Drug Register (May 2021)
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S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMULTI-INGREDIENTSMULTI-INGREDIENTSMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER11/7/2018
2NDA/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 CAPSULES1.0X6.0X10.0 CAPSULE BLISTER7/1/2000
3NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOOM SYRUPNANACHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2000
4NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR7/1/2000
5NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X50.0 ML BOTTLE7/1/2008
6NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMULTI-INGREDIENTMULTI-INGREDIENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2007
7NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPMULTI-INGREDIENTN/ASAVERA PHARMACEUTICALS PVT LTD --H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. AJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2004
8NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY POWDERS1.0X10.0X765.0 MG SACHET7/1/2009
9NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMULTI-INGREDIENTMULTI-INGREDIENTMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI INDIANASAL TOPICAL LIQUID INHALATIONS1.0X12.0X1.0 G ROD7/1/2009
10NDA/MAL/HHP/5536ABACUS PHARMA LTDJEET PHARMACEUTICALS LIMITEDMENTHO PLUS PAIN BALMMULTI-INGREDIENTN/AEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIANASAL TOPICAL OINTMENTS1.0X24.0X3.5 ML VIAL,1.0X1.2 G JAR,1.0X4.0 G JAR,1.0X9.0 G JAR,1.0X30.0 G JAR,1.0X1.2 ML VIAL,1.0X4.0 ML VIAL,1.0X9.0 ML VIAL,1.0X30.0 ML BOTTLE7/1/2004
11NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPNANACHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
12NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMULTI-INGREDIENTMULTI-INGREDIENTMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP7/1/2001
13NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2000
14NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELNANACHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL TOPICAL GELS AND SOLS1.0X50.0 G TUBE7/1/2015
15NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP7/1/2009
16NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136 BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
17NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMULTI-INGREDIENTMULTI-INGREDIENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE7/1/2001
18NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2000
19NDA/MAL/HHP/5561MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLDDROP MEDICATED COUGH DROPSMEHTA HERBALS PVT LTD-AMRUTMANTHAN HOUSE, SADAR,RAJKOT,GUJARAT - 360 001,INDIA, RAJKOT, GUJARAT 360001, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X1.0X100.0 LOZENGE CARTON7/1/2009
20NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE7/1/2000
21NDA/MAL/HHP/5570PANACEA BIOTEC LTDVITACARE LIMITEDSITCOMEUPHORBIA PROSTRATA DRY EXTRACT10MG/GPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2013
22NDA/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, INDIA INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER7/1/2004
23NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTENANA CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER7/1/2011
24NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2009
25NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDNO SCAR CREAMMULTI-INGREDIENTMULTI-INGREDIENTMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2007
26NDA/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 CITY
VIETNAMORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2016
27NDA/MAL/HHP/5587CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDMANOLL SYRUPMULTI-INGREDIENTMULTI-INGREDIENT CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X250.0 MG BOTTLE7/1/2016
28NDA/MAL/HHP/5588CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (HONEY LEMON FLAVOUR)NANACHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X3.0X4.0 LOZENGE STRIP7/1/2014
29NDA/MAL/HHP/5593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYDLER GRIPE WATERSYDLER REMEDIES PVT LTD -M-190, M.I.D.C, WALUJ, AURANGABAD 431 136 (M.S), INDIA.

INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2010
30NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDTOOCHE DROPSMULTI-INGREDIENTMULTI-INGREDIENTCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAORAL TOPICAL DROPS1.0X10.0 ML BOTTLE7/1/2014
31NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTMULTI-INGREDIENTSMULTI-INGREDIENTSVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER7/1/2000
32NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2009
33NDA/MAL/HHP/5623UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2005
34NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2005
35NDA/MAL/HHP/5630UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH REMEDYUNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2000
36NDA/MAL/HHP/5631UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
37NDA/MAL/HHP/6848CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (MINT)N/A,MULTI-INGREDIENTN/A,N/ALEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT INDIAORAL SOLID ORDINARY LOZENGES1.0X3.0X4.0 LOZENGE BLISTER7/1/2016
38NDA/MAL/HHP/6850WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.BENZIM NATURAL SYRUP 120MLMULTI-INGREDIENTN/AWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE12/3/2016
39NDA/MAL/HHP/6852WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-FLU SYRUP 120MLMULTIINGREDIENTN/AWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE12/3/2016
40NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)MULTIINGREDIENTN/AKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
41NDA/MAL/HHP/6915GREAT INDIA INDUSTRIAL & PHARAMCEUTICALS LABORATORIESMALIX PHARMA (U) LIMITEDGIPLA GRIPE WATERGIPLA GRIPE WATER135MLGREAT INDIA -19 SUN MILL COMPOUNDINDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE7/1/2014
42NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULESMULTI-INGREDIENTN/ATIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2015
43NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTPEPPERMINT KA PHOOL4.308GGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2015
44NDA/MAL/HHP/7936SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGILOBA 60 CAPSULEGINKO BILOBA60MGSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE BLISTER7/1/2013
45NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSENSUR OILPEPPERMINT KA PHOOL1.40MGGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML VIAL7/1/2015
46NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SILYMARIN175MGSQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
47NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXGINSENG EXTRACT285.71MGSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE STRIP7/1/2014
48NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONPEPPERMINT KA PHOOL3.5MGGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OTHER CREAMS1.0X50.0 ML BOTTLE7/1/2015
49NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTEUCALYPTO100MGDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
THAILANDORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2016
50NDA/MAL/HHP/7946SHEBAC PHARMANORVIK ENTERPRISES LIMITEDAPONTISGULTIGENERIC105GAEROMAC (INDIA) INC-12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIA INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X150.0 ML BOTTLE7/1/2015
51NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(HONEY LEMON)MULTI-INGREDIENTMULTI-INGREDIENTUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
52NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH (SUGAR FREE)GLYCYRRHIZA GLABRA15MGUNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X12.0 LOZENGE CONTAINER7/1/2016
53NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(RASPBERRY)MULTI-INGREDIENTMULTI-INGREDIENTUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
54NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)MULTI-INGREDIENTMULTI-INGREDIENTUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
55NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY ROLL-ONAJOWAN KA PHOOL0.5MGKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL EMULSIONS1.0X50.0 ML BOTTLE12/3/2016
56NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL (SUGAR FREE)MULTI-INGREDIENTMULTI-INGREDIENTUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
57NDA/MAL/HHP/7958KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(GINGER FLAVOUR)CINNAMOMUM CAMPHORA0.18MGKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
58NDA/MAL/HHP/7959BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTONIPHIBALTHEA OFFICINALIS10.0 MGBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2015
59NDA/MAL/HHP/7960KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(ORANGE FLAVOUR)KARPURA0.18MGKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
60NDA/MAL/HHP/7961KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES MINTCINNAMOMUM CAMPHORA NEES AND EBERM (KARPURA)0.18MGKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
61NDA/MAL/HHP/7962GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDKREMOINT BABY CARE GRIPE WATERMULTI-INGREDIENTMULTI-INGREDIENTKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE7/1/2015
62NDA/MAL/HHP/7965BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDCO-EXMULTI INGREDIENT1 MGBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2017
63NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDKIDFLAMEMULTI-INGREDIENTMULTI-INGREDIENTBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER7/1/2015
64NDA/MAL/HHP/7974WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.APPERIZE SYRUP 120MLMULTI-INGREDIENTMULTI-INGREDIENTWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE1/15/2019
65NDA/MAL/HHP/8071EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOOVE MASSAGE CREAMMULTI-INGREDIENTN/AEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTTOPICAL EXTERNAL LOTIONS1.0X1.0X40.0 G TUBE7/1/2017
66NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDPOSTORALPOSTORALN/ABHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER7/1/2017
67NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BACK PAIN ROLL-ONMULTINGREDIENTN/AAMRUTANJAN HEALTH CARE LIMITED - -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA INDIATOPICAL EXTERNAL LOTIONS1.0X50.0 ML CONTAINER7/1/2004
68NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICMULTI-INGREDIENTN/AAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2017
69NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLETMULTINGREDIENTN/A CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE9/20/2017
70NDA/MAL/HHP/8457BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDGASTICA SYRUPMULTI-INGREDIENTMULTI-INGREDIENTBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2017
71NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUPN/AMULTI-INGREDIENT CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE2/2/2018
72NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUPN/AMULTI-INGREDIENTCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
73NDA/MAL/HHP/8507SYDLER REMEDIES PVT LTD M-190ROYAL PHARMA 2011 LIMITEDCUFSOL LOZENGES ORANGEN/AMULTI-INGREDIENTSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X50.0 LOZENGE BLISTER2/2/2018
74NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUPN/AMULTI-INGREDIENT CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
75NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULEN/AMULTI-INGREDIENT CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER11/29/2017
76NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDFRICKS COUGH SYRUPN/AMULTI-INGREDIENTBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE3/6/2018
77NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTHUNDER-MYOHIMBINUM Q+SELENIUM 3X+GINSENG Q+ACID PHOS 2X+DAMIANA 3X0.02ML+0.02MG+0.02ML+0.13ML+0.03MLBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2017
78NDA/MAL/HHP/8512BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDINFAB SYRUPMULTI-INGREDIENTNABHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2017
79NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDMENIPHIBAGNUS CASTUS+IGNATIA AMARA+CYCLAMEN EUROPAEUM+IRIS VERSICOLOR+CAULOPHYLLUM THALICTROIDES178MG+42MG+84MG+60MG+84MGBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X20.0 TABLET BLISTER7/1/2016
80NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALMMULTI-INGREDIENTMULTI-INGREDIENTAMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA
PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK,
KANCHEEPURAM, DIST. – 603 110, TAMILNADU, INDIA
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X10.0 ML TUBE11/24/2017
81NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREMULTI-INGREDIENTMULTI-INGREDIENTOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDAN
JORDANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/13/2017
82NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500UNIVESTIN500MGTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER11/10/2017
83NDA/MAL/HHP/8557MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-250UNIVESTIN250MGTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER11/10/2017
84NDA/MAL/HHP/8902WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-TUZ SYRUPMULTI-INGREDIENTMULTI-INGREDIENTWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2018
85NDA/MAL/HHP/9090I_CARE PHARMA LIMITEDAIVEEN (U) LIMITEDFATNILECHITOSAN + GARCINIA COMBOGIA + VIT E + CHROMIUM PICOLINATE + SODIUM SELENITE + ZINIC SULPHATE + DIBASIC CALCIUM PHOSPHATE + ANHYDROUS LACTOSE225.00MG + 175.00MG + 35.00MG + 1.600MG + 0.109MG + 20.587MG + 34.750MG + 8.000MGWEST COAST PHARMACEUTICAL WORKS LTD-1143,MELDI ESTATE,NR PRASANG PARTY PLOT,GOTA, AHMEDEBAD INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X15.0 CAPSULE BLISTER1/28/2019
86NDA/MAL/HHP/9093BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPTOLU SOLUTION+CAPSICUM TINCTURE+CREOSOTE+ANISE OIL+LIQUORICE0.56MLS+0.25MLS+66.65MG+13.89MG+25.00MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE3/22/2019
87NDA/MAL/HHP/9094BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUPTOLU SOLUTION+CAPSICUM TINCTURE+CREOSOTE+ANISE OIL+LIQUORICE0.56MLS+0.25MLS+66.65MG+13.89MG+25.00MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE3/22/2019
88NDA/MAL/HHP/9099HINUCONBOOTS PHARMACEUTICALS LIMITEDCRAN MAX PRO SACHETCRANBERRY EXTRACT +TURMERIC EXTRACT +BACILLUS COAGULANS250MG+100MG+50MGHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON5/31/2019
89NDA/MAL/HHP/9100HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SACHETWHEAT DEXTRIN FIBRE+ GREEN TEA EXTRACT3.55G+0.015GHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON5/31/2019
90NDA/MAL/HHP/9101HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SYRUPWHEAT DEXTRIN FIBRE +GREEN TEA EXTRACTNAHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
91NDA/MAL/HHP/9102HINUCONBOOTS PHARMACEUTICALS LIMITEDEPTI SYRUPFENUGREEK EXTRACT+ FENNEL EXTRACT +GINGER EXTRACT +PEPPERMINT EXTRACT45MG+45MG+15MG+60MGHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
92NDA/MAL/HHP/9103HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS SYRUPFENNEL EXTRACT+GINGER EXTRACT+FENUGREEK EXTRACT +PEPPERMINT EXTRACT+ SODIUM BICARBONATE +WHEAT DEXTRIN100MG+10MG+50MG+140MG+160MG+1000MG/10MLHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
93NDA/MAL/HHP/9104HINUCONBOOTS PHARMACEUTICALS LIMITEDCOLOREST DROPSFUNNEL EXTRACT+ CAMOMILE EXTRACT+BALM MINT EXTRACT20MG+20MG+20MG/MLHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY DROPS1.0X30.0 ML BOTTLE5/31/2019
94NDA/MAL/HHP/9105HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA CAPSULESMYO-INOSITOL +D-CHIRO-INOSITOL+ L-METHYL FOLATE ,MYO-INOSITOL+ D-CHIRO-INOSITOL +L-METHYL FOLATE 400MG+25MG+100MCG,400MG+25MG+100MCGHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER5/31/2019
95NDA/MAL/HHP/9121HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS INSTANT SACHETMULTI-INGREDIENTN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON3/11/2020
96NDA/MAL/HHP/9122HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB DROPSMULTI INGREDIENTSN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY DROPS1.0X20.0 ML BOTTLE3/11/2020
97NDA/MAL/HHP/9123HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB PLUS SYRUPMULTI INGREDIENTSN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
98NDA/MAL/HHP/9125HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA SACHETMULTI INGREDIENTN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON3/11/2020
99NDA/MAL/HHP/9126HINUCONBOOTS PHARMACEUTICALS LIMITEDCRANMAX AQUA SYRUPMULTI INGREDIENTSN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
100NDA/MAL/HHP/9127HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO JARMULTI INGREDIENTN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X175.0 G JAR3/11/2020
101NDA/MAL/HHP/9128HINUCONBOOTS PHARMACEUTICALS LIMITEDELFERB SYRUPMULTI INGREDIENTN/AHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
102NDA/MAL/HHP/9179CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDADDYZOA CAPSULESWITHANIA SOMNIFERA TRIBULUS TERRESTRIS MUCUNA PRURIENS EMBLICA OFFICINALIS TINOSPORA CORDIFOLIANACHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER1/29/2020
103NDA/MAL/HHP/9181REDDYS PHARMA LIMITEDREDDYS PHARMA LIMITEDZEBAMULTI INGREDIENTN/AGREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIES-19,SUN MILLS COMPD,MUMBAI 400 013 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X135.0 ML BOTTLE3/11/2020
104NDA/MAL/HHP/9182NZEN ENTERPRISEHEALTHCARE LTD.HERBICUFMULTI INGREDIENTN/AASIAN LIFECARE PVT.LTD-MANJUSAR,SAVLI,VADODARA,GUJARAT, INDIA PLOT NO. 3 & 3/A,SHAH INDUSTRIAL PARK-2,NEAR LAMPDAPURA CROSSING,AT&PO INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE3/11/2020
105NDA/MAL/HHP/9185HEALTHCARE LTD.HEALTHCARE LTD.GINSEMAX-FVITAMIN A + VITAMIN B1 + VITAMIN B2 + VITAMIN B3 + VITAMIN B5 + VITAMIN B6 + VITAMIN B12 + VITAMIN C + VITAMIN D3 + VITAMIN E + FOLIC ACID + L-ARGININE + CALCIUM + PHOSPHORUS + FERROUS FUMARATE + ZINC + MAGNESIUM + POTASSIUM + MANGANESE + COPPER + IODINE2500I.U+1MG+1.5MG+10MG+5MG+1MG+1MCG+50MG+200I.U+5MG+0.15MG+25MG+75MG+58MG+30MG+10MG+3MG+2MG+0.5MG+0.5MG+0.1MGZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X2.0X15.0 CAPSULE BLISTER5/22/2020
106NDA/MAL/HHP/9186HEALTHCARE LTD.HEALTHCARE LTD.GINSEMAXGINSENG EXTRACT+VITAMIN A+VITAMIN B1+VITAMIN B2+VITAMIN B3+VITAMIN B5+VITAMIN B6+VITAMIN B12+VITAMIN C+VITAMIN D3+VITAMIN E+FOLIC ACID+L-ARGININE+CALCIUM+PHOSPHORUS+FERROUS FUMARATE+ZINC+MAGNESIUM+POTASSIUM+MANGANESE+COPPER+IODINE42.5MG+2500I.U+1MG+1.5MG+10MG+5MG+1MG+1MCG+50MG+200I.U+5MG+0.15MG+25MG+75MG+58MG+30MG+10MG+3MG+2MG+0.5MG+0.5MG+0.1MGZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X2.0X15.0 CAPSULE BLISTER5/22/2020
107NDA/MAL/HHP/9254UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES-STRAWBERRY FLAVOURGLYCYRRHIZA GLABRA ZINGIBER OFFICINALE EMBLICA OFFICINALIS MENTHOL SUGAR BASE15MG 10MG 10MG 7MGUNIQUE PHARMACEUTICAL LABORATORIES ;-SURVEY NO. 101/2 & 102/1, DAMAN INDUSTRIAL ESTATE, KAPAIYA, DAMAN 396210 INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/18/2020
108NDA/MAL/HHP/9330ECHO PHARMACYECHO PHARMACY (U) LIMITEDHEMOZEL CREAMMULTI-INGREDIENTMULTI-INGREDIENTALFA MANUFACTURING LLC-4701 NW. 77 AVENUE,MIAMI,FL 33166 UNITED STATESTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE8/7/2020
109NDA/MAL/HHP/9332MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA IVY SYRUPIVY LEAVES EXTRACT38.47MG EQUIVALENT TO DRIED IVY (HEDERA HELIX L.)LEAVES 225MGMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE8/31/2020
110NDA/MAL/HHP/9333MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA MOUTH SPRAYCHAMOMILE FLOWER EXTRACT +HONEY+PEPPERMINT OIL+EUCALYPTOL/CINEOL+PROPOLIS POWDER+LICORICE ROOT EXTRACT+ALOE VERA LEAF JUICE POWDER134.666+200.5+80.2+8.4853+3.0073+30.5887+1.0027MG/10MLMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL TOPICAL SPRAYS WITHOUT GAS1.0X10.0 ML BOTTLE8/31/2020
111NDA/MAL/HHP/9334NABROS PHARMA PVT LTD.SHREEJI PHARMACEUTICALS LIMITEDKOFANOLNANANABROS PHARMA PVT LTD-SURVEY NO. 110/A/2, AMIT FARM JAIN UPASRAYA, NEAR COCACOLA FACTORY, NH NO. 8, KAJIPURA, DIST. KHEDA-387411, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP9/17/2020
112NDA/MAL/HHP/9335SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (RASPBERRY FLAVOUR)GLYCRRHIZA GLABRA + ZINGIBER OFFICINALE + EMBELICA OFFICINALE + MENTHA PIPERITTA15MG + 10MG + 10MG + 7MGSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
113NDA/MAL/HHP/9336SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (MINT FLAVOUR)GLYCRRHIZA GLABRA + ZINGIBER OFFICINALE + EMBELICAO FFICINALE + MENTHA PIPERITTA15MG + 10MG + 10MG + 7MGSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
114NDA/MAL/HHP/9337SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (PINEAPPLE FLAVOUR)GLYCRRHIZA GLABRA + ZINGIBER OFFICINALE + EMBELICA OFFICINALE + MENTHOL15MG + 10MG +10MG + 7MGSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
115NDA/MAL/HHP/9338SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (ORANGE FLAVOUR)GLYCRRHIZA GLABRA + ZINGIBER OFFICINALE + EMBELICA OFFICINALE + MENTHOL15MG + 10MG + 10MG +7MGSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
116NDA/MAL/HHP/9339SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (STRAWBERRY FLAVOUR) GLYCYRRHIZA GLABRA + ZINGIBER OFFICINALE + EMBLICA OFFICINALIS + MENTHOL15MG + 10MG + 10MG +7MGSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
117NDA/MAL/HHP/9341SINO AFRICA MEDICALS AND HEALTHY LTDSINO AFRICA MEDICINES & HEALTH LTDLIANHUA QINGWEN CAPSULEFORSYTHIAE FRUCTUS+LONICERAE JAPONICAE FLOS, EPHEDRAE HERBA (PROCESSED WITH HONEY), ARMENIACAE AMARUM SEMEN (STIR-BAKED)+GYPSUM FIBROSUM+ISATIDIS RADIX+DRYOPTERIS CRASSIRHIZOMATIS RHIZOMA+HOUTTYNIAE HERBA+POGOSTEMONIS HERBA350MGSHIJIAZHUANG YILING PHARMACEUTICAL CO.,LTD-NO. 238 TIANSHAN STREET, HIGH-TECH AREA, SHIJIAZHUANG, HEBEI PROVINCE CHINAORAL SOLID ORDINARY OTHER CAPSULES1.0X24.0 CAPSULE BLISTER10/15/2020
118NDA/MAL/HHP/9342GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDLOZETS- ORANGEMENTHA SPICATA+ EUCALYPTUS GLOBULUS+ CINNAMOMUM CAMPHORA+ TRACHYSPERMUM AMMI+ OCIMUM SANCTUM+ CURCUMA LONGA+ SYZYGIUM AROMATICUM+ CITRUS MEDICA+ CITRUS SINENSIS5.25 MG+ 1.44 MG+ 0.25 MG+ 0.19 MG+ 5.25 MG+ 2.25 MG+ 1.00 MG+ 0.50MG+ 0.50 MGPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER11/5/2020
119NDA/MAL/HHP/9343GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDLOZETS-WARM GINGERMENTHA SPICATA+ EUCALYPTUS GLOBULUS+ CINNAMOMUM CAMPHORA+ TRACHYSPERMUM AMMI+ OCIMUM SANCTUM+ CURCUMA LONGA+ SYZYGIUM AROMATICUM+ CITRUS MEDICA+ GINGER LEMON+ ZINGIBER OFFICINALE5.25 MG+ 1.44 MG+ 0.25 MG+ 0.19 MG+ 5.25 MG+ 2.25 MG+ 1.00 MG+ 0.50MG+ Q.S.+ 5.25 MG+PRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER11/5/2020
120NDA/MAL/HHP/9344GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDLOZETS- COOL MINTMENTHA SPICATA+ EUCALYPTUS GLOBULUS+ CINNAMOMUM CAMPHORA+ TRACHYSPERMUM AMMI+ OCIMUM SANCTUM+ CURCUMA LONGA+ SYZYGIUM AROMATICUM+ MINT5.25 MG+ 1.44 MG+ 0.25 MG+ 0.19 MG+ 5.25 MG+ 2.25 MG+ 1.00 MG+ Q.S.PRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER11/5/2020
121NDA/MAL/HHP/9483LIBRA DRUGS INDIAVEERAM HEALTHCARE (U) LIMITEDGLYTUSS NATURAL COUGH SUPPRESSANT WITH HONEYADHATODA VASICA EXT + CLERODENDRON SERRATUM EXT+ GLYCYRRHIZA GLABRA EXT+ ONOSMA BRACTATUM EXT+ SOLANUMXANTHOCARPUM EXT+ SOLANUM INDICUM EXT+ ZINGIBER OFFICINALE EXT.666MG + 84MG + 417MG + 42MG + 167 MG + 167 MG + 167 MGLIBRA DRUGS INDIA-145/146/92 B, MANGALWAR PETH,PARGE CHOWK, PUNE - 411011,MAHARASTRA, INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE12/11/2020
122NDA/MAL/HHP/9484RUSAN PHARMA LTDNORVIK ENTERPRISES LIMITEDISPAHUSK ORANGEISPAGHULA HUSK3.5GRUSAN PHARMA LTD'-PLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL - ECONOMIC ZONE, GANDHIDHAM INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0X3.5 G SACHET1/27/2021
123NDA/MAL/HHP/9485AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY - PEPPERMINTMULTI IGREDIENTMULTI IGREDIENTMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE BLISTER1/27/2021
124NDA/MAL/HHP/9486AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY- GINGERMULTI INGREDIENTMULTI INGREDIENTMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE CARTON1/27/2021
125NDA/MAL/HHP/9487AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY - ORANGEMULTI INGREDIENTMULTI INGREDIENTMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE CARTON1/27/2021
126NDA/MAL/HHP/9488AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY- HONEY AND LEMONMULTI INGREDIENTMULTI INGREDIENTMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE CARTON1/27/2021
127NDA/MAL/HHP/9489KALBE INTERNATIONAL PTE LTDABACUS PHARMA (AFRICA) LIMITEDWOOD'S HERBAL COUGH SYRUPIVY LEAF EXTRACT + PHYLLANTHUS NIRRURI LEAVES EXTRACT + MINT LEAVES EXTRACT + HONEY35MG + 35MG + 25MG + 3000MGPT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- INDONESIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE2/9/2021
128NDA/MAL/HHP/9558HEALTHCARE LTD.HEALTHCARE LTD.DR.ZEE HERBAL VAPOREXMENTHOL + EUCALYPTUS OIL + CINNAMON OIL + NUTMEG + CAMPHOR + CLOVE5% + 3% + 1% + 1% + 2% + 5%ZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIANASAL TOPICAL OINTMENTS1.0X25.0 G JAR3/1/2021
129NDA/MAL/HHP/9559SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL MOUTH ULCER GELGLYCYRRHIZA GLABRA + SACCHARUM OFFICINARUM + ACACIA CATECHU + ACACIA LEEUCOPHLOEA + VALERIANA WALLICHII + SYMPLOCOSORA CEMOSA + CINNAMOMUM CAMPHORA + PLUCHEA LANCEOLATE40MG + 150MG + 134MG + 134MG + 3.2MG + 3.0MG + 1.0MG + 1.6MGSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL TOPICAL GELS AND SOLS1.0X10.0 G TUBE3/1/2021
130NDA/MAL/HHP/9568BHARGAVA PHYTOLAB PVT LTDSHREEJI CARE LIMITEDJAGUAR POWEREURYCOMA LONGIFOLIA+PANAX GI+AVENA SATIVA+NSENG+PURE HONEY1%+1%+1%+97%BHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY OTHER LIQUIDS1.0X10.0 G BOTTLE3/5/2021
131NDA/MAL/HHP/9569CHEMICURE LABORATORIES PVT. LTD.GOOD DAY PHARMACY LIMITEDVYPOGERMLOBAN PHOOL + GANDHAK + VIPADIKAHAR YOG + PUDINA KA PHOOL + MULTANI MATTI6.0% W/W+ 5.0% W/W+ 6.0%W/W + 1.0%W/W + 7.5%W/WCHEMICURE LABORATORIES PVT. LTD-325, CHARAK MARG, UDAIPUR -313001 INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TIN,1.0X12.0X18.0 G TIN3/18/2021
132NDA/MAL/HHP/9570GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDBIO-SLIM ACTIVEMULTI INGREDIENT1MGGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) INDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER3/22/2021
133NDA/MAL/HHP/9571BHARGAVA PHYTOLAB PVT LTDSONA PHARMACEUTICALS LIMITEDHERO LIQUID BALMBRYONIA ALBA + CAMPHOR + SYMPHYTUM OFFICINALIS + THYMOL + MENTHOL + RHUS TOXICODENDRON + TEREBINTHINAE OLEUM1ML + 2ML + 1ML + 1ML + 1ML + 2ML + 2MLBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML BOTTLE4/15/2021
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/VHP/8117COOPER K-BRANDS LTDCEE K-BRANDS LIMITEDSOOTHING OILCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY,
NAIROBI
|
KENYA |OILS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2016
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HDP/0002ABACUS PARENTERAL DRUGS LIMITED.ABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE+NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2011
2NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
3NDA/MAL/HDP/0013MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDIMPLANON NXTETONOGESTREL68MGN.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND NETHERLANDSPARENTERAL RETARD IMPLANTS1.0X68.0 MG IMPLANT7/1/2015
4NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI CARE LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL7/1/2011
5NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE7/1/2013
6NDA/MAL/HDP/0022GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
7NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
8NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2015
9NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL7/1/2015
10NDA/MAL/HDP/0041RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
11NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
12NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
13NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTTOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2014
14NDA/MAL/HDP/0053H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL RETARD AMPOULES1.0X1.0 ML AMPOULE7/1/2015
15NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
16NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPSDICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA TROIKAA PHARMACEUTICALS LTD-BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE7/1/2015
17NDA/MAL/HDP/0058ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE7/1/1997
18NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTANTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE + 1 APPLICATOR7/1/2006
19NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML)FOLLITROPIN ALFA22 µG/0,5 MLMERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI ITALY SWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION7/1/2015
20NDA/MAL/HDP/0063HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE + LAMIVUDINEABACAVIR 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 TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
21NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND SWITZERLANDPARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION7/1/2015
22NDA/MAL/HDP/0075SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2014
23NDA/MAL/HDP/0077ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONEDEXAMETHASONE SODIUM PHOSPHATE0.1 % W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2015
24NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2014
25NDA/MAL/HDP/0083MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2014
26NDA/MAL/HDP/0088GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC2.7MG+0.52MG+0.58MG+0.30MG+20MG PER 200ML,6.75MG+1.30MG+1.45MG+0.75MG+20MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG+20MG PER 1000ML SACHETAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS7/1/2015
27NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
28NDA/MAL/HDP/0098MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
29NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULESTETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/1998
30NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
31NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
32NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
33NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1998
34NDA/MAL/HDP/0107NVS KENYA LTDSURGIPHARM (U) LIMITEDASUNRADEFERASIROX400MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSESWITZERLANDORAL SOLID ORDINARY SOLUBLE TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2015
35NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
36NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
37NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2007
38NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
39NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
40NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5G SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.5 G VIAL + 1 AMPOULE OF WFI7/1/2013
41NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 1 AMPOULE WFI7/1/2013
42NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
43NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGBETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA TANZANIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2015
44NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
45NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
46NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
47NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
48NDA/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 AREA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/1998
49NDA/MAL/HDP/0142PFIZER LAB LTDLABOREX UGANDA LIMITEDPREVENAR 13PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED)2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,19A,19F,23F,AND 4.4MCG FOR SEROTYPE 6BWYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965UNITED STATESPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/2011
50NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
51NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
52NDA/MAL/HDP/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
53NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
54NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
55NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2016
56NDA/MAL/HDP/0162RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
57NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2015
58NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
59NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2015
60NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
61NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
62NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
63NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
64NDA/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 GAS1.0X25.0 ML BOTTLE7/1/2014
65NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
66NDA/MAL/HDP/0188AMOUN PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDLEVOXINLEVOFLOXACIN500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
67NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2013
68NDA/MAL/HDP/0192AMOUN PHARMACEUTICALS COMPANYBOOTS 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 CREAMS1.0X15.0 G TUBE7/1/2014
69NDA/MAL/HDP/0193MEDOPHARM, INDIAPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET STRIP7/1/2013
70NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
71NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
72NDA/MAL/HDP/0203GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2015
73NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM GLAXOSMITHKLINE PHARMACEUTICALS SA-GRUNWALDZKA 189 STREET, 60-322 POZNANA UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
74NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
75NDA/MAL/HDP/0207MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG +300MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/10/2013
76NDA/MAL/HDP/0209HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE INDIAORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE7/1/2013
77NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2011
78NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2012
79NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200CEFPODOXIME200MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
80NDA/MAL/HDP/0217PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT INDIAPARENTERAL ORDINARY I M AMPOULES2.0X3.0X1.0 ML AMPOULE7/1/2014
81NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
82NDA/MAL/HDP/0226AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDULTRASOLV SYRUPOXOMEMAZINE HCL & CARBOCYSTEINE & GUAIFENESIN2MG+125MG+100MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2014
83NDA/MAL/HDP/0228KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
84NDA/MAL/HDP/0230STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES PHARMA SCIENCE LIMITED (STRIDES SHASUN)-KRS GARDENS, PLOT 36/7 SURAGAJKKANAHALLI, INDLAWADI CROSS, ANKAL TALUK, BANGALORE SOUTH - 562106, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER7/1/2013
85NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
86NDA/MAL/HDP/0233MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
87NDA/MAL/HDP/0234MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
88NDA/MAL/HDP/0235MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2014
89NDA/MAL/HDP/0237MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 280ARTEMETHER + LUMEFANTRINE40 MG + 240 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET BLISTER7/1/2041
90NDA/MAL/HDP/0239MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 140ARTEMETHER + LUMEFANTRINE20 MG+ 120 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X3.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER7/1/2014
91NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
92NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
93NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2013
94NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
95NDA/MAL/HDP/0253ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTENLOW-5AMLODIPINE BESYLATE5MGLINCO N PHARMACEUTICALS LIMITED-TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
96NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADTGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
97NDA/MAL/HDP/0256HETERO LABS LTDAIVEEN (U) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET CONTAINER7/1/2015
98NDA/MAL/HDP/0257SANOFI AVENTS FRANCESURGIPHARM (U) LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE200MGSANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
FRANCEORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X15.0 TABLET BLISTER7/1/1998
99NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON7/1/2001
100NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
101NDA/MAL/HDP/0270HETERO LABS LTDAIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2001
102NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 INDIAPARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)7/1/2001
103NDA/MAL/HDP/0272HETERO LABS LTDAIVEEN (U) 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 FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2019
104NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2011
105NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
106NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
107NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
108NDA/MAL/HDP/0286GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDGLUMACARTEMETHER+LUMEFANTRINE20MG+120MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X24.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER7/1/2014
109NDA/MAL/HDP/0288UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDDUXCOSPANHYOSCINE BUTYL BROMIDE10MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
110NDA/MAL/HDP/0290LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
111NDA/MAL/HDP/0293HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR600 MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2014
112NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
113NDA/MAL/HDP/0301HETERO LABS LTDAIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
114NDA/MAL/HDP/0304HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR400MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2014
115NDA/MAL/HDP/0305SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250 DRY SYRUPCEFALEXIN250MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2013
116NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
117NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
118NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
119NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 UNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
120NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
121NDA/MAL/HDP/0322MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2009
122NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE7/1/2014
123NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
124NDA/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, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
125NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
126NDA/MAL/HDP/0338KOPRAN LIMITEDTATA UGANDA LIMITEDKORAB 20RABEPRAZOLE SODIUM20MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
127NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
128NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X10.0 TABLET BLISTER7/1/2014
129NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2014
130NDA/MAL/HDP/0344ZHUHAI UNITED LABORATORIESAARON PHARMACEUTICALS LTDCEROBACTAMOXICILLIN/CLAVULANATE POTASSIUM500MG/100MGZHUHAI UNITED LABORATORIES -12,JIALIAN ROAD,TANZHOU, ZHONGSHAN, GUANGDONG-528467, P.R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X600.0 MG VIAL7/1/2014
131NDA/MAL/HDP/0345ZHUHAI UNITED LABORATORIESAARON PHARMACEUTICALS LTDTAZILSUNPIPERACILLIN ,TAZOBACTAM400MG,500MGZHUHAI UNITED LABORATORIES -12,JIALIAN ROAD,TANZHOU, ZHONGSHAN, GUANGDONG-528467, P.R. CHINA CHINAPARENTERAL ORDINARY I M VIALS1.0X4.5 G VIAL7/1/2014
132NDA/MAL/HDP/0346ZHUHAI UNITED LABORATORIESAARON PHARMACEUTICALS LTDCEROBACTAMOXICILLIN/CLAVULANATE POTASSIUM1000MG/200MGZHUHAI UNITED LABORATORIES -12,JIALIAN ROAD,TANZHOU, ZHONGSHAN, GUANGDONG-528467, P.R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL7/1/2013
133NDA/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 DROPS1.0X10.0 ML VIAL7/1/2015
134NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI CARE LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL7/1/2013
135NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
136NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
137NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
138NDA/MAL/HDP/0355SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2015
139NDA/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 TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2014
140NDA/MAL/HDP/0358SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL7/1/2014
141NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE SWEDENORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON7/1/2001
142NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2015
143NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
144NDA/MAL/HDP/0365UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDSULFRAN- DSTRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER7/1/2015
145NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCIN 500AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
146NDA/MAL/HDP/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/1997
147NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
148NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEZYNCETLEVOCETIRIZINE5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

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149NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
150NDA/MAL/HDP/0377MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDDUINUMCLOMIFENE50MGMEDOCHEMIE LTD-CENTRAL FACTORY A-1-10 CONSTANTINOUPOLEUS STREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2014
151NDA/MAL/HDP/0380MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAVERNOLCARVEDILOL6.25NGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
152NDA/MAL/HDP/0382FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDKETAMINE FRESENIUSKETAMINE HYDROCHLORIDE50MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X10.0 ML VIAL7/1/2014
153NDA/MAL/HDP/0383FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMANNITOL FRESENIUSMANNITOL20%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BAG7/1/2014
154NDA/MAL/HDP/0384FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPANCURONIUM BROMIDE FRESENIUSPANCURONIUM BROMIDE4MG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
155NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE7/1/2014
156NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IVPARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
157NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDDOXYLEBDOXYCYCLINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
158NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X3.0X10.0 TABLET BLISTER7/1/2013
159NDA/MAL/HDP/0400CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2MESALAMINE DELAYED RELEASE1.2GMCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
160NDA/MAL/HDP/0403NEON LABARATORIES LTDAIVEEN (U) LIMITEDSUPRIDOLTRAMADOL HYDROCHLORIDE50MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
161NDA/MAL/HDP/0405NEON LABARATORIES LTDAIVEEN (U) LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
162NDA/MAL/HDP/0406NEON LABARATORIES LTDAIVEEN (U) LIMITEDEVATOCINOXYTOCIN10 I.U./ MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2015
163NDA/MAL/HDP/0407NEON LABARATORIES LTDAIVEEN (U) LIMITEDNEOROFPROPOFOL1%W/VNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X20.0 ML AMPOULE7/1/2013
164NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
165NDA/MAL/HDP/0409NEON LABARATORIES LTDAIVEEN (U) LIMITEDTYDE-S*CHLORAMPHENICOL SODIUM SUCCINATE1G/VIALNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
166NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
167NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X10.0X1.0X2.0X75.0 MG IMPLANT7/1/2003
168NDA/MAL/HDP/0412MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 5ROSUVASTATIN CALCIUM5MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
169NDA/MAL/HDP/0413NEON LABARATORIES LTDAIVEEN (U) LIMITEDXSPASHYOSCINE BUTYLBROMIDE20MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
170NDA/MAL/HDP/0414SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDRAMIPRIL 10 MG TABLETSRAMIPRIL10MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
171NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
172NDA/MAL/HDP/0416NOVARTIS ACCESSSURGIPHARM (U) LIMITEDRAMIPRILRAMIPRIL5MGLEK S.A-95 - 010 STRYKÓW, PODLIPIE 16, POLAND POLANDORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
173NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
174NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
175NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
176NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
177NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
178NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
179NDA/MAL/HDP/0427MICRO LABS LTDLABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
180NDA/MAL/HDP/0428MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2013
181NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTDNORVIK 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 TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
182NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER7/1/2013
183NDA/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 AMPOULES1.0X5.0X20.0 ML AMPOULE7/1/2014
184NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDPROHIBINGASTRO-RESISTANT OMEPRAZOLE CAPSULES BP 2020 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2010
185NDA/MAL/HDP/0435FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDLIGNOCAINE HCL FRESENIUSLIGNOCAINE HYDROCHLORIDE2%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X20.0 ML VIAL7/1/2015
186NDA/MAL/HDP/0437FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL NEONATAL FRESENIUSNALOXONE HYDROCHLORIDE0.02MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
187NDA/MAL/HDP/0439FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL FRESENIUS 0.4MG/1MLNALOXONE HYDROCHLORIDE0.4MG/1MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2015
188NDA/MAL/HDP/0440AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGICLOB-GMCLOBETASOL/GENTAMICIN/MICONAZOLE0.5MG+3.4MG+20MG/1GAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
189NDA/MAL/HDP/0441AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGISECSECNIDAZOLE1GMAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0 TABLET BLISTER7/1/2015
190NDA/MAL/HDP/0442PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDZIK-ZAK-50SILDENAFIL CITRATE 50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2014
191NDA/MAL/HDP/0444FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDNEOSTIGMINE METHYLSUIPHATE FRESENIUSNEOSTIGMINE METHYLSULPHATE2.5MG\MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2015
192NDA/MAL/HDP/0445AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAZIAGIO 500AZITHROMYCIN500MGAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2014
193NDA/MAL/HDP/0447PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®125METHYLPREDNISOLONE SODIUM SUCCINATE125MG/VIALPT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG INDONESIAPARENTERAL ORDINARY DRY VIALS1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI7/1/2014
194NDA/MAL/HDP/0449PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY GRANULES1.0X10.0X5.0 G SACHET7/1/2013
195NDA/MAL/HDP/0451PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®500METHYLPREDNISOLONE SODIUM SUCCINATE500MG/VIALPT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG INDONESIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI7/1/2014
196NDA/MAL/HDP/0453PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTSSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE7/1/2013
197NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
198NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
199NDA/MAL/HDP/0457UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROL 250MGAMINOSIDINE250MGUNIVERSAL CORPORATION LTD-UNIVERSAL CORPORATION LTDKENYAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER7/1/2012
200NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE7/1/2009
201NDA/MAL/HDP/0461BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDBEXITROL-F HFA 25/125SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+125MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X120.0 METERED DOSE CANNISTER7/1/2015
202NDA/MAL/HDP/0462BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDDECOMIT 50 HFABECLOMETHASONE50MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER7/1/2015
203NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHENPHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2011
204NDA/MAL/HDP/0465BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDDECOMIT 100 HFABECLOMETHASONE DIPROPIONATE200MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER7/1/2015
205NDA/MAL/HDP/0466BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDALPHIN DSALBENDAZOLE400MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY CHEWABLE TABLETS1.0X50.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER7/1/2015
206NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS50.0X2.0 TABLET STRIP7/1/1997
207NDA/MAL/HDP/0468NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXIT 750CEFUROXIME750MGNECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI,
P.O BAROTIWALA DIST SOLAN H.P 173205
INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 10ML WFI AMPOULE7/1/2013
208NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE DENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
209NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE DENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
210NDA/MAL/HDP/0472SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDBCG VACCINE (FREEZE DRIED)BCG VACCINE(FREEZE DRIED)1.33*100000 C.F.U/0.1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL,1.0X0.5 ML VIAL7/1/2015
211NDA/MAL/HDP/0473GULF PHARMACEUTICALS INDUSTRIESOMASI MED LIMITEDTRIMOL DSSULFAMETHOXAZOLE + TRIMETHOPRIM800MG+160MGGULF PHERMACUTICALS INDUSTRIES -AIR PORT ROAD DIGDAGA RAKAUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
212NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X25.0X4.0 TABLET BLISTER7/1/2015
213NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
214NDA/MAL/HDP/0480CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220 CIPLA LTD UNIT VII PD II-S-103 TO S-105, S-107 TO S-112, L-138, L-147/1 TO L-147/3, L-147A, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA 403722, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2014
215NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER7/1/2014
216NDA/MAL/HDP/0483FOUNTIL LIFE SCIENCES PVT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID TABLETSALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE200MG + 250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
217NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLIN GERMANYORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X28.0 TABLET BLISTER7/1/2014
218NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER7/1/2014
219NDA/MAL/HDP/0490SANOFISURGIPHARM (U) LIMITEDORELOXCEFPODOXIME200MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
220NDA/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,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X5.0 ML VIAL,1.0X10.0 ML VIAL7/1/2013
221NDA/MAL/HDP/0492BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDZOLFINACECLOFENAC100MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER7/1/2013
222NDA/MAL/HDP/0494BEXIMCO PHARMACEUTICALS LIMITEDLIFE PHARMA AFRICA LIMITEDINFORMET 500METFORMIN HYDROCHLORIDE500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
223NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
224NDA/MAL/HDP/0498BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDEVO 500LEVOFLOXACIN500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2013
225NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
226NDA/MAL/HDP/0505MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE75MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER7/1/2013
227NDA/MAL/HDP/0506REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.OPTA-ATROPINE EYE DROPSATROPINE SULPHATE1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2001
228NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP7/1/2004
229NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2006
230NDA/MAL/HDP/0522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDVAZORTAN 50LOSARTAN POTASSIUM50MGMEDLEY PHARMACEUTICALS LTD -PLOT NO. 18 AND 19, SURVEY NO. 378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM
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231NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 25AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
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232NDA/MAL/HDP/0531LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/1/2014
233NDA/MAL/HDP/0536MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER7/1/2014
234NDA/MAL/HDP/0538MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
235NDA/MAL/HDP/0540PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDHYDRICORTHYDROCORTISONE SODIUM SUCCINATE100MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X100.0 MG VIAL7/1/2014
236NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
237NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
238NDA/MAL/HDP/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
239NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
240NDA/MAL/HDP/0547NAARI LTDGITTOES PHARMACEUTICALS LIMITEDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER7/1/2013
241NDA/MAL/HDP/0548UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
242NDA/MAL/HDP/0549ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASECRACECADOTRIL100 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
243NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2014
244NDA/MAL/HDP/0552ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDHIDRASEC INFANTSRACECADOTRIL10 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X16.0 SACHET CARTON7/1/2014
245NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)7/1/2013
246NDA/MAL/HDP/0556ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASEC CHILDRENRACECADOTRIL30 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X30.0 SACHET CARTON7/1/2014
247NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPSGENTAMICIN SULPHATE0.3% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE,1.0X5.0 ML VIAL7/1/2014
248NDA/MAL/HDP/0560UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 1GLIMEPIRIDE1MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
249NDA/MAL/HDP/0562KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM COTRICO-TRIMOXAZOLE240MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS100.0 ML BOTTLE,60.0 ML BOTTLE7/1/1997
250NDA/MAL/HDP/0568RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
251NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
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252NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2010
253NDA/MAL/HDP/0573KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL PARACETAMOL-250PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
254NDA/MAL/HDP/0574IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE TABLETS 100/270ARTESUNATE AND AMODIAQUINE100MG+270MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER7/1/2013
255NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY GERMANYORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER7/1/2015
256NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
257NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTDNORVIK 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 TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
258NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
259NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE7/1/2013
260NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
261NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDASNA ANTIVENOM CB.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE25/25/20/25/25/25/25/25/20/25/20/25 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X10.0 ML VIAL7/1/2012
262NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER7/1/2013
263NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP7/1/2014
264NDA/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 TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2015
265NDA/MAL/HDP/0596MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
266NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
267NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
268NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
269NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/1999
270NDA/MAL/HDP/0604DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTD-MBARARATRIMOXOLCO-TRIMOXAZOLE480MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA DAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
271NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
272NDA/MAL/HDP/0608CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLOPINAVIR AND RITONAVIR TABLETS 200MG/50MGLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET BOTTLE7/1/2012
273NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
274NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KITLANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2014
275NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
276NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1998
277NDA/MAL/HDP/0617PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
278NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10GLUCOSE10%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2013
279NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK,1.0X5.0 ML AMPOULE IN BLISTER PACK7/1/2015
280NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE FRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL,1.0X5.0X1.0 DOSE VIAL + 1.0X5.0X0.5ML GLASS AMPOULES OF 0.9% SODIUM CHLORIDE7/1/1997
281NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0X10.0 TABLET BLISTER7/1/2015
282NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
283NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2011
284NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2013
285NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2014
286NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2009
287NDA/MAL/HDP/0636MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
288NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
289NDA/MAL/HDP/0638PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2013
290NDA/MAL/HDP/0639NEM LABORATORIES (PVT) LTDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
291NDA/MAL/HDP/0652NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS BARBERA -SPAINSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
292NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
293NDA/MAL/HDP/0657NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
294NDA/MAL/HDP/0658NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
295NDA/MAL/HDP/0665HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
296NDA/MAL/HDP/0666HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
297NDA/MAL/HDP/0669ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXEL FUNGICORT CREAMMICONAZOLE NITRATE + HYDROCORTISONE2% W/W + 1% W/WKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
298NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER7/1/2014
299NDA/MAL/HDP/0672GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
300NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
301NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
302NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
303NDA/MAL/HDP/0678ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2014
304NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
305NDA/MAL/HDP/0681EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALGENNOVA BIOPHARMACEUTICALS LIMITED-BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 INDIAPARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI7/1/2013
306NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINPARENTERAL RETARD I M AMPOULES1.0X5.0X4.0 ML AMPOULE7/1/2015
307NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINORAL LIQUID ORDINARY LIQUIDS1.0X6.0X10.0 ML SACHET7/1/2015
308NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
309NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
310NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2014
311NDA/MAL/HDP/0691MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
312NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2015
313NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2014
314NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON7/1/2013
315NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)7/1/2015
316NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL7/1/2014
317NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER7/1/2013
318NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2011
319NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
320NDA/MAL/HDP/0707HETERO LABS LTDAIVEEN (U) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
321NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
322NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE7/1/1997
323NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
324NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
325NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
326NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER7/1/2014
327NDA/MAL/HDP/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.4 ML PRE- FILLED SYRINGE7/1/2011
328NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2013
329NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY I M AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE7/1/2014
330NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2014
331NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X225.0 ML BOTTLE7/1/2013
332NDA/MAL/HDP/0728IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 25/67.5ARTESUNATE+AMODIAQUINE25MG+67.5MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
333NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
334NDA/MAL/HDP/0732MAISHA MEDICAL SUPPLIES LIMITEDAIVEEN (U) LIMITEDVOLTAMED-100DICLOFENAC100 MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
335NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
336NDA/MAL/HDP/0734MAISHA MEDICAL SUPPLIES LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2015
337NDA/MAL/HDP/0736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
338NDA/MAL/HDP/0737SANOFI AVENTISSURGIPHARM (U) LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X4.0 ML VIAL7/1/2014
339NDA/MAL/HDP/0739SANOFI AVENTISSURGIPHARM (U) LIMITEDTAXOTERE 20MGDOCETAXEL TRIHYDRATE20MG/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAIN GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0 ML VIAL7/1/2014
340NDA/MAL/HDP/0740MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
341NDA/MAL/HDP/0741MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
342NDA/MAL/HDP/0742MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE LTD-CENTRAL FACTORY A-1-10 CONSTANTINOUPOLEUS STREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
343NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KITTABLET-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 LIQUID ORDINARY UNIT DOSE POWDERS1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER7/1/2013
344NDA/MAL/HDP/0747MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE ORANGE CO-PACKGLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISSODIUM CITRATE DEHYDRATE + POTASSIUM CHLORIDE / ZINC SULPHATE13.5G + 2.6G + 2.9G + 1.5G/ SACHET + 27.43MG/5ML: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE
POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.
UGANDAORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS1.0X20.8 G SACHET + 60 ML BOTTLE7/1/2013
345NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
346NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2014
347NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
348NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
349NDA/MAL/HDP/0753AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 500MEROPENEM500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2014
350NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
351NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
352NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
353NDA/MAL/HDP/0765PHARM ACCESS AFRICA LTDUNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI CHINAPARENTERAL RETARD IMPLANTS1.0X10.0X2.0 ROD IMPLANT7/1/2010
354NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
355NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
356NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1999
357NDA/MAL/HDP/0780CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2001
358NDA/MAL/HDP/0781TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRICOLDPARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE500MG/10MG/30MG/2MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER7/1/2013
359NDA/MAL/HDP/0783TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDCYPOLIVECYPROHEPTADINE HYDROCHLORIDE4 MGTRIVENI FORMULATIONS LIMITED--PLOT NO: 52,53,54, 62,63 & 64 ALEAP INDUSTRIAL ESTATE SURAMPALI VILLAGE, GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X50.0 TABLET BLISTER7/1/2013
360NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
361NDA/MAL/HDP/0788TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRIDANTINNITROFURANTOIN100 MGTRIVENI FORMULATIONS LIMITED .- PLOT NO 52,53-54,63-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAN MANDAL KRISHNA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
362NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN PAKISTANOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2014
363NDA/MAL/HDP/0795GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
364NDA/MAL/HDP/0796HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 5AMLODIPINE BESILATE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
365NDA/MAL/HDP/0797NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 5MGEVEROLIMUS5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2015
366NDA/MAL/HDP/0798HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
367NDA/MAL/HDP/0799NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 10MGEVEROLIMUS10MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2015
368NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
369NDA/MAL/HDP/0806SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE ZINCZINC SULPHATE20MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
370NDA/MAL/HDP/0808PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDISOFLURANEISOFLURANE250MLPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH INDIAOTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2005
371NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
372NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2GLIMEPIRIDE2MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
373NDA/MAL/HDP/0820MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFIXIME 400MGCEFIXIME400MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2015
374NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3GLIMEPIRIDE3MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
375NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL7/1/2014
376NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL + PARACETAMOL37.5MG+325MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
377NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER7/1/2015
378NDA/MAL/HDP/0832MERCKUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2015
379NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
380NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
381NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2012
382NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2013
383NDA/MAL/HDP/0843MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2013
384NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
385NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2014
386NDA/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 FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2012
387NDA/MAL/HDP/0854GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-50BECLOMETASONE50MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
388NDA/MAL/HDP/0855HETERO LABS LTDAIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
389NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP7/1/2000
390NDA/MAL/HDP/0860MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFLOXSAFE 400MOXIFLOXACIN HYDROCHLORIDE400MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2012
391NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES2.0X5.0X2.0 ML AMPOULE7/1/2013
392NDA/MAL/HDP/0862GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR- 200BECLOMETASONE200MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
393NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
394NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLIDLINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
395NDA/MAL/HDP/0867HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-20PANTOPRAZOLE SODIUM20MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
396NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY VIALS1.0X2.0X6.0X2.0 ML VIAL7/1/2013
397NDA/MAL/HDP/0869SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDLARTRMARTEMETHER80MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2013
398NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2010
399NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY DRY VIALS2.0X6.0X2.0 ML VIAL7/1/2013
400NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
401NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
402NDA/MAL/HDP/0877LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X170.0 ML BOTTLE7/1/2007
403NDA/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 TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2012
404NDA/MAL/HDP/0882MERCKUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
405NDA/MAL/HDP/0883MERCKUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
406NDA/MAL/HDP/0888UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIVIR 400ACYCLOVIR400MGUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
407NDA/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/BOTTLES1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2012
408NDA/MAL/HDP/0894HETERO LABS LTDAIVEEN (U) 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 TABLETS1.0X4.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER7/1/2014
409NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTHSODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE7/1/2015
410NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2015
411NDA/MAL/HDP/0898HETERO LABS LTDAIVEEN (U) LIMITEDLOSAGEN 50LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
412NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML VIAL WFI7/1/2013
413NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SRNIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
414NDA/MAL/HDP/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
415NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
416NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/2013
417NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2013
418NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACERECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
419NDA/MAL/HDP/0913NOVARTIS PHARMASURGIPHARM (U) LIMITEDFEMARALETROZOLE2.5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
420NDA/MAL/HDP/0914VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDOSTEOTIDETERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION250MCG/MLVIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESH INDIAPARENTERAL ORDINARY VIALS1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN7/1/2015
421NDA/MAL/HDP/0915NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET STRIP7/1/2014
422NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL7/1/2012
423NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP7/1/2004
424NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
425NDA/MAL/HDP/0929IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER7/1/2012
426NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
427NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
428NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE7/1/2012
429NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 40MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
430NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE7/1/2013
431NDA/MAL/HDP/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE7/1/2012
432NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5MLLORATADINE5MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/2013
433NDA/MAL/HDP/0950JULPHAR GULF PHARMACEUTICAL INDUSTRIESOMASI MED LIMITEDEPOTINERYTHROPOIETIN4000I.UJULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAE UNITED ARAB EMIRATESPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0 PREFILLED SYRINGE CARTON7/1/2012
434NDA/MAL/HDP/0951NEON LABARATORIES LTDAIVEEN (U) LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY S C AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2013
435NDA/MAL/HDP/0952NEON LABARATORIES LTDAIVEEN (U) LIMITEDEFECATALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
436NDA/MAL/HDP/0953NEON LABARATORIES LTDAIVEEN (U) LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2013
437NDA/MAL/HDP/0954NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL7/1/2013
438NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2012
439NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER7/1/2013
440NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMODARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER7/1/2013
441NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 / 67.5ARTESUNATE + AMODIAQUINE25 MG + 67.5 MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
442NDA/MAL/HDP/0966SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCLOFENAC DTDICLOFENAC SODIUM50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
443NDA/MAL/HDP/0969EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-2.5AMLODIPINE BESILATE2.5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
444NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2015
445NDA/MAL/HDP/0978SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROX 75 SR CAPSULEAMBROXOL75MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2012
446NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
447NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
448NDA/MAL/HDP/0987SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALATROL TABLETSCETIRIZINE10MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
449NDA/MAL/HDP/0990EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUSIDERM CREAMFUSIDIC ACID2%W/WEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
450NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
451NDA/MAL/HDP/0997EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDGENUPHILGLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE375MG+375MG+300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
452NDA/MAL/HDP/0999EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
453NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE7/1/2012
454NDA/MAL/HDP/1001EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
455NDA/MAL/HDP/1003EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDZEFICAMLORNOXICAM8MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
456NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
457NDA/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 SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
458NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2012
459NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUPAMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2012
460NDA/MAL/HDP/1012NEON LABARATORIES LTDAIVEEN (U) LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY OTHER VIALS1.0X50.0 ML VIAL,1.0X20.0 ML VIAL7/1/2013
461NDA/MAL/HDP/1013NEON LABARATORIES LTDAIVEEN (U) LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X20.0 ML VIAL7/1/2013
462NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
463NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER7/1/1997
464NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO 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 RETARD LAYERED TABLETS1.0X10.0X1.0X12.0 TABLET BLISTER7/1/2012
465NDA/MAL/HDP/1022EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
466NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER7/1/2013
467NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X5.0 TABLET BLISTER7/1/2013
468NDA/MAL/HDP/1032EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDARTHFREE 20LEFLUNOMIDE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
469NDA/MAL/HDP/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOXAMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
470NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
471NDA/MAL/HDP/1038SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME TRIHYDRATE200MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER7/1/2014
472NDA/MAL/HDP/1040SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3 DSCEFIXIME TRIHYDRATE400MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2014
473NDA/MAL/HDP/1041SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN4000 I.U/1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL7/1/2013
474NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5TELMISARTAN +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 TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP7/1/2013
475NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
476NDA/MAL/HDP/1045SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIMAX 500AZITHROMYCIN500MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER7/1/2013
477NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 180MGFEXOFENADINE180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
478NDA/MAL/HDP/1048UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 120MGFEXOFENADINE120MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
479NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2012
480NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2013
481NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGENMICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
482NDA/MAL/HDP/1053GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-125 DTAMOXICILLIN125MGMILAN 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 SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
483NDA/MAL/HDP/1054GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2011
484NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENTBETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/2013
485NDA/MAL/HDP/1057NECTAR LIFESCIENCES LTDSUPER MEDIC LTDFIXINECT-200MGCEFIXIME200MGNECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
486NDA/MAL/HDP/1061SHOSAAN ASIC PACIFICRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
487NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON7/1/2013
488NDA/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 VIALS1.0X5.0 ML VIAL7/1/2012
489NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
490NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2010
491NDA/MAL/HDP/1068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAROFF 100ACECLOFENAC100MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
492NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE7/1/2014
493NDA/MAL/HDP/1071UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/25MGVALSARTAN + HYDROCHLOROTHIAZIDE160 MG + 25 MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
494NDA/MAL/HDP/1072UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 80/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
495NDA/MAL/HDP/1073GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-250BECLOMETASONE250MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
496NDA/MAL/HDP/1074NECTAR LIFESCIENCES LTDSUPER MEDIC LTDCEFUAXITCEFUROXIME500MGNECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
497NDA/MAL/HDP/1075NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPIMECEFEPIME1000MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION7/1/2013
498NDA/MAL/HDP/1076UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST 4MGMONTELUKAST SODIUM4MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
499NDA/MAL/HDP/1077NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECTRAMCEFTRIAXONE1GNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE7/1/2013
500NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
501NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
502NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
503NDA/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 INDIA
INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
504NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
505NDA/MAL/HDP/1086SHOSAAN ASIC PACIFICRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE50MG +250MG + 750MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
506NDA/MAL/HDP/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2013
507NDA/MAL/HDP/1093STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE200MG+300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
508NDA/MAL/HDP/1094MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME100MG/5MLMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
509NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2012
510NDA/MAL/HDP/1096ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDARTEMETHERARTEMETHER80MG/MLHEBEI KAIWEI PHARMACEUTICAL CO, LTD.-27 LING YUAN ROAD, QIAO DONG, ZHANGJIAKOU CITY CHINAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE,1.0X1.0X8.0X1.0 ML AMPOULE7/1/2014
511NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2012
512NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE7/1/2013
513NDA/MAL/HDP/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2011
514NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
515NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER7/1/2013
516NDA/MAL/HDP/1107SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) (PAEDIATRIC))HEPATITIS B VACCINE(RDNA)10MCG /0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY I M VIALS1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)7/1/2005
517NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2014
518NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/1997
519NDA/MAL/HDP/1114SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2012
520NDA/MAL/HDP/1117SHOSAAN ASIC PACIFICRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAOPHTHALMIC OINTMENTS1.0X20.0X3.5 G TUBE7/1/2013
521NDA/MAL/HDP/1118EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 52.5TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR), (TNK-T-PA)52.5GENNOVA BIOPHARMACEUTICALS LIMITED-BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 INDIAPARENTERAL ORDINARY I V VIALS1.0X52.5 MG VIAL + (1*10ML AMPOULE WFI)7/1/2013
522NDA/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 DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2013
523NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPARPARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2012
524NDA/MAL/HDP/1124GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE7/1/2013
525NDA/MAL/HDP/1127FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDCLARION TABLETS 500MGCLARITHROMYCIN500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
526NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS1.0X4.0 TABLET BLISTER7/1/2013
527NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2012
528NDA/MAL/HDP/1131FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDXAVOR 50LOSARTAN50MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2014
529NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2012
530NDA/MAL/HDP/1133MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDMEDICOL SUSPENSIONCHLORAMPHENICOL125MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
531NDA/MAL/HDP/1134FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDXAVOR DIULOSARTAN AND HYDROCHLORTHIAZIDE50/12.5MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
532NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL EMULSIONS1.0X1.0X100.0 ML BOTTLE7/1/2013
533NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL LOTIONS1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2013
534NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
535NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
536NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
537NDA/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 FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
538NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2005
539NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
540NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2015
541NDA/MAL/HDP/1150AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDFEBRAMOLPARACETAMOL INFUSION10MG/MLAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
542NDA/MAL/HDP/1154SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

INDIAPARENTERAL ORDINARY DRY VIALS1.0X30.0 ML VIAL7/1/2012
543NDA/MAL/HDP/1157Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDTRETINONTRETINOIN0.05%W/WY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
544NDA/MAL/HDP/1158TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRAMADOLTRAMADOL50MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
545NDA/MAL/HDP/1159Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVORENDICLOFENAC SODIUM50MGY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA MALAYSIARECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP7/1/2013
546NDA/MAL/HDP/1162TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDWINKLOTCLOPIDOGREL75MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
547NDA/MAL/HDP/1163SHOSAAN ASIC PACIFICRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
548NDA/MAL/HDP/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
549NDA/MAL/HDP/1166PANACEA BIOTEC LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
550NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2010
551NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER7/1/2013
552NDA/MAL/HDP/1170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO MEGANEURONMETHYLCOBALAMIN500MCGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY I M AMPOULES1.0X1.0 ML AMPOULE7/1/2013
553NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL,1.0X30.0 ML VIAL7/1/2010
554NDA/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 CREAMS1.0X15.0 G TUBE7/1/2013
555NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
556NDA/MAL/HDP/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO SA-1170 AUBONNE(SWITZERLAND) MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY SWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/2015
557NDA/MAL/HDP/1181TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 4MONTELUKAST SODIUM4 MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
558NDA/MAL/HDP/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
559NDA/MAL/HDP/1183HETERO DRUGS LTDAIVEEN (U) LIMITEDFLUVIROSELTAMIVIR PHOSPHATE75 MGHETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD HETERO LABS LIMITED .-UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2010
560NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
561NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
562NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
563NDA/MAL/HDP/1189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75DICLOFENAC SODIUM75MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE7/1/2013
564NDA/MAL/HDP/1194VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPISAPIPERACILLIN + TAZOBACTAM4000MG/VIAL + 500MG/VIALVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP INDIAPARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL7/1/2009
565NDA/MAL/HDP/1195UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDALTRINECETIRIZINE5MG/5MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2013
566NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE7/1/2012
567NDA/MAL/HDP/1202MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX SYRUPQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2003
568NDA/MAL/HDP/1205MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDEFAVIRENZEFAVIRENZ600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA
INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
569NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDEUNITED KINGDOMTOPICAL EXTERNAL OTHER GELS/SOLS1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER7/1/2013
570NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2011
571NDA/MAL/HDP/1209MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
572NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI CHINAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2011
573NDA/MAL/HDP/1214FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN SPAINORAL SOLID ORDINARY CAPSULES1.0X2.0X15.0 CAPSULE BLISTER7/1/2015
574NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL SUPPOSITORIES1.0X10.0 TABLET BLISTER7/1/2013
575NDA/MAL/HDP/1218BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE-50ARTESUNATE50MGM/S BLISS GVS PHARMA LIMITED -PLOT 10, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE PALGHAR, DIST. THANE - 401404 INDIARECTAL SYSTEMIC SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2009
576NDA/MAL/HDP/1219DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
577NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONARTARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BLISTER7/1/2008
578NDA/MAL/HDP/1225AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDMOSEDIN PLUS SRPSEUDOEPHEDRINE HYDROCHLORIDE + LORATADINE120MG + 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 CAPSULES1.0X1.0X10.0 CAPSULE BLISTER7/1/2013
579NDA/MAL/HDP/1226AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDSALBUTAMOLSALBUTAMOL4MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2005
580NDA/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 FILM-COATED TABLETS1.0X7.0 TABLET STRIP7/1/2013
581NDA/MAL/HDP/1229MARCK BIOSCIENCES LIMITEDPHARMA VILLE LIMITEDLIDOCAINELIDOCAINE2%W/VMARCK BIOSCIENCES LIMITED-PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2012
582NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
583NDA/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/SYRUPS/DROPS1.0X100.0 ML BOTTLE
584NDA/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 DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
585NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
586NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
587NDA/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 TABLETS1.0X10.0 TABLET BLISTER7/1/2014
588NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2012
589NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2013
590NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
591NDA/MAL/HDP/1255CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
592NDA/MAL/HDP/1256SIRMAXO CHEMICALS PVT LTDKIMSY MEDS LTDSANIQUAD PVP TPOVIDONE IODINE10%W/WSIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE7/1/2015
593NDA/MAL/HDP/1259IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ- 6.25CARVEDILOL6.25MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2013
594NDA/MAL/HDP/1261IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ-12.5CARVEDILOL12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2013
595NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS1.0X5.0 G TUBE,1.0X3.5 G TUBE7/1/2000
596NDA/MAL/HDP/1265GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
597NDA/MAL/HDP/1271INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDONASERONONDANSETRON4MG/5MLINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHORAL LIQUID ORDINARY LIQUIDS1.0X1.0X50.0 ML BOTTLE7/1/2012
598NDA/MAL/HDP/1272GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)OMASI MED LIMITEDMEBO HERBAL OINTMENTB-SITOSTEROL0.25%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA, P.O.BOX:
997,
RAS AL KHAIMAH,
U.A.E.
UNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/1999
599NDA/MAL/HDP/1274SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN250MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2007
600NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
601NDA/MAL/HDP/1276INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDPANTONIX 40 INJECTIONPANTOPRAZOLE SODIUM SEQUIHYDRATE40MGINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHPARENTERAL ORDINARY AMPOULES1.0X1.0X40.0 MG VIAL 1*10ML AMPOULE OF 0.9% NACL7/1/2013
602NDA/MAL/HDP/1278SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY TABLETS1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER7/1/2013
603NDA/MAL/HDP/1282ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDLOSABERGLOSARTAN POTASSIUM50MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
604NDA/MAL/HDP/1285SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFUR-750CEFUROXIME750MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2012
605NDA/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/DROPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2014
606NDA/MAL/HDP/1288PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITAMINAT SYRUPVITAMIN B COMPLEXMULT-INGREDIENTPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/1998
607NDA/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 CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
608NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL7/1/2012
609NDA/MAL/HDP/1293ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA - 100SILDENAFIL CITRATE100MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER7/1/2016
610NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL7/1/2012
611NDA/MAL/HDP/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/1997
612NDA/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 VIALS1.0X1.5 G VIAL,1.0X50.0X1.0 VIAL CARTON7/1/2012
613NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
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614NDA/MAL/HDP/1303MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFIBRALFINOFIBRATE200MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER, 1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
615NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
616NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
617NDA/MAL/HDP/1312BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
618NDA/MAL/HDP/1315ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-20ESOMEPRAZOLE20MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
619NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1997
620NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE7/1/2005
621NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)7/1/1997
622NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-625AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP7/1/2003
623NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
624NDA/MAL/HDP/1334MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE30MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER7/1/2016
625NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2012
626NDA/MAL/HDP/1336MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE45MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER, CAPSULE CONTAINER7/1/2015
627NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
628NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X5.0 ML VIAL7/1/2016
629NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
630NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
631NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
632NDA/MAL/HDP/1352MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPLATFREECLOPIDOGREL75MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
633NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2015
634NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2016
635NDA/MAL/HDP/1360CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET CONTAINER7/1/2016
636NDA/MAL/HDP/1361SWISS PARENTERALS LTDSHREEJI CARE LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE7/1/2016
637NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X6.0 TABLET STRIP7/1/2013
638NDA/MAL/HDP/1366F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDHERCEPTIN 440MGTRASTUZUMAB440MGF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGSTSWITZERLANDPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT7/1/2016
639NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
640NDA/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/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2010
641NDA/MAL/HDP/1369MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACK ORANGE FLAVOURDT ZINC-20 + ORAL REHYDRATION SALTS (ORS)20GMEDICAMEN BIOTECH LTD,.-SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER7/1/2016
642NDA/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 AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE7/1/2010
643NDA/MAL/HDP/1372AXA PARENTERALS LTDVITACARE LIMITEDRLLACTIC ACID + SODIUM HYDROXIDE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE(0.24 + 0.115 + 0.6 + 0.04 + 0.027)G/100MLAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
644NDA/MAL/HDP/1374HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN -125CEPHADRINE125MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2003
645NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0 ML AMPOULE7/1/2014
646NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/1997
647NDA/MAL/HDP/1381CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,+ ZIDOVUDINE150MG+300MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2007
648NDA/MAL/HDP/1384CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
649NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP7/1/2004
650NDA/MAL/HDP/1389UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDNELSTATNYSTATIN100000 I.U/MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
651NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO PUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
652NDA/MAL/HDP/1391UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIVIR 5%ACYCLOVIR5%W/WUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYATOPICAL EXTERNAL CREAMS1.0X1.0X10.0 G TUBE7/1/2010
653NDA/MAL/HDP/1392ASTRA ZENECAMACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/1997
654NDA/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 TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
655NDA/MAL/HDP/1394SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANPIME -1000CEFEPIME1000MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL7/1/2010
656NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE SWEDENPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL7/1/2010
657NDA/MAL/HDP/1399CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDASTHALINSALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2010
658NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
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659NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
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MAHARASHTRA, INDIA.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
660NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
661NDA/MAL/HDP/1407PHARMATHEN S.AGOODMAN INTERNATIONAL LTDBELIFAXOMEPRAZOLE20MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE GREECEORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BOTTLE7/1/1997
662NDA/MAL/HDP/1408TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ROSUCORROSUVASTATIN20MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
663NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X15.0 ML BOTTLE7/1/2007
664NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
665NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL TOPICAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2014
666NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
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667NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2001
668NDA/MAL/HDP/1418SHOSAAN ASIC PACIFICRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
669NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
670NDA/MAL/HDP/1423SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXYCILLIN + POTASSIUM CLAVULANATE500MG+125MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET BLISTER7/1/2016
671NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE –III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
672NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
673NDA/MAL/HDP/1427GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
674NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
675NDA/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 INDIA INDIAOTIC DROPS1.0X10.0 ML VIAL7/1/2007
676NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL7/1/1997
677NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
678NDA/MAL/HDP/1441AXA PARENTERALS LTDVITACARE LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9%W/VAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
679NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2003
680NDA/MAL/HDP/1446RENE 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, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2015
681NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENTEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER7/1/2014
682NDA/MAL/HDP/1449SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPAR SUSPENSIONALBENDAZOLE200MG/5MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2000
683NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND SWITZERLANDTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE7/1/1997
684NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE7/1/1997
685NDA/MAL/HDP/1452ASTRA ZENECAMACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
686NDA/MAL/HDP/1453ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-40ESOMEPRAZOLE40MGMADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI – 600 096, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
687NDA/MAL/HDP/1454RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/2003
688NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2006
689NDA/MAL/HDP/1459NVS KENYA LTDSURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2014
690NDA/MAL/HDP/1460VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0X2.0X0.8 ML PRE- FILLED SYRINGE7/1/2009
691NDA/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 LIQUIDS1.0X200.0 ML BOTTLE7/1/2015
692NDA/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 TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
693NDA/MAL/HDP/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFAST 50MGDICLOFENAC POTASSIUM50MGMIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY. ITALYORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X3.0 SACHET CARTON,9.0X1.0X3.0X3.0 SACHET CARTON7/1/2014
694NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID 20OMEPRAZOLE20MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/1998
695NDA/MAL/HDP/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
696NDA/MAL/HDP/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTEMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2011
697NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2016
698NDA/MAL/HDP/1476GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2016
699NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2001
700NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS7/1/1997
701NDA/MAL/HDP/1485UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDICLOFEN 25DICLOFENAC25MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANRECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER7/1/2011
702NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL7/1/2011
703NDA/MAL/HDP/1488ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU GERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP7/1/2000
704NDA/MAL/HDP/1492ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE7/1/1998
705NDA/MAL/HDP/1493AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDKOACT 1000AMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK,
POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR
INDIAORAL SOLID RETARD TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
706NDA/MAL/HDP/1494FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN SPAINTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2013
707NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/1997
708NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/1997
709NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/2005
710NDA/MAL/HDP/1500MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA NETHERLANDSORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
711NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL OTHER CREAMS1.0X20.0 G TUBE7/1/2003
712NDA/MAL/HDP/1505GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX
FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
713NDA/MAL/HDP/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE7/1/2011
714NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2009
715NDA/MAL/HDP/1509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL500MGBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100, KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
716NDA/MAL/HDP/1510JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLISTERINE ANTISEPTICTHYMOL + ALCOHOL 95%12.78MG/20ML + 5.60ML/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2001
717NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MG JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X6.0 TABLET BLISTER7/1/1997
718NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
719NDA/MAL/HDP/1517SHOSAAN ASIC PACIFICRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1998
720NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
721NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2008
722NDA/MAL/HDP/1525CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2007
723NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2015
724NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAVAMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE7/1/2012
725NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/2007
726NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
727NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN PAKISTANPARENTERAL ORDINARY VIALS1.0X1.0 MG VIAL7/1/2014
728NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2007
729NDA/MAL/HDP/1537ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY TABLETS1.0X20.0X2.0 TABLET BLISTER7/1/2005
730NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2003
731NDA/MAL/HDP/1543MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDPROMAZINE ELIXIRPROMETHAZINE HYDROCHLORIDE5MG/MLMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA UGANDAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/1997
732NDA/MAL/HDP/1544GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
733NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 UNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER7/1/1999
734NDA/MAL/HDP/1547MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLUSIA-FNORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE0.3MG/ 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2007
735NDA/MAL/HDP/1549REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.PREDNICOL EYE DROPSPREDNISOLONE/CHLORAMPHENICOL5MG/2MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/1999
736NDA/MAL/HDP/1550GALENTIC PHARMA LTDVITACARE LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIAORAL TOPICAL GELS AND SOLS1.0X30.0 G TUBE7/1/2007
737NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
738NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
739NDA/MAL/HDP/1555GALENTIC PHARMA LTDVITACARE LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE7/1/2008
740NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDDOMI UPONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
741NDA/MAL/HDP/1557GLAXOSMITHKLINEUNITED HEALTHCARE DISTRIBUTORS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)7/1/2010
742NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
743NDA/MAL/HDP/1566GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULTI-INGREDIENTMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
744NDA/MAL/HDP/1568: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAMAMOXICILLIN AND CLAVULANATE POTASSIUM156.25MG INDCHEMIE HEALTH SPECIALITIES PVT. LTD-VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2008
745NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
746NDA/MAL/HDP/1572SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDROSUVAS 20ROSUVASTATIN20MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN
EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2011
747NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2003
748NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-CHESHIRE UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
749NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/1997
750NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2011
751NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
752NDA/MAL/HDP/1583INDOCO REMEDIES LIMITEDSTAR PHARMACEUTICALS LTDABZEEALBENDAZOLE200MG/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2001
753NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2010
754NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER7/1/2005
755NDA/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 SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE7/1/1997
756NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/1997
757NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
758NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER7/1/2001
759NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SILDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X4.0 TABLET BLISTER7/1/2011
760NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2005
761NDA/MAL/HDP/1616GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2011
762NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL GELS AND SOLS1.0X30.0 G TUBE7/1/2004
763NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
764NDA/MAL/HDP/1631AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2007
765NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MG ALKEM LABORATORIES LTD .,.-VILLAGE THANA BADDI DIST-SOLAN TEHSIL NALAGARH HIMACHAL PRADESH 173205 EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF WFI7/1/2005
766NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/1997
767NDA/MAL/HDP/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2013
768NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2005
769NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON7/1/2003
770NDA/MAL/HDP/1640GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDALBEN TABLETSALBENDAZOLE400MGMEDREICH LIMITED - UNIT 3-SURVEY NO. 4/3, AVALAHALLI, ANJANAPURA, OFF KANAKAPURA ROAD, BANGALORE-560062 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET BLISTER7/1/1999
771NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
772NDA/MAL/HDP/1642UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDEUCHLOR-1000CHLORAMPHENICOL SODIUM SUCCINNATE B.P1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/2004
773NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2002
774NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID RETARD TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2006
775NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
776NDA/MAL/HDP/1655UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIGENTYLSECNIDAZOLE500MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2010
777NDA/MAL/HDP/1656MAISHA MEDICAL SUPPLIES LIMITEDAIVEEN (U) LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER7/1/2015
778NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP7/1/2005
779NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2007
780NDA/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 SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/2003
781NDA/MAL/HDP/1665GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1998
782NDA/MAL/HDP/1673GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE GLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE FRANCEORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2005
783NDA/MAL/HDP/1675MERCK SHARP & DOHME BVSURGIPHARM (U) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA UNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)7/1/2007
784NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
785NDA/MAL/HDP/1680SHOSAAN ASIC PACIFICRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
786NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2005
787NDA/MAL/HDP/1686LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
788NDA/MAL/HDP/1689SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDOMESKOMEPRAZOLE20MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2010
789NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
790NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
791NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN JORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2007
792NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2005
793NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
794NDA/MAL/HDP/1698CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER7/1/2009
795NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMINMETFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
796NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELORCLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2005
797NDA/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, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/1997
798NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
799NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
800NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MGMACLEODS PHARMACEUTICALS LTD -BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER7/1/2007
801NDA/MAL/HDP/1714REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.REMICOL EAR DROPSCHLORAMPHENICOL1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOTIC DROPS1.0X10.0 ML BOTTLE7/1/1999
802NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA TANZANIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2011
803NDA/MAL/HDP/1716ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRMIN 5SMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
804NDA/MAL/HDP/1719ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRMIN 10 PLUSMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
805NDA/MAL/HDP/1723USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMIN DROPSMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA INDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2000
806NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK UNITED KINGDOMNASAL TOPICAL SPRAYS WITHOUT GAS1.0X120.0 METERED DOSE CANNISTER7/1/2009
807NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
808NDA/MAL/HDP/1726GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDHAVRIX 720INACTIVATED HEPATITIS A VIRUS ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED720 ELISA UNITS ADSORBED ON 0.25MG ALUMINIUM HYDROXIDEGLAXOSMITHKLINE BIOLOGICALS-RUE DE L' LNSTITUT 89-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/1997
809NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP7/1/2007
810NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2008
811NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
812NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER7/1/1997
813NDA/MAL/HDP/1736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDKLERIMEDCLARITHROMYCIN500MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2009
814NDA/MAL/HDP/1739MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMELOXMELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2009
815NDA/MAL/HDP/1741AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEOPRED-PPREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B5MG/ML +5MG/ML + 1M I.U/MLAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
816NDA/MAL/HDP/1743MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2009
817NDA/MAL/HDP/1745AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIGENGENTAMYCIN SULPHATE0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
818NDA/MAL/HDP/1747IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPRESARTAN H 50LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE 50MG + 12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
819NDA/MAL/HDP/1748GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
820NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
821NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X5.0 ML AMPOULE7/1/2005
822NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL7/1/2005
823NDA/MAL/HDP/1755MEMPHIS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOPAGON TABLETSBROMOCRIPTINE2.5MGMEMPHIS COMPANY--8 EL SAWAH STREET, CAIRO. EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1999
824NDA/MAL/HDP/1756AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICROM 2%SODIUM CROMOGLYCATE2%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
825NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
826NDA/MAL/HDP/1760AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEODEXNEOMYCIN +DEXAMETHASONE0.5%W/V + 0.1%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOTIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
827NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2014
828NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
829NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
830NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER7/1/2006
831NDA/MAL/HDP/1765UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
832NDA/MAL/HDP/1766RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2005
833NDA/MAL/HDP/1767EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTEROLALFUZOSIN HYDROCHLORIDE10MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
834NDA/MAL/HDP/1768BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) ITALYPARENTERAL ORDINARY DRY VIALS1.0X5.0 VIAL CARTON7/1/1999
835NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)7/1/1997
836NDA/MAL/HDP/1772SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER7/1/2000
837NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2005
838NDA/MAL/HDP/1777CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNUZAC 20FLUOXETINE20MGCIPLA LTD ..-PLOT NO. 910 & 15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH 454775 CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2003
839NDA/MAL/HDP/1778PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 500MG CAPSULESAMOXYCILLIN TRIHYDRATE500MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/1998
840NDA/MAL/HDP/1779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SOLUTIONPOVIDONE IODINE10.0G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2006
841NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE7/1/2000
842NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2000
843NDA/MAL/HDP/1782GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
844NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/1997
845NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2005
846NDA/MAL/HDP/1785BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600MG+50MG+300MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER7/1/1997
847NDA/MAL/HDP/1786GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2001
848NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
849NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER7/1/2006
850NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 INDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL7/1/2010
851NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MGINTAS PHARMACEUTICALS LTD, VATVA-7/3 G.I.D.C. ESTATE, PHASE-1, B/H DENA BANK VATVA, AHMEDABAD-382 445 GUJARAT, INDIA
INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA
INDIAORAL SOLID RETARD FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
852NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2001
853NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
854NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP7/1/1997
855NDA/MAL/HDP/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2001
856NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X8.0 ML BOTTLE7/1/1997
857NDA/MAL/HDP/1809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
858NDA/MAL/HDP/1810GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2010
859NDA/MAL/HDP/1811CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE7/1/2001
860NDA/MAL/HDP/1812RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2001
861NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
862NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X15.0 G TUBE7/1/2003
863NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/1998
864NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/1997
865NDA/MAL/HDP/1822RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINEEPHEDRINE HYDROCHLORIDE30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
866NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2005
867NDA/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 CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
868NDA/MAL/HDP/1838INDOCO REMEDIES LIMITEDSTAR PHARMACEUTICALS LTDABZEEALBENDAZOLE400MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER7/1/2004
869NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2011
870NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
871NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2002
872NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
873NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
874NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X170.0 ML BOTTLE7/1/2013
875NDA/MAL/HDP/1847MICRO LABSMALIX PHARMA (U) LIMITEDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2007
876NDA/MAL/HDP/1848LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDPARATALPARACETAMOL500MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
877NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2011
878NDA/MAL/HDP/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER, 1.0X1000.0 TABLET CONTAINER7/1/2010
879NDA/MAL/HDP/1851PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE0.438 G + 0.335 G + 0.135 G + 0.918 GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIATOPICAL EXTERNAL EMULSION GELS1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE7/1/2011
880NDA/MAL/HDP/1853MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDAERIUS ORAL SOLUTIONDESLORATADINE0.5MG/MLSCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG BELGIUMORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE7/1/2007
881NDA/MAL/HDP/1854ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFUROSEMIDE INJECTIONFUROSEMIDE10MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE7/1/2004
882NDA/MAL/HDP/1855INTERMEDROYAL PHARMA 2011 LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2004
883NDA/MAL/HDP/1856COSMOS LTDASTRA PHARMA (U) LIMITEDPROPRANOLOL TABLETS B.P. 40MGPROPRANOLOL HYDROCHLORIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
884NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
885NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE2 GM+0.1 GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL GELS AND SOLS1.0X15.0 G TUBE7/1/2004
886NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2009
887NDA/MAL/HDP/1877RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2007
888NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPENIVPHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
889NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2004
890NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
891NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
892NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
893NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON7/1/1997
894NDA/MAL/HDP/1891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 500LEVOFLOXACIN500MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2005
895NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 250LEVOFLOXACIN250MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2012
896NDA/MAL/HDP/1894KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-480CO-TRIMOXAZOLE480MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
897NDA/MAL/HDP/1895GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO (PAEDIATRIC)CO-TRIMOXAZOLE100MG/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2007
898NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2001
899NDA/MAL/HDP/1900GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2007
900NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
901NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
902NDA/MAL/HDP/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU GERMANYPARENTERAL ORDINARY I M AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2007
903NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
904NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODEINE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
905NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2008
906NDA/MAL/HDP/1914RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2003
907NDA/MAL/HDP/1918UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIVIRACYCLOVIR200MGUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET STRIP7/1/2010
908NDA/MAL/HDP/1919GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDIDERM CREAMBECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN0.025%W/W+1%W/W+0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/1999
909NDA/MAL/HDP/1922IPCA LABORATORIES LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER7/1/2007
910NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
911NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL7/1/2013
912NDA/MAL/HDP/1925BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG - ALFENAC- PACECLOFENAC + PARACETAMOL100MG + 500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2014
913NDA/MAL/HDP/1928STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUXALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG + 250MG +250MG +250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
914NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
915NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL RETARD PRE-FILLED SYRINGES1.0X10.8 MG IMPLANT7/1/2010
916NDA/MAL/HDP/1934RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2001
917NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
918NDA/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 TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
919NDA/MAL/HDP/1938YURIA-PHARM LTDPHARMA VILLE LIMITEDINFULGANPARACETAMOL10MG/MLYURIA-PHARM LLC MANUFACTURING SITE NO. 1-108, KOBZARSKA STREET, CHERKASY, 18030 UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE7/1/2013
920NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2001
921NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL7/1/2005
922NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER7/1/2009
923NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE INDIAORAL SOLID RETARD TABLETS1.0X25.0 TABLET CONTAINER7/1/2009
924NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS10.0X10.0 TABLET STRIP7/1/1998
925NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE PFIZER LABORATORIES (PTY) LTD;--SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1998
926NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2011
927NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP7/1/2006
928NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP7/1/2011
929NDA/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 CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2006
930NDA/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 TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
931NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2003
932NDA/MAL/HDP/1962BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDNIMBEXCISATRACURIUM BESYLATE2MG/MLGLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9ITALYPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL,1.0X2.5 ML VIAL7/1/1997
933NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACINPARACETAMOL500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
934NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA ITALYORAL SOLID RETARD TABLETS1.0X30.0 TABLET CONTAINER7/1/1997
935NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
936NDA/MAL/HDP/1971GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN + CLOXACILLIN125 MG/5ML + 125 MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
937NDA/MAL/HDP/1974SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTILCEFUROXIME AXETIL500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
938NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
939NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSAR-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 TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
940NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID SPAINORAL SOLID ORDINARY TABLETS2.0X2.0 TABLET BLISTER7/1/2004
941NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2014
942NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER7/1/2005
943NDA/MAL/HDP/1997GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X1000.0 TABLET JAR (WITH STATEMENT "FOR HOSPITAL USE ONLY".)7/1/2011
944NDA/MAL/HDP/1998M.J.BIOPHARM PVT LTDVITACARE LIMITEDTEICO 500CEFEPIME500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2013
945NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER7/1/2000
946NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID RETARD TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2000
947NDA/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 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X15.0 CAPSULE BLISTER7/1/2008
948NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2005
949NDA/MAL/HDP/2007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDB-COX TABLETSVITAMIN B COMPLEXBCP FORMULAAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2001
950NDA/MAL/HDP/2008GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- CREAMCLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM1%W/W + 0.025%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2004
951NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
952NDA/MAL/HDP/2011HETERO LABS LTDAIVEEN (U) LIMITEDGIAGRA 50SILDENAFIL CITRATE50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER,1.0X10.0X1.0X4.0 TABLET BLISTER7/1/2013
953NDA/MAL/HDP/2012GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- LOTIONCLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE1%W/V + 0.025%W/VGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL LOTIONS1.0X15.0 ML BOTTLE7/1/2004
954NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/2009
955NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
956NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
957NDA/MAL/HDP/2019GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
958NDA/MAL/HDP/2020KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDQUINEQUININE SULPHATE300MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER7/1/1997
959NDA/MAL/HDP/2021PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDPREGVIT ZINCMULTIVITAMIN/MINERALSMULT-INGREDIENTPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X12.0X2.0 CAPSULE BLISTER7/1/2000
960NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1997
961NDA/MAL/HDP/2024TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.NEXPRO - 40ESOMEPRAZOLE MAGNESIUM TABLET40MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
962NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
963NDA/MAL/HDP/2027UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
964NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X7.0 CAPSULE BLISTER7/1/2005
965NDA/MAL/HDP/2029ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCHLORAMPHENICOL PALMITATECHLORAMPHENICOL PALMITATE125MG/5MLMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
966NDA/MAL/HDP/2031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
967NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2009
968NDA/MAL/HDP/2035KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNEOSIDARSULPHADOXINE + PYRIMETHAMINE500MG + 25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER7/1/2004
969NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IUELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221 LILLY FRANCE SA-FRANCE FRANCEPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE7/1/1998
970NDA/MAL/HDP/2040AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER7/1/2006
971NDA/MAL/HDP/2041IDAKIMSY MEDS LTDOXYTOCINOXYTOCIN10IUGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA GLAND PHARMA LTD-PLOT NO. 42 TO 52, SY NO. 166, 171, 172 & 177, TSIIC, PHASE III, PASHAMYLARAM (V) PATANCHERU (M), MEDAK DISTRICT 502307, TELANGANA STATE INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE,1.0X1.0X10.0X1.0X10.0 ML AMPOULE,1.0X10.0X1.0X10.0X1.0 ML AMPOULE7/1/2005
972NDA/MAL/HDP/2042SHOSAAN ASIC PACIFICRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X200.0 G TUBE,1.0X15.0 G TUBE7/1/1997
973NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/1998
974NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
975NDA/MAL/HDP/2047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDRITONAVIRRITONAVIR100MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE7/1/2011
976NDA/MAL/HDP/2049WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTAR-500CEFUROXIME AXETIL500MGSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET STRIP,1.0X1.0X10.0 TABLET BLISTER7/1/2005
977NDA/MAL/HDP/2051GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON TABLETSCHLORPHENIRAMINE MALEATE4MGGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
978NDA/MAL/HDP/2053EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-5AMLODIPINE BESILATE5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
979NDA/MAL/HDP/2055SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO. LTD.-NO. 43 QILIDIAN ROAD, GUILIN 541004 CHINAPARENTERAL ORDINARY DRY VIALS1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE7/1/2011
980NDA/MAL/HDP/2056WOCKHARDT LTDSTAR PHARMACEUTICALS LTDBRO-ZEDEXTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL1.25MG+ 4 MG+50 MG+2.5 MG/5 MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
981NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2006
982NDA/MAL/HDP/2062SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN PAEDIATRIC SYRUPDEXTROMETHORPHAN HYDROBROMIDE BP + CHLORPHENIRAMINE MALEATE BP + AMMONIUM CHLORIDE BP + PSEUDOEPHEDRINE HYDROCHLORIDE BP(5MG + 2MG + 50MG + 10MG)/ 5MLBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD SHELYS PHAMACEUTICALS LTD .-NEW BAGAMOYO RD, MWENGE, PLOT 696, DAR ES SALAAM TANZANIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2006
983NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X28.0 TABLET BLISTER7/1/1997
984NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
985NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCETIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER7/1/1999
986NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HYDROCHLORIDE50MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
987NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2010
988NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X1.0 IMPLANT CARTON7/1/2009
989NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2000
990NDA/MAL/HDP/2073SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED)MEASLES VIRUSNOT LESS THAN 1000CCID50/ DOSESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION7/1/1997
991NDA/MAL/HDP/2074GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN ORAL SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
992NDA/MAL/HDP/2075GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2006
993NDA/MAL/HDP/2076GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMIDEFUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2006
994NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
995NDA/MAL/HDP/2078LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDALCLOX SYRUPCLOXACILLIN SODIUM125MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
996NDA/MAL/HDP/2079GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDNETRAVIRACICLOVIR5%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE7/1/2005
997NDA/MAL/HDP/2080GALENTIC PHARMA LTDVITACARE LIMITEDBETAMETHASONE VALERATEBETAMETHASONE VALERATE0.1%W/VGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2009
998NDA/MAL/HDP/2083BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBEVACPURIFIED HEPATITIS B SURFACE ANTIGEN20MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 INDIAPARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)7/1/2015
999NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
1000NDA/MAL/HDP/2090RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1001NDA/MAL/HDP/2091KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCAMSTONCLOTRIMAZOLE1%W/WKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDAUGANDATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2001
1002NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP7/1/1999
1003NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1004NDA/MAL/HDP/2095GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1005NDA/MAL/HDP/2097LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDALCLOXCLOXACILLIN250MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
1006NDA/MAL/HDP/2098GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2006
1007NDA/MAL/HDP/2100MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDORALCON - FLEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE0.15MG + 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2007
1008NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
1009NDA/MAL/HDP/2102MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
1010NDA/MAL/HDP/2103MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 1000 TABAMOXYCILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
1011NDA/MAL/HDP/2104MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE/NEVIRAPINE /ZIDOVUDINE DISPERSIBLE TABLETSLAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG + 50MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET BOTTLE7/1/2009
1012NDA/MAL/HDP/2106MEDREICH PLCSURGIPHARM (U) LIMITEDAMEDIN-5AMLODIPINE5 MGMEDREICH LIMITED-UNIT 3-SURVEY NO.4/3, AVALAHALLI, ANJANAPURA, OFF KANAKAPURA ROAD, BANGALORE-560062 INDIAORAL SOLID ORDINARY TABLETS1.0X14.0X2.0 TABLET BLISTER7/1/2006
1013NDA/MAL/HDP/2111HETERO LABS LTDAIVEEN (U) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2011
1014NDA/MAL/HDP/2112MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2008
1015NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP7/1/2005
1016NDA/MAL/HDP/2120ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEGAPIMECEFEPIME1GSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL7/1/2011
1017NDA/MAL/HDP/2122ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOLPARACETAMOL120MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1018NDA/MAL/HDP/2125CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBECLATE 100BECLOMETASONE100MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIANASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER7/1/2009
1019NDA/MAL/HDP/2128HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 500MGTRANEXAMIC ACID500MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2005
1020NDA/MAL/HDP/2130IPCA LABORATORIESMEDVIN PHARMA LIMITEDZERODOL-CRACECLOFENAC200MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1021NDA/MAL/HDP/2132AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLOPINAVIR/ RITONAVIRLOPINAVIR/ RITONAVIR200MG/ 50MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2010
1022NDA/MAL/HDP/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE DENMARKPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/1997
1023NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2003
1024NDA/MAL/HDP/2137REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.SEPRODERM OINTMENTSALICYLIC ACID + SULPHUR COMPOUND3.6 + 2.4 MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1998
1025NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2005
1026NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE7/1/2014
1027NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/1997
1028NDA/MAL/HDP/2151USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1029NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1030NDA/MAL/HDP/2156ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRPID 10 INTRAVENOUS FAT EMULSIONSOYA OIL10%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2011
1031NDA/MAL/HDP/2158ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
1032NDA/MAL/HDP/2159SANOFI PASTEURLABOREX UGANDA LIMITEDVAXIGRIPINFLUENZA VIRUS STRAINS H1N1 + H3N2 + B15MCG + 15MCG + 15MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/2011
1033NDA/MAL/HDP/2160EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDACEM-500CLARITHROMYCIN500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1034NDA/MAL/HDP/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/1997
1035NDA/MAL/HDP/2165RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
1036NDA/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 TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2011
1037NDA/MAL/HDP/2173GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X5.0 TABLET BLISTER7/1/2003
1038NDA/MAL/HDP/2175CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDPARAFIZZPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP7/1/2005
1039NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2011
1040NDA/MAL/HDP/2181KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PHENPHENOXYMETHYLPENICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER7/1/1997
1041NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDROTARIXLIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPENOT LESS THAN 10? CCID?? OF THE RIX4414 STRAINGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMORAL LIQUID ORDINARY LIQUIDS1.0X1.5 ML TUBE (1 DOSE),1.0X50.0X1.5 ML TUBE (1 DOSE)7/1/2013
1042NDA/MAL/HDP/2188CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDPREDNISOLONEPREDNISOLONE5MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1043NDA/MAL/HDP/2189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL BETAMETHASONEBETAMETHASONE0.1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2008
1044NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
1045NDA/MAL/HDP/2193CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLOX-500CIPROFLOXACIN500MGCIPLA LIMITED.-PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2007
1046NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1997
1047NDA/MAL/HDP/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2013
1048NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDBENZYL BENZOATEBENZYL BENZOATE25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL EMULSIONS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE7/1/2005
1049NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1050NDA/MAL/HDP/2214ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDGENTAMICIN INJECTIONGENTAMICIN SULPHATE40MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE7/1/1997
1051NDA/MAL/HDP/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
1052NDA/MAL/HDP/2217GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMINOPHYLINEAMINOPHYLLINE20MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X50.0X10.0 ML AMPOULE7/1/2005
1053NDA/MAL/HDP/2218LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDZINECTIL-100CHLORPROMAZINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2008
1054NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER,1.0X2.0X15.0 TABLET BLISTER7/1/1997
1055NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER7/1/2003
1056NDA/MAL/HDP/2223ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2400000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X2.4 MU VIAL7/1/2002
1057NDA/MAL/HDP/2224VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 500AMOXICILLIN500MGVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1058NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X10.0X5.0 G SACHET7/1/2004
1059NDA/MAL/HDP/2231MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX WITH CODEINEMULTI-INGREDIENTMULTI-INGREDIENTMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1060NDA/MAL/HDP/2232UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST10MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1061NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL7/1/2011
1062NDA/MAL/HDP/2235WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-NINSULIN HUMAN(RECOMBINANT DNA ORIGIN)100IU/MLWOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
1063NDA/MAL/HDP/2236NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/1997
1064NDA/MAL/HDP/2237WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-30/70INSULIN HUMAN(RECOMBINANT DNA ORIGIN)100I.U/MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML VIAL7/1/2006
1065NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL ORAL SUSPENSIONCARBAMAZEPINE20MG/MLDELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE FRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2006
1066NDA/MAL/HDP/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/1997
1067NDA/MAL/HDP/2243AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMDOL TABLETSPARACETAMOL500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1068NDA/MAL/HDP/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2008
1069NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE,1.0X5.0 G TUBE7/1/2004
1070NDA/MAL/HDP/2249WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-RINSULIN100MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
1071NDA/MAL/HDP/2250GALENTIC PHARMA LTDVITACARE LIMITEDCANDIGENCLOTRIMAZOLE1%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2004
1072NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGJOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2000
1073NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
1074NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X70.0 ML BOTTLE7/1/2010
1075NDA/MAL/HDP/2258MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ300MG/300MG/600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA GREEN STONE LIMITED-PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.
INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE7/1/2009
1076NDA/MAL/HDP/2263OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCELEMIN 10 PLUSAMINO ACIDS/ELECTROLYTES10%W/V+10%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2001
1077NDA/MAL/HDP/2265HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIR/ LAMUVIDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG + 300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2010
1078NDA/MAL/HDP/2266SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDQUININE SULPHATE TABLETS BPQUININE SULPHATE300MGSKANT HEALTH CARE LTD -1802-1805 GIDC PHASE III VAPI GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
1079NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG+300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.
INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
1080NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
1081NDA/MAL/HDP/2270UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZITHROCIN 500AZITHROMYCIN500MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2006
1082NDA/MAL/HDP/2271IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER + LUMEFANTRINE20MG + 120MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X10.0X4.0X6.0 TABLET BLISTER7/1/2010
1083NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER7/1/2005
1084NDA/MAL/HDP/2278AVENTIS INTERCONTINENTALSURGIPHARM (U) LIMITEDORELOXCEFPODOXIME PROXETIL100MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1085NDA/MAL/HDP/2280REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.BETADROP-NBETAMETHASONE + NEOMYCIN0.1 %W/V + 0.5 %W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1999
1086NDA/MAL/HDP/2281SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1087NDA/MAL/HDP/2282GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPRANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
1088NDA/MAL/HDP/2283SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA TETANUS PERTUSISDIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE>25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)7/1/1997
1089NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
1090NDA/MAL/HDP/2290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
1091NDA/MAL/HDP/2291HETERO DRUGS LTDAIVEEN (U) LIMITEDVALOVIRVALACYCLOVIR500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
1092NDA/MAL/HDP/2292MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 1200AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1000MG + 200MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X5.0X20.0 ML VIAL7/1/2007
1093NDA/MAL/HDP/2293GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2005
1094NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2008
1095NDA/MAL/HDP/2298MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
1096NDA/MAL/HDP/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1097NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1098NDA/MAL/HDP/2305MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 2.5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE2.5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1099NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER7/1/2010
1100NDA/MAL/HDP/2312REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
1101NDA/MAL/HDP/2313REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
1102NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2005
1103NDA/MAL/HDP/2315MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-50CEFIXIME50MG/5MLMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2006
1104NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
1105NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
1106NDA/MAL/HDP/2320GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-125 DRY SYRUPERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2006
1107NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X1.0 CAPSULE STRIP7/1/2007
1108NDA/MAL/HDP/2324SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X7.5 ML VIAL7/1/2011
1109NDA/MAL/HDP/2326EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSYLATE-500ETAMSYLATE50MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X6.0 TABLET STRIP7/1/2004
1110NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND 34912 KURTKOY, INSTANBUL - TURKEY SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER7/1/2005
1111NDA/MAL/HDP/2333SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC)DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE>25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)7/1/1997
1112NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUSNLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT7/1/1997
1113NDA/MAL/HDP/2335GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2001
1114NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE7/1/2003
1115NDA/MAL/HDP/2339AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-375AMOXICILLIN + CLAVULANATE POTASSIUM250 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER7/1/2007
1116NDA/MAL/HDP/2342AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
1117NDA/MAL/HDP/2348SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) ADULTHEPATITIS B VACCINE(RDNA) ADULT20MCG/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY I M VIALS1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)7/1/2005
1118NDA/MAL/HDP/2356GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININEQUININE DIHYDROCHLORIDE600MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2005
1119NDA/MAL/HDP/2357ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN- 50 CAPSULESTRAMADOL50MGMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2003
1120NDA/MAL/HDP/2359REMEDICA LTDGOODMAN INTERNATIONAL LTDASPIREM 75ASPIRIN75MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X28.0 TABLET BLISTER7/1/2007
1121NDA/MAL/HDP/2361REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAREM 500CLARITHROMYCIN500MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
1122NDA/MAL/HDP/2362GALENTIC PHARMA LTDVITACARE LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2009
1123NDA/MAL/HDP/2363GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGENTAMICIN SULPHATEGENTAMICIN SULPHATE80MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE7/1/2005
1124NDA/MAL/HDP/2364MEDICO REMEDIES PVT LTDAIVEEN (U) LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2015
1125NDA/MAL/HDP/2366UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDIFICIPRO INJECTIONCIPROFLOXACIN200MG/100MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2005
1126NDA/MAL/HDP/2367REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
1127NDA/MAL/HDP/2369ARISTO PHARMACEUTICALSNORVIK ENTERPRISES LIMITEDTRANLOK 500MG INJECTIONTRANEXAMIC ACID500MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE7/1/2010
1128NDA/MAL/HDP/2371PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIZONE CREAMFUSIDIC ACID + BETAMETHASONE VALERATE20MG/G+1MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1129NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X1.0X7.0 TABLET BLISTER7/1/2010
1130NDA/MAL/HDP/2376INDOCO REMEDIES LTDSTAR PHARMACEUTICALS LTDMETCHEK-500METFORMIN500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1131NDA/MAL/HDP/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT7/1/2014
1132NDA/MAL/HDP/2381AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMTRIM-480 TABLETSCO-TRIMOXAZOLE480MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1133NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
1134NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2000
1135NDA/MAL/HDP/2386HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN100MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2005
1136NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
1137NDA/MAL/HDP/2388DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 TURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2011
1138NDA/MAL/HDP/2390BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE80MG /640MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE7/1/2008
1139NDA/MAL/HDP/2391BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDHEADAID TABLETSASPIRIN + CAFFEINE + PARACETAMOL300MG + 30MG + 250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1997
1140NDA/MAL/HDP/2394MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDSTOCRINEFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2004
1141NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.ISTAR PHARMACEUTICALS LTDFASTUM GELKETOPROFEN2.5%W/WA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY ITALYTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE7/1/2005
1142NDA/MAL/HDP/2400PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIDIC 2%FUSIDIC ACID20MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1143NDA/MAL/HDP/2401MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDENATNATURAL VITAMIN E400IUMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2005
1144NDA/MAL/HDP/2404UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1145NDA/MAL/HDP/2408RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRON TONICMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2001
1146NDA/MAL/HDP/2409TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.DEPLATTCLOPIDOGREL75MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
1147NDA/MAL/HDP/2410RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDDOXYRENDOXYCYCLINE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1148NDA/MAL/HDP/2411STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZPOVIDONE IODINE + METRONIDAZOLE5%W/W + 1%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE7/1/2010
1149NDA/MAL/HDP/2414SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1150NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/1997
1151NDA/MAL/HDP/2421INDOCO REMEDIES LIMITEDSTAR PHARMACEUTICALS LTDTAMIGEN EYE/EAR DROPSGENTAMICIN SULPHATE0.3%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE7/1/2006
1152NDA/MAL/HDP/2423MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDATORIN ATORVASTATIN10MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1153NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2000
1154NDA/MAL/HDP/2427SHOSAAN ASIC PACIFICRENE PHARMACY LTDCLONEMCLOTRIMAZOLE1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1997
1155NDA/MAL/HDP/2428DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WC.P.M. CONTRACTPHARMA GMBH & COMPANY KG-FRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM GERMANYTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
1156NDA/MAL/HDP/2429ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 100 VAGINALCLOTRIMAZOLE100MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYVAGINAL TABLETS1.0X6.0 PESSARY CARTON7/1/1998
1157NDA/MAL/HDP/2431CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 200BUDESONIDE + FORMOTEROL FUMARATE200MCG/ 6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
1158NDA/MAL/HDP/2432CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 100BUDESONIDE + FORMOTEROL FUMARATE100MCG+6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2007
1159NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2006
1160NDA/MAL/HDP/2440KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL KIDSPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
1161NDA/MAL/HDP/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 75 SRDICLOFENAC SODIUM75 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
1162NDA/MAL/HDP/2455ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 600/750 LACTABARTESUNATE + MEFLOQUINE200 MG + 250 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2004
1163NDA/MAL/HDP/2459MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDP2LEVONORGESTREL0.75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2007
1164NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
1165NDA/MAL/HDP/2461UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMERAN SR - 100DICLOFENAC100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1166NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOTCLOPIDOGREL75MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2003
1167NDA/MAL/HDP/2471GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.1% NASAL DROPSXYLOMETAZOLINE0.1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND SWITZERLANDNASAL SYSTEMIC DROPS1.0X10.0 ML BOTTLE7/1/2003
1168NDA/MAL/HDP/2472SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE,1.0X20.0 G TUBE7/1/2011
1169NDA/MAL/HDP/2473MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
1170NDA/MAL/HDP/2474SANOFI PASTEURLABOREX UGANDA LIMITEDTYPHIM VIPOLYSACCHARIDES OF SALMONELLA TYPHI(TY2 STRAIN)25MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/1997
1171NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE7/1/2001
1172NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2003
1173NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1174NDA/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 CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
1175NDA/MAL/HDP/2481GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDNETRACORTHYDROCORTISONE1%W/WGALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X20.0 G TUBE7/1/2005
1176NDA/MAL/HDP/2489UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMETAC-150RANITIDINE150MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2006
1177NDA/MAL/HDP/2496MACLEODS PDHARMACEUTICALS LTVITACARE LIMITEDZETIVAS 20ATORVASTATIN/EZETIMIBE20MG/10MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1178NDA/MAL/HDP/2497CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIMUNENEVIRAPINE50MG/5MLCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2004
1179NDA/MAL/HDP/2498MACLEODS PDHARMACEUTICALS LTVITACARE LIMITEDZETIVAS 10ATORVASTATIN/EZETIMIBE10MG/10MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1180NDA/MAL/HDP/2500MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCHLORAMPHENICOL SODIUM SUCCINATE INJECTION BPCHLORAMPHENICOL SODIUM SUCCINATE1GMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2007
1181NDA/MAL/HDP/2502ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDPROBETA N EYE DROPBETAMETHASONE + NEOMYCIN0.1%W/V+0.5%W/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANOPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1997
1182NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LTDMETRO 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 TABLETS1.0X50.0X1.0X4.0 TABLET STRIP7/1/2008
1183NDA/MAL/HDP/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X20.0 G TUBE7/1/2011
1184NDA/MAL/HDP/2507CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEXERMET 1000METFORMIN HCL1000MGCIPLA LIMITED ,.,.-VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2007
1185NDA/MAL/HDP/2508GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHYOSCINEHYOSCINE20MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2011
1186NDA/MAL/HDP/2509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDOPELE LOTIONBENZYL BENZOATE25%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYATOPICAL EXTERNAL LOTIONS1.0X50.0 ML BOTTLE7/1/1997
1187NDA/MAL/HDP/2510PANACEA BIOTEC LTDVITACARE LIMITEDGIROORDNIDAZOLE500MGPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X2.0X10.0 TABLET BLISTER7/1/2013
1188NDA/MAL/HDP/2511BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 5MGREMIFENTANIL5MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) ITALYPARENTERAL ORDINARY DRY VIALS1.0X5.0 VIAL CARTON7/1/1999
1189NDA/MAL/HDP/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/MLWUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE7/1/2009
1190NDA/MAL/HDP/2515AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDSIMFEN 200 TABLETSIBUPROFEN200MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1191NDA/MAL/HDP/2519MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDVITA CAPMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2009
1192NDA/MAL/HDP/2521MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1193NDA/MAL/HDP/2523SHOSAAN ASIC PACIFICRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/1997
1194NDA/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-396 210
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1195NDA/MAL/HDP/2525ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/1998
1196NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE7/1/1997
1197NDA/MAL/HDP/2529GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDG-CEFTRIACEFTRIAXONE1GGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI,1.0X1.0X50.0 G VIAL,1.0X1.0 VIAL CARTON7/1/2012
1198NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/1997
1199NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
1200NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP7/1/2003
1201NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE40MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP7/1/2005
1202NDA/MAL/HDP/2555COSMOS LTDASTRA PHARMA (U) LIMITEDPHENOBARBITONE TABLETS BP 30MGPHENOBARBITONE30MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
1203NDA/MAL/HDP/2556GILEAD SCIENCES INCMEDICAL ACCESS (UGANDA) LIMITEDTRUVADAEMTRICITABINE/TENOFOVIR200MG/300MGTAKEDA GMBH-16515 ORANIENBURG GERMANY AUNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
1204NDA/MAL/HDP/2557REMEDICA LTDGOODMAN INTERNATIONAL LTDEPSITRON 25 TABLETSCAPTOPRIL25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1999
1205NDA/MAL/HDP/2558RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMYCOREN SUSPENSIONNYSTATIN100000 I.U/ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2007
1206NDA/MAL/HDP/2559RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDERYTHRORENERYTHROMYCIN STEARATE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1207NDA/MAL/HDP/2561PHARMATHEN LTDGOODMAN INTERNATIONAL LTDLANOMYCINAMIKACIN SULPHATE500MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE GREECEPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/1997
1208NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1209NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
1210NDA/MAL/HDP/2570REMEDICA LTDGOODMAN INTERNATIONAL LTDAMOXAPEN 250 CAPSULESAMOXYCILLIN250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER7/1/1997
1211NDA/MAL/HDP/2571GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE180 MG + 1080 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
1212NDA/MAL/HDP/2575HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MYTEKAMONTELUKAST SODIUM10MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2005
1213NDA/MAL/HDP/2576RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEQUINE TABLETSCHLOROQUINE PHOSPHATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY TABLETS1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
1214NDA/MAL/HDP/2577TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOPCEF 200CEFIXIME200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1215NDA/MAL/HDP/2579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 300/375 LACTABARTESUNATE + MEFLOQUINE300 MG + 375 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2005
1216NDA/MAL/HDP/2580ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDHEDON TABLETSPARACETAMOL + ASPIRIN + CAFFEINE250 MG+ 300 MG + 30 MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA MILAN LABORATORIES (INDIA) PVT LTD - -63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI KENYAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1998
1217NDA/MAL/HDP/2591HEALTHCARE LTD.HEALTHCARE LTD.VITAGLOBIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTAL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2001
1218NDA/MAL/HDP/2593DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1219NDA/MAL/HDP/2594GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFEFFERROUS SULPHATE + FOLIC ACID200MG + 0.4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2009
1220NDA/MAL/HDP/2595MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDZEPILENCEFAZOLIN1000MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON7/1/2009
1221NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1222NDA/MAL/HDP/2601MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 750MGCEFUROXIME750MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON7/1/2009
1223NDA/MAL/HDP/2602: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM BIDAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MG/ 5 MLINDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2010
1224NDA/MAL/HDP/2603CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDVIRADAYTENOFOVIR + EMTRICITABINE + EFAVIRENZ300 MG + 200 MG + 600 MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2011
1225NDA/MAL/HDP/2604USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
1226NDA/MAL/HDP/2606SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDPROTAS 40ESOMEPRAZOLE40MGSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
1227NDA/MAL/HDP/2607SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDFLOTRALALFUZOSIN HCL10MGSUN PHARMACEUTICAL INDUSTRIES LTD-VILLAGE GANGUWALA, PAONTA SAHIB,173 025,DISTRICT SIRMOUR HIMACHAL PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1228NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1229NDA/MAL/HDP/2612RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRONMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2005
1230NDA/MAL/HDP/2628MICRO LABS LTDLABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2004
1231NDA/MAL/HDP/2641MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 250MGCEFUROXIME AXETIL250MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2014
1232NDA/MAL/HDP/2642MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI7/1/2009
1233NDA/MAL/HDP/2645SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANZIDIME 1000CEFTAZIDIME1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL7/1/2010
1234NDA/MAL/HDP/2647DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1235NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1236NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1237NDA/MAL/HDP/2653BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDSONADERM-GMCLOBETASOL + MICONAZOLE + GENTAMICIN0.05%W/W + 2% W/W+ 0.1%W/WBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2007
1238NDA/MAL/HDP/2654MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.BEBE VITVITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B21500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/2006
1239NDA/MAL/HDP/2671CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOLIN RESPULESIPRATROPIUM BROMIDE & SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIALUNG ADMINISTRATION LIQUID FOR INHALATION4.0X5.0X2.5 ML VIAL7/1/2005
1240NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLIBITUS PLUS SYRUPTERBUTALINE/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2011
1241NDA/MAL/HDP/2678CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0 CAPSULE BLISTER7/1/2004
1242NDA/MAL/HDP/2679CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDALERID SYRUPCETIRIZINE HYDROCHLORIDE5MG/5ML CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.
INDIAORAL LIQUID ORDINARY SYRUPS1.0X30.0 ML BOTTLE7/1/2006
1243NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1244NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1245NDA/MAL/HDP/2683RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
1246NDA/MAL/HDP/2685RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOL(SUSPENSION)PARACETAMOL120MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE7/1/2007
1247NDA/MAL/HDP/2687M.J BIOPHARM PVT LTDVITACARE LIMITEDTEICO 1000CEFEPIME1000MGM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2013
1248NDA/MAL/HDP/2690ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-250AMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2011
1249NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON7/1/2011
1250NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON7/1/2012
1251NDA/MAL/HDP/2699CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 12.5CARVEDILOL12.5 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/2005
1252NDA/MAL/HDP/2701UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMIFULVINGRISEOFULVIN500MGUMEDICA LABORATORIES PVT. LTD-PLOT 221-GIDC, 2ND PHASE, VAPI 396195 GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1253NDA/MAL/HDP/2702CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 2GLIMEPIRIDE2MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
1254NDA/MAL/HDP/2703AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 312.50CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE)250+62.50MG/ 5MLAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
1255NDA/MAL/HDP/2704MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDPRIMACORT-100HYDROCORTISONE SODIUM SUCCINATE100MGMACLEODS PHARMACEUTICALS LTD-MAHIM ROAD, NEAR KULDEEP NAGAR REGAR(W0 MAHARASHTRA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X100.0 MG VIAL7/1/2005
1256NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL7/1/2011
1257NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER7/1/2000
1258NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER7/1/1997
1259NDA/MAL/HDP/2712NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE0.025%W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2014
1260NDA/MAL/HDP/2714NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDANAFRANILCLOMIPRAMINE25MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA ITALYORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/1997
1261NDA/MAL/HDP/2715MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINELAMIVUDINE150MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X60.0 TABLET CONTAINER7/1/2008
1262NDA/MAL/HDP/2717CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2000
1263NDA/MAL/HDP/2719SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDLORASEDLORATADINE10MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP7/1/2007
1264NDA/MAL/HDP/2720SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOX 250MG POWDER FOR ORAL SUSPENSIONAMOXICILLIN +FLUCLOXACILLIN125MG/5ML+125MG/5MLSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE7/1/2007
1265NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1266NDA/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 SOLS1.0X10.0 G TUBE7/1/2007
1267NDA/MAL/HDP/2723TABROS PHARMAHEALTHCARE LTD.DURAGESIC TABLETPARACETAMOL + ORPHENADRINE450MG+35MGTABROS PHARMA-L-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1268NDA/MAL/HDP/2738WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5G/10MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAPARENTERAL ORDINARY I V VIALS1.0X5.0X10.0 ML VIAL7/1/2001
1269NDA/MAL/HDP/2745RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
1270NDA/MAL/HDP/2746ERIS LTDBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET BLISTER7/1/2000
1271NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1272NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LIMITED -PLOT NO. L121 B PHASE 111A VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER7/1/2016
1273NDA/MAL/HDP/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTECMISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YAUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
1274NDA/MAL/HDP/2761REMEDICA LTDGOODMAN INTERNATIONAL LTDTRIFLUOPERAZINETRIFLUOPERAZINE HYDROCHLORIDE5MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1275NDA/MAL/HDP/2774ACINO PHARMA AGGOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1276NDA/MAL/HDP/2776UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDTENSIMIN-100ATENOLOL100MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER7/1/1997
1277NDA/MAL/HDP/2777NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 160/12.5MG TABLETSVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/2016
1278NDA/MAL/HDP/2779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SURGICAL SCRUBPOVIDONE IODINE7.5%W/VBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE
1279NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1280NDA/MAL/HDP/2782INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKWINILQUININE DIHYDROCHLORIDE300MG/MLINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT INDIAPARENTERAL ORDINARY AMPOULES20.0X5.0X2.0 ML AMPOULE7/1/1998
1281NDA/MAL/HDP/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE FRANCERECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP7/1/2006
1282NDA/MAL/HDP/2784MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)AMOXICILLIN ORAL SUSPENSIONAMOXICILLIN125MG/5MLMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1283NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125 DTAMOXICILLIN125MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER11/19/2017
1284NDA/MAL/HDP/2788RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMULTIVITAMIN TABLETSMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1285NDA/MAL/HDP/2790UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 20ATORVASTATIN20MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2003
1286NDA/MAL/HDP/2792UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 10ATORVASTATIN10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
1287NDA/MAL/HDP/2793GILEAD SCIENCES INCMEDICAL ACCESS (UGANDA) LIMITEDVIREADTENOFOVIR DISOPROXIL FUMARATE300MGTAKEDA GMBH,PLANT ORANIENBURG-LEHNITZSTRASSE 70-98,16515,ORANIENBURG-GERMANY CANADAORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BOTTLE7/1/2004
1288NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON7/1/2001
1289NDA/MAL/HDP/2797RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDLUMARENARTEMETHER + LUMEFANTRINE20 MG + 120 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER7/1/2010
1290NDA/MAL/HDP/2800NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPID HM PENFILLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE DENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN7/1/1997
1291NDA/MAL/HDP/2802CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1292NDA/MAL/HDP/2805REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 20R TABLETSNIFEDIPINE20MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1293NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER7/1/2011
1294NDA/MAL/HDP/2808UNIVERSAL CORPORATION LTD.PHARMA VILLE LIMITEDQUININEQUININE300MGUNIVERSAL CORPORATION LTD-CLUB ROAD, KIKUYU TOWN PAST POST OFFICE, P.O. BOX 1748-00902 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2005
1295NDA/MAL/HDP/2812DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER + LUMEFANTRINE180 MG/60ML + 1080 MG/60MLS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. NETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE7/1/2005
1296NDA/MAL/HDP/2814THE ARAB DRUG COMPANYGOODMAN INTERNATIONAL LTDVENTAL PLUSSALBUTAMOL + BECLOMETHASONE DIPROPIONATE0.1MG + 0.05MG/ PUFFTHE ARAB DRUG COMPANY-5-EL MASSANEI ST AL AMEREYA CAIROEGYPTLUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 DOSE CANNISTER7/1/2014
1297NDA/MAL/HDP/2816CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-100 TABLETSATENOLOL100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1298NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2011
1299NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE7/1/1997
1300NDA/MAL/HDP/2830MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX MIXTUREQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE) UGANDAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2003
1301NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE / METRONIDAZOLE5%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 OINTMENTS1.0X20.0 G TUBE,1.0X125.0 G TUBE7/1/2011
1302NDA/MAL/HDP/2838MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 120CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE120MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2010
1303NDA/MAL/HDP/2848MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDDIPROGENTA OINTMENTBETAMETHASONE /GENTAMICIN SULPHATE0.5MG/G+1.0MG/GSCHERING-PLOUGH LABONV-INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUM CANADATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2001
1304NDA/MAL/HDP/2850MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM20MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTPARENTERAL ORDINARY AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE7/1/2007
1305NDA/MAL/HDP/2868CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 50LOSARTAN POTASSIUM50MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER7/1/2003
1306NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART BELGIUMPARENTERAL ORDINARY DRY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/2010
1307NDA/MAL/HDP/2873INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHELIGO KITTINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE500MG+ 250MG+30MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X7.0X6.0 TABLET BLISTER7/1/2001
1308NDA/MAL/HDP/2875GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.05% NASAL DROPSXYLOMETAZOLINE0.05%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND SWITZERLANDNASAL TOPICAL DROPS1.0X10.0 ML BOTTLE7/1/2003
1309NDA/MAL/HDP/2877AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDCANDICANFLUCONAZOLE0.2%W/VAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2005
1310NDA/MAL/HDP/2878PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCOCIN CREAMGENTAMYCIN SULPHATE0.1%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
1311NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER7/1/2004
1312NDA/MAL/HDP/2880REMEDICA LTDGOODMAN INTERNATIONAL LTDCARBIMAZOLE 5CARBIMAZOLE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1313NDA/MAL/HDP/2882TATA UGANDA LIMITEDTATA UGANDA LIMITEDHYOSCINE BROMIDEHYOSCINE BROMIDE2OMG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043 GLAND PHARMA LTD-PLOT NO. 42 TO 52, SY NO. 166, 171, 172 & 177, TSIIC, PHASE III, PASHAMYLARAM (V) PATANCHERU (M), MEDAK DISTRICT 502307, TELANGANA STATE INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1314NDA/MAL/HDP/2885MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDFORECOX-TRACRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER7/1/2005
1315NDA/MAL/HDP/2887MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)QUININE SULPHATEQUININE SULPHATE300MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER7/1/2009
1316NDA/MAL/HDP/2890KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL NBETAMETHASONE+NEOMYCIN1MG/G+5MG/GKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1317NDA/MAL/HDP/2891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2006
1318NDA/MAL/HDP/2892UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDNICARDIA-20 TABLETSNIFEDIPINE20MGUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1319NDA/MAL/HDP/2893DAWA LIMITEDSUPER MEDIC LTDSTOPACID SUSPENSIONMAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE250MG/5ML + 120MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1320NDA/MAL/HDP/2894EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMUCOGEL SUSPENSIONDRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE8G/100ML + 2G/100ML + 0.2 G/100MLEGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X125.0 ML BOTTLE7/1/2005
1321NDA/MAL/HDP/2896KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDMCG CREAMMICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE2.0%W/W + 0.05%W/W + 0.1 %W/WKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE7/1/2005
1322NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2006
1323NDA/MAL/HDP/2900MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-200CEFIXIME200MGMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2005
1324NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X1.0X4.0 TABLET STRIP7/1/2005
1325NDA/MAL/HDP/2905EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDBRONCHOPHANE SYRUPGUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN50MG+7.5MG+5MG+4.58MGEGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. EIPICO-10TH STREET RAMADAN CITY, FIST INDUSTRIES ARE EGYPTORAL LIQUID ORDINARY SYRUPS1.0X1.0X125.0 ML BOTTLE7/1/2007
1326NDA/MAL/HDP/2907BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART DSARTEMETHER + LUMEFANTRINE80 MG + 480 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2013
1327NDA/MAL/HDP/2908SHOSAAN ASIC PACIFICRENE PHARMACY LTDPAINGO MEDICATED CREAMMETHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE 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 CREAMS1.0X2.0X15.0 G TUBE7/1/2010
1328NDA/MAL/HDP/2910CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTENVIR EMTENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE300MG+200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2009
1329NDA/MAL/HDP/2911KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL LORATADINELORATADINE10MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1330NDA/MAL/HDP/2915VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDTREXOLMETHOTREXATE50MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS1.0X1.0X2.0 ML VIAL7/1/2009
1331NDA/MAL/HDP/2919CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 5MONTELUKAST5MGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1332NDA/MAL/HDP/2920CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDTRANSLIPO -C CREAMCLOTRIMAZOLE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE7/1/2001
1333NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PVT. LTDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X20.0 G TUBE7/1/2005
1334NDA/MAL/HDP/2941CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 20ATORVASTATIN20MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER7/1/2005
1335NDA/MAL/HDP/2942CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDARGISSEPT CREAMCHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE0.2%W/W / 1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X10.0 G TUBE7/1/2005
1336NDA/MAL/HDP/2945MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDONCETCETIRIZINE DIHYDROCHLORIDE10MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1337NDA/MAL/HDP/2946GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO ORAL SUSPENSIONCO-TRIMOXAZOLE240MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
1338NDA/MAL/HDP/2947GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO TABLETSCO-TRIMOXAZOLE480MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON7/1/1998
1339NDA/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 GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER7/1/2007
1340NDA/MAL/HDP/2950PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDXALATANLATANOPROST0.005%W/VPFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS BELGIUMOPHTHALMIC DROPS1.0X2.5 ML BOTTLE7/1/1998
1341NDA/MAL/HDP/2951BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART FORTE TABLETSARTEMETHER + LUMEFANTRINE40 MG + 240 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X6.0 TABLET BLISTER7/1/2007
1342NDA/MAL/HDP/2956ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRANLOK 500MG TABLETSTRANEXAMIC ACID500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2007
1343NDA/MAL/HDP/2957MEDIPHARM SALES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEDITROLCALCITRIOL0.25MCGMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND THAILANDORAL SOLID ORDINARY CAPSULES1.0X6.0X5.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER7/1/2009
1344NDA/MAL/HDP/2961NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDOFTALMOLOSA CUSI ERYTHROMYCIN 0.5%ERYTHROMYCIN0.5%W/WALCON CUSI SA-CAMIL FABRA 58 08320 EL MASNOUR BARCELONASPAINOPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2001
1345NDA/MAL/HDP/2966CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTENVIRTENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
1346NDA/MAL/HDP/2967CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.HAEM-FFERROUS FUMARATE200MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE INDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE BOTTLE7/1/2003
1347NDA/MAL/HDP/2969UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDTENSIMIN-50ATENOLOL50MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,14.0X10.0 TABLET BLISTER7/1/1997
1348NDA/MAL/HDP/2970USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 500METFORMIN500MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1349NDA/MAL/HDP/2971TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.LEFRA-20 TABLETSLEFLUNOMIDE20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2004
1350NDA/MAL/HDP/2974NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTRAVATANTRAVOPROST4µG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X2.5 ML VIAL7/1/2009
1351NDA/MAL/HDP/2978SANOFI PASTEURLABOREX UGANDA LIMITEDTETAVAXTETANUS VACCINE40 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/1997
1352NDA/MAL/HDP/2979ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N CREAMBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/1997
1353NDA/MAL/HDP/2980BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART TABLETSARTEMETHER + LUMEFANTRINE20 MG + 120 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X3.0X6.0 TABLET BLISTER7/1/2007
1354NDA/MAL/HDP/2982CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDNEURO-FORTE TABLETSVITAMIN B1 + VITAMIN B6 + VITAMIN B12200MG + 50MG + 1MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2004
1355NDA/MAL/HDP/2983CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFUCOL 200FLUCONAZOLE200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA CIPLA LTD KURKUMBH-D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALUKA-DAUND, PUNE, MAHARASHTRA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X1.0X4.0 CAPSULE BLISTER7/1/2004
1356NDA/MAL/HDP/2985SANOFI 410 THALESSURGIPHARM (U) LIMITEDEPILIM CHRONOSODIUM VALPROATE PH. EUR500MGSANOFI WINTHROP INDUSTRIE-1,RUE DE LA VIERGE ,AMBARES ET LAGRAVE 33565,CARBON BLANC CEDEX FRANCE FRANCEORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
1357NDA/MAL/HDP/2989METRO PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDICLOFENACDICLOFENAC25MG/MLCSPC OUYI PHARMACEUTICAL CO. LTD.-WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE7/1/2011
1358NDA/MAL/HDP/2990MICRO LABS LTDLABOREX UGANDA LIMITEDPULMOCEF-500CEFUROXIME AXETIL USP500MGMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER7/1/2004
1359NDA/MAL/HDP/2992GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDHAVRIX1440HEPATITIS A ANTIGEN(HM 175 STRAIN)NLT 1440 ELISA UNITS OF VIRAL ANTIGENS(HM 175 STRAIN)GLAXOSMITHKLINE BIOLOGICALS-RUE DE L' LNSTITUT 89-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL (1 DOSE)7/1/1997
1360NDA/MAL/HDP/2995GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGALLOPLOPERAMIDE HYDROCHLORIDE USP2MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER7/1/2007
1361NDA/MAL/HDP/2997MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDACENAC TABLETSACECLOFENAC100 MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2017
1362NDA/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-396 210
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1363NDA/MAL/HDP/3002LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDKELVINPARACETAMOL500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
1364NDA/MAL/HDP/3003GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIRACICLOVIR200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER7/1/2007
1365NDA/MAL/HDP/3004AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAUROPODOX 100CEFPODOXIME PROXETIL100MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2007
1366NDA/MAL/HDP/3005ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-100 SR DEPOCAPSDICLOFENAC SODIUM100MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL SWITZERLANDORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER7/1/1997
1367NDA/MAL/HDP/3007INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDTORTAS 5TORSEMIDE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
1368NDA/MAL/HDP/3009VENUS REMEDIES LIMITEDHARLEYS UGANDA LIMITEDSULBACTOMAX 1.5GCEFTRIAXONE+SULBACTAM1000MG+500MGVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP INDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL7/1/2009
1369NDA/MAL/HDP/3012WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1998
1370NDA/MAL/HDP/3013GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLEALBENDAZOLE400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
1371NDA/MAL/HDP/3015CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA-50 TABLETSSILDENAFIL50MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER,1.0X20.0X4.0 TABLET BLISTER7/1/2001
1372NDA/MAL/HDP/3019MJ BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN 30/70INSULIN SOLUBLE + INSULIN ISOPHANE30 I.U + 70 I.UMJ BIOPHARM PRT LTD-L-7 MIDC INDUSTRIAL AREA, TALOJA, NARI MUMBAI MAHARASHTRA INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2008
1373NDA/MAL/HDP/3020M.J BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN NINSULIN ISOPHANE100 I.U/MLM.J .BIOPHARM-L7, M.I.D.C INDUSTRIAL AREA TALOJA, NAVI MUMBAI MAHARAHTRA INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/2008
1374NDA/MAL/HDP/3021GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGLIBENCLAMIDE TABLETSGLIBENCLAMIDE5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2012
1375NDA/MAL/HDP/3022M.J BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN LINSULIN ZINC SUSPENSION100 I.U/MLM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/2008
1376NDA/MAL/HDP/3023GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAXLEVAMISOLE HYDROCHLORIDE40MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER7/1/2007
1377NDA/MAL/HDP/3024MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE150MG + 200MG + 300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.
INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
1378NDA/MAL/HDP/3029GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE SUSPENSIONALBENDAZOLE USP200 MG/ 5 MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2007
1379NDA/MAL/HDP/3030MJ BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN RINSULIN SOLUBLE100 IU/MLM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/2008
1380NDA/MAL/HDP/3031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMETHASONEDEXAMETHASONE0.5MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1381NDA/MAL/HDP/3032ACINO PHARMA AGGOODMAN INTERNATIONAL LTDXYLO-ACINO 0.05%XYLOMETAZOLINE0.05%W/VMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYNASAL TOPICAL SPRAYS WITHOUT GAS1.0X10.0 ML BOTTLE7/1/2007
1382NDA/MAL/HDP/3035GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFORTE TONICFERRIC AMMONIUM CITRATE + FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE + VITAMIN B1250MG + 0.55MG + 2.4MG + 1.2MG + 11MG + 2.5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
1383NDA/MAL/HDP/3037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT SYRUPVITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + NIACINAMIDE + VITAMIN B12 + VITAMIN C1000I.U + 200I.U + 1.5MG + 1.5MG+ 10MG + 2.5MCG + 40MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
1384NDA/MAL/HDP/3040GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODOXDOXYCYCLINE100MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1385NDA/MAL/HDP/3042PFIZER LAB LTDLABOREX UGANDA LIMITEDNEUROTINGABAPENTIN300MGPFIZER MANUFACTURING DEUTSCHLAND (PMD) GMBH-PHYSICAL ADDRESS: MOOSWALDALLEE 1D – 79090 FREIBURGGERMANYORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
1386NDA/MAL/HDP/3043INDOCO REMEDIES LTDSTAR PHARMACEUTICALS LTDFEBREX TABLETSPARACETAMOL500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1387NDA/MAL/HDP/3044CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPIRICAM-20 CAPSULESPIROXICAM20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER7/1/1997
1388NDA/MAL/HDP/3046GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2009
1389NDA/MAL/HDP/3047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDABACAVIR SULFATE+LAMIVUDINE+ZIDOVUDINEABACAVIR SULFATE + LAMIVUDINE + ZIDOVUDINE300 MG + 150 MG + 300 MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. – 431136,
MAHARASHTRA STATE, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
1390NDA/MAL/HDP/3048GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO-DS TABLETSSULFAMETHOXAZOLE/TRIMETHOPRIM800MG/160MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1391NDA/MAL/HDP/3049CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZEFAVIRENZ600MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
1392NDA/MAL/HDP/3051BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETROZOLEDILOXANIDE FUROATE+METRONIDAZOLE BENZOATE+SIMETHICONE125MG+160MG+25MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2005
1393NDA/MAL/HDP/3055CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDABACAVIR SULFATEABACAVIR SULPHATE300MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2007
1394NDA/MAL/HDP/3057GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLD-A-GO CAPSULESPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE400MG + 5MG + 12.5MG + 30MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1395NDA/MAL/HDP/3058SANOFI-AVENTISSURGIPHARM (U) LIMITEDXATRAL LP 10MGALFUZOSIN10MGSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2 FRANCEORAL SOLID ORDINARY COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1396NDA/MAL/HDP/3060GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDKETOS TABLETKETOCONAZOLE USP200 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/7/2007
1397NDA/MAL/HDP/3063GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC-50DICLOFENAC SODIUM50MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2007
1398NDA/MAL/HDP/3064GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTIN-TIN TABLETSTINIDAZOLE500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER7/1/2007
1399NDA/MAL/HDP/3067GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMAGO SYRUPPROMETHAZINE5MG/5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE7/1/2007
1400NDA/MAL/HDP/3068REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.OPTACHLOR EYE DROPSCHLORAMPHENICOL0.5%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/1999
1401NDA/MAL/HDP/3069GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOVE CAPSULESPIROXICAM20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER7/1/2007
1402NDA/MAL/HDP/3072GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL TABLETS(THANE)PARACETAMOL500 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
1403NDA/MAL/HDP/3073COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL50MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X14.0 TABLET STRIP7/1/1997
1404NDA/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 TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
1405NDA/MAL/HDP/3078JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB ALLERGY CONGESTIONPARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE500MG/ 2MG/ 30MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2010
1406NDA/MAL/HDP/3083ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 80TELMISARTAN80MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
1407NDA/MAL/HDP/3085GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD TABLETSPARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE500.MG+5.0MG+30.0MG+2.0MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER7/1/2007
1408NDA/MAL/HDP/3088CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDPILL 72LEVONORGESTREL0.75MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2014
1409NDA/MAL/HDP/3090PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOXCEFPODOXIME PROXETIL100MG/5MLPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA
JORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2004
1410NDA/MAL/HDP/3092NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDEXFORGE HCT 10MG/160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE10MG + 160MG +12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
1411NDA/MAL/HDP/3095LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDAMPHEN SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
1412NDA/MAL/HDP/3097PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDEBACRONGLICLAZIDE80MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2008
1413NDA/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 SYRUPS1.0X60.0 ML BOTTLE7/1/2004
1414NDA/MAL/HDP/3099PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDZONA 0.1% CREAMHYDROCORTISONE 17-BUTYRATE0.1%W/WPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN JORDANTOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2007
1415NDA/MAL/HDP/3101DAWA LIMITEDSUPER MEDIC LTDDACOLD SYRUPPARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE120MG/5ML+10MG/5ML+2MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2010
1416NDA/MAL/HDP/3104LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDNYSTALEB ORAL SUSPENSIONNYSTATIN100000IU/MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE