Drug Register (January 2018)

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


S/n License No License Holder Local Technical Representative Drug Name Manufacturer Name Product origin Product Dosage Form Pack Size Units
NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,6 BLISTER CARTON
NDA/MAL/HHP/5508ABACUSABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALM AMRUTANJAN HEALTHCARE LTD, CHENNAI-(42-45),LUZ CHURCH ROAD, MYLAPORE, CHENNAI INDIA -600004INDIATOPICAL EXTERNAL OTHER OINTMENTS 9 G CONTAINER
NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPAJANTA PHARMA, AURANGABAD & SAVERA PHARMACEUTICAL PVT. LIMITED,H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HHP/5536ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OINTMENTS 1.2 G CONTAINER,4 G CONTAINER,9 G CONTAINER,30 G CONTAINER,1.2 ML VIAL,4 ML VIAL,9 ML VIAL,30 ML VIAL,3.5 ML VIAL,24 VIAL CARTON
NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES 2 LOZENGE STRIP,50 STRIP CARTON,10 STRIP CARTON
NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY CAPSULES 3 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HHP/5567ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW EMAMI MENTHOPLUS RELAXING BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL LIQUIDS 8 ML BOTTLE
NDA/MAL/HHP/5570PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDSITCOMPANACEA BIOTEC LTD MALPUR BADDI DIST SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS 2 BLISTER CARTON,7 TABLET BLISTER
NDA/MAL/HHP/5571ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITED PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIAINDIATOPICAL EXTERNAL OTHER OINTMENTS 5 ML CONTAINER,10 ML CONTAINER
NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 120 ML BOTTLE
NDA/MAL/HHP/5580MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA SYRUPDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITYVIETNAMORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
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 CITYTHAILANDORAL SOLID ORDINARY CAPSULES 100 BLISTER BLISTER
NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 120 ML BOTTLE
NDA/MAL/HHP/5613ANDYCO PHARMACYANDYCO PHARMACY (UGANDA) LTDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES 100 SACHET CARTON,2 G SACHET
NDA/MAL/HHP/5544BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL LOZENGESPROPYLA BIOLOGICALS PVT LTD INDIA-GAT NO. 123, PIRANGUT,TALUK-MUISH, PUNE-412108INDIAORAL SOLID ORDINARY LOZENGES 2 LOZENGE STRIP,35 STRIP CARTON
NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER REMEDIES PVT LTD/ BETA HEALTHCARE INTERNATIONAL LTD,PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYAINDIAORAL LIQUID ORDINARY LIQUIDS 120 ML BOTTLE
NDA/MAL/HHP/7936SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGILOBA 60 CAPSULESQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212BANGLADESHORAL SOLID ORDINARY CAPSULES 3 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTD GAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212BANGLADESHORAL SOLID ORDINARY CAPSULES 3 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212BANGLADESHORAL SOLID ORDINARY CAPSULES 6 STRIP CARTON,5 CAPSULE STRIP
NDA/MAL/HHP/8288HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDDIABECONHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HHP/8289HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDGERIFORTEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER
NDA/MAL/HHP/8290HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDOPTHCAREHIMALAYA DRUG COMPANY-27256287 INDIAINDIAOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HHP/8291HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDTENETEX FORTEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HHP/5593ROYAL PHARMAROYAL PHARMA 2011 LIMITEDSYDLER GRIPE WATERSYDLER REMEDIES PVT .LTD M-190, MIDC, WALUJ AURANGABAD 431 138, MAHARASHTRAINDIAORAL LIQUID ORDINARY LIQUIDS 120 ML BOTTLE
NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDTOOCHE DROPSCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 10 ML BOTTLE
NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTACHEM INDUSTRIES-INDIAINDIATOPICAL EXTERNAL OINTMENTS 20 G CONTAINER,10 G CONTAINER
NDA/MAL/HHP/5516MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDANCARE CAPSULESVITAL CARE PVT LTD-361-362 GIDC POR RAMAGANDI VADODARAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HHP/5518MAC BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS 20 G JAR
NDA/MAL/HHP/5532MACK BROWN SHURIK LTDATMANANTHAN COLD RUBMEHTA UNANI PHARMACY & CO LTD-INDIA,META UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATIINDIANASAL TOPICAL OINTMENTS 12 G CONTAINER
NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES 2 LOZENGE STRIP,35 STRIP CARTON
NDA/MAL/HHP/5556SHURIK LTDSHURIK LTDCOLD RUB VAPORIZINGMETHA UNANI PHARMACY-INDIAINDIANASAL TOPICAL EMULSION OINTMENTS 5 G CONTAINER,9 G CONTAINER,10 G CONTAINER
NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS 12 G TUBE,1 TUBE CARTON
NDA/MAL/HHP/5561MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLDDROP MEDICATED COUCH DROPSMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES 100 LOZENGE CARTON
NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDNO SCAR CREAMMETHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODAINDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,5 BLISTER CARTON
NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY POWDERS 765 MG SACHET,10 SACHET CARTON
NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 15 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDKIMSY MEDS LTDLIBLAB SYRUPDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN.JORDANORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE BLISTER,5 BLISTER CARTON
NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDDICLODAY ROLL-ONKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIAINDIATOPICAL EXTERNAL LOTIONS 50 ML BOTTLE
NDA/MAL/HHP/7958KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (GINGER FLAVOUR)KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE BLISTER,5 BLISTER CARTON
NDA/MAL/HHP/7960KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(ORANGE FLAVOUR)KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE BLISTER,5 BLISTER CARTON
NDA/MAL/HHP/7961KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(MENTHOL FLAVOUR)KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE BLISTER,5 BLISTER CARTON
NDA/MAL/HHP/7963KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(LEMON FLAVOUR)KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE BLISTER,5 BLISTER CARTON
NDA/MAL/HHP/7962GOODDAY P HARMACYL IMITEDGOOD DAY PHARMACY LIMITED BABY CARE GRIPE WATER ORAL LIQUIDKREMOINT PHARMA PVT.L TD-B 8A, ADDITIONAL AMBERNATH MIDC,AMBERNATH E, DIST, THANE 421 506, MAHARASHTRA, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 135 ML BOTTLE
NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIAINDIATOPICAL EXTERNAL LIQUIDS 50 ML BOTTLE
NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGESUNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)-NEELAM CENTRE, B WING 4TH FLOOR, HIND CYCLE ROAD, WORLI, MUMBAI 400 030, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 5 STRIP CARTON,4 TABLET STRIP
NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH (SUGAR FREE) UNIQUE PHARMACEUTICAL LABORATORIES, SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, KADAIYA, DAMAN-396210INDIAORAL SOLID ORDINARY LOZENGES 20 CONTAINER CONTAINER,50 CONTAINER CONTAINER,150 CONTAINER CONTAINER
NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGESUNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)-NEELAM CENTRE, B WING 4TH FLOOR, HIND CYCLE ROAD, WORLI, MUMBAI 400 030, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 5 STRIP CARTON,4 TABLET STRIP
NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)-NEELAM CENTRE, B WING 4TH FLOOR, HIND CYCLE ROAD, WORLI, MUMBAI 400 030, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 5 STRIP CARTON,4 TABLET STRIP
NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)-NEELAM CENTRE, B WING 4TH FLOOR, HIND CYCLE ROAD, WORLI, MUMBAI 400 030, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIATOPICAL EXTERNAL OINTMENTS 20 G CONTAINER
NDA/MAL/HHP/5630UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH REMEDYUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 100 ML BOTTLE
NDA/MAL/HHP/5623UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE STRIP,5 STRIP CARTON
NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE STRIP,5 STRIP CARTON
NDA/MAL/HHP/5631UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(LEMON)UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIAORAL SOLID ORDINARY LOZENGES 4 LOZENGE STRIP,5 STRIP CARTON

S/n Manufacturer Drug Name Strength Product Name Number Pack Sizes Dosage Form Applicant Country of Origin ltr Reason
AQUATAIN PRODUCTS PTY LTD, AUSTRALIAAQUATAIN AMF78% W/VPOLYDIMETHYLSILOXANEPHA029LIQUID1*500ML & 1*5LMCP-MOHAUSTRALIAMOH
ARYSTA LIFE SCIENCES LIMITED 12 DENYS ROAD, RIVER CLUB, 2191,PRIMIHOSMETHYL833ML/LACTELLIC 300 CS (PRIMIHOSMETHYL)PHA043LIQUID1L HDPE BOTTLEARYSTA LIFE SCIENCES LIMITEDSOUTH AFRICAORIENTAL BUSINESS GROUP LTD
ASTRAZENECA PHARMACEUTICALS [PTY] LTDTETMOSOL SOAP5% W/WMONOSULFIRAMPHA065SOAP100GASTRAZENECA PHARMACEUTICALSMCNAUGHTONSOUTH AFRICA
AVIMAR PTY LTD, 18 ASCHENBERG STREET CHAMDOR KRUGEAVI-DDT75%W/VDDT WETTABLE POWDERPHA014POWDER1* 540GAVIMAR PTY LTDSOUTH AFRICACOOPER (U) LTD
BASF,BODIPALAYAM INDIA & STI SOLFOTECNICA ITALIANAFENDONA 5WPFENDONA 5WPALPHA-CYPERMETHRINPHA017WETTABLE POWDER1X150 G SACHETSBASF,GERMANYITALYCOOPER (U) LTD
BAYER ENVIROMENTAL SCIENCE P. O BOX 143 ,ISANDO 16K-OTHRINE WG 250250DELTAMETHRINPHA018WETTABLE POWDER1X25 G SACHETSQUALITY CHEMICALS LTDSOUTH AFRICAQUALITY CHEMICALS LTD
BCS/BES QUART DE POBLET & BAYER (PTY) LTD,A-3FICAM VC800G/KGBENDIOCARBPHA023POWDER1*125G ,1*100GBAYER ENVIRONMENT SCIENCE,BAYER EAST AFRICA LTDSPAINQUALITY CHEMICALS
BEIJING BIOSEEN CROP SCIENCES CO. LTD NO.8, XHENGOTNE ROAD LIANGXIANG TOWN FANGSHAN DISTRICT, PC: 102488, CHINAFIPRONIL50GBUIDOR 5 TCPHA056LIQUID1*50GDUDU EAST AFRICACHINAAGROMART UGANDA LTD
DAINIHON JOCHUGIKU Co., Ltd, 1-4-11, Tosabori, Nishi-Ku, Osaka, 550-0001 JapanKAGAINAKUNARU-SPRAY15.8%W/V(Metofluthrin)PHA070AEROSOL SPRAY55mlDAINIHON JOCHUGIKU Co., Ltd, 1-4-11, Tosabori, Nishi-Ku, Osaka, 550-0001 JapanJAPANSARAYA EAST AFRICA LTD
ECOLAB USAVALIANT EXPRESS 3 (EXPRESS 3 + EXPRESS BLUE)3.65% (W/V) & 8.9% (V/V)SODIUM CHLORITE AND LACTI ACIDPHA027LIQUID1L +1LECOLAB USAUSAABS TCM (U) LTD
FMC CORPORATION, 1735 MARKET STREET, PHILADELPH IABISTAR 10WP () WETTABLE POWDER10%BIFENTRIN 10%PHA012WETTABLE POWDER62.5G SACHETARYSTA LIFESCIENCES SASUSABALTON (U) LTD
GREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIES 19 SUN MILLS COMPD MUMBAI 400013AQUA-SHEILD-2010% V/VHYDROGEN PEROXIDEPHA035LIQUID1*20 MLGREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIEINDIAAARON PHARMACEUTICALS LTD
INNOVATIVE RESEARCH & DEVELOPMENT (INRAD) 4 SAUDI COMPANY BLD, HELIOPOLIS, CAIROSUN ACTIVATED FORMULATED EXTRACT (SAFE) POWDERMULTI INGRIDIENTSUN ACTIVATED FORMULATED EXTRACT (SAFE)PHA 032POWDERZINNOVATIVE RESEARCH & DEVELOPMENTEGYPTPINE PHARMACY
LARCHIFARMA SRL - SS 16 ZONA INDUSTRIALE-73010 ZOLLACHI CYM P-EC ()71.4,14.3% &,4.3%PIPERONYL BUTOXIDE- 71.4%, TETRAMETHRIN 14.3% & PERMETHRIN14.3%PHA011LIQUID1*1L &1*5LLARCHIFARMA SRL - ITALYITALYNEC HEALTH WORLD
MEDENTECH LTD WHITE MILL IND. ESTATE CLONARD ROADWATERGUARD AQUATABS69.3MGSODIUM DICHLORO ISOCYANURATE TABLETSPHA001TABLET1 * 10'SMEDENTECH LTDIRELANDPACE
MITSUI CHEMICALS AGRO INCVECTRON 20WP20% W/WETOFENPROXPHA030WETTABLE POWDER FOR IRS1* 100G SACHETMITSUI CHEMICALS AGRO INCJAPANTWIGA CHEMICALS
MOSAIC CAPITAL VENTURES(UGANDA) LTD MCV PUBLIC HEALTH SOLUTIONSBORAKILL COCKROACH BAIT30%W/WBORIC ACIDPHA028PASTE1*50GMOSAIC CAPITAL VENTURES(UGANDA) LTD MCV PUBLIC HEALTH SOLUTIONSUGANDAMOSAIC CAPITAL VENTURES
NEXGEN HEALTHCARE PVT LTD, S-25, D-6 T-BLOCK M.I.DMOSUT BODY SPRAY5.06GMDIETHLYTOLUAMIDEPHA 020SPRAY1*40MLINEXGEN HEALTHCARE PVT LTDINDIAWORLD HEALTH WORKS
RENE INDUSTRIES (E.A) LTD PLOT 680, KAMULI KIREKAAQUASAFE TABLETS70MGSODIUM DICHLORO ISOCYANURATE TABLETSPHA003TABLET1*8*10 STRIPHYDRACHEM LIMITED ENGLANDUGANDAAFFORD / UHMG
SARAYA CO. LTD 2-2-8 YUZATO HIGASHISUMIYOSHI-KU OSAKA 546-0013 JAPANSARAYAN GEL SH10.1% W/VCHLORHEXIDINE GLUCONATEPHA037GEL (TOPICAL)40MLSARAYA EAST AFRICAJAPANSARAYA EAST AFRICA
SARAYA CO. LTD 2-2-8 YUZATO HIGASHISUMIYOSHI-KU OSAKA 546-0013 JAPANALSOFT SH0.1G/ 100ML (0.1W/V)CHLORHEXIDINE GLUCONATEPHA036SOLUTION (TOPICAL)1LSARAYA EAST AFRICAJAPANSARAYA EAST AFRICA
SUMITOMO CHEMICALS, KHUSUS , MALAYSIASUREDUZ MOSQUITO CANDLEMULTI INGRIDIENTSUREDUZ MOSQUITO CANDLEPHA 044CANDLEZE AND N GLOBAL NTINDAMALAYSIAE AND N GLOBAL NTINDA
SYNGENTA HUDDERSFIELD MANUFACTURING CENTER LEEDSICON 10CS10GM/100MLLAMBDA-CYHALOTHRINPHA 013LIQUID1*62,5MLSYNGENTA EAST AFRICA LTDUKTWIGA CHEMICAL INDUSTRIES (U) LIMITED
TAGROS CHEMICALS INDIA PVT LIMITE AND VESTERGAARD FRANDSEN GROUP SAPERMANETN/ADELTAMETHRIN IMPREGNATED MOSQUITO NETPHA 053ITN NETN/AVESTDERGAAD FRANDSEN GROUP S.ANETTSHOPPEINDIA
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIATEPHRA 500EC500ECTEMEPHOSPHA 052SOLUTION1*1 LITREQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROAD
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIAFINITTO GEL0.05%FIPRONILPHA 053GEL1*10GQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIAD-FENCE 25 EC2.5% W/VDELTAMETHRINPHA 050SOLUTION1*250 MLQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIAREVITAL 100CS250WGLABDACYHALOTHRIN 10%PHA 047POWDER1*160*62.5ML SACHETQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS

S/n License No License Holder Local Technical Representative Drug Name Manufacturer Name Product origin Product Dosage Form Pack Size Units
NDA/MAL/VHP/8117Cooper K-Brands LtdCEE K-BRANDS LIMITEDCooper K. Brands Ltd P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, SOOTHING OILIndia UNKNOWN OILS 100 ML Bottle,250 ML Container

S/n License No License Holder Local Technical Representative Drug Name Generic Name Strengths Manufacturer Product origin Product Form Pack Sizes
NDA/MAL/HDP/1064VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDOXOLOXALIPLATIN2MG/MLVENUS REMEDIES LTD UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY DRY VIALS 5 ML VIAL
NDA/MAL/HDP/1460VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 2 PREFILLED SYRINGE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3110VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDZYDOTUMCEFTAZIDIME / SULBACTAM1000MG / 500MGVENUS REMEDIES LTD UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS 20 ML VIAL
NDA/MAL/HDP/3254VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDROBOLDOXORUBICIN HCL50MG/25MLVENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY I V VIALS 30 ML VIAL
NDA/MAL/HDP/3452VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPAXOLPACLITAXEL USP30MG/5MLVENUS REMEDIES LTD-UNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIAINDIAPARENTERAL ORDINARY OTHER VIALS 5 ML VIAL
NDA/MAL/HDP/3462VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDPLATOLCISPLATIN INJECTION50MG/100MLVENUS REMEDIES LTD-UNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP PHASE 1 INDIAINDIAPARENTERAL ORDINARY VIALS 100 ML VIAL
NDA/MAL/HDP/3471VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPAXOLPACLITAXEL INJECTION100MG/16.7MLVENUS REMMEDIES-UNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1(EXTENSION) BHOTOLI KALAN BADDI INDIA INDIAPARENTERAL ORDINARY VIALS 20 ML VIAL
NDA/MAL/HDP/3550VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDDOXOLDOCETAXEL20MG/0.5MLVENUS REMEDIES LTD.-UNIT 11 HILL TOP INDUSTRIAL ESTATE JHARMAJRIINDIAPARENTERAL ORDINARY VIALS 7.5 ML VIAL
NDA/MAL/HDP/3573VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN-EENOXAPARIN SODIUM40MG/0.4MLVENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 2 ML PRE- FILLED SYRINGE,1 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/3586VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDDOXOLDOCETAXEL80MG/2MLVENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 20 ML VIAL
NDA/MAL/HDP/4539VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDCRISTOLVINCRISTINE SULPHATE1MGVENUS REMIDIES LTD-UNIT-11 HILL TOP INDUSTRIAL ESTATE JHARMATIINDIAPARENTERAL ORDINARY VIALS 1 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/4798VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDCITABOLGEMCITABINE2MG/MLVENUS REMEDIES LTD, UNIT 11, HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 50 ML VIAL
NDA/MAL/HDP/5162VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDIRINOLIRINOTECAN HCL TRIHYDRATE20MG/MLVENUS REMEDIES LTD UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS 2 ML VIAL
NDA/MAL/HDP/0002ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE/ NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE MUKONOUGANDAOPHTHALMIC DROPS 10 ML VIAL
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 MUKONOUGANDAOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/0080ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABWATERSTERILE WATER FOR IRRIGATIONN/AABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONOUGANDAPARENTERAL ORDINARY OTHER INFUSIONS 500 ML BOTTLE
NDA/MAL/HDP/0217ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL LIQUID ORDINARY LIQUIDS 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR200MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O.-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0225ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKON PLUSDICLOFENAC/SALICYLATE/MENTHOL/LINSEED1%W/W+10%W/W+5%W/W+3%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL EMULSION GELS 15 G CONTAINER
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, GUJARATINDIATOPICAL EXTERNAL EMULSION GELS 20 G CONTAINER
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.UGANDAOPHTHALMIC VIALS 10 ML VIAL
NDA/MAL/HDP/0491ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EYE DROPSCHLORAMPHENICOL0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAOPHTHALMIC DROPS 10 ML VIAL,5 ML VIAL
NDA/MAL/HDP/0532ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSARTAN-50LOSARTAN POTASSIUM 50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
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.INDIAOPHTHALMIC DROPS 10 ML BOTTLE
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, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 2 CAPSULE BLISTER,4 TABLET BLISTER,7 BLISTER CARTON
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, GUJARATINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
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 MUKONOUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,250 ML BOTTLE
NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,15 AMPOULE CARTON
NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN OPTHALMIC SOLUTION0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE MUKONOUGANDAOPHTHALMIC LIQUIDS 10 ML VIAL
NDA/MAL/HDP/0638ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,UGANDAOPHTHALMIC LIQUIDS 10 ML VIAL
NDA/MAL/HDP/0641ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGYNAZOLECLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL CREAMS 30 G TUBE
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.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,250 ML BOTTLE
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.UGANDAOTIC DROPS 10 ML VIAL,5 ML VIAL
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.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,250 ML BOTTLE
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.UGANDAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,10 ML AMPOULE,7.5 ML AMPOULE,10 ML AMPOULE
NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAPARENTERAL ORDINARY VIALS 100 ML VIAL
NDA/MAL/HDP/3411ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABNAL NASAL DROPSSODIUM CHLORIDE0.9%W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONOUGANDANASAL SYSTEMIC DROPS 10 ML VIAL
NDA/MAL/HDP/3866ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDRLCOMPOUND SODIUM LACTATE INFUSION BP0.6/ 0.25 /0.04 / 0.027 % W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,250 ML BOTTLE
NDA/MAL/HDP/4030ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETA- NBETAMETHASONE + NEOMYCIN0.1%W/V +0.5%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONOUGANDAOTHER SYSTEMIC DROPS 10 ML VIAL
NDA/MAL/HDP/4394ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNSSODIUM CHLORIDE0.9% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,250 ML BOTTLE
NDA/MAL/HDP/4702ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAB-TOLMANNITOL200MG/MLABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/4703ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGYLMETRONIDAZOLE500MGABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/4784ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD50GLUCOSE INTRAVENOUS INFUSION50%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/4796ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDARROWS SOLUTION (HALF STRENGTH)KCL / NACL/ NA-LACTATE0.13% / 0.20% / 0.30%ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,MUKONOUGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE
NDA/MAL/HDP/4910ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDFLUZOLFLUCONAZOLE200MGABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/6808ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGLYGEN-500METFORMIN HYDROCHLORIDE500MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE AT. & POST- KHATRAJ TAL. KALOL DIST GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6815ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCROM EYE DROPSSODIUM CROMOGLICATE2%W/VABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191 KINGA MUKONOUGANDAOPHTHALMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/7406ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDARENAADRENALINE0.1% W/V LINCOLN PARENTERAL LTD 11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE BLISTER
NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD 2, 3, 4 & 5 SECTOR -6B I.I.E SIDCUL HARIDWAR 249 403INDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPS DICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIATOPICAL EXTERNAL PRESSURISED AEROSOLS 30 ML BOTTLE
NDA/MAL/HDP/0063HETERO LABS LTDABACUS PHARMA (AFRICA) 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.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER,1 CONTAINER CARTON
NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5GALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY I V VIALS 1.5 G VIAL
NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY I V VIALS 750 MG VIAL
NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINACHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINACHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0129HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPIOGENPIOGLITAZONE HYDROCHLORIDE15MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0255HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDCAPETERO 150CAPECITABINE150MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/0270HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD. UNIT (V)SY. NO.-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0272HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0300ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAB-DOX-100DOXYCYCLINE100MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0302ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCINAMET-400CIMETIDINE400MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, JIANGSU PROVINCE CHINACHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TEC PVT LTD, PLOT NO.1 242/243/244, VILLAGE LAKHABAVAD JAMNAGER-361006 INDIINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/0400CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2 MESALAMINE DELAYED RELEASE 1.2GMCADILA HEALTHCARE LTD.KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403 401,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0481BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDERYPRO SAFE 4000RECOMBINANT HUMAN ERYTHROPOETIN ALPHA4,000 IU/MLBIOCON LTD SPECIAL ECONOMIC ZONE PLOT 2-4 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY CARTRIDGES 1 ML CARTRIDGE
NDA/MAL/HDP/0487BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDBASALOGINSULIN GLARGINE100IU/MLBIOCON LTD BIOCON SPECIAL ECONOMIC ZONE PLOT 2-4 PHASE IV BOMMASANDRA JIGANI LINK ROAD BOMMASANDRA POST BANALORE 560099INDIAPARENTERAL ORDINARY VIALS 3 ML VIAL,3 ML PRE- FILLED SYRINGE,10 ML VIAL
NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPAN 40 PANTOPRAZOLE SODIUM 40MGALKEM LABORATORIES LTD VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/0554ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINDOCAP-25INDOMETHACIN25 MG SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD, PRIVATE ECONOMY GARDEN, XINYAN JINING CITY, SHANDONG, CHINACHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0561ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDFALCIMAX-600QUININE DIHYDROCHLORIDE 600MG/2MLJIANGSU PENGYAO PHARMACEUTICAL CO LTD NO. 10 CHAQUAN ROAD YICHENG TOWN YIXING CITY JIANGSU PROVINCECHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/0578TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDXYKAA RAPIDPARACETAMOL500MGTROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0618HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 160VALSARTAN160MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE ,PLOT NO.203-213,KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,1 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0666HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDIRBIS-H 300IRBESARTAN HYDROCHLOROTHIAZIDE300MGHETERO LABS LTD (UNIT-V),SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0696HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD ( UNIT III) 22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NRABIES VACCINE BP2.5 IUCADILA HEALTHCARE LTD SARKHEJ BAVLA N.H NO. 8 A MORAIYA TAL: SANAND DIST: AHMEDABAD 382 210INDIAPARENTERAL ORDINARY VIALS 1 ML AMPOULE,1 VIAL CARTON,1 AMPOULE CARTON,1 ML VIAL
NDA/MAL/HDP/0707HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0725TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDSPASMOTROY 40DROTAVERINE HYDROCHLORIDE 40MGTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE ,TRAMADOL HYDROCHLORIDE 50MG + 50MGTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/0733CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0755TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT- DOL TRAMADOL50MG/MLTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0780CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/0796HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 5AMLODIPINE BESILATE5MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM FOR INJECTION500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100INDIAPARENTERAL ORDINARY DRY AMPOULES 1 G VIAL,50 VIAL CARTON
NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL AND PARACETAMOL 37.5MG+325MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0867HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPANTIN-20PANTOPRAZOLE SODIUM20MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROY-KPYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/MLTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 4 ML VIAL,5 AMPOULE CARTON
NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LTD B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/0937CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDVALAZYD H 92.5VALSARTAN/HYDROCHLOROTHIAZIDE80MG/12.5MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 15 ML BOTTLE
NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LTD,B-4//5/6, MIDC INDUSTRIAL AREA,PAITHAN-431 128, AURANGBAD. 9M.S)INDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,12 TABLET BLISTER
NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD ARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD B-4/5/6, MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 /67.5ARTESUNATE AND AMODIAQUINE 25MG+67.5MGAJANTA PHARMA LTD B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY OTHER AMPOULES 3 ML AMPOULE,5 AMPOULE CARTON,2.5 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/MLTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 20 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/1026BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN R INSULIN HUMAN100 IU/MLBIOCON LIMITED SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY VIALS 10 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/1027BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN ?N INSULIN HUMAN100 IU/MLBIOCON LIMITED SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY VIALS 10 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/1028BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN -30/70 INSULIN HUMAN ,INSULIN HUMAN30/70I.U/MLBIOCON LIMITED SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS 10 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,1 BLISTER CARTON,10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1147CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVALAZYDVALSARTAN80MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONTMONTELUKAST10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1166PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1188ABACUS PHARMA (A) LTDABACUS PHARMA (AFRICA) LIMITEDGMYCIN-80GENTAMYCIN SULPHATE80MG/2MLJIANGSU PENGYAO PHARMACEUTICAL COMPANY NO 10 CHAQUAN ROAD YUXING CITY & SHANDONG XIER KANGTAI PHARMACEUTICAL CO. LTD,PRIVATE ECONOMY GARDEN,XINYAN TOWN,YANZHOU CITY,SHANDONG, CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/1189ABACUS PHARMA (A) LTDABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75 DICLOFENAC SODIUM75MG/3MLJIANGSU PENGYAO PHARMACEUTICAL COMPANY NO 10 CHAQUAN ROAD YUXING CITY & SHANDONG XIER KANGTAI PHARMACEUTICAL CO. LTD,PRIVATE ECONOMY GARDEN,XINYAN TOWN,YANZHOU CITY,SHANDONG, CHINACHINAPARENTERAL RETARD I M AMPOULES 3 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/1297CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDOLMY 40OLMESARTAN40MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIOTECH PVT LTD-PLOT 1, SURVEY NO.242/234/24, VILLAGE LAKHABAVAD, POST KHODIYAR, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,10 BLISTER CARTON
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, PAKISTANPAKISTANTOPICAL EXTERNAL OINTMENTS 5 G TUBE,15 G TUBE
NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1468CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDOCIDOMEPRAZOLE20MGCADILA HEALTHCARE LIMITED SARKHEJ-BAVLA N.H NO.8A, & S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON
NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,50 VIAL CARTON
NDA/MAL/HDP/1519CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 400BUDENOSIDE + FORMOTEROL FUMARATE120 METERED DOSES (400MCG/6MCG)CADILA HEALTHCARE LTD.CADILA HEALTHCARE LTD. SARKHINDIANASAL SYSTEMIC METERED-DOSE LIQUIDS 1 CANNISTER CARTON
NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN COUNTY, SHANDONG PROVINCE 256100CHINAPARENTERAL ORDINARY DRY VIALS 50 VIAL CARTON,4 MU VIAL
NDA/MAL/HDP/1568: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAMAMOXICILLIN AND CLAVULANATE POTASSIUM156.25MGALKEM LABORATORIES LTD, PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210INDIAORAL SOLID ORDINARY GRANULES 100 ML BOTTLE
NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LTD (PAITHAN, 431128, AURANGABAD)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 2 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MGALKEMS LABORATORIES LIMITED-PLOT 167/1 MAHATMA GHANDHI, UDYOG NAGAR, DABHEL, AMALIYA DAMAN- 396 210 UTTARANCHAL, INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1684 LINCOLN PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBUN-200IBUPROFEN200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/1723ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMINMULTIVITAMINN/ASAKAR HEALTHCARE PVT LTD, BLOCK NO10-13, M.N. DESAINDIAORAL LIQUID ORDINARY DROPS 15 ML BOTTLE
NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LTD B-4/5/6 MIDC IND AREA PAITHAN 43INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,6 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1819ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCINAMET-200CIMETIDINE200MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1843USV LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
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-361006INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN/CLOXACILLIN250MG/250MGSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIOTECH PRIVATE LIMITED-PLOT NO. 1, SURVEY NO. 242/234/244,VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,100 BLISTER CARTON
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-361006INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LTD 31-0- MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1908CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 20OLMESARTAN20MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1915HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDATAZANAVIR SULPHATE + RITONAVIRATAZANAVIR SULPHATE/RITONAVIR300MG/100MGHETERO DRUGS LTD UNIT III 22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,HETERO LABS LTD (UNIT-V) SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGARINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDARTORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON,10 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2011HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDSIFE 50SILDENAFIL CITRATE50MGHETERO LABS LTD (UNIT-V) SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M)MAHABOOBNAGARINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSKAN-DIDCLOTRIMAZOLE1%W/WS KANT HEALTHCARE, 1802-1805, GIDC PHASE 111, VAPIINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/2040AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER/LUMEFANTRINE20MG/120MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,3 BLISTER CARTON,6 TABLET BLISTER,1 BLISTER CARTON,30 BLISTER CARTON,12 TABLET BLISTER,1 BLISTER CARTON,30 BLISTER CARTON,18 TABLET BLISTER,1 BLISTER CARTON,30 BLISTER CARTON,24 TABLET BLISTER,1 BLISTER CARTON,30 BLISTER CARTON
NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/WS KANT HEALTHCARE LTD, 1802-1805 GIDC PHASE 111, VAPI- 396195,GUJARATINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/2111HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD, 22-110, 1.D.A, JEEDIMETLA HYDERABAD/ HETERO LABS LTD UNIT V SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS 120 TABLET CONTAINER
NDA/MAL/HDP/2120ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDMEGAPIMECEFEPIME1GALKEM LABORATORIES LTD 167/2 MAHATMA GANDHI UDYOG NAGAR DABHEL AMALIYA DAMAN 396 210INDIAPARENTERAL ORDINARY VIALS 1 G VIAL
NDA/MAL/HDP/2151USV LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LTD 14,15,16 ZORABIAN INDUSTRIAL COMPLEX , VEOOR , PALAGHAR (EAST) , DIST THANE 401404 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2187CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDVOMIZONDANSENTRON4MG/2MLCADILA HEALTHCARE LTD SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY AMPOULES 4 ML AMPOULE,5 AMPOULE CARTON,2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTH CARE LTD KUNDAIM , INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2265HETERO DRUGS LTD ABACUS PHARMA (AFRICA) LIMITEDTENOFOVIR/ LAMUVIDINETENOFOVIR DISOPROXIL FUMARATE/ LAMUVIDINE300MG/300MGHETEROLABS LTD, UNIT III, NO 22-110 I.D.A, JEEDIMETLA, HYDERABAD / HETERO LABS LTD UNIT V SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN 500MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/2291HETERO DRUGS LTD ABACUS PHARMA (AFRICA) LIMITEDVALOVIRVALACYCLOVIR500MGHETERO LABS LTD UNIT III 22-110 IDA JEEDIMATLA HYDERABAD ZIP 500 055/ HETERO LABS LTD UNIT V SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2414SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN125MG/5MLSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/24 JAMNAGARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2431CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 200BUDENOSIDE/ FORMOTEROL FUMARATE200MCG/ 6MCGCADILA HEALTHCARE LTD. SARKHEJ-BAVLA N.H. NO 8A, MINDIALUNG ADMINISTRATION METERED-DOSE INHALER 1 CANNISTER CARTON
NDA/MAL/HDP/2432CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 100BUDENOSIDE+FORMOTEROL FUMARATE100MCG+6MCGCADILA HEALTHCARE LTD.CADILA HEALTHCARE LTD. SARKHINDIANASAL TOPICAL METERED-DOSE LIQUIDS 120 METERED DOSE CANNISTER
NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOT CLOPIDOGREL 75MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
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, PAKISTANPAKISTANOPHTHALMIC DROPS 7.5 ML VIAL
NDA/MAL/HDP/2510 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDGIROORDNIDAZOLE 500MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA PHARMA LTD B-4/5/6 MIDC IND. AREA PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2565CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZAC INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLCADILA HEALTHCARE LIMITED,PLOT NO. 417,419,420, SARKHEJ-BAVLA N.H NO.8A, VILLAGE:MORAIYA,TAL:SANAND,AHMEDABAD-382 210,INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGCADILA HEALTHCARE LTD, KUNDAIM IND. ESTATE, PONDA & S.KANT HEALTHCARE LIMITED, PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2602: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM BIDAMOXICILLIN/CLAVULANIC ACID200MG+28.5MG/5MLALKEM LABORATORIES LTD, PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210INDIAORAL SOLID RETARD GRANULES 100 ML BOTTLE
NDA/MAL/HDP/2604ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTIVITAMINZSAKAR HEALTHCARE PVT LTD, BLOCK NO10-13, M.N. DESAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/2688ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMOXYN-250AMOXICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE 256100CHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE 256100CHINAPARENTERAL ORDINARY DRY VIALS 500 MG VIAL,50 VIAL CARTON
NDA/MAL/HDP/2698CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAZICIN-500AZITHROMYCIN500MGALLY PHARMA OPTIONS PVT-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR-401506,DIST.THANE, MARAHASHTRA,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/2699CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 12.5CARVEDILOL TABLETS12.5MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/2702CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDEUGLIM 2GLIMEPIRIDE2MGCADILA HEALTH CARE LTD KUNDAIM , INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM, GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/2816CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-100 TABLETSATENOLOL100MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2827CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDR-LOCRANITIDINE25MG/MLCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/2868CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 50LOSARTAN POTASSIUM50MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,10 BLISTER CARTON,20 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2919CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 5MONTELUKAST5MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 282 210INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2941CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 20ATORVASTATIN20MGCADILA HEALTH CARE LTD KUNDAIM , INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,5 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2957MEDIPHARM SALES (E.A) LTDABACUS PHARMA (AFRICA) LIMITEDMEDITROLCALCITROL0.25MCGMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND THAILANDORAL SOLID ORDINARY CAPSULES 5 CAPSULE BLISTER,6 BLISTER CARTON
NDA/MAL/HDP/2970ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 500METFORMIN500MGFREDUN PHARMACEUTICALS LTD 14,15,16 ZORABIAN INDUSTRIAL COMPLEX , VEOOR , PALAGHAR (EAST) , DIST THANE 401404 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
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, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 5 G TUBE,15 G TUBE
NDA/MAL/HDP/3015CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA-50 TABLETSSILDENAFIL50MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3044CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPIRICAM-20 CAPSULESPIROXICAM20MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,20 CAPSULE CARTON
NDA/MAL/HDP/3105CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEPIN-E RETARDNIFEDIPINE20MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID RETARD TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/3122ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVITMULTIVITAMINZREMIDEX PHARMA PVT LTD- B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3134PANACEA BIOTEC LTD.ABACUS PHARMA (AFRICA) LIMITEDTOFF PLUSMULTI-INGREDIENTMULTI-INGREDIENTPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3177ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM CREAMBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 5 G TUBE,15 G TUBE
NDA/MAL/HDP/3249CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR-HLOSARTAN POTASSIUM / HCT50MG / 12.5MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE PONDA GOAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 BLISTER CARTON
NDA/MAL/HDP/3279ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDHAEMOFORTE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAPAKISTANORAL LIQUID ORDINARY SYRUPS 90 ML BOTTLE,250 ML BOTTLE
NDA/MAL/HDP/3305TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDSPASMOTROYDROTAVERINE HYDRCHLORIDE20MG/MLTROIKAA PHARMACEUTICALS LIMITED -THOL,DIST,MEHSANA 382728 GUJARAT PIN:382728 GUJARAT AHMEDABAD INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/3310ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDGEMFOSRISEDRONATE SODIUM35MGALKEM LABORATORIES LTD 162/2 MAHTMA GANDHI UDYOG NAGAR DABHEL DAMAN 396 210INDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3316SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/24 JAMNAGARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3356CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYCEL-100 CAPSULESCELECOXIB100MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE PONDA GOAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3372S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMUCOLEXAMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN30MG +1MG + 30MG /5MLS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3381TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDHYDROCORTISONE SODIUM SUCCINATE FOR INJECTIONHYDROCORTISONE SODIUM SUCCINATE FOR INJECTION100MG/VIALTROIKAA PHARMACEUTICALS LIMITED -THOL,DIST,MEHSANA 382728, GUJARAT, AHMEDABAD PIN:382728 GUJARAT AHMEDABAD INDIAINDIAPARENTERAL ORDINARY DRY VIALS 100 MG VIAL,10 VIAL CARTON
NDA/MAL/HDP/3431UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDNAZOL-200KETOCONAZOLE200MGALLY PHARMA OPTION PVT LTD, J-7, MIDC, TARAPUR INDUSTRIAL AREA,BOISAR 401506 DIST THANE,MEHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3450DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTRAMADEX 50TRAMADOL50MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3487ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDR-ETHERARTEMETHER80MG/MLJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAPARENTERAL ORDINARY AMPOULES 6 AMPOULE CARTON,8 AMPOULE CARTON
NDA/MAL/HDP/3515AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 40/240ARTEMETHER/LUMEFANTRINE40MG/240MGAJANTA PHARMA LTD, B-4-5-6, MIDC, INDUSTRIAL AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3517ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTOTO ZINCZINC SULPHATE 20MGMEDICAMEN BIOTECH LTD SP-1192 A & B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST ALWAR RAJASTHANINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3527AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-500LEVOFLOXACIN500MGAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3533ABACUS PHARMA (A) LTDABACUS PHARMA (AFRICA) LIMITEDLEVOZINLEVOCETRIZINE 5MGALLY PHARMA OPTIONS PVT LTD .-J-7,MIDC,TARAPUR INDUSTRIAL ALLA,BOISAR DIST-THANE,MEHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3551AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA-500MGAZITHROMYCIN500MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3569CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCARBADAC-200CARBAMAZEPINE200MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3601SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDHYDROKANTHYDROCORTISONE ACETATE1%W/WSKANT HEALTH CARE LTD -1802-1805 GIDC PHASE III VAPI GUJARATINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/3604ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAC-FENACACECLOFENAC100MGALLY PHARMA OPTION PVT LTD, J-7, MIDC, TARAPUR INDUSTRIAL AREA,BOISAR 401506 DIST THANEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3616: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZAXTERMEROPENEM1GALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY VIALS 1 G VIAL
NDA/MAL/HDP/3626REGAL PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDORIPHEX CAPSULESCEPHALEXIN250MGSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/24, SAKAR HEALTHCARE PVT. LTD 10-13, SARKHEJ-BAVLA ROAD CHANGODAR, DIST. AHMEDABAD 382 213 INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3651CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDORIPHEX SYRUPCEPHALEXIN125MG/5MLSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/24, SAKAR HEALTHCARE PVT. LTD 10-13, SARKHEJ-BAVLA ROAD CHANGODAR, DIST. AHMEDABAD 382 213 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3653AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFANARTEMETHER/LUMEFANTRINE80MG/480MGAJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA, PAITHAN 431128, DIST. AURANGABAD, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER
NDA/MAL/HDP/3663CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 10AMLODIPINE BESYLATE10MGCADILA HEALTH CARE LTD KUNDAIM , INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM, GOA-403-115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3698REGAL PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDHIPHEN SYRUPAMOXICILLIN125MG/5MLSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/24 LAKHABAVAD, JAMNAGAR-361 006, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3702AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDATORFIT-20ATORVASTATIN20MGAJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA, PAITHAN 431128, DIST. AURANGABAD, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3704CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA 100SILDENAFIL100MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3739CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDALDRENALENDRONATE70MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE , PONDA , GOA 403401 INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/3743CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 3.125 CARVEDILOL TABS3.125MGCADILA HEALTH CARE LTD KUNDAIM , INDUSTRIAL ESTATE PONDA , GOA 403401 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3787SPARSH BIO-TECH PVT LTD ABACUS PHARMA (AFRICA) LIMITEDSPENIV PHENOXYMETHYLPENICILLIN125MG/5MLSPARSH BIOTECH PVT LTD-PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD,JAMNAGAR-361006 POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006,GUJARAT, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3827AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDATORFIT-10ATORVASTATIN10MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,6 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3867ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM OINTMENTBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANORAL TOPICAL OINTMENTS 5 G TUBE,15 G TUBE
NDA/MAL/HDP/3874AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDRIDMAL 40/320DIHYDROARTEMISININ + PIPERAQUINE40MG + 320MGAJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA, PAITHAN 431128, DIST. AURANGABAD, MAHARASTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 8 TABLET BLISTER,9 TABLET BLISTER,3 TABLET BLISTER,6 TABLET BLISTER,12 TABLET BLISTER
NDA/MAL/HDP/3899AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFEDATE SYRUPSODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID216.87MG + 1.5MG + 7.5MCG + 1.5MGAJANTA PHARMA LTD 31-0 INDUSTRIAL AREA CHAKALTHANA AURANGABAD MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/3948: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME50MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3951SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN125MG/5ML + 125MG/5MLSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3960UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBUPARPARACETAMOL/IBUPROFEN325/400MGALLY PHARMA OPTIONS PVT LTD .-J-7,MIDC,TARAPUR INDUSTRIAL AREA,BOISAR DIST-THANE,MEHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3980UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDAB-TONE TONICVITAMIN B1 + VITAMIN B2 + VITMAIN B6 + VITAMIN B12 + FOLIC ACID + VITAMIN B5 + CALCIUM GLUCONATE + VITAMIN B3 + IRON + ZINC SULPHATE + COPPER SULPHATE + MANGANESE CHLORIDE + LYSINE HCL + HONEY + MALTMG PER 5ML: 5 + 1 + 1 + 5 + 50 + 2 + 20 + 10 + 10 + 3 + 0.2 + 0.25 + 20 + 100 + 100ALLY PHARMA OPTIONS PVT LTD .-J-7,MIDC,TARAPUR INDUSTRIAL AREA,BOISAR 401506 DIST THANEINDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/3983UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDEXTRADOLPARACETAMOL/CAFFEINE TABLETS500MG/65MGALLY PHARMA OPTIONS PVT-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR 401506 DIST THANE MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,2 TABLET BLISTER,50 BLISTER CARTON
NDA/MAL/HDP/4049CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDLEVODAY 500LEVOFLOXACIN HEMIHYDRATE500MGCADILA HEALTHCARE LIMITED, SWARAJ JUDDI KLAN POST,INDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON,20 BLISTER CARTON
NDA/MAL/HDP/4067CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-50 TABLETSATENOLOL50MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4123HETERO DRUGS LTD ABACUS PHARMA (AFRICA) LIMITEDNEVIRAPINENEVIRAPINE200MGHETERO LABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055/ HETERO LABS LTD UNIT V SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/4132CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDZYCELCELECOXIB200MGCADILA HEALTHCARE LIMITED KUNDAIM INDUSTRIAL ESTATE PONDA GOAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4165CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDZEFONE INJECTIONCEFTRIAXONE SODIUM1GSAKAR HEALTH CARE PVT LTD PLOT NO.10/13 SARKEJ BAVLA ROAD / ZEISS PHARMACEUTICALS PVT LTD 72 EXPORT PROMOTION INDUSTRIAL PARK , PHASE-1 ,JHARMAJRI, BADDI DIST : SOLAN H.P INDIA; REYOUNG PHARMACEUTICAL CO. LTD,NO 6, ERLANGSHAN ROAD,SHANDONG PROVINCE,CHINAINDIAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/4169CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZYD-200FLUCONAZOLE200MGCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAORAL SOLID ORDINARY CAPSULES 4 BLISTER CARTON,7 CAPSULE BLISTER
NDA/MAL/HDP/4170CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZACTRAMADOL HYDROCHLORIDE50MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4325AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDACTINAC 100ACECLOFENAC100MGAJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/4330SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDFLUCLOXACILLIN CAPSULES FLUCLOXACILLIN SODIUM 250MGSPARSH BIOTECH PVT LTD PLOT NO. 1 SURVEY NO. 242/243/244 LAKHABAVAD JAMNAGAR 361006INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,1 STRIP CARTON
NDA/MAL/HDP/4361: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME200MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4364CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZ OD 8ONDANSETRON HYDROCHLORIDE DIHYDRATE8MGCADILA HEALTHCARE LTD KUNDAIM INDUSTRIAL ESTATE PLOT NO. 203-213 KUNDAIM GOA - 403 115INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4365AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDACTINAC PLUSACECLOFENAC/PARACETAMOL100MG/500MGAJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4366SPARSH BIO-TECH PVT LTD ABACUS PHARMA (AFRICA) LIMITEDCLOXISPACLOXACILLIN250MGSPARSH BIO-TECH LTD PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/4524DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZAL 150FLUCONAZOLE150MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1 BLISTER CARTON,1 CAPSULE BLISTER
NDA/MAL/HDP/4530DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 100ATENOLOL100MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,3 BLISTER CARTON
NDA/MAL/HDP/4531DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 50ATENOLOL50MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4532DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCID 400ACICLOVIR400 MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY OTHER TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4534DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDLORYTEC 10LORATADINE10MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4535DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 250CLARITHROMYCIN250MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY COATED TABLETS 2 BLISTER CARTON,7 TABLET BLISTER
NDA/MAL/HDP/4540DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIPROLOX500CIPROFLOXACIN500MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/4542DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 500CLARITHROMYCIN500MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4556ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 375AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM250MG + 125MGALKEM LABORATORIES LTD, 167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,2 BLISTER CARTON
NDA/MAL/HDP/4568ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 625AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM500MG + 125MGALKEM LABORATORIES LTD , 167/1 , VILLAGE DHABEL DAMAN-396210 , INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/4573ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM DT 228.5MGAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM200MG + 28.5MGALKEM LABORATORIES LTD , 167/1 , VILLAGE DHABEL DAMAN-396210 , INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 10 TABLET STRIP
NDA/MAL/HDP/4577ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDMAGTAMCEFOPERAZONE / SULBACTAM500MG + 500MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/4581ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1000AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MG ALKEM LABS LTD 167/1 VIL DABHEL AMALIYA, DAMAN-396210INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP
NDA/MAL/HDP/4591S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSILVER KANTSILVER SULPHADIAZINE USP1%W/WS.KANT HEALTHCARE LTD-1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/4594CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTINIBA-500 TABLETSTINIDAZOLE500MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY TABLETS 25 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/4621CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCARVIL 6.25CARVEDILOL6.25MGCADILA HEALTH CARE LTD KUNDAIM , INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4636DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDZOLARAM 0.5ALPRAZOLAM0.5MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4677: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEFCEFUROXIME125MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 30 ML BOTTLE,70 ML BOTTLE
NDA/MAL/HDP/4678: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEF-500CEFUROXIME AXETIL500MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/4712ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEFINAL-500MEFENAMIC ACID500MGALLY PHARMA OPTIONS PVT-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR-401506,DIST.THANE, MARAHASHTRA,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4713AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEFLAMMEFENAMIC ACID50MG/5MLAJANTA PHARMA LTD 31-0, MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/4745ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPIPZOPIPERACILLIN + TAZOBACTAM4.5GALKEM LABORATORIES LTD PLOT NO. 167/1 MAHATMA GANDHI UDYOG NAGAR AMALIYA, DABHEL VILLAGE DAMAN 396 210, INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 4.5 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/4801AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDAZEL KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4887DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE200MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER
NDA/MAL/HDP/4889DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE50MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 14 CAPSULE BLISTER
NDA/MAL/HDP/4890DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE100MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER
NDA/MAL/HDP/4958TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBENZOSEDMIDAZOLAM1MG/MLTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/4962SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDBETADBETAMETHASONE DIPROPRIONATE0.05%W/WS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/5007DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCIDACYCLOVIR200MGAEGIS LTD 17 ATHINON STREET ERGATES INDUSTRIAL AREA NICOSIACYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,25 TABLET CONTAINER
NDA/MAL/HDP/5051CADILA HEALTHCARE LIMITED SARKHEJABACUS PHARMA (AFRICA) LIMITEDDERIHALERSALBUTAMOL100MCG/DOSECADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8AINDIANASAL SYSTEMIC UNIT DOSE AEROSOLS 200 METERED DOSE CANNISTER
NDA/MAL/HDP/5073CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA EYE/EAR DROPDEXAMATHASONE SODIUM PHOSPHATE/ NEOMYCIN SULPHATE0.35/ 0.1 W/VAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAOPHTHALMIC DROPS 2.5 ML BOTTLE,5 ML BOTTLE
NDA/MAL/HDP/5074CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA INJECTIONDEXAMETHASONE DISODIUM PHOSPHATE4MG/MLCADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8AINDIAPARENTERAL ORDINARY VIALS 2 ML VIAL
NDA/MAL/HDP/5075CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA TABLETSDEXAMETHASONE0.5MGCADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8A, N.H NO.8A,INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,1000 TABLET CONTAINER,10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/5128MEDIPHARM SALES LTDABACUS PHARMA (AFRICA) LIMITEDGOFEN 400 CLEARCAPIBUPROFEN400MGMEGA LIFESCIENCES LTD 384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKANTHAILANDORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,6 BLISTER CARTON
NDA/MAL/HDP/5135S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDKETOZKETOCONAZOLE2%W/WSK ANT HEALTHCARE LTD-1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIAINDIATOPICAL EXTERNAL CREAMS 30 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/5148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDBETANASE TABLETSGLIBENCLAMIDE5MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,15 BLISTER CARTON,2 BLISTER CARTON,50 TABLET BLISTER,1000 TABLET CONTAINER
NDA/MAL/HDP/5171TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDKETAMAX-50KETAMINE50MG/MLTROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 10 ML VIAL
NDA/MAL/HDP/5186TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDISOTROY 250ISOFLURANE250MLTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIANASAL SYSTEMIC UNIT DOSE LIQUIDS 250 ML BOTTLE
NDA/MAL/HDP/5211SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDDINAC GELDICLOFENAC1%W/WS.KANT HEALTHCARE LTD-1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/5226HETERO DRUGS LTD ABACUS PHARMA (AFRICA) LIMITEDEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATEEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE200MG/300MGHETERO DRUGS LTD UNIT III 22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,HETERO LABS LTD (UNIT-V) SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGARINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5284HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDEFAVIRENZ+EMTRICITABINE+TENOFOVIREFAVIRENZ,EMTRICITABINE,TENOFOVIR600MG,200MG,300MGHETERO LABS LTD UNIT V JADECHERIA (M) MAHABOOBNAGAR DIST ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5307ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDDUOTROLGLIBENCLAMIDE,METFORMIN HYDROCHLORIDE5MG,500MGFREDUN PHARMACEUTICALS LIMITED,14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5316TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPARDICLOFENAC SODIUM,PARACETAMOL50MG,500MGTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5318TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR AQ (1ML)DICLOFENAC SODIUM75MG/MLTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY AMPOULES 5 AMPOULE CARTON,1 ML AMPOULE
