Drug Register (October 2023)
This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.

NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
NDA/MAL/HHP/10012REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDPILEENO OINTMENTPAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE28/02/2022
NDA/MAL/HHP/10013REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDSLIM TRIM CAPSULES.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BLISTER28/02/2022
NDA/MAL/HHP/10015REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDDOMO CREAM.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE28/02/2022
NDA/MAL/HHP/10016REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDTOTO CARE.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY LIQUIDS 1.0X150.0 ML BOTTLE28/02/2022
NDA/MAL/HHP/10017REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDMARKONIL CREAM.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS 1.0X100.0 G TUBE28/02/2022
NDA/MAL/HHP/10019CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN TABLETSCHARAK PHARMA PRIVATE LIMITED-JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER07/03/2022
NDA/MAL/HHP/10406GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOTUS FEMIWASHGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) | INDIA | TOPICAL EXTERNAL LIQUIDS 1.0X25.0 ML BOTTLE04/10/2022
NDA/MAL/HHP/10409CHETAN & DIPTI (C&D) PHARMA PVT LTDKAMCARE PHARMA LIMITEDHERBOXIL LOZENGESLEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X50.0X2.0 LOZENGE STRIP12/10/2022
NDA/MAL/HHP/10411BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS ORANGE LOZENGESLOZEN PHARMA PRIVATE LIMITED-RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
NDA/MAL/HHP/10412BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS MENTHOL LOZENGESLOZEN PHARMA PRIVATE LIMITED-RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
NDA/MAL/HHP/10413BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS HONEY LEMON LOZENGESLOZEN PHARMA PRIVATE LIMITED-RAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
NDA/MAL/HHP/10500GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL NATURA SYRUPTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/12/2022
NDA/MAL/HHP/10501SYNOKEM PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDGOPAYN RUB GELSARTHI PHARMA-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE02/12/2022
NDA/MAL/HHP/10588CHETAN & DIPTI (C&D) PHARMA PVT LTDKAMCARE PHARMA LIMITEDCHARCO PRO TABLETM/S BHARGAVA PHYTOLAB PRIVATE LIMITED-E-1216 PHASE-I, GHATAL, RIICO INDUSTRIAL AREA, BHIWADI, DISTRICT ALWAR (RAJASTHAN) - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER10/01/2023
NDA/MAL/HHP/10780CONFO INTERNATIONAL LTDDAVIMED PHARMA LIMITEDCONFOZHEJIANG CONBA PHARMACEUTICAL COMPANY LIMITED-1ST CONBA AVENUE, LANXI, ZHEJIANG - CHINA | CHINA | TOPICAL EXTERNAL LIQUIDS 1.0X3.0 ML CONTAINER14/03/2023
NDA/MAL/HHP/10899ARIHANT REMEDIESDAVIMED PHARMA LIMITEDRELIEF OINTMENTARIHANT REMEDIES-BLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X50.0 G TUBE27/07/2023
NDA/MAL/HHP/10901ARIHANT REMEDIESDAVIMED PHARMA LIMITEDRELIEF BALMARIHANT REMEDIES-BLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X100.0 G CONTAINER27/07/2023
NDA/MAL/HHP/10902ARIHANT REMEDIESDAVIMED PHARMA LIMITEDCOLD GRIP INHALERARIHANT REMEDIES-BLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABAD | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X0.5 ML CONTAINER27/07/2023
NDA/MAL/HHP/3115CINCINNATI CHILDREN’S HOSPITAL SHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER01/07/2001
NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOOM SYRUPCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | CHARAK PHARMA PRIVATE LIMITED-JAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2000
NDA/MAL/HHP/5502HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDGASEXHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)01/07/2000
NDA/MAL/HHP/5517HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDMENTATHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X50.0 TABLET CONTAINER01/07/2004
NDA/MAL/HHP/5518MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER01/07/2007
NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPSAVERA 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 BOTTLE01/07/2004
NDA/MAL/HHP/5520HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDPILEXHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER01/07/2001
NDA/MAL/HHP/5527HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDKOFLETHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2000
NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY POWDERS 1.0X10.0X765.0 MG SACHET01/07/2009
NDA/MAL/HHP/5530HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDLIV.52 TABLETSHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE01/07/2000
NDA/MAL/HHP/5531HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/2000
NDA/MAL/HHP/5532MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI | INDIA | NASAL TOPICAL LIQUID INHALATIONS 1.0X12.0X1.0 G ROD01/07/2009
NDA/MAL/HHP/5533HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)01/07/2000
NDA/MAL/HHP/5536ABACUS (A) PHARMA LTDJEET PHARMACEUTICALS LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI | INDIA | NASAL TOPICAL OINTMENTS 1.0X24.0X3.5 ML VIAL,1.0X1.2 G JAR,1.0X4.0 G JAR,1.0X9.0 G JAR,1.0X30.0 G JAR,1.0X1.2 ML VIAL,1.0X4.0 ML VIAL,1.0X9.0 ML VIAL,1.0X30.0 ML BOTTLE01/07/2004
NDA/MAL/HHP/5538HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER01/07/2000
NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
NDA/MAL/HHP/5547CINCINNATI CHILDREN’S HOSPITAL SHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIA | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X35.0X2.0 LOZENGE STRIP01/07/2001
NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2000
NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA | ORAL TOPICAL GELS AND SOLS 1.0X50.0 G TUBE01/07/2015
NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136 | BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
NDA/MAL/HHP/5559CINCINNATI CHILDREN’S HOSPITAL SHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X12.0 G TUBE01/07/2001
NDA/MAL/HHP/5563HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDCYSTONEHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER01/07/2001
NDA/MAL/HHP/5564AIL HEALTH CARE VRUSHIK INVESTMENT LIMITEDFRESH HERBAL COUGH SYRUPAIL HEALTH CARE-816/1 RAKANPUR KALOL GENDHINAGAR GUJRAT | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2016
NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTE CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER01/07/2011
NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2009
NDA/MAL/HHP/5583HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDEVECAREHIMALAYA DRUG COMPANY-27256287 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER01/07/2001
NDA/MAL/HHP/5587CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDMANOLL SYRUP CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA | CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X250.0 MG BOTTLE01/07/2016
NDA/MAL/HHP/5588CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (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 BLISTER01/07/2014
NDA/MAL/HHP/5623UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP01/07/2005
NDA/MAL/HHP/5629UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP01/07/2005
NDA/MAL/HHP/5630UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH REMEDYUNIQUE 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 BOTTLE01/07/2000
NDA/MAL/HHP/5631UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP01/07/2014
NDA/MAL/HHP/6848CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (MINT)LEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X3.0X4.0 LOZENGE BLISTER,1.0X2.0X6.0 LOZENGE BLISTER01/07/2016
NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULES TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER01/07/2015
NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE01/07/2015
NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTD GAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212 | BANGLADESH | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 | BANGLADESH | ORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE STRIP01/07/2014
NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA | INDIA | TOPICAL EXTERNAL OTHER CREAMS 1.0X50.0 ML BOTTLE01/07/2015
NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
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THAILAND | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2016
NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP01/07/2014
NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF 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 CONTAINER01/07/2016
NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP01/07/2014
NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP01/07/2014
NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF 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 BOTTLE01/07/2015
NDA/MAL/HHP/7972MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN BALMMONA LAB-20/2 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 CONTAINER01/07/2009
NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2017
NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE20/09/2017
NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE02/02/2018
NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 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 BOTTLE02/02/2018
NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/02/2018
NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULECHARAK 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 BLISTER29/11/2017
NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE06/03/2018
NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER10/11/2017
NDA/MAL/HHP/9093BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE22/03/2019
NDA/MAL/HHP/9094BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUP BETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE22/03/2019
NDA/MAL/HHP/9115REVITAL HEALTHCARE LTDHEALTHCARE LTD.DO-MO CAPSULES ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X4.0X10.0 CAPSULE BLISTER16/07/2019
NDA/MAL/HHP/9179CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDADDYZOA CAPSULESCHARAK 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 BLISTER29/01/2020
NDA/MAL/HHP/9182REVITAL HEALTHCARE LTDHEALTHCARE LTD.HERBICUFASIAN LIFECARE PVT.LTD-MANJUSAR,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 BOTTLE11/03/2020
NDA/MAL/HHP/9254UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES-STRAWBERRY FLAVOURUNIQUE PHARMACEUTICAL LABORATORIES ;-SURVEY NO. 101/2 & 102/1, DAMAN INDUSTRIAL ESTATE, KAPAIYA, DAMAN 396210 | INDIA | ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP18/07/2020
NDA/MAL/HHP/9332MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA IVY SYRUPMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE31/08/2020
NDA/MAL/HHP/9333MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA MOUTH SPRAYMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL TOPICAL SPRAYS WITHOUT GAS 1.0X10.0 ML BOTTLE31/08/2020
NDA/MAL/HHP/9694GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF SYRUPKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE22/07/2021
NDA/MAL/HHP/9701GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF PLUS SYRUPKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE27/08/2021
NDA/MAL/HHP/9703GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDCURODEX OINTMENTRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G BOTTLE27/08/2021
NDA/MAL/HHP/9704GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL INHALERRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 | INDIA | NASAL TOPICAL LIQUID INHALATIONS 1.0X0.5 ML INHALER27/08/2021
NDA/MAL/HHP/9711MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGINSOMINMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER07/10/2021
NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURER COUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
NDA/MAL/VHP/8117COOPER K-BRANDS LTDCKL UGANDA LIMITEDSOOTHING OILCKL AFRICA LIMITED-MASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYA | KENYA | UNKNOWN OILS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2016
NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
NDA/MAL/HDP/0002ABACUS PARENTERAL DRUGS LIMITED.ABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE+NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
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UGANDA | OPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2011
NDA/MAL/HDP/0006HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDDIAMIDEGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGHOVID 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 BLISTER01/07/2014
NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0012HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDPENGESIC SR TRAMADOL HYDROCHLORIDE SR 100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0013ORGANON SOUTH AFRICA (PTY) LTDSURGIPHARM (U) LIMITEDIMPLANON NXT ETONOGESTREL68MGN.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND | NETHERLANDS | PARENTERAL RETARD IMPLANTS 1.0X68.0 MG IMPLANT01/07/2015
NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI CARE LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X10.0X7.5 ML VIAL01/07/2011
NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE 300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE01/07/2013
NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE 50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
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INDIA | PARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE01/07/2015
NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND 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 VIAL01/07/2015
NDA/MAL/HDP/0033ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYVATE CREAMBETAMETHASONE VALERATE0.1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/1997
NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/0051H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY | DENMARK | PARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE01/07/2015
NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/2014
NDA/MAL/HDP/0053H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK | PARENTERAL RETARD AMPOULES 1.0X1.0 ML AMPOULE01/07/2015
NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK | PARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE01/07/2015
NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPS DICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | TROIKAA PHARMACEUTICALS LTD-BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE | INDIA | TOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE01/07/2015
NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
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PAKISTAN | TOPICAL EXTERNAL CREAMS 1.0X40.0 G TUBE + 1 APPLICATOR01/07/2006
NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML)FOLLITROPIN ALFA22 µG/0,5 MLMERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | ITALY PARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION01/07/2015
NDA/MAL/HDP/0063HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE + LAMIVUDINE ABACAVIR SULFATE + LAMIVUDINE600MG + 300MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER01/07/2015
NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | ITALYPARENTERAL ORDINARY CARTRIDGES 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION01/07/2015
NDA/MAL/HDP/0065HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDALENDRONATE 70MGALENDRONATE SODIUM70MGHOVID BHD-LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMOR | MALAYSIA | ORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0075 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICAL INDUSTRIES LIMITED -INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0077ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONE DEXAMETHASONE SODIUM PHOSPHATE0.1 % W/V ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
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UGANDA | OPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/2015
NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0083MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0088GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS 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/ZINC2.7MG+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 SACHETAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES 4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS01/07/2015
NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0098MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/1998
NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE | NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM 4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGBETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2015
NDA/MAL/HDP/0125DAWA LIMITED SUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE01/07/2013
NDA/MAL/HDP/0135SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDHEMOVIT SYRUPIRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2016
NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP 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 BLISTER01/07/2013
NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT 40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDVITACARE LIMITEDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM 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 BOTTLE01/07/2013
NDA/MAL/HDP/0193MEDOPHARM, INDIAVITACARE LIMITEDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM 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 STRIP01/07/2013
NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA | ORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2013
NDA/MAL/HDP/0203GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER01/07/2015
NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM | GLAXOSMITHKLINE PHARMACEUTICALS SA-GRUNWALDZKA 189 STREET, 60-322 POZNANA | UNITED KINGDOM | POLANDORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2015
NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE01/07/2013
NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2011
NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE01/07/2012
NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR200MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | S KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0233MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE 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 BLISTER01/07/2014
NDA/MAL/HDP/0234MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE 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 BLISTER01/07/2014
NDA/MAL/HDP/0235MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP01/07/2014
NDA/MAL/HDP/0239MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 140ARTEMETHER + LUMEFANTRINE20 MG+ 120 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
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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 BLISTER01/07/2014
NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER01/07/2013
NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN 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 BLISTER01/07/2014
NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | GERMANY | SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON01/07/2001
NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
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INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0270HETERO LABS LTD AIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO 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 BLISTER01/07/2013
NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)01/07/2015
NDA/MAL/HDP/0272HETERO LABS LTD AIVEEN (U) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2019
NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED-39 HAWKINS AVENUE, EPPING INDUSTRIA 1, 7460, CAPE TOWN, SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE 80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0290LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & 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 BLISTER01/07/1997
NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0301HETERO LABS LTD AIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0303HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE ABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2014
NDA/MAL/HDP/0307HETERO DRUGS LTD AIVEEN (U) LIMITEDLAMIVUDINE ORAL SOLUTION LAMIVUDINE10MG/MLHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X240.0 ML CONTAINER01/07/2013
NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2013
NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2013
NDA/MAL/HDP/0317YURIA PHARM LTD-UKRAINEPHARMA VILLE LIMITEDCIPROFLOXACIN-UFCIPROFLOXACIN2MG/MLYURIA-PHARM LLC MANUFACTURING SITE NO. 1-108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULIN SALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/W DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
NDA/MAL/HDP/0322MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP 0.5%WWKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/07/2013
NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500 AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250 AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X4.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2015
NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI CARE LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL01/07/2013
NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0355SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2015
NDA/MAL/HDP/0358SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY I M VIALS 1.0X1.0 G VIAL01/07/2014
NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE | SWEDEN | ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON01/07/2001
NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2015
NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCIN 500 AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/0383FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMANNITOL FRESENIUSMANNITOL20%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BAG01/07/2014
NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDDOXYLEBDOXYCYCLINE 100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/0401FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDL MONTUSLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGFOURRTS (INDIA) LABORATORIES (PVT) LTD-FOURRTS AVENUE, VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP01/07/2015
NDA/MAL/HDP/0404GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED WET COUGH & COLDTRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN1.25MG/30MG/100MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | EGYPT | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN01/07/1997
NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM 20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLAND | FINLAND | PARENTERAL RETARD IMPLANTS 1.0X10.0X1.0X2.0X75.0 MG IMPLANT01/07/2003
NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/0418ASTRA ZENECA MACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA 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 BLISTER01/07/2013
NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE01/07/2013
NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/0427MICRO LABS LTD LABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0428MICRO LABS LTD LABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO 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 BLISTER01/07/2013
NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS 10.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X15.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0432FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDK MAC ORAL SOLUTIONPOTASSIUM CITRATE + MAGNESIUM CITRATE22MG + 7.5MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDPROHIBINGASTRO-RESISTANT OMEPRAZOLE CAPSULES BP 2020 MGLEBEN 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 STRIP01/07/2010
NDA/MAL/HDP/0435FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDLIGNOCAINE HCL FRESENIUSLIGNOCAINE HYDROCHLORIDE2%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY VIALS 1.0X10.0X20.0 ML VIAL01/07/2015
NDA/MAL/HDP/0441AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGISECSECNIDAZOLE1GMAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0444FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDNEOSTIGMINE METHYLSUIPHATE FRESENIUSNEOSTIGMINE METHYLSULPHATE2.5MG\MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE01/07/2015
NDA/MAL/HDP/0449PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY GRANULES 1.0X10.0X5.0 G SACHET01/07/2013
NDA/MAL/HDP/0453PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTS STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEB METRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X15.0 ML BOTTLE01/07/2009
NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2011
NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS 50.0X2.0 TABLET STRIP01/07/1997
NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK | BRAZIL | FRANCEPARENTERAL ORDINARY DRY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK | BRAZIL | FRANCEPARENTERAL ORDINARY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
NDA/MAL/HDP/0472SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDBCG VACCINE (FREEZE DRIED)BCG VACCINE(FREEZE DRIED)1.33*100000 C.F.U/0.1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | SERUM INSTITUTE OF INDIA PRIVATE LIMITED-S/NO 105-110, MANJARI BUDRUK, TAL - HAVEIL, PUNE 412307 - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 ML VIAL,1.0X0.5 ML VIAL01/07/2015
NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN 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 BLISTER01/07/2015
NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN 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 BLISTER01/07/2014
NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500 AZITHROMYCIN500MGLEBEN 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 BLISTER01/07/2014
NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDSURGIPHARM (U) LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE 250MG + 200MG + 10MGADCOCK 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 BLISTER01/07/2014 00:00
NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0507FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDFILDILOL 12.5CARVEDILOL12.5 MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0509FOURRTS (INDIA) LABORATORIES (PVT) LTDDELMAW ENTERPRISES LIMITEDFILDILOL 25CARVEDILOL25MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET STRIP01/07/2004
NDA/MAL/HDP/0512FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 10ATORVASTATIN CALCIUM10MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0515FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 20ATORVASTATIN20MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0520FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 40ATORVASTATIN CALCIUM40MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 25 AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0531LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN 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 TUBE01/07/2014
NDA/MAL/HDP/0538MICRO LABS LTD LABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO 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 BLISTER01/07/2013
NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0542DAWA LIMITED SUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0547NAARI LTDUNITED HEALTHCARE DISTRIBUTORS LTDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT 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/0555HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDCARZEPINCARBAMAZEPINE200MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPS GENTAMICIN SULPHATE 0.3% W/V ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML VIAL01/07/2014
NDA/MAL/HDP/0559HOVID BHD MEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM 40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0X50.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN 250IUBHARAT 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/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS 1.0X5.0 ML VIAL01/07/2010
NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY | GERMANY | ORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER01/07/2015
NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO 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 BLISTER01/07/2014
NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO 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 BLISTER01/07/2014
NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO 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 STRIP01/07/2014
NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO 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 BLISTER01/07/2015
NDA/MAL/HDP/0596MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2011
NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2003
NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/1999
NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KIT LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN 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/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE 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 BOTTLE01/07/1998
NDA/MAL/HDP/0617ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN 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 TUBE01/07/2014
NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10 GLUCOSE10%W/V ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
|
UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN 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 PACK01/07/2015
NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
|
UGANDA | OPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALS EUROPA HEALTHCARE (U) LTDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/0636MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
NDA/MAL/HDP/0638PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
|
UGANDA | OPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/2013
NDA/MAL/HDP/0654NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER01/07/2013
NDA/MAL/HDP/0657NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0658NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0665HETERO LABS LTD AIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO 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 BLISTER01/07/2013
NDA/MAL/HDP/0666HETERO LABS LTD AIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO 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 BLISTER01/07/2013
NDA/MAL/HDP/0668CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/0672GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0678ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2014
NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/0685FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSOMAZINACITICOLINE1000MGFERRER 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 AMPOULE01/07/2015
NDA/MAL/HDP/0687FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS 1.0X6.0X10.0 ML SACHET01/07/2015
NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/2014
NDA/MAL/HDP/0691MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0692DAWA LIMITED SUPER MEDIC LTDDAWACLOX -250 CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2015
NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250 AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2014
NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON01/07/2013
NDA/MAL/HDP/0696BYANSI SERVICES LIMITEDAIVEEN (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2014
NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)01/07/2015
NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL01/07/2014
NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY GELDICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL11.6MG + 30MG + 100MG + 50MGKREMOINT 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 TUBE01/07/2013
NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2011
NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0707HETERO LABS LTD AIVEEN (U) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO 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 BLISTER01/07/2013
NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSE-INDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOE | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X20.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBH-HILDERBRAND, STR 12-37081, GOTTINGEN | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | ALLPHAMED PHARMBIL ARZNEIMITTEL GMBH-HILDERBRAND, STR 12-37081, GOTTINGEN | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT 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 SYRINGE01/07/2011
NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE 50MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2014
NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X225.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0732AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOLTAMED-100 DICLOFENAC100 MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0734AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2015
NDA/MAL/HDP/0736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/0740MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE 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 BLISTER01/07/2013
NDA/MAL/HDP/0741MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMEDOCIPRINCIPROFLOXACIN500MG 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 BLISTER01/07/2013
NDA/MAL/HDP/0742MEDOCHEMIE LTDLABOREX UGANDA LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0745CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0759MICRO LABS LTDPHARMA VILLE LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO 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 BLISTER01/07/2011
NDA/MAL/HDP/0765SHANGHAI DAHUA PHARMACEUTICAL CO., LTD.UNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI | CHINA | PARENTERAL RETARD IMPLANTS 1.0X10.0X2.0 ROD IMPLANT01/07/2010
NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/1999
NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPHENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 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 STRIP01/07/2010
NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN | PAKISTAN | OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2 GLIMEPIRIDE 2MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3 GLIMEPIRIDE 3MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/0822ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL01/07/2014
NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGMEDICO 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 CONTAINER01/07/2013
NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MG 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 CONTAINER01/07/2013
NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGMEDICO 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 CONTAINER01/07/2013
NDA/MAL/HDP/0832MERCK UNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN 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 BLISTER01/07/2012
NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN 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 BLISTER01/07/2013
NDA/MAL/HDP/0843MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCOXERINCYCLOSERINE250MGMACLEODS 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 STRIP01/07/2013
NDA/MAL/HDP/0845VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN 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 BLISTER01/07/2013
NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS 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 CONTAINER01/07/2014
NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN 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 LTDBRUSTAN GELIBUPROFEN + LEVOMENTHOL5% W/W+ 3%W/WSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X50.0 G CONTAINER01/07/2012
NDA/MAL/HDP/0855HETERO LABS LTD AIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | VAGINAL TABLETS 1.0X6.0 PESSARY STRIP01/07/2000
NDA/MAL/HDP/0858ASTRA ZENECA MACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA PHARMACEUTICAL CO LTD.-NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSU | ASTRAZENECA SWEDEN OPERATIONS-ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | CHINA | SWEDEN | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2001
NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID LINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X2.0X6.0X2.0 ML VIAL01/07/2013
NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE01/07/2010
NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLSAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE01/07/2009
NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-4SALBUTAMOL4MGLEBEN 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 BLISTER01/07/2014
NDA/MAL/HDP/0877LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X170.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/0882MERCK UNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/0883MERCK UNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/0889ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDNSSODIUM CHLORIDE + GLUCOSE0.9%W/V + 5% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/2012
NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTH SODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE01/07/2015
NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2015
NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 10 ML VIAL WFI01/07/2013
NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SR NIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2015
NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACE RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2015
NDA/MAL/HDP/0914VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDOSTEOTIDETERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION250MCG/MLVIRCHOW 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 PEN01/07/2015
NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X5.0X4.0 ML VIAL01/07/2012
NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO 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 STRIP01/07/2004
NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2013
NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210 | INDIA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2012
NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | 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 BLISTER01/07/2013
NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE01/07/2015
NDA/MAL/HDP/0978SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROX 75 SR CAPSULEAMBROXOL75MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2012
NDA/MAL/HDP/0981HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC SR TABLETS DICLOFENAC SODIUM100MGHOVID 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 BLISTER01/07/2008
NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE01/07/2012
NDA/MAL/HDP/1002SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPROKEN 750CIPROFLOXACIN750MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/10033MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDEMCARCARBAMAZEPINE200 MGMEDOPHARM-NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER14/07/2022
NDA/MAL/HDP/10036MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDMEDOMOLPARACETAMOL500 MGMEDOPHARM-NO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER14/07/2022
NDA/MAL/HDP/10037BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBORINI-KLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30 MG + 500 MG + 250 MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET STRIP14/07/2022
NDA/MAL/HDP/10038MEDOPHARM PRIVATE LIMITEDVITACARE LIMITEDCLEDOMOX 312.5 MG/5 MLAMOXILLIN TRIHYDRATE + POTASSIUM CLAVULANATE312.5 MG/5 MLMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0x1.0x100.0 ML CONTAINER14/07/2022
NDA/MAL/HDP/10041PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDPUMPINOXESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGPHARMA 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 CONTAINER06/07/2022
NDA/MAL/HDP/10042GLOBELA PHARMA PVT. LTD.SHREEJI CARE LIMITEDBACIPROCIPROFLOXACIN HYDROCHLORIDE500 MGGLOBELA 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 BLISTER19/07/2022
NDA/MAL/HDP/10046ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDARTEMETHER INJECTION 80 MG/MLARTEMETHER80 MG/ MLSCOTT-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 AMPOULE19/07/2022
NDA/MAL/HDP/10049ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDERYTHROMYCIN ESTOLATE ORAL SUSPENSION USP 125 MG/5MLERYTHROMYCIN ESTOLATE125 MG/5MLSCOTT-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 BOTTLE19/07/2022
NDA/MAL/HDP/10050SERUM INSTITUTE OF INDIA PVT LTDNORVIK ENTERPRISES LIMITEDROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL) ROTASIIL LIQUIDLIVE 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 VIAL06/07/2022
NDA/MAL/HDP/10055BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFIMABUTE-400CEFIXIME TRIHYDRATE400MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER19/07/2022
NDA/MAL/HDP/10059SAGA LIFESCIENCES LTDABACUS PHARMA (AFRICA) LIMITEDFULCOVERITRACONAZOLE100 MGSAGA 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 STRIP19/07/2022
NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/10061AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP PLUSCLOPIDOGREL + ASPIRIN75 MG + 75 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA ORAL SOLID ORDINARY OTHER CAPSULES1.0x3.0x10.0 CAPSULE BLISTER 19/07/2022
NDA/MAL/HDP/10062BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBRUCLOX-500CLOXACILLIN SODIUM500MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE STRIP19/07/2022
NDA/MAL/HDP/10063BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDCARDIONE 25SPIRONOLACTONE25MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER19/07/2022
NDA/MAL/HDP/10065LAURUS LABS LIMITED - BEYOND LOGISTICS LTDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/ 300 MG/ 300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600 MG + 300 MG + 300 MGLAURUS 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 BOTTLE19/07/2022
NDA/MAL/HDP/10069MICRO LABS LIMITEDLABOREX UGANDA LIMITEDOPELAN ODT 5OLANZAPINE5 MGMICRO LABS LIMITED .,-92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER14/07/2022
NDA/MAL/HDP/10074TAURUS CHEMICALS (P) LTD. HEALTHCARE LTD.MAGACID SUSPENSIONALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE(215 MG + 80 MG + 25 MG)/5MLAL 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 BOTTLE14/07/2022
NDA/MAL/HDP/10075ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTELPER 80TELMISARTAN80 MGGLOBELA 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 BLISTER14/07/2022
NDA/MAL/HDP/10083THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.MORCETESCITALOPRAM OXALATE20 MGSEARLE PAKISTAN LTD..-F-319, S.I.T.E., OPP. KESC POWER STATION, KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER14/07/2022
NDA/MAL/HDP/10084M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDSEDAFOLPROPOFOL10 MG/ MLASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0X20.0 ML VIAL14/07/2022
NDA/MAL/HDP/10087MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAZUNATEARTESUNATE60 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 CHLORIDE14/07/2022
NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2012
NDA/MAL/HDP/10100HETERO LABS LTD AIVEEN (U) LIMITEDPANTINPANTOPRAZOLE SODIUM SESQUIHYDRATE40 MG/VIALASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL18/07/2022
NDA/MAL/HDP/10101AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL 50VILDAGLIPTIN50 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA ORAL SOLID ORDINARY TABLETS 1.0x3.0x10.0 TABLET BLISTER 18/07/2022
NDA/MAL/HDP/10102AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDVILDARIL 100VILDAGLIPTIN100 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA ORAL SOLID ORDINARY TABLETS 1.0x3.0x10.0 TABLET BLISTER18/07/2022
NDA/MAL/HDP/10104IND-SWIFT LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT 40TELMISARTAN40 MGIND-SWIFT LIMITED /-VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJAB | INDIA | TABLETS (COATED1.0X3.0X10.0 TABLET BLISTER06/07/2022
NDA/MAL/HDP/10105IND-SWIFT LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT 80TELMISARTAN80 MGIND-SWIFT LIMITED /-VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJAB | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER06/07/2022
NDA/MAL/HDP/10114CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300/300 MGLAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300 MG + 300 MGCIPLA 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 CONTAINER06/07/2022
NDA/MAL/HDP/10117FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVENOSMILHIDROSMIN200 MGFAES FARMA SA-MAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER06/07/2022
NDA/MAL/HDP/10129HETERO LABS LTD AIVEEN (U) LIMITEDDARUNAVIR AND RITONAVIR TABLETS 400 MG/50 MGDARUNAVIR ETHANOLATE + RITONAVIR400 MG + 50 MGHETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE, | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE18/07/2022
NDA/MAL/HDP/10134MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDISONIAZID/ RIFAPENTINE COATED TABLETS 300 MG + 300 MGISONIAZID + RIFAPENTINE300MG +300MGOXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X12.0 TABLET STRIP18/07/2022
NDA/MAL/HDP/10144VIRCHOW BIOTECH PVT LTD, SURGIPHARM (U) LIMITEDCLASIPROBACILLUS CLAUSII SPORES2 X 10^9 SPORES/ 5 MLVIRCHOW BIOTECH PRIVATE LIMITED-SURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X5.0 ML AMPOULE06/07/2022
NDA/MAL/HDP/10148AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 60ETORICOXIB60MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA ORAL SOLID ORDINARY FILM COATED TABLETS 1.0x1.0x7.0 TABLET BLISTER 18/07/2022
NDA/MAL/HDP/10149AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 90ETORICOXIB90MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA ORAL SOLID ORDINARY FILM COATED TABLETS 1.0x1.0x7.0 TABLET BLISTER 18/07/2022
NDA/MAL/HDP/10150AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 120ETORICOXIB120MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA ORAL SOLID ORDINARY FILM COATED TABLETS 1.0x1.0x7.0 TABLET BLISTER 18/07/2022
NDA/MAL/HDP/10151S KANT HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFUNGARINMICONAZOLE2%W/WS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL TOPICAL GELS AND SOLS 1.0X1.0X30.0 G TUBE06/07/2022
NDA/MAL/HDP/10164ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDASPIRIN TABLETSACETYLSALICYCLIC ACID300MGELYS 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 TIN02/09/2022
NDA/MAL/HDP/10168ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDLYFEORAL REHYDRATION SALTN/AELYS 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 SACHET02/09/2022
NDA/MAL/HDP/10169ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDORODARSULFADOXINE+PYRIMETHAMINE500MG+25MGELYS 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 CONTAINER02/09/2022
NDA/MAL/HDP/10183 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDTEXAKINDTRANEXAMIC ACID500MG/5MLMANKIND PHARMA LIMITED-UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X4.0X5.0 ML AMPOULE09/09/2022
NDA/MAL/HDP/10185MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTURBOVAS-10ROSUVASTATIN CALCIUM10MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10192INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINFUTAXIM 1 GMCEFOTAXIME SODIUM1 G/ VIALZEISS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL RETARD DRY VIALS 1.0X1.0X1.0 G VIAL09/09/2022
NDA/MAL/HDP/10199MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGOFEN 200IBUPROFEN200 MGMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X6.0X1.0X1.0X10.0 CAPSULE BLISTER09/09/2022
NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID RETARD LAYERED TABLETS 1.0X10.0X1.0X12.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/10209FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRAMAPA FORT 75MG/650MGTRAMADOL HYDROCHLORIDE + PARACETAMOL75 MG + 650 MGFERRER INTERNATIONAL, S.A-C/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10213 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDPANTAKIND-40PANTOPRAZOLE SODIUM40 MGMANKIND PHARMA LIMITED-UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X6.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10214MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDILAXTEN 20 MG TABLETSBILASTINE20MG A. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL-VIA CAMPO DI PILE 67100 L'AQUILA (AQ) | ITALYORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10215ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDABAMOLPARACETAMOL10 MG/ML ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML CONTAINER09/09/2022
NDA/MAL/HDP/10218BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCOMIT-100SILDENAFIL CITRATE100 MGBLISS GVS PHARMA LIMITED-10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10219BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCOMIT-50SILDENAFIL CITRATE50 MGBLISS GVS PHARMA LIMITED-10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/10234 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDTERBINAFORCE 250TERBINAFINEHYDROCHLORIDE250 MGMANKIND PHARMA LIMITED-UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10235BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDLOFNAC GELLINSEED OIL + DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + MENTHOL3.00%W/W + 1.16% W/W + 10.00%W/W + 5.00%W/WKREMOINT PHARMA PVT LTD PLANT II-B-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST) DIST. THANE 421506 | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE09/09/2022
NDA/MAL/HDP/10239 GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTDTRIDEM PHARMA UGANDA LIMITEDZITMYCAZITHROMYCIN500MGCSPC 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 BLISTER09/09/2022
NDA/MAL/HDP/10240MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDOLMESAR 40OLMESARTAN MEDOXOMIL40MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10244ZYDUS DISCOVERY DMCCABACUS PHARMA (AFRICA) LIMITEDLIPAGLYNSAROGLITAZAR MAGNESIUM4MGCADILA HEALTHCARE LTD. -PLOT NO. 417, 419 & 420, SARKHEJ-BAVLA N.H. NO. 8A, MORAIYA, TAL: SANAND, DIST. AHMEDABAD - 382210, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10247 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 228.5AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE200MG/5ML + 28.5MG/5MLCOPMED 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 BOTTLE09/09/2022
NDA/MAL/HDP/10249FDC LTD AIVEEN (U) LIMITEDIOPROST – TLATANOPROST + TIMOLOL MALEATE(50 MCG + 5 MG)/MLFDC LIMITED, WALUJ .-PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC DROPS 1.0X1.0X2.5 ML BOTTLE09/09/2022
NDA/MAL/HDP/10250JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB SINUS PAIN EXTRA STRENGTHCODEINE PHOSPHATE +CHLORPHENIRAMINE MALEATE +PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL10 MG + 2 MG + 30 MG + 500 MGJOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X12.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10267SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDPROTOZOX-500NITAZOXANIDE500MGSAGA LIFESCIENCES LIMITED-SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10280INDCHEMIE HEALTH SPECIALITIES PVT. LTD.NUMED STORES SMC LIMITEDZENOXIM 500CEFUROXIME AXETIL500 MGINDCHEMIE HEALTH SPECIALITIES PVT. LTD-VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10281PLANET PHARMACEUTICALS UGANDA LTDPLANET PHARMACEUTICALS UGANDA LTDH- CURE ESESOMEPRAZOLE MAGNESIUM + CLARITHROMYCIN + TINIDAZOLE40MG + 500MG + 500MGFREDUN PHARMACEUTICALS LIMITED,-14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10282 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMUPIWAYSMUPIROCIN2.0 W/WNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE09/09/2022
NDA/MAL/HDP/10283DAWA LIMITED-SUPER MEDIC LTDDAZOLECLOTRIMAZOLE100MGDAWA LIMITED-PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | VAGINAL TABLETS 1.0X1.0X6.0 PESSARY BLISTER09/09/2022
NDA/MAL/HDP/10285MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDDOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION (DISPERSIBLE TABLETS) 10MGDOLUTEGRAVIR SODIUM10 MGMACLEODS 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 CONTAINER09/09/2022
NDA/MAL/HDP/10286ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPERLEX 250CEFALEXIN MONOHYDRATE250 MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER09/09/2022
NDA/MAL/HDP/10287DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDVILDA DENK 50 MGVILDAGLIPTIN50 MGDENK PHARMA GMBH & CO. KG-GOLLSTR. 1, 84529, TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10292SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDSPASMOTRITDICYCLOMINE HYDROCHLORIDE + PARACETAMOL20MG + 500MGSAGA LIFESCIENCES LIMITED-SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10294ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)ALTCIPCIPROFLOXACIN200MGALTHEA PHARMA PRIVATE LIMITED-WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE09/09/2022
NDA/MAL/HDP/10296LUPIN LIMITED-AIVEEN (U) LIMITEDRIFAMPIN, ISONIAZID, PYRAZINAMIDE, ETHAMBUTOL HYDROCHLORIDE TABLETS USP150/75/400/275MGRIFAMPIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE150MG + 75MG + 400MG + 275MGLUPIN LTD-A-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X14.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10298ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDCOXZOTA 90ETORICOXIB90 MGZOTA HEALTHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/1030LABORATORIOS SALVAT SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMALACURDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGCIRON 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 BLISTER01/07/2014
NDA/MAL/HDP/10303MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDAPZIN-5DAPAGLIFLOZIN5 MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10304MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDAPZIN-10DAPAGLIFLOZIN10 MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10305SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDSPASMO PONALGICDICYCLOMINE HYDROCHLORIDE + MEFENAMIC ACID10 MG + 250 MGSAGA LIFESCIENCES LIMITED-SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10307ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDDESLOZED-5DESLORATADINE5 MGZOTA HEALTHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10310ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDZINRO INFUSIONORNIDAZOLE500MG/100MLABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191, KINGA | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE09/09/2022
NDA/MAL/HDP/10311LAURUS LABS LIMITED - BEYOND LOGISTICS LTDLOPINAVIR AND RITONAVIR TABLETS USPLOPINAVIR + RITONAVIR200MG + 50MGLAURUS 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 BOTTLE09/09/2022
NDA/MAL/HDP/10313LAURUS LABS LIMITED - BEYOND LOGISTICS LTDLOPINAVIR AND RITONAVIR TABLETS USPLOPINAVIR + RITONAVIR100MG + 25MGLAURUS 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 BOTTLE09/09/2022
NDA/MAL/HDP/10315ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDINDOMETHACININDOMETHACIN25MGM/S SCOTT-EDIL PHARMACIA LIMITED-56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA | ORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE TIN,1.0X500.0 CAPSULE TIN,1.0X10.0X10.0 CAPSULE BLISTER01/07/2008
NDA/MAL/HDP/10317Y.S.P. INDUSTRIES (M) SDN. BHD.ROYAL PHARMA 2011 LIMITEDVOREN SUPPOSITORY 100 MGDICLOFENAC SODIUM100MGY.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 STRIP09/09/2022
NDA/MAL/HDP/10323AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDXELTINTOFACITINIB CITRATE5MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10325MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDONCETCETIRIZINE DIHYDROCHLORIDE5MG/5MLMEDLEY PHARMACEUTICALS LTD-PLOT 18 & 19 SURVEY NO. 378/7&8, 379/2&3 ZARI CAUSEWAY ROAD, KACHIGAM DAMAN-396210, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE09/09/2022
NDA/MAL/HDP/1033FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS 1.0X20.0X10.0 ML SACHET01/07/2015
NDA/MAL/HDP/10335GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDPRIDOCAINELIDOCAINE + PRILOCAINE2.5% W/W + 2.5%W/WGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE09/09/2022
NDA/MAL/HDP/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX AMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/10340GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDKERELLABETAMETHASONE DIPROPIONATE + SALICYLIC ACID(0.5 MG+ 220 MG)/GGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | TOPICAL EXTERNAL LOTIONS 1.0X1.0X30.0 ML BOTTLE09/09/2022
NDA/MAL/HDP/10343DAWA LIMITED-SUPER MEDIC LTDKENAZOLEKETOCONAZOLE2%W/WDAWA LIMITED-PLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE09/09/2022
NDA/MAL/HDP/10349SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDGLUMACARTEMETHER + LUMEFANTRINE80MG + 480MGGUILIN PHARMACEUTICAL CO LTD .-NO. 43, QULIDIAN ROAD, GUILIN 541004 | CHINA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER,30.0X6.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10358PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDVOLDIC - KDICLOFENAC POTASSIUM50MGPHARMA 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 BLISTER09/09/2022
NDA/MAL/HDP/10365MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDMYLTEGA DTDOLUTEGRAVIR SODIUM10MGMYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X90.0 TABLET BOTTLE09/09/2022
NDA/MAL/HDP/10369AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDSITAPRIL 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10370AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDSITAPRIL 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10374 B&O PHARMTRIDEM PHARMA UGANDA LIMITEDFERLIX ®FOLIXFERROUS SULFATE + FOLIC ACID200 MG + 0.4 MGBIO NOVA PHARMACEUTICALS PVT.LTD-C-66/1, OKHLA INDUSTRIAL AREA, PHASE –II, NEW DELHI INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/1038SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME TRIHYDRATE 200MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/10386MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDOLMAC 5OLANZAPINE5MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10387MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDOLMAC 10OLANZAPINE10MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10390AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DT 40/240ARTEMETHER + LUMEFANTRINE40MG + 240MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X6.0 TABLET BLISTER09/09/2022
NDA/MAL/HDP/10391SANDOZ GMBH .SURGIPHARM (U) LIMITEDHYDROXYUREA 100MGHYDROXYCARBAMIDE100MGHAUPT 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 BOTTLE09/09/2022
NDA/MAL/HDP/10392SANDOZ GMBH .SURGIPHARM (U) LIMITEDHYDROXYUREA 1000MGHYDROXYCARBAMIDE1000MGHAUPT 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 BOTTLE09/09/2022
NDA/MAL/HDP/1040SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3 DSCEFIXIME TRIHYDRATE 400MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/10417CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDDUONASAZELASTINE HYDROCHLORIDE + FLUTICASONE PROPIONATE137MCG/50MCG PER ACTUATIONCADILA HEALTHCARE LTD. -PLOT NO. 417, 419 & 420, SARKHEJ-BAVLA N.H. NO. 8A, MORAIYA, TAL: SANAND, DIST. AHMEDABAD - 382210, GUJARAT, INDIA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X1.0X30.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10418AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA CT 100SILDENAFIL CITRATE100 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X4.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10419AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSITAPRIL M 50/1000SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5 TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP01/07/2013
NDA/MAL/HDP/10420AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSITAPRIL M 50/500SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 500 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10421MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDMIOPOLOL ER 50METOPROLOL SUCCINATE50MGINVENTIA HEALTHCARE PVT LTD -F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10422MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDMIOPOLOL ER 25METOPROLOL SUCCINATE25MGINVENTIA HEALTHCARE PVT LTD -F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANE | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10423S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDMALAKANT DISPERSIBLE JUNIORSULFADOXINE + PYRIMETHAMINE250MG + 12.5MGS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X25.0X3.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10424S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDMALAKANT DISPERSIBLESULFADOXINE + PYRIMETHAMINE500MG + 25MGS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X25.0X3.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10425SUPREME PHARMA HEALTHCARE PVT. LTDABACUS PHARMA (AFRICA) LIMITEDFLOXYPREME-500LEVOFLOXACIN HEMIHYDRATE500 MGSAI MIRRA INNOPHARM PVT. LIMITED-288 & 299 SIDCO ESTATE, AMBATTUR, CHENNAI-600098. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10427AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCELMAC 400CELECOXIB40 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10428DENK PHARMA GMBH & COBENLE CONSULT LIMITEDAMOXI-DENK 1000AMOXICILLIN TRIHYDRATE1000 MGPENCEF PHARMA GMBH-BREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10429DENK PHARMA GMBH & COBENLE CONSULT LIMITEDAMOXI-DENK 500AMOXICILLIN TRIHYDRATE500 MGPENCEF PHARMA GMBH-BREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10430CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUADRIMUNEABACAVIR + LAMIVUDINE + LOPINAVIR + RITONAVIR30 MG + 15 MG + 40 MG +10 MGCIPLA 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 CONTAINER08/02/2023
NDA/MAL/HDP/10432GUFIC BIOSCIENCES LTDEUROPA HEALTHCARE (U) LTDVAMOCIN 500VANCOMYCIN HYDROCHLORIDE500MGGUFIC 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 VIAL08/02/2023
NDA/MAL/HDP/10433BIOLOGICAL E. LIMITEDGITTOES PHARMACEUTICALS LIMITEDTETANUS ANTITOXIN 1500 IU/ML BPTETANUS ANTITOXIN1500 IU/MLBIOLOGICAL E. LIMITED-18/1 & 3, AZAMABAD, HYDERABAD, TELANGANA | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0X20.0 ML VIAL08/02/2023
NDA/MAL/HDP/10434BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDAZIBRUAZITHROMYCIN DIHYDRATE200 MG/5 MLBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X30.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10435PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)AFEBRIL 5 MG/2.5MLDIAZEPAM5MG/2.5MLPROFARMA SH.A-MYSLYM KETA,TIRANA | ALBANIA | RECTAL SYSTEMIC OTHER SUPPOSITORIES 1.0X5.0X1.0 ML AMPOULE,1.0X2.5 ML AMPOULE,1.0X5.0X1.0X2.5 ML VIAL08/02/2023
NDA/MAL/HDP/10436YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.KAIYUANTANG (U) LIMITEDPETHIDINE HYDROCHLORIDE INJECTIONPETHIDINE HYDROCHLORIDE50 MG/MLYICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED-NO. 19, DALIAN ROAD, YICHANG DEVELOPING ZONE, YICHANG, HUBEI, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE08/02/2023
NDA/MAL/HDP/10437SANDOZ GMBH, KUNDLKIMSY MEDS LTDGEMCITABINE 200 MG/5MLGEMCITABINE200 MG/5ML EBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY VIALS 1.0X1.0X100.0 ML VIAL08/02/2023
NDA/MAL/HDP/10438JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDZABDENOADENOVIRUS TYPE 26 ENCODING THE ZAIRE EBOLAVIRUS (EBOV) MAYINGA VARIANT GLYCOPROTEIN (GP),NOT LESS THAN 8.75 LOG 10 INFECTIOUS UNITS (INF.U),/DOSE (0.5 ML)IDT BIOLOGIKA GMBH-AM PHARMAPARK, DESSAU-ROSSLAU, SACHSEN-ANHALT, 06861, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS 1.0X20.0X0.5 ML VIAL08/02/2023
NDA/MAL/HDP/10439JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDMVABEAONE DOSE (0.5 ML) CONTAINS:MODIFIED VACCINIA ANKARA BAVARIAN NORDIC VIRUS* ENCODING THE: ZAIRE EBOLAVIRUS (EBOV) MAYINGA VARIANT GLYCOPROTEIN (GP), SUDAN EBOLAVIRUS GULU VARIANT GP, TAÏ FOREST EBOLAVIRUS NUCLEOPROTEIN, MARBURG MARBURGVIRUS MUSOKE VARIANT NOT LESS THAN 0.7 X 108 INFECTIOUS UNITS (INF.U), /DOSE (0.5 ML)IDT BIOLOGIKA GMBH-AM PHARMAPARK, DESSAU-ROSSLAU, SACHSEN-ANHALT, 06861, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS 1.0X20.0X0.5 ML VIAL08/02/2023
NDA/MAL/HDP/10440BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDPHENIREXCHLORPHENAMINE MALEATE4 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10441BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDPREDNOVA 5PREDNISOLONE5MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10442BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACECARBCARBAMAZEPINE200MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10443BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDFUNGIDERMCLOTRIMAZOLE1 % W/WNANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE08/02/2023
NDA/MAL/HDP/10444BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDSTERODERM OINTMENTBETAMETHASONE VALERATE0.1 % W/WNANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE08/02/2023
NDA/MAL/HDP/10445BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDSTERODERM CREAMBETAMETHASONE VALERATE0.1 % W/WNANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE08/02/2023
NDA/MAL/HDP/10446BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDZITHROPLUS 500AZITHROMYCIN DIHYDRATE500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X1.0X3.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/1045SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIMAX 500 AZITHROMYCIN500MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/10452JAMJOOM PHARMACEUTICALS COMPANYMU PHARMA CO -SMC LIMITEDOPTIPREDPREDNISOLONE ACETATE1.0% W/V JAMJOOM PHARMACEUTICALS COMPANY-PLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIASAUDI ARABIA | OPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10453SANJAR PHARMA LLP.NILKANTH PHARMACY LIMITEDARTICURE 60MGARTESUNATE60MGSANJAR PHARMA LLP-SURVEY 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 AMOULE08/02/2023
NDA/MAL/HDP/10454PAMAJITA INTERNATIONAL LPPNILKANTH PHARMACY LIMITEDOMEZOLEOMEPRAZOLE SODIUM40MG PER VIALSANJAR PHARMA LLP-SURVEY 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 AMPOULE08/02/2023
NDA/MAL/HDP/10455UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDENOXAMED 2000 IU ANTI-XA /0.2 MLENOXAPARIN SODIUM2000 IU ANTI-XA /0.2 ML (EQUIVALENT TO 20 MG PER 0.2 ML)UNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.2 ML PRE- FILLED SYRINGE08/02/2023
NDA/MAL/HDP/10456UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDENOXAMED 4000 IU ANTI-XA /0.4 MLENOXAPARIN SODIUM4000 IU ANTI-XA /0.4 ML (EQUIVALENT TO 40 MG PER 0.4 ML)UNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE08/02/2023
NDA/MAL/HDP/10457UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDENOXAMED 6000 IU ANTI-XA /0.6 MLENOXAPARIN SODIUM6000 IU ANTI-XA /0.6 ML (EQUIVALENT TO 60 MG PER 0.6 ML)UNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE08/02/2023
NDA/MAL/HDP/10458UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDENOXAMED 8000 IU ANTI-XA /0.8 MLENOXAPARIN SODIUM8000 IU ANTI-XA /0.8 ML (EQUIVALENT TO 80 MG PER 0.8 ML)UNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE08/02/2023
NDA/MAL/HDP/10459UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDPARAMEDPARACETAMOL1G/100MLUNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY INFUSION BAGS 1.0X6.0X1.0X100.0 ML BAG08/02/2023
NDA/MAL/HDP/10460PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDAERIALLERG 5MGDESLORATIDINE5 MGPHARMA 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 BLISTER08/02/2023
NDA/MAL/HDP/10461PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDAERIALLERG 0.5MG/MLDESLORATIDINE0.5MG/MLPHARMA 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 BOTTLE08/02/2023
NDA/MAL/HDP/10462AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOR - LOOP 10ANHYDROUS TORSEMIDE10 MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10463FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISFORMETHOCARBAMOL500 MGFAES FARMA SA-MAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10464JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN 4 FLU TABLETSDIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE12.5MG + 500MG + 22.5MGJOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SPECGX LLC-100 LOUIS LATZER DRIVE, GREENVILLE, ILLINOIS, 62246 - UNITED STATES OF AMERICA | UNITED STATES | SOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10465AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDZESBINA 200PROGESTERONE200 MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY 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 BLISTER08/02/2023
NDA/MAL/HDP/10467ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRABIRIV-DSRRABEPRAZOLE SODIUM + DOMPERIDONE20 MG + 30 MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10468ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCORTIRIV-100HYDROCORTISONE SODIUM SUCCINATE100 MG/VIALEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL08/02/2023
NDA/MAL/HDP/10469ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAZIRIV-FS KITFLUCONAZOLE + AZITHROMYCIN DIHYDRATE + SECNIDAZOLE150 MG + 1 G + 1GEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10470ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROYODOLTRAMADOL HYDROCHLORIDE50MGPSYCHOTROPICS INDIA LTD-PLOT 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 BLISTER08/02/2023
NDA/MAL/HDP/10471ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCIPROFLOXACIN-500CIPROFLOXACIN HYDROCHLORIDE500 MGM/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 BLISTER08/02/2023
NDA/MAL/HDP/10472ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTRAMADOL HYDROCHLORIDE INJECTION 100 MG/2MLTRAMADOL HYDROCHLORIDE100 MG/2 MLM/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 AMPOULE08/02/2023
NDA/MAL/HDP/10473ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPOLYMOL SUSPENSION 125MG/5ML.PARACETAMOL125MG/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 BOTTLE08/02/2023
NDA/MAL/HDP/10474ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPOLYMOL EXTRAPARACETAMOL + CAFFEINE500 MG + 30 MGM/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 BLISTER08/02/2023
NDA/MAL/HDP/10475MARCYRL PHARMACEUTICAL INDUSTRIESSHREEJI PHARMACEUTICALS LIMITEDEVASTINEEBASTINE10 MGMARCYRL 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 BLISTER08/02/2023
NDA/MAL/HDP/10476CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDDEXCEN 10RAMIPRIL10 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10477CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDPENACAMPIROXICAM20 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10478SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDFENTANYL SANDOZ 12 µG/HFENTANYL12µG/HOURHEXAL AG -INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | TRANSDERMAL PATCHES1.0X5.0 SACHET CARTON08/02/2023
NDA/MAL/HDP/10479SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDFENTANYL SANDOZ 25 µG/HFENTANYL25µG/HOURHEXAL AG -INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | TRANSDERMAL PATCHES1.0X1.0X5.0 G TUBE08/02/2023
NDA/MAL/HDP/10480SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDFENTANYL SANDOZ 75 µG/HFENTANYL75µG/HOURHEXAL AG -INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | TRANSDERMAL PATCHES1.0X5.0 SACHET CARTON08/02/2023
NDA/MAL/HDP/10481SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDFENTANYL SANDOZ 50 µG/HFENTANYL50µG/HOURHEXAL AG -INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | TRANSDERMAL PATCHES1.0X5.0 SACHET CARTON08/02/2023
NDA/MAL/HDP/10482SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDFENTANYL SANDOZ 100 µG/HFENTANYL100µG/HOURHEXAL AG -INDUSTRIESTRASSE 25 D-83607 HOLZKIRCHEN | GERMANY | TRANSDERMAL PATCHES1.0X5.0 SACHET CARTON08/02/2023
NDA/MAL/HDP/10483NVS KENYA LTD SURGIPHARM (U) LIMITEDPATIZRARANIBIZUMAB10 MG/MLNOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONS-NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY VIALS 1.0X1.0X0.23 ML VIAL08/02/2023
NDA/MAL/HDP/10484INDIANA OPHTHALMICS SWASTIK PHARMACEUTICAL LTDTETROPTETRACYCLINE HYDROCHLORIDE1%W/W INDIANA OPHTHALMICS-135, 136, 137, GIDC ESTATE, WADHWAN-363035 | INDIA | OPHTHALMIC OINTMENTS 1.0X1.0X5.0 G TUBE08/02/2023
NDA/MAL/HDP/10485ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDRIVAROX 15RIVAROXABAN15 MGESKAYEF PHARMACEUTICAL LIMITED-400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, GAZIPUR - BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10486ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDRIVAROX 20RIVAROXABAN20 MGESKAYEF PHARMACEUTICAL LIMITED-400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, GAZIPUR - BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10487ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDKETONIC 30KETOROLAC TROMETHAMINE30 MGESKAYEF PHARMACEUTICAL LIMITED-400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, GAZIPUR - BANGLADESH | BANGLADESH | PARENTERAL ORDINARY AMPOULES 1.0X1.0X1.0 ML AMPOULE + 3 ML SYRINGE08/02/2023
NDA/MAL/HDP/10488ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDGTN 2.6 SRDILUTED NITROGLYCERIN2.6 MGESKAYEF PHARMACEUTICAL LIMITED-400 SQUIBB ROAD, TONGI INDUSTRIAL AREA, GAZIPUR - BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10489GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESSWASTIK PHARMACEUTICAL LTDTERBINTERBINAFINE HYDROCHLORIDE250 MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2013
NDA/MAL/HDP/10490GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESSWASTIK PHARMACEUTICAL LTDBISOCARD PLUS 5MG/12.5MGBISOPROLOL FUMARATE + HYDROCHLOROTHIAZIDE5MG + 12.5MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10491GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAPRETUDE 30 MGCABOTEGRAVIR30 MGGLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)-PRIORY STREET, WARE, SG12 ODJ | GLAXO WELLCOME S.A-AVENIDA EXTREMADURA 3, 09400 ARANDA DE DUERO - SPAIN | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER08/02/2023
NDA/MAL/HDP/10492MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDDOLUTEGRAVIR SODIUM TABLETS 50 MGDOLUTEGRAVIR SODIUM50 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT II-PLOT 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 BLISTER08/02/2023
NDA/MAL/HDP/10493CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDROUNOXTRAMADOL HYDROCHLORIDE50 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10494CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDFORMET 1000METFORMIN HYDROCHLORIDE1000 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10495EGYPHARWIDE SPECTRUM ENTERPRISES (U) LIMITEDHELI-CURECLARITHROMYCIN + OMEPRAZOLE + TINIDAZOLE250 MG + 20 MG + 500 MGEGYPHAR FACTORY-OBOUR CITY- INDUSTRIAL ZONE (A), BLOCK NO 13026. PIECE NO 9&0- EGYPT | EGYPT | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10496UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDIRIS SYRUPDESLORATADINE0.5 MG/MLUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY-AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10497EGYPHARWIDE SPECTRUM ENTERPRISES (U) LIMITEDZISROCINAZITHROMYCIN500MGEGYPHAR FACTORY-OBOUR CITY- INDUSTRIAL ZONE (A), BLOCK NO 13026. PIECE NO 9&0- EGYPT | EGYPT | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X3.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10499AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIRATAM 500 MG XRLEVETIRACETAM500 MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE 10MG INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/10502MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVORIOLE 200VORICONAZOLE200MGMSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION-PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10503AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDHI-ALFA SR 10ALFUZOSIN HYDROCHLORIDE10MGAUROBINDO PHARMA LIMITED UNIT 3-PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10504INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINFUROXIM 1.5 GCEFUROXIME SODIUM1.5GZEISS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.5 G VIAL (CLEAR GLASS VIAL)08/02/2023
NDA/MAL/HDP/10505ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOPTOR EYE DROPSKETOROLAC TROMETHAMINE0.5%W/VABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191, KINGA | UGANDA | OPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10506PHARMATHEN S.AGOODMAN INTERNATIONAL LTDA-CNOTREN® 10MGISOTRETINOIN10MGPHARMATHEN S.A-6, DERVENAKION STR. 15351 PALLINI ATHENS | GREECE | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10507AUROLABSWASTIK PHARMACEUTICAL LTDTOB - DEXTOBRAMYCIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE0.3%W/V + 0.1%W/VAUROLAB .-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 | INDIA | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10508BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFIMABUTE-100CEFIXIME TRIHYDRATE100MG/5MLBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10509BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDPANTRO INJECTIONPANTOPRAZOLE SODIUM40MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X40.0 MG VIAL + (1*1*10ML OF SODIUM CHLORIDE SOLUTION IN CLEAR GLASS AMPOULE)08/02/2023
NDA/MAL/HDP/10510 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDNEUROZIM 75PREGABALIN75MGZIM LABORATORIES LIMITED-B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10511VRUSHIK INVESTMENT (U) LTD.SHREEJI PHARMACEUTICALS LIMITEDMETOMETOCLOPRAMIDE HYDROCHLORIDE10MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10512CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDFINADOL ULTRAPARACETAMOL + CAFFEINE500 MG + 30 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10514ARTURA PHARMACEUTICALS PVT LTDSWASTIK PHARMACEUTICAL LTDORITA-100SILDENAFIL CITRATE100MGARTURA PHARMACEUTICALS PRIVATE LIMITED-NO. 1505, PORTIA ROAD SRI CITY SEZ, SATYAVEDU MANDAL, CHITTOOR DIST-517 588, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10515TAKEDA PHARMA A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNINLARO 2.3 MGIXAZOMIB CITRATE2.3MGHAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG | GERMANY | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X1.0X1.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10516TAKEDA PHARMA A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNINLARO 3.0 MGIXAZOMIB CITRATE3MGHAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG | GERMANY | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X1.0X1.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10517BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBRULEXIN-250CEFALEXIN MONOHYDRATE250MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10518ARTURA PHARMACEUTICALS PVT LTDSWASTIK PHARMACEUTICAL LTDGLYCOFORM 500METFORMIN HYDROCHLORIDE500MGARTURA PHARMACEUTICALS PRIVATE LIMITED-NO. 1505, PORTIA ROAD SRI CITY SEZ, SATYAVEDU MANDAL, CHITTOOR DIST-517 588, ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGEN MICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
NDA/MAL/HDP/10520ENCORE HEALTHCARE PVT. LTD.REDDYS PHARMA LIMITEDENCOBLOCPROPRANOLOL HYDROCHLORIDE40MGENCORE HEALTHCARE PVT LTD-D-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP08/02/2023
NDA/MAL/HDP/10521SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., ROYAL PHARMA 2011 LIMITEDSCOTXONE PLUSCEFTRIAXONE SODIUM + SULBACTAM SODIUM1000 MG + 500 MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED-HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X1500.0 MG VIAL08/02/2023
NDA/MAL/HDP/10522 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRIM 500CEFUROXIME AXETIL500MGZIM LABORATORIES LIMITED-B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10523 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDSYNRIAM DTARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE37.5 MG + 187.5 MGSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X3.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10524AGIO PHARMACEUTICALS LIMITEDROYAL PHARMA 2011 LIMITEDDICLOGEN RETARD 100DICLOFENAC SODIUM100MGAGIO PHARMACEUTICALS LIMITED.-T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP08/02/2023
NDA/MAL/HDP/10528THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.EZIUM 20 MGESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGTHE SEARLE COMPANY LIMITED-F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10529THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.EZIUM 40 MGESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGTHE SEARLE COMPANY LIMITED-F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10530ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDCOXZOTA 120ETORICOXIB120MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10531GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDENO CALCIUM ANTACID TABLETSCALCIUM CARBONATE500MGGLAXOSMITHKLINE LIMITED-LIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI | GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC-320 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 BLISTER08/02/2023
NDA/MAL/HDP/10532ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME TRIHYDRATE400MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10533CELON LABORATORIES PRIVATE LIMITED.GOOD DAY PHARMACY LIMITEDHYPRO 200PROPOFOL200 MG/20 MLCELON LABORATORIES PRIVATE LIMITED-PLOT NO. 2, ALEAP INDUSTRIAL ESTATE, GAJULARAMARAM, MEDCHAL - MALKAJGIRI DIST-500090, TELENGANA - INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0X20.0 ML VIAL08/02/2023
NDA/MAL/HDP/10534PSYCHOTROPICS INDIA LTD-ABACUS PHARMA (AFRICA) LIMITEDKETAMINE HYDROCHLORIDE INJECTION USP 50MG/MLKETAMINE HYDROCHLORIDE50MG/MLPSYCHOTROPICS INDIA LTD-PLOT 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 VIAL08/02/2023
NDA/MAL/HDP/10535FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGINOVAGDEQUALINIUM CHLORIDE + TYROTHRICIN + ? -GLYCYRRHETINIC ACID (ENOXOLONE) + HYDROCORTISONE ACETATE + LIDOCAINE HYDROCHLORIDE(100MG + 400MG + 60MG + 60MG+100MG) PER 100 MLFERRER INTERNATIONAL, S.A-C/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | ORAL TOPICAL SPRAYS WITHOUT GAS 1.0X1.0X10.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10536KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDMUPISOFT OINTMENTMUPIROCIN2.0% W/WCURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X5.0 G TUBE08/02/2023
NDA/MAL/HDP/10537KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNIOSOL OINTMENTCLOBETASOL PROPIONATE0.05%W/WCURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X30.0 G TUBE08/02/2023
NDA/MAL/HDP/10538KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDSUDIF CREAMFUSIDIC ACID2.0 %W/WCURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE08/02/2023
NDA/MAL/HDP/10539ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZOTAMET-850METFORMIN HYDROCHLORIDE850MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10540 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDATAZANAVIR AND RITONAVIR TABLETSATAZANAVIR SULFATE + RITONAVIR300MG + 100MGSUN 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 BOTTLE08/02/2023
NDA/MAL/HDP/10541GALENICUM HEALTH S.L.GOODMAN INTERNATIONAL LTDROSUVASTATINROSUVASTATIN20MGBIOFARM SP. Z.O.O-UL. WALBRZYSKA 13, 60-198 POZNAN - POLAND | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X7.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10542SANDOZ GMBH, KUNDLKIMSY MEDS LTDPACLITAXEL 6 MG /1 MLPACLITAXEL 300MG /50MLEBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X50.0 ML VIAL08/02/2023
NDA/MAL/HDP/10544AUROLABSWASTIK PHARMACEUTICAL LTDATROPATROPINE SULFATE1%W/VAUROLAB LIMITED-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA | BRAZIL | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10545BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDBRAMOLPARACETAMOL10MG/MLBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML VIAL08/02/2023
NDA/MAL/HDP/10546BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDOXOFERINTETRACHLORODECAOXIDE138.0 X 10^6 PMOL/100MLBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL LIQUIDS 1.0X1.0X50.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10547PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)HALOPERIDOL SOLUTION FOR INJECTION 5MG/MLHALOPERIDOL5MG/MLPROFARMA SH.A-MYSLYM KETA,TIRANA | ALBANIA | PARENTERAL ORDINARY VIALS 1.0X2.0X5.0X1.0 ML VIAL08/02/2023
NDA/MAL/HDP/10551SANJAR PHARMA LLP.MOTI PHARMA (UGANDA) LIMITEDADRENLINADRENALINE ACID TARTRATE1MGSANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 MG AMPOULE08/02/2023
NDA/MAL/HDP/10552MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDZOPIMAC 2ESZOPICLONE2MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X100.0 TABLET CONTAINER08/02/2023
NDA/MAL/HDP/10553ACINO AG.LABOREX UGANDA LIMITEDTITANAFIL 5TADALAFIL5MGPHARMACTIVE 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 BLISTER08/02/2023
NDA/MAL/HDP/10554ACINO AG.LABOREX UGANDA LIMITEDTITANAFIL 20TADALAFIL20MGPHARMACTIVE 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 BLISTER08/02/2023
NDA/MAL/HDP/10555AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDZESBINA 200PROGESTERONE200MGEUGIA PHARMA SPECIALITIES LIMITED-PLOT 5-38 SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500078 | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10556KESAR PHARMASWASTIK PHARMACEUTICAL LTDPIADINPOVIDONE IODINE5.0 W/WKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE08/02/2023
NDA/MAL/HDP/10557BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDLOFNAC-50DICLOFENAC SODIUM50MGBLISS GVS PHARMA LIMITED-10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10558KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNEOCLEAN GELCLINDAMYCIN PHOSPHATE + NICOTINAMIDE1.0 %W/W + 4.0%W/WCURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X10.0 G TUBE08/02/2023
NDA/MAL/HDP/10559KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNIOSALIC OINTMENTCLOBETASOL PROPIONATE + SALICYLIC ACID0.05%W/W + 3.00W/WCURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X30.0 G TUBE08/02/2023
NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENT BETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE01/07/2013
NDA/MAL/HDP/10560LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDWHITFIELD’S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLEBEN LABORATORIES PVT LTD .-L-14 PHASE III MIDC AKOLA 444 104 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X20.0 G TUBE08/02/2023
NDA/MAL/HDP/10561ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDWORIVALBENDAZOLE400MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10562EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDACESON-PACECLOFENAC + PARACETAMOL100MG + 500MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10563ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDENARIV-10ENALAPRIL MALEATE10MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10564MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDISONIAZID/PYRIDOXINE HYDROCHLORIDE/SULFAMETH OXAZOLE TRIMETHOPRIM TABLETS 300 MG/25 MG/800 MG/160 MGISONIAZID + PYRIDOXINE HYDROCHLORIDE + SULFAMETHOXAZOLE + TRIMETHOPRIM300 MG + 25 MG + 800 MG + 160 MGMYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BOTTLE08/02/2023
NDA/MAL/HDP/10565AUROLABSWASTIK PHARMACEUTICAL LTDPILOPILOCARPINE NITRATE2%W/VAUROLAB .-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 | INDIA | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10566AUROLABSWASTIK PHARMACEUTICAL LTDAUROCARPINEPILOCARPINE NITRATE0.5%W/VAUROLAB .-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 | INDIA | OPHTHALMIC DROPS 1.0X5.0X1.0 ML VIAL08/02/2023
NDA/MAL/HDP/10567AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDCELMAC 200CELECOXIB200MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10568AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 5/4AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE5 MG + 4 MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10569AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 5/8AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE5MG + 8MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10570AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 10/4AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE10 MG + 4 MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10571AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 10/8AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE10MG + 8MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10572MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDNAT-B FORTETHIAMINE 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 CHELATE100 MG + 200 MG + 500 MCG + 200 MCG + 200 IU + 5000 IU + 400 IU + 1.0 MG + 0.20 MG + 15.0 MGMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
NDA/MAL/HDP/10575AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBINOVEN 75VENLAFAXINE HYDROCHLORIDE75MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10576AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDQUITIDE 100QUETIAPINE FUMARATE100MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
NDA/MAL/HDP/10578BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDOCORTINHYDROCORTISONE1%W/WKREMOINT 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 TUBE08/02/2023
NDA/MAL/HDP/10579 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDBENZYL BENZOATE APPLICATION BPBENZYL BENZOATE25%W/VRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE08/02/2023
NDA/MAL/HDP/10589PSYCHOTROPICS INDIA LIMITED.ABACUS PHARMA (AFRICA) LIMITEDPILECA-EZATORVASTATIN + EZETIMIBE10 MG + 10 MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10590MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDULCEREST 20ESOMEPRAZOLE MAGNESIUM20MGMYLAN 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 BOTTLE15/02/2023
NDA/MAL/HDP/10591MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDULCEREST 40ESOMEPRAZOLE MAGNESIUM40MGMYLAN 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 BOTTLE15/02/2023
NDA/MAL/HDP/10592ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDASCARD-75ASPIRIN75MGATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMOMRIVMOMETASONE FUROATE0.1%W/WEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE15/02/2023
NDA/MAL/HDP/10597MEDISEL(K) LTDSUPER MEDIC LTDGABANERVEGABAPENTIN + METHYLCOBALAMIN300MG + 500MCGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10598DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDMIXIFCEFIXIME TRIHYDRATE400MGDAR AL DAWA-NA’UR – PRINCE HASHEM BIN AL-HUSSEIN STREET P.O. BOX 9364 AMMAN 11191 JORDAN | JORDAN | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X5.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10599ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDBETAMET CREAMBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 | PAKISTAN | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE15/02/2023
NDA/MAL/HDP/10600MEDISEL(K) LTDAIVEEN (U) LIMITEDOSTEOCERINGLUCOSAMINE SULPHATE POTASSIUM CHLORIDE + METHL SULPHONYL METHANE (MSM) + DIACEREIN750MG + 250MG + 50MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10601MSN LABORATORIES PRIVATE LIMITED,ABACUS PHARMA (AFRICA) LIMITEDVORIOLE 50VORICONAZOLE50 MGMSN 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 BLISTER15/02/2023
NDA/MAL/HDP/10602WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?.GOODMAN INTERNATIONAL LTDZIROMIN 200 MG/5 ML AZITHROMYCIN DIHYDRATE200 MG/5 MLWORLD 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 BOTTLE15/02/2023
NDA/MAL/HDP/10603SANDOZ GMBH, KUNDLKIMSY MEDS LTDETOPOSIDE 200 MG/10MLETOPOSIDE200 MG/10MLEBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0 ML AMPOULE15/02/2023
NDA/MAL/HDP/10604ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPIPERATAZ 4.5PIPERACILLIN + TAZOBACTAM4 G + 0.5 GUNI MEDICOLABS-UNI MEDICOLABS, PLOT NO. 21-22, PHARMACITY, SELAQUI, DEHRADUN - 248011 | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X4.5 G VIAL15/02/2023
NDA/MAL/HDP/10605PSYCHOTROPICS INDIA LIMITED.ABACUS PHARMA (AFRICA) LIMITEDHALOPACHALOPERIDOL5MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10606MEDISEL(K) LTDAIVEEN (U) LIMITEDEMADON SYRUPONDANSETRON HYDROCHLORIDE2MG/5MLCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X30.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10607CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.DOLACKETOROLAC TROMETHAMINE10 MGCADILA PHARMACEUTICALS LTD-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDABAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP15/02/2023
NDA/MAL/HDP/10608WILSHIRE LABORATORIES (PVT) LTD HEALTHCARE LTD.QOSMET 500/50METFORMIN HYDROCHLORIDE+ SITAGLIPTIN MONOHYDRATE PHOSPHATE500MG + 50MGWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X5.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10609FDC LIMITED -AIVEEN (U) LIMITEDOCUDORDORZOLAMIDE HYDROCHLORIDE2%W/VFDC LIMITED-WALUJ.-PLOT B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 (DIST AURANGABAD) | INDIA | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10610WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?.GOODMAN INTERNATIONAL LTDESLOTINDESLORATADINE2.5 MG/5MLWORLD 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 BOTTLE15/02/2023
NDA/MAL/HDP/10611PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDNEWSTAR 160/10 MGVALSARTAN + AMLODIPINE BESYLATE160 MG + 10 MGPHARMA 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 BLISTER15/02/2023
NDA/MAL/HDP/10612PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDNEWSTAR 160/5 MGVALSARTAN + AMLODIPINE BESYLATE160 MG + 5 MGPHARMA 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 BLISTER15/02/2023
NDA/MAL/HDP/10613ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYNER-CEF 500CEFUROXIME AXETIL500MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED-HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10614S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDAVIRAXACICLOVIR5% W/WS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE15/02/2023
NDA/MAL/HDP/10615LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLEVOZIN 5LEVOCETIRIZINE DIHYDROCHLORIDE5MGLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10616COSMOS LTD.ASTRA PHARMA (U) LIMITEDGLYSIT 5DAPAGLIFLOZIN5MGCOSMOS LTD..-RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10617COSMOS LTD.ASTRA PHARMA (U) LIMITEDGLYSIT 10DAPAGLIFLOZIN10MGCOSMOS LTD..-RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10618BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDFOLIGRAF 150 I.URECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH)150 I.U/1ML BHARAT SERUM AND VACCINES LIMITED-PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X1.0 ML PRE- FILLED SYRINGE15/02/2023
NDA/MAL/HDP/10619?LKO ?LAÇ SANAYI VE TICARET A. ?. CORE ACCESS LIMITEDDEXIRENDEXKETOPROFEN TROMETAMOL50MG/2MLIDOL LLAC DOLUM A.S-DAVUTPASA CADDESI. CEBE ALI BEY SOK. NO. 20 34010/ DAVUTPASA - TOPKAPI / ISTANBUL | TURKEY | PARENTERAL ORDINARY AMPOULES 1.0X1.0X6.0X2.0 ML AMPOULE15/02/2023
NDA/MAL/HDP/10620RENE INDUSTRIES LIMITEDRENE PHARMACY LTDBUSCORENHYOSCINE BUTYLBROMIDE10 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10621RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPENIRENPHENOXYMETHYLPENICILLIN POTASSIUM250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10622CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDPANTOPRAM 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40 MGCENTURION LABORATORIES PVT LTD-PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10623RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSTERIRENCHLORHEXIDINE GLUCONATE5% W/VRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | TOPICAL EXTERNAL LIQUIDS 1.0X5.0 L CONTAINER15/02/2023
NDA/MAL/HDP/10625LA RENON HEALTHCARE PRIVATE LIMITEDAIVEEN (U) LIMITEDESOGRESS 40ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40 MGSTANFORD 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 BLISTER15/02/2023
NDA/MAL/HDP/10628HILTON PHARMA (PVT) LTDHEALTHCARE LTD.SITAGLU MET 50/500SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE50 MG + 500 MGHILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10629HILTON PHARMA (PVT) LTDHEALTHCARE LTD.SITAGLU MET 50/1000SITAGLIPTIN PHOSPHATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGHILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10630INNOVA CAPTAB LTD.TATA UGANDA LIMITEDINFIXIME 400CEFIXIME TRIHYDRATE400MGINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10631GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDRYALTRISOLOPATADINE HYDROCHLORIDE + MOMETASONE FUROATE665 MCG/25 MCGGLENMARK PHARMACEUTICALS LIMITED-UNIT III-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIA | INDIA | NASAL SYSTEMIC DROPS 1.0X1.0X240.0 METERED DOSE BOTTLE15/02/2023
NDA/MAL/HDP/10632PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD)ROYAL PHARMA 2011 LIMITEDROSUVAT 10ROSUVASTATIN CALCIUM10 MGGLOBELA 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 BLISTER15/02/2023
NDA/MAL/HDP/10633MYLAN PHARMACEUTICAL PRIVATE LIMITED -PLOT N0. 1-A/2 KIMSY MEDS LTDFULPHILAPEGFILGRASTIM6 MG/0.6 MLBIOCON BIOLOGICS LIMITED-SPECIAL 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 SYRINGE15/02/2023
NDA/MAL/HDP/10634ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFLUSCOTPARACETAMOL + CAFFEINE + CHLORPHENIRAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE500MG + 30MG + 2MG + 10MGM/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 BLISTER15/02/2023
NDA/MAL/HDP/10636UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDUNIPROEX ER 250DIVALPROEX SODIUM250MGUNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10637ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSETRIZINCETIRIZINE10MGM/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 BLISTER15/02/2023
NDA/MAL/HDP/10638ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCLOTRIMAZOLE, BETAMETHASONE DIPROPIONATE, GENTAMICIN SULPHATE CREAMCLOTRIMAZOLE + BETAMETHASONE DIPROPIONATE + GENTAMICIN SULPHATE(10 MG + 0.5 MG + 1 MG)/GCIRON 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 TUBE15/02/2023
NDA/MAL/HDP/10639ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCIROVIRACICLOVIR5%W/WCIRON 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 TUBE15/02/2023
NDA/MAL/HDP/10640FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISTEMMETHOCARBAMOL + PARACETAMOL380 MG + 300 MGFAES FARMA SA-MAXIMO AGUIRRE 14. 48940 LEIOA – SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10642AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPACSITA 150CAPECITABINE150MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY 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 BLISTER15/02/2023
NDA/MAL/HDP/10643AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPACSITA 500CAPECITABINE500MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY 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 BLISTER15/02/2023
NDA/MAL/HDP/10646TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENZYSTAL PPANCREAS POWDEREQUIVALENT TO AMYLASE ACTIVITY 4200 PH. EUR UNITS, LIPASE ACTIVITY 3500 PH. EUR UNITS AND PROTEASE ACTIVITY 250 PH. EUR UNITSTORRENT 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 BLISTER15/02/2023
NDA/MAL/HDP/10647LITHA PHARMA (PTY) LTD.LABOREX UGANDA LIMITEDMETHYLPHENIDATE HCL-DOUGLASMETHYLPHENIDATE HYDROCHLORIDE10MGDOUGLAS MANUFACTURING LIMITED-CORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND | NEW ZEALAND | ORAL SOLID ORDINARY TABLETS 1.0X2.0X15.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10648 CIPLA LTDQUALITY CHEMICALS LTDTENVIR-AFTENOFOVIR ALAFENAMIDE FUMARATE25MGCIPLA LIMITED-PLOT NO. A-33, A-2 & A-37/2/2 (UNIT-I), A-42(UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE15/02/2023
NDA/MAL/HDP/10649PINNACLE LIFE SCIENCE PVT. LTDABACUS PHARMA (AFRICA) LIMITEDESOCID 40ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER01/07/2007
NDA/MAL/HDP/10651PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBROZELINAMBROXOL HYDROCHLORIDE + SALBUTAMOL + GUAIPHENESIN + MENTHOL(30 MG + 2 MG + 50 MG + 1 MG)/5 MLTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10652ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZ-OFLOX 200OFLOXACIN200MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10653ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDCOXZOTA-60ETORICOXIB60MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10654ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)COMPOUND SODIUM LACTATE INTRAVENOUS INFUSIONSODIUM LACTATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE0.320%W/V + 0.600%W/V + 0.040%W/V + 0.027%W/VALTHEA PHARMA PRIVATE LIMITED-WORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10655HETERO LABS LTD AIVEEN (U) LIMITEDTENOFOVIR ALAFENAMIDE TABLETSTENOFOVIR ALAFENAMIDE HEMIFUMARATE25MGHETERO 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 BOTTLE15/02/2023
NDA/MAL/HDP/10656AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDBIOGLITA PLUS 15/500MG FC TABLETSPIOGLITAZONE + METFORMIN HYDROCHLORIDE15MG + 500MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART 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 BLISTER15/02/2023
NDA/MAL/HDP/10657AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDBIOGLITA PLUS 15/850MG FC TABLETSPIOGLITAZONE + METFORMIN HYDROCHLORIDE15MG + 850MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART 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 BLISTER15/02/2023
NDA/MAL/HDP/10658AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATORKEY 40ATORVASTATIN CALCIUM TRIHYDRATE40MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10659MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDACENAC-PACECLOFENAC + PARACETAMOL100MG + 500MGMEDLEY PHARMACEUTICALS LTD-LANE 03, PHASE 1, SIDCO INDUSTRIAL COMPLEX, BARI BRAHMANA JAMMU 181133 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10660ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDAZITOZ-250AZITHROMYCIN DIHYDRATE250MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10661ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLIVOTA-750LEVOFLOXACIN HEMIHYDRATE750MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10662ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDTOMOZAMOSAPRIDE CITRATE DIHYDRATE5MGZOTA HEATHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10663FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRAMAPA 37.5 MG/325 MGTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5 MG/325 MGFERRER INTERNATIONAL, S.A-C/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES, | SPAIN | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10664FDC LTD AIVEEN (U) LIMITEDOCUDORT-TDORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE(20 MG + 5 MG)/MLFDC LIMITED, WALUJ .-PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10665AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCIATUFF 10TADALAFIL10 MGAUROBINDO PHARMA LTD, UNIT VII-SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X4.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10667VINS BIOPRODUCTS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVINRAB 1000 IUEQUINE ANTIRABIES IMMUNOGLOBULIN FRAGMENTS F (AB’) 2 NOT LESS THAN 200 IU PER MLVINS BIOPRODUCTS LIMITED-SY. NO. 117, THIMMAPUR (V), KOTHUR MANDAL), RANGA REDDY (DIST), TELANDANA | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL15/02/2023
NDA/MAL/HDP/10668LUPIN LIMITEDAIVEEN (U) LIMITEDDOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMERATE 50MG/300MG/300MGDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50 MG + 300 MG + 300 MGLUPIN LIMITED NAGPUR-PLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET CONTAINER15/02/2023
NDA/MAL/HDP/10669AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDCARDIOTIMIDE 20 MGTORSEMIDE20 MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/10670HILTON PHARMA (PVT) LTDHEALTHCARE LTD.DOLGINADEXLANSOPRAZOLE30MGHILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10671HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN-STRANEXAMIC ACID1000MG/10MLHILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | PARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0 ML AMPOULE15/02/2023
NDA/MAL/HDP/10672OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDDNSSODIUM CHLORIDE + ANHYDROUS GLUCOSE0.9%W/V & 5%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED-SURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 | INDIA | PARENTERAL ORDINARY INFUSION BAGS 1.0X1.0X500.0 ML BAG15/02/2023
NDA/MAL/HDP/10673EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDCETARIVCETIRIZINE HYDROCHLORIDE5MG/5MLEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10674VINS BIOPRODUCTS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAFRIVEN-10NAJA MELANOLEUCA+ NAJA NIGRICOLLIS + NAJA HAJE + DENDROASPIS POLYLEPIS + DENDROASPIS VIRIDIS + DENDROASPIS JAMESONI + BITIS GABONICA + BITIS ARIETANS + ECHIS LEUCOGASTER + ECHIS OCELLATUSNOT 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 LD50VINS BIOPRODUCTS LIMITED-SY. NO. 117, THIMMAPUR (V), KOTHUR MANDAL), RANGA REDDY (DIST), TELANDANA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X5.0X10.0 ML VIAL15/02/2023
NDA/MAL/HDP/10675THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.JENTIN 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50 MGTHE SEARLE COMPANY LIMITED-F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10676THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.JENTIN 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100 MGTHE SEARLE COMPANY LIMITED-F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10678KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDARTELUMARTEMETHER + LUMEFANTRINE20 MG + 120 MGKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X24.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10679ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDPG-75PREGABALIN75 MGZOTA HEALTHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10680RAPTAKOS, BRETT & CO. LTD.EUROPA HEALTHCARE (U) LTDNEOPEPTINE PLUS DROPSALPHA AMYLASE (BACTERIAL 1:800) + PAPAIN(20MG + 10MG) PER MLRAPTAKOS, BRETT & COMPANY LIMITED-1ST POKHRAN ROAD, THANE 400606, MIDC, MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY DROPS 1.0X1.0X15.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10681BIODEAL LABORATORIES LTD PLOT NO.123ABACUS PHARMA (AFRICA) LIMITEDPODOSAL OINTMENTPODOPYLLUM RESIN + SALICYLIC ACID20%W/W + 25%W/WBIODEAL LABOARATORIES LTD-123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBI | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE15/02/2023
NDA/MAL/HDP/10682M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDRALTEGRAVIR TABLETSRALTEGRAVIR POTASSIUM400 MGHETERO 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 CONTAINER15/02/2023
NDA/MAL/HDP/10683AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY ER 750METFORMIN HYDROCHLORIDE750 MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10684GALENICUM HEALTH S.L.GOODMAN INTERNATIONAL LTDDUTASVITAE 0.5MGDUTASTERIDE0.5MGCYNDEA PHARMA, S.L-POLIGONO INDUSTRIAL EMILIANO REVILLA SANZ. AVDA. DE AGREDA, 31 OLVEGA 42110 (SORIA) | SPAIN | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10685AVACARE GLOBALGOODMAN INTERNATIONAL LTDDEMOXMOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE PHOSPHATE(5MG + 1MG)/MLWORLD 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 BOTTLE15/02/2023
NDA/MAL/HDP/10686HETERO LABS LTD AIVEEN (U) LIMITEDCELOFEN 200CELECOXIB200MGHETERO 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 BLISTER15/02/2023
NDA/MAL/HDP/10687AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDIRNIZET 300IRINOTECAN HYDROCHLORIDE TRIHYDRATE300 MG/15MLEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X15.0 ML VIAL15/02/2023
NDA/MAL/HDP/10688MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDUROKADUTASTERIDE0.5 MGMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10689ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLOSARZED-100LOSARTAN POTASSIUM100 MGZOTA HEALTHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10690SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDPROTAC-40PANTOPRAZOLE SODIUM40 MGSUNRISE INTERNATIONAL LABS LTD-PLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10691GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROGLOPENTIN 400 MGGABAPENTIN400MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10692GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROGLOPENTIN 300 MGGABAPENTIN300MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10693SWISS PARENTERALS LTDSHREEJI CARE LIMITEDGEN DEX EYE DROPSGENTAMICIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE0.3% W/V + 0.1% W/VSWISS 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 BOTTLE15/02/2023
NDA/MAL/HDP/10694MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDOTYCULF 500 MGFLUCYTOSINE500MGMYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X100.0 TABLET BOTTLE15/02/2023
NDA/MAL/HDP/10695UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDGLUCOSE 5 % UNIMEDGLUCOSE ANHYDROUS5%W/VUNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BAG15/02/2023
NDA/MAL/HDP/10696MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCELEBIB CAPSULES 200MGCELECOXIB200MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10697BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDASPORELIXCETRORELIX ACETATE0.25MGBHARAT SERUM AND VACCINES LIMITED-PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY I V VIALS 1.0X0.25 MG VIAL + 1*1ML GLASS AMPOULE OF WFI15/02/2023
NDA/MAL/HDP/10698EBEWE PHARMA GES.M.B.H. NFG. KGKIMSY MEDS LTDPACLITAXEL 6 MG /1 MLPACLITAXEL6 MG /1 MLEBEWE PHARMA GES.M.B.H. NFG.KG-MONDSEESTRABE 11 4866 UNTERACH AM ATTERSEE - AUSTRIA | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X16.7 ML VIAL15/02/2023
NDA/MAL/HDP/10699PHARMA BAVARIA INTERNACIONAL PORTUGALGOODMAN INTERNATIONAL LTDRHINIZILL 50MOMETASONE FUROATE MONOHYDRATE50 ?G/ACTUATIONFARMEA-10 RUE BOUCHE THOMAS, ZAC D'ORGEMONT, 49007 ANGERS CEDEX 01 | FRANCE | NASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X1.0X120.0 METERED DOSE CANNISTER15/02/2023
NDA/MAL/HDP/10702UNIMED TECHNOLOGIES CO., LTDOMAB UGANDA LIMITEDVAAMOX 1G/200 MGSODIUM AMOXICILLIN + POTASSIUM CLAVULANATE.(1 G + 200 MG)VIALUNIMED LABORATORIES-P.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIA | TUNISIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL15/02/2023
NDA/MAL/HDP/10703MOTI PHARMA(U) LTD.MOTI PHARMA (UGANDA) LIMITEDTOPSUNATEARTESUNATE60 MGSANJAR PHARMA LLP-SURVEY 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 AMPOULE15/02/2023
NDA/MAL/HDP/10704PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEMEFILM-4ONDANSETRON HYDROCHLORIDE4 MGSHILPA THERAPEUTICS PVT. LIMITED-PLOT NO. 118, PHASE-III, IDA, CHERLAPALLY, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD - 500016, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X5.0 SACHET CARTON15/02/2023
NDA/MAL/HDP/10705BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDSUPADOL 500PARACETAMOL500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10706BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDNTSUGA 500METFORMIN HYDROCHLORIDE500 MGBIOMATRIX 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 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10707MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDZOPIMAC 3ESZOPICLONE3MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X100.0 TABLET CONTAINER15/02/2023
NDA/MAL/HDP/10708BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDCAFENOLACETYLSALICYLIC ACID + CAFFEINE375MG + 25MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO. LR 209/6554, MOGADISHU ROAD INDUSTRIAL AREA, NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X8.0X20.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10709CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDVINGLYN M 50/850VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 850 MGEAST 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 BLISTER15/02/2023
NDA/MAL/HDP/10710CADILA HEALTHCARE LIMITED;ABACUS PHARMA (AFRICA) LIMITEDOXALGIN GELDICLOFENAC DIETHYLAMINE+ METHYL SALICYLATE + VIRGIN LINSEED OIL + CAPSAICIN + RACEMENTHOL1.0%W/W + 10.0%W/W + 3.0%W/W + 0.05%W/W + 5.0%W/WEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE15/02/2023
NDA/MAL/HDP/10713BIOMATRIX HEALTHCARE PVT LTD.-MEDIWORLD PHARMA AFRICA LTDIMMUNCEE 500ASCORBIC ACID + SODIUM ASCORBATE100MG + 450MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10714BIOMATRIX HEALTHCARE PVT LTD.-MEDIWORLD PHARMA AFRICA LTDDICLOTRIX PLUSDICLOFENAC SODIUM + PARACETAMOL50MG + 500MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10715AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/500VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 500MGAJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10716AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/850VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 850 MGAJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10717AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/1000VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 1000 MGAJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10718 ZIM LABORATORIES LTDREDDYS PHARMA LIMITEDLIPIZAR 10ATORVASTATIN CALCIUM TRIHYDRATE10MGZIM LABORATORIES LIMITED-B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10719HETERO LABS LTD AIVEEN (U) LIMITEDGOAB 5SOLIFENACIN SUCCINATE5 MGM/S. ANNORA PHARMA PRIVATE LIMITED-SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10720HETERO LABS LTD AIVEEN (U) LIMITEDGOAB 10SOLIFENACIN SUCCINATE10MGM/S. ANNORA PHARMA PRIVATE LIMITED-SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10721MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDFLEXABENZ GELDICLOFENAC DIETHYLMAINE + LINSEED OIL + METHYL SALICYLATE + MENTHOL + CYCLOBENZAPRINE HYDROCHLORIDE1.0%W/W + 3.0%W/W + 10.0%W/W + 5.0%W/W + 2.0%W/WOXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE15/02/2023
NDA/MAL/HDP/10722AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEDWINMEDROXYPROGESTERONE ACETATE150MG/MLEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL15/02/2023
NDA/MAL/HDP/10725AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 2.5BISOPROLOL FUMARATE2.5MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10726AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 5BISOPROLOL FUMARATE5MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10727AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 10BISOPROLOL FUMARATE10MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10728LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRAPI-COOLCHOLINE SALICYLATE + LIDOCAINE HYDROCHLORIDE8.70% W/W + 2.00% W/WLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE15/02/2023
NDA/MAL/HDP/10730UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNICHLOR 25CHLORTHALIDONE25MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10731UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNICHLOR 50CHLORTHALIDONE50 MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10732 B&O PHARMTRIDEM PHARMA UGANDA LIMITEDBREAZLAXMONTELUKAST4MGBILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10733 B&O PHARMTRIDEM PHARMA UGANDA LIMITEDBREAZLAXMONTELUKAST5MGBILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10734 B&O PHARMTRIDEM PHARMA UGANDA LIMITEDBREAZLAXMONTELUKAST10MGBILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10735 CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLADON PLUSPARACETAMOL + DOXYLAMINE SUCCINATE + CAFFEINE + CODEINE PHOSPHATE450MG + 5MG + 30MG + 10MGCIPLA 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 BLISTER15/02/2023
NDA/MAL/HDP/10736UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIPROEX ER 500DIVALPROEX SODIUM500MGUNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER (ALU-ALU BLISTER),1.0X3.0X10.0 TABLET BLISTER (ACLAR – PVC BLISTER)15/02/2023
NDA/MAL/HDP/10737LAURUS LABS LIMITED - BEYOND LOGISTICS LTDABACAVIR 600 MG AND LAMIVUDINE 300 MG FILM COATED TABLETSABACAVIR SULFATE + LAMIVUDINE600MG + 300MGLAURUS 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 BOTTLE15/02/2023
NDA/MAL/HDP/10738SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTDTATA UGANDA LIMITEDDOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETSDOLUTEGRAVIR + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50 MG + 300 MG + 300 MGSHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD-1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE15/02/2023
NDA/MAL/HDP/10742CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDVINGLYNVILDAGLIPTIN50 MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10743CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDVINGLYN M 50/500VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 500 MGEAST 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 BLISTER15/02/2023
NDA/MAL/HDP/10745PUNISKA HEALTHCARE PRIVATE LIMITEDNORVIK ENTERPRISES LIMITEDEBROXONCEFTRIAXONE SODIUM1 G/VIALZEISS PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL15/02/2023
NDA/MAL/HDP/10746 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDFEBLORIKA-80FEBUXOSTAT80 MGMANKIND PHARMA LIMITED-UNIT - 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 BLISTER15/02/2023
NDA/MAL/HDP/10747M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 400 MG/300 MG/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400 MG + 300 MG + 300 MGHETERO 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 CONTAINER15/02/2023
NDA/MAL/HDP/10748KESAR PHARMAVEERAM HEALTHCARE (U) LIMITEDLULI CREAMLULICONAZOLE1% W/WKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE15/02/2023
NDA/MAL/HDP/10749LAURUS LABS LIMITED - BEYOND LOGISTICS LTDTENOFOVIR ALAFENAMIDE TABLETS 25 MGTENOFOVIR ALAFENAMIDE FUMARATE25MGLAURUS 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 BOTTLE15/02/2023
NDA/MAL/HDP/10750LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCIN PLUSPARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE500 MG + 15 MG + 10 MG + 2 MGLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10753LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDHISTALIN 8BETAHISTINE DIHYDROCHLORIDE8 MGLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10754LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDHISTALIN 16BETAHISTINE DIHYDROCHLORIDE16 MGLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10755NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDZADYCINE-250AZITHROMYCIN DIHYDRATE250 MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10756NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIGRA 100SILDENAFIL CITRATE100 MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X1.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10757NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDZADYCINE-500AZITHROMYCIN DIHYDRATE500 MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10758NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIZOLEALBENDAZOLE400 MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10760TORQUE PHQRCEAUTICALS PVT LTDSHURIK LTDSKINNCARECLOBETASOL PROPIONATE + SALICYLIC ACID0.05% W/W+ 3.00%W/WTORQUE PHARMACEUTICALS PVT. LTD. -UNIT-1, VILLAGE- ISSAPUR, DAPPAR, POST- DAPPAR, PUNJAB- 140506 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X20.0 G TUBE15/02/2023
NDA/MAL/HDP/10761WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?.GOODMAN INTERNATIONAL LTDZIROMINAZITHROMYCIN DIHYDRATE500MGWORLD 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 BLISTER15/02/2023
NDA/MAL/HDP/10762MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLINEZOLID TABLETS 600 MGLINEZOLID 600 MGMYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10763AUROLABSWASTIK PHARMACEUTICAL LTDAUROCORTTRIAMCINOLONE ACETONIDE40 MG/MLAUROLAB LIMITED-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X5.0X1.0 ML VIAL15/02/2023
NDA/MAL/HDP/10764 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOPIVIDCLOPIDOGREL HYDROGEN SULPHATE75MGHOVID 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 BLISTER15/02/2023
NDA/MAL/HDP/10765GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDHEXGABALIN 75PREGABALIN75MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY | EGYPT | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10766CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAMA-50TRAMADOL HYDROCHLORIDE50MGCACHET PHARMACEUTICAL PVT LTD.-VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10767AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDZESBINA 100PROGESTERONE100 MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY 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 BLISTER15/02/2023
NDA/MAL/HDP/10768AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEBUNTA 5NEBIVOLOL HYDROCHLORIDE5 MGAJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10769RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIREN-500AMOXICILLIN TRIHYDRATE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER15/02/2023
NDA/MAL/HDP/10770MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDFITINLEVOCETIRIZINE DIHYDROCHLORIDE2.5MG/5MLMEDLEY PHARMACEUTICALS LTD-PLOT 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 BOTTLE15/02/2023
NDA/MAL/HDP/10771AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. HEALTHCARE LTD.MIZICINAZITHROMYCIN DIHYDRATE250MGAL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10772WILSHIRE LABORATORIES (PVT) LTD HEALTHCARE LTD.QOSMET 1000/50METFORMIN HYDROCHLORIDE+ SITAGLIPTIN MONOHYDRATE PHOSPHATE1000MG + 50MGWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X5.0 TABLET BLISTER15/02/2023
NDA/MAL/HDP/10773AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. HEALTHCARE LTD.GESIDOLTRAMADOL HYDROCHLORIDE50MGAL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10774PSYCHOTROPICS INDIA LTD-BIOGEN PHARMA LIMITEDQNN 300QUININE DIHYDROCHLORIDE300MG/MLPSYCHOTROPICS INDIA LTD-PLOT 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 AMPOULE15/02/2023
NDA/MAL/HDP/10775AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. HEALTHCARE LTD.FICLO SR 100DICLOFENAC SODIUM100MGAL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN | PAKISTAN | ORAL SOLID RETARD CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER15/02/2023
NDA/MAL/HDP/10776CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDLEEFLOXLEVOFLOXACIN HEMIHYDRATE0.5%W/VCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)-PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10777CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDGLUCOTIM 0.5%TIMOLOL MALEATE0.5%W/VCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)-PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 | INDIA | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
NDA/MAL/HDP/10778 ZIM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDZIMFIL-ODS 20TADALAFIL20MGZIM LABORATORIES LIMITED-B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY OTHER SPECIAL FORMS 1.0X10.0 STRIP PACK15/02/2023
NDA/MAL/HDP/10779INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCLAVIX AS 75CLOPIDOGREL BISULFATE+ ASPIRIN75MG + 75MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP15/02/2023
NDA/MAL/HDP/1078MICRO LABS LTD LABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/10783RUSAN PHARMA LTDNORVIK ENTERPRISES LIMITEDBIORANDICLOFENAC SODIUM75MG/3MLRUSAN PHARMA LIMITED-PLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL ECONOMIC ZONE, GANDHIDHAM KUTCH 370 230 GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X3.0 ML AMPOULE03/05/2023
NDA/MAL/HDP/10784AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCIATUFF 10TADALAFIL10MGAUROBINDO PHARMA LTD, UNIT VII-SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X4.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10785VINS BIOPRODUCTS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTETAVINTETANUS ANTITOXIN1500 IU/MLVINS BIOPRODUCTS LIMITED-SY. 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 VIAL03/05/2023
NDA/MAL/HDP/10786AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVIATUFF 50SILDENAFIL CITRATE50MGAUROBINDO PHARMA LTD, UNIT VII-SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X2.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10787PSYCHOTROPICS INDIA LIMITED.BIOGEN PHARMA LIMITEDAZIGENAZITHROMYCIN DIHYDRATE200 MG/5 MLPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49, SECTOR-6A,IIE, SIDCUL,HARIDWAR -249403( UTTARAKHARD) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE03/05/2023
NDA/MAL/HDP/10788THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.DIULACTONE 25 MGSPIRONOLACTONE25MGSEARLE PAKISTAN LIMITED,-F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10789 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDFEBLORIKA-40FEBUXOSTAT40MGMANKIND PHARMA LIMITED-UNIT - 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 BLISTER03/05/2023
NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2000
NDA/MAL/HDP/10790THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.DIULACTONE 100 MGSPIRONOLACTONE100MGSEARLE PAKISTAN LIMITED,-F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10791THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.VAPTOR 20MGROSUVASTATIN20MGSEARLE PAKISTAN LIMITED,-F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10792MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDNEBIMAC 5NEBIVOLOL HYDROCHLORIDE5 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10793THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.NUBIN INJECTION 10MG/MLNALBUPHINE HYDROCHLORIDE10MG/1MLSEARLE PAKISTAN LIMITED,-F-319, SITE KARACHI | PAKISTAN | PARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE03/05/2023
NDA/MAL/HDP/10794THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.MORCET 10 MGESCITALOPRAM OXALATE10MGSEARLE PAKISTAN LIMITED,-F-319, SITE KARACHI | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10795PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)DIAZEPAM 10MG/2MLDIAZEPAM 10MG/2MLPROFARMA SH.A-MYSLYM KETA,TIRANA | ALBANIA | PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE03/05/2023
NDA/MAL/HDP/10796PINNACLE LIFE SCIENCE PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSECNIZOLE TABLETSSECNIDAZOLE1000MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X2.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10797GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDAPREZOAPREMILAST10MG TABLETS CO-PACKED WITH 20MG TABLETS AND 30MG TABLETSGLENMARK PHARMACEUTICALS LIMITED-PLOT NO. 2, PHASE-II, PHARMA ZONE, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR DIST. DHAR, (M.P.) PIN CODE 454775 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 19*30MG TABLETS],1.0X1.0 CARTON CARTON [4*10MG CO-PACKED WITH 4*20MG CO-PACKED WITH 47*30MG TABLETS] 03/05/2023
NDA/MAL/HDP/10798STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDSTEDNAC PLUSACECLOFENAC + PARACETAMOL100 MG + 325 MGSTEDMAN 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 BLISTER03/05/2023
NDA/MAL/HDP/10799CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDGEFITINIB 250MG TABLETSGEFITINIB250MGCIPLA 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 BLISTER03/05/2023
NDA/MAL/HDP/10800HILTON PHARMA PVT LTDBOOTS PHARMACEUTICALS LIMITEDROLIPEZEROSUVASTATIN CALCIUM + EZETIMIBE10 MG + 10 MGHILTON 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 BLISTER03/05/2023
NDA/MAL/HDP/10801MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERIS (900 IU + 450 IU)/1.44MLFOLLITROPIN ALFA + LUTROPIN ALFA(900 IU + 450 IU)/1.44MLMERCK 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 NEEDLES03/05/2023
NDA/MAL/HDP/10802MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERIS (300 IU + 150 IU)/1.44MLFOLLITROPIN ALFA + LUTROPIN ALFA(300 IU + 150 IU)/1.44MLMERCK 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 NEEDLES03/05/2023
NDA/MAL/HDP/10803MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERIS (450 IU + 225 IU)/0.72 MLFOLLITROPIN ALFA + LUTROPIN ALFA(450 IU + 225 IU)/0.72MLMERCK 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 PEN03/05/2023
NDA/MAL/HDP/10804WALLACE PHARMACEUTICALS PVT. LTDSTAR PHARMACEUTICALS LTDCOLIMEX TABLETSDICYCLOVERINE HYDROCHLORIDE + PARACETAMOL20MG + 500MGWALLACE PHARMACEUTICALS PVT LTD-BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10805AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBISODAC-HF 5BISOPROLOL FUMARATE5 MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10806ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLOSARZED-50LOSARTAN POTASSIUM50MGZOTA HEALTHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10808ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDROSUNA-10ROSUVASTATIN CALCIUMROSUNA-10ZOTA HEALTHCARE LIMITED-PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10809AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATORKEY 40ATORVASTATIN CALCIUM TRIHYDRATE40 MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10810BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBUCLAPOXIME 200CEFPODOXIME PROXETIL200 MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10812MICRO LABS LTDLABOREX UGANDA LIMITEDURYSOREN-5SOLIFENACIN SUCCINATE5 MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10813MICRO LABS LTD LABOREX UGANDA LIMITEDURYSOREN-10SOLIFENACIN SUCCINATE10 MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10814CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCAVIT SUSPENSIONELEMENTAL CALCIUM (IN CALCIUM PHOSPHATE) + ELEMENTAL PHOSPHORUS (IN CALCIUM PHOSPHATE) + MAGNESIUM HYDROXIDE + ZINC GLUCONATE + VITAMIN D3300 MG + 150 MG + 75 MG + 4 MG + 200 IUCACHET PHARMACEUTICALS PVT LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X150.0 ML BOTTLE03/05/2023
NDA/MAL/HDP/10816LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDAMITRYP-25AMITRIPTYLINE HYDROCHLORINE25 MGLINCOLN 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 BLISTER03/05/2023
NDA/MAL/HDP/10817M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDCELOFEN 100CELECOXIB100 MGHETERO LABS LIMITED (UNIT III)-VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 | HETERO LABS LIMITED (UNIT V)-SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER03/05/2023
NDA/MAL/HDP/10819APPASAMYPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNASOALDOMOMETASONE FUROATE50 MCG/ NASAL SPRAYLABORATORIO ALDO-UNION, S.L-3, 08950 ESPLUGUES DE LLOBREGAT (BARCELONA) | SPAIN | NASAL TOPICAL SPRAYS WITHOUT GAS 1.0X20.0 ML BOTTLE 1*140 ACTATIONS03/05/2023
NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/10820AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDOLOPAT EYE DROPSOLOPATADINE HYDROCHLORIDE0.1%W/VCIRON 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 CONTAINER03/05/2023
NDA/MAL/HDP/10821PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)ADRENALINE 1 MG/1MLADRENALINE HYDROGENTARTRATE1 MG/1MLPROFARMA SH.A-MYSLYM KETA,TIRANA | ALBANIA | PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE03/05/2023
NDA/MAL/HDP/10823AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVACODIL 12.5CARVEDILOL12.5MGAUROBINDO PHARMA LIMITED UNIT 3-PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/06/2023
NDA/MAL/HDP/10824AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM OD 5OLANZAPINE5MGAUROBINDO PHARMA LTD, UNIT VII-SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X4.0X7.0 TABLET BLISTER06/06/2023
NDA/MAL/HDP/10828TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FENOTOR 200FENOFIBRATE200MGTORRENT PHARMACEUTICALS LIMITED-PLOT NO. Z104-106, DAHEJ SEZ PART II, TALUKA: VAGRA, DIST.: BHARUCH-392130, GUJARAT- INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER06/06/2023
NDA/MAL/HDP/10829TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FENOTOR 67FENOFIBRATE67 MGTORRENT PHARMACEUTICALS LIMITED-PLOT NO. Z104-106, DAHEJ SEZ PART II, TALUKA: VAGRA, DIST.: BHARUCH-392130, GUJARAT- INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER06/06/2023
NDA/MAL/HDP/10830DAFRA PHARMA GMBH MULTIPHAR UGANDA LIMITEDMUSCURELTHIOCOLCHICOSIDE8 MGBILIM ILAC SAN.VE TIC.A.S-GEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEY | TURKEY | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER06/06/2023
NDA/MAL/HDP/10831AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDLASTAVIN 80VALSARTAN80 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER19/06/2023
NDA/MAL/HDP/10832AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLASTAVIN 160VALSARTAN160MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/06/2023
NDA/MAL/HDP/10833AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMOLNAFLUMOLNUPIRAVIR200MGAUROBINDO PHARMA LIMITED UNIT 3-PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 | AUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X40.0 CAPSULE BOTTLE06/06/2023
NDA/MAL/HDP/10834MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 100SITAGLIPTIN HYDROCHLORIDE100MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023
NDA/MAL/HDP/10835MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 50SITAGLIPTIN HYDROCHLORIDE50MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X18.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023
NDA/MAL/HDP/10836MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 25SITAGLIPTIN HYDROCHLORIDE25MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X16.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023
NDA/MAL/HDP/10838SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTDTATA UGANDA LIMITEDDOLUTEGRAVIR TABLETS 50MGDOLUTEGRAVIR SODIUM50MGSHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD-1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER06/06/2023
NDA/MAL/HDP/10839 STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDZEEDERMZINC OXIDE15%W/WSTEDMAN PHARMACEUTICALS PVT. LTD.-C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE06/06/2023
NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/10840 STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZ THROAT SPRAYPOVIDONE IODINE0.45%W/VSTEDMAN 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 CONTAINER06/06/2023
NDA/MAL/HDP/10841AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUTABIT PLUS 0.5/0.4DUTASTERIDE + TAMSULOSIN HYDROCHLORIDE0.5 MG + 0.4 MGAUROBINDO PHARMA LTD, UNIT VII-SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER06/06/2023
NDA/MAL/HDP/10842WOCKHARDT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEMROKLEVONADIFLOXACIN800 MG / 100MLWOCKHARDT 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 VIAL06/06/2023
NDA/MAL/HDP/10845MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTURBOVAS-20ROSUVASTATIN CALCIUM20MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10846ZIM LABORATORIES LTD-REDDYS PHARMA LIMITEDCEFRAZ SUSPENSIONCEFIXIME100MG/5MLZIM LABORATORIES LIMITED-B-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 LTDSTAR PHARMACEUTICALS LTDBUDESMABUDESONIDE200 MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT III-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER02/06/2023
NDA/MAL/HDP/10848 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDMEFENA FORTE-500MEFENAMIC ACID500MGAGOG 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 BLISTER03/05/2023
NDA/MAL/HDP/10849 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDLIRAPYN 25PREGABALIN25MGSUN 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 BLISTER03/05/2023
NDA/MAL/HDP/10850MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-HOLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE20MG + 12.5MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10851DEVA HOLDING A.S-SHREEJI PHARMACEUTICALS LIMITEDLOSAPRES PLUS 50 MG / 12.5 MGLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50 MG + 12.5 MGDEVA 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 BLISTER03/05/2023
NDA/MAL/HDP/10852INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINTRAMTRAMADOL HYDROCHLORIDE50MGFREDUN PHARMACEUTICALS LIMITED,-14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANE | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER03/05/2023
NDA/MAL/HDP/10853SAVA HEALTHCARE LIMITED - PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUTIAIR-S 250SALMETEROL + FLUTICASONE PROPIONATE(50 MCG + 250 MCG)/CAPSULESAVA 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 CAPSULE02/06/2023
NDA/MAL/HDP/10854CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDGLIMITAB 2 TABLETSGLIMEPIRIDE2MGCENTAUR 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 BLISTER03/05/2023
NDA/MAL/HDP/10855M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDTECAVIR 0.5ENTECAVIR MONOHYDRATE0.5MGHETERO 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 BLISTER03/05/2023
NDA/MAL/HDP/10856MS PHARMA JORDAN CO.LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDKEPAM 500MG/5MLLEVETIRACETAM500MG/5MLMS PHARMA - JORDAN-PLOT NO. 356, STREET NO. 6, KING ABDULLAH II BIN AL- HUSSEIN INDUSTRIAL ESTATE, SOUTH- WESTERN EDGE SAHAB ZONE. | JORDAN | PARENTERAL ORDINARY VIALS 1.0X10.0X5.0 ML VIAL (CLEAR GLASS VIAL)03/05/2023
NDA/MAL/HDP/10857AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDANDOPOXETINE 60 MGDAPOXETINE HYDROCHLORIDE60MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10858SYNOKEM PHARMACEUTICALS LIMITEDBIOGEN PHARMA LIMITEDDEFLAGENDEFLACORT6MGSYNOKEM PHARMACEUTICALS LIMITED-SYNOKEM 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 BLISTER03/05/2023
NDA/MAL/HDP/10859AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDPERFORMA 5% EXTRAMINOXIDIL5G/100MLAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | TOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML BOTTLE03/05/2023
NDA/MAL/HDP/10860ASPIRO PHARMA LIMITEDAIVEEN (U) LIMITEDYESOM 40ESOMEPRAZOLE SODIUM40MGASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X5.0 ML VIAL (CLEAR GLASS VIAL)03/05/2023
NDA/MAL/HDP/10862MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBIFRIL 7.5MGZOFENOPRIL CALCIUM7.5MGA. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL-VIA CAMPO DI PILE 67100 L'AQUILA (AQ) | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X12.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10863ABBOTT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDBETASERC 24BETAHISTINE DIHYDROCHLORIDE24MGMYLAN LABORATORIES SAS-ROUTE DE BELLEVILLE, LIEU DIT MAILLARD, 01400 CHATILLON-SUR-CHALARONNE, FRANCE | FRANCE | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER03/05/2023
NDA/MAL/HDP/10865MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDLOREZELORATADINE10MGMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X5.0X1.0X1.0X10.0 CAPSULE BLISTER02/06/2023
NDA/MAL/HDP/10866LES LABORATOIRES SERVIERHARLEYS UGANDA LIMITEDCOVERSYL 10MGPERINDOPRIL ARGININE10MGSERVIER 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/10867LES LABORATOIRES SERVIERHARLEYS UGANDA LIMITEDCOVERSYL 5 MGPERINDOPRIL ARGININE5MGSERVIER 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/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2013
NDA/MAL/HDP/10873MARCYRL PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTORSAMOLEX 10MGTORSEMIDE10 MGMARCYRL 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 BLISTER17/08/2023
NDA/MAL/HDP/10874: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDPAN IVPANTOPRAZOLE SODIUM40MGEAST AFRICAN (INDIA) OVERSEAS-PLOT 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/10877CTK BIOTECH, INC.ABACUS PHARMA (AFRICA) LIMITEDRABEGUARD IVRABEPRAZOLE SODIUM20 MG/VIALRATNAMANI HEALTHCARE PRIVATE LIMITED-SURVEY NO. 750/1, AHMEDABAD - MEHSANA HIGHWAY, VILLAGE-INDRAD, NR. CHHATRAL G.I.D.C., TALUKA-KADI, DIST-MEHSANA, PIN-382721 (NG), GUJARAT - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 MG VIAL + 1*10 ML WATER FOR INJECTION IN LDPE CONTAINER17/08/2023
NDA/MAL/HDP/10878LUPIN LIMITED-AIVEEN (U) LIMITEDLINEZOID 600 MG TABLETSLINEZOLID600MGLUPIN LIMITED, JAMMU-LUPIN LIMITED, EPIP,SIDCO INDUSTRIAL COMPLEX, KARTHOLI BARI BRAHMANA, JAMMU (J&K) – 181133, INDIAINDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10879LUPIN LIMITED-AIVEEN (U) LIMITEDISONIAZID TABLETS 300MGISONIAZID300MGLUPIN LIMITED -A-28/1 MIDC CHIKALTHANA AURANGABAD | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10880TABROS PHARMAHEALTHCARE LTD.HEMSAMIC CAPSULETRANEXAMIC ACID500MGTABROS PHARMA-L-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTAN | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER24/07/2023
NDA/MAL/HDP/10881MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR PR-750METFORMIN HYDROCHLORIDE750MGINVENTIA 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 BLISTER17/08/2023
NDA/MAL/HDP/10882BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDFOLIGRAF 1200 IURECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH)1200IU/VIAL (MULTIDOSE)BHARAT SERUM AND VACCINES LIMITED-PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL 1 PREFILLED SYRINGE OF DILUENT + 15 DISPOSABLE SYRINGES]17/08/2023
NDA/MAL/HDP/10883 CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDAPAGLIFLOZIN TABLETS 10 MGDAPAGLIFLOZIN PROPANEDIOL10MGCIPLA LIMITED-PLOT NOS. L-139, S-103 & M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA, 403 722 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER17/08/2023
NDA/MAL/HDP/10884ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMALOTEM 80/480MGARTEMETHER + LUMEFANTRINE80 MG + 480 MGM/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 BLISTER17/08/2023
NDA/MAL/HDP/10885MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDNEBIMAC 10NEBIVOLOL HYDROCHLORIDE10MGMACLEODS 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 BLISTER17/08/2023
NDA/MAL/HDP/10886LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCLOTRILIN-VCLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | VAGINAL CREAMS 1.0X1.0X15.0 G TUBE17/08/2023
NDA/MAL/HDP/10888M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDCOVIFORREMDESIVIR100MG/VIALASPIRO PHARMA LIMITED-SY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL17/08/2023
NDA/MAL/HDP/10890M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDZIQUANTAPRAZIQUANTEL600MGHETERO 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 CONTAINER17/08/2023
NDA/MAL/HDP/10891LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBINAFINTERBINAFINE HYDROCHLORIDE1%W/WLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE17/08/2023
NDA/MAL/HDP/10894REYOUNG PHARMACEUTICAL CO LTDBIOGEN PHARMA LIMITEDFRUSOGENFUROSEMIDE20MG/2MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE17/08/2023
NDA/MAL/HDP/10896REYOUNG PHARMACEUTICAL CO LTDBIOGEN PHARMA LIMITEDAMPIGENAMPICILLIN SODIUM + CLOXACILLIN SODIUM(250MG + 250MG)VIALREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X0.5 G VIAL17/08/2023
NDA/MAL/HDP/10897HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDDAPADAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE5MGHILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10898HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDROLIP EZE TABLETSROSUVASTATIN CALCIUM + EZETIMIBE20MG +10MGHILTON 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 BLISTER17/08/2023
NDA/MAL/HDP/10900DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDTRAMADOL DENKTRAMADOL HYDROCHLORIDE100MG/2 MLSOLUPHARM GMBH -INDUSTRIESTRASSE 3, 34212 MELSUNGEN | GERMANY | PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE17/08/2023
NDA/MAL/HDP/10903MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDBIDSIPTINVILDAGLIPTIN50MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10904MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDUROKA PLUSDUTASTERIDE + TAMSULOSIN HYDROCHLORIDE0.5MG + 0.4MGSAG MANUFACTURING S.L-CARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAIN | SPAIN | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER17/08/2023
NDA/MAL/HDP/10905BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDVERQUVO 2.5 MG TABLETVERICIGUAT2.5MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER17/08/2023
NDA/MAL/HDP/10906BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDVERQUVO 5MG TABLETVERICIGUAT5MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER17/08/2023
NDA/MAL/HDP/10907BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDVERQUVO 10 MG TABLETVERICIGUAT10MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X28.0 TABLET CONTAINER17/08/2023
NDA/MAL/HDP/10908BDR PHARMACEUTICALS INTERNATIONAL PVT LTDONCOPHARM (U) LTDLIVONIBESORAFENIB TOSYLATE20 MGBDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED-R.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 CONTAINER17/08/2023
NDA/MAL/HDP/10909NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDCADZOLECLOTRIMAZOLE1% W/WNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE17/08/2023
NDA/MAL/HDP/10910NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVI-IBUIBUPROFEN200MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10911NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIZOLEALBENDAZOLE200MG/5MLNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL LIQUID ORDINARY EMULSIONS 1.0X1.0X10.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10912NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDFLUZINECETIRIZINE DIHYDROCHLORIDE10MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10914DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDHI CEF 250CEFALEXIN MONOHYDRATE250 MGINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER17/08/2023
NDA/MAL/HDP/10915DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDDAVICEF 1 GCEFTRIAXONE SODIUM1G/VIALINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0X10.0 ML VIAL17/08/2023
NDA/MAL/HDP/10916DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDCEFOTECCEFOTAXIME SODIUM1G/VIALINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | PARENTERAL RETARD DRY VIALS 1.0X1.0X1.0 G VIAL17/08/2023
NDA/MAL/HDP/10917DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDCEFTRIAXONECEFTRIAXONE SODIUM1G/VIALINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X25.0X1.0X1.0 G VIAL17/08/2023
NDA/MAL/HDP/10918BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDESUPRONEESOMEPRAZOLE SODIUM40 MG/VIALBLISS INDASI LIFESCIENCE PRIVATE LIMITED-PLOT 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 PACK17/08/2023
NDA/MAL/HDP/10919BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSANFIXIME 400CEFIXIME TRIHYDRATE400MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER17/08/2023
NDA/MAL/HDP/10920ACINO AG.GOODMAN INTERNATIONAL LTDPARACONICA™ PLUS 500 MG/150 MGPARACETAMOL + IBUPROFEN500 MG + 150 MGSIGMA LABORATORIES PRIVATE LIMITED-PLOT NO. 6, 7, 8 TIVIM INDUSTRIAL ESTATE, TIVIM, MAPUSA-GOA 403526, INDIA.INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10921AVACARE GLOBALGOODMAN INTERNATIONAL LTDAVAFLOX 500LEVOFLOXACIN HEMIHYDRATE500 MGWORLD 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 BLISTER17/08/2023
NDA/MAL/HDP/10922LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABCLAV 1G TABLETSAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE875MG + 125MGLABORATORY & 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 BLISTER17/08/2023
NDA/MAL/HDP/10923BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDROSUSTAR 10MGROSUVASTATIN CALCIUM10MGBAROQUE PHARMACEUTICALS PVT. LTD-PLOT 192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10924BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDMETOPRIX 10METOCLOPRAMIDE10 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10925BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDHERPIRAX 200ACICLOVIR200 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10926BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACELEVO 500LEVOFLOXACIN HEMIHYDRATE500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10927BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACELEVO 750LEVOFLOXACIN HEMIHYDRATE750MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10928FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDFIX-ACEFIXIME TRIHYDRATE100MG/5MLTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X75.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10930RATNAMANI HEALTHCARE PVT. LTDJEET PHARMACEUTICALS LIMITEDDIKOPARDICLOFENAC SODIUM + PARACETAMOL50MG + 500MGRATNAMANI HEALTHCARE PRIVATE LIMITED-SURVEY NO. 750/1, AHMEDABAD - MEHSANA HIGHWAY, VILLAGE-INDRAD, NR. CHHATRAL G.I.D.C., TALUKA-KADI, DIST-MEHSANA, PIN-382721 (NG), GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10932SHREEJI CARE LIMITEDSHREEJI CARE LIMITEDCALCIGLO-LCALCIUM LACTATE300MGGLOBELA 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 CONTAINER17/08/2023
NDA/MAL/HDP/10933BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE20 MG + 160 MGBLISS GVS PHARMA LIMITED-10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X3.0 TABLET BLISTER,1.0X2.0X3.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10934FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDALERCONOLOPATADINE HYDROCHLORIDE1 MG/MLTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10935FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDSUPERPIME 1G IM/IV INJECTIONCEFEPIME HYDROCHLORIDE1 G/VIALTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL17/08/2023
NDA/MAL/HDP/10938AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATORKEY 80ATORVASTATIN CALCIUM TRIHYDRATE80 MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/1094MICRO LABS LTD LABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME 100MG/5MLMICRO 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 BOTTLE01/07/2013
NDA/MAL/HDP/10940BRAWN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDMASTIC-LCMONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE10MG + 5MGBRAWN LABORATORIES LIMITED-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10944TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TORLEVA 500MGLEVETIRACETAM500MGTORRENT 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 BLISTER17/08/2023
NDA/MAL/HDP/10945ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDXYLOPIL-2%LIDOCAINE HYDROCHLORIDE20MG/MLPSYCHOTROPICS INDIA LTD-PLOT 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/10946MACLEODS PHARMACEUTICALS LTDAIVEEN (U) LIMITEDMONTEMAC-10MONTELUKAST SODIUM10MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10947MACLEODS PHARMACEUTICALS LTDAIVEEN (U) LIMITEDOLMESAR HOLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE20 MG + 12.5 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10948WALLACE PHARMACEUTICALS PVT. LTDSTAR PHARMACEUTICALS LTDFLUCOLDPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE500 MG + 10 MG + 2 MGWALLACE PHARMACEUTICALS PVT LTD-BHATIAN, NALAGARH, DIST. SOLAN HP 174101 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X5.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10949BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCLAMOXIN-375 TABLETSAMOXICILLIN SODIUM + POTASSIUM CLAVULANATE250MG + 125 MGMEDOPHARM PVT LIMITED-NO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/10950 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDDICORATE ER 500DIVALPROEX SODIUM500 MGSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | ORAL SOLID RETARD COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10951THE UNITED PHARMACEUTICALS MFG, CO. LTD,WIDE SPECTRUM ENTERPRISES (U) LIMITEDVIVAZAC PLUSIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 25MGUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY-AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10952MINAPHARM PHARMACEUTICAL & CHEMICAL INDUSTRIESSWASTIK PHARMACEUTICAL LTDHYDROQUINEHYDROXYCHLOROQUINE SULPHATE200 MGSUNRUSE INTERNATIONAL LABS LTD-PLOT 100, LANE 5, SECTOR II, PHASE II, IDA CHERLAPALLY, HYDERABAD, TELANGANA-500051 | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10953KOPRAN LIMITEDTATA UGANDA LIMITEDLOKIT HPCLARITHROMYCIN + TINIDAZOLE + OMEPRAZOLE250 MG + 500 MG + 20 MGKOPRAN LIMITED-VILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY COMBINATION PACK COATED TABLETS 1.0X7.0X1.0X1.0X6.0 TABLET STRIP (EACH STRIP CONTAINS 2 TABLETS OF CLARITHROMYCIN + 2 TABLETS OF TINIDAZOLE + 2 CAPSULES OF OMEPRAZOLE)17/08/2023
NDA/MAL/HDP/10954RENATA LIMITEDUHAI PHARMACYFUROCEF®CEFUROXIME AXETIL500MGRENATA LIMITED, CEPHALOSPORIN PRODUCTION FACILITY (CPF)- NOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR - 1700, BANGLADESHBANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X6.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10957ORCHIDIA PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-AVAZIRTOBRAMYCIN + DEXAMETHASONE(3 MG + 1 MG)/MLORCHIDIA PHARMACEUTICAL INDUSTRIES-AL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPT | EGYPT | OPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10958ORCHIDIA PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDALPHANOVABRIMONIDINE TARTRATE0.15%W/VORCHIDIA PHARMACEUTICAL INDUSTRIES-AL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPT | EGYPT | OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10959MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDVALMACA 160/10AMLODIPINE BESYLATE + VALSARTAN10 MG + 160 MGMACLEODS 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 BLISTER17/08/2023
NDA/MAL/HDP/1096ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDARTEMETHERARTEMETHER80MG/MLSANJAR PHARMA LLP HIMATNAGAR-VIJOPUR HIGHWAY, DEDHROTA HIMATNAGAR 383 220, GUJARAT INDIAINDIA | PARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE,1.0X1.0X8.0X1.0 ML AMPOULE01/07/2014
NDA/MAL/HDP/10960AXA PARENTERALS LTDVITACARE LIMITEDAXADEX D5GLUCOSE ANHYDROUS5% W/VAXA PARENTERALS LTD-PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X100.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10961ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDLEPTROGINE 25MGLAMOTRIGINE25 MGADWIA S.A.E.-1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10962MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDDARUNAVIR/RITONAVIR TABLETS 400 MG/50 MGDARUNAVIR ETHANOLATE + RITONAVIR400 MG + 50 MGMYLAN 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 CONTAINER17/08/2023
NDA/MAL/HDP/10964RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAZIRENAZITHROMYCIN DIHYDRATE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10966EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSKYTINIB 12.5SUNITINIB MALATE12.5 MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER17/08/2023
NDA/MAL/HDP/10967EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSKYTINIB 25SUNITINIB MALATE25 MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER17/08/2023
NDA/MAL/HDP/10968HALEWOOD LABORATORIES PVT. LTD.AIVEEN (U) LIMITEDELECTRORUSH POWDER ORS BPSODIUM CHLORIDE + POTASSIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + DEXTROSE ANHYDROUS2.60 G + 1.50 G + 2.90 G + 13.50 GHALEWOOD LABORATORIES PVT. LIMITED-319, PHASE - II, GIDC, VATVA, AHMEDABAD - 382445, GUJARAT | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X20.5 G SACHET17/08/2023
NDA/MAL/HDP/10969FDC LTD AIVEEN (U) LIMITEDVITCOFOLFERROUS FUMARATE + FOLIC ACID + CYANOCOBALAMIN(100MG + 0.5MG + 5MCG)/5MLFDC LIMITED, WALUJ .-PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABAD | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10970UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDOLMETAN-H20/12.5 MGOLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE20 MG + 12.5 MGUMEDICA LABORATORIES PVT. LTD-PLOT 221-GIDC, 2ND PHASE, VAPI 396195 GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10971AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIRATAM 1000MGLEVETIRACETAM1000MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10972AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM OD 15OLANZAPINE15MGAUROBINDO PHARMA LTD, UNIT VII-SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302, | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X4.0X7.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10973SWISS PARENTERALS LTD.SHREEJI PHARMACEUTICALS LIMITEDADRENALINE INJECTION BP 1MG/ML 1MLADRENALINE ACID TARTRATE1MG/MLSWISS 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 AMPOULE17/08/2023
NDA/MAL/HDP/10974EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSKYTINIB 50SUNITINIB MALATE50 MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER17/08/2023
NDA/MAL/HDP/10975VERVE HUMAN CARE LABORATORIESABACUS PHARMA (AFRICA) LIMITEDBUPIVER-HBUPIVACAINE HYDROCHLORIDE5MG/MLVERVE HUMAN CARE LABORATORIES-PLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X4.0 ML AMPOULE17/08/2023
NDA/MAL/HDP/10976SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDPARAGESICDICLOFENAC SODIUM + PARACETAMOL + CHLORZOXAZONE50 MG + 325 MG + 250 MGSAGA 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 BLISTER17/08/2023
NDA/MAL/HDP/10977BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDFIRIALTA®FINERENONE10MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10978AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDANDORIVABANRIVAROXABAN10MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES-PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10979BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDFIRIALTA®FINERENONE20MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10980 CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEFENEC PLUSMEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE250 MG + 20 MGRAVIAN LIFE SCIENCE PVT. LIMITED-PLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHAND | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10981 CIPLA LTD.QUALITY CHEMICALS LTDBUDECORT 0.5 MG RESPULESBUDESONIDE0.5 MG/ 2MLCIPLA LIMITED INDORE (UNIT 1)-PLOT 9 & 10 INDORE SPECIAL ECONOMIC ZONE, PHASE-II, PITHAMPUR, DISTRICT DHAR, PIN CODE;454775, MADHYA PRADESH | INDIA | LUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X5.0X4.0X2.0 ML AMPOULE17/08/2023
NDA/MAL/HDP/10982COMED CHEMICALS LTD.LEGIT MEDEQ 2007 LIMITEDRAPCO-DSRRABEPRAZOLE SODIUM + DOMPERIDONE20 MG + 30 MGCOMED 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 BLISTER17/08/2023
NDA/MAL/HDP/10983AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDENALAPRIL-AGIO TABLETENALAPRIL MALEATE5MGAGIO PHARMACEUTICALS LIMITED.-T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10984AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDENALAPRIL-AGIO TABLETENALAPRIL MALEATE10MGAGIO PHARMACEUTICALS LIMITED.-T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10985APEX LABORATORIES PRIVATE LIMITED NORVIK ENTERPRISES LIMITEDZINCOVIT DROPSVITAMIN 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)MLAPEX 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/10986THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.JENTIN METSITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGTHE SEARLE COMPANY LIMITED-F-319, S.I.T.E KARACHI 75530 - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10987LUPIN LIMITED-AIVEEN (U) LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG AND 300 MGLAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300 MG + 300 MGLUPIN LTD-PLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER17/08/2023
NDA/MAL/HDP/10988Y.S.P. INDUSTRIES (M) SDN. BHD.ROYAL PHARMA 2011 LIMITEDLACTULLACTULOSE670MG/MLY.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/10989M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDBINFIN 5FINASTERIDE5MGHETERO 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 BLISTER17/08/2023
NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2012
NDA/MAL/HDP/10990AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBISODAC-HF 10BISOPROLOL FUMARATE10MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10991BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDIXAROLA 10 FILM-COATED TABLETSRIVAROXABAN10MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10992BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDIXAROLA 20 FILM-COATED TABLETSRIVAROXABAN20MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10993BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDIXAROLA 15 FILM-COATED TABLETSRIVAROXABAN15MGBAYER PHARMA AG- 51368 LEVERKUSEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10994DINLAS PHARMA EPZ LIMITEDAFRICURE PHARMACEUTICALS U LIMITEDPARADOLPARACETAMOL500MGDINLAS PHARMA EPZ LIMITED-PLOT NO. LR 7149/121, MOMBASA ROAD, SYOKIMAU | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/10998ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDMOCINMOXIFLOXACIN HYDROCHLORIDE400MG/100MLABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191, KINGA | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE17/08/2023
NDA/MAL/HDP/10999MARCYRL PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDURICODROPFEBUXOSTAT80MGMARCYRL 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 BLISTER17/08/2023
NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X5.0 G TUBE01/07/2013
NDA/MAL/HDP/11000JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB SINUS PAIN NON-DROWSYPARACETAMOL + PSEUDOEPHEDRINE HYDROCHLORIDE500 + 30 MGJOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/11001UNISON PHARMACEUTICALS PVT. LTD.HARLEYS UGANDA LIMITEDAKILOS-CRACECLOFENAC200MGUNISON PHARMACEUTICALS PRIVATE LIMITED – UNIT 1-UNIT I, C/6, STEEL TOWN, OPP. NOVA PETRO, MORAIYA, TA. SANAND, DIST.: AHMEDABAD - 382213, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
NDA/MAL/HDP/11002CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDMICONA VAGINAL CREAMMICONAZOLE NITRATE2%W/WCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 2)-PLOT NO 39-41TIVIM INDUSTRIAL ESTATE, KARASWADA - MAPUSA, GOA-403526 | INDIA | VAGINAL CREAMS 1.0X1.0X40.0 G TUBE17/08/2023
NDA/MAL/HDP/11003MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDBAROLERABEPRAZOLE20MGNAPROD LIFE SCIENCES PVT. LTD-G-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X20.0 MG VIAL17/08/2023
NDA/MAL/HDP/11004FAROMED LIFESCIENCES LLPTRIDEM PHARMA UGANDA LIMITEDFAST 125PARACETAMOL125MGTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH | BANGLADESH | RECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP17/08/2023
NDA/MAL/HDP/11012COSMOS LTD.ASTRA PHARMA (U) LIMITEDCEMET 400CIMETIDINE 400MGCOSMOS LTD..-RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG 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 BLISTER01/07/2011
NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BERHAD,-LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAK | MALAYSIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/1107SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) (PAEDIATRIC))HEPATITIS B VACCINE(RDNA)10MCG /0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS 1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)01/07/2005
NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE 2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GEL DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE01/07/2013
NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OTIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
NDA/MAL/HDP/1124GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS 1.0X1.0X500.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY COMBINATION PACK TABLETS 1.0X4.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS 500MGLINCOLN PHARMACEUTICALS LIMITED-TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2012
NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL EMULSIONS 1.0X1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL LOTIONS 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2012
NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOL CLOTRIMAZOLE 1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE01/07/2005
NDA/MAL/HDP/1154 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

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INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X30.0 ML VIAL01/07/2012
NDA/MAL/HDP/1160DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA | KENYA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2009
NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE 5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2013
NDA/MAL/HDP/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY | ITALYPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON01/07/2015
NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANT DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1188ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDGMYCIN-80GENTAMYCIN SULPHATE80MG/2MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE01/07/2013
NDA/MAL/HDP/1189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75 DICLOFENAC SODIUM75MG/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 AMPOULE01/07/2013
NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE 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 CONTAINER01/07/2013
NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2011
NDA/MAL/HDP/1209MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1211ASTRA ZENECA MACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1214FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X15.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | VAGINAL SUPPOSITORIES 1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1219DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART ARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BLISTER01/07/2008
NDA/MAL/HDP/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X1.0X25.0 G TUBE01/07/1997
NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
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INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2007
NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK 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 BLISTER01/07/2014
NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK 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 BLISTER01/07/2014
NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS 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 CONTAINER01/07/1998
NDA/MAL/HDP/1255CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD | INDIA | ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR 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 TUBE01/07/2000
NDA/MAL/HDP/1265GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
NDA/MAL/HDP/1278SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY TABLETS 1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300 IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL01/07/2012
NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL01/07/2012
NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
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INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
NDA/MAL/HDP/1303MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFIBRALFINOFIBRATE200MGMICRO 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 BLISTER01/07/2013
NDA/MAL/HDP/1304MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN2MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1312 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER01/07/2007
NDA/MAL/HDP/1324MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X18.0 ML BOTTLE01/07/2005
NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS 1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)01/07/1997
NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2012
NDA/MAL/HDP/1337FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFOURTS BTHIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2016
NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2016
NDA/MAL/HDP/1343MICRO LABS LTDPHARMA VILLE LIMITEDPRAZIQUANTELPRAZIQUANTEL 600MGMICRO LABS LIMITED .,-92, SIPCOT, HOSUR 635126 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER01/07/2009
NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2009
NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY 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/1361SWISS PARENTERALS LTDSHREEJI CARE LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE01/07/2016
NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X6.0 TABLET STRIP01/07/2013
NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPAR ACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1368ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD5GLUCOSE5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/1370ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSTERILIZED WATER FOR INJECTIONWATER FOR INJECTIONNEUTRALABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE01/07/2010
NDA/MAL/HDP/1372AXA PARENTERALS LTDVITACARE LIMITEDRLLACTIC ACID + SODIUM HYDROXIDE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE(0.24 + 0.115 + 0.6 + 0.04 + 0.027)G/100MLAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/1382HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDINOX CAPSULESITRACONAZOLE100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES 1.0X7.0X4.0 CAPSULE BLISTER01/07/2012
NDA/MAL/HDP/1383HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOFEN GELKETOPROFEN2.5%W/WHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G CONTAINER01/07/2013
NDA/MAL/HDP/1384CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETS LAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA 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 BOTTLE01/07/2013
NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0X10.0 CAPSULE STRIP01/07/2004
NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR 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 BLISTER01/07/2010
NDA/MAL/HDP/1392ASTRA ZENECA MACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON01/07/1997
NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE | SWEDEN | PARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL01/07/2010
NDA/MAL/HDP/1397ASTRA ZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA PHARMACEUTICAL CO LTD.-NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSU | ASTRAZENECA SWEDEN OPERATIONS-ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE | CHINA | SWEDEN | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2001
NDA/MAL/HDP/1399CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDASTHALIN SALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER01/07/2010
NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITED PANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE LIMITED-F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | ORAL SOLID RETARD TABLETS 1.0X5.0X20.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITED PANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE LIMITED-F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA | INDIA | ORAL SOLID RETARD TABLETS 1.0X5.0X20.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN 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 BOTTLE01/07/2014
NDA/MAL/HDP/1409PHARMACTIV FZCOJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X15.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA 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 BOTTLE01/07/2014
NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2001
NDA/MAL/HDP/1419GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL 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 BLISTER01/07/2005
NDA/MAL/HDP/1427GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL01/07/1997
NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | GERMANY | SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/1441AXA PARENTERALS LTDVITACARE LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9%W/VAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL01/07/2003
NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENT EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER01/07/2014
NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X50.0 G TUBE01/07/1997
NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | PARENTERAL ORDINARY AMPOULES 1.0X3.0 ML AMPOULE01/07/1997
NDA/MAL/HDP/1456FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDSUCRAFIL O GELSUCRALFATE + OXETACAINE10MG + 0.2MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/1460VENUS REMEDIES LTDREDDYS PHARMA LIMITEDPARIN EENOXAPARIN80MGVENUS 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 SYRINGE01/07/2009
NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2015
NDA/MAL/HDP/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFAST 50MGDICLOFENAC POTASSIUM50MGMIPHARM 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 CARTON01/07/2014
NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID 20OMEPRAZOLE20MG 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 STRIP01/07/1998
NDA/MAL/HDP/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE01/07/2016
NDA/MAL/HDP/1476GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2016
NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER01/07/2001
NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | SANOFI PASTEUR S.A-2,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 NS01/07/1997
NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL01/07/2011
NDA/MAL/HDP/1488DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU | GERMANY | RECTAL SYSTEMIC ADULT SUPPOSITORIES 10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP01/07/2000
NDA/MAL/HDP/1492DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. | GERMANY | PARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE01/07/1998
NDA/MAL/HDP/1494FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/2013
NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & 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 TUBE01/07/1997
NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | LABORATE PHARMACEUTICAL INDIA LIMITED UNIT II-31, RAJBAN ROAD, NARIWALA, PAONTA SAHIB, DISTT., SIRMOUR, HIMACHAL PRADESH | CHINA | INDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE01/07/2005
NDA/MAL/HDP/1500MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA | CANADAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2008
NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALS KARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | TOPICAL EXTERNAL OTHER CREAMS 1.0X20.0 G TUBE01/07/2003
NDA/MAL/HDP/1505GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX |
FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON01/07/2007
NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2009
NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X6.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1525CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/1526FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV AMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE01/07/2012
NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO 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 BLISTER01/07/2007
NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN | PAKISTAN | PARENTERAL ORDINARY VIALS 1.0X1.0 MG VIAL01/07/2014
NDA/MAL/HDP/1535ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UINJECT CARE PARENTERALS PVT LTD-PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | INDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL01/07/2011
NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2003
NDA/MAL/HDP/1544GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X5.0X2.0X10.0 CAPSULE BLISTER01/07/1999
NDA/MAL/HDP/1554ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | INDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/1557GLAXOSMITHKLINEUNITED HEALTHCARE DISTRIBUTORS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)01/07/2010
NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/1566GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULTI-INGREDIENTMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | NULL | ORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT 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 LIMITEDSTAR PHARMACEUTICALS LTDROSUVAS 20ROSUVASTATIN20MGSUN 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 BLISTER01/07/2011
NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS 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 BLISTER01/07/2003
NDA/MAL/HDP/1577SEARLE PAKISTAN LTDHEALTHCARE LTD.SPIROMIDESPIRONOLACTONE + FRUSEMIDE50MG+20MGTHE SEARLE COMPANY-32-KM MULTAN ROAD, LAHORE | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET STRIP01/07/2005
NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN 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 BLISTER01/07/2005
NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT 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 BLISTER01/07/2005
NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS 1.0X30.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1616GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2011
NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | VAGINAL GELS AND SOLS 1.0X30.0 G TUBE01/07/2004
NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/1631AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO 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 BOTTLE01/07/2007
NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL01/07/1997
NDA/MAL/HDP/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE DUNGARAVAN LTD-KNOCKBRACK DUNGARVAN CO. WATERFORD | GRANULES INDIA LIMITED-SY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA | IRELAND | INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON01/07/2003
NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2004
NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA 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 BLISTER01/07/2002
NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2009
NDA/MAL/HDP/1656AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP01/07/2005
NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/2003
NDA/MAL/HDP/1665GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | INDIA | CHINAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1998
NDA/MAL/HDP/1675MERCK SHARP & DOHME BVSURGIPHARM (U) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA | UNITED STATES | PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)01/07/2007
NDA/MAL/HDP/1678ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MG/VIALINDASI LIFESCIENCE PRIVATE LIMITED-PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X10.0X100.0 MG VIAL01/07/2007
NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDCIPROLEBCIPROFLOXACIN500MGLEBEN 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 BLISTER01/07/2007
NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1689SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDOMESKOMEPRAZOLE20MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2010
NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2004
NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/07/2005
NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1698CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAZICIP 500AZITHROMYCIN500MGCIPLA LTD ;-VILLAGE UPPER MALPUR P.O BHUD THE NALAGARH DIST. SOLAN HIMACHAL PRADESH PIN 173205 | CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIA | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X3.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELOR CLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE01/07/2005
NDA/MAL/HDP/1704DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM 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 BLISTER01/07/2011
NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/1709REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MG OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH | MACLEODS PHARMACEUTICALS LIMITED, UNIT II-PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN - 396210 (UT) - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA 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 BOTTLE01/07/2011
NDA/MAL/HDP/1723USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMIN DROPSMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE01/07/2000
NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM | NASAL TOPICAL SPRAYS WITHOUT GAS 1.0X120.0 METERED DOSE CANNISTER01/07/2009
NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO 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 STRIP01/07/2007
NDA/MAL/HDP/1731REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/1997
NDA/MAL/HDP/1732MICRO LABS LTD LABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1999
NDA/MAL/HDP/1736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDKLERIMEDCLARITHROMYCIN 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 BLISTER01/07/2009
NDA/MAL/HDP/1739MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMELOX MELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/1743MEDOCHEMIE LTDLABOREX UGANDA LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & 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 CONTAINER01/07/1997
NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
|
SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER01/07/2006
NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS 1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)01/07/1997
NDA/MAL/HDP/1772 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN 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 BLISTER01/07/2000
NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MG 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 BLISTER01/07/2005
NDA/MAL/HDP/1777CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNUZAC 20FLUOXETINE20MGCIPLA LTD ..-PLOT NO. 910 & 15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH 454775 | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2003
NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2000
NDA/MAL/HDP/1782GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & 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 TUBE01/07/1997
NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS 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 BLISTER01/07/2005
NDA/MAL/HDP/1785BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600MG+50MG+300MGBETA 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 BLISTER01/07/1997
NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL01/07/2010
NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE10MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | VAGINAL TABLETS 1.0X1.0X6.0 PESSARY STRIP01/07/1997
NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA 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 CARTON01/07/2001
NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X8.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/1809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/1810GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
NDA/MAL/HDP/1811CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDAORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE01/07/2001
NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL OTHER OINTMENTS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2003
NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/1998
NDA/MAL/HDP/1820CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDAZICIN-250AZITHROMYCIN250MGEAST 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 BLISTER01/07/2009
NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/1997
NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2006
NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2000
NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
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INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN 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 CONTAINER01/07/2011
NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN 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 BOTTLE01/07/2013
NDA/MAL/HDP/1848LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDPARATALPARACETAMOL500MGLABORATORY & 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 BLISTER01/07/1997
NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
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UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2011
NDA/MAL/HDP/1851PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE0.438 G + 0.335 G + 0.135 G + 0.918 GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL EMULSION GELS 1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE01/07/2011
NDA/MAL/HDP/1853MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDAERIUS ORAL SOLUTIONDESLORATADINE0.5MG/ML MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA | SOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/1854ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFUROSEMIDE INJECTIONFUROSEMIDE10MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 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 AMPOULE01/07/2004
NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN 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 CONTAINER01/07/2011
NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS 1.0X5.0 ML VIAL01/07/2009
NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTD ABACUS PHARMA (AFRICA) LIMITEDSPENIV PHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2004
NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
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INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2004
NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2004
NDA/MAL/HDP/1891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 500LEVOFLOXACIN 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 BLISTER01/07/2005
NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 250LEVOFLOXACIN 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 BLISTER01/07/2012
NDA/MAL/HDP/1895GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO (PAEDIATRIC)CO-TRIMOXAZOLE100MG/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
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INDIA | ORAL SOLID ORDINARY CAPSULES 3.0X10.0 CAPSULE BLISTER01/07/2001
NDA/MAL/HDP/1900GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP01/07/2007
NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/2008
NDA/MAL/HDP/1919GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDIDERM CREAMBECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN0.025%W/W+1%W/W+0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/1999
NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA | PARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL01/07/2013
NDA/MAL/HDP/1927REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/1928STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUXALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG + 250MG +250MG +250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | PARENTERAL RETARD PRE-FILLED SYRINGES 1.0X10.8 MG IMPLANT01/07/2010
NDA/MAL/HDP/1932ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDCANDISTAT CREAMCLOTRIMAZOLE1%W/WELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
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KENYA | ORAL TOPICAL CREAMS 1.0X20.0 G TUBE01/07/2001
NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO 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 CONTAINER01/07/2005
NDA/MAL/HDP/1938YURIA-PHARM LTDPHARMA VILLE LIMITEDINFULGANPARACETAMOL10MG/MLYURIA-PHARM LLC MANUFACTURING SITE NO. 1-108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE01/07/2013
NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL01/07/2005
NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD TABLETS 1.0X25.0 TABLET CONTAINER01/07/2009
NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
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INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 10.0X10.0 TABLET STRIP01/07/1998
NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | ITALYORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER01/07/1998
NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS 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 BLISTER01/07/2011
NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | MACLEODS PHARMACEUTICALS LIMITED, UNIT VI-VILLAGE 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 BLISTER01/07/2006
NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
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INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2006
NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
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INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2005
NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
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INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACIN PARACETAMOL 500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMAC CETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1971GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN + CLOXACILLIN125 MG/5ML + 125 MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1998
NDA/MAL/HDP/1974SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTILCEFUROXIME AXETIL500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
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INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2007
NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID | SPAIN | ORAL SOLID ORDINARY TABLETS 2.0X2.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/1987FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOMYCETINCHLORAMPHENICOL250MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
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INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
NDA/MAL/HDP/1989FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2014
NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X2.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/1997GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X1000.0 TABLET JAR (WITH STATEMENT "FOR HOSPITAL USE ONLY".)01/07/2011
NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER01/07/2000
NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | ORAL SOLID RETARD TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER01/07/2000
NDA/MAL/HDP/2004MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDR.B.TONEFERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MGMEDLEY PHARMACEUTICALS LTD-PLOT 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 BLISTER01/07/2008
NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2008GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- CREAMCLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM1%W/W + 0.025%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2004
NDA/MAL/HDP/2012GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- LOTIONCLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE1%W/V + 0.025%W/VGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL LOTIONS 1.0X15.0 ML BOTTLE01/07/2004
NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE01/07/2009
NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2000
NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2019GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2024TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.NEXPRO - 40ESOMEPRAZOLE MAGNESIUM TABLET40MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2004
NDA/MAL/HDP/2025REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X7.0 CAPSULE BLISTER01/07/2005
NDA/MAL/HDP/2029ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCHLORAMPHENICOL PALMITATECHLORAMPHENICOL PALMITATE125MG/5MLMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
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INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2014
NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2009
NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IUELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221 | LILLY FRANCE SA-FRANCE | FRANCE | UNITED STATES OF AMERICAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE01/07/1998
NDA/MAL/HDP/2040AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MG AJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | 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 BLISTER01/07/2006
NDA/MAL/HDP/2047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDRITONAVIRRITONAVIR100MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
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INDIA | ORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE01/07/2011
NDA/MAL/HDP/2055SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDARTESUNARTESUNATE120MGGUILIN 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 CHLORIDE01/07/2011
NDA/MAL/HDP/2056WOCKHARDT LTDSTAR PHARMACEUTICALS LTDBRO-ZEDEXTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL 1.25MG+ 4 MG+50 MG+2.5 MG/5 MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | NAXPAR PHARMA PRIVATE LIMITED-182, VILLAGE GURUMAJRA, TEHSIL NALAGARH, BADDI, DIST. SOLAN (H.P), 174101 INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS 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 CONTAINER01/07/2006
NDA/MAL/HDP/2062SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN PAEDIATRIC SYRUPDEXTROMETHORPHAN HYDROBROMIDE BP + CHLORPHENIRAMINE MALEATE BP + AMMONIUM CHLORIDE BP + PSEUDOEPHEDRINE HYDROCHLORIDE BP(5MG + 2MG + 50MG + 10MG)/ 5MLBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE01/07/2006
NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL. 0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X1.0X28.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X30.0 G TUBE,1.0X100.0 G TUBE,1.0X100.0 G TUBE01/07/2010
NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2000
NDA/MAL/HDP/2073SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED)MEASLES VIRUSNOT LESS THAN 1000CCID50/ DOSESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION01/07/1997
NDA/MAL/HDP/2074GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN ORAL SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1998
NDA/MAL/HDP/2075GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2076GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMIDE FUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/2083BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBEVACPURIFIED HEPATITIS B SURFACE ANTIGEN20MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | PARENTERAL ORDINARY VIALS 1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)01/07/2015
NDA/MAL/HDP/2089HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN XR 500MGMETFORMIN HCL EXTENDED RELEASE500MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP01/07/1999
NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/2095GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER01/07/2010
NDA/MAL/HDP/2098GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2100MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDORALCON - FLEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE0.15MG + 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2104MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE/NEVIRAPINE /ZIDOVUDINE DISPERSIBLE TABLETSLAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG + 50MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
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INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X60.0 TABLET BOTTLE01/07/2009
NDA/MAL/HDP/2108ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYMOX CAPSULES 250MGAMOXYCILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
NDA/MAL/HDP/2111HETERO LABS LTD AIVEEN (U) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER01/07/2011
NDA/MAL/HDP/2112MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER01/07/2008
NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS 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 STRIP01/07/2005
NDA/MAL/HDP/2125CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBECLATE 100BECLOMETASONE100MCG/DOSECIPLA 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 CANNISTER01/07/2009
NDA/MAL/HDP/2128HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 500MGTRANEXAMIC ACID500MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | PARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE01/07/2005
NDA/MAL/HDP/2132AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLOPINAVIR/ RITONAVIRLOPINAVIR/ RITONAVIR200MG/ 50MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER01/07/2010
NDA/MAL/HDP/2133NOVO NORDISKPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | DENMARK | FRANCE | PARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL01/07/1997
NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | TOPICAL EXTERNAL SUPPOSITORIES 1.0X6.0 SUPPOSITORY STRIP01/07/2003
NDA/MAL/HDP/2140 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDAVIRANZEFAVIRENZ600MGSUN 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 CONTAINER01/07/2006
NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE01/07/2005
NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MG 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/2145FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDMETFIL 500METFORMIN500MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER01/07/2005
NDA/MAL/HDP/2147FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDDICLOFEN -50DICLOFENAC50MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE01/07/1997
NDA/MAL/HDP/2150ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN MIXTUREHUMAN INSULIN70/30 I.ULILLY 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 CARTRIDGE01/07/1997
NDA/MAL/HDP/2151USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN 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 BLISTER01/07/2000
NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN 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 BLISTER01/07/2000
NDA/MAL/HDP/2155FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDDOXEFILDOXYCYCLINE100MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2005
NDA/MAL/HDP/2170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDALSARTAN-AMLOSARTAN + AMLODIPINE50MG + 5MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/2173 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X5.0 TABLET BLISTER01/07/2003
NDA/MAL/HDP/2175CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLADONPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP01/07/2005
NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDROTARIXLIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPENOT LESS THAN 10? CCID?? OF THE RIX4414 STRAINGLAXOSMITHKLINE AUSTRALIA.-GLAXOSMITHKLINE AUSTRALIA, 1061 MOUNTAIN HIGHWAY, BORONIA, VICTORIA, 3155 AUSTRALIA | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | AUSTRALIAORAL 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 ONLY01/07/2009
NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE01/07/1997
NDA/MAL/HDP/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081 | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2214ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDGENTAMICIN INJECTIONGENTAMICIN SULPHATE40MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE01/07/2007
NDA/MAL/HDP/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDE METOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE01/07/2005
NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER,1.0X2.0X15.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2224VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 500AMOXICILLIN500MGVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X10.0X5.0 G SACHET01/07/2004
NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | LUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X4.0X5.0X2.0 ML VIAL01/07/2011
NDA/MAL/HDP/2235WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-NINSULIN HUMAN(RECOMBINANT DNA ORIGIN)100IU/MLWOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA | INDIA | PARENTERAL ORDINARY S C VIALS 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL01/07/2006
NDA/MAL/HDP/2237WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-30/70INSULIN HUMAN(RECOMBINANT DNA ORIGIN)100I.U/MLWOCKHARDT 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 VIAL01/07/2006
NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL SYRUPCARBAMAZEPINE20MG/MLDELPHARMA 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 BOTTLE01/07/2006
NDA/MAL/HDP/2249WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-RINSULIN 100MLWOCKHARDT 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 VIAL01/07/2006
NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER01/07/2000
NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/1998
NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X70.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/2265HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIR/ LAMUVIDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG + 300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE01/07/2010
NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG+300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE01/07/2007
NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X2.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2280REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.BETADROP-NBETAMETHASONE + NEOMYCIN0.1 %W/V + 0.5 %W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS 1.0X7.5 ML VIAL01/07/1999
NDA/MAL/HDP/2281PHARMACTIV FZCOJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2282GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPRANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
NDA/MAL/HDP/2283SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA TETANUS PERTUSISDIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE>25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)01/07/1997
NDA/MAL/HDP/2290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMYLAN 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 BOTTLE01/07/2008
NDA/MAL/HDP/2293GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2005
NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE01/07/2008
NDA/MAL/HDP/2298MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MG MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/2305MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 2.5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE2.5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X3.0X35.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS 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 STRIP01/07/2005
NDA/MAL/HDP/2315MICRO LABS LTD LABOREX UGANDA LIMITEDGRAMOCEF-O-50CEFIXIME50MG/5MLMICRO 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 BOTTLE01/07/2006
NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2320GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-125 DRY SYRUPERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2006
NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCAN FLUCONAZOLE150MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X1.0 CAPSULE STRIP01/07/2007
NDA/MAL/HDP/2324SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X7.5 ML VIAL01/07/2011
NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | SWITZERLAND | TURKEYORAL 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 BLISTER01/07/2005
NDA/MAL/HDP/2333SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC)DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE>25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)01/07/1997
NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUSNLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50 SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS 1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT01/07/1997
NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE01/07/2003
NDA/MAL/HDP/2348SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) ADULTHEPATITIS B VACCINE(RDNA) ADULT20MCG/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS 1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)01/07/2005
NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION METERED-DOSE INHALER 1.0X100.0 DOSE CANNISTER01/07/2001
NDA/MAL/HDP/2352REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAY TIMEPARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE500MG+30MG+30MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X1.0X12.0 CAPSULE BLISTER01/07/2007
NDA/MAL/HDP/2353ASTRA ZENECA MACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID ORDINARY GRANULES 1.0X28.0 SACHET CARTON01/07/2013
NDA/MAL/HDP/2356GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININEQUININE DIHYDROCHLORIDE600MG/2MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2005
NDA/MAL/HDP/2360ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDFUNGISTIN PESSARIESNYSTATIN100000 IUELYS 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 CONTAINER01/07/2002
NDA/MAL/HDP/2363GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGENTAMICIN SULPHATEGENTAMICIN SULPHATE80MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 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 AMPOULE01/07/2005
NDA/MAL/HDP/2364AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/2366UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDIFICIPRO INJECTIONCIPROFLOXACIN200MG/100MLUNIQUE 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 BOTTLE01/07/2005
NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2007
NDA/MAL/HDP/2369ARISTO PHARMACEUTICALSNORVIK ENTERPRISES LIMITEDTRANLOK 500MG INJECTIONTRANEXAMIC ACID500MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X5.0X5.0 ML AMPOULE01/07/2010
NDA/MAL/HDP/2371PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIZONE CREAMFUSIDIC ACID + BETAMETHASONE VALERATE20MG/G+1MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2007
NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X1.0X7.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/2388DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM 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 BOTTLE01/07/2011
NDA/MAL/HDP/2389ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELOCIN ERYTHROMYCIN250MGELYS 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 CONTAINER01/07/2007
NDA/MAL/HDP/2390BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE80MG /640MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE01/07/2008
NDA/MAL/HDP/2394MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDSTOCRIN EFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA |CHINA | ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE01/07/2004
NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.IPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFASTUM GELKETOPROFEN 2.5%W/WA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY | ITALY | TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE01/07/2005
NDA/MAL/HDP/2397SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDVITAMAKSMULTI-INGREDIENTMULTI-INGREDIENTS KANT HEALTH CARE LTD-PLOT 1802 – 1805 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/2399 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINI MULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA | TOPICAL EXTERNAL OTHER GELS/SOLS 1.0X1.0X30.0 G TUBE01/07/2005
NDA/MAL/HDP/2401MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDENAT NATURAL VITAMIN E400IUMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2005
NDA/MAL/HDP/2411STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZPOVIDONE IODINE + METRONIDAZOLE5%W/W + 1%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE01/07/2010
NDA/MAL/HDP/2414SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1998
NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2000
NDA/MAL/HDP/2428DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WC.P.M. CONTRACTPHARMA GMBH & COMPANY KG-FRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM | GERMANY | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/1998
NDA/MAL/HDP/2429DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCLOTRI-DENK 100 VAGINALCLOTRIMAZOLE100MG 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 CARTON01/07/1998
NDA/MAL/HDP/2431ZYDUS LIFESCIENCES LIMITEDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 200BUDESONIDE + FORMOTEROL FUMARATE200MCG/ 6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON01/07/2007
NDA/MAL/HDP/2432CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 100BUDESONIDE + FORMOTEROL FUMARATE100MCG+6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER01/07/2007
NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2452REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDDELASED CHEST COUGH SYRUP (NON DROWSY)GUAIFENESIN + MENTHOL100MG/5ML + 1.1MG/5MLREGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/2459MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDP2LEVONORGESTREL0.75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X2.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2462REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDHISTALIN SYRUPCHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE1.0MG+ 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 JERRYCAN01/07/1997
NDA/MAL/HDP/2471GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.1% NASAL DROPSXYLOMETAZOLINE0.1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | NASAL SYSTEMIC DROPS 1.0X10.0 ML BOTTLE01/07/2003
NDA/MAL/HDP/2473MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE01/07/2001
NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2003
NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2492FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDPROFIL 25PROMETHAZINE HYDROCHLORIDE25MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER01/07/1997
NDA/MAL/HDP/2497CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIMUNE NEVIRAPINE50MG/5MLCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA |
INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2004
NDA/MAL/HDP/2502ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDPROBETA N EYE DROPBETAMETHASONE + NEOMYCIN0.1%W/V+0.5%W/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | OPHTHALMIC DROPS 1.0X7.5 ML VIAL01/07/1997
NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCINPARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL500MG+ 2MG+ 2MG + 30MGLINCOLN PHARMACEUTICALS LIMITED-TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET STRIP01/07/2008
NDA/MAL/HDP/2507CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEXERMET 1000METFORMIN HCL1000MGCIPLA LIMITED ,.,.-VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 | CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDOPELE LOTIONBENZYL BENZOATE25%W/VBETA 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 BOTTLE01/07/1997
NDA/MAL/HDP/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/MLWUHAN 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 AMPOULE01/07/2009
NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2521MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD-PLOT 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 BLISTER01/07/2005
NDA/MAL/HDP/2525DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID RETARD TABLETS 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/1998
NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | VAGINAL COMBINATION PACK TABLETS 1.0X1.0 PESSARY BLISTER + 1*20G TUBE01/07/2009
NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE01/07/1997
NDA/MAL/HDP/2529B & O PHARM ZACTRIDEM PHARMA UGANDA LIMITEDG-CEFTRIACEFTRIAXONE1GCHINA 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 CARTON01/07/2012
NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA 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 BLISTER01/07/2005
NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP01/07/2003
NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE 40MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP01/07/2005
NDA/MAL/HDP/2556GILEAD SCIENCES INCMEDICAL ACCESS (UGANDA) LIMITEDTRUVADAEMTRICITABINE/TENOFOVIR200MG/300MGPATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9
COUNTRY: CANADA
| TAKEDA GMBH-16515 ORANIENBURG GERMANY
CANADA | GERMANYORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2005
NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGS.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 BLISTER01/07/1997
NDA/MAL/HDP/2575HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MYTEKAMONTELUKAST SODIUM10MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMAGNOMINT TABLETSALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE125MG + 250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
NDA/MAL/HDP/2580ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDHEDON TABLETSPARACETAMOL + ASPIRIN + CAFFEINE250 MG+ 300 MG + 30 MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | MILAN LABORATORIES (INDIA) PVT LTD - -63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP01/07/1998
NDA/MAL/HDP/2593DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2594GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFEFFERROUS SULPHATE + FOLIC ACID200MG + 0.4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/2595MEDOCHEMIE LTDLABOREX UGANDA LIMITEDZEPILENCEFAZOLIN1000MGMEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.0 G VIAL01/07/2009
NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -BRUDER-GRIMM-STRABE 62, 36396, STEINAU AN DER STRABE | BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY | RECTAL SYSTEMIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP01/07/2005
NDA/MAL/HDP/2600IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDCLARIE-ODCLARITHROMYCIN(EXTENTED RELEASE)500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X1.0X7.0 TABLET BLISTER01/07/2008
NDA/MAL/HDP/2601MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 750MGCEFUROXIME 750MGMEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS 1.0X10.0X750.0 MG VIAL01/07/2009
NDA/MAL/HDP/2604USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2000
NDA/MAL/HDP/2614REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDDIALINLOPERAMIDE HCL2MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER01/07/2007
NDA/MAL/HDP/2615ASTRA ZENECA ABMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL160MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 DOSE CANNISTER,1.0X120.0 DOSE CANNISTER01/07/2001
NDA/MAL/HDP/2628MICRO LABS LTD 92 SIPCOTLABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/2641MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 250MGCEFUROXIME AXETIL250MGMEDOCHEMIE 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 STRIP01/07/2014
NDA/MAL/HDP/2642MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE (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 WFI01/07/2016
NDA/MAL/HDP/2647DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MG 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 BLISTER01/07/2005
NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -BRUDER-GRIMM-STRABE 62, 36396, STEINAU AN DER STRABE | BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY | RECTAL SYSTEMIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP01/07/2005
NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 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 BLISTER01/07/2005
NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2653BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDSONADERM-GMCLOBETASOL + MICONAZOLE + GENTAMICIN0.05%W/W + 2% W/W+ 0.1%W/WBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2007
NDA/MAL/HDP/2654MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.BEBE VITVITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B2 1500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY LIQUIDS 1.0X30.0 ML BOTTLE01/07/2006
NDA/MAL/HDP/2656ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAMINOPHYLLINEAMINOPHYLLINE100MGSCOTT-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 BLISTER01/07/2008
NDA/MAL/HDP/2661FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFUNGIFENCLOTRIMAZOLE1%W/WFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/1997
NDA/MAL/HDP/2671CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOLIN RESPULESIPRATROPIUM BROMIDE & SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA 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 VIAL01/07/2005
NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLIBITUS PLUS SYRUPTERBUTALINE/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2011
NDA/MAL/HDP/2678CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X5.0 CAPSULE BLISTER01/07/2006
NDA/MAL/HDP/2679CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDALERID SYRUPCETIRIZINE HYDROCHLORIDE5MG/5ML CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA. |
INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X30.0 ML BOTTLE01/07/2006
NDA/MAL/HDP/2690ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-250AMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2011
NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGINJECT CARE PARENTERALS PVT LTD-PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA | INDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON01/07/2011
NDA/MAL/HDP/2695FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDIDUMSTRAPARACETAMOL + IBUPROFEN + CAFFEINE325MG + 200MG + 40MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X20.0X10.0 CAPSULE BLISTER01/07/2009
NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | PARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON01/07/2012
NDA/MAL/HDP/2697REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/1997
NDA/MAL/HDP/2698CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAZICIN-500AZITHROMYCIN500MGPINNACLE 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 BLISTER01/07/2009
NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | LUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X4.0X5.0X2.0 ML VIAL01/07/2011
NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER01/07/2000
NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2715MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINELAMIVUDINE150MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1.0X60.0 TABLET CONTAINER01/07/2008
NDA/MAL/HDP/2717CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA | INDIA | OPHTHALMIC OINTMENTS 1.0X3.5 G TUBE01/07/2000
NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE01/07/2007
NDA/MAL/HDP/2723TABROS PHARMAHEALTHCARE LTD.DURAGESIC TABLETPARACETAMOL + ORPHENADRINE450MG+35MGTABROS PHARMA-L-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2726ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUININE INJECTIONQUININE DIHYDROCHLORIDE600MG/2MLWUHAN 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 AMPOULE01/07/2008
NDA/MAL/HDP/2738WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5G/10MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | PARENTERAL ORDINARY I V VIALS 1.0X5.0X10.0 ML VIAL01/07/2001
NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2001
NDA/MAL/HDP/2743BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDDUO-COTECXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGKBN- ZHEJIANG PHARMACEUTICAL CO. LTD-NO. 340 YUNHAI ROAD JIAXING ECONOMIC DEVELOPMENT ZONE, JIAXING CITY, ZHEJIANG PROVINCE | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER,1.0X30.0X9.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2746DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET BLISTER01/07/2000
NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2009
NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC 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 BLISTER01/07/2016
NDA/MAL/HDP/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTEC MISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YA | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/2760REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL14MG+6.5MG+57MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2763ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDCANDISTATCLOTRIMAZOLE100MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | VAGINAL SUPPOSITORIES 1.0X2.0X3.0 PESSARY STRIP01/07/1997
NDA/MAL/HDP/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2004
NDA/MAL/HDP/2776UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDTENSIMIN-100ATENOLOL100MGUNIQUE 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 BLISTER01/07/1997
NDA/MAL/HDP/2777NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 160/12.5MG TABLETSVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X10.0 SUPPOSITORY STRIP01/07/2006
NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125 DTAMOXICILLIN125MGMEDOPHARM 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 BLISTER01/07/2013
NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 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 CARTON01/07/2001
NDA/MAL/HDP/2800NOVO NORDISKPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDACTRAPID FLEXPEN 100 I.U/MLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK | BRAZIL | FRANCEPARENTERAL ORDINARY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN,1.0X5.0X1.5 ML PREFILLED PEN01/07/1997
NDA/MAL/HDP/2802CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2005
NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 QILIDIAN 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 BLISTER01/07/2011
NDA/MAL/HDP/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE01/07/2001
NDA/MAL/HDP/2812DAFRA PHARMA LTD MULTIPHAR UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER + LUMEFANTRINE180 MG/60ML + 1080 MG/60MLS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE01/07/2005
NDA/MAL/HDP/2813REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/1997
NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2011
NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE / METRONIDAZOLE 5%W/W / 1%W/WLINCOLN PHARMACEUTICALS LIMITED-TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE,1.0X125.0 G TUBE01/07/2011
NDA/MAL/HDP/2837FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDGRAMOFIL TABLETSNALIDIXIC ACID500MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2838MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 120CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE120MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2010
NDA/MAL/HDP/2850MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM20MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT | PARENTERAL ORDINARY AMPOULES 1.0X2.0X3.0X1.0 ML AMPOULE01/07/2007
NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY DRY VIALS 1.0X0.5 ML VIAL (1 DOSE)01/07/2010
NDA/MAL/HDP/2875GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.05% NASAL DROPSXYLOMETAZOLINE0.05%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND | NASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE01/07/2003
NDA/MAL/HDP/2885MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDFORECOX-TRACRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER01/07/2005
NDA/MAL/HDP/2891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2892UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDNICARDIA-20 TABLETSNIFEDIPINE20MGUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.
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INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2893DAWA LIMITEDSUPER MEDIC LTDSTOPACID SUSPENSIONMAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE250MG/5ML + 120MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2009
NDA/MAL/HDP/2894EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMUCOGEL SUSPENSIONDRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE 8G/100ML + 2G/100ML + 0.2 G/100MLEGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X125.0 ML BOTTLE01/07/2005
NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2006
NDA/MAL/HDP/2900MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-200CEFIXIME 200MGMICRO 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 BLISTER01/07/2005
NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS 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 STRIP01/07/2005
NDA/MAL/HDP/2905EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDBRONCHOPHANE SYRUPGUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN50MG+7.5MG+5MG+4.58MGORCHIDIA-10TH STREET RAMADAN CITY, FIST INDUSTRIES ARE | EGYPT | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X125.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/2906MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDRIFAMPICIN/ISONIAZID/ETHAMBUTOLRIFAMPICIN+ISONIAZID+ETHAMBUTOL150MG+75MG+275MGMACLEODS 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 BLISTER01/07/2012
NDA/MAL/HDP/2907BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART DSARTEMETHER + LUMEFANTRINE80 MG + 480 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER01/07/2008
NDA/MAL/HDP/2910CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTENVIR EMTENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE300MG+200MGCIPLA 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 BOTTLE01/07/2009
NDA/MAL/HDP/2914REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDCHLOROCIDE SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2917REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCETAMOL TABLETSPARACETAMOL500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP,1.0X100.0X10.0 TABLET BLISTER01/07/1997
NDA/MAL/HDP/2919CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 5MONTELUKAST5MGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
NDA/MAL/HDP/2920CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDTRANSLIPO -C CREAMCLOTRIMAZOLE1%W/WCENTAUR 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 TUBE01/07/2001
NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PVT. LTDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
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INDIA | TOPICAL EXTERNAL OTHER GELS/SOLS 1.0X20.0 G TUBE01/07/2005
NDA/MAL/HDP/2942CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDARGISSEPT CREAMCHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE0.2%W/W / 1%W/WCENTAUR 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 TUBE01/07/2005
NDA/MAL/HDP/2946GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO ORAL SUSPENSIONCO-TRIMOXAZOLE240MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/1998
NDA/MAL/HDP/2947GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO TABLETSCO-TRIMOXAZOLE480MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON01/07/1998
NDA/MAL/HDP/2948DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDMETFORMIN DENK 850METFORMIN HYDROCHLORIDE850MG 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 BLISTER01/07/2007
NDA/MAL/HDP/2951 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART FORTE TABLETSARTEMETHER + LUMEFANTRINE40 MG + 240 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X2.0X6.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2956ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRANLOK 500MG TABLETSTRANEXAMIC ACID500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/2957MEDIPHARM SALES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEDITROLCALCITRIOL0.25MCGMEGA 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 BLISTER01/07/2009
NDA/MAL/HDP/2959REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDCETAMOL SYRUPPARACETAMOL120MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
NDA/MAL/HDP/2969UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDTENSIMIN-50ATENOLOL50MGUNIQUE 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 BLISTER01/07/1997
NDA/MAL/HDP/2970USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 500METFORMIN500MGFREDUN 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 BLISTER01/07/2000
NDA/MAL/HDP/2971TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.LEFRA-20 TABLETSLEFLUNOMIDE20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/2974NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTRAVATANTRAVOPROST4µG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS 1.0X2.5 ML VIAL01/07/2009
NDA/MAL/HDP/2979ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N CREAMBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/1997
NDA/MAL/HDP/2980BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART TABLETSARTEMETHER + LUMEFANTRINE20 MG + 120 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X3.0X6.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2982CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDNEURO-FORTE TABLETSVITAMIN B1 + VITAMIN B6 + VITAMIN B12200MG + 50MG + 1MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/2983CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFUCOL 200FLUCONAZOLE200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | CIPLA LTD KURKUMBH-D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALUKA-DAUND, PUNE, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X5.0X1.0X4.0 CAPSULE BLISTER01/07/2004
NDA/MAL/HDP/2985SANOFI 410 THALESLABOREX UGANDA LIMITEDEPILIM CHRONOSODIUM VALPROATE PH. EUR500MGSANOFI WINTHROP INDUSTRIE-1,RUE DE LA VIERGE ,AMBARES ET LAGRAVE 33565,CARBON BLANC CEDEX FRANCE | FRANCE | ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2004
NDA/MAL/HDP/2990MICRO LABS LTD LABOREX UGANDA LIMITEDPULMOCEF-500CEFUROXIME AXETIL USP500MGMICRO 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 BLISTER01/07/2004
NDA/MAL/HDP/2995GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGALLOP LOPERAMIDE HYDROCHLORIDE USP2MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER01/07/2007
NDA/MAL/HDP/2997MEDLEY PHARMACEUTICALS EUROPA HEALTHCARE (U) LTDACENAC TABLETSACECLOFENAC100 MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/2998MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDFITIN-5LEVOCETIRIZINE DIHYDROCHLORIDE5MGMEDLEY PHARMACEUTICALS LTD-PLOT 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 BLISTER01/07/2009
NDA/MAL/HDP/3003GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIR ACICLOVIR 200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/3007INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDTORTAS 5TORSEMIDE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
NDA/MAL/HDP/3012WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
|
INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1998
NDA/MAL/HDP/3013GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE ALBENDAZOLE 400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/3017ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDLIDOCAINE INJECTIONLIDOCAINE HYDROCHLORIDE 20MG/MLSANJAR PHARMA LLP HIMATNAGAR-VIJOPUR HIGHWAY, DEDHROTA HIMATNAGAR 383 220, GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X25.0X20.0 ML VIAL,1.0X30.0 ML VIAL01/07/2008
NDA/MAL/HDP/3021GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGLIBENCLAMIDE TABLETSGLIBENCLAMIDE5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/3023GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAXLEVAMISOLE HYDROCHLORIDE40MGAGOG 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 CONTAINER01/07/2007
NDA/MAL/HDP/3024MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE150MG + 200MG + 300MGMYLAN 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 | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA | ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE01/07/2008
NDA/MAL/HDP/3029GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE SUSPENSIONALBENDAZOLE USP200 MG/ 5 MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/3031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMETHASONE DEXAMETHASONE0.5MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2007
NDA/MAL/HDP/3035GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFORTE TONICFERRIC AMMONIUM CITRATE + FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE + VITAMIN B1250MG + 0.55MG + 2.4MG + 1.2MG + 11MG + 2.5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/3037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT SYRUPVITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + NIACINAMIDE + VITAMIN B12 + VITAMIN C1000I.U + 200I.U + 1.5MG + 1.5MG+ 10MG + 2.5MCG + 40MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/3040GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODOX DOXYCYCLINE 100MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2007
NDA/MAL/HDP/3046GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE01/07/2009
NDA/MAL/HDP/3048GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO-DS TABLETSSULFAMETHOXAZOLE/TRIMETHOPRIM800MG/160MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2007
NDA/MAL/HDP/3051BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETROZOLEDILOXANIDE FUROATE+METRONIDAZOLE BENZOATE+SIMETHICONE125MG+160MG+25MGBETA 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 BOTTLE01/07/2005
NDA/MAL/HDP/3057GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLD-A-GO CAPSULESPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE400MG + 5MG + 12.5MG + 30MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2007
NDA/MAL/HDP/3063GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC-50DICLOFENAC SODIUM 50MGAGOG 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 BLISTER01/07/2007
NDA/MAL/HDP/3064GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTIN-TIN TABLETSTINIDAZOLE500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER,1.0X24.0X4.0 TABLET BLISTER,25.0X4.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/3067GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMAGO SYRUPPROMETHAZINE5MG/5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/3068REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.OPTACHLOR EYE DROPSCHLORAMPHENICOL0.5%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/1999
NDA/MAL/HDP/3069GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOVE CAPSULESPIROXICAM 20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER01/07/2007
NDA/MAL/HDP/3072GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL TABLETS(THANE)PARACETAMOL500 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
NDA/MAL/HDP/3076ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 40TELMISARTAN40MGARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046 | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/3077REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDUNISTEN HC CREAM CLOTRIMAZOLE + HYDROCORTISONE1%W/W + 1%W/WREGAL PHERMACUTICALS -PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYA | KENYA | TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2008
NDA/MAL/HDP/3078JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB ALLERGY CONGESTIONPARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE500MG/ 2MG/ 30MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2010
NDA/MAL/HDP/3083ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 80TELMISARTAN80MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP01/07/2007
NDA/MAL/HDP/3085GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD TABLETSPARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE500.MG+5.0MG+30.0MG+2.0MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER01/07/2007
NDA/MAL/HDP/3090PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOXCEFPODOXIME PROXETIL100MG/5MLPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA |
JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE01/07/2004
NDA/MAL/HDP/3091SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDONDIONDANSETRON2MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE01/07/2013
NDA/MAL/HDP/3092NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDEXFORGE HCT 10MG/160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE10MG + 160MG +12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER01/07/2015
NDA/MAL/HDP/3095LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDAMPHEN SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2007
NDA/MAL/HDP/3099PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDZONA 0.1% CREAMHYDROCORTISONE 17-BUTYRATE 0.1%W/WPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/07/2007
NDA/MAL/HDP/3101DAWA LIMITEDSUPER MEDIC LTDDACOLD SYRUPPARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE120MG/5ML+10MG/5ML+2MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2010
NDA/MAL/HDP/3104