | POWDER | 1*500GM HDPE JAR | 19/02/2021 |
| 192 | THA615 | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | CAYEN LUWOMBO TEA | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | UGANDA | POWDER | 60G, 120G, 250G, AND 400G IN A PLASTIC CONTAINER | 27/01/2020 |
| 193 | THA616 | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | VILLALI NATURAL TEA | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | UGANDA | POWDER | 60G, 120G, 250G AND 400G IN A PLASTIC CONTAINER | 27/01/2020 |
| 194 | THA617 | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | DABUTO SSICABRA TREE OIL | MR. KATEETE MOSES MALE (BULAMU LUWOMBO ORGANIC CONSULT) (0755802131/ 0776802131) | UGANDA | LIQUID | 1*15ML IN A PLASTIC BOTTLE | 27/01/2020 |
| 195 | THA618 | CURE ORGANIC LIVING PRODUCTS (U) LTD BUDDU HOUSE WANDEGEYA. TEL:0700801609 | CURE ORGANIC LIVING PRODUCTS (U) LTD BUDDU HOUSE WANDEGEYA. TEL:0700801609 | DIABEX PRO | CURE ORGANIC LIVING PRODUCTS (U) LTD BUDDU HOUSE WANDEGEYA. TEL:0700801609 | UGANDA | POWDER | 1*50G AND 120G IN A WHITE PLASTIC TIN | 05/03/2020 |
| 196 | THA621 | MUKWAYA JAMIR LUTAAKOME | MUKWAYA JAMIR LUTAAKOME | SMAKO HERBAL MEDICINE PRODUCT | MUKWAYA JAMIR LUTAAKOME NDEEBA- YW COMPLEX- OPPOSITE TOTAL PETROL STATION TEL:0772538794/0702538794 | UGANDA | POWDER | 250GM HDPE CONTAINER | 13/01/2022 |
| 197 | THA623 | BISUBI BUSINESS SOLUTIONS KAYUNGA WAKISO GOMBE AT FUTUREBELL HIGH SCHOOL Tel: 0756405871/0772801508 | BISUBI BUSINESS SOLUTIONS KAYUNGA WAKISO GOMBE AT FUTUREBELL HIGH SCHOOL Tel: 0756405871/0772801508 | BISUBI HERBAL JELLY | BISUBI BUSINESS SOLUTIONS KAYUNGA WAKISO GOMBE AT FUTUREBELL HIGH SCHOOL Tel: 0756405871/0772801508 | UGANDA | OINTMENT | 1*250GMS | 14/11/2019 |
| 198 | THA624 | NEW LIFE COMPANY,P.O BOX 29,FORTPORTAL,KABAROLE DISTRICT TEL: 0789 931467/0702-319514 | NEW LIFE COMPANY,P.O BOX 29,FORTPORTAL,KABAROLE DISTRICT TEL: 0789 931467/0702-319514 | STINKWOOD HERBAL POWDER | NEW LIFE COMPANY,P.O BOX 29,FORTPORTAL,KABAROLE DISTRICT TEL: 0789 931467/0702-319514 | UGANDA | POWDER | 1*100G IN A TRANSPARENT PLASTIC TIN | 05/03/2020 |
| 199 | THA634 | KYEMEZA HERBAL RESEARCH P.O.BOX 1328 MASAKA-UGANDA TEL: +256772517535 | KYEMEZA HERBAL RESEARCH P.O.BOX 1328 MASAKA-UGANDA TEL: +256772517535 | EARLIER COUGH MIXTURE | KYEMEZA HERBAL RESEARCH P.O.BOX 1328 MASAKA-UGANDA TEL: +256772517535 | UGANDA | LIQUID | 1*200ML PLASTIC BOTTLE | 19/03/2021 |
| 200 | THA636 | KYABAGGU JOSEPH, LISAAKYE HEALTHCARE | KYABAGGU JOSEPH, LISAAKYE HEALTHCARE | KHC KISAKYE COUGH MIXTURE | KYABAGGU JOSEPH, LISAAKYE HEALTHCARE, P.O.BOX 28712, KAMPALA, UGANDA +256 752697378/ 783737678 | UGANDA | LIQUID | 1*125ML HDPE BOTTLE | 19/02/2021 |
| 201 | THA639 | JOY INDUSTRIES NABBINGO- MASAKA ROAD TEL: 0778 164596, 0754 757490, 0701 713388 | JOY INDUSTRIES NABBINGO- MASAKA ROAD TEL: 0778 164596, 0754 757490, 0701 713388 | JOY HERBAL JELLY | JOY INDUSTRIES NABBINGO- MASAKA ROAD TEL: 0778 164596, 0754 757490, 0701 713388 | UGANDA | OINTMENT | 100G HDPE CONTAINER | 09/11/2020 |
| 202 | THA640 | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | SAAMI HERBAL JELLY | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE EMAIL: SANIHUZA@YAHOO.COM TEL: 0704175890, 0778976418 UGANDA | UGANDA | JELLY | 120GM IN PLASTIC CONTAINER | 01/10/2021 |
| 203 | THA642 | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE | SAAMI SOAP | NALUBOWA FARIDAH SANYU SAAMI BEAUTY PRODUCTS BULENGA SSUBWE EMAIL: SANIHUZA@YAHOO.COM TEL: 0704175890, 0778976418 UGANDA | UGANDA | SOAP | 120GM | 01/10/2021 |
| 204 | THA646 | SMARTECH SUPPLY TEL; 0773 924357 | SMARTECH SUPPLY TEL; 0773 924357 | T.BALM OINTMENT | ELOIPHARM (U) LTD, KABATEREINE BUILDING, KYEBANDO CENTRAL ZONE, P.O BOX 36766, KAMPALA. | UGANDA | OINTMENT | 1*20G IN LDPE JAR IN A CARTON | 01/08/2019 |
| 205 | THA647 | KATTA ORGANIC AND NATURAL PRODUCTS | KATTA ORGANIC AND NATURAL PRODUCTS | WHITKATTA HERBAL MOUTH WASH | KATTA ORGANIC AND NATURAL PRODUCTS, LOCATED AT JESCO BEAUTY CENTRE, ROOM KD20,3RD FLOOR 0700928623 | UGANDA | SOLUTION | 50ML HDPE BOTTLE | 19/02/2021 |
| 206 | THA648 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA GARLIC | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/2019 |
| 207 | THA649 | VICTORIA HEALTHCARE LIMITED,KAMPALA TEL: 0751432584/ 0705501076 | VICTORIA HEALTHCARE LIMITED,KAMPALA TEL: 0751432584/ 0705501076 | VICTORIA CHARCOAL | VICTORIA HEALTHCARE LIMITED,KAMPALA TEL: 0751432584/ 0705501076 | UGANDA | TABLETS | 1*60 IN A GREEN LDPE BOTTLE | 27/01/2020 |
| 208 | THA650 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HIBISCUS | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/2019 |
| 209 | THA651 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA TURMERIC | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/2019 |
| 210 | THA652 | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY | VICTORIA ALOE VERA | VICTORIA HEALTHCARE LIMITED,P.O.BOX 12181,KAMPALA,KAZO,NABWERU,NANSANA MUNICIPALITY 0751432584 / 0758 437225 | UGANDA | TABLETS | 1*60 IN GREEN LDPE BOTTLE | 10/10/2019 |
| 211 | THA654 | BAMWEYANA HERBAL GROUP LOCATED AT ENTEBBE ROAD, OPPOSITE FREEDOM CITY. | BAMWEYANA HERBAL GROUP LOCATED AT ENTEBBE ROAD, OPPOSITE FREEDOM CITY. | JELLO HERBAL POWDER | BAMWEYANA HERBAL GROUP LOCATED AT ENTEBBE ROAD, OPPOSITE FREEDOM CITY. +256702536879/+2567025380 | UGANDA | POWDER | 200G PET BOTTLE | 19/02/2021 |
| 212 | THA659 | SMARTECH SUPPLY TEL; 0773 924357 | SMARTECH SUPPLY TEL; 0773 924357 | T NASAL INHALER | ELOIPHARM (U) LTD, KABATEREINE BUILDING, KYEBANDO CENTRAL ZONE, P.O BOX 36766, KAMPALA | UGANDA | INHALER | 1*1G IN HDPE | 28/08/2019 |
| 213 | THA678 | DA-MERAN HERBAL DUTCH LOCATED AT KIBUYE NEAR XING XING FURNITURE ALONG RING ROAD | DA-MERAN HERBAL DUTCH LOCATED AT KIBUYE NEAR XING XING FURNITURE ALONG RING ROAD | PIXSTER V | DA-MERAN HERBAL DUTCH LOCATED AT KIBUYE NEAR XING XING FURNITURE ALONG RING ROAD. 0708222444 0781222444 | UGANDA | POWDER | 1*200G IN PLASTIC JAR | 19/02/2021 |
| 214 | THA684 | THE EDENS HERBAL PHARMACY SEGUKU OPP MPUNGU PLAZA TEL;0785120896/0751746467 | THE EDENS HERBAL PHARMACY SEGUKU OPP MPUNGU PLAZA TEL;0785120896/0751746467 | VENEREUS | THE EDENS HERBAL PHARMACY SEGUKU OPP MPUNGU PLAZA TEL;0785120896/0751746467 | UGANDA | POWDER | 1*250G WHITE HDPE JAR WITH A GREEN HDPE LID | 19/02/2021 |
| 215 | THA690 | MORPHANS HERBAL MEDICINE, BULANGA TOWN COUNCIL,WANFUKO ZONE,P.O.BOX 578,IGANGA,UGANDA | MORPHANS HERBAL MEDICINE, BULANGA TOWN COUNCIL,WANFUKO ZONE,P.O.BOX 578,IGANGA,UGANDA | MOHPANS HERBAL COUGH MIXTURE | MORPHANS HERBAL MEDICINE, BULANGA TOWN COUNCIL,WANFUKO ZONE,P.O.BOX 578,IGANGA,UGANDA TEL:0782 646495/0700859430/0759 479206 | UGANDA | LIQUID | 1*200ML PET BOTTLE | 30/07/2021 |
| 216 | THA697 | DAMA MEDICINAL HERBS, P.O BOX 25216, KAMPALA UGANDA | DAMA MEDICINAL HERBS, P.O BOX 25216, KAMPALA UGANDA | SHAKE OUT | DAMA MEDICINAL HERBS, P.O BOX 25216, KAMPALA UGANDA. +256777733338 kagdoryn@gmail.com 0772774338 | UGANDA | POWDER | 18.2 GRAMS | 19/02/2021 |
| 217 | THA699 | SEZ MEDICAL CENTRE LTD.BWAISE NABWERU RD(KAZOC/U PRIMARY SCHOOL),0774009790/ 0700384840 | SEZ MEDICAL CENTRE LTD.BWAISE NABWERU RD(KAZOC/U PRIMARY SCHOOL),0774009790/ 0700384840 | SEZ CHARCOAL TOOTHPASTE | SEZ MEDICAL CENTRE LTD.BWAISE NABWERU RD(KAZOC/U PRIMARY SCHOOL),0774009790/ 0700384840 | UGANDA | PASTE | 50G | 19/02/2021 |
| 218 | THA703 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | LUK HERBAL TONIC | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | UGANDA | LIQUID | 500 ML PET BOTTLE | 19/03/2021 |
| 219 | THA704 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | RED LIQUID PLUS | RASHID LUKWAGO HERBAL GROUP, KYENGERA OFF MASAKA ROAD, KAMPALA 078413626 | UGANDA | LIQUID | 500 ML PET BOTTLE | 19/03/2021 |
| 220 | THA705 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD? TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | BAYCONE HERBAL MEDICINE FOR ALLERGY | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | LIQUID | 1*200ML WHITE PET BOTTLE | 05/11/2019 |
| 221 | THA706 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | ALSAGON | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | POWDER | 38G HDPE TIN & 75G HDPE TIN | 05/11/2019 |
| 222 | THA712 | SCENSOR INVESTMENTS, LWASA STAGE-SALAAMA RD,MUNYONYO,MAKINDYE DIVISION | SCENSOR INVESTMENTS, LWASA STAGE-SALAAMA RD,MUNYONYO,MAKINDYE DIVISION | SCENSOR HENA HERBAL OINTMENT | SCENSOR INVESTMENTS, LWASA STAGE-SALAAMA RD,MUNYONYO,MAKINDYE DIVISION 0758 111966/0788 802892 | UGANDA | OINTMENT | 1*150GM PET JAR | 15/07/2021 |
| 223 | THA713 | SCENSOR INVESTMENTS | SCENSOR INVESTMENTS | SCENSOR PAMSA HERBAL POWDER | SCENSOR INVESTMENTS,LWASA STAGE-SALAAMA RD, MUNYONYO, MAKINDYE DIVISION +256758111966 +256756439989 | UGANDA | POWDER | 1*100GM PLASTIC JAR | 19/02/2021 |
| 224 | THA714 | SCENSOR INVESTMENTS | SCENSOR INVESTMENTS | SCENSOR SATA HERBAL POWDER | SCENSOR INVESTMENTS,LWASA STAGE-SALAAMA RD, MUNYONYO, MAKINDYE DIVISION +256758111966 +256756439989 | UGANDA | POWDER | 1*60GM PLASTIC JAR | 19/02/2021 |
| 225 | THA722 | AISHA PHYTO CENTRE NAMASUBA ENTEBBE ROAD | AISHA PHYTO CENTRE NAMASUBA ENTEBBE ROAD | STRICKER PLUS | AISHA PHYTO CENTRE NAMASUBA ENTEBBE ROAD 0782193367/0750382437 NASSALI.AISHA@YAHOO.COM TEL: 0782193367 / 0750382437 | UGANDA | POWDER | 60GM WHITE HDPE CONTAINER | 19/02/2021 |
| 226 | THA742 | SANYU NATURAL HEALTH PRODUCT MASAJJA ZONE A, KAMPALA TEL: +256700865708/0770827218 | SANYU NATURAL HEALTH PRODUCT MASAJJA ZONE A, KAMPALA TEL: +256700865708/0770827218 | SAWA SAWA HERBAL SOLUTION | SANYU NATURAL HEALTH PRODUCT MASAJJA ZONE A, KAMPALA TEL: +256700865708/0770827218 | UGANDA | LIQUID | 120 ML AMBER COLOURED PET BOTTLE | 19/03/2021 |
| 227 | THA752 | AISHA PHYTOCENTRE,NAMASUBA ENTEBBE ROAD 078219367/075382437 LUKWAGO.AISHA@YAHOO.COM | AISHA PHYTOCENTRE,NAMASUBA ENTEBBE ROAD 078219367/075382437 LUKWAGO.AISHA@YAHOO.COM | GUAVA NATURAL TEA | AISHA PHYTOCENTRE,NAMASUBA ENTEBBE ROAD 078219367/075382437 LUKWAGO.AISHA@YAHOO.COM | UGANDA | POWDER | 100GM | 07/09/2022 |
| 228 | THA757 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | POTEN DETOX RELIEF | MUPHEN HERBALISTS,NDEJJE WAKISO TEL:0782922421 | UGANDA | LIQUID | 500ML WHITE PET BOTTLE | 09/02/2022 |
| 229 | THA758 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | POTEN COUGH MIXTURE | MUPHEN HERBALISTS,NDEJJE WAKISO TEL:0782922421 | UGANDA | LIQUID | 200ML GREEN PET BOTTLE | 09/02/2022 |
| 230 | THA759 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | MUPHENS HERBALISTS,NDEJJE WAKISO TEL:0782922421/075922421 | POTEN SYRUP | MUPHEN HERBALISTS,NDEJJE WAKISO TEL:0782922421 | UGANDA | LIQUID | 500ML WHITE PET BOTTLE | 09/02/2022 |
| 231 | THA760 | AL-HAJI SADAM RASHID LUKWAGO Nateete Wakaliga Tel:0772512372 0700875051 | AL-HAJI SADAM RASHID LUKWAGO Nateete Wakaliga Tel:0772512372 0700875051 | SHID V-WASH | AL-HAJI SADAM RASHID LUKWAGO Nateete Wakaliga Tel:0772512372 0700875051 | UGANDA | LIQUID | 50ML PINK HDPE CANISTER SEALED WITH A WHITE HDPE SPRAY PUMP | 21/11/2021 |
| 232 | THA762 | NAMIREMBE PRODUCTS.BULENGA. NANKUWADDE ZONE KAMPALA-UGANDA TEL: 0774843982/0705792111 | NAMIREMBE PRODUCTS.BULENGA. NANKUWADDE ZONE KAMPALA-UGANDA TEL: 0774843982/0705792111 | NAMBIREMBE HERBAL COUGH & FLU SYRUP | NAMIREMBE PRODUCTS.BULENGA. NANKUWADDE ZONE KAMPALA-UGANDA TEL: 0774843982/0705792111 | UGANDA | SYRUP | 200ML AND 60ML IN AMBER PET BOTTLE | 19/02/2021 |
| 233 | THA768 | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LIMITED LOCATED IN KAGOMA-BOMBO ROAD | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LIMITED LOCATED IN KAGOMA-BOMBO ROAD | TONSOZIN ORAL DROPS | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LIMITED LOCATED IN KAGOMA-BOMBO ROAD. TEL:0783811801 0752540140 | UGANDA | SOLUTION | 30ML | 09/11/2020 |
| 234 | THA770 | DR.SSEGWANYI GODFREY,SMAT MEDS INDUSTRIES | DR.SSEGWANYI GODFREY,SMAT MEDS INDUSTRIES | MENTHOTOP | DR.SSEGWANYI GODFREY,SMAT MEDS INDUSTRIES TEL:0751 762 135,SMAT MEDS LTD, PLOT 738 MAYA. MASAKA ROAD | UGANDA | OINTMENT | 9G | 30/07/2021 |
| 235 | THA774 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | JENAPEP | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | LIQUID | 200ML PET BOTTLE | 02/12/2022 |
| 236 | THA775 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | ARTEMUNE | JENA HERBALS UGANDA LTD, PLOT 11.WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: JENAHERBALS@GMAIL.COM +256 779-617612/0756-299255 | UGANDA | POWDER | 100G CONTAINER | 27/02/2023 |
| 237 | THA776 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENAFLU | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: JENAHERBALS@GMAIL.COM +256 779-617612/0756-299255 | UGANDA | LIQUID | 1*60ML PET BOTTLE | 02/12/2022 |
| 238 | THA777 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENAMAL | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: JENAHERBALS@GMAIL.COM +256 779-617612/0756-299255 | UGANDA | GRANULES | 1*100GM | 13/01/2022 |
| 239 | THA778 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | JENA DM | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | PELLETS | 100G PET JAR | 04/11/2022 |
| 240 | THA779 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | JENA HT | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | POWDER | 100G PET JAR | 02/12/2022 |
| 241 | THA781 | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENA HERBALS UGANDA LTD, PLOT 11,WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD | JENAFIT | JENA HERBALS UGANDA LTD, PLOT 11.WALNUT AVENUE,AKRIGHT CITY, ENTEBBE ROAD EMAIL: JENAHERBALS@GMAIL.COM +256 779-617612/0756-299255 | UGANDA | POWDER | 100G CONTAINER | 27/02/2023 |
| 242 | THA782 | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | DR. OGWANG PATRICK ENGEU MOB: 0779-617612 E-MAIL: JENAHERBALS@GMAIL.COM | JENACURE | JENA HERBALS (U) LTD ALKRIGHT CITY ENTEBBE ROAD WALNUT 11 TEL: 0785374967/0700412666 0779617612/07002450938 | UGANDA | LIQUID | 15ML HDPE DROPPER BOTTLE | 04/11/2022 |
| 243 | THA783 | S.R BODY SOLUTION | S.R BODY SOLUTION | FOZ HERBAL MIXTURE | SEMPIJJA RONALD, S.R BODY SOLUTION, KAWEMPE TULA ROAD(KIGANDA) TEL:0759080579/0779189962 EMAIL SSEMPIJARONNIE22@GMAIL.COM | UGANDA | LIQUID | 1*200ML PET BOTTLE | 07/09/2022 |
| 244 | THA785 | AAFIYA (A) LTD TAHARI TOWER-NAMIREMBE ROAD,UGANDA TEL: 0772030835 | AAFIYA (A) LTD TAHARI TOWER-NAMIREMBE ROAD,UGANDA TEL: 0772030835 | AAF-FLU DROPS | AAFIYA (A) LTD TAHARI TOWER-NAMIREMBE ROAD,UGANDA TEL: 0772030835 | UGANDA | LIQUID | 1*5ML PLASTIC BOTTLE | 01/10/2021 |
| 245 | THA786 | AFIYA INDUSTRIES KASANGATI KITI A-WAKISO TEL: +256772030835 | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | PRINCESS COUGH SYRUP | PRINCESS PHARMACY (U) LTD,KAWEMPE,TTULA ROAD 0772 030835 /0700 554730 | UGANDA | SYRUP | 100ML AMBER COLOURED PET BOTTLE | 15/07/2021 |
| 246 | THA798 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | CEFTY COUGH SYRUP | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | UGANDA | SYRUP | 1*100ML AMBER PET BOTTLE | 15/07/2021 |
| 247 | THA799 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | CEFU | BUZIRA HERBAL COMPANY KASUBI-KAWAALA TEL: +256782549300 | UGANDA | LIQUID | 1*125ML PET BOTTLE | 15/07/2021 |
| 248 | THA801 | WILAN PRODUCTS KIGUMIRA-BUKUSU ON GULU NORTHEN HIGHWAY P.O BOX 207,WOBULENZI | WILAN PRODUCTS KIGUMIRA-BUKUSU ON GULU NORTHEN HIGHWAY P.O BOX 207,WOBULENZI | NATURAL MEDICINAL TEA BAGS | WILAN PRODUCTS KIGUMIRA-BUKUSU ON GULU NORTHEN HIGHWAY P.O BOX 207,WOBULENZI UGANDA TEL: 0772867533,+256-77-464365 | UGANDA | POWDER | 1*200GMS | 07/09/2022 |
| 249 | THA808 | NAMARA APOLLO TEL;0777496080 APROHEN-UGANDA FORTPORTAL KABALORE | NAMARA APOLLO TEL;0777496080 APROHEN-UGANDA FORTPORTAL KABALORE | CINCHONA HONEY SYRUP | NAMARA APOLLO TEL;0777496080 APROHEN-UGANDA FORTPORTAL KABALORE | UGANDA | LIQUID | 200ML AMBER PET BOTTLE | 27/09/2021 |
| 250 | THA814 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELODIABET | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA ELOIPHARM@GMAIL.COM | UGANDA | LIQUID SOLUTION | 200 MLS | 16/12/2022 |
| 251 | THA815 | ELOIPHARM (U) LTD P.O. BOX 36766 KAMPALA, UGANDA 0758329111 | ELOIPHARM (U) LTD, P.O. BOX 36766, KAMPALA, UGANDA 0758329111 | ELOPROSTINE | ELOIPHARM (U) LTD PLOT 160 MULAGO II ZONE ALONG LOWER NSOOBA ROAD P.O BOX 36766 KAMPALA UGANDA ELOIPHARM@GMAIL.COM | UGANDA | LIQUID SOLUTION | 200MLS | 27/02/2023 |
| 252 | THA816 | MUBIRU HADIJAH KALAGALA MUKONO TEL: 0752618771 | MUBIRU HADIJAH KALAGALA MUKONO TEL: 0752618771 | GO ORGANIC OIL | TRAMI MEDICINAL FOODS AND NATURAL PRODUCTS,LOCATED AT KALAGALA,MUKONO ON GAYAZA KALAGI ROAD,18 MILES FROM KAMPALA | UGANDA | OIL | 20ML AMBER PET BOTTLE | 27/05/2022 |
| 253 | THA828 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | BAYCONE HERBAL COUGH REMEDY | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | LIQUID | 100MLS WHITE PET BOTTLE. | 09/11/2020 |
| 254 | THA838 | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | BAYCONE.G.I | NIWAGABA BRIAN. MAKENKE INDUSTRIAL AREA MBARARA MASAKA ROAD TEL 0701691169/0773329401. | UGANDA | LIQUID | 100MLS WHITE PET BOTTLE. | 09/11/2020 |
| 255 | THA844 | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD WAKISO | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD WAKISO | GENWASH LADY OIL | BAKITONSA HERBAL GROUP MAYA NANZIGA OFF MASAKA ROAD WAKISO TEL: 0709900200 0759100200 0758651913 0776664207 | UGANDA | LIQUID | 30ML SOLUTION IN PET BOTTLE | 27/05/2022 |
| 256 | THA852 | PRINCESS PHARMACY-OPPOSITE AVIS INDUSTRY TULA ROAD | PRINCESS PHARMACY-OPPOSITE AVIS INDUSTRY TULA ROAD | SKY COUGH SYRUP | PRINCESS PHARMACY-OPPOSITE AVIS INDUSTRY TULA ROAD MUTEBI RAMATHAN TEL: 0772030835 E-MAIL: MRAMAH26@GMAIL.COM | UGANDA | SYRUP | 100ML AMBER COLOURED PET BOTTLE | 21/11/2021 |
| 257 | THA854 | NAKIBUUKA HARRIET GARLIC MIRACULOUS CHLOROPHYLL (U) LTD | NAKIBUUKA HARRIET GARLIC MIRACULOUS CHLOROPHYLL (U) LTD | NDERM | NAKIBUUKA HARRIET GARLIC MIRACULOUS CHLOROPHYLL (U) LTD NAKAWA MARKET P.O BOX 70546 KAMPALA-UGANDA LTD TEL: 0780326213/07688405 | UGANDA | OINTMENT | 60G TRANSPARENT WHITE BOTTLE WITH BLACK LID & 25G TRANSPARENT BOTTLE WITH WHITE LID | 09/02/2022 |
| 258 | THA855 | WHITE MARK COSMETICS LOCATION: KABULENGWA NANSANA IN WAKISO DISTRICT ALONG HOIMA ROAD | WHITE MARK COSMETICS LOCATION: KABULENGWA NANSANA IN WAKISO DISTRICT ALONG HOIMA ROAD | HONEY POT HERBAL GENTLE WASH | WHITE MARK COSMETICS LOCATION: KABULENGWA NANSANA IN WAKISO DISTRICT ALONG HOIMA ROAD. TEL: 0701 188367 | UGANDA | LIQUID | 100ML TRANSPARENT PET BOTTLE | 01/10/2021 |
| 259 | THA856 | ASUMAN NUWAMANYA RWEBIKONA KAMUKUZI MBARARA TEL:256772911286/+256702911286 | ASUMAN NUWAMANYA RWEBIKONA KAMUKUZI MBARARA TEL: +256772911286/+256702911286 | B4 AMAZIIMA | ASUMAN NUWAMANYA AHW MEDICINAL HERBS RESEARCH AND TREATMENT CENTRE RWEBIKONA KAMUKUZI MBARARA CITY TEL:+256772911286/+256702911286 | UGANDA | LIQUID | 500ML HDPE BOTTLE | 07/09/2021 |
| 260 | THA859 | BENEBYONA HERBAL CLINIC NATEETE OPPOSITE TOTAL PETROL STATION TEL: 078039335 | BENEBYONA HERBAL CLINIC NATEETE OPPOSITE TOTAL PETROL STATION TEL: 078039335 | PESHA V POWDER | BENEBYONA HERBAL CLINIC NATEETE OPPOSITE TOTAL PETROL STATION TEL: 078039335 | UGANDA | POWDER | 1*200GM IN WHITE PET JAR | 19/02/2021 |
| 261 | THA861 | MICHEAL SSANGO, 9 MILES MITYANA ROAD BULAGA SSUMBWE B PARISH. | MICHEAL SSANGO, 9 MILES MITYANA ROAD BULAGA SSUMBWE B PARISH. | GYNO FORMULA BULOBA | MICHEAL SSANGO, 9 MILES MITYANA ROAD BULAGA SSUMBWE B PARISH. TEL: 0785114009/0758665451 EMAIL:HERBALVILLAGEDC@GMAIL.COM | UGANDA | LIQUID | 700ML HDPE BOTTLE | 29/10/2021 |
| 262 | THA863 | KAMPALA UNIVERSITY BODY CARE (U) LTD. | KAMPALA UNIVERSITY BODY CARE (U) LTD. | PILOSA HERBAL PAIN RELIEF | KAMPALA UNIVERSITY BODY CARE (U) LTD. P.O.BOX 25454 KAMPALA, BUZIGA, KATUUSO RISE. TEL: 0703593862/0772450601/0775289297 | UGANDA | OINTMENT | 1*25GM IN WHITE PET JAR SEALED WITH GREEN SCREW CAP. | 15/07/2021 |
| 263 | THA864 | SHAKA ORGANICS, NDEJJE,KAMPALA UGANDA | SHAKA ORGANICS, NDEJJE,KAMPALA UGANDA | SHAKA ORGANIC COLD &FLU SYRUP | SSERUNJOGI SHAFIQ. MANAGING DIRECTOR.SHAKA ORGANICS,NDEJJE ,KAMAPALA ,UGANDA TEL: 0787 366726/0706347173 | UGANDA | LIQUID | 1*200ML IN AMBER PET BOTTLE | 19/02/2021 |
| 264 | THA868 | KIIZA MUZAMIRU KYOGA WAKISO TOWN 0777863654/ 0758358990/ 0701888617 | KIIZA MUZAMIRU KYOGA WAKISO TOWN 0777863654/ 0758358990/ 0701888617 | BUTONDE COUGH SYRUP | BUTONDE AFRICAN SOLUTIONS KIIZA MUZAMIRU KYOGA WAKISO TOWN 0777863654/ 0758358990 /0701888617 | UGANDA | LIQUID | 100ML AMBER HDPE BOTTLE SEALED WITH A RED HDPE SCREW CAP. | 09/12/2021 |
| 265 | THA874 | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE | UBV-01 | NATURAL CHEMOTHERAPEUTICS RESEARCH INSTITUTE. PLOT 2B,LOURDEL ROAD KAMPALA P.O.BOX 4864, KAMPALA UGANDA. | UGANDA | SOLUTION | 20OML HDPE | 25/02/2021 |
| 266 | THA875 | CORTEZ PRODUCTS LTD, ,P.O .BOX 10815, BULOBA OFF MITYANA ROAD C/O +256703513645 | CORTEZ PRODUCTS LTD, ,P.O .BOX 10815, BULOBA OFF MITYANA ROAD C/O +256703513645 | CORTEZ HERBAL MOUTH FRESHNER | CORTEZ PRODUCTS LTD, ,P.O .BOX 10815, BULOBA OFF MITYANA ROAD C/O +256703513645 | UGANDA | LIQUID | 1*30ML PET BOTTLE | 15/07/2021 |
| 267 | THA877 | DR. ABALA PATRICK, MPERERWE SEKATTE ZONE,TEL:0782977283/0705170096 | DR. ABALA PATRICK, MPERERWE SEKATTE ZONE,TEL:0782977283/0705170096 | TARAMEL TOOTH TABS | BALMOI ORALCARE LTD,MPERERWE GAYAZA ROAD.KAMAPALA.UGANDA TEL:0782977283/ 0705170096 | UGANDA | TABLETS | 1*120 TABLETS HDPE BOTTLE | 07/09/2021 |
| 268 | THA879 | LUKWAGO ISMAIL ADDRESS:KAMPALA, NAJJANANKUMBI TEL: 0708766496/0705346041 | LUKWAGO ISMAIL ADDRESS:KAMPALA, NAJJANANKUMBI TEL: 0708766496/0705346041 | RENA HERBAL MOUTHWASH | KAMEKETA ENTERPRISES LTD P.O.BOX 6555 KAMPALA UGANDA TEL: +256705346041 | UGANDA | LIQUID | 60ML PET SPRAY BOTTLE | 27/02/2023 |
| 269 | THA881 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | REPLENISH + MAMA CARE | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | UGANDA | HARD GELATIN CAPSULES | 6*10 ALU-PVC BLISTER PACK | 04/06/2021 |
| 270 | THA882 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | REPLENISH + JUNIOR | DOCTOR`S CHOICE LIMITED P.O BOX 314 JINJA INDUSTRIAL AREA,PLOT 9-17 JINJA +256-485-660-69 | UGANDA | TABLETS | 30`S HDPE BOTTLE | 04/06/2021 |
| 271 | THA907 | MWENYA UGANDA DENTAL CLINIC, P.O.BOX 467, MPIGI TOWN,KULUMBA HILL 0758021933/0703826185 | MWENYA UGANDA DENTAL CLINIC, P.O.BOX 467, MPIGI TOWN,KULUMBA HILL 0758021933/0703826185 | MWENYA NATURAL MOUTH WASH | MWENYA LIFE UGANDA LTD P.O.BOX 467 MPIGI TOWN.KULUMBA HILL 0758021933/0703826185 EMAIL: MWENYAUGANDADENTALCLINICMPIGI@GMAIL.COM | UGANDA | LIQUID | 200ML HDPE BOTTLE | 07/09/2022 |
| 272 | THA917 | KALUMIRA STEVEN HERBAL TALK (U) LTD LUGALA-MASANAFU, SENTEMA RD TEL: 0704644322 | KALUMIRA STEVEN HERBAL TALK (U) LTD LUGALA-MASANAFU, SENTEMA RD TEL: 0704644322 | KOFFLEX HERBAL COUGH SYRUP | HERBAL TALK (U) LTD LUGALA-MASANAFU, SENTEMA RD TEL: 0704644322 E-MAIL:HERBALTALK@GMAIL.COM | UGANDA | LIQUID | 100ML AND 200ML LIQUID HDPE AMBER BOTTLE | 27/05/2022 |
| 273 | THA918 | MED BIIN PHARMACEUTICALS LTD, PLOT 1512,MAWANDA ROAD KAMPALA-UGANDA TEL:+256 393 246 090 | MED BIIN PHARMACEUTICALS LTD, PLOT 1512,MAWANDA ROAD KAMPALA-UGANDA TEL:+256 393 246 090 | MINTOCID | MED BIIN PHARMACEUTICALS LTD, PLOT 1512,MAWANDA ROAD KAMPALA-UGANDA TEL:+256 393 246 090 | UGANDA | LIQUID | 100ML & 200ML AMBER PET BOTTLE | 13/01/2022 |
| 274 | THA927 | TRANSFORM ABAFRICA PRODUCTS LIMITED P.O.BOX 6332 KAMPALA 0774495428/0704088886 | TRANSFORM ABAFRICA PRODUCTS LIMITED P.O.BOX 6332 KAMPALA 0774495428/0704088886 | ABAFRICA COUGH SYRUP | TRANSFORM ABAFRICA PRODUCTS LIMITED P.O.BOX 6332 KAMPALA 0774495428/0704088886 BUKINDA-RUKIGA DISTRICT | UGANDA | SOLUTION | 1*100ML AMBER PET BOTTLE | 26/05/2023 |
| 275 | THA928 | JENA HERBALS (U) LTD AKRIGHT CITY, ENTEBBE ROAD PLOT 11, WALNUT | JENA HERBALS (U) LTD AKRIGHT CITY, ENTEBBE ROAD PLOT 11, WALNUT | COVIDEX | JENA HERBALS (U) LTD AKRIGHT CITY, ENTEBBE ROAD PLOT 11, WALNUT TEL: 0785374967/0700412666 0779617612/0702450938 | UGANDA | LIQUID | 20 MLS IN WHITE HDPE DROPPER BOTTLE WITH GREEN LID | 29/06/2021 |
| 276 | THA932 | MUYOMBYA SOLOMON TEL: 0703531491/0787368458 | MUYOMBYA SOLOMON TEL: 0703531491/0787368458 | DELAY TEA | TENDO-MUYO ORGANIC HERBALS LTD, TEL: 070-531491/0787-368458 LOCATION: KIJABO-GAYAZA RD | UGANDA | POWDER | 180G HDPE CONTAINER | 02/12/2022 |
| 277 | THA933 | MUYOMBYA SOLOMON 0772166541 | MUYOMBYA SOLOMON 0772166541 | CHAMA | TENDO HERBS TEL: 0703-531491/ 0787-368458 ANNET PLAZA BELOW OLD TAXI PARK LEVEL 2 ROOM S.04 MPERERWE NAMERE | UGANDA | POWDER | 100GM POWDER IN HDPE CONTAINER | 26/05/2023 |
| 278 | THA935 | BAANA BAKINTU HERBAL PRODUCTS, MUBENDE MUNICIPALITY | BAANA BAKINTU HERBAL PRODUCTS, MUBENDE MUNICIPALITY | BB001 GREEN TEA | BAANA BAKINTU HERBAL PRODUCTS, MUBENDE MUNICIPALITY, BAKIJULULA LC 1 TEL: 0772-913916/0752-150387 | UGANDA | POWDER | 200GM PLASTIC CONTAINER | 07/09/2022 |
| 279 | THA936 | KIGGUNDU HERBAL GROUP NDEEBA NEAR SHELL PETROL STATION WAMALA ROAD O7O2839934 | KIGGUNDU HERBAL GROUP NDEEBA NEAR SHELL PETROL STATION WAMALA ROAD O7O2839934 | STK POWDER | KIGGUNDU HERBAL GROUP NDEEBA NEAR SHELL PETROL STATION WAMALA ROAD O7O2839934 | UGANDA | POWDER | 200GM PET JAR | 07/09/2022 |
| 280 | THA937 | NALONGO MUSANA HERBAL CLINIC, KINZINGISA OFF GAYAZA ROAD 0701693848/0781544591 | NALONGO MUSANA HERBAL CLINIC, KINZINGISA OFF GAYAZA ROAD 0701693848/0781544591 | NALONGO MUSANA B.E HERBAL SOLUTION | NALONGO MUSANA HERBAL CLINIC, KINZINGISA OFF GAYAZA ROAD 0701693848/0781544591 | UGANDA | POWDER | 750ML PET BOTTLE | 07/09/2022 |
| 281 | THA938 | KAZIRE HEALTH PRODUCTS LIMITED, PLOT 178 KABALE ROAD, MBARARA CITY. | KAZIRE HEALTH PRODUCTS LIMITED, PLOT 178 KABALE ROAD, MBARARA CITY. | VIDICINE | KAZIRE HEALTH PRODUCTS LIMITED, PLOT 178 KABALE ROAD, MBARARA CITY. PHONE: +256704714736 EMAIL: info@kazire.com | UGANDA | LIQUID | 200ML PLASTIC BOTTLE | 07/09/2021 |
| 282 | THA939 | PHERB FORMULATIONS (U) LTD, P.O BOX 4462, KAMPALA – UGANDA 0704356951 / 0776290548 | PHERB FORMULATIONS (U) LTD, P.O BOX 4462, KAMPALA – UGANDA 0704356951 / 0776290548 | MINTEX DROPS-5MLS | YECO ORGANICS MANAGEMENT LTD,KYEBANDO,KATALE ZONE,GAYAZA ROAD, KAMPALA – UGANDA | UGANDA | LIQUID | 1*5ML WHITE PET CAPPED BOTTLE WITH A WHITE DROPPER PER CARTON | 29/10/2021 |
| 283 | THA943 | NARURAL HEALTH CARE CONSULTATIONS PLOT 2B, LOURDEL ROAD, KAMPALA P.O BOX 2004,KAMPALA-UGANDA | NARURAL HEALTH CARE CONSULTATIONS PLOT 2B, LOURDEL ROAD, KAMPALA P.O BOX 2004,KAMPALA-UGANDA | NAHECCO HERBAL COUGH SYRUP | NARURAL HEALTH CARE CONSULTATIONS PLOT 2B, LOURDEL ROAD, KAMPALA P.O BOX 2004,KAMPALA-UGANDA TEL: +256704187510/+256706553709 | UGANDA | SYRUP | 1*100 & 200ML AMBER PET BOTTLE | 26/05/2023 |
| 284 | THA948 | OCHEN ANTHONY, SHUMUK HOUSE COLVILLE STREET KAMPALA 0772192567/O705395388 | OCHEN ANTHONY, SHUMUK HOUSE COLVILLE STREET KAMPALA 0772192567/O705395388 | HEAMORIX | HHEMORIX UGANDA SSHUMUK HOUSE, COLVILLE STREET, KAMPALA 0771473717/0709861096 | UGANDA | OINTMENT | 1*1*20G PET JAR. | 04/11/2022 |
| 285 | THA949 | WAISWA DANIEL 07707567718 TUMWINE PIUS 0778003721 | WAISWA DANIEL 07707567718 TUMWINE PIUS 0778003721 | ZOE PURE NATURAL SYRUP | LIFE IMPACT CONSORTIUM (LIC) LTD,P.O.BOX 4674 KAMPALA(U) KIREKA- NAMUGONGO ROAD TEL+256(0) 200 920 929 | UGANDA | SYRUP | 100ML PLASTIC BOTTLE | 07/09/2022 |
| 286 | THA950 | NAMBATYA JOANITAH KYENGERA-MUGONGO, OFF MASAKA KAMPALA ROAD 0754884766 | NAMBATYA JOANITAH KYENGERA-MUGONGO, OFF MASAKA KAMPALA ROAD 0754884766 | GARRY HERBAL POWDER | GARRY HERBS KINAAWA HILL MUSOKE ROAD KYENGERA OFF MASAKA ROAD TEL:0774088895 0754884766 | UGANDA | POWDER | 250GMS IN AN HDPE TIN | 27/05/2022 |
| 287 | THA951 | TORWOMWE SEMA FRANCIS MUNYONYO, GABA ROAD 0705666333 /078266661 | TORWOMWE SEMA FRANCIS MUNYONYO, GABA ROAD 0705666333 /078266661 | VIGOR IMMUNE PLUS | WORLD- WIDE HAPPINESS INTERNATIONALKAMPALA ROAD MABIRIZI COMPLEX.LEVEL 4.ROOM NO:15 (L4-15) P.O.BOX 71233 CLOCK TOWER KAMPALA | UGANDA | POWDER | 1*50GM GLASS JAR | 09/12/2021 |
| 288 | THA970 | MALUGGE ARNOLD TEL: 0783811801 | MALUGGE ARNOLD TEL: 0783811801 | MOMMY`S LACTATION TEA | PIANTA PRODUCT RESEARCH AND DEVELOPMENT LTD LOCATED IN KAGOMA-BOMBO RD P,O BOX 16843, WANDEGEYA, UGANDA TEL: +256782769582/+256752540140 | UGANDA | POWDER | 200G LDPE BAG PACKED THE SECONDARY BOX | 09/02/2022 |
| 289 | THA971 | MALUGGE ARNOLD TEL: 0783811801 | MALUGGE ARNOLD TEL: 0783811801 | IMMUNE UP | JOLIKA LTD P.O BOX 23333, KAMPALA,UGANDA TEL: +256-706353088/773466690 WWW.JOLIKAUG.COM | UGANDA | LIQUID | 200ML AMBER PET BOTTLE | 09/02/2022 |
| 290 | THA975 | TENDO ORGANIC HERBALS LTD LOCATED:KIJABIJO OFF GAYAZA ROAD,WAKISO 0703531491/0787368458 | TENDO ORGANIC HERBALS LTD LOCATED:KIJABIJO OFF GAYAZA ROAD,WAKISO 0703531491/0787368458 | IMUNOX 23RD-WELLNESS | TENDO ORGANIC HERBALS LTD LOCATED:KIJABIJO OFF GAYAZA ROAD,WAKISO 0703531491/0787368458 | UGANDA | ORAL LIQUID | 200ML PET BOTTLE | 06/07/2023 |
| 291 | THA982 | DAMA MEDICINAL HERBS P.O.BOX 25216 KAMPALA | DAMA MEDICINAL HERBS P.O.BOX 25216 KAMPALA | DAMA TONIC SOLUTION | DAMA MEDICINAL HERBS,P.O.BOX 25216 KAMPALA,PLOT 3118 BBIIRA,BULENGA TEL:0772684274/0774258892/0777733338/0754318926 | UGANDA | LIQUID | 1*670ML PET BOTTLE | 26/05/2023 |
| 292 | THA988 | VIGOR DOCTOR (U) LTD/ VIGOR IMMUNE PLUS (U) LTD | VIGOR DOCTOR (U) LTD/ VIGOR IMMUNE PLUS (U) LTD | VGR-IMM-PLUS | VIGOR DOCTOR (U) LTD/ VIGOR IMMUNE PLUS (U) LTD MUKWANO MALL, PLOT 1, KYAGWE RD P.O BOX 456, KAMPALA, UGANDA TEL: 0701074540/0781960612 | UGANDA | POWDER | 700G PLASTIC CONTAINER | 27/05/2022 |
| 293 | THA995 | KAGOYA DIANA BUSABALA WAKISO TEL: 0753509324 | KAGOYA DIANA BUSABALA WAKISO TEL: 0753509324 | KAGOYA HERBAL JELLY | KAGOYA DIANA BUSABALA WAKISO TEL: 0753509324 | UGANDA | JELLY | 60GM,100GM & 250GM,PLASTIC CONTAINER | 07/09/2022 |
| 294 | THA999 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | MUTIBWA CHRISTOPHER BULOBA ,WAKISO DISTRICT O754221423/0779288797 0775827379/0755540110 | ULVOP HERBAL MIXTURE | VAX ORGANIC PRODUCTS BULOBA ALONG MITYANA ROAD ,WAKISO DISTRICT TEL:0775827379/0755540110 | UGANDA | LIQUID | 200ML PET BOTTLE | 27/02/2023 |
| 295 | THA876 | RUPEX HEALTH PRODUCTS TEL: +256755927058 +256783653309 | RUPEX HEALTH PRODUCTS TEL: +256755927058 +256783653309 | CUREXI53 | RUPEX HEALTH PRODUCTS LIMITED NAJJERA BULABIRA E-MAIL: INFO@RUPEXHEALTHPRODUCTS.COM TEL: +256756378785, +256775575752 | UGANDA | LOTION | 65GM HDPE CONTAINER | 16/11/2023 |
| 296 | THA1171 | FABEL KANYANYA GABRIEL +256772457024 +44795828806 KIREKA | FABEL KANYANYA GABRIEL +256772457024 +44795828806 KIREKA | ACTIMAX HERBAL BOOST | FABROSE PREMIMIUM HEALTH BOOSTER LTD KIREKA ZONE A TEL:+44958288067 +246772457024 | UGANDA | POWDER | 100G PET CONTAINER | 13/10/2023 |
| 297 | THA1132 | NSAALE HEALTH PRODUCTS PLOT 424 RUBAGA WAKALIGA B ZONE 0789261851/0753275292 | NSAALE HEALTH PRODUCTS PLOT 424 RUBAGA WAKALIGA B ZONE 0789261851/0753275292 | NSAALE ANTISEPTIC SOLUTION | NSAALE HEALTH PRODUCTS PLOT 424 RUBAGA WAKALIGA B ZONE 0789261851/0753275292 | UGANDA | LIQUID | 100ML AND 500ML CLEAR PLASTIC BOTTLE | 13/10/2023 |
| 298 | THA998 | TWINAMATSIKO FRANK SHAKUR HERBAL GROUP KAWEMPE 0704463646/0775252041 | TWINAMATSIKO FRANK SHAKUR HERBAL GROUP KAWEMPE 0704463646/0775252041 | SHAKUR MODERN HERBAL TEA | SHAKUR HERBAL GROUP TTULA-KIROKOLE NEAR LUUKA PLASTICS, KAWEMPE, KAMPALA, UGANDA. 0704463646/0775252041 | UGANDA | POWDER | 75 AND 160 GRAMS PET BOTTLE | 4/10/2023 |
| 299 | THA1178 | MUSOKE H. TAMALE | MUSOKE H. TAMALE | SEAET SOLUTION | MUSOKE H. TAMALE KALAMA VILLAGE, KIKONGE-NSYAMBYA ROAD MITYANA DISTRICT P.BOX 11301, KAMPALA TEL: 0772306061, 0200961133 | UGANDA | LIQUID | 500ML PLASTIC BOTTLE | 15/09/2023 |
| 300 | THA792 | BUKABEMPA (U) LTD P.O BOX 71, RUSHERE KIRUHURA DISTRICT TEL: 0772852054/0701852054 | BUKABEMPA (U) LTD P.O BOX 71, RUSHERE KIRUHURA DISTRICT TEL: 0772852054/0701852054 | MPAWARB HERBAL POWDER | BUKABEMPA (U) LTD P.O BOX 71, RUSHERE KIRUHURA DISTRICT TEL: 0772852054/0701852054 | UGANDA | POWDER | 50 GMS IN A TRANSPARENT PLASTIC JAR | 30/10/2023 |
Updated on 8th April 2024