NDA/MAL/HDP/5319TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR SRDICLOFENAC SODIUM100MGTROIKAA PHARMACEUTICALS LTD, SARA INDUSTRIAL ESTATE SEKAQUI, DEHRADUN- 248 197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5358CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCADISTIN EXPECTORANTMULTI-INGREDIENTN/ASAKAR HEALTHCARE PLOT NO 10/13 SARKHEJ BAVLA RD, CINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/5378ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDX-VITAMULTIINGREDIENTN/AALLY PHARMA OPTIONS PVT LTD .-J-7,MIDC,TARAPUR INDUSTRIAL AREA,BOISAR DIST-THANE,MEHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 15 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/5379AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZOLANAS-30LANSOPRAZOLE30MGAJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER BLISTER,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5405CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLANDUSOLANZAPINE10MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5446ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDPHENICOL- 250CHLORAMPHENICOL250MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5473TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROYPOFOLPROPOFOL1%W/VTROIKAA PHARMACEUTICALS LTD C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY VIALS 20 ML VIAL,50 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/5497ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDEXPENBENZYLPENICILLIN 1MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAPARENTERAL ORDINARY DRY VIALS 1 MU VIAL,50 VIAL CARTON
NDA/MAL/HDP/6092SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPOTCLAV 1000AMOXICILLIN TRIHYDRATE,CLAVULANATE POTASSIUM875MG,125MGSPARSH BIO-TECH PVT. LTD-PLOT NO. 1; SURVEY NO. 242/243/244, LAKHABAVAD, JAMNAGAR-361 006, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6093SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPOTCLAV 625AMOXICILLIN TRIHYDRATE,CLAVULANATE POTASSIUM500MG,125MGSPARSH BIO-TECH PVT. LTD-PLOT NO. 1; SURVEY NO. 242/243/244,LAKHABAVAD, JAMNAGAR-361 006, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6094SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPOTCLAV 375AMOXICILLIN TRIHYDRATE,CLAVULANATE POTASSIUM250MG,125MGSPARSH BIO-TECH PVT. LTD-PLOT NO. 1; SURVEY NO. 242/243/244,LAKHABAVAD JAMNAGAR 361006INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6095S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDDIPGENBETAMETHASONE DIPROPIONATE,GENTAMICIN SULFATE0.64MG/G,1MG/GS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIATOPICAL EXTERNAL CREAMS 1 TUBE CARTON,30 G TUBE,15 G TUBE
NDA/MAL/HDP/6096ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDABGYL-200METRONIDAZOLE200MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6099ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDHARIPIL-60ARTESUNATE60MGPSYCHOTROPICS INDIA LTD PLOT NO. 12 & 12A INDUSTRIAL PARK PHASE 1 SALEMPUR MEHMOOD 2 HARIDWAR 249403 (UTTARAKHAND)INDIAPARENTERAL ORDINARY DRY VIALS 60 MG VIAL,1 VIAL CARTON
NDA/MAL/HDP/6102ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTELPRESS 80TELMISARTAN80MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6103ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDOZACE MD 5OLANZAPINE5MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6104ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDFUROSEMIDEFUROSEMIDE10MG/MLPSYCHTROPICS INDIA LTD PLOT NO.12 & 12A INDUSTRIAL PARK II PHASE 1 SALEMPUR MEHDOOD 2 HARIDWAR 249403INDIAPARENTERAL ORDINARY I V AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/6105PSYCHTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDAZOPIL 200AZITHROMYCIN200MG/5MLPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL LIQUID ORDINARY SUSPENSIONS 15 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6122 TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDROCUTROYROCURONIUM BROMIDE10MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/6123OCTOBER PHARMAABACUS PHARMA (AFRICA) LIMITEDMONOMAKISOSORBIDE NITRATE20MGOCTOBER PHARMA-1ST INDUSTRIAL ZONE STREET 25 PLOT 190 6TH OCTOBER CITY CAIROEGYPTORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6135ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTRIXONE-SCEFTRIAXONE SODIUM,SULBACTAM 1000MG,500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY VIALS 1 VIAL CARTON,20 ML VIAL
NDA/MAL/HDP/6165UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFTRISONE - 1000CEFTRIAXONE SODIUM1G/VIALAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, 249 403 INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/6167UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAKUROSEIRON SUCROSE20MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR 249 403 HARIDWAR,UTTARAKHANDINDIAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/6181UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAZINOWEL-500AZITHROMYCIN500MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RANIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6189UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDWORMEE-4ALBENDAZOLE400MGALLY PHARMA OPTIONS PVT LTD .-J-7,MIDC,TARAPUR INDUSTRIAL ALLA,BOISAR 401 506 DIST-THANE,MEHARASHTRAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6197UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDNYSTATINNYSTATIN100,000 IUALLY PHARMA OPTIONS PVT LTD .-J-7,MIDC,TARAPUR INDUSTRIAL AREA,BOISAR 401 506 DIST-THANE,MEHARASHTRAINDIAVAGINAL TABLETS 14 PESSARY STRIP,1 STRIP CARTON
NDA/MAL/HDP/6201SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDAMOXICILLIN AND FLUCLOXACILLIN CAPSULES 500MGAMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM250MG + 250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP
NDA/MAL/HDP/6207S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDGO!GELDICLOFENAC DIETHYLAMINE+METHYL SALICYLATE1.16%W/W + 10%W/WS KANT HEALTH CARE LTD-PLOT 1802 ? 1805 GIDC PHASE III VAPI GUJARAT 396195INDIATOPICAL EXTERNAL GELS AND SOLS 30 G TUBE
NDA/MAL/HDP/6209 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDRESPIWEL 4RISPERIDONE4MGAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6229SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCO-FLUAMPICIL CAPSULES BP 500MGFLUCLOXACILLIN SODIUM + AMPICILLIN TRIHYDRATE250MG +250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,1 STRIP CARTON
NDA/MAL/HDP/6237HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDLOPINAVIR/RITONAVIRLOPINAVIR/ RITONAVIR100MG/25MGHETERO LABS LTD22-110, I.D.A. JEEDIMENTHA,HYDRABAD ? 500 055, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 120 TABLET BOTTLE
NDA/MAL/HDP/6377REGAL PHARMACEUTICALS LTD ABACUS PHARMA (AFRICA) LIMITEDEPHICOL CAPSULESCHLORPHENIRAMINE MALEATE+ PARACETAMOL+ CAFFEINE ANHYDROUS+ PHENYLEPHRINE HCL 2MG+500 MG+30 MG+5MGREGAL PHARMACEUTICALS LTD PLOT NO. 7879/18 OFF BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 12 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6397MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDINDOSUPP 100INDOMETHACIN100 MGMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY STRIP,2 STRIP CARTON
NDA/MAL/HDP/6400MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDFENSUPP-100DICLOFENAC SODIUM 100MGMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY STRIP,2 STRIP CARTON
NDA/MAL/HDP/6401MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDSUPPOL 250 SUPPOSITORIESACETAMINOPHEN 250MGMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY STRIP,1 STRIP CARTON
NDA/MAL/HDP/6615UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDPINPAC 50DILOFENAC SODIUM50MGALLY PHARMA OPTIONS PVT-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR-401506,DIST.THANE, MARAHASHTRA,INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6617AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPFLUCHLOROPHENERAMINE + PARACETAMOL + VITAMIN C0.5MG + 120MG + 50MGAJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6621MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDBAROLE 20RABEPRAZOLE20MGINVENTIA HEALTHCARE PVT. LTD-FI ? FI /1 ADDITIONAL AMBERNATH(EAST) ? 421 506,MAHARASHTRA DIST. THANE, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6641UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFTISONE- SCEFTRIAXONE SODIUM + SULBACTAM SODIUM1.0G + 0.5GAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR 249 403, UTTARAKHANDINDIAPARENTERAL ORDINARY DRY VIALS 1.5 G VIAL,1 VIAL CARTON,10 ML AMPOULE,1 AMPOULE CARTON
NDA/MAL/HDP/6642UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDDIBETINMETFORMIN HYDROCHLORIDE500MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6654 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDLIVOLUK FIBRELACTULOSE + ISPAGHULA HUSK10G + 3.5G/ 15GPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL SOLID ORDINARY GRANULES 90 G CONTAINER
NDA/MAL/HDP/6663 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDSITCOMEUPHORBIA PROSTATA DRY EXTRACT10MG/GPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIATOPICAL EXTERNAL CREAMS 30 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/6664SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOX 125 KIDAMOXICILLIN TRIHYDRATE125MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.INDIAORAL SOLID ORDINARY OTHER TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6667SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOX 250 DTAMOXICILLIN TRIHYDRATE250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.INDIAORAL SOLID ORDINARY OTHER TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/6673ABACUS PHARMA (A) LTDABACUS PHARMA (AFRICA) LIMITEDTRIXONE-TZCEFTRIAXONE SODIUM + TAZOBACTAM1000MG + 125MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/6675UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNOSEMIDE -10FUROSEMIDE10MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR HARIDWAR,249 403 UTTARAKHANDINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6820ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDABBORI EAR DROPSBORIC ACID1.83%W/VABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191 KINGA MUKONOUGANDAOTIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/7674ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDABLEVOXLEVOFLOXACIN HEMIHYDRATE5G/LABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/7682ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAB-TETRA-250TETRACYCLINE250MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD NO 10 CHAQUAN ROAD YIXING JIANGSUCHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7687ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDARTIRAQUIN DIHYDROARTEMISININ+PIPERAQUINE PHOSPHATE 40MG + 320MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD NO. 10 CHAQUAN ROAD YIXING JIANGSUCHINAORAL SOLID ORDINARY TABLETS 9 TABLET BLISTER
NDA/MAL/HDP/7735AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDIBUMOL 400PARACETAMOL + IBUPROFEN 325MG + 400MGAJANTA PHARMA LTD.-B-4-5-6, MIDC PAITHAN, 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7740UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMETHICOWEL 1500METHYLCOBALAMIN1500 MCG/MLAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/7751UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNODEX COUGH SYRUPBROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE8MG + 10MG + 100MG AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT II, PLOT NO. 22, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: HARIDWAR 249 403, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/7760ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDOZACE MD 10OLANZAPINE10MGPSYCHOTROPICS INDIA LTD PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY OTHER TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7764ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTELPRESS-H 40/12.5TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY LAYERED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7912UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDGLIMEWEL M-1GLIMEPIRIDE + METFORMIN HYDROCHLORIDE1MG + 500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY LAYERED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8078AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 100/270ARTESUNATE / AMODIAQUINE100MG/ 270MGAJANTA PHARMA LTD.-B-4-5-6, MIDC INDUSTRIAL AREA PAITHAN 431128 AURANGABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,1 BLISTER CARTON,6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8087ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 4MG/2MLONDANSETRON4MG/2MLALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/8088ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 8MG/4MLONDANSETRON8MG/4MLALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY AMPOULES 4 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/8096ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDBENZALINBENZATHINE BENZYLPENICILLIN SODIUM2.4MEGA/ VIALREYOUNG PHARMACEUTICAL CO. LTD NO.6 ERLANGSHAN ROAD YIYUAN COUNTY SHANDONG PROVINCECHINAPARENTERAL ORDINARY VIALS 50 VIAL CARTON
NDA/MAL/HDP/8103UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDWELQUINE 500LEVOFLOXACIN500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/8104ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTELPRESS 40TELMISARTAN40MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8105UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDXERINLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8106UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPLENMOXIMOXIFLOXACIN HYDROCHLORIDE0.4%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.- 2,3,4 & 5 SECTOR 6B I.I.E, SIDCUL, RANIPUR,HARIDWAR 249 403, DISTRICT: UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/8107UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDWELRAB 20RABEPRAZOLE SODIUM20MGAKUMS DRUGS & PHARMACEUTICALS LTD,-19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8109ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDIRON FOLATEFERROUS IRON + FOLIC ACID65MG + 0.4MGMEDICAMEN BIOTECH LTD SP -1192 A & B PHASE IV INDUSTRIAL AREA BHIWADI 301019INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8192LINCOLN PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDL-KELFINSULPHADOXINE + PYRIMETHAMINE500MG + 25MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,3 TABLET BLISTER,25 BLISTER CARTON,3 TABLET BLISTER,50 BLISTER CARTON
NDA/MAL/HDP/8217S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMETFOKANTMETFORMIN HYDROCHLORIDE850MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8227HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDALZER 5DONEPEZIL HYDROCHLORIDE5MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8233CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCOLSTIMFILGRASTIM300?G/MLCADILA HEALTHCARE LTD PLOT SURVEY NO. 23, 25/P, 37, 40/P, 42 TO 47 SARKHEJ BAVLA N.H NO.8A OPP.RAMDEV MASALA CHANGODAR TAL. SANAND DIST AHMEDABAD 382213INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/8238MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDMETROSUPP 500METRONIDAZOLE500MGMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C KABILPORE, NAVSARI 396424 GUJARAT ,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY STRIP,2 STRIP CARTON
NDA/MAL/HDP/8275HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLETEROLETROZOLE2.5MGHETERO LABS LTD (UNIT-VI) SY. NO. 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DIST ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/8276HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDGEMTERO 1GGEMCITABINE1G/VIALHETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIAINDIAPARENTERAL ORDINARY VIALS 1 G VIAL
NDA/MAL/HDP/8277HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDGEMTERO 200MGGEMCITABINE200MGHETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIAINDIAPARENTERAL ORDINARY VIALS 200 MG VIAL
NDA/MAL/HDP/8343 TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDXYKAA EXTEND 1000PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE)325MG+675MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8346AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDADERAN 8CANDESARTAN CILEXETIL 8MGAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST: AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8353AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDNURIFER CAPSULESCARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE 100MG+1.5+15MCG+75MG+61.8MGAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST: AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8356UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLORFACT-DDESLORATIDINE5MG,AKUMS DRUGS & PHARMACEUTICALS LTD..ADDRESS: PLANT I, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: HARIDWAR, UTTARAKHAND COUNTRY: INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/8359ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDASUNATE 120ARTESUNATE + SODIUM CHLORIDE+ SODIUM BICARBONATE120MG + 0.9%W/V + 5.0%W/VABACUS PARENTERRAL DRUGS LTD BLOCK 191 PLOT NO.114 KINGA MUKONOINDIAPARENTERAL ORDINARY COMBINATION PACK AMPOULES 20 ML AMPOULE,5 ML AMPOULE,1 ML AMPOULE
NDA/MAL/HDP/0036MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDDOCETAXEL FOR INJECTION DOCETAXEL40MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506, MAHARASTRA, INDIA.INDIAPARENTERAL ORDINARY VIALS 10 ML VIAL,6 ML VIAL
NDA/MAL/HDP/0037MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDL-ASPASEL-ASPARGINASE 1000 I.UNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 ,MAHARASTRA, INDIA.INDIAPARENTERAL ORDINARY I M VIALS 10 ML VIAL
NDA/MAL/HDP/0038MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDARZI 200DACARBAZINE FOR INJECTION USP200MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 , MAHARASTRA, INDIA.INDIAPARENTERAL ORDINARY VIALS 20 ML VIAL
NDA/MAL/HDP/0039MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNZYTOPETOPOSIDE INJECTION USP100MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506, MAHARASTRA, INDIA.INDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/0042MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDCISPLATINCISPLATIN1MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506, MAHARASTRA, INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 50 ML VIAL
NDA/MAL/HDP/0044MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRO-TAXPACLITAXEL6MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506, MAHARASTRA, INDIA.INDIAPARENTERAL ORDINARY OTHER VIALS 20 ML VIAL
NDA/MAL/HDP/0046MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEM GEMCITABINE200MGNAPROD LIFE SCIENCES PVT LTD-30TH, TOWN CENTRE, ANDHERI-KURLIA ROAD, ANDERI (EAST), MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/0468NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXIT 750CEFUROXIME750MGNECTAR LIFESCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI,P.O BAROTIWALA DIST SOLAN H.P 173 205INDIAPARENTERAL ORDINARY DRY VIALS 750 MG VIAL,1 VIAL CARTON,10 ML AMPOULE
NDA/MAL/HDP/0611GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI SOLAN HIMACHAL PRADESH-173 205 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0814MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDCANCYTCYTARABINE100MG/5MLNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY VIALS 5 ML VIAL
NDA/MAL/HDP/0827GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCLANOXY 1.2 AMOXICILLIN/CLAVULANATE1000MG/200MGGALPHA LABORATORIES LTD AT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210INDIAPARENTERAL ORDINARY I V VIALS 20 ML VIAL
NDA/MAL/HDP/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFE SCIENCES LIMITED. UNIT VI, BHATOLIKALAN, P.O BAROTIKALAN, DISTT SOLAN, HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD UNIT VI BHATOLIKALAN DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFE SCIENCES LTD UNIT VI BHATOLIKALAN VILLAGE DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP
NDA/MAL/HDP/1075NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPIMECEFEPIME 1000MGNECTOR LIFE SCIENCES LTD UNIT VI BHATOLIKALAN BAROTIWALA DIST SOLAN HPINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,10 ML VIAL
NDA/MAL/HDP/1077NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECTRAMCEFTRIAXONE1GNECTAR LIFESCIENCES LTD UNIT VI BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,10 ML AMPOULE
NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI SOLAN HIMACHAL PRADESH-173 205 INDIAINDIAORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS 200 ML BOTTLE
NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUM CEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY I V VIALS 750 MG VIAL
NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1G/VIALALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/1404MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRODOX-10DOXORUBICIN HCL100MG/VIALNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/3386MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDAMBROSE 2CHLORAMBUCIL2MGNAPROD LIFE SCIENCES PVT LTD G 17 MIDC TARAPUR INDUSTRIAL AREA BIOSAR THANE MUMBAIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BOTTLE
NDA/MAL/HDP/3410MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRODOX-50DOXORUBICIN50MGNAPROD LIFE SCIENCES PVT LTD-G17 MIDC TARAPUR IND AREA THONE, MUMBAI INDIAINDIAPARENTERAL ORDINARY DRY VIALS 25 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/3685GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDODICEFCEFTRIAXONE1GALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY VIALS 1 G VIAL
NDA/MAL/HDP/4746MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEM-200GEMCITABINE200MGNAPROD LIFE SCIENCES PVT LTD-G17 MIDC TARAPUR IND AREA THONE, MUMBAI INDIAINDIAPARENTERAL ORDINARY VIALS 200 MG VIAL
NDA/MAL/HDP/5385NAPROD LIFE SCIENCES PVT LTDAIVEEN (U) LIMITEDVINROS A-1VINCRISTINE SULPHATE1MGNAPROD LIFE SCIENCES PVT LTD, G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 10 ML VIAL
NDA/MAL/HDP/6422MEDISEL(K) LTDAIVEEN (U) LIMITEDEMADONONDANSETRON4MGCORONA REMEDIES PVT LTD.-CORONA HOUSE, "C" MONDEAL BUSINESS PARK,NEAR GURUDWARA, S. G. HIGHWAY, THALTEJ,AHMEDABAD,CORONA REMEDIES PVT LTD..-VILLAGE JATOLI,POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. OLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7139LIFEPHARM FZEAIVEEN (U) LIMITEDCOLDIFED SYRUPPSEUDOEPHEDRINE DROCHLORIDE+HYTRIPROLIDINE HYDROCHLORIDE30MG+1.25MG/5MLLIFEPHARMA FZE JEBEL ALI -DUBAI UAEUNITED ARAB EMIRATESORAL LIQUID ORDINARY SYRUPS 120 ML BOTTLE
NDA/MAL/HDP/8230LIFEPHARM FZEAIVEEN (U) LIMITEDPANALIFEPARACETAMOL500MGLIFE PHARMA FZE JEBEL ALI DUBAI U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS 12 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0815NAPROD LIFE SCIENCES PVT LTDAIVEEN (U) LTD - WILSON ROADABINGEM-200GEMCITABINE200MGNAPROD LIFE SCIENCES PVT LTD G-17 MIDC TARAPUR INDUSTRIAL AREA BOISAR THANE MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 200 MG VIAL,1 VIAL CARTON
NDA/MAL/HDP/7130LIFEPHARM FZEAIVEEN (U) LTD - WILSON ROADHEMOVIT CAPSULESDRIED FERROUS SULPHATE + FOLIC ACID150MG +500MCGESKAYEF BANGLADESH LIMITED 400 SQUIBB ROAD, INDUSTRIAL AREA TONGI, GAZIPUR, BANGLADESHUNITED ARAB EMIRATESORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDDOXYLEBDOXYCYCLINE 100MGLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDPROHIBINOMEPRAZOLE20MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,10 CAPSULE STRIP,10 STRIP CARTON
NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDMETROLEB METRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD PLOT NO. L-4 PHASE III MIDC AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDAZILEB-500 AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD PLOT NO. L-4 PHASE III MIDC AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/0486LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM-SRDICLOFENAC SODIUM 100MGLEBEN LABORATORIES PVT LTD PLOT NO. L-4 PHASE III MIDC AKOLA 444 104INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD L-4 PHASE III MIDC AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0526LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDAMILEB- 25 AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0531LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDENDERM-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.INDIATOPICAL EXTERNAL CREAMS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, AKOLA 444 104 MAHARASHTRAHONG KONGORAL SOLID ORDINARY TABLETS 10 BLISTER CARTON,20 TABLET BLISTER
NDA/MAL/HDP/0877LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 170 ML BOTTLE
NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C,AKOLA 444104 MAHARASHTRA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMCOTRIMOXAZOLE (BP)240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, AKOLA 444104INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT 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.INDIAORAL LIQUID ORDINARY SUSPENSIONS 170 ML BOTTLE
NDA/MAL/HDP/1847LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/2078LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOX SYRUPCLOXACILLIN SODIUM125MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2097LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOXCLOXACILLIN250MGLEBEN LABORATORIES PVT LTD L-4 PHASE 111 MIDC AKOLA 444104 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2218LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDCHLORPROMAZINE TABLETSCHLORPROMAZINE100MGLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, AKOLA 444104 MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLIBITUS PLUS SYRUPTERBUTALIN/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD L-4 PHASE III MIDC AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3002LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDKELVINPARACETAMOL500MGLEBEN LABORATORIES LTD L-4 PHASE 111 MIDC AKOLA 444104 MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/3095LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDAMPHEN SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3104LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDNYSTALEB ORAL SUSPENSIONNYSTATIN 100000IU/MLLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/3232LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMSULFAMETHOXAZOLE + TRIMETHOPRIM400MG + 80MGLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/3535LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM-50DICLOFENAC SODIUM TABLETS BP50MGLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3784LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE2MG/5MLLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/4057LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDLAMPYAMPICILLIN250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/4086LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDKELVIN SUSPENSIONPARACETAMOL120MG/5MLLEBEN LABORATORIES PVT LTD-L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE
NDA/MAL/HDP/4093LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDBECLOMIN OINTMENTBECLOMETHASONE+MICONAZOLE+NEOMYCIN0.025%W/W + 2%W/W + 0.5%W/WLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/4095LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDIBUT-200IBUPROFEN200MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4379LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDSINURHONMULTI-INGREDIENT5MG/ 2MG/ 500MG / 30MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,6 BLISTER CARTON,40 TABLET BLISTER,12 BLISTER CARTON,500 TABLET CONTAINER
NDA/MAL/HDP/4920LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDFOLIBENFOLIC ACID5MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5109LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA ORAL SOLUTIONSALBUTAMOL2MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY OTHER LIQUIDS 100 ML BOTTLE
NDA/MAL/HDP/5320LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDINDOLINDOMETHACIN25MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 BLISTER CARTON,1000 CAPSULE CONTAINER,100 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HDP/5381LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM GELDICLOFENAC DIETHYLAMINE1.16%W/W LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,AKOLA? 444 104 (MS).INDIATOPICAL EXTERNAL OTHER GELS/SOLS 30 G TUBE
NDA/MAL/HDP/5454LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMOXILEBAMOXICILLIN125MG/5ML LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY POWDERS 100 ML BOTTLE
NDA/MAL/HDP/6118LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDL-TRIM DSSULPHAMETHOXAZOLE,TRIMETHOPRIM800MG,160MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6119 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDSUPER CVAMOXICILLIN SODIUM+POTASSIUM CLAVULANATE1G+0.2G/VIAL NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY VIALS 1.2 G VIAL,10 VIAL CARTON
NDA/MAL/HDP/6120 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDKMINEKETAMINE HYDROCHLORIDE50MG/ML NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA NEPALNEPALPARENTERAL ORDINARY VIALS 10 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/6144 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDNIKOPARACETAMOL500MG NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,100 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6166 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDGMICINGENTAMICIN SULPHATE0.3%W/V NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALOPHTHALMIC DROPS 10 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6325LEBEN LABORATORIES PVT. LTD.ANDYCO PHARMACY (UGANDA) LTDPZQ TABLETPRAZIQUANTEL600MGLEBEN LABORATORIES PVT. LTD PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7227 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDNEMADOL 50TRAMADOL HYDROCHLORIDE 50MG NATIONAL HEALTHCARE PVT. LTD. (WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPALNEPALORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7230 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDHISTABLOC 2MLRANITIDINE HYDROCHLORIDE25MG/MLNATIONAL HEALTHCARE PVT. LTD. (WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPALINDIAPARENTERAL ORDINARY VIALS 2 ML VIAL,10 VIAL CARTON
NDA/MAL/HDP/7231 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDLIGNAT 2%LIDOCAINE HYDROCHLORIDE 2% W/V NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARAINDIAPARENTERAL ORDINARY VIALS 30 ML VIAL
NDA/MAL/HDP/7708LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDLAMPYKLOX CAPSULESAMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM250MG+250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8221 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDNEMADOLTRAMADOL HYDROCHLORIDE50MG/ML NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/8320 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDSTACEF 1 GMCEFTRIAXONE SODIUM 1 GMNATIONAL HEALTHCARE PVT. LTD. (WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPALINDIAPARENTERAL ORDINARY DRY VIALS 15 ML VIAL
NDA/MAL/HDP/8329LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDARTEFLO - 40PROPANOLOL40MGLEBEN LABORATORIES PVT. LTD PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS).INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/8393 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDNACLOR EYE DROPS 10MLCHLORAMPHENICOL0.5% W/VNATIONAL HEALTHCARE PVT. LTD. (WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPALINDIAOPHTHALMIC DROPS 10 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/0025ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-5 AMLODIPINE5MGASTRA LIFECARE INDIA PVT LTD PLOT NO.57/P SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0026ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-10 AMLODIPINE10MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0028ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-50ATENOLOL50MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0029ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-100ATENOLOL100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0085HETERO LABS LTD UNIT IXASTRA PHARMA (U) LIMITEDPIOGEN-30PIOGLITAZONE HYDROCHLORIDE30MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIAINDIAORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0093ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLORASLORATIDINE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/0096ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 15 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0099ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDCARBASCARBAMAZEPINE200MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY TABLETS 10 BLISTER CARTON,10 TABLET BLISTER,1000 TABLET CONTAINER
NDA/MAL/HDP/0141COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT SUSPENSIONNYSTATIN100,000 I.U/MLCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE,BOLLARAM MEDAK DISTRICT 502 325 A.P INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0169ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 10ROSUVASTATIN 10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 2 BLISTER CARTON,15 TABLET BLISTER
NDA/MAL/HDP/0256HETERO LABS LTDASTRA PHARMA (U) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOB NAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 120 TABLET CONTAINER
NDA/MAL/HDP/0261HETERO LABS LTDASTRA PHARMA (U) LIMITEDLOSAGEN -100LOSARTAN POTASSIUM100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),INDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0266GITTOES PHARMACEUTICALS LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2400000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 50 VIAL CARTON
NDA/MAL/HDP/0267HETERO LABS LTDASTRA PHARMA (U) LIMITEDPENVIR 750FAMCICLOVIR750MGHETERO LABS LTD. UNIT (V)NO. 438, 439, 440 & 458, APIIC FORMULATION,SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD,P.O BOX 414 33 - INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0289ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDTETRASTETRACYCLINE HYDROCLORIDE250MG ASTRA LIFE CARE (INDIA) PVT-PLOT 57/P, ROJADA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,10000 CAPSULE CONTAINER
NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA,P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/0301HETERO LABS LTDASTRA PHARMA (U) LIMITEDMONTE - H 10 MONTELUKAST SODIUM10MGHETERO LABS LTD (UNIT V),JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0330ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASBUTOL-4 SALBUTAMOL4MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0332ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 20ROSUVASTATIN CALCIUM20MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 2 BLISTER CARTON,15 TABLET BLISTER
NDA/MAL/HDP/0336ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAS-DP TABLETSDICYCLOMINE HCL + PARACETAMOL20MG+500MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/0385ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFORMINMETFORMIN HYDROCHLORIDE500MGASTRA LIFECARE (INDIA) PVT. LTD. -PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0402IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYSONE OPHTHALMIC SUSPENSIONHYDROCORTISONE ACETATE1%W/VIVEE INFUSIONS EPZ LTD,LR NO.18474/84,-ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC SUSPENSIONS 5 ML VIAL
NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD -P.O BOX 414 33, NAIROBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0426HETERO LABS LTDASTRA PHARMA (U) LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG +300MG + 200MGHETERO LABS LTD, UNIT III- 22-110 IDA JEEDIMETIA HYDERABAD ANDHRA,KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN,HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/0508ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTARGANPROMETHAZINE HYDROCHLORIDE25MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0615HETERO LABS LTDASTRA PHARMA (U) LIMITEDVALSAR 80VALSARTAN80MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0621HETERO LABS LTDASTRA PHARMA (U) LIMITEDALZERDONEPEZIL HYDROCHLORIDE10MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0665HETERO LABS LTDASTRA PHARMA (U) LIMITEDIRBIS-H 150IRBESARTAN HYDROCHLOROTHIAZIDE150MGHETERO LABS LTD. UNIT (V)-438,439, 440 & 458, APIIC, FORMULATION, SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXASTRA PHARMA (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT V) JADCHERIA (M) MAHABOOBNAGAR DIST ANDHRA PRADESH/ HETERO LABS LTD (UNIT II & III) BADDI THE NALAGARH DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KIT TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,10.3 G SACHET,4 SACHET CARTON
NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA INDIAORAL SOLID ORDINARY CAPSULES 3 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P SARKHEJ- BAVLA HIGHWAY, AHMEDABAD, RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/0798HETERO LABS LTDASTRA PHARMA (U) LIMITEDAMLO-H 10AMLODIPINE BESILATE10MGHETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0855HETERO LABS LTDASTRA PHARMA (U) LIMITEDLAZINELEVOCETRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD, UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA, KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXASTRA PHARMA (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM 40MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0898HETERO LABS LTDASTRA PHARMA (U) LIMITEDLOSAGEN 50 LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V) SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DIST ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0900ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLAPSONEDAPSONE100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5ML LORATADINE5MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL LIQUID ORDINARY LIQUIDS 60 ML BOTTLE
NDA/MAL/HDP/0982ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMETO-10METOCLOPRAMIDE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1010ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOPA TABLETSMETHYLDOPA250MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUP AMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/1096ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDARTEMETHERARTEMETHER80MG/MLHEBEI KAIWEI PHARMACEUTICAL CO, LTD. 27 LING YUAN ROAD, QIAO DONG, ZHANGJIAKOU CITYCHINAPARENTERAL ORDINARY I M AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON,8 AMPOULE CARTON
NDA/MAL/HDP/1178HETERO DRUGS LTD ASTRA PHARMA (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO DRUGS LTD UNIT III. 22-110, IDA, JEEDIMETLA, HYDERABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/1228 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDLUMETHERARTEMETHER/LUMEFANTRINE20MG/120MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBIKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/1346ASTRA PHARMA LTD ASTRA PHARMA (U) LIMITEDASIXFRUSEMIDE40MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220 TALUKA BAVLA, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITED PANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE, MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY OTHER TABLETS 20 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITED PANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE, MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY OTHER TABLETS 20 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/1420IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDSODIUM CHLORIDE + GLUCOSESODIUM CHLORIDE + GLUCOSE0.9%W/V + 5%W/VIVEE INFUSIONS EPZ LTD, LR NO.18474/84,ATHI RIVER EXPORT PROCESSING ZONE, ATHI RIVER,KENYAKENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE
NDA/MAL/HDP/1481ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTROGYLMETRONIDAZOLE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA,382220 BAVIA,AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1565COSMOS LTDASTRA PHARMA (U) LIMITEDSALBUT SYRUP 2MG/5MLSALBUTAMOL2MG/5MLCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA, BOX 414 33, NAIORBI, INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SIDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA, 382220 BAVIA,AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1678ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MG/VIALZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY DRY VIALS 100 MG VIAL,10 VIAL CARTON
NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - P.O BOX 414 33 INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/1808ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTACIDMAGNESIUM TRISILICATE370MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1832ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDICLOASDICLOFENAC SODIUM50MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,20 TABLET BLISTER,5 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1833ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMOXAMOXICILLIN500MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1856COSMOS LTDASTRA PHARMA (U) LIMITEDPROPRANOLOL TABLETS B.P. 40MGPROPRANOLOL HYDROCHLORIDE40MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA ROAD, P.O BOX 414 33, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1905ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON,100 AMPOULE CARTON
NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODIENE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE 30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGUO (SHIJIAZHUANG) PHARMACEUTICAL CO.LTD-NO. 47 FENGSHOU ROAD, SHIJIAZHUANG CHINACHINAPARENTERAL ORDINARY DRY VIALS 500 MG VIAL,50 VIAL CARTON
NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 15 ML BOTTLE,30 ML BOTTLE
NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSCLOXACILLIN,ATTAPULGITE/ ALUMINIUM HYDROXIDE250MG,N/ACOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, P.O BOX 414 33 INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,25 STRIP CARTON
NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATIDINE10MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2081IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDCOMPOUND SODIUM LACTATESODIUM LACTATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE+ CALCIUM CHLORIDE DIHYDRATE0.32G+0.6G+0.04+0.027/100MLIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 KENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE
NDA/MAL/HDP/2085COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORHEXIDINE GLUCONATE SOLUTIONCHLORHEXIDINE GLUCONATE20%W/VCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYATOPICAL EXTERNAL LIQUIDS 500 ML BOTTLE,1 L JERRYCAN,5 L JERRYCAN
NDA/MAL/HDP/2086ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDBENDASALBENDAZOLE200MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIAINDIAORAL SOLID ORDINARY TABLETS 2 TABLET STRIP
NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2115ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRIMCO-TRIMOXAZOLE480MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2214SINO AFRICA MEDICINES AND HEALTH LTDASTRA PHARMA (U) LIMITEDGENTAMICIN INJECTIONGENTAMICIN SULPHATE40MG/MLZHEJIANG TIANFENG PHARMACEUTICAL FACTORY-NO.518 DA, KAIFA ROAD CHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/2241IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYPHENOCOL EYE DROPSCHLORAMPHENICOL0.5%W/VIVEE INFUSIONS EPZ LTD-LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5 ML VIAL,10 ML VIAL
NDA/MAL/HDP/2244IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXNICOL EYE DROPSDEXAMETHASONE/CHLORAMPHENICOL0.1% & 1%W/VIVEE INFUSIONS EPZ LTD-LR NO.18474/84, ATHI RIVER 25251 00100 NAIROBI KENYA, ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/2274ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDPARACETAMOL TABLETS 500MGPARACETAMOL 500MGZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAITEE ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/2317ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASMOLPARACETAMOL500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA LUNGA ROAD -P.O. BOX 414 33 INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2370IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYBETANEOCIN EYE DROPSBETAMETHASONE/ENOMYCIN0.1%W/V & 0.35%W/VIVEE INFUSIONS EPZ LTD- LR NO.18474/84, ATHI RIVER, BOX 25251 00100 NAIROBI KENYA, ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE,10 ML BOTTLE
NDA/MAL/HDP/2374COSMOS LTDASTRA PHARMA (U) LIMITEDPYRAZINAMIDE TABLETSPYRAZINAMIDE500MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM 5MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA LUNGA ROAD - INDUSTRIAL AREA P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA LUNGA ROAD - INDUSTRIAL AREA P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS 500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,10 AMPOULE CARTON,100 AMPOULE CARTON
NDA/MAL/HDP/2549ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-250AZITHROMYCIN250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P,SARKEJ BAVLA HIGHWAY, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2555COSMOS LTDASTRA PHARMA (U) LIMITEDPHENOBARBITONE TABLETS BP 30MGPHENOBARBITONE 30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA,P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/2724ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDCHLORAMPHENICOL 250MG CAPSULES BPCHLORAMPHENICOL250MGZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD-KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,100 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/2725ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDSTREPTOMYCIN SULPHATE FOR INJECTIONSTREPTOMYCIN SULPHATE1GMCSPC ZHONGUO (SHIJIAZHUANG) PHARMACEUTICAL CO.LTD-NO. 188 GONGNONGCHINAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,50 VIAL CARTON
NDA/MAL/HDP/2726ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUININE INJECTIONQUININE DIHYDROCHLORIDE600MG/2MLZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD-KAIFA ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAPARENTERAL ORDINARY AMPOULES 100 AMPOULE CARTON,2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 50 VIAL CARTON
NDA/MAL/HDP/2799IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYCHLORNICOL EAR DROPSCHLORAMPHENICOL5%W/VIVEE INFUSIONS EPZ LTD- LR NO.18474/84, ATHI RIVER BOX 25251 00100 NAIROBI KENYA, ATHI RIVER,KENYAKENYAOTIC DROPS 5 ML BOTTLE,10 ML BOTTLE
NDA/MAL/HDP/2926ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDTETRACYCLINE 250MG CAPSULES BPTETRACYCLINE 250MG ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAITEE ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/2934ASTRA LIFE CARE PVT LTDASTRA PHARMA (U) LIMITEDASTOLONPREDNISOLONE5MGASTRA LIFE CARE PVT LTD-57/P RAJODA-382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 10 BLISTER CARTON,10 TABLET BLISTER,1000 TABLET CONTAINER
NDA/MAL/HDP/2936ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFEMIN-PNYSTATIN100,000IUASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAVAGINAL TABLETS 15 PESSARY BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2939ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTODIUMLOPERAMIDE HYDROCHLORIDE2MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HDP/2962ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTIDINCIMETIDINE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,1 STRIP CARTON,10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2991ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 15 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3011ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDGYNESTCLOTRIMAZOLE 100MG ASTRA LIFE CARE (INDIA) PVT-PLOT 57 ROJADA 382220, BAVLA AHMEDABAD INDIAINDIAVAGINAL TABLETS 1 BLISTER CARTON,6 TABLET BLISTER
NDA/MAL/HDP/3017ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDLIDOCAINE INJECTIONLIDOCAINE HYDROCHLORIDE 20MG/MLZHEJIANG RUIXIN PHARMACEUTICALS CO LTD-KAIFA ROAD TIANNING IDOUS ZONE LISHUI CITY CHINAPARENTERAL ORDINARY AMPOULES 20 ML AMPOULE,25 AMPOULE CARTON
NDA/MAL/HDP/3056ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCAFCHLORAMPHENICOL250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, SARKEJ BAULA HIGHWAY 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/3073COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL50MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA P.O.BOX 41433, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/3161ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCILLINAMPICILLIN250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, SARKEJ BAULA HIGHWAY RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/3178COSMOS LTDASTRA PHARMA (U) LIMITEDBENDURIC TABLETSBENDROFLUMETHIAZIDE5MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3185ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMINOPHYLLINE INJECTIONAMINOPHYLLINE25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,10 AMPOULE CARTON,50 AMPOULE CARTON
NDA/MAL/HDP/3270ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4000000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.INDIAPARENTERAL ORDINARY DRY VIALS 50 VIAL CARTON
NDA/MAL/HDP/3345ASTRA PHARMACY (U) PVT LTDASTRA PHARMA (U) LIMITEDPAINOL-PPARACETAMOL + CAFFEIN650MG + 50MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,25 STRIP CARTON
NDA/MAL/HDP/3366ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDIASGLIBENCLAMIDE5MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/3374COSMOS LIMITEDASTRA PHARMA (U) LIMITEDZITHROX 250MGAZITHROMYCIN 250MGCOSMOS LTD, RANGWE ROAD, OFF LUNGA LUNGA ROAD INDUSTRIAL AREA,P.O BOX 414 33 NAIROBIKENYAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3401ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCODYLBISACODYL5MGASTRA LIFE CARE (INDIA) LTD, PLOT 57/P SHARKHEJ-BAVLA HIGHWAY, RAJODA 382220, TALUKA, BAVLAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3493ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASVIRACICLOVIR200MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3505ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFLICFOLIC ACID5MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/3516COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS BP 5MGTRIHEXYPHENIDYL HYDROCHLORIDE5MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3518ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFLOXCIPROFLOXACIN500MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3560ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDDERMIZOLKETOCONAZOLE200MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3564ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDATROPINE INJECTIONATROPINE SULPHATE1MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON,100 AMPOULE CARTON
NDA/MAL/HDP/3570ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3577ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDMETOCLOPRAMIDEMELOCLOPRAMIDE5MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON,10 AMPOULE CARTON
NDA/MAL/HDP/3599ASTRA PHARMA LTD ASTRA PHARMA (U) LIMITEDCHLORPROMAZINE INJECTIONCHLORPROMAZINE25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON,10 AMPOULE CARTON
NDA/MAL/HDP/3610COSMOS LTDASTRA PHARMA (U) LIMITEDPROMETHAZINE TABLETS BP 25MGPROMETHAZINE HYDROCHLORIDE25MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,100 TABLET CONTAINER
NDA/MAL/HDP/3618ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDCLOXACILLIN SODIUMCLOXACILLIN SODIUM500MGCSPC ZHONGUO (SHIJIAZHUANG) PHARMACEUTICAL CO.LTD-NO. 188 GONGNONGCHINAPARENTERAL ORDINARY DRY VIALS 50 VIAL CARTON
NDA/MAL/HDP/3652ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDBENDAS-400ALBENDAZOLE400MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3654IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYNOZVIN A NASAL DROPSXYLOMETAZOLINE HYDROCHLORIDE1MG/MLIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYANASAL SYSTEMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/3660ASTRA PHARMA (U) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRASILDENAFIL CITRATE100MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3673ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDPROMETHAZINEPROMETHAZINE HCL25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/3675ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCOPANHYOSCINE BUTYLBROMIDE10MGASTRA LIFE CARE PVT LTD PLOT 57/P RAJODA 382 220 INDIAORAL SOLID ORDINARY OTHER COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3752COSMOS LTDASTRA PHARMA (U) LIMITEDPAINOTAB 200PARACETAMOL/CAFFEINE500MG+65MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3837COSMOS LTDASTRA PHARMA (U) LIMITEDNITROFURANTOINNITROFURANTOIN100MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/3878ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDASTIDIN 400CIMETIDINE TABLETS400 MGASTRA LIFECARE PVT INDIA-57/P RAJODA 382220 AHMEDABAD INDIAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3895ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDASNORNORFLOXACIN400MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3900ASTRA PHARMA UGANDA LTDASTRA PHARMA (U) LIMITEDASTIBA-500TINIDAZOLE500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,25 BLISTER CARTON
NDA/MAL/HDP/3904COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT PESSARIESNYSTATIN100,000 I.UCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAVAGINAL TABLETS 14 PESSARY STRIP,1 STRIP CARTON,14 PESSARY STRIP,50 STRIP CARTON
NDA/MAL/HDP/3911ASTRA PHARMA UGANDA LTDASTRA PHARMA (U) LIMITEDASIDOMEPRAZOLE20MGASTRA LIFECARE PVT LTD, 57/P RAJODA 382220 BAVLA AHMEDABADUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3921ASTRA PHARMA (U) PVT LTDASTRA PHARMA (U) LIMITEDAS-BPYRIDINE-3-CARBOXAMIDE/ RIBOFLAVIN/ THIAMINE NITRATE17.25MG/ 1.3MG/ 1.3MGASTRA LIFECARE (INDIA) PVT. LTD. -PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3923ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDAXASONEDEXAMETHASONE0.5MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4021ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-500AZITHROMYCIN500MGASTRA LIFECARE INDIA PVT LTD PLOT NO. 57/P SARKEJ BAVLA HIGHWAY RAJODA AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4022ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPI-MCHLORPHENIRAMINE4MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4052HETERO DRUGS LTD ASTRA PHARMA (U) LIMITEDEFAVIRENZEFAVIRENZ600MGHETERO LABS LTD, UNIT-111, 22-110 I.D.A, JEEDIMET / HETERO LABS LTD UNIT V SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/4084IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDWATER FOR INJECTIONSTERILIZED WATER FOR INJECTIONN/AIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYAPARENTERAL ORDINARY OTHER AMPOULES 10 ML VIAL
NDA/MAL/HDP/4144COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT OINTMENTNYSTATIN100.000 I.UCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYATOPICAL EXTERNAL OINTMENTS 30 G TUBE
NDA/MAL/HDP/4148COSMOS LIMITEDASTRA PHARMA (U) LIMITEDAMITRIPTYLINE TABLETSAMITRIPTYLINE25MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/4295ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTRAFLAM TABLETSPARACETAMOL + IBUPROFEN500MG + 400MGASTRA LIFECARE (INDIA) PVT LTD PLOT NO. 57/P SARKHEJ BAVLA HIGHWAY POST RAJODA 382220 TALUKA BAVLA DIST AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4309HETERO DRUGS LTD ASTRA PHARMA (U) LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGHETEROLABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055 ,HETERO LABS LTD (UNIT-V) SY. NO. 438, 439, 440 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/4340ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDVITAMIN B COMPLEXVITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM10MG + 1.37MG + 15MG + 1MG + 0.5MGZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAITEE ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON,100 AMPOULE CARTON
NDA/MAL/HDP/4400COSMOS LTDASTRA PHARMA (U) LIMITEDORAL REHYDRATION SALT (DTS)ORAL REHYDRATION SALT N/ACOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 20.6 G SACHET,100 SACHET CARTON,10.3 G SACHET,100 SACHET CARTON
NDA/MAL/HDP/4480MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDKIPEL 5MONTELUKAST5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA.INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4544COSMOS LTDASTRA PHARMA (U) LIMITEDSALBUT TABLET 4MGSALBUTAMOL4MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4545CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDCACH-ART 20/120ARTEMETHER/LUMEFANTRINE20MG/120MGCACHET PHARMACEUTICALS PVT LTD, VILLAGE-THANA, BADDI, HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 8 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4571ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPICLOXAMPICILLIN/CLOXACILLIN250MG/250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P,SARKEJ BAULA HIGHWAY RAJODA, 382220, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/4662ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOLTRAMADOL50MGASTRA LIFECARE (I) PVT PLOT NO.57/P SARKHEJ BAVLA RAJODA 382220 TALUKA BAVLA DIST AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4710COSMOS LTDASTRA PHARMA (U) LIMITEDMEDOPRESS TABLETS 250MGMETHYLDOPA250MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4870ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE150MGASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P SARKEJ BAVLA HIGHWAY RAJODA AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4873ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE200MGASTRA LIFECARE (INDIA) PVT LTD PLOT NO 57/P SARKEJ BAVLA HIGHWAY RAJODA AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 4 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/4881ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOXINDOXYCYCLINE100MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, SARKH RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4883ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFEN-FCIBUPROFEN200MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, SARKEJ BAULA HIGHWAY RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4884ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFULVIN-500GRISEOFULVIN500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BAVLA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4888ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASOMYCINERYTHROMYCIN250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, SARKEJ BAULA HIGHWAY RAJODA, 382220, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4974COSMOS LTDASTRA PHARMA (U) LIMITEDFRUSEMIDE TABLETS BP 40MGFUROSEMIDE40MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/4976MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDPERGLIM 2GLIMEPIRIDE2MGINVENTIA HEALTHCARE PVT. LTD-FI ? FI /1 ADDITIONAL AMBERNATH,M.I.D.C. AMBERNATH (EAST) ? 421 506, DIST. THANE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4982COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMAG TABLETSMAGNESIUM TRISILICATE370MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY CHEWABLE TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/5001ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDGENTAMICIN INJECTIONGENTAMYCIN80MG/2MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON,100 AMPOULE CARTON
NDA/MAL/HDP/5042COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM DS TABLETSCO-TRIMOXAZOLE960MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/5099COSMOS LTDASTRA PHARMA (U) LIMITEDGLUCOMETMETFORMIN500MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5164COSMOS LTDASTRA PHARMA (U) LIMITEDBROMSAL EXPECTORANTMULTI-INGREDIENTN/ACOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/5191IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYBETASONE EYE DROPSBETAMETHASONE1MG/MLIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,LR NO.18474/84,ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/5192IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXGENT EYE/EAR DROPSDEXAMETHASONE/GENTAMICIN0.1% & 0.3%W/VIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/5193IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXNEOCIN EYE DROPSDEXAMETHASONE/NEOMYCIN0.1% & 0.35%W/VIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE,10 ML BOTTLE
NDA/MAL/HDP/5194IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXONE EYE DROPSDEXAMETHASONE0.1%W/VIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/5195IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFRIN P NASAL DROPSEPHEDRINE HYDROCHLORIDE0.5%W/VIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYANASAL SYSTEMIC DROPS 15 ML BOTTLE,10 ML BOTTLE
NDA/MAL/HDP/5196IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFRIN NASAL DROPSEPHEDRINE HYDROCHLORIDE1%W/VIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYANASAL SYSTEMIC DROPS 15 ML BOTTLE
NDA/MAL/HDP/5197IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYGENTACIN EYE/EAR DROPGENTAMICIN SULPHATE0.3%W/VIVEE INFUSIONS EPZ LTD L.R NO 18474/84 ATHI RIVER BOX 25251 00100 NAIROBI KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE,7.5 ML BOTTLE,10 ML BOTTLE
NDA/MAL/HDP/5200COSMOS LTDASTRA PHARMA (U) LIMITEDHYDRALAZINE TABLETS B.P 25MG.HYDRALAZINE HYDROCHLORIDE25MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5259COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL100MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/5328ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDINDOMETACIN 25MG CAPSULES BPINDOMETACIN25MGZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,100 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/5334COSMOS LTDASTRA PHARMA (U) LIMITEDETHAM-400ETHAMBUTOL400MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIROBIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5423HETERO LABS LTDASTRA PHARMA (U) LIMITEDEFAVIRENZ+LAMIVUDINE+TENOFOVIREFAVIRENZ+LAMIVUDINE+TENOFOVIR600MG/300MG/300MGHETERO LABS LTD UNIT III 22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH & HETERO LABS LTD (UNIT V),SY. NO.439,440,441&458,TSIIC FORMULATION SEZ,POLEPALLY (V), JADCHERLA (M),MAHABOONAGAR DISTRICT,TELANGANA,INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5494ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASMOXAMOXYCILLIN250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, RAJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/6128IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFLURFLURBIPROFEN SODIUM0.03%W/VIVEE INFUSIONS EPZ LTD L.R.NO. 18474/84 ATHI RIVER NAIROBIKENYAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/6130ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDIVYSINE EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE0.05%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474/84 NAIROBIKENYAOPHTHALMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/6228CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDACINETAMOXICILLIN,POTASSIUM CLAVULANATE500MG,125MGALKEM LABORATORIES LTD -PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6230CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDEMITINOONDANSENTRON4MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6244CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDCABALINPREGABALIN75MGCACHET PHARMACEUTICALS PVT. LTD.VILLAGE THANA NEAR BADDI TEHSIL NALAGARH DIST- SOLAN HIMACHAL PRADESH -173205INDIAORAL SOLID ORDINARY CAPSULES 12 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6370IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITED IVYCROM EYE DROPSSODIUM CROMOGLYCATE2%W/VIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,LR NO.18474/84,ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/6372ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDIVYTIMOL EYE DROPSTIMOLOL MALEATE0.25%W/VIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,LR NO.18474/84, ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/6509 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASPYROX PIROXICAM20MGASTRA LIFECARE (INDIA) PVT LTD PLOT NO. 57/P SARKHEJ BAVLA HIGHWAY POST RAJODA 382220 TALUKA BAVLA DIST AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,3 BLISTER CARTON
NDA/MAL/HDP/6698COSMOS LTDASTRA PHARMA (U) LIMITEDALBUZOL 400MG TABLETSALBENDAZOLE400MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/6700CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDARTIMEDDICLOFENAC SODIUM50MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6701 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-ART DSARTEMETHER / LUMEFANTRINE80MG/ 480MGCACHETPHARMACEUTICALS PVT LTD VILLAGE THANA BADDI HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6703 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHCOLD PLUSPARACETAMOL/ CAFFEINE/ PHENYLEPHRINE/ CHLORPHENIRAMINE500MG/ 30MG/ 5MG/ 2MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,50 STRIP CARTON
NDA/MAL/HDP/6704 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHETCETIRIZINE HCL10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/6705 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHEWORMMEBENDAZOLE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/6706 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-E-WORMMEBENDAZOLE100MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6707 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHFERIRON + FOLIC ACID + VITAMIN B1232MG/15ML + 0.5MG/15ML + 7.5MCG/15MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,200 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6709 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL500MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/6711 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL125MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6712 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACID-OOMEPRAZOLE20MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON
NDA/MAL/HDP/6713 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAMETMETOCLOPRAMIDE HYDROCHLORIDE10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6715 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN200MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 15 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6717 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN500MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6718 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCETPROCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6722MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDCILZEC 40TELMISARTAN40MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6724MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDCILZEC 80TELMISARTAN80MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6728COSMOS LTDASTRA PHARMA (U) LIMITEDCIPROCOS-500 TABLETSCIPROFLOXACIN500MGCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIORBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/6729COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF 'C' LINCTUSMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIORBIKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6732COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF EXPECTORANT ORIGINALMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIORBIKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6734 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDEASCOFBROMHEXIDINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN24MG/100ML + 42MG/100ML + 1G/MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6737 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDESENVITGLYCERIN/ ZINC SULPHATE/ SODIUM MOLYBDATE/ MANGANESE CHLORIDE/ LYSINE HCL5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/ 612MGCACHET PHARMACEUTICALSPVT.LTD.415,SHAH NAHAR,WORLIINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,1 BOTTLE CARTON,60 ML CARTON
NDA/MAL/HDP/6762COSMOS LTDASTRA PHARMA (U) LIMITEDFLUCOLD CAPSULESMULTI-INGREDIENTN/ACOSMOS LTD, RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIORBIKENYAORAL SOLID ORDINARY CAPSULES 100 BLISTER CARTON
NDA/MAL/HDP/6765 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDIBUCACH 200IBUPROFEN200MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/6775IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYSOLONEPREDNISOLONE ACETATE1%W/VCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA,IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC SUSPENSIONS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/6780IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYTIMOLTIMOLOL MALEATE0.5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 5 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6782IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYXOLOLBETAXOLOL HYDROCHLORIDE0.5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 5 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6784IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYZOXANCIPROFLOXACIN HYDROCHLORIDE0.3%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 5 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6790MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDLIMZEROMEPRAZOLE + DOMPERIDONE20MG + 30MGINVENTIA HEALTHCARE PVT. LTD-FI ? FI /1 ADDITIONAL AMBERNATH, M.I.D.C. AMBERNATH (EAST) ? 421 506, DIST. THANE, INDIA INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,3 STRIP CARTON
NDA/MAL/HDP/6793 CACHET PHARMACEUTICALS LTDASTRA PHARMA (U) LIMITEDNESTAMINOPHYLLINE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/6794HETERO LABS LTD ASTRA PHARMA (U) LIMITEDZOLIDLINEZOLID600MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7105CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRAMACETAL TABLETSACETAMINOPHEN +TRAMADOL HYDROCHLORIDE 325MG+37.5MGCACHET PHARMACEUTICALS PVT LTD VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7706CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCACEF 200CEFPODOXIME PROXETIL200MGALKEM LABORATORIES LIMITED -VILLAGE- THANA BADDI, YEH NALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8009COSMOS LTD.ASTRA PHARMA (U) LIMITEDGRISO-500GRISEOFULVIN500MGCOSMOS LIMITED -RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIORBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8010COSMOS LTD.ASTRA PHARMA (U) LIMITEDMETROZOLE TABLETSMETRONIDAZOLE200MGCOSMOS LIMITED -RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIORBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/8177MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDCILZEC PLUSTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY LAYERED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8180COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOL TABLETS 500MGPARACETAMOL500MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 2 TABLET STRIP,50 STRIP CARTON,100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/8248CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCLAVACE SUSPENSIONAMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM457MG/5MLALKEM LABORATORIES LTD -PLOT NO. 167, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN, INDIA.INDIAORAL SOLID ORDINARY POWDERS 100 ML BOTTLE
NDA/MAL/HDP/8264CACHET PHARMA PVT LTDASTRA PHARMA (U) LIMITEDEMITINO ORAL SOLUTIONONDANSETRON2MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 30 ML BOTTLE
NDA/MAL/HDP/8274HETERO LABS LTD ASTRA PHARMA (U) LIMITEDBICATERO 50BICALUTAMIDE50MGHETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/8278HETERO LABS LTDASTRA PHARMA (U) LIMITEDANATEROANASTROZOLE1MGHETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/8283ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUINASQUININE SULPHATE BP300MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY COATED TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8297COSMOS LTDASTRA PHARMA (U) LIMITEDISONIAZIDE TABLETSISONIAZID100MGCOSMOS LIMITED -RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA P.O BOX 414 33, NAIORBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/8324CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDLOOBID TABLETSOFLOXACIN + ORNIDAZOLE 200MG + 500 MG CACHET PHARMACEUTICAL PVT LTD. HIMACHAL-THANA, BADDI, HIMACHAL PRADESH-173 205, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8344CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA DRY SYRUPCEFUROXIME AXETIL USP125 MG/5 MLALKEM LABORATORIES LTD. PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESHINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE
NDA/MAL/HDP/8345CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA 500CEFUROXIME AXETIL USP 500 MGALKEM LABORATORIES LTD. PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8406HETERO LABS LTD UNIT IXASTRA PHARMA (U) LIMITEDPIOGEN45PIOGLITAZONE HYDROCHLORIDE45MGHETERO LABS LIMITED S.NO.10, I.D.A., GADDAPOTHARAM VILLAGE, JINNARAM MANDAL,MEDAK DISTRICT, ANDHRA PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 5 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG WENDLANDSTR. 129439 LUCHOWGERMANYORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG WENDLANDSTR. 129439 LUCHOWGERMANYORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG WENDLANDSTR. 129439 LUCHOWGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLINGERMANYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLINGERMANYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MGDENK PHARMA GMBH & CO.KG 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2 GLIMEPIRIDE 2MGDENK PHARMA GMBH & CO.KG 84529 TITTMONING GERMANYORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3 GLIMEPIRIDE 3MGDENK PHARMA GMBH & CO.KG 84529 TITTMONING GERMANYORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/1219DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH & CO.KG 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1488ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA M?NSTER GMBH-SCHLEEBR?GGENKAMP 15 48159 M?NSTER GERMANY GERMANYRECTAL SYSTEMIC SUPPOSITORIES 10 SUPPOSITORY STRIP,10 STRIP CARTON,5 SUPPOSITORY STRIP,1 STRIP CARTON
NDA/MAL/HDP/1492ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLDENK PHARMA, GOLLSTR., 1-D-845 529 TITTMONING GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMETTEL GMBH HIDEBRAND STRASSE 12 D-37081 GOTTINGENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2296ERIS LTDBENLE CONSULT LIMITEDRANI-DENK 150RANITIDINE150MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,20 TABLET BLISTER,50 TABLET CONTAINER
NDA/MAL/HDP/2428ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYTOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/2429ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 100 VAGINALCLOTRIMAZOLE100MGDENK PHARMA GMBH & CO.KG PRINZREGENTESTR.79.81675 MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING GER GERMANYVAGINAL TABLETS 6 PESSARY CARTON
NDA/MAL/HDP/2525ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID RETARD TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/2593E DENK OHGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG ,WENDLANDSTRABE 1 ,29439 LUCHOW , GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL SUPPOSITORY250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY STRIP,1 STRIP CARTON,2 STRIP CARTON
NDA/MAL/HDP/2647DENK PHARMABENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,2 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY BLISTER,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE/PYRIDOXINE100MG/200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,10 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2746ERIS LTDBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/2948DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDMETFORMIN DENK 850METFORMIN HYDROCHLORIDE850MGDENK PHARMA GMBH & CO.KG PRINZREGENTESTR.79.81675 MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING GERGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 15 TABLET BLISTER,8 BLISTER CARTON,15 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3197ERIS LTDBENLE CONSULT LIMITEDTRIAM-DENK 40 INJECTIONTRIMCINOLONE ACETONIDE40MG/MLDENK PHARMA, GOLLSTR., 1-D-845 529 TITTMONING GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/3423DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDAMOXICLAV-DENK 1000/125AMOXICILLIN TRIHYDTATE/POTASSIUM CLAVULANATE1000MG/125MGPENCEF PHARMA GMBH BRITENBACHSTR ASSE 13 D-13509 BERLINGERMANYORAL SOLID ORDINARY POWDERS 3 G SACHET,8 SACHET CARTON,3 G SACHET,12 SACHET CARTON
NDA/MAL/HDP/3583DENK PHARMA GMBH & COBENLE CONSULT LIMITEDSIMVA-DENK 40SIMVASTATIN40MGDENK PHARMA GMBH & CO-G0 11 STR.1 84529 T,HMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3589DENK PHARMA GMBH & COBENLE CONSULT LIMITEDSIMVA-DENK 20SIMVASTATIN20MG DENK PHARMA GMBH & CO-.GK GOII STR.1 84529 TIHMONINGGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3619ERIS LTDBENLE CONSULT LIMITEDCAPTOPRIL DENK -25CAPTOPRIL25MGDENK PHARMA, GOLLSTR., 1-D-845 529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/3631DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDENA-DENK 10ENALAPRIL MALEATE10MGDENK PHARMA GMBH & CO.KG PRINZREGENTESTR.79.81675 MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/3728ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 50DICLOFENAC SODIUM50MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/4147ERIS LTDBENLE CONSULT LIMITED NIFEDI-DENK 20 RETARDNIFEDIPINE20MGDENK PHARMA GMBH & CO.KG PRINZREGENTESTR.79.81675 MUENCHEN,GERMANY, GOLLSTR., 1-D -845529 TITTMONING GERMANY GERMANYORAL SOLID RETARD COATED TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/4315DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDDESLORA-DENK 5DESLORATIDINE5MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4317DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDCOLOSA-DENK 50/12.5LOSARTAN / HYDROCHLOROTHIAZIDE50MG/ 12.5MGDENK PHARMA GMBH & CO.KG GOLLESTR 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/4322DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDVALSAR-DENK 160VALSARTAN160MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/4332DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDVALSAR-DENK 320VALSARTAN320MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/4334DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDLOSAR-DENK 50LOSARTAN50MGDENK PHARMA GMBH & CO.KG GOLLESTR 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4337DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDVALSAR-DENK 80VALSARTAN80MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4634DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDLOSAR-DENK 100LOSARTAN100MGDENK PHARMA GMBH & CO.KG GOLLESTR 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4757ERIS LTDBENLE CONSULT LIMITEDMETFORMIN-DENK 500METFORMIN500MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/4758DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDMETFORMIN DENK 1000METFORMIN1000MGDENK PHARMA GMBH & CO.KG GOLLESTR 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 15 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/5392DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMLO-DENK 10AMLODIPINE MESILATE MONOHYDRATE10MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/5393DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMLO-DENK 5AMLODIPINE MESILATE MONOHYDRATE5MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/6116DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDZOLEDRO-DENK 4MG/5MLZOLEDRONIC ACID4MG/5ML HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/6117DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDGRAN-DENKGRANISETRON HYDROCHLORIDE1MG/ML HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/6179DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDON.SETRON-DENK 4MG ODTONDANSENTRON4MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6185DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDDOLOFORTE DENKTRAMADOL HYDROCHLORIDE,PARACETAMOL37.5MG,325MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6267DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTRAMADOL DENK 50TRAMADOL HYDROCHLORIDE50MGLOSAN PHARMA GMBH- OTTO-HAHN-STR 13 79395 NEUENBURGGERMANYORAL SOLID ORDINARY EFFERVESCENT TABLETS 10 TABLET BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6811DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 160/12.5VALSARTAN + HYDROCHLOROTHIAZIDE160MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/6813DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 320/12.5VALSARTAN + HYDROCHLOROTHIAZIDE320MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/6814DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 80/12.5VALSARTAN + HYDROCHLOROTHIAZIDE80MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/6817DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDLETROZOLE DENK 2.5LETROZOLE2.5MGHAUPT PHARMA M?NSTER GMBH-SCHLEEBR?GGENKAMP 15 48159 M?NSTER GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6833DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDON.SENTRON-DENK 8MG ODTONDANSETRON8MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7491DENK PHARMA GMBH & CO.KGBENLE CONSULT LIMITEDCIPRO-DENK 750CIPROFLOXACIN HYDROCHLORIDE750MGALLPHAMED PHARBIL ARZNEIMITTEL GMBH. -HILDEBRANDSTRABE 12 37081 GOTTINGENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7523DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDLEVOFLOX-DENK 5 MG/MLLEVOFLOXACIN HEMIHYDRATE5MG/MLSOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH-INDUSTRIESTR. 3 34212 MELSUNGEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML VIAL
NDA/MAL/HDP/8023DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMOXICLAV-DENK 500/62.5AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE500MG/ 62.5MGPENCEF PHARMA GMBH BRITENBACHSTR ASSE 13 D-13509 BERLINGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 8 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8095DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDCOLOSAR-DENK 100/12.5LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE100MG + 12.5MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8145DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR 10MONTELUKAST SODIUM10MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8146DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 4MONTELUKAST SODIUM4MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8147DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 5 DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8231DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDANASTROZOLE DENKANASTROZOLE1MGHAUPT PHARMA GMBH & CO KG-SCHLEEBRUGGENKAMP 15, 48159 MUNSTER, GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1198HEMIS MEDICARE LTDBETA HEALTHCARE UGANDA LIMITEDMALITHER INJECTIONARTEMETHER80MG/MLTHEMIS MEDICARE LTD SECTOR 6A ,PLOT NO. 16,17 & 18 IIE,BHEL SIDCUL , HARIDWAR UTTARAKHAND 249403INDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA HEALTH CARE INTERNATIONAL LTD INDUSTRIAL AREA MOGADISHU ROAD OFF LUNGA ROAD NAIROBIKENYAORAL TOPICAL LIQUIDS 200 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALCARE INTERNATIONAL LTD, BONDO ROAD P.O BOX 42569, NAIROBI, KENYA.KENYAORAL SOLID ORDINARY TABLETS 30 TABLET BLISTER
NDA/MAL/HDP/1785BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE/CAFFEINE/PARACETAMOL600MG/50MG/400MGBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 110 TABLET CONTAINER,200 TABLET CONTAINER,100 STRIP CARTON,12 TABLET STRIP
NDA/MAL/HDP/1839BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL500MGBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,KENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/2509BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDOPELE LOTIONBENZYL BENZOATE25%W/VBETA HEALCARE INTERNATIONAL MOGADISHU ROAD PLOT NO 209/655A INDUSTRIAL AREA NAIROBI KENYAKENYATOPICAL EXTERNAL LOTIONS 50 ML BOTTLE
NDA/MAL/HDP/3051BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLEDILOXANIDE FUROATE/METRONIDAZOLE25MG/ML + 20MG/MLBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3181THEMIS MEDICARE LTDBETA HEALTHCARE UGANDA LIMITEDEMALALPHA & BETA ARTEETHER150MG/2ML THEMIS MEDICARE LIMITED-SECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,3 AMPOULE CARTON
NDA/MAL/HDP/3266BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDSALIMIA LINIMENTMETHYL SALICYLATE TURPENTINE OIL5ML 25MLBETA HEALTHCARE INTERNATIONAL LTD-INDUSTRIAL AREA, BONDO ROADKENYATOPICAL EXTERNAL LIQUIDS 50 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/3542BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDMARA MOJAASPIRIN + PARACETAMOL + CAFFEINE400MG + 200MG + 50MGBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 2 TABLET STRIP,50 STRIP CARTON,110 STRIP CARTON
NDA/MAL/HDP/3829BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETACOOLDRIED ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE /MAGNESIUM ALUMINUM SILICATE/SIMETHICANE 300MG / 25MG / 50MG / 25MGBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 50 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/3835GLAXOSMITHKLINE LTDBETA HEALTHCARE UGANDA LIMITEDHEDEX CAPLETS PARACETAMOL500MGSMITHKLINE BEECHAM (NAIROBI) , BETA HEALTHCARE LTD LOCATED ON PLOT NO 209/6554 MOGADISHU ROAD ,INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 20 BLISTER CARTON,110 TABLET CARTON,100 TABLET CARTON
NDA/MAL/HDP/4014BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDFUSIGENSODIUM FUSIDATE20MG/GGENO PHARMACEUTICALS LTD TIVIM INDUSTRIAL ESTATE KARASWADA, MAPUSA, GOAINDIATOPICAL EXTERNAL OINTMENTS 10 G TUBE
NDA/MAL/HDP/4347BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDVERTIGONCINNARAZINE25MGGENO P'CALS LTD, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOAINDIAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4965BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETAFEN SYRUPIBUPROFEN100MG/5MLBETA HEALCARE INTERNATIONAL LTD, BONDO ROAD P.O BOX 42569, NAIROBI, KENYA.KENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/5004GLAXOSMITHKLINE LIMITED LIKONIBETA HEALTHCARE UGANDA LIMITEDCOFTA TABLETSMUTI-INGREDIENTMUTI-INGREDIENTGLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 50 TABLET CARTON,100 TABLET CARTON,150 TABLET CARTON
NDA/MAL/HDP/5080BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDLOBAKDICLOFENAC/PARACETAMOL/CHLORZOXAZONE50MG/325MG/250MGGENO PHARMACEUTICALS LTD TIVIM INDUSTRIAL ESTATE KARASWADA, MAPUSA, GOAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/5134BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDGOODMORNING COUGH TABLETSMULTIINGREDIENTN/ABETA HEALCARE INTERNATIONAL MOGADISHU ROAD PLOT NO 209/655A INDUSTRIAL AREA NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 100 TABLET CARTON
NDA/MAL/HDP/5136BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDGOODMORNING LUNG TONICMULTIINGREDIENTN/ABETA HEALTHCARE INTERNATIONAL LTD-INDUSTRIAL AREA, BONDO ROADKENYAORAL LIQUID ORDINARY SYRUPS 50 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/5154BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETASIL PAEDIATRIC SYRUPIPECACUANHA TINCTURE0.5MLBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,KENYAORAL LIQUID ORDINARY SYRUPS 50 ML BOTTLE
NDA/MAL/HDP/5407THEMIS PHARMACEUTICALSBETA HEALTHCARE UGANDA LIMITEDE MAL-75ALPHA-BETA ARTEETHER75MG/MLTHEMIS PHARMACEUTICALS-PHYSICAL ADDRESS: 69/B, G.I.D.C., INDUSTRIAL ESTATE, VAPI 396 195, DISTRICT:-VALSAD, GUJARAT, INDIA INDIAPARENTERAL ORDINARY AMPOULES 3 AMPOULE CARTON,1 ML AMPOULE
NDA/MAL/HDP/5448BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDFLUNER-5FLUNARIZINE5MGGENO PHARMACEUTICALS LTD TIVIM INDUSTRIAL ESTATE KARASWADA, MAPUSA, GOAINDIAORAL SOLID ORDINARY TABLETS 10 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/6756BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDFEVERIX TOTO SUSPENSIONPARACETAMOL120MG/5MLBETA HEALCARE INTERNATIONAL MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE
NDA/MAL/HDP/8211SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCO-ASTHALIN SYRUPBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/0192AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDAMOCOMB CREAMNEOMYCIN &TRIAMCINOLONE ACETONIDE & GRAMICIDIN0.25GM + 0.1G+100000IU+0.025G/100GAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTTOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/0227AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDCYRINOL SYRUP PHOLCODINE + EPHEDRIN HCL + CARBINOXAMINE MALEATE 4MG + 7MG + 2MG /5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/0233MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY FACTORY C 2 MICHAEL ERAKLEOUS STREET AGIOS ATHANASSIOS INDUSTRIAL AREA LIMASSOLCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 5 TABLET BLISTER
NDA/MAL/HDP/0741MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOCIPRINCIPROFLOXACIN500MGMEDOCHEMIE LTD 2 MICHAEL ERAKLEOUS STREET AGIOS ATHANASSIOS INDUSTRIAL AREA 4101 AGIOS ATHANASSIOS LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0809BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDPARAPAEDPARACETAMOL120MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/0812BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDFENPAEDIBUPROFEN100MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1081BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDACIDEX SODIUM BICARBONATE + SODIUM ALGINATE + CALCIUM CARBONATE267MG + 500MG + 160MG /10MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SUSPENSIONS 200 ML BOTTLE
NDA/MAL/HDP/1176AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HYDROCHLORIDE1%W/WAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTTOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1225AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDMOSEDIN PLUS SRPSEUDOEPHEDRINE HCL+ LORATIDINE120MG + 5MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1227AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HCL250MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTORAL SOLID ORDINARY TABLETS 7 TABLET STRIP
NDA/MAL/HDP/1240BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDCETIRIZINE HYDRCHLORIDECETIRIZINE HYDRCHLORIDE5MG/5MLPINEWOOD LABORATORIES LTD. -BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/1736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDKLERIMEDCLARITHROMYCIN 500MG MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, 3CYPRUSORAL SOLID ORDINARY TABLETS 7 BLISTER CARTON,2 TABLET BLISTER
NDA/MAL/HDP/1743MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDDAPRILLISONOPRIL DIHYDRATE10MG MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, 3CYPRUSORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2595MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDZEPILENCEFAZOLIN1000MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1 G VIAL,10 VIAL CARTON
NDA/MAL/HDP/2601MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 750MGCEFUROXIME 750MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 10 VIAL CARTON
NDA/MAL/HDP/2642MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, 3CYPRUSPARENTERAL ORDINARY DRY VIALS 1 G VIAL,10 VIAL CARTON,10 ML AMPOULE
NDA/MAL/HDP/3609AMOUN PHARMACEUTICAL INDUSTRIES COBOOTS PHARMACEUTICALS LIMITEDANTINALNIFUROXAZIDE200MGAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 12 CAPSULE BLISTER,1 BLISTER CARTON,12 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3650AMOUN PHARMACEUTICAL INDUSTRIES COBOOTS PHARMACEUTICALS LIMITEDANTINALNIFUROXAZIDE220MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE
NDA/MAL/HDP/6574MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDARCHIFARMEROPENEM1GMEDOCHEMEMIE LTD 1-10 CONSTANTINOUPOLEOS STREET 3011 LIMASSOLCYPRUSPARENTERAL ORDINARY DRY VIALS 1 G VIAL,10 VIAL CARTON
NDA/MAL/HDP/8314ZIFAM PINNACLE PTY. LTD. BOOTS PHARMACEUTICALS LIMITEDCIPROZIF ? 500CIPROFLOXACIN HYDROCHLORIDE USP 500MG FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4946ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICALS CO. LTDMOVATECLOBETASOL0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL CREAMS 30 G TUBE
NDA/MAL/HDP/5106ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICALS CO. LTDLEMOVATE CREAMCLOBETASOL PROPIONATE0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL CREAMS 30 G TUBE
NDA/MAL/HDP/6619ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICALS CO. LTDORANVATECLOBETASOL PROPIONATE0.05G/100GESAPHARMA SRL PHARMACEUTICAL LABORATORY VIA DE GASPERI 13 20066 MELZO (MILAN) ITALYTOPICAL EXTERNAL GELS AND SOLS 30 G TUBE
NDA/MAL/HDP/0196CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIRLAMIVUDINE/ZIDOVUDINE150MG/300MGQUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK + KAMPALA CIPLA LTD, VERNA IND ESTATE SALCETTE GOA, UGANDAORAL SOLID ORDINARY OTHER TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/0197CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIR-600EFAVIRENZ600MGCIPLA LTD, PLOT NO. L-139, VERNA, GOA 403 722 INDI + CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA INDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/0198CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIMUNENEVIRAPINE200MGQUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/1906CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/3118CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLUMARTEMARTEMETHER /LUMEFANTRINE20MG /120MGQUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 24 TABLET BLISTER,1 BLISTER CARTON,30 BLISTER CARTON,6 TABLET BLISTER,1 BLISTER CARTON,30 BLISTER CARTON,12 TABLET CARTON,1 BLISTER CARTON,30 BLISTER CARTON,18 TABLET CARTON,1 BLISTER CARTON,30 BLISTER CARTON
NDA/MAL/HDP/7162CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTEXAVIRTENOFOVIR DISOPROXIL FUMARATE 300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/7274CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIR 0.5MGENTECAVIR0.5MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7663CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIRENTECAVIR MONOHYDRATE1.0MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8093CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR-NZIDOVUDINE/ LAMUVIDINE/ NEVIRAPINE300MG/150MG/ 200MGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET BOTTLE,30 TABLET BOTTLE
NDA/MAL/HDP/6121?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD DEXIRENDEXKETOPROFEN TROMETAMOL25MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7293?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD ALRINASTDESLORATADINE5MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7716CORE ACCESSCORE ACCESS LTD ALRINAST 2.5 MG / 5 ML SYRUPDESLORATIDINE2.5 MG / 5 ML?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL LIQUID ORDINARY SYRUPS 150 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/8348?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD IRBECOR PLUS 300MG/12.5MGIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG?LKO ?LA? SANAYI VE TIC. A.?. 3. ORGANIZE SANAYI B?LGESI. KUDDUSI CAD. 23. SOK. NO: 1, SEL?UKLU-KONYA/TURKEYINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8392?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD IRBECOR PLUS 150MG/12.5MGIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG?LKO ?LA? SANAYI VE TIC. A.?. 3. ORGANIZE SANAYI B?LGESI. KUDDUSI CAD. 23. SOK. NO: 1, SEL?UKLU-KONYA/TURKEYTURKEYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER, 2 BLISTER CARTON
NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER
NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCIN 500 AZITHROMYCIN500MGBLISS GVS PHARMA LTD PLOT NO. 10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE PALGHAR DIST THANEINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/0367BLISS GVS PHARMA PVT LTDDELMAW ENTERPRISES LIMITEDBG-ZOLE -400 ALBENDAZOLE400MGBLISS GVS PHARMA LIMITED PLOT NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER
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, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 200 ML BOTTLE
NDA/MAL/HDP/0662BLISS GVS PHARMA LTDDELMAW ENTERPRISES LIMITEDRECTIN 100INDOMETHACIN100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 5 SUPPOSITORY STRIP,2 STRIP CARTON
NDA/MAL/HDP/0663BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGLYCERINGLYCERIN1GBLISS GVS PHARMA LIMITED-PLOT NO. 10 SURVEY NO.38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 5 SUPPOSITORY STRIP,1 STRIP CARTON
NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-PLOT NO. 10 SURVEY NO.38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 5 SUPPOSITORY BLISTER
NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE,NEOMYCIN,NYSTATIN500,65000I.U,100000I.UBLISS GVS PHARMA LIMITED-PLOT NO. 10 SURVEY NO.38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL COMBINATION PACK TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1260BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDIABETAGLIBENCLAMIDE 5MGBLISS GVS PHARMA LIMITED-PLOT NO. 10 SURVEY NO.38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX- DS 100CEFIXIME100MG/5MLSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/1290SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX 400 CAPCEFIXIME400MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1299SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE PLUS-1000CEFTRIAXONE/SULBACTAM1000MG/500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.5 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/1312BLISS GVS PHARMA LTDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LTD, PLOT NO 10, SURVEY NO 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, MAHARASHTRAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 5 SUPPOSITORY BLISTER
NDA/MAL/HDP/1393SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFURCEFUROXIME500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/1394SANCE LABORATORIES PRIVATE LTDDELMAW ENTERPRISES LIMITEDSAPIME -1000CEFEPIME1000MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 15 ML VIAL,1 VIAL CARTON
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, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/1707XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDFEBRICOL TABLETSPARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE500MG / 30MG /2MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/1925BLISS GVS PHARMA LTDDELMAW ENTERPRISES LIMITEDG - ALFENAC- PACECLOFENAC + PARACETAMOL100MG + 500MGBLISS GVS PHARMA LTD PLOT NO. 10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE PALGHAR, DIST THANEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2195XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDEUDERM CREAMUREA10%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 45 G TUBE
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-INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 80 ML BOTTLE
NDA/MAL/HDP/2450BLISS GVS PHARMA LTDDELMAW ENTERPRISES LIMITEDTODAY PESSARYNONOXYNOL-95%W/VBLISS GVS PHARMA LTD PLOT NO. 10 SURVEY NO.381 DEWAN UDYOG NAGAR ALIYALI VILLAGE PALGHAR DIST THANE MAHARASHTRAINDIAVAGINAL TABLETS 5 PESSARY BLISTER
NDA/MAL/HDP/2458XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDPRISTINEX 2% CREAMKETOCONAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 15 G TUBE,2 TUBE CARTON
NDA/MAL/HDP/2479SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH-250 CAPCEPHALEXIN250MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2645SANCE LABORATORIES PRIVATE LTDDELMAW ENTERPRISES LIMITEDSANZIDIME 1000CEFTAZIDINE1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 20 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/2695FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDIDUMSTRAPARACETAMO + IBUPROFEN + CAFFEINE325MG + 200MG + 40MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/2809BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDMAITRIPEG 150OBP/ PEG 1000BP1280MG/ 320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 5 PESSARY STRIP,1 STRIP CARTON
NDA/MAL/HDP/2907BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONARTARTEMETHER/ LUMEFANTRINE80 MG/480 MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGEINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2951 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART FORTE TABLETSARTEMETHER/LUMEFANTRINE40MG/240MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGEINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/2980BLISS GVS PHARMA PVT LTDDELMAW ENTERPRISES LIMITEDLONART TABLETSARTEMETHER/LUMEFANTRINE20MG/120MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGEINDIAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,30 BLISTER CARTON
NDA/MAL/HDP/3123BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDRECTOL 250 SUPPOSITORYPARACETAMOL SUPPOSITORY BP 250MG250MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 5 SUPPOSITORY BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3130BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE 200 SUPPOSITORYARTESUNATE SUPPOSITORY200MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 6 SUPPOSITORY STRIP,1 STRIP CARTON
NDA/MAL/HDP/3340BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDPOVEDPOVIDONE IODINE200MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 7 PESSARY STRIP,2 STRIP CARTON
NDA/MAL/HDP/3429XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDEZEDELORATIDINE10MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3528BLISS GVS PHARMA LTDDELMAW ENTERPRISES LIMITEDLONART-DISPERSABLEARTEMETHER/LUMEFANTRINE20MG/120MGBLISS GVS PHARMA LTD PLOT NO.10 SURVEY NO 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST THANE MAHARASTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 6 TABLET BLISTER,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/3600BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXIN TABLETSDIHYDROARTEMISININ/PIPERAQUINE PHOSPHAE40/320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 9 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3655FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDQUADRAJEL GELCHLORHEXIDINE/METRONIDAZOLE/LIDOCAINE5%W/W+1.61%W/W+2.13%W/WFOURRTS (INDIA) LABORATORIES LTD, VANDALUR RD, KELINDIAORAL TOPICAL GELS AND SOLS 15 G TUBE
NDA/MAL/HDP/3678FOURRTS LABORATORIES LTDDELMAW ENTERPRISES LIMITEDREDINPLUSIRON PENTACARBONYL + ZINC SULPHATE MONOHYDRATE + FOLIC ACID + SODIUM SELENITE + LYSINE HYDROCHLORIDE + HISTIDINE HYDROCHLORIDE + CHOLINE BITARTRATE100MG + 30MG + 7.5MG + 0.11MG + 26MG + 4.4MG + 52MGFOURRTS LABORATORIES LTD, VANDALUR ROAD, KERLAMBAKINDIAORAL SOLID ORDINARY CAPSULES 30 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3734XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDZARICORT CREAMMICONAZOLE/HYDROCORTISONE2%W/W + 1%W/WXEPA SAUL PATTINSON MALAYSIA-1-5 INDUSTRIAL ESTATE 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/3736BLISS GVS PHARMA PVT LTDDELMAW ENTERPRISES LIMITEDRECTOL 125 SUPPOSITORYPARACETAMOL125MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGEINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3803BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDICLODYNE SUPPOSITORYDICLOFENAC SODIUM100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3982BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART SUPPOSITORYARTEMETHER/LUMEFANTRINE20/120MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGEINDIARECTAL SYSTEMIC SUPPOSITORIES 6 SUPPOSITORY STRIP,1 STRIP CARTON
NDA/MAL/HDP/4287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE 1000CEFTRIAXONE1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 10 ML VIAL,50 VIAL CARTON
NDA/MAL/HDP/4680SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH DSCEPHALEXIN125MG/5MLSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/4839BLISS GVS PHARMA PVT LTDDELMAW ENTERPRISES LIMITEDANOMEXMULTI-INGREDIENTN/ABLISS GVS PHARMA LTD, PLOT NO. 10, SURVEY NO 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, MAHARASHTRAINDIARECTAL SYSTEMIC SUPPOSITORIES 5 SUPPOSITORY BLISTER,1 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/4906XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDAVORAX TABLETSACYCLOVIR200MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 5 TABLET STRIP,5 STRIP CARTON
NDA/MAL/HDP/4944XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDBENA EXPECTORANTDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE14MG + 135MG + 57.5MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL LIQUID ORDINARY LIQUIDS 120 ML BOTTLE
NDA/MAL/HDP/5010XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDZARIN CREAMCLOTRIMAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/5076XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDDEXTRACIN EYE DROPSDEXAMETHASONE + NEOMYCIN0.1MG + 0.5MGXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/5119FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDKONTRAC 200MISOPROSTOL200MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 BLISTER CARTON,2 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/5169BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGVGYL SUPPOSITORYMETRONIDAZOLE BP500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 2 BLISTER CARTON,5 SUPPOSITORY BLISTER
NDA/MAL/HDP/5324FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDIBUFIL 400IBUPROFEN400MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5338XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDHYDROSIL TABLETSMULTI-INGREDIENTMULTI-INGREDIENTXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6176BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG-GLUTAMIN PLUSVITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID100MG+50MG+100MCG+50MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6239 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATEARTESUNATE60MG/VIAL BLISS GVS PHARMA LTD- PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT)INDIAPARENTERAL ORDINARY DRY VIALS 5 ML AMPOULE,1 ML AMPOULE,1 AMPOULE CARTON,60 MG VIAL,1 VIAL CARTON
NDA/MAL/HDP/6796SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH DSCEPHALEXIN125MG/5MLSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/0722FDC LTDECHO PHARMACY (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/0972PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN DIHYDRATE250MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 15 ML BOTTLE
NDA/MAL/HDP/0975PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDCETRAK SYRUPCETIRIZINE DIHYDROCHLORIDE5MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY SYRUPS 120 ML BOTTLE
NDA/MAL/HDP/0977PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDCETRAKCETERIZINE DIHYDROCHLORIDE10MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0980 PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN250MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1865FDC LTDECHO PHARMACY (U) LIMITEDMYCODERM-C POWDERCLOTRIMAZOLE1%W/WFDC LTD B-8 MIDC INDUSTRIAL AREA WALUJ AURANGABAD 431 136 MAHARASHTRAINDIATOPICAL EXTERNAL OTHER POWDERS/GRANULES 75 G TUBE
NDA/MAL/HDP/2754FDC LTDECHO PHARMACY (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LTD PLOT NO. L121 B VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8143NAARI AGECHO PHARMACY (U) LIMITEDLYDIA POSTPILLEVONORGESTREL1.5MGJAGSONPAL PHARMACEUTICALS LTD PLOT NO 14-16/55-57 SECTOR 5 II E PANT NAGAR (U.S NAGAR) 263153 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8144NAARI AGECHO PHARMACY (U) LIMITEDMA KAREMIFEPRISTONE + MISOPROSTOL200MG+ 200MCG JAGSONPAL PHARMACEUTICALS LTD-PLOT NO.14-16,55-57,SECTOR-5,IIE PANT NAGAR,SIDCUL,RUDRAPUR UDHAM SINGH NAGAR,UTTARAKHAND-263153 INDIAINDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER
NDA/MAL/HDP/8251HEALTHCARE PHARMACEUTICALS LTDECHO PHARMACY (U) LIMITEDFUROTILCEFUROXIME AXETIL250MGHEALTHCARE PHARMACEUTICALS LTD -RAJENDRAPUR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0174GLAXO SMITHKLINE LTDERIS LTDFLIXOTIDE 50FLUTICASONE PROPIONATE50MCG/ACTUATIONGLAXO WELLCOME S.A. AVENIDA DE EXTREMADURA 3 09400 ARANDA DE DUERO BURGOSSPAINNASAL TOPICAL UNIT DOSE AEROSOLS 120 METERED DOSE CANNISTER
NDA/MAL/HDP/0201GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE 125FLUTICASONE PROPIONATE125MCG/ACTUATIONGLAXO WELLCOME S.A.SPAINNASAL TOPICAL METERED DOSE AEROSOLS 120 METERED DOSE CANNISTER
NDA/MAL/HDP/0203GLAXOSMITHKLINE LTDERIS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUXFRANCEOTHER SYSTEMIC PRESSURISED AEROSOLS 120 METERED DOSE CANNISTER
NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY FILM COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/0275GLAXOSMITHKLINE LTDERIS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD HAWKINS AVENUE EPPING 7460SOUTH AFRICAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0284GLAXOSMITHKLINE LTDERIS LTDCLAVULINAMOXICILLIN/CLAVULANIC ACID1000MG/200MGSMITHKLINE BEECHAM PHARMACEUTICALS, CLAREDON ROAD, WORTHING WEST, SUSSEX, BN1480HUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 1.2 G VIAL,10 VIAL CARTON
NDA/MAL/HDP/0404GLAXOSMITH KLINE LTDERIS LTDACTIFED WET COUGH & COLDTRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN1.25MG/30MG/100MGGLAXO WELLCOME EGYPT SAE, EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,2 L JERRYCAN
NDA/MAL/HDP/0576GLAXOSMITH KLINE LTDERIS LTDDUODARTDUTASTERIDE, TAMSULOSIN0.5MG,0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANYGERMANYORAL SOLID ORDINARY CAPSULES 30 CAPSULE HDPE BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULINAMOXICILLIN/CLAVULANIC ACID156MG/5MLSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 70 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR 440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS 20 ML BOTTLE
NDA/MAL/HDP/0903GLAXO WELLCOME(KENYA) LTDERIS LTDZANTACRANITIDINE50MG/2MLGLAXO SMITHKLINE MANUFACTURING S.P.A STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA)ITALYPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/1258GLAXO WELLCOME(KENYA),LTDERIS LTDMYOLGIN CAPSULESCHLORZOXANE/PARACETAMOL250MG/300MGGLAXO WELLCOME EGYPT SAE, EL SALAM CITY 11491, CAIROEGYPTORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER, 1 BLISTER CARTON; 10 CAPSULE BLISTER, 2 BLISTER CARTON
NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDENGERIX-B VACCINEHEPATITIS B VACCINE20MCGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY SUSPENSIONS 10 VIAL CARTON,25 VIAL CARTON
NDA/MAL/HDP/1356GLAXO SMITH KLINE LTDERIS LTDREQUIP PD 24 HOUR 2 MGROPINIROLE2MGGLAXO WELLCOME S.A ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1357GLAXO SMITH KLINE LTDERIS LTDREQUIP PD 24 HOUR 4 MGROPINIROLE4MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1472GLAXO WELLCOME (KENYA) LTDERIS LTDFORTUM INJECTIONCEFTAZIDIME1GMGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS 1 G VIAL, 1 VIAL CARTON
NDA/MAL/HDP/1505GLAXOSMITHKLINEERIS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION, 23 RUE LAVOISUER INDUST , GLAXO WELLCOME EVREUX , FRANCEFRANCETOPICAL METERED-DOSE PRESSURISED AEROSOLS 1 CANNISTER CARTON
NDA/MAL/HDP/1522GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPENAMOXAMOXYCILLIN250MGMEDREICH STERILAB LTD, 12TH MILE, OLD MADRAS RD, V INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/1557GLAXOSMITHKLINEERIS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE PROTEIN D VACCINE1 DOSE (0.5ML), 2DOSES (1.0ML)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1 DOSE PRE- FILLED SYRINGE
NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN125MG/5MLSMITHKLINE BEECHAM CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDERIS LTDPANADOL EXTRAPARACETAMOL,CAFFEINE500MG,65MGGLAXOSMITHKLINE LTD LIKONI ROAD, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,20 TABLET BLISTER,100 TABLET CARTON
NDA/MAL/HDP/1640GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDALBEN TABLETSALBENDAZOLE400MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA ,MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIAINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,10 TABLET BLISTER,500 TABLET CONTAINER
NDA/MAL/HDP/1673GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION TERRAS 2, ZONE INDUSTRIELLE DE LA PEYENNIERE,53100 MAYENNE, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1694GLAXO WELLCOME(KENYA),LTDERIS LTDBETNOVATE CREAMBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDERIS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOMUNITED KINGDOMNASAL SYSTEMIC UNIT DOSE AEROSOLS 120 METERED DOSE CANNISTER
NDA/MAL/HDP/1726GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDHAVRIX 720HEPATITIS A VACCINE720 ELISASMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUMBELGIUMPARENTERAL ORDINARY SUSPENSION 1 VIAL CARTON
NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDENGERIX-B VACCINEHEPATITIS B VACCINE10MCGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY SUSPENSION 10 VIAL CARTON,25 VIAL CARTON
NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOX NEONATAL DROPSAMPICILLIN/CLOXACILLIN90MG/0.6MLMEDREICH STERILAB LTD.-49(B&C)BOMMASANDRA IND. AREA ANEKOL, TALUCK,BANGALORE 562 158, INDIAUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 8 ML BOTTLE
NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDERIS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/1985GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXA ORAL SUSPENSION 250MG/5MLCEFUROXIME AXETIL250MG/5MLGLAXO OPERATIONS UK LTD, HAMIRE ROAD, BARNARD CASTUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE
NDA/MAL/HDP/2003GLAXO SMITHKLINE LTDERIS LTDPROTEDEX 1GCEFTRIAXONE1GGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS 1 G VIAL
NDA/MAL/HDP/2051GLAXO SMITH KLINE LTDERIS LTDPIRITON TABLETSCHLORPHENIRAMINE MALEATE4MGGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1000 TABLET CONTAINER
NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDERIS LTDROTARIXROTAVIRUS VACCINE LIVENLT 10 TO POWER 6 CCID50GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMLYOPHILIZED POWDER FOR ORAL SUSPENSION 1.5 ML BOTTLE
NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDERIS LTDAUGMENTIN 457MG/5MLAMOXICILLIN/CLAVULANIC ACID400MG+57MG/5MLSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY GRANULES FOR SUSPENSION70 ML BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDERIS LTDZINNATCEFUROXIME AXETIL250MGGLAXO OPERATIONS UK LTD, BARNARD CASTLEUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,50 TABLET CARTON
NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULINAMOXICILLIN/CLAVULANIC ACID228MG/5MLSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 70 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2375GLAXOSMITHKLINE LTDERIS LTDCLAVULIN IGAMOXICILLIN/CLAVULANIC ACID875MG/125MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2378GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTINAMOXICILLIN/CLAVULANIC ACID1000MG/200MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 1.2 G VIAL,10 VIAL CARTON
NDA/MAL/HDP/2383GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTINAMOXICILLIN/CLAVULANIC ACID500MG/100MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 25 ML VIAL,10 VIAL CARTON
NDA/MAL/HDP/2505GLAXO WELLCOME(KENYA),LTDERIS LTDBETNOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDERIS LTDZINNATCEFUROXIME AXETIL500MGGLAXO OPERATIONS UK LTD,-BARNARD CASTLEUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,50 TABLET CARTON
NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTIN BDAMOXICILLIN/CLAVULANIC ACID500MG/125MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER
NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDERIS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,2 L BOTTLE
NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDERIS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY AMPOULES 0.5 ML AMPOULE
NDA/MAL/HDP/2884NOVARTIS PHARMA SERVICES INC.ERIS LTDHYCAMTINTOPOTECAN HYDROCHLORIDE4MGGLAXOSMITHKLINE MANUFACTURING SPA STRADA PROVINCIALE ASOLANA 9043056 SAN POLO DI TORRILE PHARMAITALYPARENTERAL ORDINARY VIALS 17 ML VIAL,5 VIAL CARTON
NDA/MAL/HDP/2986GLAXO WELLCOME(KENYA) LTDERIS LTDOXYBRAL SRVINCAMINE30MGGLAXO WELLCOME EGYPT SAE, EL SALAM CITY 11491, CAIROEGYPTORAL SOLID ORDINARY SLOW RELEASE CAPSULES 10 CAPSULE BLISTER,1 BLISTER CARTON; 10 CAPSULE BLISTER, 2 BLISTER CARTON
NDA/MAL/HDP/2992GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDHAVRIX 1440AMPICILLIN TRIHYDRATE BP,HEPATITIS A VACCINE1440 ELISASMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUMBELGIUMPARENTERAL ORDINARY SUSPENSION VIALS 1 VIAL CARTON
NDA/MAL/HDP/3033GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPENAMOXAMOXICILLIN125MG/5MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3046GLAXOSMITHKLINE LTDERIS LTDCLAVULINAMOXICILLIN/CLAVULANIC ACID400MG/57MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY GRANULES FOR SUSPENSION 70 ML BOTTLE
NDA/MAL/HDP/3111GLAXOSMITH KLINE LTDERIS LTDCALPOLPARACETAMOL120MG/5MLGLAXOSMITHKLINE LIMITED, LIKONI ROAD INDUSTRIAL AREA, VIWANDANI OO507, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3285GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN250MG/5MLSMITHKLINE BEECHAM CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3384GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXA 250MGCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3387GLAXO SMITH KLINE LTDERIS LTDPROXIMEXA 500MGCEFUROXIME AXETIL500MGGLAXO OPERATIONS UK LTD, HAMIRE ROAD, BARNARD CASTUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3393GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTINAMOXICILLIN/CLAVULANIC ACID250MG/125MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3404GLAXOSMITHKLINE LTDERIS LTDCLAVULINAMOXICILLIN/CLAVULANIC ACID500MG/100MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 600 MG VIAL,10 VIAL CARTON
NDA/MAL/HDP/3405GLAXO SMITH KLINE LTDERIS LTDPANADOL BABY AND INFANT 120MG/5MLPARACETAMOL ORAL SUSPENSION120MG/5MLFARMACLAIR FRANCEORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3460GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDMALANIL ADULT TABLETSATOVAQUONE + PROGUANIL HCL250MG + 100MGGLAXO WELLCOME S.A. AVDA EXTREMADURA 309400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 12 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3530GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE ACCUHALERFLUTICASONE PROPIONATE100MCGGLAXO WELLCOME PRODUCTION ZONE INDUSTRIELLE NO.2 23 RUE LAVOISIER 27000 EVREUXFRANCEDRY POWDER INHALATION 1*60 BLISTERS INHALATION DEVICE
NDA/MAL/HDP/3615GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOXAMPICILLIN/CLOXACILLIN250MG/250MGMEDREICH STERILAB LTD.-49(B&C)BOMMASANDRA IND. AREA ANEKOL, TALUCK,BANGALORE 562 158, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3622GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXACEFUROXIME AXETIL 125MG/5MLGLAXO OPERATIONS UK LTD, HARMIRE RD, BARNARD CASTLUNITED KINGDOMORAL LIQUID ORDINARY GRANULES FOR SUSPENSION50 ML BOTTLE
NDA/MAL/HDP/3639GLAXO SMITH KLINE LTDERIS LTDPANADOL ADVANCEPARACETAMOL500MGGLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER; 10 BLISTER CARTON,11 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3668GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTIN BDAMOXICILLIN/CLAVULANIC ACID228MG/5MLSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 70 ML BOTTLE,140 ML BOTTLE
NDA/MAL/HDP/3671GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULIN TABLETSAMOXICILLIN/CLAVULANIC ACID500MG/125MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,20 TABLET STRIP,14 TABLET STRIP
NDA/MAL/HDP/3762GLAXO WELLCOME (KENYA) LTDERIS LTDLAMICTAL 2MGLAMOTRIZINE2MGGLAXO WELLCOME INCUNITED STATESORAL SOLID ORDINARY TABLETS 30 TABLET BLISTER, 1 BLISTER CARTON
NDA/MAL/HDP/3885GLAXO WELLCOME(KENYA) LTDERIS LTDZANTACRANITIDINE150MGGLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER, 1 BLISTER CARTON; 20 TABLET CARTON,30 TABLET CARTON
NDA/MAL/HDP/3903PFIZER LABS LTDERIS LTDCELSENTRI 300MGMARAVIROC300MGGODECKE GMBH -MOOSWALDALLEE 179090, FREIBERG GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/3907GLAXOSMITH KLINE LTDERIS LTDANDREWS LIVER SALT REGULARMAGNESIUM SULPHATE +SODIUM HYDROGEN CARBONATE +CITRIC ACID17.4 %W/W+22.6 % W/W+19.5 % W/WSMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYAKENYAORAL SOLID ORDINARY POWDERS 5 G SACHET,8 SACHET CARTON; 5 G SACHET, 48 SACHET CARTON
NDA/MAL/HDP/3914GLAXOSMITHKLINE LTDERIS LTDAUGMENTINAMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3981GLAXO SMITH KLINE LTDERIS LTDPENAMOXAMOXYCILLIN500MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,20 CAPSULE BLISTER,25 BLISTER CARTON,500 CAPSULE CONTAINER
NDA/MAL/HDP/4062GLAXO SMITH KLEINE LIMITED ERIS LTDKIVEXAABACAVIR/LAMIVUDUNE600MG + 300MGGLAXO OPERATIONS (UK) LTD, PRIORY STREET, WARE, HERTFORDSHIRE UNITED KINGDOMORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4085GLAXO WELLCOME (KENYA) LTDERIS LTDZINACEFCEFUROXIME SODIUM750MGGLAXO WELLCOME -VERONA ITALYITALYPARENTERAL ORDINARY DRY VIALS 750 MG VIAL, 1 VIAL CARTON
NDA/MAL/HDP/4097GLAXOSMITHKLINE LTDERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS 25 G TUBE,1 TUBE CARTON; 30 G TUBE, 1 TUBE CARTON
NDA/MAL/HDP/4103GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPOLIO SABIN - ONE AND THREE [ORAL]BIVALENT ORAL POLOIMYELITIS VACCINE TYPES 1 & 3 ( BOPV)POLIOVIRUS TYPE 1 :>/= 10 TO POWER 6 CCID50 + POLIO VIRUS TYPE 3: >/= 10 TO POWER 5.8 CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSARTBELGIUMORAL LIQUID ORDINARY LIQUIDS 20 DOSE VIAL,100 VIAL CARTON
NDA/MAL/HDP/4289GLAXOSMITHKLINE LTDERIS LTDTWINRIX ADULTHEPATITIS A ANTIGEN (INACTIVATED) HEPATITIS B SURFACE ANTIGEN720 ELISA UNITS, 20MCGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1 ML VIAL
NDA/MAL/HDP/4294GLAXO SMITHLINE LIMITEDERIS LTDFLIXOTIDE ACCUHALER 250FLUTICASONE PROPIONATE250MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCEDRY POWDER INHALATION 250MCG BLISTER, 60 BLISTERS INHALATION DEVICE
NDA/MAL/HDP/4302GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE ACCUHALER 500FLUTICASONE PROPIONATE500MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCEDRY POWDER INHALATION 500MCG BLISTER, 60 BLISTERS INHALATION DEVICE
NDA/MAL/HDP/4310GLAXOSMITHLINE LTDERIS LTDACTIFED SYRUPTRIPLORIDINE HCL/PSEUDOEPHEDRINE1.25MG/30MGGLAXO WELLCOME EGYPT SAE, EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE,2 L JERRYCAN
NDA/MAL/HDP/4339GLAXOSMITHKLINE LIMITEDERIS LTDSERETIDE 125 EVOHALERSALMETEROL XINAFOATE + FLUTICASONE PROPIONATE120 METERED DOSES (25/125MCG)GLAXO WELLCOME PRODUCTION, 23 RUE LAVOISUER INDUST ,GLAXO WELLCOME EVREUX , FRANCEFRANCELUNG ADMINISTRATION METERED-DOSE INHALER 120 METERED DOSE CANNISTER, 1 CANNISTER CARTON
NDA/MAL/HDP/4380GLAXO WELLCOME (KENYA) LTDERIS LTDZINNAT SUSPENSIONCEFUROXIME AXETIL-125MG/5MLGLAXO OPERATIONS UK LTD,-BARNARD CASTLEUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/4541GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN500MGGLAXO WELLCOME PRODUCTION TERRAS 2, ZONE INDUSTRIELLE DE LA PEYENNIERE,53100 MAYENNE, FRANCEUNITED KINGDOMORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4620GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDMALANIL PAEDIATRIC TABLETATOVAQUONE/ PROGUANIL62.5MG/ 25.0 MGGLAXO WELLCOME S.A. AVDA EXTREMADURA 309400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 12 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4640GLAXOSMITHLINE LTDERIS LTDREQUIP PD 24 HOUR 8 MGROPINIROLE8MGGLAXO WELLCOME S.A ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4722GLAXO SMITHKLINE LTDERIS LTDACTIFED COLD TABLETSMULTI-INGREDIENTMULTI-INGREDIENTGLAXO WELLCOME EGYPT SAE, EL SALAM CITY 11491, CAIROEGYPTORAL SOLID ORDINARY TABLETS 12 TABLET BLISTER,96 TABLET BLISTER,480 TABLET BLISTER,500 TABLET BLISTER
NDA/MAL/HDP/4724GLAXOSMITH KLINE LTDERIS LTDACTIFED DRY COUGH & COLDMULTI-INGREDIENTN/AGLAXO WELLCOME EGYPT SAE, EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE,2 L JERRYCAN
NDA/MAL/HDP/4779GLAXO WELLCOME (KENYA) LTDERIS LTDCUTIVATEFLUTICASONE PROPIONATE0.05%W/WGLAXO WELLCOME (UK)-UKUNITED KINGDOMTOPICAL EXTERNAL CREAMS 30 G TUBE
NDA/MAL/HDP/4780GLAXO WELLCOME (KENYA) LTDERIS LTDCUTIVATEFLUTICASONE PROPIONATE0.005%W/WGLAXO WELLCOME (UK)-UKUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 30 G TUBE
NDA/MAL/HDP/4859GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDFLOXAPENFLUCLOXACILLIN250MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY CAPSULES 100 BLISTER CARTON
NDA/MAL/HDP/4862GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDFLOXAPEN SYRUPFLUCLOXACILLIN125MG/5MLMEDREICH LIMITED-12TH MIL,OLD MADRAS ROAD,VIRGONAGAR,BANGALORE-560 049,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/4935GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBANMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD HARMIRE ROAD, BARNARD CASTUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 3 G TUBE,15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/4938GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBANMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD HAMIRE RD BARNARD CASTLE DURHAM COUNTYUNITED KINGDOMTOPICAL EXTERNAL CREAMS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/4941GLAXO SMITH KLINE LTDERIS LTDBEECHAMS POWDERS HOT LEMONMULTI-INGREDIENTN/ASMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYAKENYAORAL SOLID ORDINARY POWDERS 5.6 G SACHET,5 SACHET CARTON,48 SACHET CARTON
NDA/MAL/HDP/5018GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSABUTAMOL100MCGGLAXOWELLCOME PRODUCTION , EVREUX- FRANCE FRANCEMETERED-DOSE PRESSURISED AEROSOLS 100 METERED DOSE CANNISTER
NDA/MAL/HDP/5020GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL2MG/MLGLAXO WELLCOME, LIKONI KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,150 ML BOTTLE
NDA/MAL/HDP/5023GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCOTREICHCO-TRIMOXAZOLE240MG/5MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/5055GLAXOSMITHKLINE LTD UKERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 25 G TUBE,30 G TUBE
NDA/MAL/HDP/5124GLAXOSMITHKLINE LTD BELGIUMERIS LTDINFANRIX-HEXADIPHTHERIA + PERTUSSIS + BORDETELLA/PERTUSSIS + PERTUSSIS + HAEMAGGLUTININ + PERTACTIN + (HEPATITIS B/POLIOVIRUS TYPE 1 +2 +3)NLT 30 IU + NLT 40IU + 25MCG + 25MCG + 8MCG + 10MCG + (TYPE I 40D +TYPE 2 + TYPE 3)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY COMBINATION PACK VIALS 0.5 ML VIAL
NDA/MAL/HDP/5255GLAXOSMITHKLINE LTDERIS LTDENO LEMONFRUIT SALTMULTI-INGREDIENT4.5GGLAXOSMITHKLINE CAPE TOWN , SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY POWDERS 4.5 G SACHET,8 SACHET CARTON; 4.5 G SACHET, 10 SACHET CARTON; 4.5 G SACHET, 48 SACHET CARTON
NDA/MAL/HDP/5400GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDALBEN SUSPENSIONALBENDAZOLE400MG/10MLPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL LIQUID ORDINARY SUSPENSIONS 10 ML BOTTLE
NDA/MAL/HDP/6129GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTRIUMEQDOLUTEGRAVIR + ABACAVIR + LAMIVUDINE50MG + 600MG + 300MGGLAXO OPERATIONS UK LTD WARE UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 30 TABLET HDPE CONTAINER, 1 CONTAINER CARTON
NDA/MAL/HDP/6192GLAXOSMITHKLINE LIMITEDERIS LTDENO FRUIT SALT ORANGESODIUM BICARBONATE ,CITRIC ACID 55.80%W/W,43.20W/WGLAXOSMITHKLINE LTD LIKONI ROAD INDUSTRIAL AREAKENYAORAL SOLID ORDINARY GRANULES 5 G SACHET,10 SACHET CARTON; 5 G SACHET, 48 SACHET CARTON
NDA/MAL/HDP/6807GLAXOSMITHKLINE LTDERIS LTDAUGMENTIN ESAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE600MG + 42.9MGGLAXO WELLCOME PRODUCTION Z.I DE LA PEYENNIERA 53100 MAYENNEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS( STRAWBERRY FRUIT FLAVOUR) 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6810GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCERVARIXHUMAN PAPILLOMA VIRUS VACCINE (RDNA)TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL)GLAXOSMITHKLINE BIOLOGICALS S.S, RUE DE L'INSTITUTEBELGIUMPARENTERAL ORDINARY SUSPENSION0.5ML PRE-FILLED SYRINGE, 1 PRE-FILLED SYRINGE CARTON; 0.5ML VIAL, 10 VIAL CARTON + 25G NEEDLE
NDA/MAL/HDP/6834GLAXO SMITH KLINE LTDERIS LTDRELVAR ELLIPTA 100/25FLUTICASONE FUROATE + VILANTEROL100MCG + 25MCGGLAXO OPERATIONS UK LTD WARE HERTFORDSHIREUNITED KINGDOMLUNG ADMINISTRATION UNIT DOSE POWDER INHALER NON-REFILLABLE 30 DOSE CANNISTER, 1 CANNISTER CARTON
NDA/MAL/HDP/6836GLAXO SMITH KLINE LTDERIS LTDRELVAR ELLIPTA 200/25FLUTICASONE FUROATE + VILANTEROL200MCG + 25MCGGLAXO OPERATIONS UK LTD WARE HERTFORDSHIREUNITED KINGDOMLUNG ADMINISTRATION UNIT DOSE POWDER INHALER NON-REFILLABLE 30 DOSE CANNISTER, 1 CANNISTER CARTON
NDA/MAL/HDP/8100GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOXAMPICILLIN/ CLOXACILLIN250MG/5MLMEDREICH STERILAB LTD.-49(B&C)BOMMASANDRA IND. AREA ANEKOL, TALUCK,BANGALORE 562 158, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/8149GLAXO SMITHKLINE LTDERIS LTDAVODARTDUTASTERIDE0.5MGGLAXOSMITHKLINE PHARMACEUTICALS S.A. UL. GRUNWALDZKA 189 60-322 POZNA?POLANDORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8239GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDUMBIPRO GELCHLORHEXIDINE 4%W/WGLAXO OPERATIONS UK LTD HARMIRE ROAD BARNARD CASTLE CO.DURHAM DL12 8DTUNITED KINGDOMTOPICAL EXTERNAL GELS AND SOLS 7 SACHET CARTON
NDA/MAL/HDP/8246PHARMACIA S.P.AERIS LTDALDACTONESPIRONOLACTONE25MGPIRAMAL HEALTHCARE UK LTD WHALTON ROAD MORPEFT NORTHMBERLAND NE613YA UNITED KINGDOMORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4318UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDAKUGABALIN PREGABALIN 75MG CAPSULES75MGAKUMS DRUGS & PHARMACEUTICALS LTD 19, 20,21 SECTOR 6A I.I.E SIDCUL RANPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY CAPSULES 3 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HDP/6086 UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWEL-PACECLOFENAC,PARACETAMOL100MG+500MGAKUMS DRUGS & PHARMACEUTICALS LTD 19, 20,21 SECTOR 6A I.I.E SIDCUL RANPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6090 UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDPROSTAR 200PROGESTERONE100MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD 47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403INDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/6141UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWELACECLOFENAC100MGAKUMS DRUGS & PHARMACEUTICALS LTD 19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/6647UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDJOYCLAV -625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG + 125MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7692UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCEFECTRON-S 1.5 GCEFOPERAZONE SODIUM+SULBACTAM SODIUM1000MG + 500MG AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.5 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/7695UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCORTUM 500CEFUROXIME AXETIL500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7745UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTAZOGARDPIPERACILLIN +TAZOBACTAM 4G + 0.5GAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY DRY VIALS 4.5 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/7747UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTHERMODOLPARACETAMOL1.0%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LTD UNIT II VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/1893UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTRIKA 0.25 TABLETSALPRAZOLAM0.25MGUNICHEM LABORATORIES LTD, 17/18 PILERNE IND. ESTAT INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSA-HLOSARTAN / HYDROCHLOROTHIAZIDE50MG / 12.5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCITIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LTD, VILLAGE BHATAULI KALA, BINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HCL50MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2404UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD, VILLAGE BHATAULI KALA, BINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2790UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 20ATORVASTATIN20MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER, 1 BLISTER CARTON
NDA/MAL/HDP/2792UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 10ATORVASTATIN10MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/3444UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 10AMLODIPINE BESILATE10MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/3547UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORBIS-10BISOPROLOL10 MGUNICHEM LABORATORIES LIMITED UNIT -II, VILLAGE BHATAULI , BADDI, 173205 DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/3733UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HCL100MG/2MLUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,50 AMPOULE CARTON,25 AMPOULE CARTON
NDA/MAL/HDP/3767UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAMPOXIN 500AMPICILLIN/CLOXACILLIN250MG/250MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3777UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAMPOXIN 500AMPICILLIN/CLOXACILLIN250MG/250MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAPARENTERAL ORDINARY DRY VIALS 500 MG VIAL
NDA/MAL/HDP/3872UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCET SYRUPCETIRIZINE HYDROCHLORIDE5MG/5MLUNICHEM LABORATORIES LTD, C31 & 32 INDUSTRIAL AREA INDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/5489UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORBIS-5BISOPROLOL5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/0806SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE ZINCZINC SULPHATE20MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY DISPERSIBLE TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0966SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCLOFENAC DTDICLOFENAC SODIUM50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTD KALIAKOIR GAZIPURBANGLADESHORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/0978SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROX 75 SR CAPSULEAMBROXOL75MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 3 BLISTER CARTON,10 CAPSULE BLISTER
NDA/MAL/HDP/0983SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDANADOL CAPSULESTRAMADOL HYDROCHLORIDE 50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0987SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALATROL TABLETS CETIRIZINE10MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1002SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPROCIN T 750CIPROFLOXACIN750MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER, 2 BLISTER CARTON
NDA/MAL/HDP/1038SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME TRIHYDRATE 200MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1040SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3 DSCEFIXIME TRIHYDRATE 400MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER
NDA/MAL/HDP/1043SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDFLEXI 100 ACECLOFENAC100MGSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1045SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIMAX 500 AZITHROMYCIN500MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1180SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIF TIMED RELEASED CAPSULESDRIED FERROUS SULPHATE+ZINC SULPHATE MONOHYDRATE+FOLIC ACID150MG+61.8MG+0.5MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2606SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDPROTAS 40ESOMEPRAZOLE40MGSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2735SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDFORCECETPIROME1GSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHPARENTERAL ORDINARY DRY VIALS 1 G VIAL,1 VIAL CARTON,10 ML AMPOULE (WFI)
NDA/MAL/HDP/4720SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEFTRONCEFTRIAXONE1GSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHPARENTERAL ORDINARY DRY VIALS 1 G VIAL, 1 VIAL CARTON,10 ML AMPOULE(WFI)
NDA/MAL/HDP/6106SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDTREVOX 500LEVOFLOXACIN HEMIHYDRATE500MGSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6107SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSULPREXIPRATROPIUM BROMIDE,SALBUTAMOL SULPHATE500MCG/2.5ML,2.5MG/2.5MLSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHLUNG ADMINISTRATION LIQUID FOR NEBULIZATION 10 AMPOULE CARTON
NDA/MAL/HDP/6108SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDTREVOX 750LEVOFLOXACIN HEMIHYDRATE750MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6109SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMEXLOLOMEFLOXACIN HYDROCHLORIDE0.3%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 5 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6110SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROXAMBROXOL HYDROCHLORIDE15MG/5ML SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6111SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMOTIFASTDOMPERIDONE10MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY DISPERSIBLE TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6112SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSULTOLINSALBUTAMOL SULPHATE2.5MG/2.5ML SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHLUNG ADMINISTRATION LIQUID FOR NEBULIZATION 2.5 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6139SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSERVIN CAPSULEFERROUS SULPHATE+FOLIC ACID+THIAMINE MONONITRATE+RIBOFLAVIN+PYRIDOXINE HYDROCHLORIDE+NICOTINAMIDE+ASCORBIC ACID150MG+0.5MG+2MG+2MG+1MG+10MG+50MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6170SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALACOT 0.1% EYE DROPSOLOPATADINE HYDROCHLORIDE0.1%W/VSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHOPHTHALMIC DROPS 5 ML HDPE BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/6182SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALARIDKETOTIFEN FUMARATE0.025%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/6623SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDREFINAC SRDICLOFENAC SODIUM100MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6624SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDCIPROKENCIPROFLOXACIN HYDROCHLORIDE0.3%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 5 ML LDPE BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/7246 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDDESLORATDESLORATIDINE5MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/7291 PHARCO PHARMACEUTICALSGAMA PHARMACEUTICALS (U) LIMITEDDERMATIN CREAMCLOTRIMAZOLE1%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTTOPICAL EXTERNAL CREAMS 12 G TUBE, 1 TUBE CARTON
NDA/MAL/HDP/8287 PHARCO PHARMACEUTICALSGAMA PHARMACEUTICALS (U) LIMITEDDERMATIN 1% POWDERCLOTRIMAZOLE+ZINC OXIDE0.01G + 2.500GPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTTOPICAL EXTERNAL POWDERS 10 G CONTAINER
NDA/MAL/HDP/0007 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORID2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/0022 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/0045 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/0088 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKZINC SULPHATE/ANHYDROUS GLUCOSE/SODIUM CHLORIDE/TRISODIUM CITRATE/POTASSIUM CHLORIDE(2.7G/0.52G/0.58G/0.3G)/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COMBINATION PACK SPECIAL FORMS 200 ML SACHET,10 SACHET CARTON + 10 TABLET BLISTER; 1000 ML SACHET,2 SACHET CARTON + 10 TABLET BLISTER; 500 ML SACHET,4 SACHET CARTON+10 TABLET BLISTER
NDA/MAL/HDP/0101AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES (THANE)TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,500 CAPSULE CONTAINER,100 CAPSULE CONTAINER,1000 CAPSULE CONTAINER
NDA/MAL/HDP/0105AGOG PHARMA 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 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER BLISTER,100 TABLET CONTAINER,500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDTETANUS VACCINE ADSORBEDTETANUS 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 500078INDIAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,0.5 ML AMPOULE
NDA/MAL/HDP/0292MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDNAZANEEN ANTACID SUSPENSIONALUMINUM HYDROXIDE+MAGNESIUM HYDROXIDE+ SIMETHICONE3.75+2.724+0.399G/ 200MLMILAN LABS PVT LTD-63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAIINDIAORAL LIQUID ORDINARY SUSPENSIONS 200 ML BOTTLE
NDA/MAL/HDP/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/0422 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/0423AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/0463 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHEN PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 CAPSULE CONTAINER,100 BLISTER CARTON
NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN 250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY VIALS 2 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDASNA ANTIVENOM C B.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE/ N.MELANOLEUCA/ E.CARNATUS25/25/20/25/25/25/25/25/20/25/20/25 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY VIALS 10 ML VIAL
NDA/MAL/HDP/0635AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/0670 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 4 CAPSULE BLISTER,1 BLISTER CARTON; 4 CAPSULE BLISTER, 5 BLISTER CARTON
NDA/MAL/HDP/0672AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/0674 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON; 10 TABLET BLISTER, 100 BLISTER CARTON
NDA/MAL/HDP/0677 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON; 10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/0679AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/0688 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0689 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID 500MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0694AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0795 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-250PHENOXYMETHYL PENICILLIN POTASSIUM250MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0835AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/0902 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SRNIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1037AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE + TENOFOVIRLAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/1049AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/1052 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDMICLOGEN MICLONAZOLE/CLOBETASOL/GENTAMICIN 2%/0.05/0.1 W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1053AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-125 DT AMOXICILLIN125MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIAORAL SOLID ORDINARY DISPERSIBLE TABLETS 10 TABLET BLISTER, 2 BLISTER CARTON; 10 TABLET BLISTER, 3 BLISTER CARTON; 10 TABLET BLISTER, 10 BLISTER CARTON
NDA/MAL/HDP/1054AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER, 1 BLISTER CARTON
NDA/MAL/HDP/1056AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENT BETAMETHASONE AND NEOMYCIN0.1%W/W AND 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/1079AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUINE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/1087AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/1100 AGOG PHARMA LTDGITTOES 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 INDIAINDIATOPICAL EXTERNAL CREAMS 5 G TUBE,10 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/1103 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1112AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE CAPSULESZIDOVUDINE100MGAUROBINDO PHARMA LTD, UNIT III SURVEY NO.313 BACHU INDIAORAL SOLID ORDINARY CAPSULES 100 CAPSULE CONTAINER
NDA/MAL/HDP/1123AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPAR PARACETAMOL500MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,100 TABLET CONTAINER,10 BLISTER CARTON
NDA/MAL/HDP/1124 AGOG PHARMA LTDGITTOES 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 INDIAINDIATOPICAL EXTERNAL LIQUIDS 500 ML BOTTLE
NDA/MAL/HDP/1136AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL EMULSIONS 100 ML BOTTLE
NDA/MAL/HDP/1138 AGOG PHARMA LTDGITTOES 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 INDIAINDIATOPICAL EXTERNAL LOTIONS 60 ML PET BOTTLE, 1 BOTTLE CARTON; 100 ML PET BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/1139AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE0.1W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1140AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1142 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE 1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/1242 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1247 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1264CENTAUR DRUG HOUSE PVT LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORID1%W/WCENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIAINDIAOPHTHALMIC OINTMENTS 3.5 G TUBE,5 G TUBE
NDA/MAL/HDP/1265 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEX VIT.B1/ VIT.B2/ NICOTINAMIDE/ VIT.B61.0MG/ 1.0MG/ 15MG/ 0.5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/1344GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDLIDOCAINELIDOCAINE2%W/VNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/1427AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON,14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1474 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODICDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL GELS AND SOLS 30 G TUBE
NDA/MAL/HDP/1476 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OTHER CREAMS 20 G TUBE
NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/1544 AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1566AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULITI-INGREDIENTN/AAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY SUGAR-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDRHOCLONEANTI RHO-D IMMUNOGLOBULIN INJECTION, MONOCOLNAL300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY FREEZE DRIED VIALS 2 ML VIAL,1 VIAL CARTON
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 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,200 ML BOTTLE,170 ML BOTTLE
NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 30 ML BOTTLE
NDA/MAL/HDP/1598 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1616AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 30 ML BOTTLE,60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/1631AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD,UNIT III, SURVEY NO.313, BACHINDIAORAL SOLID ORDINARY SUSPENSIONS 240 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/1642 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDEUCHLOR-1000CHLORAMPHENICOL SODIUM SUCCINNATE B.P1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/1660AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,10 TABLET STRIP,100 STRIP CARTON
NDA/MAL/HDP/1665 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/1748AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 3 CAPSULE BLISTER
NDA/MAL/HDP/1765 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1782 AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS 30 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/1786 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1809AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1810AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1868AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE300MGAUROBINDO PHARMA LTD, UNIT III SURVEY NO.313 BACHU INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/1895 AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1900 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY HARD GELATIN CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON;10 CAPSULEBLISTER,2 BLISTER CARTON
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.INDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/1955MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER; 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/1957MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIATOPICAL EXTERNAL OTHER CREAMS 35 G TUBE
NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/1971AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN/CLOXACILLIN250MG+250MG/5MLMILAN LABORATORIES (INDIA) PVT LTD PLOT NOS 63/67/87 JAWAHAR CO-OP INDUSTRIAL ESTATE LTD KAMOTHE PANVEL NAVI MUMBAI 410209 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/1976CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDOROGELCHOLINE SALICYLATE+LIGNOCAINE HCL+BENZALKONIUM CHL8.7%W/W+2%W/W+0.01%W/WCENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 10 G TUBE
NDA/MAL/HDP/1997AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 BLISTER CARTON,14 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON,14 TABLET BLISTER,2 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2007AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDB-COX TABLETSTETRACYCLINE ,VITAMIN B COMPOUND250,BPC FORMULAAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPMULTI-INGRDIENTMULTI-INGRDIENTCENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/2019AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2031AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID TABLETS100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER; 10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/2039GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDRANITIDINE INJECTION USPRANITIDINE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/2074AGOG PHARMA 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,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2075 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2076 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMIDE FUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,100 BLISTER CARTON
NDA/MAL/HDP/2083BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDHEPATITIS B VACCINE (RDNA)HEPATITIS B VACCINE (RDNA)PAEDIATRIC 0.5ML-1DOSE , ADULT 1ML-1 DOSEBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY VIALS 35 VIAL CARTON
NDA/MAL/HDP/2095AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2098 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2114AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXA-LEVOLEVOFLOXACIN HEMIHYDRATE500MG/100MLAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677INDIAPARENTERAL ORDINARY INFUSION BOTTLES 100 ML BOTTLE
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),INDIAINDIAORAL SOLID ORDINARY TABLETS 120 TABLET CONTAINER
NDA/MAL/HDP/2141CENTAUR DRUG HOUSE PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENT,MULTIINGREDIENTN/A,N/ACENTAUR PHARMA PVT. LTD, PLANT I-PLOT 3, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOA INDIATOPICAL EXTERNAL OINTMENTS 30 G TUBE
NDA/MAL/HDP/2168ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDHYDROCORTISONE INJECTIONHYDROCORTISONE SODIUM SUCCINATE100MGROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAUGERMANYPARENTERAL ORDINARY DRY VIALS 8 ML VIAL
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, CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/2217GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMINOPHYLINE AMINOPHYLINE 25MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,50 AMPOULE CARTON
NDA/MAL/HDP/2253GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDINDOMETHACININDOMETHACIN25MGNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2282 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2289GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOLCHLORAMPHENICOL250MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON; 1000 CAPSULE CONTAINER
NDA/MAL/HDP/2320 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDERO-125ERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY DRY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/2327AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/2335AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBEN TABLETS(THANE)MEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,250 TABLET CONTAINER,100 TABLET CONTAINER,500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/2346AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULFATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLAUROBINDO PHARMA LTD, UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA INDIAORAL LIQUID ORDINARY LIQUIDS 240 ML BOTTLE
NDA/MAL/HDP/2349 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTEANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE,POTASSIUM CHLORIDE2.7G/200ML,0.52G/200ML,0.58G/200ML,0.30G/200MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY POWDERS 200 ML SACHET,500 ML SACHET,1000 ML SACHET
NDA/MAL/HDP/2356GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININEQUININE 600MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
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, CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/2461 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDUMERAN SR - 100DICLOFENAC100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2489 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDUMETAC-150RANITIDINE150MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2508GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHYOSCINEHYOSCINE20MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/2571 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER/LUMEFANTRINE180MG/1080MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 60 ML BOTTLE,30 ML BOTTLE
NDA/MAL/HDP/2594 AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/2672ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDLIDOCAINELIDOCAINE2%W/VROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAUGERMANYPARENTERAL ORDINARY VIALS 20 ML VIAL,25 VIAL CARTON
NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD PLOT NO. K-27 ANANDNAGAR ADDITIONAL M.I.D.CINDIAPARENTERAL ORDINARY VIALS 50 MG VIAL, 1 VIAL CARTON
NDA/MAL/HDP/2717CENTAUR DRUG HOUSE PVT LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAOPHTHALMIC OINTMENTS 3.5 G TUBE
NDA/MAL/HDP/2798UMEDICA LABS PVT LTDGITTOES PHARMACEUTICALS LIMITEDOMEGARDOMEPRAZOLE20MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2802CENTAUR DRUG HOUSE PVT LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/2920CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDTRANSLIPO -C CREAMCLOTRIMAZOLE1%W/WCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIATOPICAL EXTERNAL CREAMS 10 G TUBE,15 G TUBE,20 G TUBE
NDA/MAL/HDP/2940CENTAUR DRUG HOUSE PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR DRUG HOUSE PRIVATE LTD-PLOT 39-41 IND ESTATE KARASWADA MAPUSA GOA 403526 INDIAINDIATOPICAL EXTERNAL OTHER GELS/SOLS 20 G TUBE
NDA/MAL/HDP/2942CENTAUR DRUG HOUSE PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDARGISSEPT CREAMCHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE0.2%W/W / 1%W/WCENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIAINDIATOPICAL EXTERNAL CREAMS 10 G TUBE,20 G TUBE
NDA/MAL/HDP/2946 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO ORAL SUSPENSION(THANE)CO-TRIMOXAZOLE240MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2947AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO TABLETSCO-TRIMOXAZOLE480MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON; 10 TABLET BLISTER, 100 BLISTER CARTON; 250 BLISTER CARTON,500 TABLET BLISTER,1000 TABLET CONTAINER
NDA/MAL/HDP/2982CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDNEURO-FORTE TABLETSVITAMIN B1 + VITAMIN B6 + VITAMIN B12200MG+50MG+1MGCENTAUR PHARMACEUTICALS LTD, KARASWADA MAPUSA GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2995 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDGALLOP LOPERAMIDE HCL CAPSULES USP2MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY HARD GELATIN CAPSULES 10 BLISTER CARTON,10 CAPSULE BLISTER,100 CAPSULE CONTAINER
NDA/MAL/HDP/3003 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOVIR ACICLOVIR 200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3013 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE ALBENDAZOLE 400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,500 TABLET CONTAINER
NDA/MAL/HDP/3021 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDGLIBENCLAMIDE TABLETSGLIBENCLAMIDE TABLETS BP 5MG5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,100 BLISTER CARTON
NDA/MAL/HDP/3023 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOTRAXLEVAMISOLE HCL TABLETS USP40MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 3 TABLET STRIP,10 STRIP CARTON,10 TABLET STRIP,10 STRIP CARTON,500 TABLET CONTAINER
NDA/MAL/HDP/3029AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE SUSPENSIONALBENDAZOLE ORAL SUSPENSION USP200MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 10 ML BOTTLE
NDA/MAL/HDP/3031 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETHASONE DEXAMETHASONE0.5MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3035 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFORTE TONICFERRIC AMMONIUM/FOLIC ACID/PYRIDOXINE/THIAMINE50/0.55/2.4/1.2 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/3037AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT SYRUPVIT A+VIT D3+VIT B1+RIBOFLAVIN+NICOTINAMIDE+VIT B11000IU+200IU+1.5MG+1.5MG+10MG+2.5MCG+40MG / 5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/3040 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODOX DOXYCYCYLINE 100MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY HARD GELATIN CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 CAPSULE CONTAINER,1000 CAPSULE CONTAINER,100 BLISTER CARTON
NDA/MAL/HDP/3048AGOG PHARMA 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,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,14 TABLET BLISTER,3 BLISTER CARTON,6 BLISTER CARTON,2 BLISTER CARTON,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3057AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLD-A-GO CAPSULESPARACETAMOL/PHENYLEPHRINE HCL/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,INDIAINDIAORAL SOLID ORDINARY HARD GELATIN CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/3060AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDKETOS TABLETKETOCONAZOLE TABLETS USP200MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3063AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC-50DICLOFENAC SODIUM 50MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY ENTERIC COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CARTON,1000 TABLET CONTAINER,100 TABLET CONTAINER
NDA/MAL/HDP/3064 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTIN-TIN TABLETSTINIDAZOLE500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/3067AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMAGO SYRUPPROMETHAZINE5MG/5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/3069 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMOVE CAPSULESPIROXICAM 20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY HARD GELATIN CAPSULES 10 BLISTER CARTON,10 CAPSULE BLISTER,100 CAPSULE CONTAINER
NDA/MAL/HDP/3072AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL TABLETS(THANE)PARACETAMOL TABLETS BP500MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER,500 TABLET CONTAINER,1000 TABLET CONTAINER,100 BLISTER CARTON
NDA/MAL/HDP/3085AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD TABLETSPARACETAMOL/PHENYLEPHRINE HCL/CAFFEINE/CHLORPHENIRAMINE HCL500MG/5MG/30MG/2MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON; 4 TABLET BLISTER,1 BLISTER CARTON; 4 TABLET BLISTER, 25 BLISTER CARTON; 4 TABLET BLISTER, 50 BLISTER CARTON
NDA/MAL/HDP/3113ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDPANCURONIUMPANCURONIUM BROMIDE4MG/2MLROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/3127AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED - RELEASDIDANOSINE DELAYED RELEASE250MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY HARD GELATIN CAPSULES30 CAPSULE CONTAINER, 1 CONTAINER CARTON
NDA/MAL/HDP/3198AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-125PHENOXYMETHYL PENICILLIN SODIUM125MG/MLMILAN LABORATORIES (INDIA) PVT LTD PLOT NOS 63/67/87 JAWAHAR CO-OP INDUSTRIAL ESTATE LTD KAMOTHE PANVEL NAVI MUMBAI INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3219AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPHENOL ORAL SUSPENSIONCHLORAMPHENICOL125MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3246 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCOMPOUND MAGNESIUM TRISILICATEMAGNESIUM TRISILICATE370MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3255AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDSATISFIL-50SLIDENAFIL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER, 1 BLISTER CARTON
NDA/MAL/HDP/3309 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDCLOTRIMAZOLE PESSARIESCLOTRIMAZOLE100MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAVAGINAL TABLETS 6 PESSARY STRIP, 1 STRIP CARTON
NDA/MAL/HDP/3315 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDERO-250 TABLETSERYTHROMYAIN STEARATE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3322AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE NEVIRAPINE50MGAUROBINDO PHARMA LTD UNIT III SURVEY NO.313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL R.R DISTRICT ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS FOR SUSPENSION 30 TABLET CONTAINER
NDA/MAL/HDP/3328GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN INJECTION1MEGA UNITCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO.LTD NO. 47 FENGSHOU ROAD, SHIJIAZHUANG CITY CHINACHINAPARENTERAL ORDINARY DRY VIALS 1 MU VIAL,10 VIAL CARTON,50 VIAL CARTON
NDA/MAL/HDP/3357CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDESOREST 20ESOMEPRAZOLE20MGCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3360GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICAL5%W/VNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAOTIC DROPS 10 ML VIAL
NDA/MAL/HDP/3364CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDESOREST 40ESOMEPRAZOLE40MGCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3367AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL SUSPENSIONPARACETAMOL125MG/MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3377 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAMILINE AMITRIPTYLINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/3378 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCHLOZINE TABLETSCHLORPROMAZINE100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3382 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFEN SUSPENSIONIBUPROFEN100MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL LIQUID ORDINARY SUSPENSIONS/SYRUPS/DROPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3383 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZEPINCARBAMEZAPINE 200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3391 AGOG PHARMA LTD=D1363,C1365:E1376ARMACEUTICALS LIMITEDCEZIN TABLETCETRIZINE10MGAGOG PHARMA LTD PLOT NO.33 SECTOR II THE VASI TALUKA INDUSTRIAL ESTATE DIST THANEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON; 1000 TABLET CONTAINER; 10 TABLET BLISTER,100 TABLET CARTON; 2(5*10)
NDA/MAL/HDP/3397AUROBINDO PHARMA LTD GITTOES PHARMACEUTICALS LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGAUROBINDO PHARMA LTD UNIT III SURVEY NO 313 & 314 BACHUPALLY VILLAGE QUTUBULLAPAR MANDAL R.R DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/3412GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTETRACYCLINETETRACYCLINE HYDROCHLORIDE250 MGNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/3422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGENTAMICIN EYE/ EAR DROPSGENTAMYCIN0.3%W/VNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAOPHTHALMIC/OTIC DROPS 10 ML VIAL
NDA/MAL/HDP/3451AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPHENOL CAPSULES (THANE0CHLORAMPHENICOL250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 CAPSULE CONTAINER,500 CAPSULE CONTAINER,100 CAPSULE CONTAINER
NDA/MAL/HDP/3482AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLOX-250CLOXACILLIN250MGMILAN LABORATORIES (INDIA) PVT LTD PLOT NOS 63/67/87 JAWAHAR CO-OP INDUSTRIAL ESTATE LTD KAMOTHE PANVEL NAVI MUMBAI INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3522GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCLOXACILLIN SODIUM FOR INJECTIONCLOXACILLIN SODIUM500MGCSPC ZHONGNUO (SHIJIAZHUANG) PHARMACEUTICAL CO LTD NO.188 GONGNONG ROAD SHIJIAZHUANGCHINAPARENTERAL ORDINARY DRY VIALS 500 MG VIAL,10 VIAL CARTON
NDA/MAL/HDP/3525AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLLINAMPICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA) PVT LTD PLOT NOS 63/67/87 JAWAHAR CO-OP INDUSTRIAL ESTATE LTD KAMOTHE PANVEL NAVI MUMBAIINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/3561 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCILLIN ORAL SUSPENSIONAMPICILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE, 1 BOTTLE CARTON
NDA/MAL/HDP/3574CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 2.5 TABLETMETOLAZONE TABLETS USP2.5MGCENTAUR PHARMA PVT.LIMITED-PLANT I-PLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 BLISTER CARTON
NDA/MAL/HDP/3581CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 5METOLAZONE5MGCENTAUR PHARMA PVT.LTD-PLANT I-PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET CARTON,10 BLISTER CARTON,3 BLISTER CARTON
NDA/MAL/HDP/3634 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPLUSPARACETAMOL/ DEXTROMETHORPHAN HCL/ CHLORPHENIRAMINE/ CAFFEINE500MG/ 15MG/ 2MG /10MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3647 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO ORAL SUSPENSIONNYSTATIN100000 IUAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL TOPICAL SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/3711BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDPOLY-MXBPOLYMYXIN B500,000 UNITSBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY DRY VIALS 5 ML VIAL
NDA/MAL/HDP/3717GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEFTRIAXONE SODIUMCEFTRIAXONE SODIUM1GCSPC ZHONGNUO (SHIJIAZHUANG) PHARMACEUTICAL CO LTD NO.88 YANGZI ROAD, SHIJIAZHUANG CHINAINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/3731AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ 50MGEFAVIRENZ50MGAUROBINDO PHARMA LTD, UNIT 111, SURVEY NO 313, BACHUPALLY VILLAGE, QUTUBULLAPUR , HYDERABADINDIAORAL SOLID ORDINARY CAPSULES 30 CAPSULE CONTAINER
NDA/MAL/HDP/3746AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENDROBENDROFLUMETHIAZIDE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3748AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPIRINACETYL SALICYLIC ACID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/3754CENTAUR DRUG HOUSE PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDSINAREST PD NASAL DROPSOXYMETAZOLINE HYDROCHLORIDE0.025%W/VCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIAINDIANASAL SYSTEMIC DROPS 10 ML VIAL
NDA/MAL/HDP/3773 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBUTOL-4SULBUTAMOL SULPHATE4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/3790AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDAGOFLOX-PPEFLOXACIN400MGAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3794 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMET-200 (THANE)METRONIDAZALE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3800CENTAUR DRUG HOUSE PVT LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLDARESTPARACETAMOL/PHENYLEPHERINE HYDROCHLORIDE/CHLORPHENIRAMINE MALEATE/CAFFEINE500MG+5MG+2MG+30MGCENTAUR PHARMACEUTICALS LTD, PLOT NO 3, TIVIM INDUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,4 TABLET STRIP,50 STRIP CARTON
NDA/MAL/HDP/3807GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDARTEMETHER INJECTIONARTEMETHER80MG/MLNINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/3860AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOLACLACTULOSE3.35MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/3893GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDEPINEPHRINE INJECTION USPEPINEPHRINE HCL1MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/3908AUROBINDO PHARMAGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE100MGAUROBINDO PHARMA LTD UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 100 CAPSULE CONTAINER
NDA/MAL/HDP/3912AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE/ZIDOVUDINE/NEVIRAPINELAMIVUDINE/ZIDOVUDINE/NEVIRAPINE150MG/300MG/200MGAUROBINDO PHARMA LTD UNIT VII SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/3925GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCALCIUM GLUCONATE INJECTIONCALCIUM GLUCONATE10%W/VNINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINACHINAPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,50 AMPOULE CARTON
NDA/MAL/HDP/3967AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLOX-125CLOXACILLIN125MG/5MLMILAN LABORATORIES (INDIA) PVT LTD PLOT NOS 63/67/87 JAWAHAR CO-OP INDUSTRIAL ESTATE LTD KAMOTHE PANVEL NAVI MUMBAI INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3985 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMYCIN SUSPENSIONERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3991AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFULVINGRISEOFULVIN TABLETS500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0538MICRO LABS LTD LABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD 92 SIPCOT HOSUR 635 126 TAMIL NADU VERNA INDUSTRIAL ESTATE, PHASE III VERNA GOA-403 722, INDIAINDIAORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120 MGMICRO LABS LTD 92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/0544MICRO LABS LTD LABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC/PARACETAMOL100MG/500MGMICRO LABS LTD, NO 92, SIPCOT HOSUR-635 126,TAMIL NADU INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0575MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOXMOXIFLOXACIN400MG/100MLAHLCON PARENTERALS LTD SP-918 PHASE III INDUSTRIAL AREA BHIWADI 301 019 DIST ALWA RAJASTHANINDIAPARENTERAL ORDINARY INFUSION BAGS 100 ML CONTAINER
NDA/MAL/HDP/0599MICRO LABS LTD LABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICRO LABS LTD PLOT NO.121-124 4TH PHASE KIADB BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER
NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABBIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 1 VIAL CARTON
NDA/MAL/HDP/0724JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE200MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/0737SANOFI AVENTIS LABOREX UGANDA LIMITEDTAXOTERE 80MGDOCETAXOLE TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL RETARD I M AMPOULES 4 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/0739SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 20MGDOCETAXOLE TRIHYDRATE20MGSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAINGERMANYPARENTERAL ORDINARY I M VIALS 1 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/0751MICRO LABS LTDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100 MGMICRO LABS LTD 92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0759MICRO LABS LTDLABOREX UGANDA LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD 92 SIPCOT INDUSTRIAL COMPLEX HOSUR 635126 (T.N)INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/0787MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV DRY SYRUPAMOXICILLIN/CLAVULANIC ACID250MG+62.5MG/5MLMICRO LABS LTD, PLOT 16 VEERASANDRA INDUSTRIAL AREINDIAORAL SOLID ORDINARY POWDERS 100 ML BOTTLE
NDA/MAL/HDP/0811MICRO LABS LTD LABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LTD, PLOT NO 16, VEERASANDRA INDUSTRIALINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,2 STRIP CARTON,6 TABLET STRIP
NDA/MAL/HDP/1025SANOFI ?AVENTIS DEUTSCHLANDLABOREX UGANDA LIMITEDINSUMAN COMB 30INSULIN HUMAN100IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS 10 ML VIAL,3 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/1078MICRO LABS LTD LABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLAXACIN HEMIHYDRATE INFUSION500MG /100ML AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/1101MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O 100CEFIXIME100MGMICRO LABS LTD, NO 121-124, 4TH PHASE K.I.A.D.B BOINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1160DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1217SANOFI AVENTIS LABOREX UGANDA LIMITEDINSUMAN BASALRECOMBINANT HUMAN INSULIN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/1277SANOTI AVENTISLABOREX UGANDA LIMITEDINSUMAN RAPIDINSULIN HUMAN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY INDIAPARENTERAL ORDINARY S C VIALS 5 ML VIAL
NDA/MAL/HDP/1347MICRO LABS LTDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1354PFIZER LABS LIMITED LABOREX UGANDA LIMITEDARTHROTECDICLOFENAC SODIUM + MISOPROSTOL50MG + 200MCGPIRAMAL HEALTHCARE UK LTD WALTON ROAD MORPETH NORTHUMBERLAND NE 613 YAUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1362MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN/CLAVULANATE875MG/125MGMICRO LABS LTD PLOT NO.121-124 4TH PHASE KIADB BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET STRIP
NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 1 DOSE CARTON
NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV AMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LTD VEERASANDRA INDUSTRIAL AREA BANGALOREINDIAORAL SOLID ORDINARY POWDERS 100 ML BOTTLE
NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN/ CLAVULANATE POTASSIUM500MG/125MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1558PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDGABBRORALAMINOSIDINE SULPHATE250MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSITALYORAL SOLID ORDINARY TABLETS 12 TABLET STRIP
NDA/MAL/HDP/1666SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 1GLIMEPIRIDE1MG SANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1669SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/1670SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICRO LABS LTD, NO 121-124, 4TH PHASE K.I.A.D.B BOINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1773MICRO LABS LTD LABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MG MICRO LABS LTD, 92 SIPCOT INDUSTRIAL COMPLEX, HOSURINDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/1866JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH, BUNSENSTRASSE 4, 22946 TRITTAU, GERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYRATE500MGPFIZER LABORATORIES (PTY) LTD-5 PROMED RD, WILLOWTON PIETERMARITZBURG, S.ASOUTH AFRICAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,2 TABLET BLISTER
NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRIDSPAINORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IULILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS, INDIANA 46285 USAFRANCEPARENTERAL ORDINARY VIALS 10 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD, 92 SIPCOT INDUSTRIAL COMPLEX HOSUR - 635126, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2102MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 625AMOXYCILLIN/ CLAVULANATE POTASSIUM500MG/125MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2103MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1000 TABAMOXYCILLIN/CLAVULANATE POTASSIUM875MG/125MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2105MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 156MG/5MLAMOXYCILLIN/CLAVULANATE POTASSIUM125MG+31.5MG/5MLMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/2106MEDREICH PLCLABOREX UGANDA LIMITEDAMEDIN-5AMLODIPINE5 MGMEDREICH LTD 49 (B&C) BOMMA SANDRA IND. AREA ANEKEINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2107MEDREICH PLCLABOREX UGANDA LIMITEDAMEDIN 10AMLODIPINE 10 MGMEDREICH LTD 49 (B&C) BOMMA SANDRA IND. AREA ANEKEINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2118AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDRIFAFOURE E-275MULTINGREDIENTMULTINGREDIENTAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/2150ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN MIXTUREHUMAN INSULIN 70/30I.LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS, INDIANA 46285 USAFRANCEPARENTERAL ORDINARY VIALS 10 ML VIAL,4 ML VIAL,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/2159SANOFI PASTEURLABOREX UGANDA LIMITEDVAXIGRIPH1N1/ H3N2/ B/FLORIDA/4/200615MCG/ 15MCG/ 15MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 0.5 ML VIAL
NDA/MAL/HDP/2196PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDMYCOBUTINRIFABUTIN150MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALYITALYORAL SOLID ORDINARY CAPSULES 30 CAPSULE BOTTLE
NDA/MAL/HDP/2276MEDREICH PLCLABOREX UGANDA LIMITEDFUNGRALKETOCONAZOLE200MGMEDRIECH STERILAB LTD,BANGALORE-MEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2278AVENTIS INTERCONTINENTALLABOREX UGANDA LIMITEDORELOXCEFPODOXIME PROXETIL100MGSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2FRANCEORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2285MEDREICH PLCLABOREX UGANDA LIMITEDBRUMEDIBUPROFEN100MG/5MLMEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062INDIAORAL LIQUID ORDINARY LIQUIDS 100 ML BOTTLE
NDA/MAL/HDP/2292MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1200AMOXYCILLIN/CLAVULANATE POTASSIUM1000MG/200MGNATCO PHARMA LTD, VIJAYAPUR, NORTH NAGARIJUNA SAGAINDIAPARENTERAL ORDINARY DRY VIALS 20 ML VIAL,5 VIAL CARTON
NDA/MAL/HDP/2315MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-50CEFIXIME50MG/5MLMICRO LABS LTD, NO 121-124, 4TH PHASE K.I.A.D.B BOINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 30 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2388DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM PHARMACEUTICALS ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 70 ML BOTTLE
NDA/MAL/HDP/2474SANOFI PASTEURLABOREX UGANDA LIMITEDTYPHIM VITYPHOID VACCINE2MCG/DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 2 MCG VIAL
NDA/MAL/HDP/2566MEDREICH PLCLABOREX UGANDA LIMITEDZEBENALBENDAZOLE400MGMEDREICH STERILAB LTD, UNIT VI 54/2 BOODHIHALLI VIINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1 TABLET BLISTER,10 TABLET BLISTER,100 BLISTER CARTON,500 TABLET CONTAINER
NDA/MAL/HDP/2569SANOFI AVENTIS LABOREX UGANDA LIMITEDNO-SPA DROTAVERINE HYDROCHLORIDE40MG/2MLCHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.HUNGARYPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/2628MICRO LABS LTD LABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LIMITED-PLOT NO. S-155 TO S 159, VERNA INDUSTRIAL ESTATE, PHASE III VERNA GOA-403 722, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/2652AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDFLAGENTYL TABLETSSECNIDAZOLE500MGFAMAR LYON-29 AVENUE CHARLES DE GAULLE SAINTFRANCEORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTEC MISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND ITALYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2812DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER/LUMEFANTRINE180MG/60ML+1080MG/60MLMANUFACTURING PACKAGING FARMACIA APPELHOF OUDEHASK-NETHERLANDSNETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 60 ML BOTTLE
NDA/MAL/HDP/2900MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-200CEFIXIME 200MGMICRO LABS LTD, NO 121-124, 4TH PHASE K.I.A.D.B BOINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER
NDA/MAL/HDP/2950PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDXALATANLATANOPROST0.005%W/VPFIZER MANUFACTURING BELGIUM -NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMOPHTHALMIC DROPS 2.5 ML BOTTLE
NDA/MAL/HDP/2978SANOFI PASTEURLABOREX UGANDA LIMITEDTETAVAXTETANUS VACCINE40 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 1 VIAL CARTON
NDA/MAL/HDP/2985SANOFI WINTHROP A.M.OLABOREX UGANDA LIMITEDEPILIM CHRONOSODIUM VALPROATE PH. EUR500MGSANOFI WINTHROP INDUSTRIE, 1 RUE DE LA VIERGE , CARBON BLANC , AMBARES ET LAGRAVE CEDEX F -33565FRANCEORAL SOLID RETARD TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2990MICRO LABS LTDLABOREX UGANDA LIMITEDPULMOCEF-500CEFUROXIME AXETIL USP500MGMICRO LABS LTD, NO 121-124, 4TH PHASE K.I.A.D.B BOINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,4 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3058SANOFI-AVENTISLABOREX UGANDA LIMITEDXATRAL LP 10MGALFUZOSIN10MGSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2FRANCEORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3102PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDEPANUTIN READY MIXEDPHENYTOIN SODIUM50MG/MLPFIZER ITALIA SPL VIA DEL COMMERCIO 63046 MARINO DEL TRONTO(AP) ITALYITALYPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE
NDA/MAL/HDP/3106GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDLABOREX UGANDA LIMITEDPENAMOXAMOXICILLIN250MG/5MLMEDREICH STERILAB, UNIT IINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3133MEDREICH LTDLABOREX UGANDA LIMITEDOMIZECOMEPRAZOLE20MGMEDREICH LTD, 49 B&C BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE, 560099, KARNATAKAINDIAORAL SOLID ORDINARY CAPSULES 7 CAPSULE BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/3155MEDREICH PLCLABOREX UGANDA LIMITEDBIOFERONFERRIC AMMONIUM CITRATE + CYANOCOBALAMIN + FOLIC A200MG/5ML + 10MG/5ML + 750MCG/5MLMEDREICH LTD, SURVEY NO 4/3, AVALAHALLI, ANJANAPUR ,TEJKAMAL PHARMACEUTICALSPVT. LTDSURVEYNO. 6/2,ALADAHALLI VILLAGESOMAPURAINDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/3165MEDREICH PLCLABOREX UGANDA LIMITEDMUCODIL EXPECTORANTTERBUTALINE SULPHATE +BROMHEXINE HYDROCLORIDE + GUAIFENESIN2.5MG + 8MG + 100MGMEDREICH LTD, SURVEY NO 4/3, AVALAHALLI, ANJANAPURINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3368PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDVIAGRA 50MGSLIDENAFIL10MGPFIZER LABORATORIES (PTY) LTD SA-SASOUTH AFRICAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,8 TABLET BLISTER,12 TABLET BLISTER
NDA/MAL/HDP/3438MEDREICH PLCLABOREX UGANDA LIMITEDPROXACINCIPROFLOXACIN500MGMEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/3440ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOGINSULIN LISPRO100IULILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY VIALS 10 ML VIAL
NDA/MAL/HDP/3446SANOFI-AVENTISLABOREX UGANDA LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE50MG/MLSANOFI WINTHROP INDUSTRIE LAGRAGE 33565 CARBON BLANC CEDEX FRANCEFRANCEPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE
NDA/MAL/HDP/3489PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDNEO MEDROLMETHYLPREDNISOLONE ACETATE+ NEOMYCIN SULFATE 2.5MG+2.5MGPATHEON YM INC. TORONTO- TORONTO, CANADACANADATOPICAL EXTERNAL LOTIONS 25 ML BOTTLE
NDA/MAL/HDP/3536SANOFI PASTEURLABOREX UGANDA LIMITEDTETRAXIMDIPHTERIA/ TETANUS/ PERTUSSIS (ACELLULAR, COMPONENT) POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)301IU/ 401IU/ 25MCG/ POLIOMYELITIS - 40DU (TYPE 1)/ 8DU TYPE 2/ 32DU TYPE 3SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/3565PFIZER LABS LIMITED LABOREX UGANDA LIMITEDUNASYNSULTAMICILLIN TOSYLATE DIHYDRATE375MGHAUPT PHARMA LATINA S.R.L -S.S 156 KM BORGO SAN MICHELE LATINAITALYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/3591DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 80MG/MLARTEMETHER80MG/MLROTEXMEDICA GMBH ARZNEIMITTELWERK BUNSENSTRASSE 4,GERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/3597DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIAN 20MG/MLARTEMETHER20MG/MLROTEXMEDICA GMBH ARZNEIMITTELWERK BUNSENSTRASSE 4,GERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/3624AVENTIS INTERCONTINENTALLABOREX UGANDA LIMITEDORELOXCEFPODOXIME40MG/5MLSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3693JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDIMODIUMLOPERAMIDE HCL2MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER
NDA/MAL/HDP/3708SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL MGLIMEPIRIDE/METFORMIN HYDROCHLORIDE 2MG +500MGHANDOK PHARMACEUTICALS CO. LTD CHUNGCHEONGBUK-DONORTH KOREAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3720JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDHALDOL DECANOASHALOPERIDOL DECANOATE50MG/MLJANSSEN PHARMACEUTICA N.V TURNHOUTSEWEG 30 B-2340 BEERSEBELGIUMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/3763PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDNORVASCAMLODIPINE5MGPFIZER LABORATORIES PTY LIMITED-241 MAIN RD RETREAT 7945 CAPE TOWN REPUBLIC OF SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3772ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN N NPHHUMAN INSULIN ISOPHANE100IULILLY PHARMA S.A.S & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS, INDIANA 46285 USAEGYPTPARENTERAL ORDINARY VIALS 10 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/3792MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 228.5CO-AMOXICLAV USP200/28.5MGMEDREICH LTD, OLD MADRAS ROAD, VIRGONAGAR, BANGALOINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 70 ML BOTTLE
NDA/MAL/HDP/3814MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDPETHIDINE INJECTIONPETHIDINE 50MG/1MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD, HAROLD HILL ROMFORD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/3828MEDREICH PLCLABOREX UGANDA LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL400MG + 325MGMEDREICH STERILAB LTD, UNIT VI 54/2 BOODHIHALLI VIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3836MEDREICH PLCLABOREX UGANDA LIMITEDIBEXPARACETAMOL+IBUPROFEN+CAFFEINE325MG+200MG+30MGMEDREICH LIMITED-59 B&C BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE 560099 INDIAINDIAORAL SOLID ORDINARY CAPSULES 12 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3887PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDLYRICA 150MGPREGABALIN150 MGPFIZER GMBH ARZEIMITELWORK - GODECKE, MOSWALDA 1144 79090 FREUBURGGERMANYORAL SOLID ORDINARY CAPSULES 2 BLISTER CARTON,14 CAPSULE BLISTER
NDA/MAL/HDP/3889PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDLYRICA 75MGPREGABALIN75 MGPFIZER GMBH ARZEIMITELWORK - GODECKE MOSWALDA 1144 79090 FREUBURGGERMANYORAL SOLID ORDINARY CAPSULES 2 BLISTER CARTON,14 CAPSULE BLISTER
NDA/MAL/HDP/3961MEDREICH PLCLABOREX UGANDA LIMITEDBIOFERONMULTI INGREDIENTN/AMEDREICH LTD, 49 B&C BOMMASANDRA INDUSTRIAL AREA, INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3977CHINOIN PHARMACEUTICALS AND CHEMICAL WORKS, CO. LTDLABOREX UGANDA LIMITEDNO-SPADROTAVERINE HYDROCHLORIDE40MGCHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.HUNGARYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,20 TABLET BLISTER
NDA/MAL/HDP/4006SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5% FOR ADULTS SUGARFREECARBOCISTEINE5G/100MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/4007SANOFI PASTEURLABOREX UGANDA LIMITEDSHANCHOL CHOLERA VACCINEV.CHOLERA STRAINS- 01 INABA FORMALDEHYDE KILLED +01 OGAWA HEAT KILLED + 01 OGAWA FORMALDEHYDE KILLED + 01 INABA HEAT KILLED + 0139 FORMALDEHYDE KILLED600 + 300 +300 +300 + 600 ELISA UNITS(EU) OF LIPOPOLYSACCHARIDE (LPS)SHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL ? 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.5 ML VIAL
NDA/MAL/HDP/4018MEDREICH PLCLABOREX UGANDA LIMITEDZEBENALBENDAZOLE 100MG/5MLMEDREICH LTD, 4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 20 ML BOTTLE
NDA/MAL/HDP/4056PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDFASIGYNTINIDAZOLE500MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,4 TABLET BLISTER
NDA/MAL/HDP/4082SANOFI AVENTIS LABOREX UGANDA LIMITEDNO-SPA FORTEDROTAVERINE HCL80MGCHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.HUNGARYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4113MICRO LABS LTD LABOREX UGANDA LIMITEDEROSTINEBASTINE10 MGMICRO LABS LTD, 92 SIPCOT INDUSTRIAL COMPLEX, HOSURINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4127SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDEPILIMSODIUM VALPROATE200MG/5MLUNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770FRANCEORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE,300 ML BOTTLE
NDA/MAL/HDP/4141SANOFI WINTHROP A.M.OLABOREX UGANDA LIMITEDEPILIM 200SODIUM VALPROATE200MG FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS)-RIELL, SPAINSPAINORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4142DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESAINEARTEMETHER + LUMEFANTRINE360MG + 2160MGMPF BV, APPELHOF 13 8465 OUDEHASKE + QUERCUS LABO BVBA , WIJMENSTRAAT 21P B-9030 MARIAKERKE GENTNETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 120 ML BOTTLE
NDA/MAL/HDP/4303PFIZER LABORATORIES (PTY)LABOREX UGANDA LIMITEDSAYANA PRESSMEDROXYPROGESTERONE ACETATE104MG/0.65MLPFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMPARENTERAL ORDINARY OTHER PRE-FILLED SYRINGES 0.65 ML PRE- FILLED SYRINGE,200 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/4343PASTEUR MERIEUX CONNANGHTLABOREX UGANDA LIMITEDEUVAX B (PAEDIATRIC)HEPATITIS B VACCINE, RECOMBINANT20MCG/MLLG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JESOUTH KOREAPARENTERAL ORDINARY VIALS 0.5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/4375PFIZER LAB LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYRATE200MG/5MLPFIZER LABORATORIES (PTY) LTD-5 PROMED RD, WILLOWTON PIETERMARITZBURG, S.AITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 15 ML BOTTLE,30 ML BOTTLE
NDA/MAL/HDP/4543SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5% CARBOCISTEINE5%W/VA.NATTERMANN & CIE GMBH NATTERMANNALLEE 1 50829 KOLNGERMANYORAL LIQUID ORDINARY SUSPENSIONS 125 ML BOTTLE
NDA/MAL/HDP/4550SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDRHINATHIOL 2%CARBOCISTEINE20MG/MLUNITHER LIQUID MANUFACTURING, INDUSTRIE COLOMIERS 1-3 ALEE DE LA NESTE Z L DEN SIGAL 31770 , NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 ,50829 COLOGNE , GERMANYFRANCE/GERMANYORAL LIQUID ORDINARY SYRUPS 125 ML BOTTLE
NDA/MAL/HDP/4601SANOFI PASTEURLABOREX UGANDA LIMITEDPENTAXIM VACCINEMULTI-INGREDIENTMULTI-INGREDIENTSANOFI PASTEUR, CAMPUS MERIEUX, 1541, AVENUE MARCEL, MERIEUX 69280, MARCY, L'ETOILE. 2. SANOFI PASTEUR, AVENUE PONT PASTEUR, 69007- LYONFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE,0.5 ML VIAL
NDA/MAL/HDP/4602ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMALOG MIX 50INSULIN LISPRO100 .IU(50 I.U+50 I.U)LILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON,3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/4611DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE200MG + 28MGBILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 70 ML BOTTLE
NDA/MAL/HDP/4635SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5%CARBOCISTEINE5%W/VUNITHER LIQUID MANUFACTURING, INDUSTRIE COLOMIERS 1-3 ALEE DE LA NESTE Z L DEN SIGAL 31770FRANCEORAL LIQUID ORDINARY SYRUPS 125 ML BOTTLE
NDA/MAL/HDP/4681SANOFI AVENTIS LABOREX UGANDA LIMITEDINSUMAN COMB 30DISSOLVED INSULIN+CRYSTALLINE PROTAMINE INSULIN30%+70%SANOFI ?AVENTIS DEUTSCHLAND GMBH INDUSTRIEPARK HOECHST BRUNINGSTRASSEN BUILDING H650 65926 FRANKFURT AM MAINGERMANYPARENTERAL ORDINARY VIALS 3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/4711MEDREICH PLCLABOREX UGANDA LIMITEDMEDVITE GOLDMULTI-INGREDIENTMULTIVITAMINSMEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062INDIAORAL SOLID ORDINARY TABLETS 21 TABLET CONTAINER
NDA/MAL/HDP/4730SANOFI PASTEURLABOREX UGANDA LIMITEDMENACTRAMENINGOCCOCAL GROUPS/ DIPTHERIA TOXOID VACCINES4MCG/48MCGSANOFI PASTEUR,INC DISCOVERY DRIVE SWIFTWATER PENNSYLVANIA 183370-0187UNITED STATESPARENTERAL ORDINARY OTHER VIALS 0.5 ML VIAL
NDA/MAL/HDP/4734SANOFI PASTEURLABOREX UGANDA LIMITEDMENINGOCOCCAL VACCINE A+CMENINGOCOCCAL A+C VACCINE50MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY OTHER VIALS 0.5 ML VIAL
NDA/MAL/HDP/4752PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDADRIBLASTINA RDDOXORUBICIN HYDROCHLORIDE10MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALYSPAINPARENTERAL ORDINARY OTHER VIALS 10 ML VIAL,50 MG VIAL
NDA/MAL/HDP/4785JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTACORTMICONAZOLE NITRATE+HYDROCORTISONE2%W/W+1%W/WSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/4787JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTARINMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/4788JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTARIN ORAL GELMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL TOPICAL GELS AND SOLS 40 G TUBE
NDA/MAL/HDP/4789PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE300MGPFZIER PGM AMBOISE -ZONE INDUSTRIELLE , 29 ROUTE DES INDUSTRIES , 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY CAPSULES 8 CAPSULE STRIP,2 STRIP CARTON,100 CAPSULE CARTON
NDA/MAL/HDP/4790PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE150MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMORAL SOLID ORDINARY CAPSULES 8 CAPSULE STRIP,2 STRIP CARTON,100 CAPSULE CARTON
NDA/MAL/HDP/4791PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN PALMITATE75MG/5MLPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 80 ML BOTTLE
NDA/MAL/HDP/4792PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN PHOSPHATE150MG/MLPFIZER MANUFACTURING BELGIUM-NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 2 ML BOTTLE,4 ML BOTTLE
NDA/MAL/HDP/4793PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN TCLINDAMYCIN PHOSPHATE1%W/VPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMTOPICAL EXTERNAL LIQUIDS 30 ML BOTTLE
NDA/MAL/HDP/4874SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE 180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.6 ML PRE- FILLED SYRINGE,2 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/4876SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE 180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.8 ML PRE- FILLED SYRINGE,2 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/4877SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE 180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.4 ML PRE- FILLED SYRINGE,2 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/4879SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE 180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.2 ML PRE- FILLED SYRINGE,2 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/4929MARTINDALE AND AURUM PHARMACEUTICAL LABOREX UGANDA LIMITEDMORPHINE INJECTIONMORPHINE15MG/MLMARTINDALE PHARMACEUTICALS BAMPTON RD HAROLD HILL ROMFORDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/4932MARTINDALE AND AURUM PHARMACEUTICAL LABOREX UGANDA LIMITEDMORPHINE INJECTIONMORPHINE10MG/MLMARTINDALE PHARMACEUTICALS BAMPTON RD HAROLD HILL ROMFORDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/4937JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDMOTILIUMDOMPERIDONE10MGJANSSEN-CILAG PHARMACEUTICAL (PTY) LTD-6 COUNTRY CLUB ESTATE, 21 WOODLANDS DRIVE, WOODMEAD, 219SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 20 TABLET CARTON,30 TABLET CARTON
NDA/MAL/HDP/5002ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOG MIX 25INSULIN LISPRO + INSULIN LISPRO PROTAMINE 25I.U+75I.ULILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY VIALS 10 ML VIAL,3 ML CARTRIDGE,5 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/5027PFIZER LAB LTDLABOREX UGANDA LIMITEDTERRA-CORTRILMULTI-INGREDIENTMULTI-INGREDIENTPFIZER PGM ORLEANS FRANCE-AVENUE DE CONCYR, F-450FRANCEOPHTHALMIC LIQUIDS 4 ML BOTTLE,5 ML BOTTLE,10 ML BOTTLE
NDA/MAL/HDP/5030PFIZER LAB LTDLABOREX UGANDA LIMITEDSOLU-MEDROLMETHYLPREDNISOLONE HEMISUCCINATE125MG/2MLPFIZER MANUFACTURING BELGIUM-NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,8 ML AMPOULE
NDA/MAL/HDP/5040PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDDEPO-MEDROLMETHYLPREDNISOLONE ACETATE40MG/MLPFIZER MANUFACTURING BELGIUM-NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,2 ML AMPOULE,5 ML AMPOULE
NDA/MAL/HDP/5044PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDDEPO-PROVERAMEDROXYPROGESTERONE ACETATE150MG/MLPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,3.5 ML AMPOULE
NDA/MAL/HDP/5054SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDMAALOXMAGNESIUM HYDROXIDE/ALUMINIUM HYDROXIDE200MG/200MGWINTHROP PHARMACEUTICALS (PYT) 315, WALTALOO PRETORIA, SANOFI S.P.A, S.S.17 KM 22,67019,SCOPPITO (AQ), ITALYSOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON; 10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/5056AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDMAALOX SUSPENSIONMAGNESIUM HYDROXIDE/ALUMINIUM HYDROXIDE665MG+200MG/5MLAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,150 ML BOTTLE,350 ML BOTTLE,500 ML BOTTLE
NDA/MAL/HDP/5057SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDMAALOX PLUSMAGNESIUM HYDROXIDE/ALUMINIUM HYDROXIDE/SIMETHICONE200MG/200MG/25MGWINTHROP PHARMACEUTICALS (PYT) 315, WALTALOO PRETORIA, SANOFI S.P.A, S.S.17 KM 22,67019,SCOPPITO (AQ), ITALYSOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/5059AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDMAALOX PLUS SUSPENSIONMAGNESIUM HYDROXIDE/ALUMINIUM HYDROXIDE665MG+200MG/5MLAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,150 ML BOTTLE,350 ML BOTTLE,500 ML BOTTLE
NDA/MAL/HDP/5095MICRO LABS LTD 92 SIPCOT INDUSTRIALLABOREX UGANDA LIMITEDDIAPRIDE PLUSGLIMEPIRIDE + METFORMIN1MG + 500MGMICRO LABS LTD -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5140PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDIFLUCANFLUCONAZOLE200MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY CAPSULES 7 CAPSULE BLISTER
NDA/MAL/HDP/5175JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDGYNO-DAKTARINMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAVAGINAL CREAMS 40 G TUBE
NDA/MAL/HDP/5181JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDGYNO-DAKTARIN OVULESMICONAZOLE NITRATE400MGJANSSEN PHARMACEUTICAL PTY LTD-15TH ROAD HALFWAY HOUSJANSSEN PHARMACEUTICA PTY LTD. 15TH ROAD HALFWAY HOUSE & CATALENT FRANCE BEINHEIM, JASSEN-CILAGE FRANCESOUTH AFRICAVAGINAL CAPSULES 3 CAPSULE BLISTER
NDA/MAL/HDP/5251PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDIFLUCANFLUCONAZOLE150MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY CAPSULES 1 CAPSULE BLISTER
NDA/MAL/HDP/5254PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDFARMORUBICIN RDEPIRUBICIN HYDROCHLORIDE10MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSSPAINPARENTERAL ORDINARY VIALS 10 ML VIAL,50 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/5301SANOFI PASTEURLABOREX UGANDA LIMITEDDULTAVAXDIPHTERIA/ TETANUS/ AND (INACTIVATED) POLIOMYELITIS VACCINE (ADSORBED)2 IU/ 20IU/ POLIOMYELITIS (40DU/ 8DU/ 32DU)SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY I V PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE,1 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/5336SANOFI PASTEURLABOREX UGANDA LIMITEDAVAXIM 160UINACTIVATED HEPATITIS A VACCINE ADSORBED160 ANTIGEN UNITSSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY I V PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5337SANOFI PASTEURLABOREX UGANDA LIMITEDAVAXIM 80IU PAEDIATRICINACTIVATED HEPATITIS A VACCINE ADSORBED80 ANTIGEN UNITSSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY I V PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5395MICRO LABS LTDLABOREX UGANDA LIMITEDOFLOXOFLOXACIN200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5413PASTEUR MERIEUX CONNANGHTLABOREX UGANDA LIMITEDEUVAX B (ADULT)HEPATITIS B VACCINE1MLPASTEUR MERIEUX CONNANGHT-SOUTH KOREA,LG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JESOUTH KOREAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 ML AMPOULE,1 AMPOULE CARTON
NDA/MAL/HDP/5461SANOFI AVENTISLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINEARTESUNATE+AMODIAQUINE25MG+67.5MGMAPHAR S.A GROUP OF SANOFIKM 10 ROUTE COTIERE 111,MOROCCOORAL SOLID ORDINARY LAYERED TABLETS 3 TABLET BLISTER,25 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/5463SANOFI AVENTISLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE WINTHROPARTESUNATE+AMODIAQUINE100MG+270MGMAPHAR S.A GROUP OF SANOFIKM 10 ROUTE COTIERE 111,MOROCCOORAL SOLID ORDINARY LAYERED TABLETS 3 TABLET BLISTER,25 BLISTER CARTON,6 TABLET BLISTER,25 BLISTER CARTON,6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6055SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.ALABOREX UGANDA LIMITEDEURARTESIMPIPERAQUINE TETRAPHOSPHATE + DIHYDROARTEMISININ160MG + 20MGSIGMA TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A VIA PONTINA KM 30 400 POMEZIA ROMEITALYORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/6495DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDMACROLYN? 500 MG FILM COATED TABLETS AZITHROMYCIN DIHYRATE500MGDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/6797MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDPETHIDINE INJECTIONPETHIDINE100MG/2MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD, HAROLD HILL ROMFORD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/6821LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITEDMAGNESIUM SULPHATE INJECTIONMAGNESIUM SULPHATE INJECTION50%W/VMARTINDALE PHARMACEUTICALS ROMFORD ESSEX RM3 8UG UKUNITED KINGDOMPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6823LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITEDEPHEDRINE HYDROCHLORIDEEPHEDRINE HYDROCHLORIDE30MG/MLMARTINDALE PHARMACEUTICALS ROMFORD ESSEX RM3 8UG UK UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/7715JANSSEN-CILAG INTERNATIONAL NVLABOREX UGANDA LIMITEDSIRTUROBEDAQUILINE FUMARATE100MGRECIPHARM PHARMACEUTICALS PVT LTD (FORMERLY KEMWELL BIOPHARMA PVT. LTD)BELGIUMORAL SOLID ORDINARY FILM-COATED TABLETS 188 TABLET BOTTLE
NDA/MAL/HDP/7721SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDMAALOX LEMON FLAVORINGALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE175MG + 200MG + 25MG/ 5MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SUSPENSIONS 250 ML BOTTLE,355 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/7722SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDMAALOX MINT FLAVORINGALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE175MG + 200MG/ 5MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SUSPENSIONS 250 ML BOTTLE,355 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/7784DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDLORATOLLORATADINE 5MG/5MLNOBEL ILAC SANAYIINVE TICARET A.S SANCAKLAR 81100 DUZCETURKEYORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/7909SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDLANTUSINSULIN GLARGINE100 UNITS/MLSANOFI AVENTIS DEUTSCHLAND GMBH D-65926 FRANKFURT AM MAIN ALLEMAGNEGERMANYPARENTERAL ORDINARY S C VIALS 10 ML VIAL
NDA/MAL/HDP/7910SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDLANTUSINSULIN GLARGINE100 UNITS/MLSANOFI AVENTIS DEUTSCHLAND GMBH D-65926 FRANKFURT AM MAIN ALLEMAGNEGERMANYPARENTERAL ORDINARY CARTRIDGES 3 ML CARTRIDGE,5 CARTRIDGE CARTON
NDA/MAL/HDP/7911SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDLANTUS SOLOSTARINSULIN GLARGINE100 UNITS/MLSANOFI AVENTIS DEUTSCHLAND GMBH D-65926 FRANKFURT AM MAIN ALLEMAGNEGERMANYPARENTERAL ORDINARY PRE-FILLED PENS 3 ML PREFILLED PEN,5 PREFILLED PEN CARTON
NDA/MAL/HDP/8043DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDRABEZOLRABEPRAZOLE SODIUM20MGB?L?M PHARMACEUTICALS-GOSB 41480 GEBZE-KOCAEL?/TURKETURKEYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER
NDA/MAL/HDP/8061PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDLYRICA 25MGPREGABALIN75MGPFIZER GMBH ARZEIMITELWORK -MOOSWADALLE 179090, FREIBERG GERMANYGERMANYORAL SOLID ORDINARY CAPSULES 14 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/8062PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDPROSTIN E2DINOPROSTONE3MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMVAGINAL TABLETS 4 TABLET STRIP
NDA/MAL/HDP/8063PFIZER LABORATORIES (PTY) LTD ITALYLABOREX UGANDA LIMITEDUNASYN 1.5AMPICILLIN / SULBACTAM1000MG/ 500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELEITALYPARENTERAL ORDINARY DRY VIALS 1.5 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/8222MICRO LABS LTDLABOREX UGANDA LIMITEDLUBREXSODIUM CARBOXYMETHYL CELLULOSE0.5%W/VMICRO LABS LTD PLOT NO. 113 - 116 4TH PHASE KIADB BOMMASANDRA INDL AREA BANGALORE 560 099INDIAOPHTHALMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/8254MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-CVCEFIXIME TRIHYDRATE + CLAVULANIC ACID200MG + 125MGMICRO LABS LTD NO. 121-124 4TH PHASE KIADB BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB GURTUNAVARGEN SE-151 85 SODERTAIJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,14 TABLET BLISTER,28 TABLET BLISTER
NDA/MAL/HDP/0418ASTRA ZENECA MACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.UNITED STATESORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.UNITED STATESORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/0685FERRER INTERNACIONAL S.AMACNAUGHTON LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL RETARD I M AMPOULES 4 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/0687FERRER INTERNACIONAL S.AMACNAUGHTON LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL LIQUID ORDINARY LIQUIDS 10 ML SACHET,6 SACHET CARTON
NDA/MAL/HDP/0752FERRER INTERNACIONAL S.AMACNAUGHTON LIMITEDNUCLEO C.M.P FORTECYTIDINE + URIDINE10MG + 6MGFERRER INTERNACIONAL S.A GRAN VIA CARLOS III 94 08028 BARCELONAGERMANYPARENTERAL ORDINARY DRY PRE-FILLED PENS 3 ML AMPOULE
NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0892ASTRA ZENECA MACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN2.5MGBRISTOL MYERS SQUIBB 4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620UNITED STATESORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/0904ASTRA ZENECA MACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA,ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/0946ASTRAZENECAMACNAUGHTON LIMITEDTENORETICATENOLOL/CHLORTHALIDONE100/25MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/1033FAES FARMA S.AMACNAUGHTON LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAINORAL LIQUID ORDINARY LIQUIDS 10 ML SACHET,20 SACHET CARTON
NDA/MAL/HDP/1211ASTRA ZENECA MACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)UNITED KINGDOMORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/1214FERRER INTERNACIONAL S.AMACNAUGHTON LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINORAL SOLID ORDINARY CAPSULES 15 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOUNITED KINGDOMORAL SOLID ORDINARY TABLETS 2 BLISTER CARTON,14 TABLET BLISTER
NDA/MAL/HDP/1392ASTRA ZENECA MACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA MACCLESFIELD CHESHIREUNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA, KVARNBERGAGATAN12, SE-151 SODERTALIJESWEDENPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON,5 ML VIAL,10 VIAL CARTON
NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1415ASTRA ZENECA MACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS, TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJESWEDENORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1452ASTRA ZENECA MACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD CHESHIRE-UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1494FERRER INTERNACIONAL S.AMACNAUGHTON LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINTOPICAL EXTERNAL CREAMS 30 G TUBE
NDA/MAL/HDP/1526LABORATORIOS NOVAG SAMACNAUGHTON LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNACIONAL S.A BARCELONA FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISNOPRIL20MGASTRAZENECA MACCLESFIELD CHESHIRE / ASTRAZENECA WUXI CHINAUNITED KINGDOM/CHINAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA MACCLESFIELD CHESHIRE / ASTRAZENECA WUXI CHINAUNITED KINGDOM/CHINAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,1 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP, NEWARK, DELAWAREUNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION METERED-DOSE INHALER 60 DOSE CANNISTER
NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB, GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,14 TABLET CARTON,28 TABLET CARTON
NDA/MAL/HDP/1828ASTRAZENECAMACNAUGHTON LIMITEDTENORETATENOLOL/CHLORTHALIDONE50/12.5MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES 10.8 MG IMPLANT
NDA/MAL/HDP/1989FERRER INTERNACIONAL S.AMACNAUGHTON LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINTOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION KVARNBERGAGATANLZ SE-151 -85 SODERTAJJESWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION 2 ML AMPOULE,20 AMPOULE CARTON
NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDENOSIDE200MCGASTRAZENECA AB, GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION METERED-DOSE INHALER 100 DOSE CANNISTER
NDA/MAL/HDP/2353ASTRA ZENECA MACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY GRANULES 28 SACHET CARTON
NDA/MAL/HDP/2615ASTRA ZENECA ABMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL160MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION METERED-DOSE POWDER INHALER 60 DOSE CANNISTER
NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION KVARNBERGAGATANLZ SE-151 -85 SODERTAJJESWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION 2 ML AMPOULE,20 AMPOULE CARTON
NDA/MAL/HDP/2772ASTRAZENECAMACNAUGHTON LIMITEDTENORMINATENOLOL100MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,500 TABLET CONTAINER
NDA/MAL/HDP/3376ASTRAZENECAMACNAUGHTON LIMITEDTENORMINATENOLOL50MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,500 TABLET CONTAINER
NDA/MAL/HDP/3494LABORATORIOS NOVAG SAMACNAUGHTON LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B62G + 2G + 1G +1GFERRER INTERNACIONAL S.A BARCELONA FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL LIQUID ORDINARY LIQUIDS 100 ML BOTTLE
NDA/MAL/HDP/3701ASTRA ZENECA MACNAUGHTON LIMITEDDIPRIVANPROPOFOL20MG/MLCORDEN PHARMA SPA VIALE DELL INDUSTRIA 3 REPAR TO VIA GAB'LEI 1720040 LOPONAGO MILANITALYPARENTERAL ORDINARY VIALS 50 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/3713ASTRA ZENECA MACNAUGHTON LIMITEDDIPRIVANPROPOFOL10MG/MLCORDEN PHARMA SPA VIALE DELL INDUSTRIA 3 REPAR TO VIA GAB'LEI 1720040 LOPONAGO MILANITALYPARENTERAL ORDINARY VIALS 50 ML VIAL,1 VIAL CARTON,20 ML VIAL,5 VIAL CARTON
NDA/MAL/HDP/3771FAES FARMA S.AMACNAUGHTON LIMITEDBRONQUIDIAZINA C.RTRIMETHOPRIM/SULFAMETHOXAZOLE/BROMHEXINE/SODIUM BENZOATE/TOLU BALSAM80MG/400MG/4MG/250MG/325MGFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAINORAL LIQUID ORDINARY LIQUIDS 150 ML BOTTLE
NDA/MAL/HDP/4190ASTRAZENECAMACNAUGHTON LIMITEDNOLVADEXTAMOXIFEN10MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/4360ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL5MGASTRAZENECA MACCLESFIELD CHESHIRE- UK / ASTRAZENECA WUXI CHINAUNITED KINGDOM/CHINAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/4367ASTRA ZENECA MACNAUGHTON LIMITEDATACAND 8MGCANDESARTAN8MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJEINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4411ASTRA ZENECA MACNAUGHTON LIMITEDATACAND PLUSCANDESARTAN/HYDROCHLOROTHIAZIDE16MG/12.5MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJEUNITED KINGDOMORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4617ASTRA ZENECA MACNAUGHTON LIMITEDCRESTORROSUVASTATIN10MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4645ASTRA ZENECA MACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM20MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4740ASTRA ZENECA MACNAUGHTON LIMITEDMERONEMMEROPENEM500MGSUMITOMO PHARMACEUTICALS CO. LTD OSAKA, LAPAN 2. ACS DOBFAR ITALIAJAPAN/ITALYPARENTERAL ORDINARY OTHER VIALS 10 ML VIAL
NDA/MAL/HDP/4742ASTRA ZENECA MACNAUGHTON LIMITEDMERONEMMEROPENEM1GSUMITOMO PHARMACEUTICALS CO. LTD OSAKA, JAPAN 2. ACS DOBFAR ITALIAJAPANPARENTERAL ORDINARY OTHER VIALS 10 G VIAL
NDA/MAL/HDP/4943ASTRAZENECAMACNAUGHTON LIMITEDNOLVADEXTAMOXIFEN20MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5143ASTRA ZENECA MACNAUGHTON LIMITEDBETALOC ZOKMETOPROLOL25MGASTRA ZENECA AB GARTUNAVGEN SE 151 58 SODAERTAJJESWEDENORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/5146ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOKMETOPROLOL100MGASTRA ZENECA AB GARTUNAVGEN SE 151 58 SODAERTAJJESWEDENORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5147ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOKMETOPROLOL50MGASTRA ZENECA AB GARTUNAVGEN SE 151 58 SODAERTAJJESWEDENORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5362ASTRA ZENECA MACNAUGHTON LIMITEDCASODEX 150MGBICALUTAMIDE150MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY TABLETS 2 STRIP CARTON,14 TABLET STRIP
NDA/MAL/HDP/5363ASTRA ZENECAMACNAUGHTON LIMITEDCASODEX 50MGBICALUTAMIDE50MGASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA. 2.BULK CORDEN PHARMA GMBH OTT HAHN STRASSE ,68723 PLANKSTADTUNITED KINGDOM/GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 2 BLISTER CARTON,14 TABLET BLISTER
NDA/MAL/HDP/5496ASTRA ZENECA MACNAUGHTON LIMITEDATACAND 16MGCANDESARTAN CILEXETIL16MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6218ASTRA ZENECA MACNAUGHTON LIMITEDFORXIGADAPAGLIFLOZIN10MGBRISTOL-MYERS SQUIBB COMPANY-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620, USAUNITED STATESORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7611FERRING GMBHMACNAUGHTON LIMITEDPABALCARBETOCIN100MCG/MLFERRING GMBH WITTLAND 11, D-24109 KIELGERMANYPARENTERAL ORDINARY VIALS 1 ML VIAL,5 VIAL CARTON
NDA/MAL/HDP/7724FERRING GMBHMACNAUGHTON LIMITEDMENOPURHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU]75 IU + 75 IU/ 4ML VIALFERRING (PTY) LTD WITTLAND II 24146 KIELGERMANYPARENTERAL ORDINARY DRY VIALS 4 ML VIAL,10 VIAL CARTON
NDA/MAL/HDP/4875PHARM ACCESS AFRICA LTDMARIE STOPES UGANDA LIMITEDMISOCLEARMISOPROSTOL200MCGACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/8396MARIE STOPES INTERNATIONALMARIE STOPES UGANDA LIMITEDBACK-UPLEVONORGESTREOL1.5MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER
NDA/MAL/HDP/0559HOVID BHD MEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIAORAL SOLID RETARD TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1569ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDKALETRALOPINAVIR+RITONAVIR80 + 20 MGABBOTT LABORATORIES, LTD, QUEENSBOROUGH, KENT ME11 SELUNITED KINGDOMORAL LIQUID ORDINARY LIQUIDS 60 ML BOTTLE, 5 BOTTLE CARTON
NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBOT T GMBH & CO., 50 KNOLLSTRASSE, 67061 LUDWIGSHAFENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABOTT GMBH & CO KG KNOLLSTRASSE 67061 LUDWIGSHAFENGERMANYORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/2453ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR80MG/MLAESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENTUNITED KINGDOMORAL LIQUID ORDINARY LIQUIDS 90 ML BOTTLE
NDA/MAL/HDP/2556GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDTRUVADAEMTRICITABINE/TENOFOVIR200MG/300MGPATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9 COUNTRY: CANADA ,TAKEDA GMBH-16515 ORANIENBURG GERMANY,ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA CANADA/GERMANY/SOUTH AFRICAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/2793GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDVIREADTENOFOVIR DISOPROXIL FUMARATE300MGPATHEON YM INC. TORONTO- TORONTO, CANADA,ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICACANADAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/3831ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIALOPINAVIR+RITONAVIR200/50 MGABBOT T GMBH & CO., 50 KNOLLSTRASSE, 67061 LUDWIGSHAFEN ,ABBVIE LTD ,ABBOTT LABORATORIES LTD,QUEENSBOROUGH,KENT, ME IIGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 120 TABLET CONTAINER
NDA/MAL/HDP/4389PHARMACARE LTDMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR600MGJANSSEN ORTHO LLC STATE ROAD 933 KM 0.1 MAMEY WARD GURABO PUERTO RICOUNITED STATESORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/6127JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDINTELENCEETRAVIRINE25MGJANSSEN-CILAG S.P.A VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAITALYORAL SOLID ORDINARY TABLETS 120 TABLET BOTTLE
NDA/MAL/HDP/6169ASPEN PHARMCAREMEDICAL ACCESS (UGANDA) LIMITEDINTELENCEETRAVIRINE100MGJANSSEN-CILAG S.P.A VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAITALYORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 120 TABLET BOTTLE
NDA/MAL/HDP/6257JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDEDURANTRILPIVIRINE25MGJANSSEN CILAG S.P.A VIA C. JANSSEN BORGO S, MICHELE 04010 LATINAITALYORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/6792JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR400MGJANSSEN ORTHO LLC STATE ROAD 933 KM 0.1 MAMEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/7337JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTA 150 DARUNAVIR150MGJANSSEN ORTHO LLC STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778USAORAL SOLID ORDINARY FILM-COATED TABLETS 240 TABLET BOTTLE
NDA/MAL/HDP/7396GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDHARVONI SOFOSBUVIR+LEDIPASVIR 400 MG+90 MGPATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9 COUNTRY: CANADACANADAORAL SOLID ORDINARY FILM-COATED TABLETS 28 TABLET BOTTLE
NDA/MAL/HDP/8315JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTA 75DARUNAVIR75MGJANSSEN ORTHO LLC STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 480 TABLET BOTTLE
NDA/MAL/HDP/8255KORLYNS THERAPEUTICS LTDMEDICATRIX (U) LTDPROSTAN EDLATANOPROST0.005%W/VLUNAN BETTER PHARMACEUTICAL CO., LTD.-NO.209, HONGQI AVENUE, LANSHAN DISTRICT LINYI, SHANDONG, 276006 CHINA +86-5398331258 ?CHINAOPHTHALMIC DROPS 2.5 ML BOTTLE,6 BOTTLE CARTON
NDA/MAL/HDP/8108MEDIPHARM INDUSTRIES LTDMEDIPHARM SALES LIMITEDORSGLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE6.75G + 1.45G + 1.3G + 0.75G: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.UGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 25 G SACHET,10 SACHET CARTON
NDA/MAL/HDP/8200MEDIPHARM INDUSTRIES LTDMEDIPHARM SALES LIMITEDORS ORANGEGLUCOSE ANHYDROUS + TRISODIUM CITRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE6.75G + 1.45G + 1.3G + 0.75G / SACHETMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGEREREUGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 10.4 G SACHET
NDA/MAL/HDP/0894HETERO LABS LTDMEDNET HEALTHCARE LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/0248EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE DELAYED RELEASE TABLETS 40MGIPCA LABORATORIES LTD PLOT NO 255/1 ATHAL SILVASSA 396230 DADRA & NAGAR HAVELIINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IV PARACETAMOL INFUSION1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V AMPOULES 20 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/0436PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 130 POLY (0-2-HYDROXYETHYL) STARCH30GPT SANBE FARMA JI INDUSTRI NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION BAGS 500 ML BOTTLE
NDA/MAL/HDP/0438PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 200POLY (0-2-HYDROXYETHYL) STARCHMW 200,000PT SANBE FARMA JI INDUSTRI NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION BAGS 500 ML BOTTLE
NDA/MAL/HDP/0447PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON?125METHYLPREDNISOLONE SODIUM SUCCINATE125MG/VIALPT SANBE FARMA JI INDUSTRI NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V VIALS 125 MG VIAL
NDA/MAL/HDP/0451PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON?500 METHYLPREDNISOLONE SODIUM SUCCINATE 500MG/VIALPT SANBE FARMA JI INDUSTRI NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V VIALS 500 MG VIAL
NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE 500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION BAGS 100 ML BOTTLE
NDA/MAL/HDP/0522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDVAZORTAN 50 LOSARTAN POTASSIUM50MGMEDLEY PHARMACEUTICALS LTD PLOT NO. 18 & 19 ZARI CAUSEWAY ROAD KACHIGAM DAMANINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, ZAIRI CAUSEWAYINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITEDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD PLOT NO. 18 AND 19 , SURVEY NO. 378/8 & 379/2 KEBRA INDUSTRIAL ESTATE, KACHIGAM DAMAN 396210INDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/0929IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MGIPCA LABORATORIES LTD PLOT NO.255/1 ATHAL SILVASA 396 230 DADRA & NAGAR HAVELIINDIAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,10 BLISTER CARTON,9 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1239IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPECTYLIN-CMULTIINGREDIENTN/AIPCA LABORATORIES LTD,RATLAMINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-626AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD, PLOT NO 69-72B, KASEZ, GHANDHIDHAM 370230INDIAORAL SOLID ORDINARY TABLETS 3 TABLET STRIP,7 STRIP CARTON,2 TABLET STRIP,5 STRIP CARTON
NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEYPHARMACEUTICALS LTD PLOT 18 & 19 SURVEY NO. 378/7 ,379/2 & 3 ZARI CAUSEWAY ROAD KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1352MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPLATFREECLOPIDOGREL75MGMEDLEY PHARMACEUTICALS LTD PLOT NO.18 & 19 SURVEY NO. 378/8 & 379/2 ZARI CASE WAY ROAD KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY PHARMACEUTICALS LTD PLOT NO. 18 & 19 ZARI CAUSEWAY ROAD KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 2 CAPSULE BLISTER,4 TABLET BLISTER,7 BLISTER CARTON
NDA/MAL/HDP/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTERMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG, WEST JAVA INDONESIAINDONESIAOPHTHALMIC OINTMENTS 3.5 G TUBE
NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/1747IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPRESARTAN H 50LORSATAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGIPCA LABORATORIES LIMITED PLOT 225/1 VILLAGE ATHAL SILVASSA 396 230 DADRA AND NAGAR HAVELIINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1922IPCA LABORATORIES LIMITED MEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500 MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2004MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDR.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 & 19 ZARI CAUSEWAY ROAD, KACHIGAM, DAMAN, INDIAINDIAORAL SOLID ORDINARY CAPSULES 15 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2130IPCA LABORATORIES MEDVIN PHARMA LIMITEDZERODOL-LAACECLOFENAC200MGIPCA LABORATORIES LTD PLOT NO.255/1 ANTHAL SILVASSA 396 230 DADRA AND NAGAR HAVELIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2271EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER/LUMEFANTRINE20MG/120MGIPCA LABORATORIES LTD, PLOT NO.255/1, SILVASA 396320 (D & NH)INDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,10 BLISTER CARTON,20 BLISTER CARTON,30 BLISTER CARTON,40 BLISTER CARTON,60 BLISTER CARTON,90 BLISTER CARTON,120 BLISTER CARTON,12 TABLET BLISTER,18 TABLET BLISTER,24 TABLET CARTON
NDA/MAL/HDP/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY VIALS 1 VIAL CARTON
NDA/MAL/HDP/2423MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITEDATORINATORVASTATIN10MGMEDLEYPHARMACEUTICALS LTD PLOT 18 & 19 SURVEY NO. 378/7 ,379/2 & 3 ZARI CAUSEWAY ROAD KACHIGAM DAMANINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2521MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD, 18 & 19 ZAIRI CAUSEWAYINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPANTAZ TABLETSPANTOPRAZOLE40MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2524MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPRIMODIL-5AMLODIPINE BESYLATE5MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2945MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDONCETCETIRIZINE DIHYDROCHLORIDE10MGMEDLEY PHARMACEUTICALS LTD, L-2 MIDC AREA, CHIKALINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2997MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITEDACENAC TABLETSACECLOFENAC TABLETS100 MGMEDLEY PHARMACEUTICALS LTD, PLT 18&19, ZARI CAUSEWINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 BLISTER CARTON
NDA/MAL/HDP/2998MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDFITIN-5LEVOCETIRIZINE DIHYDROCHLORIDE5MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3108IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDZERODOLACECLOFENAC100MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3152PT SANBE FARMAMEDVIN PHARMA LIMITEDPOLDAN MIGPARACETAMOL + ASPRIN + CAFFEINE400MG + 250MG + 65MGPT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNGINDONESIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,25 STRIP CARTON
NDA/MAL/HDP/3196MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD, PLOT NO.11, SURVEY NO INDIAORAL LIQUID ORDINARY SYRUPS 30 ML BOTTLE
NDA/MAL/HDP/3202IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPRESARTAN-50 LOSARTAN50MGIPCA LABORATORIES LIMITED PLOT 225/1 VILLAGE ATHAL SILVASSA 396 230 DADRA AND NAGAR HAVELIINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3205EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-250AZITHROMYCIN250MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3656IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDLARITEMARTEMETHER / LUMEFANTRINE80MG/480MGIPCA LABORATORIES LTD SEJAVTA RATLAM 457002 MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3725MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDNEW TUXIRILDEXTROMETHOPHAN HBR + PHENYLEPHRINE HCL + MENTHOL10MG/ML + 5MG/10ML + 5MG/10MLMEDLEY PHARMACEUTICALS LTD, PLT 18&19, ZARI CAUSEWAYINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3729MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDDECIFEN-SR DICLOFENAC SODIUM100MGMEDLEY PHARMCEUTICALS LTD, PLOT 18& 19 ZARI CAUSEINDIAORAL SOLID ORDINARY TABLETS 20 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/3737MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDECOFLOX 500 TABLETSCIPROFLOXACIN HCL500MGMEDLEY PHARMACEUTICALS LTD, PLOT NO 18 &19, ZARI CAUSEWAYINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3809MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDCOLDRID DAY & NIGHTPARACETAMOL+CHLORPHENIRAMINE MALEATE+PHENYLEPRINE HYDROCHLORIDE + CAFFEINE500MG+2MG+5MG+15MGMEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,9 STRIP CARTON
NDA/MAL/HDP/3816IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-375AMOXYCILLIN+CLAVULANIC ACID250MG /125MGIPCA LABORATORIES LTD, PLOT NO 69-72B, KASEZ, GHANDHIDHAM 370230INDIAORAL SOLID ORDINARY TABLETS 3 TABLET STRIP,7 STRIP CARTON,2 TABLET STRIP,5 STRIP CARTON
NDA/MAL/HDP/3973IPCA LABORATORIES LIMITED MEDVIN PHARMA LIMITEDLARITHERARTEMETHER80MG/MLIPCA LABORATORIES LTD, SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,8 AMPOULE CARTON,6 AMPOULE CARTON
NDA/MAL/HDP/4658PT SANBE FARMAMEDVIN PHARMA LIMITEDMEROSAN 0.5MEROPENEM0.5GPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS 0.5 G VIAL
NDA/MAL/HDP/4697PT SAMBE FARMAMEDVIN PHARMA LIMITEDSANBE CLANEKSIAMOXICILLIN /CLAVULANIC ACID1000MG/ 200MGPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI CIMAHI WEST JAVA, INDONESIAINDONESIAPARENTERAL ORDINARY VIALS 6 VIAL CARTON
NDA/MAL/HDP/4721PT SAMBE FARMAMEDVIN PHARMA LIMITEDMEGABALMECOBALAMIN5000MCGPT SANBE FARMA JI INDUST/1 NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVAINDONESIAORAL SOLID ORDINARY CAPSULES 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/4749PT SANBE FARMAMEDVIN PHARMA LIMITEDMEROSANMEROPENEM1GPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI CIMAHI WEST JAVA, INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/4983PT SAMBE FARMAMEDVIN PHARMA LIMITEDPELASTINIMIPENE/CILASTATIN500MG/500MGPT SANBE FARMA JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVAINDONESIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/5388IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDLARINATEARTESUNATE+SODIUM CHLORIDE+SODIUM BICARBONATE60MG+5ML+1MLIPCA LABORATORIES LTD, SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAPARENTERAL ORDINARY DRY VIALS 60 MG VIAL,5 ML AMPOULE,1 ML AMPOULE
NDA/MAL/HDP/6507 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDZITRAM PACETAMINOPHEN + TRAMADOL HYDROCHLORIDE325MG + 37.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6985MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDCOLDRID SYRUPCETIRIZINE DIHYDROCHLORIDE + PHENYLEPHRINE HCL + PARACETAMOL2.5MG + 5MG + 125MGMEDLEY PHARMACEUTICALS LTD 18 & 19 ZARI CAUSEWAY RD KACHIGAM DAMANINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/6986MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDREPRAZ 20 TABLETSRABEPRAZOLE SODIUM20MGMEDLEY PHARMACEUTICALS LTD 18 & 19 ZARI CAUSEWAY RD KACHIGAM DAMANINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6987MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPORAZ CAPSULESOMEPRAZOLE 20MGMEDLEY PHARMACEUTICALS LTD 18 & 19 ZARI CAUSEWAY RD KACHIGAM DAMANINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON
NDA/MAL/HDP/7670 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR 50CHLORTHALIDONE50MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7671 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR-25CHLORTHALIDONE25MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8110MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDR.B.TONE SYRUPMULTI-INGREDIENTN/AMEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZAIRI CAUSE WAY ROAD KACHIGAM DAMAN INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/8198MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDZYMEX DROPSMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD,-PLOT NO 11, SURVEY NO.INDIAORAL LIQUID ORDINARY DROPS 15 ML BOTTLE
NDA/MAL/HDP/8199MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDZYMEX SYRUPMULTIVITAMIN/ DIASTASE/PEPSINMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD, PLOT NO.11, SURVEY NO INDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/0143UNIMED INDIAMETAPLUS (U) LIMITEDSPECTRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3890UNIMED INDIAMETAPLUS (U) LIMITEDPARACETAMOL SYRUPPARACETAMOL 120MG/5MLUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/4849UNI-MED INDIAMETAPLUS (U) LIMITEDMETRONIDAZOLE ORAL SUSPENSIONMETRONIDAZOLE BENZOATE125MG/5MLUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/5008UNIMEDMETAPLUS (U) LIMITEDCOLDAFEXMULTI-INGREDIENTMULTI-INGREDIENTUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/5011UNIMEDMETAPLUS (U) LIMITEDCOLDAFEX TABLETSMULTI-INGREDIENTMULTI-INGREDIENTUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,50 STRIP CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8281UNIMED INDIAMETAPLUS (U) LIMITEDCO-TRIMOXAZOLE TABLET BPCO-TRIMOXAZOLE480MGUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1000 TABLET CONTAINER
NDA/MAL/HDP/8292META PRODUCTS UGANDA LTDMETAPLUS (U) LIMITEDPARACETAMOLPARACETAMOL500MGHEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368 JIANSHE ST HENGSHUI CITY HEBEI 053000CHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/0252 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0475 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER,25 BLISTER CARTON
NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 10 G TUBE
NDA/MAL/HDP/0716 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/0721LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0836 LINCOLN PHARMACEUTICALS LIMITEDMETRO 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 INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 2 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0845LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,5 BLISTER CARTON
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 INDIAORAL SOLID ORDINARY COMBINATION PACK COATED TABLETS 2 CAPSULE + 4 TABLET BLISTER,7 BLISTER CARTON
NDA/MAL/HDP/0931 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDARH JUNIOR?-? ARTEETHER INJECTION75 MGSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY VIALS 1 ML AMPOULE,3 ML CARTON
NDA/MAL/HDP/0939 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDARH?-? ARTEETHER INJECTION150 MGSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,3 AMPOULE CARTON
NDA/MAL/HDP/0942 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDARH FORTE?-? ARTEETHER INJECTION225 MGSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,3 AMPOULE CARTON
NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 12 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS 500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1141 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCALBONECALCIUM CARBONATE + COLECALCIFEROL250MG+125MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN/ HYDROCHLOROTHIAZIDE50MG/ 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1556LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOMI UPONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/1559LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDOLOMOLPARACETAMOL500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113,LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,100 BLISTER CARTON
NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN PHARMACEUTICALS, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1682LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICALS, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1686 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGLINCOLN PHARMACEUTICALS, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/1687LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDALLDOXDOXYCYLINE 100MGLINCOLN PHARMACEUTICALS LTD 10,12,13, TRIMUL EST, AFER VADSAR VILLAGE, NEAR KHATRAJ CHOKODI, VADSAR GANDHINGARINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1749LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDVITAMIN B COMPLEXVITAMIN B COMPLEXN/ALINCOLN PARENTERALS PVT LTD 11 TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/1975 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE/NEOMYCIN0.1W/W / 0.5W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDRESTOCINPARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL500MG+ 2MG+ 2MG + 30MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,50 STRIP CARTON
NDA/MAL/HDP/2821 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE/METFORMIN HYDROCHLORIDE TABLETS5MG/500MGLINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGARINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE/METRONIDAZOLE OINTMENT5%W/W /1%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIATOPICAL EXTERNAL OINTMENTS 20 G TUBE,125 G TUBE
NDA/MAL/HDP/3087LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSULPHATRIM TABLETS B.P. 480CO-TRIMOXAZOLE480MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3225LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDIFLAME DICLOFENAC DIETHLAMINE/LINISEED OIL/METHYL SALICYLATE MENTHOLN/ASAKAR HEALTHCARE PVT LTD PLOT NO.10-13 SARKHEJ BAVLA ROADINDIATOPICAL EXTERNAL OTHER GELS/SOLS 30 G TUBE,15 G TUBE
NDA/MAL/HDP/3231LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/CHLORPHENIRAMINE MALEATE500MG/10MG/15MG/2MGLINCOLN PARENTERAL LIMITED,11,TRIMUL ESTATE,KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,2 BLISTER CARTON,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3237LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDKONAZOL CREAMKETOCONAZOLE CREAM2% W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/3241LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE CREAM1%W/WLINCOLN PHARMACEUTICALS, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIATOPICAL EXTERNAL CREAMS 20 G TUBE,15 G TUBE
NDA/MAL/HDP/3275LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDMEFLIN-500MEFENAMIC ACID500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3297LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDNEPIN-SR-20NIFEDIPINE20MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3321LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDERMOLIN-GMCLOBETASOL/GENTAMICIN/MICONAZOLE0.05%W/W+0.1%W/W+2%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/3341LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDAZILIN-250AZITHROMYCIN250MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3352LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDOMLINK-20OMEPRAZOLE20MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3369LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDAZILIN-500AZITHROMYCIN500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3666LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSTROM 50TRAMADOL HCL50MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3950LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSTROMTRAMADOL HYDROCHLORIDE50MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/4004 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDANTHELALBENDAZOLE400MGLINCOLN PHARMACEUTICALS, TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1 TABLET BLISTER
NDA/MAL/HDP/4273 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDSOLUDINE 10%POVIDINE IODINE10 %W/VLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIAINDIATOPICAL EXTERNAL LIQUIDS 1 L BOTTLE
NDA/MAL/HDP/4381 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITED DICLOFENAC SODIUMDICLOFENAC SODIUM50MGLINCOLN PHARMACEUTICALS LTD 10,11,13 TRIMUL ESTATE KHATRAJ NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4391 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDMOBYLE-AACECLOFENAC/PARACETAMOL100MG/325MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE AT & POST KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4402LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE100MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 KALOL DIST GANDHINAGARINDIAVAGINAL TABLETS 6 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/4588LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDFLUCAN 200FLUCONAZOLE200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4592LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDPENTALINK 40PANTOPRAZOLE40MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET STRIP,10 STRIP CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4595LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDVAST-20ATORVASTATIN20MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4866 LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDFLUCANFLUCONAZOLE150MGLINCOLN PHARMACEUTICALS LTD TRIMUL ESTATE KHATRAJ 382 721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5100LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDL-GENTAGENTAMICIN0.3%W/VLINCOLN PARENTERALS PVT LTD 11 TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/5292LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDOMI 10DOMPERIDONE10MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5409LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDMINTO GELALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/SIMETHICONE150MG/150MG/25MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 180 ML BOTTLE
NDA/MAL/HDP/6501PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARTROGYL 200 TABLETMETRONIDAZOLE200MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6568PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPINNADIP 50 TABLETDICLOFENAC50MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6776LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITED M-FORLIN 500METFORMIN500MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7013PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAZITHRAA 500AZITHROMYCIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7014PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDACEAAR 100 TABLETACECLOFENAC100MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/7021PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPINNOFEC PLUSACECLOFENAC+PARACETAMOL100MG+500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7022PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPINNAFLAM PLUSDICOFENAC SODIUM+PARACETAMOL50MG+500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7078 ICPA HEALTH PRODUCTS LTDMETRO PHARMACEUTICALS LIMITEDHEXIDINE?CHLORHEXIDINE GLUCONATE0.2 %W/V ICPA HEALTH PRODUCTS LIMITED-286/287, GIDC, ANKLESHWAR-393002. GUJARAT, INDIA.INDIATOPICAL EXTERNAL LIQUIDS 160 ML BOTTLE
NDA/MAL/HDP/7091PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARLEFLOX 500 TABLETSLEVOFLOXACIN HEMIHYDRATE500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7218PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARTMIN 500METFORMIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7229PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARCIFLOX 500CIPROFLOXACIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7421PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDGESIC ADL 200IBUPROFEN200MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8225LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDARTELIN60ARTESUNATE60MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 60 MG VIAL
NDA/MAL/HDP/8338PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDACEAAR PACECLOFENAC + PARACETAMOL100MG +325MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7257PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LTD - WILSONPAARPIN TABLET PARACETAMOL 650 MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0047MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIHOPE ETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG + 300MG + 300MGMACLEODS PHARMACEUTICALS LTD VILLAGE THEDA PO LODHIMAJRA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH INDIA 174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SR NO 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/0207MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE 300MG +300MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO.366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN MACLEODS PHARMACEUTICALS LTD,BLOCK N2,VILL. THEDA P.O LODHIMAJRA TEHSIL BADDI, DIST SOLAN (H.P) INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/0251MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE/ZIDOVUDINE/NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO.366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN MACLEODS PHARMACEUTICALS LTD,BLOCK N2,VILL. THEDA P.O LODHIMAJRA TEHSIL BADDI, DIST SOLAN (H.P) INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LTD PLOT NO. 208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462 046 DISTRICT RAISEN MADHYA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS 200 ML BOTTLE
NDA/MAL/HDP/0381MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDEFAVIRENZ/EMTRICITABINE/TENOFOVIR EFAVIRENZ + EMTRICITABINE + TENOFOVIR600MG + 200MG + 300MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SR NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T)INDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
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. INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 TABLET BLISTER,10 BLISTER CARTON
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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,15 BLISTER CARTON
NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS 15 ML BOTTLE
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, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 0.5 ML VIAL,1 ML VIAL
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) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE,PIOGLITAZONE + METFORMIN HYDROCHLORIDE 1MG + 15MG + 500MGARISTO PHARMACEUTICALS PVT LTD VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 TABLET BLISTER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE,PIOGLITAZONE + METFORMIN HYDROCHLORIDE 2MG + 15MG + 500MGARISTO PHARMACEUTICALS PVT LTD VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE AND DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON,3 STRIP CARTON
NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS SELAQUI, CAMP ROAD, DEHRADUN-248 197 UTARANCHALINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0841MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDETHOMIDETHIONAMIDE250MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27, SURVEY NO 366 PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT) 396210INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/0843MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD. UNIT I/UNIT II, PLOT 25-27, SR. NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (U.T) INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,10 STRIP CARTON
NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMOXIMACNOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 5 TABLET BLISTER
NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY TABLETS 10 BLISTER CARTON,10 TABLET BLISTER,100 TABLET BLISTER
NDA/MAL/HDP/0849MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMONOPAS-4GPARA-AMINOSALICYLATE SODIUM60%W/WMACLEODS PHARMACEUTICALS LTD PLOT 25-27, SURVEY NO 366 PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT) 396210INDIAORAL SOLID RETARD GRANULES 4 G SACHET,30 SACHET CARTON
NDA/MAL/HDP/0852MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKAPOCIN-1GCAPREOMYCIN1000MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO.366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T)INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,50 VIAL CARTON
NDA/MAL/HDP/0856MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDKANAMAC-1000KANAMYCIN1GMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO.366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T)INDIAPARENTERAL ORDINARY DRY VIALS 50 VIAL CARTON
NDA/MAL/HDP/0943MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSTREPTOMYCIN INJECTION BPSTREPTOMYCIN1GMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO.366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T)INDIAORAL LIQUID ORDINARY LIQUIDS 1 G VIAL,100 VIAL CARTON
NDA/MAL/HDP/1041SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN4000 I.U/1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1 ML VIAL,1 VIAL CARTON,1 ML PRE- FILLED SYRINGE,1 PREFILLED SYRINGE CARTON
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. INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON,10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE 10MG INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
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, INDIAINDIAPARENTERAL ORDINARY VIALS 0.5 ML VIAL,10 VIAL CARTON,5 ML VIAL,25 VIAL CARTON
NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE 5 MGARISTO PHARMACEUTICALS PVT LTD 23-A SHAH INDUSTRIAL ESTATE, OFF VEERA DESAI ROAD, ANDHERI (W) MUMBAI-400053INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID/ MAGNESIUM HYDROXIDE/ ALUMINIUM HYDROXIDE/ SIMETHICONE100MG/250MG/ 125MG/ 50MGARISTO PHARMACEUTCALS PVT LTD PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS 200 ML BOTTLE
NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/1325MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMACLEODS PHARMACEUTICALS LTD PLOT NO. 25-27 SURVEY NO.366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN 396 210 (U.T)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MG1.INTAS PHARMACEUTICALS LTD CAMP ROAD SELAQUI DEHRADUN, 2.MAPS LABORATORIES PVT. LIMITED-38, G.I.D.C. INDUSTRIAL ESTATE, RAFALESHWAR-363642,NH-8A,JAMBUDIA, TALUKA: MORBI, DISTRICT :RAJKOT, GUJARAT.INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD CAMP ROAD ,SELAQUI DEHRADUN , INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE STRIP,5 STRIP CARTON
NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDTORTAS 10TORASEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
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. INDIAORAL LIQUID ORDINARY LIQUIDS 200 ML BOTTLE
NDA/MAL/HDP/1464ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNIDAORNIDAZOLE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1550GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIAINDIAORAL TOPICAL GELS AND SOLS 30 G TUBE
NDA/MAL/HDP/1555GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIAINDIATOPICAL EXTERNAL LIQUIDS 500 ML BOTTLE
NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LTD, CAMP ROAD, SELAQUI, DEHRADUNINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,4 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LTD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1677MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDZIDOVUDINEZIDOVUDINE300MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 25-27 SURVEY 366 PREMIER INDUSTRIAL ESTATE KACHIGAMINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDLUMITERARTEMETHER/LUMEFANTRINE20MG/120MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,3 BLISTER CARTON,6 TABLET BLISTER,12 TABLET BLISTER,18 TABLET BLISTER,6 TABLET BLISTER,24 TABLET BLISTER,30 BLISTER CARTON
NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 14 TABLET STRIP,10 STRIP CARTON,10 TABLET STRIP
NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LTD, BLOCK N-1 , VILLAGE THEDA LODHI MAJRA TEHSIL NALAGARH , DIST SOLAN , HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MGINTAS PHARMACEUTICALS LTD, 7/3 GIDC ESTATE VATVA AHMEDABAD 382 445 INDIA , INTAS PHARMACEUTICALS LTD CAMP ROAD SELAQUI 248191 DEHRADUN (UTTARAKHAND)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER
NDA/MAL/HDP/1891MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 500LEVOFLOXACIN 500MG MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 250LEVOFLOXACIN 250MG MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,1 STRIP CARTON,10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2073SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES VACCINE LIVEMEASLES VACCINE LIVE1000CCIDSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/2079GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRAVIRACICLOVIR5%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIAINDIATOPICAL EXTERNAL CREAMS 10 G TUBE,5 G TUBE
NDA/MAL/HDP/2080GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONE VALERATEBETAMETHASONE VALERATE0.1%W/VGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIAINDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 25-27 SURVEY 366 PREMIER INDUSTRIAL ESTATE KACHIGAMINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,10 TABLET STRIP,10 STRIP CARTON
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. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS CAMP ROAD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/2206GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDNETRA CORT HYDRO CORTISONE ACETATE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBENZYL BENZOATEBENZYL BENZOATE 25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIAINDIATOPICAL EXTERNAL EMULSIONS 100 ML BOTTLE,200 ML BOTTLE,1000 ML BOTTLE
NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIAINDIAOPHTHALMIC OINTMENTS 5 G TUBE,3.5 G TUBE
NDA/MAL/HDP/2250GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCANDIGENCLOTRIMAZOLE1%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIAINDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/2283SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA TETANUS PERTUSISVACCINEVACCINESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 VIAL CARTON,1 AMPOULE CARTON
NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY TABLETS 3 STRIP CARTON,10 TABLET STRIP
NDA/MAL/HDP/2333SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA & TETANUS VACDIPHTHERIA & TETANUS TOXOIDMULTINGREDIENTSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 AMPOULE CARTON,1 VIAL CARTON
NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES MUMPS RUBELLA VACCINEMULT-IINGREDIENTSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/2362GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIAINDIATOPICAL EXTERNAL OINTMENTS 30 G TUBE
NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2481GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRACORTHYDROCORTISONE1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE,20 G TUBE
NDA/MAL/HDP/2692INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRAMITAS 5RAMIPRIL5MGINTAS PHARMACEUTICALS LTD, CAMP ROAD SELAQUI DEHRADUN -248 197INDIAORAL SOLID ORDINARY CAPSULES 3 STRIP CARTON,10 CAPSULE STRIP
NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LTD SELAQUI FEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2782INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKWINILQUININE DIHYDROCHLORIDE300MG/MLINTAS PHARMACEUTICLS LTD PLOT 457/458 SARKHEJ-BAVLA HIGHWAY MATODA 382 210 DIST SANAND AHMEDABADINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/2873INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHELIGO KITTINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE500MG+ 250MG+30MGINTAS PHARMACEUTICLS LTD PLOT 457/458 SARKHEJ-BAVLA HIGHWAY MATODA 382 210 DIST SANAND AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,7 BLISTER CARTON
NDA/MAL/HDP/2885MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFORECOX-TRACRIF + INH + PZA + ETH150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,10 BLISTER CARTON,28 TABLET BLISTER,24 BLISTER CARTON
NDA/MAL/HDP/2891MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 25-27 SURVEY 366 PREMIER INDUSTRIAL ESTATE KACHIGAMINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 25-27 SURVEY 366 PREMIER INDUSTRIAL ESTATE KACHIGAMINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS PHARMACEUTICALS LTD. BLOCK N- 1, VILLAGE THEDA, PO: LODHI MAJRA, TEHSIL NALAGARH, DIST. SOLAN, HIMACHAL PRADESH, 174 101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET STRIP,15 STRIP CARTON
NDA/MAL/HDP/2906MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRIFAMPICIN/ISONIAZID/ETHAMBUTOLRIFAMPICIN+ISONIAZID+ETHAMBUTOL150MG+75MG+275MGMACLEODA PHARMACEUTICALS LTD PLOT NO. 25-27 SR.NO 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 28 TABLET BLISTER,24 BLISTER CARTON
NDA/MAL/HDP/2956ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRANLOK 500TRANEXAMIC ACID500MG/5MLARISTO PHARMACEUTICALS PVT LTD, PLOT NO. 208 NEW INDUSTRIAL AREA NO 11, MANDIDEEP - 462046 (DISTRICT) - RAISEN, MADHYA PRADESHINDIAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/3007INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDTORTAS 5TORASEMIDE5MGINTAS PHARMACEUTICALS LTD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3070ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3076ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 40TELMISARTAN40MGARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/3083ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 80TELMISARTAN80MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/3147ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 40/12.5TELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/3203SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDTETANUS ANTITOXINTETANUS ANTITOXIN1500 I.USERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,50 AMPOULE CARTON
NDA/MAL/HDP/3252GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDPYLOOCAINBETAMETHASONE + PHENYLEPHRINE + LIDOCAINEO.5MG/G + IMG/G + 25MG/GGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 30 G TUBE
NDA/MAL/HDP/3580ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFEXOFEN-120FEXOFENADINE HYDROCHLORIDE120MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3588ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDFEXOFEN-180FEXOFENADINE180MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3612INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLOSARTAS-HTLOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 50MG /12.5MGINTAS PHARMACEUTICALS LTD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3676MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCOTRIMOXAZOLECO-TRIMOXAZOLE480MGMACLEODS PHARMACEUTICALS LTD PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3692MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCOTRIM 120CO-TRIMOXAZOLE120MGMACLEODS PHARMACEUTICALS LTD PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3707INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDOBETAS-120ORLISTAT120MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3810GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDTRIOSPORINE OINTMENTNEOMYCIN/ POLYMYCIN B /BACTRACIN3.4%W/W +5%W/W + 0.4%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIAOPHTHALMIC OINTMENTS 5 G TUBE
NDA/MAL/HDP/3815ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDQURE 500LEVOFLOXACIN HEMIHYDRATE500MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,5 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3818SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN2000 I.U/0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML VIAL,0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/3826MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDKETOMACKETOCONAZOLE200 MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,10 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/3854INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLOSARTAS 50 TABLETSLOSARTAN POTASSIUM50MGINTAS PHARMACEUTICALS LTD CAMP ROAD ,SELAQUI DEHRADUN , INDIAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/3871INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDDOVERIN 40DROTAVERINE HYDROCHLORIDE40MGINTAS PHARMACEUTICLS LTD PLOT 457/458 SARKHEJ-BAVLA HIGHWAY MATODA 382 210 DIST SANAND AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3947INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDRABTAS-20RABEPRAZOLE SODIUM20 MGINTAS PHARMACEUTICLS LTD PLOT 457/458 SARKHEJ-BAVLA HIGHWAY MATODA 382 210 DIST SANAND AHMEDABADINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4362MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 750LEVOFLOXACIN HEMIHYDRATE750MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4371MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDNEVIHOPE 200NEVIRAPINE200MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.INDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/4519ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDS-AMLOSAFE 5AMLODIPINE BESILATE5MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4522ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDS-AMLOSAFE 2.5AMLODIPINE BESILATE 2.5 MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY OTHER TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4523ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDBIGOMET SR 500METORMIN HYDROCHLORIDE 500 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4528ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPIOSAFE MF 15/500PIOGLITAZONE + METFORMIN15 MG + 500 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4606INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 10ROSUVASTATIN10MGINTAS PHARMACEUTICALS LTD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/4614GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCOMPOUND BENZOIC ACID OINTMENTBENZOIC ACID/SALICYLIC ACID6%W/W + 3%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 25 G TUBE,500 G TUBE
NDA/MAL/HDP/4652SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII TETANUS TOXOID VACCINETETANUS TOXOIDMULTI INGREDIENTSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 AMPOULE CARTON,1 VIAL CARTON
NDA/MAL/HDP/4731SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDMENAFRIVACMENINGOCCOCAL A CONJUGATE VACCINE(10MCG +33MCG)/0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 10 ML VIAL,5 ML AMPOULE
NDA/MAL/HDP/5231INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDENAPRIL 10ENALAPRIL MALEATE10MGINTAS PHARMACEUTICLS LTD PLOT 457/458 SARKHEJ-BAVLA HIGHWAY MATODA 382 210 DIST SANAND AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5232INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDENAPRIL-5ENALAPRIL MALEATE5MGINTAS PHARMACEUTICALS LTD, CAMP ROAD ,SELAQUI , DEHRADUN INDAIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5245INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFABUTAS-40FEBUXOSTAT40MGINTAS PHARMACEUTICALS LTD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/5269INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDIVAA OD 500DIVALPROEX500MGINTAS PHARMACEUTICALS LTD, CAMP ROAD, SELAQUI, DEHRADUNINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5277MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDEFAVIRENZEFAVIRENZ600MGMACLEODS PHARMACEUTICALS LTD PLOT NO.25-27 SR. NO .366 PREMIERE INDL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5404INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENAC PACECLOFENAC/PARACETAMOL100MG/500MGINTAS PHARMACEUTICALS LTD SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5406INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENAC SRACECLOFENAC SR200MGINTAS PHARMACEUTICALS LTD, CAMP ROAD, SELAQUI, DEHRADUNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/5418MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPAEDIATRIC CO-TRIMOXAZOLECO-TRIMOXAZOLE240MG/5MLMACLEODS PHARMACEUTICALS LTD, BLOCK N-2 , VILLAGE THEDA LODHI MAJRA TEHSIL NALAGARH , DIST SOLAN , HIMACHAL PRADESH 174101 INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/5507GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCALADIN LOTIONCALAMINE LOTION15%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL LOTIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/6134MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDZAMADOL PTRAMADOL HYDROCHLORIDE+ACETAMINOPHEN37.5MG+325MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6439MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDLIZOMAC 600LINEZOLID 600MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,6 STRIP CARTON,10 STRIP CARTON
NDA/MAL/HDP/6465MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDNEUROGAB 75PREGABALIN 75MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6760MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRIFAMPACIN/ ISONIAZID DISPERSIBLE TABLETRIFAMPACIN/ ISONIAZID60/30 MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/6772ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDPIOSAFE 30PIOGLITAZONE HCL30MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6773ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITED ACECLOACECLOFENAC100MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7424MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDZINC SULFATE TABLETS USP 20MGZINC SULFATE MONOHYDRATE 20MGMACLEODS PHARMACEUTICALS LTD VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7481ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDSILDENAFIL ACCORD 100SILDENAFIL CIRATE100MGINTAS PHARMACEUTICALS LTD PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7488ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDFINASTERIDE 5MGFINASTERIDE 5MGINTAS PHARMACEUTICALS LTD PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7490ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDSILDENAFIL ACCORD 50SILDENAFIL CITRATE 50MGINTAS PHARMACEUTICALS LTD PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7726MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR100MG + 25MGMACLEODS PHARMACEUTICALS LTD (BLOCK N2) VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA -174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/8097SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITIN 5000ERYTHROPOIETIN5000IU/ 0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE,6 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/8115MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDLAMIVUDINELAMIVUDINE150MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA.INDIAORAL SOLID ORDINARY TABLETS 60MG BOTTLE
NDA/MAL/HDP/8116MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE200MG + 300MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SR NO 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/8118MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMACLEODS PHARMACEUTICALS LTD PLOT 25-27 SR NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T)INDIAORAL SOLID ORDINARY TABLETS 120 TABLET CONTAINER
NDA/MAL/HDP/8193MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDECOX 400ETHAMBUTOL400MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 1 & 2 KULDEEP NAGAR MAHIM PALGAR (W) 401 404 DIST. THANE MAHARASTRA INDIA MFG LIC: KD/36INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/8194MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDSOLONEX-100ISONIAZID100MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 1 & 2 KULDEEP NAGAR MAHIM PALGAR (W) 401 404 DIST. THANE MAHARASTRA INDIA MFG LIC: KD/36INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/8195MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRH-COMRIFAMPICIN & ISONIAZID150MG +75MGMACLEODS PHARMACEUTICALS LTD, PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/8196MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDANTI-THYROXCARBIMAZOLE5MGMACLEODS PHARMACEUTICALS LTD, PLOT NO. 1 & 2 KULDINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8202MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDISONIAZIDISONIAZID300MGMACLEODS PHARMACEUTICALS LTD VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH 174101INDIAORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8213FDC LTDNORVIK ENTERPRISES LIMITEDZOCON 200FLUCONAZOLE200MGFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/8394MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRIFAMPICIN 75 MG ISONIAZID 50 MG AND PYRAZINAMIDE 150 MG DISPERSIBLE TABLETSRIFAMPICIN + ISONIAZID + PYRAZINAMIDE75MG + 50MG + 150MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 10 TABLET STRIP,10 STRIP CONTAINER
NDA/MAL/HDP/8395MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRIFAMPICIN 75 MG ISONIAZID 50 MG DISPERSABLE TABLETSRIFAMPICIN + ISONIAZID75MG + 50MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 28 TABLET STRIP,3 STRIP CARTON,100 TABLET BAG
NDA/MAL/HDP/8407INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 20TORASEMIDE20MGINTAS PHARMACEUTICALS LTD -CAMP ROAD, SELAQUI ? 248 197 DEHRADUN (UK)INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2348SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LTD -MBARARAHEPATITIS B VACCINE(RDNA) ADULTHEPATITIS B VACCINE(RDNA) ADULT20MCG/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY VIALS 10 ML VIAL,10 VIAL CARTON,1 ML VIAL,50 VIAL CARTON
NDA/MAL/HDP/8340MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LTD -MBARARAMONTEMAC 5MONTELUKAST SODIUM 5 MGMACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101INDIAORAL SOLID ORDINARY GELATIN-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO., AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE
NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LTDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA ARCA AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LTDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL CO. AL-QASTAL AREA AIRPORT ROAD AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 2 BLISTER CARTON,7 TABLET BLISTER
NDA/MAL/HDP/3090PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFODOXCEFPODOXIME PROXETIL100MG/5MLPHARMA INTERNATIONAL CO. MAIN STREET -AL - QASTAL IND ARCA AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE
NDA/MAL/HDP/3575PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFIX 400 CAPSULESCEFIXIME 400MGPHARMA INTERNATIONAL CO., AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL SOLID ORDINARY CAPSULES 5 CAPSULE BLISTER
NDA/MAL/HDP/5179PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFIX 200MG CAPSULESCEFIXIME TRIHYDRATE200MGPHARMA INTERNATIONAL CO., AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL SOLID ORDINARY CAPSULES 8 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/5346PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFUTIL 500CEFUROXIME AXETIL500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET CONTAINER
NDA/MAL/HDP/5347PHARMA INTERNATIONAL COMPANYOMAB UGANDA LTDCEFUTIL 250CEFUROXIME AXETIL250MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/5368PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFIX 100MG/5ML DRY SUSPENSIONCEFIXIME100MG/5MLPHARMA INTERNATIONAL CO., AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS 60 ML BOTTLE
NDA/MAL/HDP/5417PHARMA INTERNATIONAL COOMAB UGANDA LTDCIPROPHARMCIPROFLOXACIN500MGPHARMA INTERNATIONAL CO., MAIN STREET AL-QASTAL INDUSTRIAL AREA, AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/5474PHARMA INTERNATIONAL COOMAB UGANDA LTDCEFODOXCEFPODOXIME200MGPHARMA INTERNATIONAL CO. MAIN STREET -AL - QASTAL IND ARCA AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/0013MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDIMPLANON NXT ETONOGESTREL68MGN.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDNETHERLANDSPARENTERAL RETARD IMPLANTS 1 IMPLANT CARTON,68 MG IMPLANT
NDA/MAL/HDP/0051H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBYDENMARKPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/0053H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARKPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,1 AMPOULE CARTON
NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARKPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/0322MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEZYNCETLEVOCETRIZINE5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,10 TABLET CARTON,10 BLISTER CARTON
NDA/MAL/HDP/0449PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY GRANULES 5 G SACHET,10 SACHET CARTON
NDA/MAL/HDP/0453PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTS STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 200 ML BOTTLE
NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PREFILLED PEN 3 ML PREFILLED PEN,5 PREFILLED PEN CARTON
NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PREFILLED PEN 3 ML PREFILLED PEN,5 PREFILLED PEN CARTON
NDA/MAL/HDP/0483FOUNTIL LIFE SCIENCES PVT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID TABLETSALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXID + MAGNESIUM TRISILICATE + SIMETICONE 200MG + 250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET STRIP,3 STRIP CARTON
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) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/0681GENNOVA BIOPHARMACEUTICALS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALEMCURE PHARMACEUTICALS LTD P-2 IT BT PARK PHASE II MIDC HINJWADI PUNE MAHARASTHTRAINDIAPARENTERAL ORDINARY DRY VIALS 40 MG VIAL +8 ML VIAL WFI
NDA/MAL/HDP/0691MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20MGMICRO LABS LTD,NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1006MICRO LABS LTD 92 SIPCOTPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE / PIOGLITAZONE/ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1209MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1304MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD 92,SIPCOT INDUSTRIAL COMPLEX HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD, HOSUR 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR - 635 126, TAMIL NADU INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1500MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGMERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEMNETHERLANDSORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/1510JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLISTERINE ANTISEPTICTHYMOL + ALCOHOL 95%12.78MG/20ML + 5.60ML/MLJOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 500 ML BOTTLE,250 ML BOTTLE
NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD, 17/18 PILERNE IND. ESTATINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD, 92, SIPCOT, HOSUR- 635 126, T.NINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSMULTI INGREDIENTMULTI INGREDIENTUNICHEM LABORATORIES LTD, C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/1675MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) 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, USAUNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML VIAL,10 VIAL CARTON,0.5 ML PRE- FILLED SYRINGE,1 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL +THYMOL95%+12MGJOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 500 ML CONTAINER,250 ML CONTAINER
NDA/MAL/HDP/1800MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD, 92 SIPCOT INDUSTRIAL COMPLEX, HOSUR-635 126 (T.N)INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/1805MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEENBOROUGH LTD NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/1851PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN/DICLOFENAC/LEVOMENTHOL/METHYL SALICYLATE0.438G/0.335G/0.135G/0.918GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL EMULSION GELS 10 G TUBE,20 G TUBE
NDA/MAL/HDP/1853MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAERIUS ORAL SOLUTIONDESLORATIDINE0.5MG/MLSCHERING-PLOUGH LABO N.V, INDUSTRIE PARK 30 ZONE A B2220 HEIST OP-DEN BERG& MSD (PTY) LTD LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICABELGIUMORAL LIQUID ORDINARY SYRUPS 150 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/1869MERCK SHARP & DOHME INTERPHARMAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 200EFAVIRENZ200MG1.MERCK SHARP & DOHME B.V WAARDERWEG 39, PC HAARLEM. HOLLAND 2. ZHEJIANG HUAHAI PHARMACEUTICAL CO.LTD, XUNQIAO,LINHAI,ZHEJIANGNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS 90 TABLET BOTTLE
NDA/MAL/HDP/1873MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEENBOROUGH LTD NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/1952JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY TABLETS 80 ML BOTTLE
NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD, C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/2037MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 50EFAVIRENZ50MGMERCK SHARP & DOHME B.V,ZHEJIANG HUAHAI PHARMACEUTICAL CO.LTDNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER
NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD, 92 SIPCOT INDUSTRIAL COMPLEX, HOSURINDIAORAL SOLID ORDINARY TABLETS 3 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/2321JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN CHESTYORCIPREALINE/BROMOHEXENE5MG/5ML,+ MG/5MLJOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/2339AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-375AMOXICILLIN/CLAVULANATE POTASSIUM250MG/125MGAUROBINDO PHARMA LTD, UNIT XII, SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESHINDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,4 BLISTER CARTON,20 BLISTER CARTON
NDA/MAL/HDP/2394MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN EFAVIRENZ600MGMERCK SHARP & DOHME B.V,ZHEJIANG HUAHAI PHARMACEUTICAL CO.LTDINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/2473MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT - HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2581MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAVAS-10ATORVASTATIN10MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2848MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROGENTA OINTMENTBETAMETHASONE /GENTAMICIN 0.5%W/WSCHERING PLOUGH CORPORATION POINTE CLAIRE QUEBECCANADATOPICAL EXTERNAL OINTMENTS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/3078JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB ALLERGY CONGESTIONPARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE500MG/ 2MG/ 30MGJOHNSON & JOHNSON, 241MAIN ROAD, RETREAT, CAPE TOWNSOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3138JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANUSOL SUPPOSITORYBISMUTH SUBGALLATE/BISMUTH OXIDE/ZINC OXIDE59MG/24MG/296MGJOHNSON & JOHNSON, 241MAIN ROAD, RETREAT, CAPE TOWNSOUTH AFRICARECTAL SYSTEMIC SUPPOSITORIES 10 SUPPOSITORY BLISTER
NDA/MAL/HDP/3156PFIZER LABORATORIES (PTY)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN FOR COLDSPSEUDOEPHEDRINE HCL + IBUPROFEN30MG + 200MGJOHNSON & JOHNSON, 241MAIN ROAD, RETREAT, CAPE TOWNSOUTH AFRICAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/3199MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDISENTRESSRALTEGRAVIR400MGZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD -ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANGCHINAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/3334UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 375AMOXICILLIN/CLAVULANIC ACID250MG/125MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 10 TABLET STRIP,2 STRIP CARTON,6 STRIP CARTON
NDA/MAL/HDP/3373UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 625AMOXILLICIN/CLAVULANATE500MG/125MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY OTHER COATED TABLETS 10 TABLET STRIP,6 STRIP CARTON,7 TABLET STRIP,2 STRIP CARTON
NDA/MAL/HDP/3389BAYER PHARMA AGPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLARINASE REPE TABSLORATIDINE + PSEUDOEPHEDRINE5MG + 120MGSCHERING PLOUGH LABO N V, HEIST-OP-DENBERGBELGIUMORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3413JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOMBANTRINPYRANTEL PAMOATE125MGJOHNSON&JOHNSON PTY LTD -241 MAIN RD/HOOFWEG 241, SOUTH AFRICAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,100 TABLET CONTAINER
NDA/MAL/HDP/3457JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANUSOL OINTMENTBISMUTH SUBGALLATE/BISMUTH OXIDE/ZINC OXIDE22.5MG/8.75MG/107.5MGJOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794SOUTH AFRICARECTAL SYSTEMIC UNIT DOSE OINTMENTS AND PASTES 25 G TUBE
NDA/MAL/HDP/3461MYLAN LABORATORIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDZIDOVUDINEZIDOVUDINE300MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/3464JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTARTAR CONTROL LISTERINE ANTISEPTICZINC CHLORIDE + DENATURED ALCOHOL MENTHOL 95% + THYMOL18MG/ 20ML + 0.9ML/20ML + 12.7MG/20MLJOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794SOUTH AFRICAORAL LIQUID ORDINARY OTHER LIQUIDS 250 ML BOTTLE,500 ML BOTTLE
NDA/MAL/HDP/3483JOHNSON&JOHNSON PTY LTD. 241PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB 3-WAYIBUPROFEN + PSEUDOEPHEDRINE HCL200MG + 30MGJOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794SOUTH AFRICAORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3504MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBIFRILZOFENOPRIL30MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS 2 BLISTER CARTON,14 TABLET BLISTER
NDA/MAL/HDP/3712MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLOZAARLOSARTAN POTASSIUM / AMLODIPINE 50MG/ 5MGMICRO LABS LTD-92,SIPCOT INDUSTRIAL COMPLEX,HOSUR-635-126(T.N)INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3850MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-HLOSARTAN POTASSIUM/HYDROCHLORTHIAZIDE50MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3989UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELIB 200MGCELECOXIB200MGUNICHEM LABORATORIES LTD, 17/18 PILERNE IND. ESTATINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4033JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE7MG/5MLJOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/4092PRISMA P'CALSPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLORANORMSACCHAROMYCES BOULARDII250MGBHARAT BIOTECH INTERNATIONAL LTD-TURKPALLY SHAMEX 500 078 MYDERAHAD INDIAINDIAORAL SOLID ORDINARY POWDERS 250 MG SACHET,2 SACHET CARTON,10 SACHET CARTON
NDA/MAL/HDP/4126UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELIB 100MGCELECOXIB100MGUNICHEM LABORATORIES LTD, 17/18 PILERNE IND. ESTATINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4173MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNASONEXMOMETASONE FUROATE MONOHYDRATE0.05%W/VSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM,MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685BELGIUM/ SOUTH AFRICANASAL SYSTEMIC METERED-DOSE LIQUIDS 120 METERED DOSE CANNISTER
NDA/MAL/HDP/4358A.MENARINI INDUSTRIE FARMACEUTICHE S.R.IPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLIOTONHEPARIN SODIUM1000 I.U/GA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L 50131 FIRENZE ITALYITALYTOPICAL EXTERNAL GELS AND SOLS 15 G TUBE,30 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/4694 MERCK SHARP & DOHME INTAPHARMAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDROTATEQROTAVIRUS LIVE REASSORTANT VIRUS G1,G2,G3,G4 &P1G1 2.2M IU/DOSE+G2 2.8M IU/DOSE +G3 2.2M IU/DOSE+ G4 2.0M IU/DOSE+P1 2.3M IU/DOSEMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USAUNITED STATESORAL LIQUID ORDINARY EMULSIONS 10 ML BOTTLE
NDA/MAL/HDP/4777MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCRIXIVANINDINAVIR SULPHATE400MGMERCK SHARP & DOHME B.V WAARDERWEG 39, PC HAARLEM. HOLLANDHOLLANDORAL SOLID ORDINARY CAPSULES 180 CAPSULE BOTTLE
NDA/MAL/HDP/4949JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN DRY COUGH DMDEXTROMETHORPHAN HYDROBROMIDE15MG/MLJOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/4951JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN ORIGINALDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE12.5MG/5ML + 125MG/5MLJOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE,2.5 L BOTTLE
NDA/MAL/HDP/4952JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN WITH CODEINEDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE12.5MG/5ML +125MG/5ML +10MG/5MLJOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/4972JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOOLMINT LISTERINEMENTHOL + ALCOHOL 95%0.02% + 4.58MLJOHNSON&JOHNSON PTY LTD. 241 MAIN ROAD RETREAT 794SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 250 ML CONTAINER,500 ML CONTAINER
NDA/MAL/HDP/5038UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-CAM TABLETSMELOXICAM15MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/5065N.V. ORGANONPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMARVELONDESOGESTREL/ETHINYLESTRADIOL150MG/30MGN.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDNETHERLANDSORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,100 TABLET BLISTER
NDA/MAL/HDP/5092MICRO LABS LTD 92 SIPCOTPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDEGLIMEPRIDE2MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5104NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVEMIR FLEXPENINSULIN DETERMIR100 I.U/MLNOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PRE-FILLED PENS 3 ML PRE- FILLED SYRINGE,5 PREFILLED PEN CARTON
NDA/MAL/HDP/5256MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROFOS INJECTIONBETAMETHASONE SODIUM PHOSPHATE/DIPROPIONATE2MG+5MG/MLSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM,MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685BELGIUM/ SOUTH AFRICAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE
NDA/MAL/HDP/5263MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROSALIC OINTMENTBETAMETHASONE/SALICYLIC ACID0.5%/0.3%SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAMBELGIUMTOPICAL EXTERNAL OINTMENTS 30 MG TUBE
NDA/MAL/HDP/5265MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROSONE OINTMENTBETAMETHASONE DIPROPIONATE0.5%W/WSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAMBELGIUMTOPICAL EXTERNAL OINTMENTS 10 G TUBE,30 G TUBE
NDA/MAL/HDP/5290MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELOCOM CREAMMOMETASONE FUROATE0.1%W/WSCHERING PLOUGH CORPORATION POINTE CLAIRE QUEBECCANADATOPICAL EXTERNAL CREAMS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/5293MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELOCOM LOTIONMOMETASONE FUROATE0.1%W/VSCHERING PLOUGH CORPORATION POINTE CLAIRE QUEBEC & MSD (PTY) LTD LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICACANADA/ SOUTH AFRICATOPICAL EXTERNAL LOTIONS 30 ML BOTTLE
NDA/MAL/HDP/5294MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELOCOM OINTMENTMOMETASONE FUROATE0.1%W/WSCHERING PLOUGH CORPORATION POINTE CLAIRE QUEBECCANADATOPICAL EXTERNAL OINTMENTS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/5349MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELESTAMINE TABLETSBETAMETHASON + ,DEXCHLORPHENIRAMINE0.25MG + 2MGSCHERING PLOUGH LABO N.V INDUSTRIE PARK 30 ZONE A B2220 HEIST OP-DEN BERG& MSD (PTY) LTD LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICABELGIUM/ SOUTH AFRICAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/5377JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN FOUR FLU LIQUIDDIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE25MG/20ML + 1G/20ML + 45MG/20MLJOHNSON&JOHNSON PTY LTD. /(EDMS) BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/5444MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAERIUS TABLETSDESLORATIDINE5MGSCHERING PLOUGH CORPORATION POINTE CLAIRE QUEBEC& MSD (PTY) LTD LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICACANADA/SOUTH AFRICAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/5685JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE20MG/5MLSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/6301AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM 10OLANZAPINE 10MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/6457AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOXIWAR 400MOXIFLOXACIN HYDROCHLORIDE400MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 5 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6470AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 1000METFORMIN HYDROCHLORIDE1000MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6620MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET 5MG NEBIVOLOL HYDROCHLORIDE5MGBERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLINGERMANYORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,2 BLISTER CARTON,14 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6625MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/12.5NEBIVOLOL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE5MG/12.5MGBERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, -) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL) TEMPELHOFER WEG 83 D-12347 BERLIN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6629MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/25NEBIVOLOL+HYDROCHLOROTHIAZIDE5MG+25MGBERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION-TEMPELHOFER WEG 83 D-12347 BERLIN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6921 GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUFENAC DICLOFENAC SODIUM75MGGUILIN PHARMACEUTICAL CO LTD NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 10 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7288MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKETESSE FILM COATED TABLETSDEXKETOPROFEN TROMETAMOL25MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,4 BLISTER CARTON
NDA/MAL/HDP/7298MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-2.5 NEBIVOLOL HYDROCHLORIDE 2.5 MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7651MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUVIA 25SITAGLIPTIN25MGMSD PTY LTD-117 16TH ROAD, PRIVATE BAG 3 HALFWAY HOUSE 1685SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7652MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUVIA 100SITAGLIPTIN100MGMSD PTY LTD-117 16TH ROAD, PRIVATE BAG 3 HALFWAY HOUSE 1685SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7653MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUVIA 50SITAGLIPTIN50MGMSD PTY LTD-117 16TH ROAD, PRIVATE BAG 3 HALFWAY HOUSE 1685SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7656A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSPASMOMENOTILONIUM BROMIDE40MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA CAMPO DI PILE, L?AQUILA (AQ), ITALYITALYORAL SOLID ORDINARY FILM-COATED TABLETS 15 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7660SPECPHARM (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTENEMCOMEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE200MG + 300MGHETERO LABS LTD UNIT III 22-110, IDA JEEDIMETLA HYDERABAD-500055, ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/7903MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMELMET-1000SRMETFORMIN HYDROCHLORIDE1000MGMICRO LABS LTD, 92 SIPCOT INDUSTRIAL COMPLEX, HOSUR-635 126 (T.N)INDIAORAL SOLID RETARD COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8234ABBOT LABORATORIES S.A. (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDINFUVAC 2015INACTIVATED INFLUEZA VACCINE-SURFACE ANTIGEN [A/CALIFORNIA/7/2009(H1N1) PDM09 + A/SWITZERLAND/9715293/2013(H3N2) + B/PHUKET/3073/2013-LIKE STRAINS]15?G + 15?G +15?GABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE,1 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/8331MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTORSINEX-20TORSEMIDE20MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8333MICRO LABS LTD 92 SIPCOT INDUSTRIALPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAVAS-20ATORVASTATIN 20MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8339SPECPHARM (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEFTENEMEFAVIRENZ+EMITRICITABINE+TENOFOVIR DISOPROXIL FUMARATE600MG+200MG+300MGHETERO LABS LTD LABS LIMITED UNIT V APIIC FORMULATION SEZ POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOB NAGAR (DIST) -509301, ANDHRA PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/8355AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDONECLAPZ 75CLOPIDOGREL75MGAUROBINDO PHARMA LTD UNIT VII SEZ PLOT S1 SPECIAL ECONOMIC ZONE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 228.5AMOXICILLIN/CLAVULANATE200MG/28.5MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS 70 ML BOTTLE
NDA/MAL/HDP/0193MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 625AMOXICILLIN/CLAVULANIC ACID500MG/125MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILIN/CLOXACILLIN250MG/250MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1232MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOCILLIN 125AMPICILLIN125 MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDAMOXICILLIN TABLETS FOR ORAL SUSPENSIONAMOXICILLIN125MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 10 TABLET STRIP,2 STRIP CARTON,3 STRIP CARTON,10 STRIP CARTON
NDA/MAL/HDP/3173MEDOPHARM PRIVATE LIMITED,CHENNAIPLANET PHARMACEUTICALS UGANDA LTDMEDOCILLIN 250AMPICILLIN250MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3507MEDOPHARM PRIVATE LIMITED,CHENNAIPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 250AMOXICILLIN250MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/4670MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 500AMOXICILLIN500MGMEDOPHARM PVT LTD NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7536PLANET PHARMACEUTICALS (U) LTDPLANET PHARMACEUTICALS UGANDA LTDNETVAICAINBUPIVACAINE HYDROCHLORIDE + DEXTROSE5MG + 80MG /MLSWISS PARENTERALS PVT LTD 809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 282 220 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 4 ML AMPOULE,10 AMPOULE CARTON,10ML AMPOULE,2AMPOULE CARTON
NDA/MAL/HDP/8326MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 250 DTAMOXICILLIN250MGMEDOPHARM PRIVATE LIMITED, NO. 50, KAYARAMBEDU VILLAGE, GUDUVANCHERRY- 603 202, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/6059RESONANT PHARMACEUTICALS PVT LTDPNR PHARMACEUTICALS LTDNEUROZONEMECOBALAMIN + PREGABALIN750MCG + 75MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7362RESONANT PHARMACEUTICALS PVT LTDPNR PHARMACEUTICALS LTDTRAM-DOL-50TRAMADOL HYDROCHLORIDE50MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8249RESONANT PHARMACEUTICALS PVT LTDPNR PHARMACEUTICALS LTDPANZOL-DPANTOPRAZOLE+DOMPERIDONE20MG + 10MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8328RESONANT PHARMACEUTICALSPNR PHARMACEUTICALS LTDAZITHROCINAZITHROMYCIN500MGACME FORMULATION LTD, ROPAR ROAD, NALAGARH, DIST SOLAN HIMACHAL PRADESH-174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/8330RESONANT PHARMACEUTICALSPNR PHARMACEUTICALS LTDCOARTLUMEFANTRINE + ARTEMETHER 480 MG + 80 MGACME FORMULATION LTD, ROPAR ROAD, NALAGARH, DIST SOLAN HIMACHAL PRADESH-174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0189CIPLA LTDQUALITY CHEMICALS LTDNEVIMUNE TABLETSNEVIRAPINE200MGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403, CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAINDIA/UGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,6 BLISTER CARTON,60 TABLET CONTAINER
NDA/MAL/HDP/0480CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUALITY CHEMICALS LTDTRIODAYEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA LTD MIDC PATALGANGA MAHARASHTRA 410 220 ,CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAINDIA/UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/0608CIPLA LTDQUALITY CHEMICALS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD A-42 MIDC PATALGANGA 410220 DISTRICT RAIGAD MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 120 TABLET BOTTLE
NDA/MAL/HDP/1156CIPLA LTDQUALITY CHEMICALS LTDFUNGICIPCLOTRIMAZOLE CREAM USP1%W/WCIPLA LTD L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/1255CIPLA LTDQUALITY CHEMICALS LTDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD MIDC PATALGANGA MS 410 220 INDIA MFG LICINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1360CIPLA LTDQUALITY CHEMICALS LTDABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/1381CIPLA LTDQUALITY CHEMICALS LTDLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,/ ZIDOVUDINE TABLETS150/ 300MGCIPLA LTD , PLOT NO. L-139 TO L-146 VERNA IND. ESTINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/1384CIPLA LTDQUALITY CHEMICALS LTDLAMIVUDINE AND ZIDOVUDINE TABLETS LAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD, VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403722 INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/1399CIPLA LTD.QUALITY CHEMICALS LTDASTHALIN SALBUTAMOL100MCG/DOSECIPLA LTD, INDORE SEZ PITHAMPURINDIALUNG ADMINISTRATION METERED-DOSE INHALER200 METERED DOSE CANNISTER
NDA/MAL/HDP/1525CIPLA LTDQUALITY CHEMICALS LTDBENDEXALBENDAZOLE20MG/5MLCIPLA LTD, VERNA INDUSTRIAL AREA GOAINDIAORAL LIQUID ORDINARY SUSPENSIONS 10 ML BOTTLE
NDA/MAL/HDP/1531CIPLA LTDQUALITY CHEMICALS LTDNOVATAXCEFOTAXIME1GMMEDISPRAY LABORATORIES PVT LTD, L-1/1, L-1/2/2,L-2 ADDITIONAL MIDC AREA, SATARA 415004 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/1698CIPLA LTDQUALITY CHEMICALS LTDAZEE-500AZITHROMYCIN500MGCIPLA LTD, VERNA INDUSTRIAL ESTATE GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1777CIPLA LTDQUALITY CHEMICALS LTDNUZAC 20FLUOXETINE20MGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403INDIAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1811CIPLA LTDQUALITY CHEMICALS LTDDUOVIRZIDOVUDINE + LAMIVUDINE300MG + 150MGCIPLA LTD, VERNA IND ESTATE SALCETTE GOA 403, CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAINDIA/UGANDAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE,10 TABLET BLISTER,6 BLISTER CARTON
NDA/MAL/HDP/1907CIPLA LTDQUALITY CHEMICALS LTDABACAVIR ABACAVIR 300MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/2092CIPLA LTDQUALITY CHEMICALS LTDDUOVIR-NLAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403INDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE,60 TABLET BOTTLE
NDA/MAL/HDP/2175CIPLA LTDQUALITY CHEMICALS LTDPARAFIZZPARACETAMOL500MGCIPLA LTD PLOT 9 &10 INDORE SEZ PITHAMPUR M.P 454775INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 12 TABLET STRIP,4 STRIP CARTON,4 TABLET STRIP,4 STRIP CARTON
NDA/MAL/HDP/2188CIPLA LTDQUALITY CHEMICALS LTDPREDNISOLONEPREDNISOLONE5MGCIPLA LTD, PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2247CIPLA LTD.QUALITY CHEMICALS LTDESOMAC ESOMEPRAZOLE 20MGOKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2262CIPLA LTD QUALITY CHEMICALS LTDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD PLOT S-103-105,S-107-112 $ L-147-L-147-1 VERNA IND.AREAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/2497CIPLA LTDQUALITY CHEMICALS LTDNEVIMUNE NEVIRAPINE50MG/5MLCIPLA LTD, PLOT 9 & 10 , INDORE SEZ , PITHAMPUR , M.P 454775 , INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/2507CIPLA LTDQUALITY CHEMICALS LTDEXERMET 1000METFORMIN HCL1000MGCIPLA LTD, D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2527CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUALITY CHEMICALS LTDACIVIR CREAMACICLOVIR 5%W/WCIPLA LTD, VERNA INDUSTRIAL ESTATE, GOAINDIATOPICAL EXTERNAL CREAMS 5 G TUBE,10 G TUBE
NDA/MAL/HDP/2603CIPLA LTDQUALITY CHEMICALS LTDVIRADAYTENOFOVIR/ EMTRICITABINE/ EFAVIRENZ300/200/600MGCIPLA LTD PLOT NO. S-103 TO S-105, S-107 TO S-112 , L-147 TO L-147-1 VERNA INDUSTRIAL ESTATE VERNA GOAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/2671CIPLA LTD..QUALITY CHEMICALS LTDDUOLIN RESPULESIPRATROPIUM BROMIDE + SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA LTD, VERNA IND ESTATE SALCETTE GOA-403 722INDIAOTHER SYSTEMIC LIQUID INHALATIONS 2.5 ML VIAL,20 VIAL CARTON
NDA/MAL/HDP/2679CIPLA LTD.QUALITY CHEMICALS LTDALERID SYRUPCETRIZINE HYDROCHLORIDE5MG/5MLCIPLA LTD PLOT NO. 143 ANDL-144A VERNA IND. ESTATE SALCETTE GOA 403 722INDIAORAL LIQUID ORDINARY SYRUP 30 ML BOTTLE
NDA/MAL/HDP/2910CIPLA LTDQUALITY CHEMICALS LTDTENVIR EMTENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE300MG+200MGCIPLA LTD ,VERNA INDUSTRIAL ESTATE, VERNA GOA,403 722INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/2966CIPLA LTDQUALITY CHEMICALS LTDTENVIRTENOFOVIR DISPROXIL FUMARATE TABLETS300MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/2983CIPLA LTD.QUALITY CHEMICALS LTDFORCAN-200FLUCONAZOLE200MGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403INDIAORAL SOLID ORDINARY CAPSULES 4 CAPSULE BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/3041CIPLA LTDQUALITY CHEMICALS LTDLEVOFLOXACINLEVOFLOXACIN250MGCIPLA LTD, L-139 TO L-146, VERNA INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3049CIPLA LTD..QUALITY CHEMICALS LTDEFAVIRENZEFAVIRENZ600MGCIPLA LTD PLOT NO. L-139 TO L-146 VERNA IND. ESINDIAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/3055CIPLA LTD.QUALITY CHEMICALS LTDABACAVIR SULFATEABACAVIR SULPHATE300MGCIPLA LTD MIDC PATALGANGA 410 220 DIST. RAIGAD INDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/3062CIPLAQUALITY CHEMICALS LTDLAMIVUDINE,ZIDOVUDINE, NEVIRAPINELAMIVUDINE/ZIDOVUDINE/NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD PLOT NO. L-139 TO L-146 VERNA IND. ES,CIPLA LTD, PLOT 9 & 10 , INDORE SEZ , PITHAMPUR , M.P 454775 , INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/3084CIPLA LTDQUALITY CHEMICALS LTDNEVIRAPINENEVIRAPINE200MGCIPLA LTD PLOT NO. L-139 TO L-146 VERNA IND. ESINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/3088CIPLA LTDQUALITY CHEMICALS LTDPILL 72LEVONORGESTREL0.75MGCIPLA GOA UNIT 8 , L-147 TO L 147/1 , L-147-3 TO L-138 , VERNA INDUSTRIAL ESTATE , VERNA GOAINDIAORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER
NDA/MAL/HDP/3141CIPLA LTD.QUALITY CHEMICALS LTDAMLOPRESS-5AMLODIPINE BESYLATE5MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3182CIPLA LTDQUALITY CHEMICALS LTDTADACIP 20TADALAFIL20MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3191CIPLA LTDQUALITY CHEMICALS LTDSILAGRA 100SILDENAFIL CITRATE100 MGCIPLA LIMITED D-7-MIDC, KURKUMBH DISTRICT PUNE 413802INDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3193CIPLA LTDQUALITY CHEMICALS LTDSILAGRASILDENAFIL CITRATE50MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802INDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,10 BLISTER CARTON,4 TABLET BLISTER,1 BLISTER CARTON,10 TABLET BLISTER
NDA/MAL/HDP/3212CIPLA LTD.QUALITY CHEMICALS LTDCLOPIVAS 75MGCLOPIDOGREL BISULPHATE75MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3215CIPLA LTDQUALITY CHEMICALS LTDSEROFLO-125MGSALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 125MCGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIAINDIALUNG ADMINISTRATION METERED-DOSE INHALER120 METERED DOSE CANNISTER
NDA/MAL/HDP/3220CIPLA LTDQUALITY CHEMICALS LTDPYLO KITLANSOPRAZOLE/TINIDAZOLE/CLARITHROMYCIN30/500/250 MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802INDIAORAL SOLID ORDINARY TABLETS 2 CAPSULE BLISTER,4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3228CIPLA LTDQUALITY CHEMICALS LTDENTOSECSECNIDAZOLE1000MGCIPLA LTD, VERNA IND ESTATE SALCETTE GOAINDIAORAL SOLID ORDINARY TABLETS 2 TABLET STRIP
NDA/MAL/HDP/3286CIPLA LIMITEDQUALITY CHEMICALS LTDLOMAC-20OMEPRAZOLE CAPSULES20MGCIPLA LTD, INDORE SEZ PITHAMPURINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3302CIPLA LTDQUALITY CHEMICALS LTDAMOXICILLIN ORAL SUSPENSIONAMOXICILLIN125MG/5MLOKASA PVT LTD, 346 KUNDAIM INDUSTRIAL ESTATE GOA, 403 115INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3326CIPLA LTDQUALITY CHEMICALS LTDAMICIPAMIKACIN500MG/2MLCIPLA LTD M-61, M-62 &M-63 UNIT IX VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE GOA 403 722INDIAPARENTERAL ORDINARY VIALS 5 VIAL CARTON,2 ML VIAL
NDA/MAL/HDP/3333CIPLA LTD.QUALITY CHEMICALS LTDNOVACLAV-625AMOXICILLIN/CLAVULANATE POTASSIUM500MG/125MGOKASA PVT , 346 KUNDAIM , INDUSTRIAL ESTATE , KUNDINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3441CIPLA LTDQUALITY CHEMICALS LTDLEVOFLOXACINLEVOFLOXACIN500MGCIPLA LTD, L-139 TO L-146, VERNA IND ESTATE SALCETTEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3480CIPLA LTDQUALITY CHEMICALS LTDHYOSPANHYOSCINE BUTYL BROMIDE10MGCIPLA LTD, MIDC, PATALGANGA, M.S. 410220, INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/3491CIPLA LTD.QUALITY CHEMICALS LTDBENDEX-400ALBENDAZOLE400MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3548CIPLA LTDQUALITY CHEMICALS LTDBECLATE 200BECLOMETASONE200MCG/DOSECIPLA LTD, L-139, L-146, VERNA INDUSTRIAL ESTATE, GOAINDIALUNG ADMINISTRATION METERED-DOSE INHALER200 METERED DOSE CANNISTER
NDA/MAL/HDP/3553CIPLA LTD.QUALITY CHEMICALS LTDFALCIMON 25/67.5 B/LARTESUNATE+AMODIAQUINE25MG+67.5MGCIPLA LTD UNIT II A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY LAYERED TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/3558CIPLA LTDQUALITY CHEMICALS LTDSEROFLO-250SALMETEROL + FLUTCASONE PROPIONATE25MCG + 250MCG PER METERED DOSECIPLA LTD, L-139, L-146, VERNA INDUSTRIAL ESTATE, INDIALUNG ADMINISTRATION METERED-DOSE INHALER120 METERED DOSE CANNISTER
NDA/MAL/HDP/3684CIPLA LTDQUALITY CHEMICALS LTDI-PILLLEVONORGESTEREL1.5MGCIPLA LTD-PLOT NO. L-139, S,-103, M-62, VERNAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3920CIPLA LTDQUALITY CHEMICALS LTDPHOTERICIN BAMPHOTERICIN B50MGCIPLA LTD M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE VERNA GOAINDIAPARENTERAL ORDINARY VIALS 50 MG VIAL
NDA/MAL/HDP/3968CIPLA LTDQUALITY CHEMICALS LTDNORLUT-N NORETHINDRONE ACETATE5MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3972CIPLA LTD.QUALITY CHEMICALS LTDFERTOMID-50CLOMIFEN50MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4351CIPLA LTDQUALITY CHEMICALS LTDABACAVIR SULFATEABACAVIR SULPHATE60MGCIPLA LTD, PATALGANGA UNIT II PLOT MO A-33 A42 MIDC RAIGADINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/4376CIPLA LTD.QUALITY CHEMICALS LTDEFAVIRENZ+LAMIVUDINE & TENOFOVIR TABLETSEFAVIRENZ + LAMIVUDINE + TENOFOVIR600MG +300MG + 300MGCIPLA LTD MIDC PATALGANGA 410 220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/4647CIPLA LTD..QUALITY CHEMICALS LTDLEVOLIN LEVOSALBUTAMOL50MCGCIPLA LTD VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOAINDIALUNG ADMINISTRATION METERED-DOSE INHALER 200 METERED DOSE CANNISTER
NDA/MAL/HDP/4869CIPLA LIMITED.QUALITY CHEMICALS LTDMICOGEL CREAMMICONAZOLE NITRATE2%W/WCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/4880CIPLA LTDQUALITY CHEMICALS LTDMISOPROST 200MISOPROSTOL200MCGCIPLA LTD (CIPLA GOA UNIT 8) L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER, 1 BLISTER CARTON, 7 BLISTER CARTON,15 BLISTER CARTON
NDA/MAL/HDP/4899CIPLA LIMITEDQUALITY CHEMICALS LTDCLOSERINECYCLOSERINE250MGCIPLA LTD VERNA INDUSTRIAL ESTATE GOA 403722INDIAORAL SOLID ORDINARY CAPSULES 40 CAPSULE BOTTLE
NDA/MAL/HDP/5202CIPLA LIMITEDQUALITY CHEMICALS LTDHYDROCORT INJECTIONHYDROCORTISONE SODIUM SUCCINATE100MGCIPLA LTD, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, 403722INDIAPARENTERAL ORDINARY DRY VIALS 100 MG VIAL,1 VIAL CARTON
NDA/MAL/HDP/5236CIPLA LTD.QUALITY CHEMICALS LTDETHIONAMIDE TABLETS USPETHIONAMIDE250MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER
NDA/MAL/HDP/5252CIPLA LIMITED.QUALITY CHEMICALS LTDENCLEX-40ENOXAPARIN SODIUM40MG/0.4MLCIPLA LTD, VERNA INDUSTRIAL ESTATE, VERNA GOAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.4 ML PRE- FILLED SYRINGE,2 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/5360CIPLA LIMITEDQUALITY CHEMICALS LTDMOXICIP 400MOXIFLOXACIN400MGCIPLA LTD MIDC PATALGANGA MS 410 220INDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER
NDA/MAL/HDP/5371CIPLA LIMITED.QUALITY CHEMICALS LTDLAMIVUDINELAMIVUDINE10MG/MLCIPLA LTD PLOT NO. L-139 TO L-146 VERNA IND. ESINDIAORAL LIQUID ORDINARY LIQUIDS 100 ML BOTTLE
NDA/MAL/HDP/5372CIPLA LTD QUALITY CHEMICALS LTDDUOMUNELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA LTD, MIDC KURKUMBH, DIST. PUNE ; CIPLA QUALITY CHEMICALS INDUSTRIES LIMITED PLOT 1-7 ,1ST RING ROAD LUZIRAINDIA/UGANDAORAL SOLID ORDINARY TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/5374CIPLA LIMITED.QUALITY CHEMICALS LTDLAMIVIR ORAL SOLUTIONLAMIVUDINE50MG/5MLCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403 ,CIPLA LTD, PLOT 9 & 10 , INDORE SEZ , PITHAMPUR , M.P 454775 , INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 100 ML CONTAINER,240 ML BOTTLE
NDA/MAL/HDP/5389CIPLA LTDQUALITY CHEMICALS LTDLUMARTEMARTEMETHER/LUMEFANTRINE20MG/120MGCIPLA LTD PLOT NO.9 & 10 PHARMA ZONE PHASE II INDORE SPECIAL ECONOMIC ZONE PITHAMPUR (M.P) 454 775INDIAORAL SOLID ORDINARY TABLETS
NDA/MAL/HDP/5457CIPLA LIMITEDQUALITY CHEMICALS LTDFALCIMON 100/270 B/LARTESUNATE+AMODIAQUINE100MG+270MGCIPLA LTD UNIT II A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,6 TABLET BLISTER
NDA/MAL/HDP/5458CIPLA LTDQUALITY CHEMICALS LTDFALCIMON 50/135 B/LARTESUNATE+AMODIAQUINE50MG+135MGCIPLA LTD UNIT II A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/5478CIPLA LTDQUALITY CHEMICALS LTDBECLATE-50BECLOMETASONE50MCG/ACTUATIONCIPLA LTD, L-146 VERNA INDUSTRIAL ESTATE, VERNA GOA, 403722INDIAORAL TOPICAL METERED-DOSE PRESSURISED AEROSOLS 200 METERED DOSE CANNISTER
NDA/MAL/HDP/5480CIPLA LTDQUALITY CHEMICALS LTDBECLATE NASAL SPRAYBECLOMETHASONE DIPROPIONATE50MCGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403INDIANASAL SYSTEMIC UNIT DOSE AEROSOLS 200 METERED DOSE CANNISTER
NDA/MAL/HDP/6061CIPLA LTD..QUALITY CHEMICALS LTDNASEHALERMOMETASONE FUROATE50MCG /SPRAYCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIANASAL TOPICAL SPRAYS WITHOUT GAS 140 METERED DOSE BOTTLE
NDA/MAL/HDP/6173CIPLA LTD..QUALITY CHEMICALS LTDMONTAIR 5MONTELUKAST SODIUM5MGCIPLA LTD VERNA INDL. ESTATE GOA 403 722INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/6183CIPLA LTD..QUALITY CHEMICALS LTDPRAZIQUANTEL TABLETSPRAZIQUANTEL600MGCIPLA LTD 352 KUNDAIM INDL. ESTATE KUNDAIM GOA 403 115INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 100 TABLET BOTTLE
NDA/MAL/HDP/6652 CIPLA LTD.QUALITY CHEMICALS LTDLAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA LTD MIDC PATALGANGA M.S. 410 220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/6655 CIPLA LTD.QUALITY CHEMICALS LTDATORLIP-20ATORVASTATIN CALCIUM20MGCIPLA LTD MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6657 CIPLA LTD.QUALITY CHEMICALS LTDMETFORMINMETFORMIN HYDROCHLORIDE500MGCIPLA LTD, MIDC, PATALGANGA 410220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8021CIPLA LIMITEDQUALITY CHEMICALS LTDLAMIVIR-150 TABLETSLAMIVUDINE150MGCIPLA LTD, L-139 VERNA IND ESTATE SALCETTE GOA-403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,60 TABLET BOTTLE
NDA/MAL/HDP/8022CIPLA LTD.QUALITY CHEMICALS LTDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG +50MG + 60MGCIPLA LTD VERNA GOA 403 722INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/8032CIPLA LTD.QUALITY CHEMICALS LTDABACAVIR SULFATE/LAMIVUDINEABACAVIR SULFATE/LAMIVUDINE600MG /300MGCIPLA LTD A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET BOTTLE
NDA/MAL/HDP/8229CIPLA LTD.QUALITY CHEMICALS LTDABACAVIR SULFATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE60MG + 30MGCIPLA LTD A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/8250CIPLA LTDQUALITY CHEMICALS LTDLUMARTEM DTARTEMETHER+LUMEFANTRINE20MG+120MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 6 TABLET BLISTER,12 TABLET BLISTER,6 TABLET BLISTER, 30 BLISTER CARTON,12 TABLET BLISTER,30 BLISTER CARTON
NDA/MAL/HDP/0945CLARIS LIFE SCIENCES LIMITEDREDDYS PHARMA LIMITEDZOFEXOFLOXACIN INFUSION2MG/MLCLARIS OTSUKA PRIVATE LIMITED N3INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/1377CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/ACLARIS OTSUKA PRIVATE LIMITED N3INDIAPARENTERAL ORDINARY AMPOULES 10 AMPOULE CARTON
NDA/MAL/HDP/1520ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDFLUCANOLFLUCONAZOLE2MG/MLCLARIS INJECTABLE LIMITED, CHACHARWADI- VASANA, SANINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/1533CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITED5DGLUCOSE50G/LCLARIS OTSUKA LIMITED-INDIAINDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 250 ML BOTTLE,500 ML BOTTLE
NDA/MAL/HDP/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLE LIMITED CHACHARWADDI SANAND DIST. AHMEINDIAPARENTERAL ORDINARY VIALS 20 ML VIAL
NDA/MAL/HDP/2263CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITEDCELEMIN 10 PLUSAMINO ACIDS/ELECTROLYTES10%W/V+10%W/VCLARIS OTSUKA LIMITED-VILLAGE ? VASANA ? CHACHARWADIP,TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION BAGS 500 ML BAG
NDA/MAL/HDP/2670ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDSENSINILLIDOCAINE2%W/VCLARIS INJECTABLE LIMITED, CHACHARWADI VASANA AHMEDAINDIAPARENTERAL ORDINARY VIALS 30 ML VIAL,1 VIAL CARTON,20 ML VIAL,5 VIAL CARTON,20 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/2749CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITEDHESTAR-200 PENTASTARCHHYDROXYETHYLSTARCH6%W/VCLARIS OTSUKA PRIVATE LIMITED N3INDIAPARENTERAL ORDINARY INFUSION BAGS 500 ML BOTTLE
NDA/MAL/HDP/3396ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICAN HEAVYBUPIVACAINE HYDROCHLORIDE IN DEXTROSE 0.5%W/VCLARIS INJECTABLE LIMITED,CHACHARWADI -VASANA,INDIAPARENTERAL ORDINARY AMPOULES 4 ML AMPOULE,25 AMPOULE CARTON
NDA/MAL/HDP/3628CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDCELEMIN 5SAMINO ACIDS/SORBITOL5%W/V+5%W/VCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY INFUSION BAGS 500 ML BAG
NDA/MAL/HDP/3797ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDPROVIVE 1%PROPOFOL10MG/MLCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 20 ML VIAL,1 VIAL CARTON,50 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/4016CLARIS LIFE SCIENCES LIMITEDREDDYS PHARMA LIMITEDCOMPOUND SODIUM LACATE INTRAVENOUS INFUSIONMULTIINGREDIENTN/ACLARIS OTSUKA LIMITED-INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE
NDA/MAL/HDP/4823CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDMETRIS INFUSIONMETRONIDAZOLE5MG/MLCLARIS OTSUKA LIMITED-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/5348CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDCELEPID 20INTRAVENOUS FAT EMULSION20%W/VCLARIS OTSUKA PRIVATE LIMITEDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 250 ML BOTTLE,500 ML BOTTLE
NDA/MAL/HDP/5416CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDCIPROXCIPROFLOXACIN0.2%W/VCLARIS OTSUKA PRIVATE LIMITEDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/5438ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDTAMINPARACETAMOL10MG/MLCLARIS INJECTABLE LIMITED CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE,50 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/5472CLARIS LIFESCIENCES LTD REDDYS PHARMA LIMITEDNSSODIUM CHLORIDE0.9%W/VCLARIS OTSUKA LIMITED-INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,250 ML BOTTLE
NDA/MAL/HDP/6063CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITEDANSEDFLUMAZENIL0.1MG/MLCLARIS LIFE SCIENCES LTD-CHACHARWADI-VASANA,SANAND, AHMEDABAD GUJARAT-382213 INDIAINDIAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,25 AMPOULE CARTON
NDA/MAL/HDP/6124CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDSPIVAPROPOFOL1%W/VCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY I V VIALS 20 ML VIAL
NDA/MAL/HDP/6140CLARIS OTSUKA LIMITEDREDDYS PHARMA LIMITEDKIDROLYTESODIUM ACETATE + DIBASIC POTASSIUM PHOSPHATE + MAGNESSIUM CHLORIDE + DEXTROSE MONONOHYDRATE + POTASSIUM CHLORIDE(0.32G + 0.026G + 0.031G + 5.50G + 0.13G)/100MLCLARIS OTSUKA LTD VILLAGE VASANA CHACHARWADI TAL:SANAD DIST -AHMEDABAD 382 213INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6660ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDKETAJEXKETAMINE50MG/MLCLARIS LIFESCIENCES LTD, CHACHARWADI VASANA AHMEDAINDIAPARENTERAL ORDINARY VIALS 10 ML VIAL
NDA/MAL/HDP/8247SAKAR HEALTH CARE PVT .LTDREDDYS PHARMA LIMITEDE-DOLTRAMADOL HYDROCHLORIDE50MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAYTIME AND NIGHT TIME CAPSULE DAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHDRINE 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, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 8 CAPSULE BLISTER,3 BLISTER CARTON
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,KENYAKENYATOPICAL EXTERNAL OINTMENTS 25 G TUBE
NDA/MAL/HDP/1501REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCURAQUIN SYRUPQUININE HCL100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/1709REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 5 G TUBE,10 G TUBE,15 G TUBE
NDA/MAL/HDP/1731REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE+SALICYCLIC ACID0.05%+3%REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,250 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSION 10 ML BOTTLE
NDA/MAL/HDP/1927REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2025REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
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, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 12 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/2452REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDDELASED CHEST COUGH SYRUP (NON DROWSY)GUAIFENESIN + MENTHOL100MG/5ML + 1.1MG/5MLREGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
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-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,5 L JERRYCAN
NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2516REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIAMP DRY SUSPENSIONAMPICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAVAGINAL COMBINATION PACK SUPPOSITORIES 1 PESSARY BLISTER,20 G TUBE
NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMAGNOMINT TABLETS MAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE250MG+120MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,2 TABLET BLISTER,50 BLISTER CARTON,100 BLISTER CARTON,500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/2596REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDURISEPTICNALIDIXIC ACID500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/2614REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDDIALINLOPERAMIDE HCL2MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2697REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/2760REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDDELASED DRY COUGH SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 25 G TUBE
NDA/MAL/HDP/2813REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/2914REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCHLOROCIDE SYRUPCHLORAMPHENICOL PALMITATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2917REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCETAMOL TABLETSPARACETAMOL500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 2 TABLET STRIP,50 STRIP CARTON,10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,500 TABLET CONTAINER
NDA/MAL/HDP/2959REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCETAMOL SYRUPPARACETAMOL120MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
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 KENYAKENYATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/3263REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDTRIMEX MUCOLYTIC SYRUPSALBUTAMOL SULPHATE + BROMHEXINE HCL + GUAIFENESIN2MG/5ML + 4MG/5ML + 100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3288REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3292REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED PAEDIATRIC SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/3343REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDIVEN-CREAMBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/3347REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN TABLETSPHENOXYMETHYLPENICILLIN250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3354REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDIVEN OINTMENTBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/3426REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRUBEM CREAMMETHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE 1%W/W+0.1%W/W+5%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 25 G TUBE
NDA/MAL/HDP/3458REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXILAMOXYCILLIN TRIHYDRATE250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/3549REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDTRIMEX PAEDIATRIC COUGH EXPECTORANTCHLORPHENIRAMINE MALEATE+PSEUDO EPHEDRINE HCL+GUAIPHENISIN+MENTHOL1.0MG+15.0MG+50.0MG+0.5MG / 5MLREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/3556REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDGRISACTIN-500 TABLETSGRISEOFULVIN TABLETS500MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3674REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTAMINE SYRUPPROMETHAZINE HYDROCHLORIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,5 L JERRYCAN
NDA/MAL/HDP/3703REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSONATECCETYLPYRIDINIUM CHLORIDE0.05%W/VREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAOTHER SYSTEMIC LIQUIDS 250 ML BOTTLE
NDA/MAL/HDP/3732REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL TABLETS 200MGALBENDAZOLE200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER
NDA/MAL/HDP/3757REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3949REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMAGNOMINT SUSPENSION MAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE500MG/5ML+250MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3987REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDROHISOL SYRUPLEVAMISOLE HYDROCHLORIDE40MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 500 ML BOTTLE,15 ML BOTTLE
NDA/MAL/HDP/3990REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL SYRUPAMOXYCILLIN TRIHYDRATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/4114REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINALIN SYRUPCHLORPHENIRAMINE MALEATE2MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/4115REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDPREDILONEPREDNISOLONE5.0 MGREGAL PHARMACEUICALS LTD-PLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/4348REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDICLOAMP SYRUPCLOXACILLIN+AMPICILLIN250MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/4408REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN CREAMCLOTRIMAZOLE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/4549REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL 500MGAMOXYCILLIN TRIHYDRATE500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/4723REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDMEGYL SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/4725REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEGYL TABLETMETRONIDAZOLE200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,250 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/4891REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDASPEC TABLETMULTI-INGREDIENTN/AREGAL PHARMACEUTICALS LTD-OFF BABA DOGO RD, RUARAKA, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 TABLET CARTON,100 TABLET CONTAINER,500 TABLET CONTAINER
NDA/MAL/HDP/4931REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDFOLIC ACID TABLETFOLIC ACID5MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5015REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCOLDCAP CAPSULESMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,12 CAPSULE BLISTER,10 CAPSULE BLISTER,10 BLISTER CARTON,500 CAPSULE CONTAINER,12 CAPSULE BLISTER,8 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/5017REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCOLDCAP SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 100 ML CONTAINER
NDA/MAL/HDP/5032REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUP (NON DROWSY)DEXTROMETHORPHAN7.5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/5034REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEBENDAZOLE TABLETMEBENDAZOLE100MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5142REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDINTAMINE CREAMMEPYRAMINE MALEATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 25 G TUBE,400 G TUBE
NDA/MAL/HDP/5180REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDISORYN DROPS ( PAEDRIATRIC)EPHEDRINE HYDROCHLORIDE5MG/MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYANASAL SPRAY15 ML BOTTLE
NDA/MAL/HDP/5182REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDISORYN DROPS (ADULT)EPHEDRINE HYDROCHLORIDE10MG/MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYANASAL SPRAY15 ML BOTTLE
NDA/MAL/HDP/5271REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDERYTHYL SYRUPERYTHROMYCIN ETHYL SUCCINATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/5283REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDIBUMEX GELIBUPROFEN5%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL EMULSION GELS 25 G TUBE
NDA/MAL/HDP/5288REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDIBUMEX SUSPENSIONIBUPROFEN100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/5291REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDIBUMEX TABLETIBUPROFEN200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 20 TABLET BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON, 500 TABLET CONTAINER
NDA/MAL/HDP/5433REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCOLDCAP NIGHT TIMEPARACETAMOL+CHLORPHENIRAMINE500MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 12 CAPSULE BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6665REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSALBUMOL SYRUPSALBUTAMOL2MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/0041 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCEMITIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/0161RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0162 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENAREN PROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE SUSPENSION100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/0350 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/0568 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1446 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN B COMPLEXVITAMINS B1 + B2 + B6 + NIACINAMIDE0.5 MG + 0.5MG + 7.5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/1454 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL AND ASPIRIN AND CAFFEINE500MG+400MG +50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,25 STRIP CARTON
NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN TRIHYDRATE125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS100 ML BOTTLE
NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/1766 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLD EASE MULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE
NDA/MAL/HDP/1812 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1822 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINE EPHEDRINE HYDROCHLORIDE 30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASEMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 500 TABLET CONTAINER
NDA/MAL/HDP/1877 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1000 TABLET CONTAINER,500 TABLET CONTAINER
NDA/MAL/HDP/1914 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/1934 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN/CLOXACILLIN250MG/250MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 100 CAPSULE CONTAINER
NDA/MAL/HDP/2090 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2165 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PEL MEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2408RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRON TONICMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY TONIC 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/2410 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDDOXYRENDOXYCYCLINE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2558 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMYCOREN SUSPENSIONNYSTATIN SUSPENSION100000IU/ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/2559 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDERYTHRORENERYTHROMYCIN STEARATE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/2576 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEQUINE TABLETSCHLOROQUINE PHOSPHATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,250 TABLET CONTAINER
NDA/MAL/HDP/2612RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENIRONMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER
NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER
NDA/MAL/HDP/2683 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2685 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOL(SUSPENSION)PARACETAMOL120MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAINDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2745 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2788RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMULTIVITAMIN TABLETSMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2797 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDLUMARENARTEMETHER/ LUMEFANTRINE20MG/ 120MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3262RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEGELMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE250MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CHEWABLE COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3318RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM TABLETSCO-TRIMOXAZOLE480MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/3370RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDDERMOREN 500GRISEOFULVIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3439RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR CAPSULECHLORAMPHENICOL250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3474RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMCLOREN DRY SYRUPAMPICILLIN + CLOXACILLIN125MG+125MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 100 ML BOTTLE
NDA/MAL/HDP/3478RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDDICLORENDICLOFENAC SODIUM BP50MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3546RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM D.SSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,500 TABLET CONTAINER,1000 TABLET CONTAINER
NDA/MAL/HDP/3582RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSULPHADIMIDINESULPHADIMIDINE500MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/3614RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDERYTHROREN SUSPENSIONERYTHROMYCIN STEARATE125MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/3670RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTETRAREN CAPSULESTETRACYCLINE HYDROCLORIDE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/3677 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDIBURENIBUPROFEN200MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3681RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOLPARACETAMOL500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/3747RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER,30 BLISTER CARTON
NDA/MAL/HDP/3888 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPYRIRENPYRIDOXINE HYDROCHLORIDE25MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3928 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMALARENSULPHADOXINE + PYRIMETHAMINE500MG/25MGRENE INDUSTRIES LTD-RENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,3 TABLET BLISTER,50 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4128 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAREN SYRUPVITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B31500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/4172RENE INDUSTRIESRENE INDUSTRIES LIMITEDKOF OFF EXPECTORANTMULTIINGREDIENTN/ARENE INDUSTRIES-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 110 ML BOTTLE
NDA/MAL/HDP/4352RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN SYRUP QUININE HYDROCHLORIDE100MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/4425RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN FCQUININE 300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/4622RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCLOXARENCLOXACILLIN250MGRENE INDUSTRIES-PLOT 680 KAMULI KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4623RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDLOPERARENLOPERAMIDE HYDROCHLORIDE2MGRENE INDUSTRIAL LTD-RENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4854RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMETROREN FCMETRONIDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/4856RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMETROREN METRONIDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,20 BLISTER CARTON
NDA/MAL/HDP/4858RENE INDUSTRIESRENE INDUSTRIES LIMITEDMETROREN SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/4936 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOMBIFENIBUPROFEN / PARACETAMOL400MG/500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/4939 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFOLIRENFOLIC ACID5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/5107RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDINDOREN CAPSULESINDOMETHACIN25MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/5137 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDKETORENKETOCONAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5391 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDNITROFURANTOINNITROFURANTOIN100MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/5439 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENIRON SYRUPVIT B6 + FERROUS GLUCONATE + VIT B1 + VIT C + VIT B22MG/5ML + 200MG/5ML + 2MG/5ML + 20MG/5ML + 2MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/6065 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPROXYRENPIROXICAM20MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7101 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDASTHARENSALBUTAMOL SULPHATE4MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7102 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREPRAZINECHLORPROMAZINE HYDROCHLORIDE100MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/7106 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREVIVEGLUCOSE ANHYDROUS + TRISODIUM CITRATE DIHYDRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE13.5G + 2.9G + 2.6G + 1.5GRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL SOLID ORDINARY POWDERS 1 SACHET CARTON
NDA/MAL/HDP/7346 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREZN TABLETSZINC SULFATE MONOHYDRATE 20MGRENE INDUSTRIES LTD MANUFACTURERS OF PHARMACEUTICALS PO BOX 6034, PLOT NO 680, KAMULI, KIREKA, KAMPALA, UGANDAUGANDAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8091 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEGEL SUSPENSIONALUMINIUM HYDROXIDE+MAGNSIUM TRISLILICATE120MG+250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/0639NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/0773HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDARTEMETHER INJECTIONARTEMETHER80MG/MLANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/1061NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBISALAXBISACODYL5MGNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS PHARMACEUTICALS PVT LTD N-118 MIDC TARAPUR BOISAR DIST THANE 401 506 MAHARASTRAINDIAPARENTERAL ORDINARY AMPOULES 100 AMPOULE CARTON,1 ML AMPOULE
NDA/MAL/HDP/1086NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSYNOGEN TABLETSDIACERIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE 50MG +250MG + 750MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA ? INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE ? 401 210, MAHARASHTRA ? INDIAINDIATOPICAL EXTERNAL CREAMS 20 G CONTAINER
NDA/MAL/HDP/1116NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVITAL ESSENTIAL BALMMENTHOL + CAMPHOR + PEPPERMINT OIL + EUCALYPTUS OIL + CLOVE OIL+ CINNAMON +WINTER GREEN OIL140MG + 140MG + 80MG +80MG +40MG +40MG +120MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE ? 401 210, MAHARASHTRA ? INDIAINDIATOPICAL EXTERNAL OINTMENTS 24 G CONTAINER
NDA/MAL/HDP/1117NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE ? 401 210, MAHARASHTRA ? INDIAINDIAOPHTHALMIC OINTMENTS 3.5 G TUBE,20 TUBE CARTON
NDA/MAL/HDP/1163NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDFRUSEMIDE FRUSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE ? 401 210, MAHARASHTRA ? INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD .-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/1171CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDBETNEW EYE / EAR DROPBETAMETHASONE+NEOMYCIN0.1%W/W+0.5%W/WCIRON DRUGS AND PHARMACEUTICALS PVT LTD .-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAOPHTHALMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD .-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAPARENTERAL ORDINARY VIALS 20 ML VIAL,30 ML VIAL
NDA/MAL/HDP/1418NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1432CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICOL5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOTIC DROPS 10 ML VIAL
NDA/MAL/HDP/1448HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDVITAMIN B INJECTIONINVIT B1 + VIT B2 + VIT B6 + NICOTINAMIDE + CALCIUM DEXTROPANTOTHENATE20MG + 2MG + 2MG + 30MG + 1MG /2MLANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/1517NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/1680NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/1867RENE PHARMACY LTDRENE PHARMACY LTDLEVATEX TABLETSLEVAMISOLE HYDROCHLORIDE40MGCYANO PHARMA(P) 115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 500 TABLET CONTAINER,3 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2042NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,200 G TUBE
NDA/MAL/HDP/2061RENE INDUSTRIES LIMITEDRENE PHARMACY LTDADSOCARB TABLETSACTIVATED CHARCOAL250MGCYANO PHARMA(P) 115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER
NDA/MAL/HDP/2427NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDCLONEMCLOTRIMAZOLE1%W/WNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/2472NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL EMULSION GELS 20 G TUBE,30 G TUBE
NDA/MAL/HDP/2523NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 25 G TUBE
NDA/MAL/HDP/2640CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDBENZYL BENZOATE APPLICATIONBENZYL BENZOATE25%W/WALKEM LABORATORIES LTD VILLAGE THANA, BADDI, HIMACHAL PRADESH 173205, INDIAINDIATOPICAL EXTERNAL LOTIONS 100 ML BOTTLE
NDA/MAL/HDP/2806RENE INDUSTRIES LIMITEDRENE PHARMACY LTDPHENOBARBITONE TABLETSPHENOBARBITONE 30MGCYANO PHARMA(P) 115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/2908NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDPAINGO MEDICATED CREAMMETHYLSALICYLATE+CAPSICUM OLEORESIN+TUPENTINE OIL15%W/W + 1%W/W + 1.47%W/WNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 2 TUBE CARTON,15 G TUBE
NDA/MAL/HDP/3233NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDWHITFIELD'S OINTMENT BPMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 20 G TUBE
NDA/MAL/HDP/3259NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTIGBODERMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 3 G TUBE,15 G TUBE
NDA/MAL/HDP/3485CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDERGOMETRINEERGOMETRINE MALEATE0.5MG/MLCIRON DRUGS AND PHARMACEUTICALS PRIVATE LTD-N-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/3526CYANO PHARMA(P)RENE PHARMACY LTDPROMETHAZINE TABLETSPROMETHAZINE HYDROCHLORIDE25MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3584CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EYE DROPSCHLORAMPHENICOL0.5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/3594CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDSTERILE QUININE DIHYDROCHLORIDEQUININE DIHYDROCHLORIDE300MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LIMITED-N-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/3635CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROGANPROMRTHAZINE25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD N-118 N-119 MIDC TARAPUR BOISAR DIST THANE-401 506 MAHARASHTRAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/3637NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTINODERMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 18 G TUBE
NDA/MAL/HDP/3873CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORPROMAZINE INJECTION B.PCHLORPROMAZINE25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/3938CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDADRENALINE INJECTIONADRENALINE1MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/3993NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDNEM SCABMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/4038NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDPREDSONEPREDISOLONE5MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4587CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIRATROATROPINE1MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/4781CYANO PHARMA(P)RENE PHARMACY LTDCYANO IRON TABLETSFERROUS SULPHATE200MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/4794NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDDALADOLDICLOFENAC SODIUM + PARACETAMOL50MG+500MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4979CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDFUROSEMIDEFUROSEMIDE10MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 ML CARTON
NDA/MAL/HDP/5013CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDGENTAMYCIN EYE/EAR DROPSGENTAMYCIN0.3%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/5067CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUFENACDICLOFENAC 25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/5072CYANO PHARMA(P)RENE PHARMACY LTDDEXAMETHASONE TABLETSDEXAMETHASONE 0.5MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/5114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDLATONE MULTIVITAMINMULTIVITAMINMULTI-INGREDIENTNEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5155NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBETAVELMULTI-INGREDIENTN/ANEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/5157NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBETAVEL NMULTI-INGREDIENTN/ANEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 3 G TUBE,15 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/5207NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDDIGOXIN TABLETSDIGOXIN0.25MGNEM LABORATORIES PVT. LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA - INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5356NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBURNNEMMULTI-INGREDIENTN/ANEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/5380CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROZEPDIAZEPAM5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/5382HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDDICLOFENAC SODIUMDICLOFENAC75MG/3MLANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/5442NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDCHLORAMPHENICOL OPHTHALMIC OINTMENT USP 1%CHLORAMPHENICOL OPHTHALMIC OINTMENT1%W/WNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAOPHTHALMIC OINTMENTS 3.5 G TUBE,20 TUBE CARTON
NDA/MAL/HDP/6067RENE PHARMACY LTDRENE PHARMACY LTDDIAZEPAMDIAZEPAM5MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6220NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDMETHYLDOPAMETHYLDOPA250MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6246CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUTHERARTEMETHER80MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/7422CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAV 625MGAMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM500MG+125MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER, 2 BLISTER CARTON
NDA/MAL/HDP/7597CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAVAMOXICILLIN SODIUM + CLAVULANIC ACID1000MG + 200MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1.2 G VIAL,10 VIAL CARTON
NDA/MAL/HDP/8090HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDGENTAMYCIN INJECTIONGENTAMYCIN 80MG/2MLANHUI CHENGSHI MANUFACTURE MEDICINE CO LTD-NEW INDUSTRIAL ZONE BENGBU CITY ANHUI PROVINCECHINAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/8124RENE PHARMACY LTD..RENE PHARMACY LTDCODEINE PHOSPHATE CODEINE PHOSPHATE30 MGCYANO PHARMA(P) 115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER
NDA/MAL/HDP/8201CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCENTROZINECETIRIZINE HYDROCHLORIDE5MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/8208 CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL SODIUM SUCCINATECHLORAMPHENICOL SODIUM SUCCINATE1GCIRON DRUGS PHARMACEUTICAL PVT LTD, N-118 MIDC TARAPUR BOOSAR THANEINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL,25 VIAL CARTON
NDA/MAL/HDP/8209 CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDTHIOPENTAL SODIUM INJECTIONTHIOPENTAL SODIUM 1GM / VIALCIRON DRUGS & PHARMACEUTICALS PVT LTD N-118 N-119 MIDC TARAPUR BOISAR DIST THANE-401 506 MAHARASHTRAINDIAPARENTERAL ORDINARY VIALS 1 G VIAL, 50 VIAL CARTON
NDA/MAL/HDP/8210CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDHYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BPHYDROCORTISONE100MGCIRON DRUGS PHARMACEUTICAL PVT LTD, N-118 MIDC TARAPUR BOOSAR THANEINDIAPARENTERAL ORDINARY DRY VIALS 100 MG VIAL, 50 VIAL CARTON
NDA/MAL/HDP/2223ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2400000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO. LTDNO. 188 GONGNONG ROAD AND NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 2.4 MU VIAL,1 VIAL CARTON
NDA/MAL/HDP/3817ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1000000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO. LTDNO. 188 GONGNONG ROAD AND NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1 MU VIAL,1 VIAL CARTON
NDA/MAL/HDP/3847ROYAL PHARMAROYAL PHARMA 2011 LIMITEDPROCAINE PENICILLINPROCAINE PENICILLIN FORTIFIED4.000.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO. LTDNO. 188 GONGNONG ROAD AND NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/6426ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDSODIUM CHLORIDE INTRAVENOUS INFUSION BPSODIUM CHLORIDE0.9%W/VABARIS HEALTHCARE PVT LTD SYRVEY NO.1407-11 VILLAGE RAJPUR TALUKA KADI DIST MEHSANA 382 740INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE
NDA/MAL/HDP/6456ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDGLUCOSE INTRAVENOUS INFUSION BP (5% W/V) GLUCOSE ANHYDROUS 5%W/VABARIS HEALTHCARE PVT LTD SYRVEY NO.1407-11 VILLAGE RAJPUR TALUKA KADI DIST MEHSANA 382 740INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 500 ML BOTTLE
NDA/MAL/HDP/6479SWISS PARENTERALS PVT. LTD.ROYAL PHARMA 2011 LIMITEDTRAMADOL HYDROCHLORIDE INJECTION 100MG/2MLTRAMADOL HYDROCHLORIDE100MG/2MLSWISS PARENTERALS PVT LTD 809, KERALA G.I.D.C., NR. BAVLA DIST.: AHMEDABAD-382220 GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6548 CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDCIROPAIN GEL DICLOFENAC DIETHYLAMINE BP1%W/WCIRON DRUGS & PHARMACEUTICALS PVT LTD N-118/119 MIDC TARAPUR BOISAR DIST THANE 401 506INDIATOPICAL EXTERNAL GELS AND SOLS 20 G TUBE
NDA/MAL/HDP/6595RAVIAN LIFE SCIENCE PVT. LTDROYAL PHARMA 2011 LIMITEDMOLURAVLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MG RAVIAN LIFE SCIENCE PVT LTD-PLOT NO.34,SECTOR-8A,IIE,HARIDWAR-249403, UTTARKHANDINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7154ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN 2MG/MLABARIS HEALTHCARE PVT. LTD.,406, SAFFRON, PANCHVATI, AMBAVADI, AHMEDABAD - 380 006, GUJARAT, INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/8182STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDSTRICORTHYDROCORTISONE500MGSTRIDES ARCOLAB LTD OPP.IIM, BILEKAHALLI, BANNERGHATTA ROAD BANGALOREINDIAPARENTERAL RETARD DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/8183STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDSTRICORT-100HYDROCORTISONE SODIUM SUCCINATE100MGSTRIDES ARCOLAB LTD OPP.IIM, BILEKAHALLI, BANNERGHATTA ROAD BANGALOREINDIAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/8184STRIDES ARCOLAB LIMITEDROYAL PHARMA 2011 LIMITEDTETRACYCLINETETRACYCLINE HYDROCHLORIDE250MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,100 CAPSULE CONTAINER,1000 CAPSULE CONTAINER
NDA/MAL/HDP/8185STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDINDOMETHACIN CAPSULESINDOMETHACIN25MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,1000 CAPSULE CONTAINER
NDA/MAL/HDP/8186STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDCELOVANVANCOMYCIN HCL500MGSTRIDES ACROLAB LTD, OPP. 11M BILEKAHALLI, BANNERGINDIAPARENTERAL ORDINARY VIALS 1 VIAL CARTON
NDA/MAL/HDP/8205Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDANLODINAMLODIPINE BESYLATE10MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8228STRIDES SHASUN LTDROYAL PHARMA 2011 LIMITEDVITAMIN B-COMPLEX (BEEKO)VITAMINS B1 + B2 + B6 + NIACINAMIDE1MG +1MG +1MG +15MGSTRIDES SHASUN LTD PLOT 9-12 DEWAN & SONS INDL AREA VEOOR PALGHARINDIAORAL SOLID ORDINARY OTHER COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8253REYOUNG PHARMACEUTICAL CO LTDROYAL PHARMA 2011 LIMITEDDICLOFENAC SODIUMDICLOFENAC SODIUM25MG/MLREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/8334PRIDE INTERNATIONALROYAL PHARMA 2011 LIMITEDS-AUGPROAMOXICILLIN TRIHYDRATE+CLAVULANIC ACID200MG+ 28.5MGALKEM LABORATORIES LIMITED, PLOT NO. 167/1 MAHATMA GANDHI UDYOG NAGAR, AMALIYA DAMAN -396210, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/8337SWISS PARENTERALS PVT LTD 304ROYAL PHARMA 2011 LIMITEDARTESUNATE 120 MGARTESUNATE120 MGSWISS PARENTERALS PVT LTD 809, KERALA G.I.D.C., NR. BAVLA DIST.: AHMEDABAD-382220 GUJARAT, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 10 ML VIAL
NDA/MAL/HDP/0003UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL CLAV 625AMOXICILLIN/CLAVULANATE POTASSIUM500MG/125MGUNI MEDICOLABS 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0005STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDALPRAZEC 0.25ALPRAZOLAM0.25MGACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/0008STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDOMEPRICOMEPRAZOLE DELAYED-RELEASE20MGACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0010STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITED02-LON OFLOXACIN + ORNIDAZOLE200MG + 500MGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0017SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYCORTHYDROCORTISONE100MGSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NR BAVLA DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 7.5 ML VIAL,10 VIAL CARTON
NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NR BAVLA DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.2 G VIAL
NDA/MAL/HDP/0355SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS PARENTERALS PVT LTD 809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 382 220 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/0358SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY DRY I.M VIALS 1 G VIAL
NDA/MAL/HDP/0362SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE INJECTION5MG/MLSWISS PARENTERALS PVT LTD 809 KERALA GIDC NEAR BAVLA DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 20 ML VIAL
NDA/MAL/HDP/1361SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE120MG SWISS PARENTERALS PVT LTD 809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 382 220 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 120MG VIAL + 1 AMPOULE OF NAHCO3 + 1 AMPOULE OF 0.9%NACL
NDA/MAL/HDP/1584UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY DRY VIALS 500 MG VIAL
NDA/MAL/HDP/2238UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOCLOXAMPICILLIN + CLOXACILLIN125MG +125MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/2324SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDSWISSCLOXAAMPICILLIN / CLOXACILLIN250MG/250MGSWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY DRY VIALS 7.5 ML VIAL
NDA/MAL/HDP/2923CIRON DRUGS & PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCOLD PLUS SYRUPPARACETAMOL + PHENYLEPHRINE HYDRCHLORIDE + CHLORPHENIRAMINE MALEATE125MG + 2.5MG + 2.5MG/ 5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3244UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMICILLINAMPICILLIN250MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3359SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDARTIARTEMETHER80MG/MLSWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/3595UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL 125AMOXICILLIN TRIHYDRATE125MG/5MLUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/3825UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL 250AMOXICILLIN250MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3906SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDLEROLEPANTOPRAZOLE40MGSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NEAR BAVLA DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 40 MG VIAL,10 ML VIAL
NDA/MAL/HDP/3922SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDDIAZIDIAZEPAM5MG/MLSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/3945SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDCEFONECEFTRIAXONE1GSWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY DRY VIALS 10 ML VIAL,1 G VIAL
NDA/MAL/HDP/4042SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDS-CHLORCHLORAMPHENICOL1GSWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/4276SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE60MG/VIALSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY DRY VIALS 60MG VIAL + 5ML 0.9% NACL AMPOULE+ 1ML NAHCO3 AMPOULE CARTON
NDA/MAL/HDP/4388SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDTAZOBAKPIPERACILLIN SODIUM AND TAZOBACTAM SODIUM 4.5GSWISS PARENTERALS PVT LTD 809 KERALA GIDC NR. BAVLA DISST AHMEDABAD 382 220 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 4.5 G VIAL,1 VIAL CARTON
NDA/MAL/HDP/4737CIRON DRUGS AND PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCICOL DROPSDICYCLOMINE HYDROCHLORIDE + SIMETICONE10MG + 40MG/ 5MLCIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAORAL LIQUID ORDINARY DROPS 10 ML BOTTLE
NDA/MAL/HDP/4739SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDMEROMEROPENEM1GSWISS PARENTERALS PVT LTD 809, KERALA IND ESTATE ,GI.D.C, NR BAVLA DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/4783CIRON DRUGS AND PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCYPOTINCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 100 ML BOTTLE
NDA/MAL/HDP/5591SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDSWISSCILLINAMPICILLIN500MGSWISS PARENTERALS PVT LTD 809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382 22O GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 500 MG VIAL
NDA/MAL/HDP/6070DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDVAZKORAMLODIPINE BESILATE10MGDEVA HOLDING A.S-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLITURKEYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,9 BLISTER CARTON
NDA/MAL/HDP/6071DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDVAZKORAMLODIPINE BESILATE5MGDEVA HOLDING A.S -CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLITURKEYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,9 BLISTER CARTON
NDA/MAL/HDP/6072SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE20MG/MLSWISS PARENTERAL PVT LTD 809 KERALA GIDC NR BAVLA DIST AHMEDABAD 382 220 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6074MARCYRL PHARMACEUTICAL INDUSTRIESSHREEJI PHARMACEUTICALS LIMITEDCARDILOL CSCARVEDILOL25MGMARCYRL PHARMACEUTICAL INDUSTRIES -WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITYEGYPTORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6076SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE30MGSWISS PARENTERAL PVT LTD 809 KERALA GIDC NR BAVLA DIST AHMEDABAD 382 220 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 30 MG VIAL + 5ML 0.9%NACL + 1ML 5%NAHCO3
NDA/MAL/HDP/6143MARCYRL PHARMACEUTICAL INDUSTRIESSHREEJI PHARMACEUTICALS LIMITEDCONTRACTUBEXEXTRACT CEPAE FLUID +HEPARIN SODIUM+ALLANTOIN10G+5000 I.U+1G/100GMARCYRL PHARMACEUTICAL INDUSTRIES -WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITYUGANDATOPICAL EXTERNAL OTHER GELS/SOLS 20 G TUBE
NDA/MAL/HDP/6158DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDESEFINCEFTRIAXONE SODIUM1GDEVA LIAC SAN. VE TIC. A.S. -ORGANISE SANAYI BOLGESI ATATURK MAH. ATATURK CAD. NO: 32 KARAAGAC CERKEZKOYTURKEYPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/7475UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOCLOX 500AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM250MG+250MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8015SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDD-FENDICLOFENAC SODIUM25MG/MLSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE GIDC NEAR BAVLA DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/8119SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDHALOPERIDOL DECANOATEHALOPERIDOL DECANOATE50MG/MLSWISS PARENTERALS PVT LTD 809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 382 220 GUJARATINDIAPARENTERAL ORDINARY VIALS 1 ML VIAL,10VIAL CARTON
NDA/MAL/HDP/8120SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDABTALPHA-BETA ARTEETHER75MG/MLSWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,3 AMPOULE CARTON
NDA/MAL/HDP/8121SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSWISSQUINEQUININE300MG/MLSWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABADINDIAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/8127SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2% W/VSWISS PARENTERALS PVT LTD 809 KERALA GIDC NR BAVLA DIST AHMEDABAD 382220 GUJARATINDIAPARENTERAL ORDINARY VIALS 30 ML VIAL
NDA/MAL/HDP/8131DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDEGRASILDENAFIL CITRATE50MGDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/8135BAL PHARMA LIMITEDSHREEJI PHARMACEUTICALS LIMITEDREGAMOLPARACETAMOL500MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/8216SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSEFOTAXCEFOTAXIME SODIUM1GSWISS PARENTERALS PVT LTD 809 KERALA INDUSTRIAL ESTATE NR. BAVLA DIST AHMEDABAD - 382 220 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/8226DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDSALRESSALBUTAMOL SULPHATE120.5MCG/SPRAYDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYLUNG ADMINISTRATION METERED-DOSE INHALER 200 DOSE CANNISTER
NDA/MAL/HDP/8332DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDAZITRO 500 MGAZITHROMYCIN 500MG DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 6 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 1405INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
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 VILLAGE ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 30 G TUBE
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 PVT LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS 225 ML BOTTLE
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 ISSAPUR P.O DAPPARINDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN/ PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD, ISSAPUR, DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 160 ML BOTTLE,400 ML BOTTLE
NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 1405INDIAORAL LIQUID ORDINARY LIQUIDS 18 ML BOTTLE
NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 160 ML BOTTLE,400 ML BOTTLE
NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 1405INDIATOPICAL EXTERNAL CREAMS 30 G TUBE
NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 1405INDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD, ISSAPUR, DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 2 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACIN PARACETAMOL 500MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 1405INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMAC CETIRIZINE10MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,225 ML BOTTLE
NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPANOLOL40MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,50 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL TOPICAL GELS AND SOLS 10 G TUBE
NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPROMIDE HCL10MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/2949MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL V TABLETCLOTRIMAZOLE100MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAVAGINAL TABLETS 6 PESSARY STRIP
NDA/MAL/HDP/3282MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDKOFF-GOPHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHOPHARN5MG/5ML + 2MG/5ML + 10MG/5MLTORQUE PHARMACEUTICALS (P) LTD, P.O.DAPPAR VILLISSINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3664MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDAZZYAZITHROMYCIN500MGTORQUE PHARMACEUTICALS PVT LTD PO DAPPAR VILL ISSAPUR PUNJABINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/3745MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDWINDERM CREAMBECLOMETHOSONE/CLOTRIMAZOLE/NEOMYCIN S040.025%W/W+1.0%W/W+0.5%W/WTORQUE PHARMACEUTICALS LTD, ISSAPUR, DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/3813MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDACTIPAR PIPERAZINE CITRATE500MG/5MLTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 30 ML BOTTLE
NDA/MAL/HDP/3823MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORM ORAL SUSPENSIONALBENDAZOLE200MG/5MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140506 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 10 ML BOTTLE
NDA/MAL/HDP/3840MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTORACTIN TABLETSCYPROHEPTADINE4MGTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,50 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3892MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTETRAXLEVAMISOLE HYDROCHLORIDE40MG/5MLTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS 15 ML BOTTLE
NDA/MAL/HDP/4171MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTOREX MULTIINGREDIENTN/ATORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4726MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDADB MIN MULTIPOWERMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,300 ML BOTTLE
NDA/MAL/HDP/5005MACK BROWN SHURIK LTDCOLD GOMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,50 STRIP CARTON
NDA/MAL/HDP/5125MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDGLYGESIC FORTE RHUMETIC CREAMMULTI INGREDIENTN/ATORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/5141MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDKETOMAC SHAMPOOKETOCONAZOLE2%W/VTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 75 ML BOTTLE
NDA/MAL/HDP/5317MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDDR MAC'S COUGH FROMULAGUANFENESIN+BROMOHEXINE100MG+8MG/5MLTORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/5361MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCALFICMULTI-INGREDIENTN/ATORQUE PHARMACEUTICALS LTD ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/7928MACK BROWN PHARMACEUTICALS PVT LIMITED SHURIK LTDCOLDROP HERBAL COUGH SYRUPMULTINGREDIENT100MLMACK BROWN PHARMACEUTICALS PVT LIMITEDINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/1988KUNMING PHARMACEUTICALS CORPSINO AFRICA MEDICINES & HEALTH LTDARTEMEDINE INJECTIONARTEMETHER80MG/MLKUNMING PHARMACEUTICAL CORP.-QIGONGLI, WEST SURBURB, KUNMING 650106 - YUNNAM PROVINCE, P.R. CHINACHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/2744KUNMING PHARMACEUTICALS CORPSINO AFRICA MEDICINES & HEALTH LTDARCOARTEMESININ/NAPTHOQUINE250MG/100MGKUNMING PHARMACEUTICAL CORPORATION 650100 QIGONGLI WEST SUBURB KUNMING YUNNAN PROVINCCHINAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/2846SINO AFRICA MEDICINES AND HEALTH LTDSINO AFRICA MEDICINES & HEALTH LTDBENZATHINE BENZYL PENICILLIN FOR INJECTIONBENZATHINE BENZYL PENICILLIN 2400000 I.USHIJIAZHUANG PHARMA GROUP, ZHOUGNUO, PHARMACEUTICAL-N0188 GONGNONG ROAD, SHIJIAZHUANG CITY HEBEI PROVINCE, PEOPLE'S REP. CHINACHINAPARENTERAL ORDINARY DRY VIALS 2.4 MU VIAL,50 VIAL CARTON,10 VIAL CARTON
NDA/MAL/HDP/3018ROYAL PHARMA 2011 LIMITEDSINO AFRICA MEDICINES & HEALTH LTDDICLOFENAC SODIUMDICLOFENAC SODIUM75MG/3MLZHEJIANG TIANFENG PHARMACEUTICAL FACTORY-NO.518 DA,KIVI PHARM CO. LTD-DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,XUANHUA,ZHANGJIAKOU CITY,HEBEI CHINACHINAPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/4308SINO AFRICA MEDICINES AND HEALTH LTDSINO AFRICA MEDICINES & HEALTH LTDBENZYL PENICILLIN SODIUMBENZYL PENICILLIN SODIUM1000000 I.USHIJIAZHUANG PHARMA GROUP, ZHOUGNUO, PHARMACEUTICAL-N0188 GONGNONG ROAD, SHIJIAZHUANG CITY HEBEI PROVINCE, PEOPLE'S REP. CHINACHINAPARENTERAL ORDINARY DRY VIALS 1 MU VIAL,10 VIAL CARTON,50 VIAL CARTON
NDA/MAL/HDP/5642SHIJIAZHUANG SECOND PHARMACEUTICALSSINO AFRICA MEDICINES & HEALTH LTDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4MEGA UNITSSHIJIAZHUANG PHARMA GROUP, ZHOUGNUO, PHARMACEUTICAL-N0188 GONGNONG ROAD, SHIJIAZHUANG CITY HEBEI PROVINCE, PEOPLE'S REP. CHINACHINAPARENTERAL ORDINARY DRY VIALS 10 VIAL CARTON,50 VIAL CARTON
NDA/MAL/HDP/0075 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE/PIPERAQUINE PHOSPHATE150MG/750MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIAINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/0098MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0110MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD, MSN HOUSE PLOT NO.42 ANRICH INDUSTRIAL ESTATE BOLLARAM, MEDAK DISTRICT, 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0111MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD, MSN HOUSE PLOT NO.42 ANRICH INDUSTRIAL ESTATE BOLLARAM, MEDAK DISTRICT, 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0116MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0286GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDGLUMACARTEMETHER+LUMEFANTRINE20MG+120MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINACHINAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER,12 TABLET BLISTER,18 TABLET BLISTER,24 TABLET BLISTER
NDA/MAL/HDP/0327GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR 8LORNOXICAM8MGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DISTRICT SOLAN (HIMACHAL PRADESH) 174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0328GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR PLORNOXICAM + PARACETAMOL4MG + 500MGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DISTRICT SOLAN (HIMACHAL PRADESH) 174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/0408MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDALGIC - PACECLOFENAC/PARACETAMOL100MG/500MGMSN LABORATORIES LTD PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,5 STRIP CARTON
NDA/MAL/HDP/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LTD BIOTECH PARK H-14/2 MIDC WALIJ AURANGABAD 431136INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.4 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/0854GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-50BECLOMETASONE50MCGGLENMARK PHARMACEUTICALS LTD UNIT III VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN HIMACHAL PRADESHINDIALUNG ADMINISTRATION METERED-DOSE INHALER 200 METERED DOSE CANNISTER
NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAVAGINAL TABLETS 6 PESSARY STRIP
NDA/MAL/HDP/0862GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR- 200BECLOMETASONE200MCGGLENMARK PHARMACEUTICALS LTD UNIT III VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN HIMACHAL PRADESHINDIALUNG ADMINISTRATION METERED-DOSE INHALER 200 METERED DOSE CANNISTER
NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID LINEZOLIDE2MG/MLAMANTA HEALTHCARE LIMITED, PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE,300 ML BOTTLE
NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO LTD NO. 43 QILIDIAN ROAD,GUILIN, CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/1073GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-250BECLOMETASONE250?GGLENMARK PHARMACEUTICALS LTD UNIT III VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN HIMACHAL PRADESHINDIALUNG ADMINISTRATION METERED-DOSE INHALER 200 METERED DOSE CANNISTER
NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS 10 G TUBE
NDA/MAL/HDP/1154 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 30 ML VIAL
NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO LTD NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DISTRICT SOLAN (HIMACHAL PRADESH) 174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DISTRICT SOLAN (HIMACHAL PRADESH) 174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1246GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 4MONTELUKAST4MGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DISTRICT SOLAN (HIMACHAL PRADESH) 174101INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1278GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO. LTD NO.43 SHANGHAI ROAD GUILIN 541002 GUANGXICHINAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,9 TABLET BLISTER
NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/1489GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDPARACETAMOLPARACETAMOL500MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINACHINAORAL SOLID ORDINARY TABLETS 500 TABLET CONTAINER
NDA/MAL/HDP/1490GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDMETRONIDAZOLE TABLETS BPMETRONIDAZOLE TABLETS BP200MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINACHINAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED, PLOT NO 57 VILLAGE KUNJHAL POSTINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP
NDA/MAL/HDP/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCHARDT LTD BIOTECH PARK H14/2 MIDC WALUJ AURANGABAD 431 136 INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/1552BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS, DISPERSIBLECEFADROXIL125MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/1586WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTARCEFUROXIME125MG/5MLWOCKHARDT LIMITED, B-15/2, MIDC WALUJ AURANGABAD 4INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 50 ML BOTTLE
NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAVAGINAL GELS AND SOLS 30 G TUBE
NDA/MAL/HDP/1772 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPD MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/1806BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUMOX PAMOXYCILLIN125MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,20 STRIP CARTON
NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL OTHER OINTMENTS 15 G TUBE
NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO LTD NO.17 SHANGHAI ROAD GUILIN 541002 GUANGXICHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/1852 RANBAXY LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDVERCEF ORAL SUSPENSIONCEFACLOR125MG/5MLRANBAXY LABORATORIES-LABORATORIES LIMITED INDUSTRIAL AREA 3 DEWAS 455001INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN ROAD GUILINCHINAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
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 ,DINDIATOPICAL EXTERNAL CREAMS 15 G TUBE,5 G TUBE
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 ,DINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/2012GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- LOTIONCLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE1% + 0.025%GLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL LOTIONS 15 ML BOTTLE
NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/2023WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTARCEFUROXIME750MG/10ML VIALWOCKHARDT LIMITED-B-15/2 MIDC, WALUJ, AURANGABAD 431136, MAHARASHTRA STATE, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 10 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/2055GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN ROAD GUILIN 541002 GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 120 MG VIAL+2 ML AMPOULE 5% NAHCO3 + 10ML AMPOULE 0.9% NACL
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 NO 57 VILLAGE KUNJHAL POSTINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY VIALS 10 ML VIAL
NDA/MAL/HDP/2173 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.ISTAR PHARMACEUTICALS LTDFASTUM GELKETOPROFEN 2.5%W/WA. MENARINI MANUFACTURING LOGICTICS AND SERVICES, VIA ROSOLINO PILO 4 50131 FLORENCEINDIATOPICAL EXTERNAL GELS AND SOLS 30 G TUBE,50 G TUBE,20G TUBE,100G DISPENSER TUBE
NDA/MAL/HDP/2399 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINI MULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIAINDIATOPICAL EXTERNAL OTHER GELS/SOLS 30 G TUBE
NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1% W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL GELS AND SOLS 15 G TUBE
NDA/MAL/HDP/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS 10 G TUBE
NDA/MAL/HDP/2529GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDG-CEFTRIACEFTRIAXONE1GGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN ROAD GUILIN 541004,QUANGXICHINAPARENTERAL ORDINARY DRY VIALS 1 G VIAL + 10 ML AMPOULE WFI
NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,10 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE 40MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,10 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/2617BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS DISPERSABLECEFADROXIL250MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON
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-403722INDIATOPICAL EXTERNAL CREAMS 10 G TUBE
NDA/MAL/HDP/2800NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPID HM PENFILLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY PRE-FILLED PENS 1.5 ML PREFILLED PEN,3 ML PREFILLED PEN
NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUN PLUSARTESUNATE/AMODIAQUINE100MG/270MGGUILIN PHARMACEUTICAL CO. LTD NO 43 SHANGHAI ROAD GUILIN GUANGXICHINAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,20 BLISTER CARTON,6 TABLET BLISTER,20 BLISTER CARTON
NDA/MAL/HDP/2852BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDLEK-500LEVOFLOXACIN HEMIHYDRATE500MGBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3052GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDIBUPROFEN TABLETSIBUPROFEN200MGGUILIN PHARMACEUTICAL CO. LTD, NO.17 SHANGHAI ROAD, GUILIN 541002 GUANGXICHINAORAL SOLID ORDINARY COATED TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/3204GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDRELCER GELALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/SIMETHICONE/LIQUORICEN/AGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY LIQUIDS 180 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/3289GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID DUSTING POWDERCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL POWDERS 30 G BOTTLE,100 G BOTTLE
NDA/MAL/HDP/3291 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDFINTOPBUTENAFINE HCL1%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/3295 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVATECLOBETASOL0.05%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E-37, 39, D-INDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/3314 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSILVEREX SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE10MG/G+10MG/GSUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIAINDIATOPICAL EXTERNAL OTHER CREAMS 25 G TUBE,10 G TUBE,250 G TUBE
NDA/MAL/HDP/3346WOCKHARDT LTDSTAR PHARMACEUTICALS LTDZEDEXBROMHEXINE +AMMONIUM CHLORIDE+ MENTHOL + DEXTROMETHORPHAN8MG+100MG+5MG+10MGWOCKHARDT LIMITED, PLOT NO 57 VILLAGE KUNJHAL POSTINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/3385BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL-P-SUSPENSIONMEFENAMIC ACID100MG/5MLBLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL LIQUID ORDINARY SUSPENSIONS 60 ML BOTTLE
NDA/MAL/HDP/3415GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID V-1CLOTRIMAZOLE500MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAVAGINAL MECHANICAL PESSARIES WITH SUBSTANCE 1 PESSARY STRIP
NDA/MAL/HDP/3545GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID MOUTH PAINTCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY OILS 15 ML BOTTLE
NDA/MAL/HDP/3566GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE FOR INJECTION60MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN ROAD GUILIN 541002 GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 60 MG VIAL + 1ML AMPOULE 5%NAHCO3 + 5ML AMPOULE 0.9%NACL
NDA/MAL/HDP/3843WOCKHARDT LTDSTAR PHARMACEUTICALS LTDAZIWOKAZITHROMYCIN250MGWOCKHARD LTD-WOCKHARDT TOWER BANDRA KURLA COMPLEX BANDRA EAST MUMBAI 400 051 INDIAINDIAORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER
NDA/MAL/HDP/3848WOCKHARDT LTDSTAR PHARMACEUTICALS LTDAZIWOKAZITHROMYCIN200MG/5MLWOCKHARD LTD-WOCKHARDT TOWER BANDRA KURLA COMPLEX BANDRA EAST MUMBAI 400 051 INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 15 ML BOTTLE
NDA/MAL/HDP/3954WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPOWERCEF 1GM INJECTIONCEFTRIAXONE SODIUM1GM1.ZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA. 2. WOCKHARDT LIMITED, B-15/2, MIDC WALUJ AURANGABAD 4INDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/3999 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDPANSEC DRPANTOPRAZOLE SODIUM40MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 7 TABLET STRIP,4 STRIP CARTON
NDA/MAL/HDP/4075 RANBAXY LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDCHERICOF COUGH FORMULARCHLORPHENIRAMINE/DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL2MG/10MG/5MGRANBAXY LABORATORIES LTD AT: THE MADRAS PHARMACEUTICALS 137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/4099GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEVO I.VLEVOFLOXAXIN500MG/100MLAMANTA HEALTHCARE LIMITED, PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/4187BAYER PHARMA AGSTAR PHARMACEUTICALS LTDNORIGYNON ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE 5 MG+50 MG / MLBAYER PHARMA AG-D - 51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/4553GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUN ARTESUNATE30MGGUILIN PHARMACEUTICAL CO.LTD NO.43 QILIDIAN ROAD GUILIN 541002 GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 30 MG VIAL + 0.5 ML AMPOULE 5%NAHCO3
NDA/MAL/HDP/4715BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL FORTEMEFENAMIC ACID/ PARACETAMOL500MG/450MGBLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4717BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL-SPASMEFENAMIC ACID/DICYCLOMINE HYDROCHLORIIDE250MG/10MGBLUE CROSS LABORATORIES LTD, L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4855GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDASCORIL EXPECTORANTMULTI-INGREDIENTN/AGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,200 ML BOTTLE
NDA/MAL/HDP/4904NOVO NORDISKSTAR PHARMACEUTICALS LTDMIXTARD 30 INSULIN HUMAN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS 10 ML VIAL
NDA/MAL/HDP/4908NOVO NORDISKSTAR PHARMACEUTICALS LTDMIXTARD 30 PENFILLBIPHASIC ISOPHANE INSULIN (HUMAN)100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY CARTRIDGE1.5ML CARTRIDGE,3 ML CARTRIDGE
NDA/MAL/HDP/4957GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON (111) POLYMALTOSE CPLX + FOLIC ACID100MG + 500MCGGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5079GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 5MONTELUKAST5MGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DISTRICT SOLAN (HIMACHAL PRADESH) 174101INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5131NOVO NORDISKSTAR PHARMACEUTICALS LTDINSULATARD HMISOPHANE INSULIN (HUMAN)100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEBELGIUMPARENTERAL ORDINARY VIALS 10 ML VIAL
NDA/MAL/HDP/5139NOVO NORDISKSTAR PHARMACEUTICALS LTDINSULATARD HM PENFILLISOPHANE INSULIN (HUMAN)100I.U/MLNOVO NORDISK PHARMA-NOVO ALLEBELGIUMPARENTERAL ORDINARY PRE-FILLED PENS 1.5 ML CARTRIDGE ,3 ML CARTRIDGE
NDA/MAL/HDP/5150GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDKETO PLUS SHAMPOOKETOCONAZOLE/ZINC PYRITHIONE1%W/V+2%W/VGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 60 ML BOTTLE
NDA/MAL/HDP/5167 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBRUSTAN TABLETSIBUPROFEN/ PARACETAMOL400MG/300MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/5170GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDITRAL CAPSULEITRACONAZOLE100MGGLENMARK PHARMACEUTICALS LTD, PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY CAPSULES 4 CAPSULE STRIP
NDA/MAL/HDP/5352GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON(111) POLYMALTOSE COMPLEX50MG/5MLGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 150 ML BOTTLE
NDA/MAL/HDP/5397 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-100BECLOMETHASONE100MCGGLENMARK PHARMACEUTICALS LTD UNIT III VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN HIMACHAL PRADESHINDIALUNG ADMINISTRATION METERED-DOSE INHALER 200 METERED DOSE CANNISTER
NDA/MAL/HDP/5460GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUN-PLUSARTESUNATE+AMODIAQUINE50MG+135MGGUILIN PHARMACEUTICAL CO LTD NO.43 SHANGHAI ROAD GUILIN GUANG CHINACHINAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5479 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDRANFERON 12 CAPSULESMULTI-INGREDIENTMULTI-INGREDIENT SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIAINDIAORAL SOLID ORDINARY CAPSULES 30 CAPSULE BLISTER
NDA/MAL/HDP/5483GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUN-PLUSARTESUNATE / AMODIAQUINE25MG / 67.5MGGUILIN PHARMACEUTICAL CO LTD NO.43 SHANGHAI ROAD GUILIN GUANG CHINACHINAORAL SOLID ORDINARY TABLETS 20 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5487GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDIBICAR-SSALBUTAMOL + BECLOMETASONE100MCG/ACTUATION + 50MCG/ACTUATIONGLENMARK PHARMACEUTICALS LTD UNIT III VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN HIMACHAL PRADESHINDIALUNG ADMINISTRATION METERED-DOSE INHALER 200 METERED DOSE CANNISTER
NDA/MAL/HDP/6039GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCOMBIWAVE SF 250SALMETEROL XINAFOATE/FLUTICASONE PROPIONATE25MCG+250MCG/ACTUATIONGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN (H.P) 174 101INDIALUNG ADMINISTRATION BREATH-ACTUATED METERED-DOSE INHALER 120 METERED DOSE CANNISTER
NDA/MAL/HDP/6042GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDCOMBIWAVE SF 125SALMETEROL XINAFOATE/ FLUTICASONE PROPIONATE25MCG+125MCG/ACTUATIONGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN (H.P) 174 101INDIALUNG ADMINISTRATION METERED-DOSE INHALER 120 METERED DOSE CANNISTER
NDA/MAL/HDP/6044GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDCOMBIWAVE SF 50SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+50MCG/ACTUATIONGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD DIST SOLAN (H.P) 174 101INDIALUNG ADMINISTRATION METERED-DOSE INHALER 120 METERED DOSE CANNISTER
NDA/MAL/HDP/6048GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE AZMOMETASONE FUROATE / AZELASTINE HYDROCHLORIDE50MCG/140MCGGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARARH DIST SOLAN (H.P) 174 101INDIANASAL TOPICAL METERED DOSE AEROSOLS 150 METERED DOSE BOTTLE
NDA/MAL/HDP/6208WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWOCKLAVAMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE200MG/5ML+28.5MG/5MLMEDOPHARM PVT LTD-50, KAYARAMBEDU VILLAGE, GUDUVANANCHERRY - 603202, TAMIL NADU, INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6231GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPP DISPERSIBLEDIHYDROARTEMISININ/PIPERAQUINE20MG/160MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY OTHER TABLETS 3 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6234GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPP DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE40MG/320MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY OTHER TABLETS 3 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6242GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE80MG/640MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6436GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDMOXAFMOXIFLOXACIN HYDROCHLORIDE 400 MGGUILIN PHARMACEUTICAL CO LTD NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 5 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6678BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ-DXCHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE2MG/5ML + 15MG/5ML + 5MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/6679BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDWOMIBAN TABLETSALBENDAZOLE400MGBLUE CROSS LABORATORIES LTD, A-12, M.I.D.C AMBAD NASHIK-422010INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1 TABLET STRIP,1 STRIP CARTON
NDA/MAL/HDP/6753BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ X SYRUPTERBUTALINE+BROMHEXINE+GUAIFENESIN1.25MG+4MG+50MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE
NDA/MAL/HDP/7313 PANACEA BIOTEC LTDSTAR PHARMACEUTICALS LTDEASYFIVE-TT (FULLY LIQUID PENTAVALENT VACCINE)DIPTHERIA TOXOID + TETANUS TOXOID + INACTIVATED W-B, PERTUSSIS + HBSAG + HIB (PRP-TT)30 IU + 60 IU + 4 IU + 10MCG + 10 MCGPANACEA BIOTEC LTD MALPUR BADDI DISTT, SOLAN (H.P) 173 205INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGE 0.5ML PRE-FILLED SYRINGE
NDA/MAL/HDP/8212FDC LTDSTAR PHARMACEUTICALS LTDBACTIGEN EYE/EAR DROPSGENTAMYCIN0.3%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC VIALS 5 ML VIAL,10 ML VIAL
NDA/MAL/HDP/8232GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDMOMATEMOMETASONE FUROATE MONOHYDRATE50MCG/ SPRAYGLENMARK PHARMACEUTICALS LTD VILLAGE KISHANPURA BADDI NALAGARH ROAD TEHSIL NALAGARH DIST SOLAN (H.P) 174 101INDIANASAL SYSTEMIC METERED-DOSE LIQUIDS 120 METERED DOSE DOSES,1 BOTTLE CARTON
NDA/MAL/HDP/3781EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDALZANTELALBENDAZOLE20MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL LIQUID ORDINARY SUSPENSIONS 20 ML BOTTLE
NDA/MAL/HDP/8197EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMIKACINAMIKACIN SULPHATE500MG/2ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 2 ML VIAL
NDA/MAL/HDP/5279EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOSINDOXAZOCIN2MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/4401EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE DISODIUM2G EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 2 G VIAL,1 VIAL CARTON,5 ML AMPOULE,2 AMPOULE CARTON
NDA/MAL/HDP/4413EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE1G EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 1 G VIAL,1 VIAL CARTON,2 AMPOULE CARTON
NDA/MAL/HDP/4417EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE SODIUM500MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 0.5 G VIAL,1 VIAL CARTON,5 ML AMPOULE,1 AMPOULE CARTON
NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 3 VIAL CARTON,3 AMPOULE CARTON
NDA/MAL/HDP/4419EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIGONAL 75HUMAN MENOPAUSAL GONADOTROPHIN75IU/5ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON,1 ML AMPOULE
NDA/MAL/HDP/4774EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFERROFOL VIT-ZFERROUS SULPHATE/FOLIC ACID/ ASCORBIC ACID/ THIAMINE MONONITRATE/RIBOTLAVINE/PYRIDOXINE HCL/ NICOTINAMIDE /ZINC150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER,5 BLISTER CARTON
NDA/MAL/HDP/3502EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 2 ML AMPOULE,100 MG VIAL
NDA/MAL/HDP/3245EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNYSTATIN ORAL DROPSNYSTATIN100,000 I.U/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL LIQUID ORDINARY DROPS 30 ML BOTTLE
NDA/MAL/HDP/6075EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOLOHISTINEOLOPATADINE HYDROCHLORIDE1MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/7686EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTGENTGENTAMICIN SULPHATE0.3W/V EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 5 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/6078EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIMOLOL MALEATETIMOLOL MALEATE5MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,2 BLISTER CARTON
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 AREAEGYPTORAL SOLID ORDINARY CAPSULES 6 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6058FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDFENTANYL FRESENIUSFENTANYL100MCG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 2 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6194FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDFENTANYL FRESENIUSFENTANYL CITRATE500MCG/10MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 10 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/6037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAVITVITAMIN A200,000 IUOLIVE HEALTHCARE 197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T)INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON,30 CAPSULE BLISTER
NDA/MAL/HDP/6788SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDROYAL VIT GMULTI-INGREDIENTSMULTI-INGREDIENTSSEDICO PHARMACEUTICAL CO.EGYPTORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3859UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDIFIMOLPARACETAMOL10MG/MLUNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS AND PHARMACEUTICALS LTD) PLOT 4 PHASE IV GIDC PANLI 394116 GUJURATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/5326UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDECODAX G CREAMECONAZOLE NITRATE,GENTAMYCIN,BECLAMETASONE1%+0.1%+0.025%UNIQUE PHARMACEUTICALSLABORATORIESPLOT NO. 215-219INDIATOPICAL EXTERNAL CREAMS 10 G TUBE,100 G TUBE
NDA/MAL/HDP/6405 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLOPRAZCLOPIDOGREL BISULFATE75MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR ? 441501,DIST. NAGPUR,MAHARASHTRA,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6407 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMCOX 200CELECOXIB200 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR ? 441501,DIST. NAGPUR,MAHARASHTRA,INDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6243ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDSURVANTABERACTANT100MG/4MLABBVIE NORTH CHICAGO FACILITY 1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000UNITED STATESOTHER SYSTEMIC OTHER LIQUIDS 4 ML VIAL,8ML VIAL
NDA/MAL/HDP/3005ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-100 SR DEPOCAPSDICLOFENAC SODIUM100MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY OTHER CAPSULES 10 CAPSULE BLISTER
NDA/MAL/HDP/3686ACINO PHARMA AGGOODMAN INTERNATIONAL LTDNEURORUBINEMULTIVITAMINMULTINGREDIENTACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/4736ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMEPHAQUIN LACTABMEFLOQUINE250MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/8241ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCLOPACINCLOPIDOGREL BESILATE75MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONOGESTREL1.5MGACME FORMULATION PVT LTD ROPER ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/7189ACULIFE HEALTHCARESUPER MEDIC LTDMERONIRMEROPENEM SODIUM1000MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 20 ML VIAL,20 ML AMPOULE
NDA/MAL/HDP/7255ACULIFE HEALTHCARESUPER MEDIC LTDNIRIXONECEFTRIAXONE SODIUM1000MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/7344ACULIFE HEALTHCARESUPER MEDIC LTDHEPANIRHEPARIN SODIUM1000IU/MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/8317ACULIFE HEALTHCARESUPER MEDIC LTDMERONIR 500MEROPENEM500MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 20 ML VIAL,10 ML AMPOULE
NDA/MAL/HDP/8318ACULIFE HEALTHCARESUPER MEDIC LTDB-CANE HEAVYBUPIVACAINE HYDROCHLORIDE BP5 MG/MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE
NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMYPRODOLPARACETAMOL,IBUPROFEN,CODEINE PHOSPHATE250MG,200MG,10MGADCOCK INGRAM LTD NO.49 C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALOREINDIAORAL SOLID ORDINARY CAPSULES 20 CAPSULE BLISTER
NDA/MAL/HDP/4356ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDFRESHENBISACODYL5MGADCOCK INGRAM LTD NO. 49C & D BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE 560099INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 12 TABLET BLISTER
NDA/MAL/HDP/6079ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDALLERGEXCHLORPHENIRAMINE MALEATE4MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6758ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDADCO-NAPAMOLPARACETAMOL500MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/6759ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDBETAPYNPARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE450 MG+10 MG+5 MG+50 MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 18 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/6763ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDCOMPRAL HEADACHE TABLETSPARACETAMOL+ASPIRIN+CAFFEIN ANHYDROUS100MG+400MG+130MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 2 TABLET STRIP,48 STRIP CARTON
NDA/MAL/HDP/6060SANDOZ GMBH KENYA C/O NORVATIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDTAMUXXAIRSALBUTAMOL100MCGAEROPHARM GMBH...-RUDOLSTADT ALLEMAGNEGERMANYLUNG ADMINISTRATION LIQUID FOR INHALATION 200 METERED DOSE CONTAINER
NDA/MAL/HDP/3506ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDULTANESEVOFLURANE100%W/WAESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENTUNITED KINGDOMNASAL SYSTEMIC UNIT DOSE LIQUIDS 250 ML BOTTLE
NDA/MAL/HDP/6783ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFORANEISOFLURANE99.9%W/VAESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENTUNITED KINGDOMOTHER SYSTEMIC LIQUID INHALATIONS 250 ML BOTTLE
NDA/MAL/HDP/8084AGILA SPECIALTIES PRIVATEKIMSY MEDS LTDTAZPENPIPERACILLIN + TAZOBACTAM4+0.5 G/VIALAGILA SPECIALTIES PRIVATE LIMITED -STERILE PRODUCTS DIVISION SPD , OPP IIM BILEKAHALLI , BANNERGHATTA ROAD BANGLOREINDIAPARENTERAL ORDINARY VIALS 4.5 G VIAL
NDA/MAL/HDP/4766GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEN SUSPENSIONMEBENDAZOLE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 30 ML BOTTLE
NDA/MAL/HDP/4769 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBEXMEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 BLISTER CARTON,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/8151 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO-C (THANE)VITAMIN C100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET STRIP,10 STRIP CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5495 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCAL TABLETSCALCIUM LACTATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6142AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCARBACTIVATED CHARCOAL0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 100 TABLET BOTTLE,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4002AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIDALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE250MG/5ML+ 250MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE,170 ML BOTTLE
NDA/MAL/HDP/4001AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD PLUS SYRUPPARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/4809 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCORTHYDROCORTISONE0.1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 15 MG TUBE,1 TUBE CARTON
NDA/MAL/HDP/4329AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE MALEATE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/5419AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4605AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODRYL SYRUPBROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/4805 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFENIBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4806 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFERFERROUS SULPHATE+FOLIC ACID200MG + 0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/4807 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFORMINMETFORMIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON1000 TABLET CONTAINER
NDA/MAL/HDP/8154 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGCORTHYDROCORTISONE ACETATE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/4811 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGYLMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/3998AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOKOFF SYRUPTERBUTALINE SULPHATE +GUAIFENESIN+BROMOHEXINE HCL+LEVOMENTHOL1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/5482 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOLINSALBUTAMOL2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE,100 ML BOTTLE
NDA/MAL/HDP/4812 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL SUSPENSIONMETRONIDAZOLE BENZOATE125MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 100 ML BOTTLE
NDA/MAL/HDP/4813 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL TABLETS (THANE)METRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 100 TABLET CONTAINER,500 TABLET CONTAINER,1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/4188AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPRAZPRAZIQUANTEL600MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON,10 TABLET BLISTER,10 BLISTER CARTON,4 TABLET BLISTER,2BLISTER CARTON
NDA/MAL/HDP/3996AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTOIN TABLETSNITROFURANTOIN BP100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/6213 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN 250 DTAMOXICILLIN TRIHYDRATE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1 BLISTER CARTON,2 BLISTER CARTON
NDA/MAL/HDP/4598 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 6 TABLET BLISTER
NDA/MAL/HDP/4526AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER
NDA/MAL/HDP/6041 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAVAGINAL TABLETS 6 PESSARY STRIP
NDA/MAL/HDP/5429AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCIPRO-500CIPROFLOXACIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1*10*10, 1*100, 1*1000 ,1*100*10 BLISTER
NDA/MAL/HDP/4903AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDCMT-TABLETSMAGNESIUM TRISILICATE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER,10 TABLET BLISTER,100 BLISTER CARTON
NDA/MAL/HDP/5464AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER/LUMEFANTRINE20MG/120MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 8 TABLET BLISTER,6 TABLET BLISTER,2 BLISTER CARTON,3 BLISTER CARTON,4 BLISTER CARTON
NDA/MAL/HDP/8157 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD LYTE- PLAINANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE13.50G + 2.60G + 2.90G +1.50G/ 1LAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY GRANULES 20.5 G SACHET
NDA/MAL/HDP/5272 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIXDIGOXIN0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/6190 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTEANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE DIHYDRATE,POTASSIUM CHLORIDE2.7G + 0.52G + 0.58G + 0.30G/ 200MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY POWDERS 200 ML SACHET,500 ML SACHET,1000 ML SACHET,1 SACHET CARTON
NDA/MAL/HDP/4751 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFEROLFERROUS SULPHATE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARYOTHER COATED TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/4940 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFOLONFOLIC ACID5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5305AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDIBUGOIBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/5302 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDIBUGO-COMBIIBUPROFEN/PARACETAMOL/CAFFEINE200MG/325MG/30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,2 BLISTER CARTON,10 BLISTER CARTON,100 BLISTER CARTON
NDA/MAL/HDP/5115AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDINDOS-25(THANE)INDOMETHACIN25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1000 CAPSULE CONTAINER,5 CAPSULE BLISTER,20 BLISTER CARTON,10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/5188AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDITRAZ CAPSULESITRACONAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 5 CAPSULE BLISTER,3 BLISTER CARTON,10 CAPSULE BLISTER,6 BLISTER CARTON
NDA/MAL/HDP/4836AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETRONMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON,100 BLISTER CARTON,1000 TABLET CONTAINER
NDA/MAL/HDP/4924AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMULTIVIT TABLETMULTIVITAMINMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/8178 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO TABLETSNYSTATIN500,000I.UAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON,10 BLISTER CARTON,100 TABLET BOTTLE
NDA/MAL/HDP/5435 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPICPARACETAMOL+IBUPROFEN+CAFFEINE500MG+200MG+30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET STRIP,25 STRIP CARTON
NDA/MAL/HDP/4406AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDSATISFIL -100SILDENAFIL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/4064AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTERAFINETERBINAFINE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 14 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6082EXPHAR SASURGIPHARM (U) LIMITEDCROMSOLSODIUM CROMOGLICATE2%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)INDIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/6354EXPHAR SA.SURGIPHARM (U) LIMITEDTIMOSOL ?TIMOLOL MALEATEO.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)INDIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/7241EXPHAR SA.SURGIPHARM (U) LIMITEDGENTASOLGENTAMICIN SULFATE0.3%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)INDIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/6202MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSALPRAZ 20PANTOPRAZOLE SODIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD SY. NO. 172 & L173 APPAREL PARK ROAD DULAPALLY VILLAGE QUTHBULLAPUR MANDAL R.R DIST HYDERABAD 500100INDIAORAL SOLID RETARD FILM-COATED TABLETS 7 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/7707MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDZOLIGLIT 15PIOGLITAZONE15MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD SY. NO. 172 & L173 APPAREL PARK ROAD DULAPALLY VILLAGE QUTHBULLAPUR MANDAL R.R DIST HYDERABAD 500100INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8128MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 10ATORVASTATIN CALCIUM10MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD SY. NO. 172 & L173 APPAREL PARK ROAD DULAPALLY VILLAGE QUTHBULLAPUR MANDAL R.R DIST HYDERABAD 500100INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8129MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 20ATORVASTATIN CALCIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD SY. NO. 172 & L173 APPAREL PARK ROAD DULAPALLY VILLAGE QUTHBULLAPUR MANDAL R.R DIST HYDERABAD 500100INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8132MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDZOLIGLIT 30PIOGLITAZONE HYDROCHLORIDE30MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD SY. NO. 172 & L173 APPAREL PARK ROAD DULAPALLY VILLAGE QUTHBULLAPUR MANDAL R.R DIST HYDERABAD 500100INDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8134MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSALPRAZ 40PANTOPRAZOLE40MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD SY. NO. 172 & L173 APPAREL PARK ROAD DULAPALLY VILLAGE QUTHBULLAPUR MANDAL R.R DIST HYDERABAD 500100INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2416IDAKIMSY MEDS LTDSODIUM STIBOGLUCONATE INJECTIONSODIUM STIBOGLUCONATE100MG/MLALBERT DAVID LTD 15-CHITTARANJAN AVE. KOLKATAINDIAPARENTERAL ORDINARY VIALS 30 ML VIAL
NDA/MAL/HDP/0572S.A ALCON-COUVREUR N.VKARURI PHARMACEUTICALS LTD.AZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/4927ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.AZOPTBRINZOLAMIDE10MG/MLALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC SUSPENSIONS 5 ML BOTTLE
NDA/MAL/HDP/3331ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.BETOPTICBETAXOLOLO.5%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML VIAL
NDA/MAL/HDP/4738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.CILOXANCIPROFLOXACIN0.3%W/VALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/4326ALCON CUSI S.AKARURI PHARMACEUTICALS LTD.CUSICROM 4% EYE DROPSSODIUM CROMOGLYCATE0.04ALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/4321ALCON CUSI S.AKARURI PHARMACEUTICALS LTD.CUSIMOLOL 0.5%TIMOLOL MALEATE0.005ALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS 5 ML VIAL
NDA/MAL/HDP/2768ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ECONOPRED PLUSPREDNISOLONE ACETATE1%W/WALCON (PUETRO RICO) LABORATORIES-INC USAUNITED STATESOPHTHALMIC SUSPENSIONS 5 ML BOTTLE
NDA/MAL/HDP/3718ALCON PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ISOPTO ATROPINE 1%ATROPINE SULPHATE1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMSPAINOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/2050ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ISOPTO CARPINE 2%PILOCARPINE2%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 15 ML BOTTLE
NDA/MAL/HDP/5050ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MAXIDEXDEXAMETHASONE0.1%W/VALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/5041ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W +0.1%W/W+6000 I.UALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC OINTMENTS 3.5 G TUBE
NDA/MAL/HDP/5043ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W+3500I.U/ML+6000I.U/MLALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/2961ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.OFTALMOLOSA CUSI ERYTHROMYCIN 0.5%ERYTHROMYCIN0.5%W/WALCON CUSI SA-CAMIL FABRA 58 08320 EL MASNOUR BARCELONASPAINOPHTHALMIC OINTMENTS 3.5 MG TUBE
NDA/MAL/HDP/1864ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.PATANOLOLOPTADINE HYDROCHLORIDE1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML VIAL
NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 15 ML BOTTLE
NDA/MAL/HDP/4060ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TOBRADEXTOBRAMYCIN/DEXAMETHASONE0.3%W/V+ 0.1%W/VALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML VIAL
NDA/MAL/HDP/2545ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML VIAL
NDA/MAL/HDP/2974ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TRAVATANTRAVOPROST4?G/MLALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 2.5 ML VIAL
NDA/MAL/HDP/1636S.A.ALCON COUVREUR N.VKARURI PHARMACEUTICALS LTD.VIGAMOXMOXIFLOXACIN5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 10 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/1745AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIGENGENTAMYCIN AS SULPHATE0.3% W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 10 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 5 ML VIAL
NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/1756AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPRICROMSODIUM CROMOGLYCATE2%W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/1760AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEODEXNEOMYCINE+DEXAMETHASONE0.5%V/V+0.1%V/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANEYE/EAR DROPS10 ML VIAL
NDA/MAL/HDP/1741AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEOPRED-PPREDNISOLONE ACETATE + NEOMYCIN SO4 + POLYMYXIN-B5MG/ML +5MG/ML + 1M I.UAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANEYE/EAR SUSPENSION10 ML VIAL
NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC1%W/VAMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 5 ML AMPOULE,1 AMPOULE CARTON
NDA/MAL/HDP/4000AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIDONE SYRUPCHLORPHENARIMINE MALEATE/DEXAMETHASONE2MG/5ML, 0.5MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE,EL OBOUR CITY, CAIRO, EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 125 ML BOTTLE
NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL TOPICAL SPRAYS WITHOUT GAS 25 ML BOTTLE
NDA/MAL/HDP/3459AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDENEMAXHYPERTONIC SOLUTION OF SODIUM PHOSPHATES6GM AND 16GM/100MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTRECTAL SYSTEMIC ENEMA LIQUIDS 120 ML BOTTLE
NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6191AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON AMPOULETRAXENAMIC ACID500MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTPARENTERAL ORDINARY AMPOULES 5 ML AMPOULE,6 AMPOULE CARTON
NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/3098AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOSEDINLORATADINE5MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL LIQUID ORDINARY SYRUPS 60 ML BOTTLE
NDA/MAL/HDP/3798AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROTON TABLETTHIAMINE/ PYNDOXINE/ CYCUNOCOBALAMINE/ RIBUFLAMINE250/ 200/ 0.250/ 20AMOUN PHARMACETICAL COMPANY-1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPTEGYPTORAL SOLID ORDINARY COATED TABLETS 10 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL, CETYL PYRIDINUM CHLORIDE2GM + 0.1GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 15 G TUBE
NDA/MAL/HDP/3770AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDXITHRONEAZITHROMYCIN500 MGAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPTEGYPTORAL SOLID ORDINARY COATED TABLETS 5 TABLET BLISTER
NDA/MAL/HDP/3778AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDXITHRONEAZITHROMYCIN200MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 15 ML BOTTLE
NDA/MAL/HDP/2577TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOPCEF 200CEFIXIME200MGANKUR DRUGS PHARMA LTD VILLAGE MANAKPUR P.O BOX LODHI MAJARA NALAGARH DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,5 BLISTER CARTON,10 BLISTER CARTON
NDA/MAL/HDP/3210ACINO PHARMA AGGOODMAN INTERNATIONAL LTDLOFRAL 5AMLODIPINE5MGATLANTIC PHARMA SA,-ZONA INDUSTRIAL DA ABRUHEIRAPORTUGALORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3424ACINO PHARMA AGGOODMAN INTERNATIONAL LTDLOFRAL 10AMLODIPINE10MGATLANTIC PHARMA SA,-ZONA INDUSTRIAL DA ABRUHEIRAPORTUGALORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8189AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATE TABLETSABACAVIR SULPHATE300MGAUROBINDO PHARMA LTD. UNIT III, SURVEY NO. 313. BACHUPALLY VILLAGE, QUTHUBULLARPUR MANDALINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/8191AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED-RELEASEDIDANOSINE DELAYED-RELEASE400MGAUROBINDO PHARMA LTD. UNIT III, SURVEY NO. 313. BACHUPALLY VILLAGE, QUTHUBULLARPUR MANDALINDIAORAL SOLID ORDINARY CAPSULES 30 CAPSULE BOTTLE
NDA/MAL/HDP/5275AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ200MGAUROBINDO PHARMA LTD, UNIT III, SURVEY NO. 313(P)INDIAORAL SOLID ORDINARY CAPSULES 30 CAPSULE CONTAINER,90 CAPSULE CONTAINER
NDA/MAL/HDP/4039AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ50MGAUROBINDO PHARMA LTD UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 30 CAPSULE CONTAINER
NDA/MAL/HDP/5281AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXILEFAVIRENZ + EMITRICITABINE + TENOFOVIR DISOPROXIL FUMARATE600MG +200MG + 300MGAUROBINDO PHARMA LTD UNIT VII SEZ APIIC PLOT NO. S1 S.NO'S 411, 425,434,435 & 458, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERIA MANDAL, MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5287AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATEEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE600MG + 300MG + 300MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGEINDIAORAL SOLID ORDINARY TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/5224AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATEEMTRICITABINE + TENOFOVIR DISOPROXIL200MG + 300MGAUROBINDO PHARMA LTD, UNIT 111 SURVEY NO.313, BACHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 30 TABLET CONTAINER
NDA/MAL/HDP/4682AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINELAMIVUDINE10MG/MLAUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA.INDIAORAL LIQUID ORDINARY LIQUIDS 240 ML BOTTLE
NDA/MAL/HDP/5369AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINELAMIVUDINE150MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/5376AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE & ZIDOVUDINELAMIVUDINE & ZIDOVUDINE150 & 300MGAUROBINDO PHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL, HYDERABAD,RANGA REDDY (DT),ANDHRA PRADESH - 500090 INDIA.INDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/8188AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGAUROBINDO PHARMA LTD UNIT VII SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/8190AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE TABLETSLAMIVUDINE150 MGAUROBINDO PHARMA LTD. UNIT III, SURVEY NO. 313. BACHUPALLY VILLAGE, QUTHUBULLARPUR MANDALINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/4068AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE/ZIDOVUDINE/EFAVIRENZLAMUVIDINE+ZIDOVUDINE + EFAVIRENZ150MG+300MG+600MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 15 TABLET BLISTER,6 BLISTER CARTON
NDA/MAL/HDP/8159AUROBINDAUROBINDO PHARMA LIMITED (UNIT III)GITTOES PHARMACEUTICALS LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR100MG + 25MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/4570AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINENEVIRAPINE200MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET CONTAINER
NDA/MAL/HDP/5431AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 60 TABLET BOTTLE
NDA/MAL/HDP/4686AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE ORAL SOLUTION USPZIDOVUDINE50MG/5MLAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 240 ML BOTTLE
NDA/MAL/HDP/7448AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDSORID OINTMENTCALCIPOTRIOL MONOHYDRATE + BETAMETHASONE DIPROPIONATE50MCG +0.5MGAUROCHEM LABORATORIES (I) PVT. LTD 8, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD. PALGHAR ? 401 404, DISTRICT THANE, INDIAINDIATOPICAL EXTERNAL OINTMENTS 30 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/7450AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDDOLOACT GELKETOPROFEN + CAPSICUM OLEORESIN2.50%W/W + 0.25%W/WAUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 30 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/7452AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDXTRADERM CREAMBETAMETHASONE DIPROPIONATE USP + GENTAMICIN SULFATE BP + CLOTRIMAZOLE USP(0.64+ 0.1+10)MG/1GAUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIAINDIATOPICAL EXTERNAL CREAMS 20 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/7588AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDEXEVATE-MF OINTMENTBETAMETHASONE DIPROPIONATE USP + SALICYLIC ACID BP + UREA BP + LACTIC ACID BP + SODIUM LACTATE SOLUTION BP0.05 % W/W + 3.0 % W/W + 10.0 % W/W + 3.0 % W/W + 2.0 % W/WAUROCHEM LABORATORIES (I) PVT. LTD 8, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD. PALGHAR ? 401 404, DISTRICT THANE, INDIAINDIATOPICAL EXTERNAL OINTMENTS 20 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/7589AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDLACX SYRUPLACTULOSE10G/15MLAUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE,1 BOTTLE CARTON
NDA/MAL/HDP/7482AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDFUSIGO-B CREAMFUSIDIC ACID BP AND BETAMETHASONE VALERATE BP 2.0%W/W+0.1%W/WAUROCHEM LABORATORIES (I) PVT LTD 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/7586AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDCLEAR-T GELCLINDAMYCIN PHOSPHATE + TRETINOIN1.0%W/W + 0.025%W/WAUROCHEM LABORATORIES (I) PVT LTD 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL GELS AND SOLS 20 G TUBE,1 TUBE CARTON
NDA/MAL/HDP/8243AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDTRANEXAMIC ACID + MEFENAMIC ACIDTRANEXAMIC ACID + MEFENAMIC ACID500MG + 250MGAUROCHEM LABORATORIES (I) PVT LTD 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7365AUROCHEM PHAMACEAUTICALS (1) LTD)SUPER MEDIC LTD - PLOT 22DOLOACT MRPARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE500 MG+50 MG+250 MGAUROCHEM PHARMACEUTICALS (I) PVT.LTD.-58, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD.PALGHAR ?INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/7373AUROCHEM LABORATORIES (I) PVT LTDSUPER MEDIC LTD - PLOT 22FUSIGO CREAMFUSIDIC ACID2.0 % W/WAUROCHEM LABORATORIES (I) PVT LTD 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL CREAMS 10 G TUBE
NDA/MAL/HDP/7374AUROCHEM LABORATORIES (I) PVT LTDSUPER MEDIC LTD - PLOT 22FUSIGO-HC CREAMFUSIDIC ACID +HYDROCORTISONE ACETATE2.0 % W/W+1.0 % W/WAUROCHEM LABORATORIES (I) PVT LTD 8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDINSOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC SUSPENSIONS 5 ML BOTTLE
NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC LIQUIDS 10 ML CONTAINER
NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC LIQUIDS 5 ML VIAL
NDA/MAL/HDP/4279AUROLABSWASTIK PHARMACEUTICAL LTDAUROTIMTIMOLOL MALEATE0.5% W/VAUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAIINDIAOPHTHALMIC LIQUIDS 5 ML BOTTLE
NDA/MAL/HDP/4390AUROLABSWASTIK PHARMACEUTICAL LTDAUROCOLCHLORAMPHENICOL0.5%WVAUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAIINDIAOPHTHALMIC DROPS 10 ML BOTTLE
NDA/MAL/HDP/0594AUROLABSWASTIK PHARMACEUTICAL LTDAUROVISC-2ML PFSHYPROMELLOSE OPTHALMIC SOLUTION USP2%W/VAUROLAB SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC PRE-FILLED SYRINGES 2 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/6062AUROLABSWASTIK PHARMACEUTICAL LTDOFPREDOFLOXACIN + PREDNISOLONE SODIUM PHOSPHATE0.3W/V + 0.5%W/VAUROLAB SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/6223AUROLABSWASTIK PHARMACEUTICAL LTDAUROPROST- RTLATANOPROST0.005%W/VAUROLAB SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC DROPS 2.5 ML BOTTLE
NDA/MAL/HDP/7446AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDCIPLUMECIPROFLOXACIN HYDROCHLORIDE0.3% W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAOPHTHALMIC DROPS 10 ML VIAL
NDA/MAL/HDP/7906AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDIVMOLPARACETAMOL10MG/MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/8245AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDMOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAOPHTHALMIC DROPS 5 ML BOTTLE
NDA/MAL/HDP/4909AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXAGYLMETRONIDAZOLE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/0587CADILA PHARMACUETICALS LTDKARURI PHARMACEUTICALS LTD.CADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/3571CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CADIPHEN EXPECTORANTCHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE2MG//80MG/100MGCADILA PHARMACEUTICALS LTD, 1389 TRASAD RD DHOLKA AHMEDABABADINDIAORAL LIQUID ORDINARY SYRUPS 100 ML BOTTLE,60 ML BOTTLE
NDA/MAL/HDP/0988CADILA PHARMACUETICALS LTDKARURI PHARMACEUTICALS LTD.CADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/5233CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENVAS 10 MG TABLETSENALAPRIL10MGCADILA PHARMACEUTICALS LTD, 1389 TRASAD RD DHOLKA AHMEDABABADINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6843CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FYTOBACTCEFOPERAZONE/SULBACTAM604.96MG/570.03MGCADILA PHARMACEUTICALS LTD, 1389 TRASAD RD DHOLKAINDIAPARENTERAL ORDINARY DRY VIALS 1 G VIAL
NDA/MAL/HDP/6845CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FYTOBACT 2GSULBACTAM SODIUM + CEFOPERAZONE SODIUM1G + 1GCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387 810INDIAPARENTERAL ORDINARY DRY VIALS 2 G VIAL
NDA/MAL/HDP/2765CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HAEM FFOLICACID+ VITAMIN B12+FE AMMONIUM CITRATE1MG+5MCG+200MG/15MLCADILA PHARMACEUTICALS LTD, 1389 TRASAD RD DHOLKA AHMEDABABADINDIAORAL LIQUID ORDINARY SYRUPS 200 ML BOTTLE
NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0514MANKIND PHARM LTDTATA UGANDA LIMITEDCEFAKIND-500CEFUROXIME AXETIL500MGBAROQUE PHARMACEUTICALS PVT, 192/2 & 3, SOKHADA-388620,TAL.KHAMBHAT DIST.ANAND. GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/0519MANKIND PHARM LTDTATA UGANDA LIMITEDCEFAKIND-250CEFUROXIME AXETIL250MGBAROQUE PHARMACEUTICALS PVT, 192/2 & 3, SOKHADA-388620,TAL.KHAMBHAT DIST.ANAND. GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/3714BAYER PHARMA AGSURGIPHARM (U) LIMITEDADALAT LANIFEDIPINE30MGBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,2 STRIP CARTON,10 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/8007BAYER AGSURGIPHARM (U) LIMITEDADALAT RETARDNIFEDIPINE20MGBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY OTHER TABLETS 10 TABLET BLISTER,6 BLISTER CARTON
NDA/MAL/HDP/6690SCHERING N.V.SA...SURGIPHARM (U) LIMITEDADVANTAN OINTMENTMETHYLPREDNISOLONE ACEPONATE0.1%W/WBAYER HEALTH CARE MANUFACTURING S.R.L, ITALYITALYTOPICAL EXTERNAL OINTMENTS 15 G TUBE
NDA/MAL/HDP/3148BAYER AGSURGIPHARM (U) LIMITEDALKA-SELTZERACETYL SALICYLIC ACID/ SODIUM HYDROGEN CARBONATE/ CITRIC ACID342MG/1625MG/965MGBAYER AG -D-51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY EFFERVESCENT TABLETS 10 TABLET STRIP,12 TABLET STRIP,2 STRIP CARTON,6 STRIP CARTON
NDA/MAL/HDP/4901BAYER AGSURGIPHARM (U) LIMITEDAVELOX IVMOXIFLOXACIN HCL400MG/250MLBAYER AG -D-51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 250 ML BOTTLE
NDA/MAL/HDP/4055BAYER PHARMA AGSURGIPHARM (U) LIMITEDBAYER ASPIRIN CARDIOACETYLSALICYLIC ACID100MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10 TABLET STRIP,3 STRIP CARTON
NDA/MAL/HDP/1491BAYER PHARMA AGSURGIPHARM (U) LIMITEDBILTRICIDE TABLETSPRAZIQUANTEL600MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,4 BLISTER CARTON
NDA/MAL/HDP/5634BAYER PHARMA AGSURGIPHARM (U) LIMITEDCIPROBAYCIPROFLOXACIN500MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/4753BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDCIPROBAY 750CIPROFLOXACIN750MGBAYER HEALTHCARE AG, D-51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/4750BAYER PHARMA AGSURGIPHARM (U) LIMITEDCIPROBAY I.VCIPROFLOXACIN2MG/MLBAYER PHARMA AG-D - 51368 LEVERKUSEN,GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 100 ML BOTTLE
NDA/MAL/HDP/4754BAYER PHARMA AGSURGIPHARM (U) LIMITEDCIPROBAY XRCIPROFLOXACIN500MGBAYER AG -D-51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLA SINELEVONORGESTEREL2*75MGBAYER PHARMA OY-PANSLONTIE 47 20210 TURKFINLANDPARENTERAL ORDINARY IMPLANTS 1 IMPLANT STRIP,3 STRIP CARTON
NDA/MAL/HDP/3789BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL5MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY OTHER TABLETS 4 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/3846BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL20MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/3802BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRA 10MGVARDENAFIL MONOHYDROCHLORIDE TRIHYDRATE10MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 4 TABLET BLISTER
NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA AG-D - 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,2 BLISTER CARTON
NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER WEIMER GMBH- DOBEREINERSTRASSE 20, D-99427 WEIMER 2.BAYER PHARMA AG 13342, BERLINGERMANYORAL SOLID ORDINARY TABLETS 35 TABLET BLISTER,3 BLISTER CARTON
NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER PHARMA OY-PANSLONTIE 47 20210 TURKFINLANDPARENTERAL RETARD IMPLANTS 1 IMPLANT CARTON
NDA/MAL/HDP/3568BAYER PHARMA AGSURGIPHARM (U) LIMITEDMYCOSPOR CREAMBIFONAZOLE1%W/WBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL CREAMS 15 G TUBE,50 G TUBE
NDA/MAL/HDP/2167BAYER PHARMA AGSURGIPHARM (U) LIMITEDMYCOSPOR SOLUTIONBIFONAZOLE10MGBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL LIQUIDS 15 ML BOTTLE,50 ML BOTTLE
NDA/MAL/HDP/5469BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOPNIMODIPINE0.2MG/MLBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/3768BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOP 30MGNIMODIPINE30MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1 ML PRE- FILLED SYRINGE,1 ML AMPOULE,100 AMPOULE CARTON
NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYLESTRDIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG + 0.15MG / 75MGBAYER SCHERING PHARMA AG 13342 BERLINGERMANYORAL SOLID ORDINARY TABLETS 28 TABLET BLISTER,30 BLISTER CARTON
NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROTERONE HEXANOATE250MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1 ML AMPOULE
NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER PHARMA AG-D - 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,3 BLISTER CARTON,30 TABLET BOTTLE
NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER PHARMA AG GMBH & CO. PRODUKTIONS KG DOBERRENSTRASSE 20 99427 WEIMARGERMANYORAL SOLID ORDINARY TABLETS 20 TABLET STRIP
NDA/MAL/HDP/2943SCHERING N.V.SA...SURGIPHARM (U) LIMITEDSCHERIPROCT OINTMENTPREDNISOLONE CAPROATE/ CICHOCAINE HCL1.9MG/G & 5MG/GBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYRECTAL SYSTEMIC UNIT DOSE OINTMENTS AND PASTES10 G TUBE,30GTUBE
NDA/MAL/HDP/1487BAYER PHARMA AGSURGIPHARM (U) LIMITEDSCHERIPROCT SUPPOSITORIESPREDNISOLONE CAPROATE/ CICHOCAINE HCL1.3MG/ 1MGBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYRECTAL SYSTEMIC SUPPOSITORIES 12 SUPPOSITORY STRIP
NDA/MAL/HDP/2993SCHERING N.V.SA...SURGIPHARM (U) LIMITEDTRAVOCORTDIFLUCORTONE VALERATE + ISOCONAZOLE NITRATE0.1% + 1% W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 15 G TUBE
NDA/MAL/HDP/6740SCHERING N.V.SA...SURGIPHARM (U) LIMITEDTRAVOGEN CREAMISOCONAZOLE NITRATE1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 20 G TUBE
NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER SCHERING PHARMA AG-13342, BERLINGERMANYPARENTERAL ORDINARY VIALS 50 ML VIAL,100 ML VIAL
NDA/MAL/HDP/8142BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDXARELTORIVAROXABAN2.5MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER
NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER
NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 14 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/2743BEIJING HOLLEY COTEC PHARMACEUTICALS CO. LTDSUPER PHARMACEUTICALS LIMITEDDUO-COTECXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGZHEIJIANG HOLLEY NANHU PHARMACEUTICAL CO. LTD. NO.205,YUNHAI ROAD, JIAXING DEVELOPMENT ZONE, JIANXING CITY, ZHEJIANG PROVINCECHINAORAL SOLID ORDINARY FILM-COATED TABLETS 9 TABLET BLISTER,1 BLISTER CARTON,4 TABLET BLISTER,9 TABLET BLISTER,30 BLISTER CARTON
NDA/MAL/HDP/3730BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOXMOXIFLOXACIN HYDROCHLORIDE400MGBAYER PHARMA AG 51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 5 TABLET BLISTER,2 BLISTER CARTON,1 BLISTER CARTON
NDA/MAL/HDP/4404BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDFOLIGRAFRECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE75I.U/ VIALBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIAINDIAPARENTERAL RETARD OTHER VIALS 1 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/7907BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDHUCOG 5000 HPCHORIONIC GONADOTROPHIN5000 I.U/ VIALBHARAT SERUMS AND VACCINES LTD PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH( E) 421 501INDIAPARENTERAL ORDINARY DRY VIALS 5000 I.U VIAL,1 VIAL CARTON
NDA/MAL/HDP/8162BHARAT SERUMS AND VACCINES LTDTATA UGANDA LIMITEDHUMOG 75 HPHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U75 IU + 75 IU/ 150 I.U VIALBHARAT SERUMS AND VACCINES LTD PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY COMBINATION PACK VIALS 1 VIAL CARTON,1 AMPOULE CARTON
NDA/MAL/HDP/6137BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDLUPRODEXLEUPROLIDE ACETATE3.75MGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIAINDIAPARENTERAL ORDINARY S C VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/6040BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDU-TRYPULINASTATIN100,000 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST),421501 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1 VIAL CARTON
NDA/MAL/HDP/4824MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)FERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.25MGBIO NOVA PHARM LTD-OKHLA INDUSTRIAL ARA PHASEII NEW DELHIINDIAORAL SOLID ORDINARY COATED TABLETS 1000 TABLET CONTAINER
NDA/MAL/HDP/4820IDAKIMSY MEDS LTDFERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.4MGBIO NOVA PHARM LTD-OKHLA INDUSTRIAL ARA PHASEII NEW DELHIINDIAORAL SOLID ORDINARY COATED TABLETS 1000 TABLET CONTAINER,10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN SELECTINSULIN GLARGINE(R-DNA ORGIN)100I.U/MLBIOCON LIMITED,-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAINDIAPARENTERAL ORDINARY S C PRE-FILLED SYRINGES 3 ML PREFILLED PEN
NDA/MAL/HDP/6147MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN VAILINSULIN GLARGINE (R-DNA ORIGIN)100I.U/MLBIOCON LIMITED,-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAINDIAPARENTERAL ORDINARY S C VIALS 10 ML VIAL
NDA/MAL/HDP/6047MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 150TRASTUZUMAB (R-DNA ORIGIN)150MGBIOCON LIMITED,-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAINDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 15 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/8244MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 440TRASTUZUMAB (R-DNA ORIGIN)440MGBIOCON LIMITED,-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 440 MG VIAL
NDA/MAL/HDP/8156TATA (U) LTDGITTOES PHARMACEUTICALS LIMITEDDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINEDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE25LF + 5.5LF + 16 IOU + 12.5 MCG + 11MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY I M AMPOULES 0.5 ML AMPOULE,48 AMPOULE CARTON,5 ML AMPOULE,24 AMPOULE CARTON
NDA/MAL/HDP/4607BODENE (PTY) LIMITEDSURGIPHARM (U) LIMITEDPETOGEN-FRESEMIOSMEDROXYPROGESTERONE150MG/MLBODENE (PTY) LTD TRADING AS-INTRAMED 6-GIBAUD ROAD KORSTEN ELIZABETH 6001SOUTH AFRICAPARENTERAL ORDINARY VIALS 1 ML VIAL,100 VIAL CARTON
NDA/MAL/HDP/6447BRAWN LABORATORIES LTDHEALTHCARE LTD.AZIBRU 500AZITHROMYCIN DIHYDRATE500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 3 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6857BRAWN LABORATORIES LTDHEALTHCARE LTDBRUCIPRO TABLETSCIPROFLOXACIN500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6431BRAWN LABORATORIES LTDHEALTHCARE LTD.BRUMOX 125AMOXICILLIN TRIHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100 ML BOTTLE
NDA/MAL/HDP/6875BRAWN LABORATORIES LTDHEALTHCARE LTD.BRUMOX-250 CAPSULESAMOXICILLIN TRIHYDRATE250MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY CAPSULES 10 CAPSULE BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6874BRAWN LABORATORIES LTDHEALTHCARE LTD.CEZIN TABLETSCETIRIZINE HYDROCHLORIDE10MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6862BRAWN LABORATORIES LTDHEALTHCARE LTD.DITS GELDICLOFENAC DIETHYLAMINE1%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIATOPICAL EXTERNAL EMULSION GELS 15 G TUBE,30 G TUBE
NDA/MAL/HDP/6865BRAWN LABORATORIES LTDHEALTHCARE LTD.DITS INJECTIONDICLOFENAC SODIUM25MG/MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAPARENTERAL ORDINARY AMPOULES 3 ML AMPOULE,10 AMPOULE CARTON
NDA/MAL/HDP/6433BRAWN LABORATORIES LTDHEALTHCARE LTD.FICYC CREAMACICLOVIR5%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIATOPICAL EXTERNAL CREAMS 10 G TUBE
NDA/MAL/HDP/6455BRAWN LABORATORIES LTDHEALTHCARE LTD.FICYC TABLETSACYCLOVIR200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/6435BRAWN LABORATORIES LTDHEALTHCARE LTD.FIMABUTE 200CEFIXIME TRIHYDRATE200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10 TABLET BLISTER,1 BLISTER CARTON
NDA/MAL/HDP/6870BRAWN LABORATORIES LTDHEALTHCARE LTD.HYDROSONE 100MGHYDROCORTISONE SODIUM SUCCINATE100MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAPARENTERAL ORDINARY DRY VIALS 5 ML VIAL,50 VIAL CARTON
NDA/MAL/HDP/6872BRAWN LABORATORIES LTDHEALTHCARE LTD.NETRACORTIL EYE/EAR SUSPENSIONOXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE10MG+5MG+10000I.U/MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAOPHTHALMIC SUSPENSIONS 5 ML TUBE
NDA/MAL/HDP/8123CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MYCIDAC- CMYCOBACTERIUM W (HEAT KILLED) + SODIUM CHLORIDE0.5 *10 TO POWER 9 BACILLI + 0.9%W/VCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387 810INDIAPARENTERAL RETARD I M PRE-FILLED SYRINGES 0.2 ML PRE- FILLED SYRINGE,1 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/0586CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY VIALS 4 ML AMPOULE,5 AMPOULE CARTON,2 ML AMPOULE,5 AMPOULE CARTON
NDA/MAL/HDP/0676CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETT 4ONDANSETRON4MGCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 10 TABLET BLISTER,10 BLISTER CARTON
NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LTD, 1389 TRASAD RD DHOLKA AHMEDABABADINDIAPARENTERAL ORDINARY VIALS 5 ML VIAL,1 VIAL CARTON
NDA/MAL/HDP/0668CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LTD 1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE