Drug Register (July 2024)
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S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURING SITECOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/10012REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDPILEENO OINTMENTPAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTANPAKISTAN TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE28/02/2022
2NDA/MAL/HHP/10013REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDSLIM TRIM CAPSULES.PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTANPAKISTAN ORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BLISTER28/02/2022
3NDA/MAL/HHP/10014REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDNEUROCAREPAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTANPAKISTANTOPICAL EXTERNAL OINTMENTS 1X50 G TUBE28/02/2022
4NDA/MAL/HHP/10015REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDDOMO CREAM.PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTANPAKISTAN TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE28/02/2022
5NDA/MAL/HHP/10016REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDTOTO CARE.PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTANPAKISTAN ORAL LIQUID ORDINARY LIQUIDS 1.0X150.0 ML BOTTLE28/02/2022
6NDA/MAL/HHP/10017REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDMARKONIL CREAM.PAUL BROOKS HOMOEO LABSA-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTANPAKISTAN TOPICAL EXTERNAL CREAMS 1.0X100.0 G TUBE28/02/2022
7NDA/MAL/HHP/10019CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN TABLETSCHARAK PHARMA PRIVATE LIMITEDJAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER07/03/2022
8NDA/MAL/HHP/10024GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOZETS MENTHOMAX PLUSPRINCE SUPPLICOPLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGARINDIAORAL SOLID ORDINARY LOZENGES 1X50X2 LOZENGE BLISTER05/04/2022
9NDA/MAL/HHP/10026ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDNEOSILS HERBAL COUGH LOZENGESLEAMARK HEALTHCARE PVT LTDSARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY LOZENGES 1.0X25.0X2.0 LOZENGE STRIP11/04/2022
10NDA/MAL/HHP/10027BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDACTIVATED CHARCOAL TABLETSBHARGAVA PHYTOLAB PVT.LTDE-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X90.0 TABLET BOTTLE21/04/2022
11NDA/MAL/HHP/10409CHETAN & DIPTI (C&D) PHARMA PVT LTDKAMCARE PHARMA LIMITEDHERBOXIL LOZENGESLEAMARK HEALTHCARE PVT LTDSARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARATINDIA ORAL SOLID ORDINARY LOZENGES 1.0X50.0X2.0 LOZENGE STRIP12/10/2022
12NDA/MAL/HHP/10411BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS ORANGE LOZENGESLOZEN PHARMA PRIVATE LIMITEDRAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
13NDA/MAL/HHP/10412BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS MENTHOL LOZENGESLOZEN PHARMA PRIVATE LIMITEDRAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
14NDA/MAL/HHP/10413BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS HONEY LEMON LOZENGESLOZEN PHARMA PRIVATE LIMITEDRAGHAV ESTATE, KSSIDC, INDUSTRIAL AREA, SAVANUR, DISTT. HAVERI, KARNATAKA - 581 118, INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER16/11/2022
15NDA/MAL/HHP/10500GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL NATURA SYRUPTHE MADRAS PHARMACEUTICALS..NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/12/2022
16NDA/MAL/HHP/10501SEGURA PHARMA PRIVATE LTDABACUS PHARMA (AFRICA) LIMITEDGOPAYN RUB GELSYNOKEM PHARMACEUTICALS LTD-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE02/12/2022
17NDA/MAL/HHP/10588CHETAN & DIPTI (C&D) PHARMA PVT LTDKAMCARE PHARMA LIMITEDCHARCO PRO TABLETM/S BHARGAVA PHYTOLAB PRIVATE LIMITEDE-1216 PHASE-I, GHATAL, RIICO INDUSTRIAL AREA, BHIWADI, DISTRICT ALWAR (RAJASTHAN) - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER10/01/2023
18NDA/MAL/HHP/10899ARIHANT REMEDIESDAVIMED PHARMA LIMITEDRELIEF OINTMENTARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABADINDIA TOPICAL EXTERNAL OINTMENTS 1.0X50.0 G TUBE27/07/2023
19NDA/MAL/HHP/10901ARIHANT REMEDIESDAVIMED PHARMA LIMITEDRELIEF BALMARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABADINDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X100.0 G CONTAINER27/07/2023
20NDA/MAL/HHP/10902ARIHANT REMEDIESDAVIMED PHARMA LIMITEDCOLD GRIP INHALERARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABADINDIA NASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X0.5 ML CONTAINER27/07/2023
21NDA/MAL/HHP/11013ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDDEEP RUBY BALMARIHANT REMEDIESBLOCK NO. 444,ASHWAMEGH IND. ESTATE OPP. M.N DESAI PUMP,CHANGODAR-382213 AHMEDABADINDIATOPICAL EXTERNAL OINTMENTS 1X1X10 G BOTTLE13/10/2023
22NDA/MAL/HHP/11014ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDDEEP RUBY ROLL ONHILTON PHARMA CHEMPLOT NO. 225, G.I.D.C, SIDHPUR - 384151, PATAN - INDIAINDIATOPICAL EXTERNAL LIQUIDS 1X1X10 ML BOTTLE13/10/2023
23NDA/MAL/HHP/3115CINCINNATI CHILDREN’S HOSPITAL SHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTDINDIAINDIA TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER01/07/2001
24NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOOM SYRUPCHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA CHARAK PHARMA PRIVATE LIMITEDJAURASI ROAD, PAUTI VILLAGE, SAMALKHA, DIST. PANIPAT - 132 101, HARYANA, INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2000
25NDA/MAL/HHP/5502HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDGASEXHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)01/07/2000
26NDA/MAL/HHP/5517HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDMENTATHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X50.0 TABLET CONTAINER01/07/2004
27NDA/MAL/HHP/5518MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTDINDIAINDIA TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER01/07/2007
28NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPSAVERA PHARMACEUTICALS PVT LTD -H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. AJANTA PHARMA LTD - 31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2004
29NDA/MAL/HHP/5520HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDPILEXHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER01/07/2001
30NDA/MAL/HHP/5527HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDKOFLETHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2000
31NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATEAMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY POWDERS 1.0X10.0X765.0 MG SACHET01/07/2009
32NDA/MAL/HHP/5530HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDLIV.52 TABLETSHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE01/07/2000
33NDA/MAL/HHP/5531HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY27256287 INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/2000
34NDA/MAL/HHP/5532MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVTG 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATIINDIA NASAL TOPICAL LIQUID INHALATIONS 1.0X12.0X1.0 G ROD01/07/2009
35NDA/MAL/HHP/5533HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)01/07/2000
36NDA/MAL/HHP/5536ABACUS (A) PHARMA LTDJEET PHARMACEUTICALS LIMITEDMENTHO PLUS PAIN BALMEMAMI LTDEMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIA NASAL TOPICAL OINTMENTS 1.0X24.0X3.5 ML VIAL,1.0X1.2 G JAR,1.0X4.0 G JAR,1.0X9.0 G JAR,1.0X30.0 G JAR,1.0X1.2 ML VIAL,1.0X4.0 ML VIAL,1.0X9.0 ML VIAL,1.0X30.0 ML BOTTLE01/07/2004
37NDA/MAL/HHP/5538HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDSEPTILINHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER01/07/2000
38NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
39NDA/MAL/HHP/5547CINCINNATI CHILDREN’S HOSPITAL SHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTDINDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X35.0X2.0 LOZENGE STRIP01/07/2001
40NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2000
41NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAINDIA ORAL TOPICAL GELS AND SOLS 1.0X50.0 G TUBE01/07/2015
42NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTDSARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES 1.0X10.0X2.0 LOZENGE STRIP, 1.0X50.0X2.0 LOZENGE STRIP01/07/2009
43NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER REMEDIES PVT LTDM-190 MIDC WALUJ AURANGABAD 431136 BETA HEALTHCARE INTERNATIONAL LTD-PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYAINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
44NDA/MAL/HHP/5559CINCINNATI CHILDREN’S HOSPITAL SHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTDINDIAINDIA TOPICAL EXTERNAL OINTMENTS 1.0X12.0 G TUBE01/07/2001
45NDA/MAL/HHP/5563HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDCYSTONEHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER01/07/2001
46NDA/MAL/HHP/5564AIL HEALTH CARE VRUSHIK INVESTMENT LIMITEDFRESH HERBAL COUGH SYRUPAIL HEALTH CARE816/1 RAKANPUR KALOL GENDHINAGAR GUJRATINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2016
47NDA/MAL/HHP/5570PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDSITCOMPANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER01/07/2013
48NDA/MAL/HHP/5571ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITEDPLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIAINDIA TOPICAL EXTERNAL OTHER OINTMENTS 1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER01/07/2004
49NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTE CHARAK PHARMA PVT LTDJAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER01/07/2011
50NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2009
51NDA/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 SYRUPS 1X60 ML BOTTLE01/07/2016
52NDA/MAL/HHP/5583HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDEVECAREHIMALAYA DRUG COMPANY27256287 INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER01/07/2001
53NDA/MAL/HHP/5587CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDMANOLL SYRUPCHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA CHARAK PHARMA PVT LTDJAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X250.0 MG BOTTLE01/07/2016
54NDA/MAL/HHP/5588CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (HONEY LEMON FLAVOUR)CHARAK PHARMA PVT LTD,EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X2.0X6.0 LOZENGE BLISTER01/07/2014
55NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIESPLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA
INDIATOPICAL EXTERNAL OINTMENTS 1X20 G CONTAINER01/07/2009
56NDA/MAL/HHP/5623UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2005
57NDA/MAL/HHP/5629UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2005
58NDA/MAL/HHP/5630UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH REMEDYUNIQUE PHARMACEUTICAL LABORATORIES -PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA.INDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE01/07/2000
59NDA/MAL/HHP/5631UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES(LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
60NDA/MAL/HHP/6848CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (MINT)LEAMARK HEALTHCARE PVT LTDSARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARATINDIA ORAL SOLID ORDINARY LOZENGES 1.0X3.0X4.0 LOZENGE BLISTER,1.0X2.0X6.0 LOZENGE BLISTER01/07/2016
61NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULES TIRUPATI LIFESCIENCESNAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER01/07/2015
62NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDGAMA PHARMACEUTICALS (U) LIMITEDLIBLAB SYRUPDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN.JORDAN ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2012
63NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIA TOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE01/07/2015
64NDA/MAL/HHP/7936SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGILOBA 60 CAPSULESQUARE HERBAL AND NUTRACEUTICALS LTD48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212BANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE BLISTER01/07/2013
65NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTD GAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SQUARE HERBAL AND NUTRACEUTICALS LTD 48 MOHAKHALI COMERCIAL AREA, DHAKA-1212BANGLADESH ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
66NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXSQUARE HERBAL AND NUTRACEUTICALS LTD48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212BANGLADESH ORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE STRIP01/07/2014
67NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONSYDLER REMEDIESPRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA GLENMARK PHARMACEUTICAL LIMITED61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIA TOPICAL EXTERNAL OTHER CREAMS 1.0X50.0 ML BOTTLE01/07/2015
68NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
THAILAND ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2016
69NDA/MAL/HHP/7946SHEBAC PHARMANORVIK ENTERPRISES LIMITEDAPONTISAEROMAC (INDIA) INC12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIAINDIA TOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X150.0 ML BOTTLE01/07/2015
70NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES(HONEY LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
71NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES -PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA.INDIA ORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE CONTAINER01/07/2016
72NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES(RASPBERRY)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
73NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP01/07/2014
74NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES. SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
75NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDREDDYS PHARMA LIMITEDKIDFLAMEBHARGAVA PHYTOLAB PVT LTDB-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA)INDIA ORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0 TABLET BLISTER01/07/2015
76NDA/MAL/HHP/7972MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN BALMMONA LAB20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010INDIA TOPICAL EXTERNAL OINTMENTS 1.0X9.0 G JAR,1.0X5.0 G CONTAINER01/07/2009
77NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDPROSTORALBHARGAVA PHYTOLAB PVT. LTD E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X15.0 TABLET BLISTER01/07/2017
78NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTD ABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BACK PAIN ROLL-ONAMRUTANJAN HEALTH CARE LIMITED - PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA INDIA TOPICAL EXTERNAL LOTIONS 1.0X50.0 ML CONTAINER01/07/2004
79NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - 31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE01/07/2017
80NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTDINDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIA ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE20/09/2017
81NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUPCHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA CHARAK PHARMA PVT LTDINDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE02/02/2018
82NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUP CHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/02/2018
83NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUPCHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA CHARAK PHARMA PVT LTDINDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE02/02/2018
84NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULECHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER29/11/2017
85NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE06/03/2018
86NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2017
87NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X20.0 TABLET BLISTER01/07/2016
88NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALM AMRUTANJAN HEALTH CARE LIMITED PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA
PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK,
KANCHEEPURAM, DIST. – 603 110, TAMILNADU, INDIA
INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X10.0 ML TUBE24/11/2017
89NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCESNAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER10/11/2017
90NDA/MAL/HHP/8837PILLAR PHARMA LIMITEDPILLAR LOGISTICS LIMITEDHEPTOVITMILENNIUM HERBAL CARE LTD12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021INDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER07/06/2018
91NDA/MAL/HHP/9093BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD PLOT NO LR 209/6534 MOGADISHU ROADKENYA ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE22/03/2019
92NDA/MAL/HHP/9094BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUP BETA HEALTHCARE INTERNATIONAL LTD PLOT NO LR 209/6534 MOGADISHU ROADKENYA ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE22/03/2019
93NDA/MAL/HHP/9099HINUCONBOOTS PHARMACEUTICALS LIMITEDCRAN MAX PRO SACHETHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0 SACHET CARTON31/05/2019
94NDA/MAL/HHP/9100HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SACHETHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0 SACHET CARTON31/05/2019
95NDA/MAL/HHP/9101HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SYRUPHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE31/05/2019
96NDA/MAL/HHP/9102HINUCONBOOTS PHARMACEUTICALS LIMITEDEPTI SYRUPHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE31/05/2019
97NDA/MAL/HHP/9103HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS SYRUPHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE31/05/2019
98NDA/MAL/HHP/9104HINUCONBOOTS PHARMACEUTICALS LIMITEDCOLOREST DROPSHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY DROPS 1.0X30.0 ML BOTTLE31/05/2019
99NDA/MAL/HHP/9105HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA CAPSULESHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER31/05/2019
100NDA/MAL/HHP/9115REVITAL HEALTHCARE LTDHEALTHCARE LTD.DO-MO CAPSULES ABARIS HEALTHCARE PVT. LTDSURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740INDIA ORAL SOLID ORDINARY CAPSULES 1.0X4.0X10.0 CAPSULE BLISTER16/07/2019
101NDA/MAL/HHP/9121HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS INSTANT SACHETHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0 SACHET CARTON11/03/2020
102NDA/MAL/HHP/9122HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB DROPSHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY DROPS 1.0X20.0 ML BOTTLE11/03/2020
103NDA/MAL/HHP/9123HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB PLUS SYRUPHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE11/03/2020
104NDA/MAL/HHP/9125HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA SACHETHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0 SACHET CARTON11/03/2020
105NDA/MAL/HHP/9126HINUCONBOOTS PHARMACEUTICALS LIMITEDCRANMAX AQUA SYRUPHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE11/03/2020
106NDA/MAL/HHP/9127HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO JARHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X175.0 G JAR11/03/2020
107NDA/MAL/HHP/9128HINUCONBOOTS PHARMACEUTICALS LIMITEDELFERB SYRUPHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE11/03/2020
108NDA/MAL/HHP/9179CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDADDYZOA CAPSULESCHARAK PHARMA PVT. LTD,PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER29/01/2020
109NDA/MAL/HHP/9182REVITAL HEALTHCARE LTDHEALTHCARE LTD.HERBICUFASIAN LIFECARE PVT.LTDMANJUSAR,SAVLI,VADODARA,GUJARAT, INDIA PLOT NO. 3 & 3/A,SHAH INDUSTRIAL PARK-2,NEAR LAMPDAPURA CROSSING,AT&POINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE11/03/2020
110NDA/MAL/HHP/9254UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES-STRAWBERRY FLAVOURUNIQUE PHARMACEUTICAL LABORATORIES ;SURVEY NO. 101/2 & 102/1, DAMAN INDUSTRIAL ESTATE, KAPAIYA, DAMAN 396210INDIA ORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP18/07/2020
111NDA/MAL/HHP/9332MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA IVY SYRUPMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILAND ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE31/08/2020
112NDA/MAL/HHP/9333MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA MOUTH SPRAYMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILAND ORAL TOPICAL SPRAYS WITHOUT GAS 1.0X10.0 ML BOTTLE31/08/2020
113NDA/MAL/HHP/9570GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDBIO-SLIM ACTIVEGAYATRI AYUPHARMA PRIVATE LIMITED234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA)INDIAORAL SOLID ORDINARY CAPSULES 1X6X10 CAPSULE BLISTER22/03/2021
114NDA/MAL/HHP/9694GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF SYRUPKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE22/07/2021
115NDA/MAL/HHP/9701GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF PLUS SYRUPKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE27/08/2021
116NDA/MAL/HHP/9703GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDCURODEX OINTMENTRAJESH PHARMACEUTICALS7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481INDIA TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G BOTTLE27/08/2021
117NDA/MAL/HHP/9704GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL INHALERRAJESH PHARMACEUTICALS7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481INDIA NASAL TOPICAL LIQUID INHALATIONS 1.0X0.5 ML INHALER27/08/2021
118NDA/MAL/HHP/9709HINUCONBOOTS PHARMACEUTICALS LIMITEDLIV LIV CAPSULESHINUCON PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTANPAKISTAN ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER02/09/2021
119NDA/MAL/HHP/9711MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGINSOMINMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILAND ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER07/10/2021
120NDA/MAL/HHP/9923GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDCHARCO-PLUSGAYATRI AYUPHARMA PRIVATE LIMITED234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA)INDIAORAL SOLID ORDINARY CAPSULES 1X10X10 CAPSULE BLISTER21/12/2021
121NDA/MAL/HHP/11328ADMARK HERBALS LIMITEDPLATINUM PLUS UGANDA LIMITEDIMMUNE UPLIFT HERBAL CAPSULESADMARK HERBAL LIMITED (JETPUR ROAD, N.H. NO. 8-B, DHORAJ 360410, GUJARAT)INDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE TIN07/05/2024
NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
NDA/MAL/VHP/8117CKL AFRICA LIMITEDCKL UGANDA LIMITEDSOOTHING OILCKL AFRICA LIMITEDMASHIARA PARK,KAPTAGAT ROAD,LORESHO P.O.BOX 40596-00100 NAIROBI,KENYAKENYAUNKNOWN OILS 1X100 ML BOTTLE, 1X250 ML BOTTLE01/07/2016
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURING SITECOUNTRY 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
UGANDA OPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2011
2NDA/MAL/HDP/0003ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDUMOXIL CLAV 625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGUNI MEDICOLABS21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER01/07/2015
3NDA/MAL/HDP/0006HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDDIAMIDEGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGHOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAKMALAYSIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X12.0 TABLET BLISTER01/07/2014
4NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2013
5NDA/MAL/HDP/0012HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDPENGESIC SR TRAMADOL HYDROCHLORIDE SR 100MGHOVID BHDLOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIA ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
6NDA/MAL/HDP/0013ORGANON SOUTH AFRICA (PTY) LTDSURGIPHARM (U) LIMITEDIMPLANON NXT ETONOGESTREL68MGN.V. ORGANONKLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDNETHERLANDS PARENTERAL RETARD IMPLANTS 1.0X68.0 MG IMPLANT01/07/2015
7NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
8NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X10.0X7.5 ML VIAL, 1.0X50.0X100.0 MG VIAL01/07/2011
9NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE 300MG/MLSAKAR HEALTHCARE PVT. LTDPLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE01/07/2013
10NDA/MAL/HDP/0022GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
11NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
12NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE 50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIA PARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE01/07/2015
13NDA/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 PRADESHINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.5 G VIAL01/07/2015
14NDA/MAL/HDP/0033ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYVATE CREAMBETAMETHASONE VALERATE0.1%W/WELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/1997
15NDA/MAL/HDP/0041 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
16NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
17NDA/MAL/HDP/0051H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S OTTILIAVEJ 9,2500 VALBYDENMARK PARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE01/07/2015
18NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPTEGYPT TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/2014
19NDA/MAL/HDP/0053H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARK PARENTERAL RETARD AMPOULES 1.0X1.0 ML AMPOULE01/07/2015
20NDA/MAL/HDP/0054GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDFUNGOALCLOTRIMAZOLE1%W/WKREMOINT PHARMA PVT LTD--B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIA TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
21NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARK PARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE01/07/2015
22NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPS DICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTDTHOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA TROIKAA PHARMACEUTICALS LTDBLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATEINDIA TOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE01/07/2015
23NDA/MAL/HDP/0058ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTDVILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIA PARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE01/07/1997
24NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTAN TOPICAL EXTERNAL CREAMS 1.0X40.0 G TUBE + 1 APPLICATOR01/07/2006
25NDA/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 MERCK SERONO S.A -SUCCURSALE D'AUBONNE, ZONE INDUSTRIELLE DE L'OURIETTAZ, 1170 AUBONNE, SWITZERLAND ITALY SWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION01/07/2015
26NDA/MAL/HDP/0063HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE + LAMIVUDINE ABACAVIR SULFATE + LAMIVUDINE600MG + 300MGHETERO LABS LTD. UNIT (V)439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER01/07/2015
27NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND ITALY SWITZERLANDPARENTERAL ORDINARY CARTRIDGES 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION01/07/2015
28NDA/MAL/HDP/0065HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDALENDRONATE 70MGALENDRONATE SODIUM70MGHOVID BHDLOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMORMALAYSIA ORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER01/07/2015
29NDA/MAL/HDP/0067SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDARTEESALPHA-BETA ARTEETHER75MG/MLSAKAR HEALTHCARE PVT LTD - (406, SILVER OAKS COMMERCIAL COMPLEX,)INDIAPARENTERAL ORDINARY AMPOULES 1X3.0X2.0 ML AMPOULE01/07/2013
30NDA/MAL/HDP/0071AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSUMAFIX 100SUMATRIPTAN SUCCINATE100 MGAUROBINDO PHARMA LIMITED (UNIT III) AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET BLISTER01/07/2014
31NDA/MAL/HDP/0075 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICAL INDUSTRIES LIMITED INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
32NDA/MAL/HDP/0077ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONE DEXAMETHASONE SODIUM PHOSPHATE0.1 % W/V ABACUS PARENTERAL DRUGS LTD.PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDA OPHTHALMIC DROPS 1.0X10.0 ML VIAL01/07/2015
33NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER01/07/2014
34NDA/MAL/HDP/0083MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER01/07/2014
35NDA/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 LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES 4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS01/07/2015
36NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2013
37NDA/MAL/HDP/0098MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
38NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/1998
39NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2014
40NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
41NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X2.0 TABLET BLISTER01/07/2014
42NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
43NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
44NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
45NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AGH-4332 STEIN SCHAFFAUSERTRASSE SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2007
46NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM 4MGMSN LABORATORIES LTD PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
47NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
48NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGSANCE LABORATORIES PVT LTDVI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.INDIA PARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL + 1 AMPOULE WFI01/07/2013
49NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED BABA DOGO RWARAKAKENYA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
50NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGBETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA KENYA ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2015
51NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2015
52NDA/MAL/HDP/0125DAWA LIMITED SUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA TOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE01/07/2013
53NDA/MAL/HDP/0135SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDHEMOVIT SYRUPIRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD KENYA ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2013
54NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKAKENYA ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER01/07/2014
55NDA/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 AREAKENYA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE01/07/1998
56NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
57NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
58NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITEDC–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2016
59NDA/MAL/HDP/0161RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
60NDA/MAL/HDP/0162 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2015
61NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENAREN PROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2015
62NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
63NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIA ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
64NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE01/07/2015
65NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIA ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
66NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
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72NDA/MAL/HDP/0188AMOUN PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDLEVOXIN LEVOFLOXACIN500MGAMOUN PHARMACEUTICALS CO. S.A.E1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER01/07/2014
73NDA/MAL/HDP/0190AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDACNE FREE CREAMTRETINOIN50MGAMOUN PHARMACEUTICALS CO. S.A.E1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTTOPICAL EXTERNAL CREAMS , 1X30 G TUBE01/07/2014
74NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDVITACARE LIMITEDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM PVT LTD.NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE01/07/2013
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76NDA/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, KAMPALAUGANDA ORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2013
77NDA/MAL/HDP/0203GLAXOSMITHKLINE TRADING SERVICES LTD, IRELANDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOMEPRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUXFRANCE LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER01/07/2015
78NDA/MAL/HDP/0204VIIV HEALTHCARE UK LTD-UNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXOSMITHKLINE PHARMACEUTICALS SAGRUNWALDZKA 189 STREET, 60-322 POZNANA GLAXO OPERATIONS UK LTDWARE SG120DJ UNITED KINGDOMUNITED KINGDOM POLANDORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2015
79NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MGMACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE01/07/2013
80NDA/MAL/HDP/0209HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATEINDIAORAL LIQUID ORDINARY LIQUIDS 1X240 ML BOTTLE01/07/2013
81NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPTEGYPT ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2011
82NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICAL CO.PLANT: ABU-SULTAN, ISMAILIA, EGYPTEGYPT ORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE01/07/2012
83NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKAKENYA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
84NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR200MGS KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. LINCOLN PHARMACEUTICALS LTD .10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
85NDA/MAL/HDP/0226AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDULTRASOLV SYRUP OXOMEMAZINE HCL & CARBOCYSTEINE & GUAIFENESIN2MG+125MG+100MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPT ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE01/07/2014
86NDA/MAL/HDP/0230STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGUNIVERSAL CORPORATION LIMITEDPLOT NO 13777, PO BOX 1748-00902 KIKUYU CLUB RD STRIDES PHARMA SCIENCE LIMITED (STRIDES SHASUN)KRS GARDENS, PLOT 36/7 SURAGAJKKANAHALLI, INDLAWADI CROSS, ANKAL TALUK, BANGALORE SOUTH - 562106, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER01/07/2013
87NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
88NDA/MAL/HDP/0233MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS CYPRUS ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER01/07/2014
89NDA/MAL/HDP/0234MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUS ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
90NDA/MAL/HDP/0235MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUS ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP01/07/2014
91NDA/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
INDIA ORAL SOLID ORDINARY TABLETS 1.0X6.0X3.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER01/07/2014
92NDA/MAL/HDP/0244SAKAR HEALTHCARE PVT LTDROYAL PHARMA 2011 LIMITEDHYOCINHYOSCINE BUTYLBROMIDE20MG/MLSAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARATINDIA PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2014
93NDA/MAL/HDP/0248IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG.IPCA LABORATORIES LTDPLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
94NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT KESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER01/07/2013
95NDA/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, GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
96NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGWINTHROP PHARMACEUTICALS(PTY) LTD,315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) MERCK KGAA250 FRANKFRUTER STRASSE 250-64293 DARMSTADTGERMANY SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
97NDA/MAL/HDP/0255BYANSI SERVICES LIMITEDAIVEEN (U) LIMITEDCAPETERO 150CAPECITABINE150MGHETERO LABS (UNIT VI), INDIAAPIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X60 TABLET CONTAINER01/07/2015
98NDA/MAL/HDP/0256HETERO LABS LTD AIVEEN (U) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIAAPIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET CONTAINER01/07/2015
99NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTDNO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407)CHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON01/07/2001
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
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER01/07/2014
101NDA/MAL/HDP/0270HETERO LABS LTD AIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
102NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTDPLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIA PARENTERAL ORDINARY AMPOULES 1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)01/07/2015
103NDA/MAL/HDP/0272HETERO LABS LTD AIVEEN (U) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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104NDA/MAL/HDP/0275GLAXOSMITHKLINE TRADING SERVICES LTD, IRELANDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED39 HAWKINS AVENUE, EPPING INDUSTRIA 1, 7460, CAPE TOWN, SOUTH AFRICASOUTH AFRICA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER01/07/2011
105NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE 80MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
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, NAIROBIKENYA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
107NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKAKENYA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2013
108NDA/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, KENYAKENYA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
109NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
110NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE01/07/2013
111NDA/MAL/HDP/0301HETERO LABS LTD AIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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112NDA/MAL/HDP/0303HETERO LABS LTD AIVEEN (U) LIMITEDABACAVIR SULPHATE ABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III 22-110, IDA, JEEDIMETLAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER01/07/2014
113NDA/MAL/HDP/0305SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250 DRY SYRUPCEFALEXIN250MG/5MLSAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIA ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2013
114NDA/MAL/HDP/0307HETERO DRUGS LTD AIVEEN (U) LIMITEDLAMIVUDINE ORAL SOLUTION LAMIVUDINE10MG/MLHETERO DRUGS LTD, UNIT III 22-110, IDA, JEEDIMETLAINDIA ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X240.0 ML CONTAINER01/07/2013
115NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
116NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOM PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2013
117NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTDPLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2013
118NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844UNITED KINGDOM PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2013
119NDA/MAL/HDP/0317YURIA PHARM LTD-UKRAINEPHARMA VILLE LIMITEDCIPROFLOXACIN-UFCIPROFLOXACIN2MG/MLYURIA-PHARM LLC MANUFACTURING SITE NO. 1108, KOBZARSKA STREET, CHERKASY, 18030UKRAINE PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
120NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULIN SALBUTAMOL4MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
121NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/W DAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
122NDA/MAL/HDP/0322MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2009
123NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITEDPLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE01/07/2014
124NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625 AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2014
125NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP 0.5%WWKREMOINT PHARMA PVT LTDB-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/07/2013
126NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500 AZITHROMYCIN500MGIND SWIFT LTDGLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER, 1.0X10.0X1.0X3.0X10.0 TABLET BLISTER01/07/2014
127NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250 AZITHROMYCIN250MGIND SWIFT LTDGLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER, 1.010.0X1.0X6.0 TABLET BLISTER01/07/2014
128NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTDGLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIA ORAL SOLID ORDINARY TABLETS 1.0X4.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
129NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTDGLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIA ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER01/07/2014
130NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDA OPHTHALMIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2015
131NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS (UNIT-2), PLOT 402, 412-414, KERALA INDUSTRIAL ESTATE, G.I.D.C., NR. BAVLA, DIST. AHMEDABAD- 382 220, GUJARAT, INDIA.INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL01/07/2013
132NDA/MAL/HDP/0350 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
133NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER01/07/2014
134NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITEDVILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2013
135NDA/MAL/HDP/0355SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE01/07/2015
136NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGALLPHAMED PHARMBIL ARZNEIMITTEL GMBH HILDERBRAND, STR 12-37081, GOTTINGEN GERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2014
137NDA/MAL/HDP/0358SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIA PARENTERAL ORDINARY I M VIALS 1.0X1.0 G VIAL01/07/2014
138NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJEGARTUNAYEGEN, SODERTALJESWEDEN ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON01/07/2001
139NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2015
140NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER01/07/2014
141NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCIN 500 AZITHROMYCIN500MGBLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER01/07/2014
142NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2010
143NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLEZYNCETLEVOCETIRIZINE 5MGUNICHEM LABORATORIES LIMITEDUNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

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144NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTDLANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
145NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE01/07/2014
146NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDA ORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/1997
147NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IV PARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2014
148NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDDOXYLEBDOXYCYCLINE 100MGLEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
149NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTDLANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X3.0X10.0 TABLET BLISTER01/07/2013
150NDA/MAL/HDP/0401FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDL MONTUSLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGFOURRTS (INDIA) LABORATORIES (PVT) LTDFOURRTS AVENUE, VANDALUR ROADINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP01/07/2015
151NDA/MAL/HDP/0403NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDSUPRIDOLTRAMADOL HYDROCHLORIDE 50MG/ML NEON LABORATORIES LTD -PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIA PARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2013
152NDA/MAL/HDP/0405NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
153NDA/MAL/HDP/0406NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEVATOCINOXYTOCIN10 I.U./ ML NEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2015
154NDA/MAL/HDP/0407NEON LABARATORIES LTD.NORVIK ENTERPRISES 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, MAHARASHTRAINDIA PARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2013
155NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
156NDA/MAL/HDP/0409NEON LABARATORIES LTD.NORVIK ENTERPRISES 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, MAHARASHTRAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL01/07/2013
157NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM 20MGMSN LABORATORIES LTD PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
158NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OYPANSIONATE 47 20210 TURKU FINLANDFINLAND PARENTERAL RETARD IMPLANTS 1.0X10.0X1.0X2.0X75.0 MG IMPLANT01/07/2003
159NDA/MAL/HDP/0413NEON LABARATORIES LTD.NORVIK ENTERPRISES 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, MAHARASHTRAINDIA PARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE01/07/2013
160NDA/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 140506INDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/1997
161NDA/MAL/HDP/0418ASTRA ZENECA MACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATES ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE,1.0X4.0X7.0 TABLET BLISTER01/07/2013
162NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATES ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE01/07/2013
163NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITED,METRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTDPLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
164NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
165NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
166NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
167NDA/MAL/HDP/0427MICRO LABS LTD LABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADUINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
168NDA/MAL/HDP/0428MICRO LABS LTD LABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X5.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
169NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIA ORAL SOLID ORDINARY TABLETS 10.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2014
170NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITEDPLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X15.0X10.0 TABLET BLISTER01/07/2013
171NDA/MAL/HDP/0432FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDK MAC ORAL SOLUTIONPOTASSIUM CITRATE + MAGNESIUM CITRATE22MG + 7.5MGFOURRTS INDIA LABORATORIES PVT. LIMITEDVANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2013
172NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIA PARENTERAL ORDINARY I V AMPOULES 1.0X5.0X20.0 ML AMPOULE01/07/2014
173NDA/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 MAHARASHTRAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP01/07/2010
174NDA/MAL/HDP/0441AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGISECSECNIDAZOLE1GMAGIO PHARMACEUTICALS LTDPLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0 TABLET BLISTER01/07/2015
175NDA/MAL/HDP/0447PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®125METHYLPREDNISOLONE SODIUM SUCCINATE125MG/VIALPT SANBE FARMA UNIT 3.JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNGINDONESIA PARENTERAL ORDINARY DRY VIALS 1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI01/07/2014
176NDA/MAL/HDP/0449PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIA ORAL SOLID ORDINARY GRANULES 1.0X10.0X5.0 G SACHET01/07/2013
177NDA/MAL/HDP/0451PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®500 METHYLPREDNISOLONE SODIUM SUCCINATE 500MG/VIALPT SANBE FARMA UNIT 3.JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNGINDONESIA PARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI01/07/2014
178NDA/MAL/HDP/0453PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTS STEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE01/07/2013
179NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE 500 MGPT SANBE FARMA JI INDUSTRINO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2014
180NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEB METRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2014
181NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X15.0 ML BOTTLE01/07/2009
182NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN PHENYTOIN100MGAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2011
183NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL SOLID ORDINARY TABLETS 50.0X2.0 TABLET STRIP01/07/1997
184NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERDDENMARK BRAZIL FRANCEPARENTERAL ORDINARY DRY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
185NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK PRODUCTION SAS45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDAAV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERDDENMARK BRAZIL FRANCEPARENTERAL ORDINARY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
186NDA/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 PRIVATE LIMITEDS/NO 105-110, MANJARI BUDRUK, TAL - HAVEIL, PUNE 412307 - INDIA SERUM INSTITUTE OF INDIA LTD212/2 HADAPSAR, PUNE, 411028, INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 ML VIAL,1.0X0.5 ML VIAL01/07/2015
187NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X25.0X4.0 TABLET BLISTER01/07/2015
188NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1.0X10.0 TABLET BLISTER01/07/2014
189NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500 AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X3.0 TABLET BLISTER01/07/2014
190NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER01/07/2014
191NDA/MAL/HDP/0491ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EYE DROPSCHLORAMPHENICOL0.5% W/VABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDA OPHTHALMIC DROPS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL01/07/2013
192NDA/MAL/HDP/0493MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDPRASUSAFE 10PRASUGREL10MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1X3X10 TABLET BLISTER01/07/2013
193NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDSURGIPHARM (U) LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE 250MG + 200MG + 10MGADCOCK INGRAM LIMITED 49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIA ORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
194NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTDPLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/1997
195NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
196NDA/MAL/HDP/0507FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDFILDILOL 12.5CARVEDILOL12.5 MGFOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103,
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INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
197NDA/MAL/HDP/0509FOURRTS (INDIA) LABORATORIES (PVT) LTDDELMAW ENTERPRISES LIMITEDFILDILOL 25CARVEDILOL25MGFOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103,
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INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
198NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,DINDIA ORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET STRIP01/07/2004
199NDA/MAL/HDP/0512FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 10ATORVASTATIN CALCIUM10MGFOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
200NDA/MAL/HDP/0515FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 20ATORVASTATIN20MGFOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
201NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2014
202NDA/MAL/HDP/0520FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 40ATORVASTATIN CALCIUM40MGFOURRTS(INDIA) LABORATORIES PVT.LIMITEDVANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER01/07/2014
203NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPAN 40 PANTOPRAZOLE SODIUM 40MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
204NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 25 AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTDPLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
205NDA/MAL/HDP/0531LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIA TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE01/07/2014
206NDA/MAL/HDP/0538MICRO LABS LTD LABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2013
207NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
208NDA/MAL/HDP/0542DAWA LIMITED SUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTDBABA DOGO ROAD RUARAKA KENYA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
209NDA/MAL/HDP/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDAN ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
210NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
211NDA/MAL/HDP/0547NAARI LTDUNITED HEALTHCARE DISTRIBUTORS LTDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITEDPLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER01/07/2013
212NDA/MAL/HDP/0548UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST MONTELUKAST 5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDAN ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
213NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
214NDA/MAL/HDP/0551SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOXAMOXICILLIN + CLAVULANIC ACID125 MG/ 5 ML + 31.25 MG/ 5 ML SAKAR HEALTH CARE PVT, LTD (BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA)INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2014
215NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIA PARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)01/07/2013
216NDA/MAL/HDP/0555HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDCARZEPINCARBAMAZEPINE200MGHOVID BHDLOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
217NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPS GENTAMICIN SULPHATE 0.3% W/V ABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDA OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML VIAL01/07/2014
218NDA/MAL/HDP/0559HOVID BHD MEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHDLOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIA ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
219NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM 40MGIND-SWIFT-LTD,GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIA ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
220NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTDPLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIA ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0X50.0 ML BOTTLE01/07/2013
221NDA/MAL/HDP/0568 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITEDPLOT 680, KAMULI ROAD, KIREKAUGANDA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
222NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN 250IUBHARAT SERUMS AND VACCINES LIMITED,PLOT NO. K-27, ADDITIONAL MIDC,
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INDIA PARENTERAL ORDINARY I M VIALS 1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
223NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NVRIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUM OPHTHALMIC DROPS 1.0X5.0 ML VIAL01/07/2010
224NDA/MAL/HDP/0573ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL PARACETAMOL-250 PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
225NDA/MAL/HDP/0574IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE TABLETS 100/270ARTESUNATE AND AMODIAQUINE100MG+270MG IPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER01/07/2013
226NDA/MAL/HDP/0576GLAXOSMITHKLINE TRADING SERVICES LTD, IRELANDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANYGERMANY ORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER01/07/2015
227NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
228NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTDVILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
229NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD--VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
230NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
231NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLABNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIAINDIA OPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE01/07/2013
232NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD--VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
233NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLABNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIAINDIA OPHTHALMIC LIQUIDS 1.0X10.0 ML CONTAINER01/07/2013
234NDA/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 PRADESHINDIA ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP01/07/2014
235NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD--VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2015
236NDA/MAL/HDP/0596MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2011
237NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2003
238NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITEDPLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
239NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
240NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/1999
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242NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
243NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KIT LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD .10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2016
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245NDA/MAL/HDP/0614GLAXOSMITHKLINE TRADING SERVICES LTD, IRELANDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE BEECHAM PHARMACEUTICALS,CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOM ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
246NDA/MAL/HDP/0617ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
247NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10 GLUCOSE10%W/V ABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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250NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDPLOT M 444B STRETCHER ROAD NTINDAUGANDA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
251NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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252NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALS EUROPA HEALTHCARE (U) LTDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTDPLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2014
253NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2009
254NDA/MAL/HDP/0636MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER01/07/2014
255NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTAN TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
256NDA/MAL/HDP/0638ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTDPLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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257NDA/MAL/HDP/0639NEM LABORATORIES (PVT) LTDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/1997
258NDA/MAL/HDP/0654NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHRGERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER01/07/2013
259NDA/MAL/HDP/0657NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHRGERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
260NDA/MAL/HDP/0658NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHRGERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
261NDA/MAL/HDP/0665HETERO LABS LTD AIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
262NDA/MAL/HDP/0666HETERO LABS LTD AIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
263NDA/MAL/HDP/0667ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXEL MICONAZOLEMICONAZOLE NITRATE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIA TOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/2013
264NDA/MAL/HDP/0668CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
265NDA/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 MALAYSIA TOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/2013
266NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER01/07/2014
267NDA/MAL/HDP/0672GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
268NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
269NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (A) LTD.AXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD 1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIAKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
270NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
271NDA/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 INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2014
272NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
273NDA/MAL/HDP/0681EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALGENNOVA BIOPHARMACEUTICALS LIMITEDBLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057INDIA PARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI01/07/2013
274NDA/MAL/HDP/0685FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONASPAIN PARENTERAL RETARD I M AMPOULES 1.0X5.0X4.0 ML AMPOULE01/07/2015
275NDA/MAL/HDP/0687FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONASPAIN ORAL LIQUID ORDINARY LIQUIDS 1.0X6.0X10.0 ML SACHET01/07/2015
276NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
277NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
278NDA/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 LTDISSAPUR P.O DAPPAR 140506INDIA TOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE01/07/2014
279NDA/MAL/HDP/0691MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
280NDA/MAL/HDP/0692DAWA LIMITED SUPER MEDIC LTDDAWACLOX -250 CLOXACILLIN SODIUM250MGDAWA LIMITED BABA DOGO RWARAKAKENYA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2015
281NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250 AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKAKENYA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2014
282NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON01/07/2013
283NDA/MAL/HDP/0696BYANSI SERVICES LIMITEDAIVEEN (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2014
284NDA/MAL/HDP/0700ZYDUS LIFESCIENCES LIMITEDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UZYDUS LIFESCIENCES LIMITED -PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIA PARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)01/07/2015
285NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL01/07/2014
286NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY GELDICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL11.6MG + 30MG + 100MG + 50MGKREMOINT PHARMA PVT LTD--B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE01/07/2013
287NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTDUNIT II & III BADDI THE NALAGARH DIST SOLAN H.P HETERO LABS LTD (UNIT-V)SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER01/07/2013
288NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITEDTRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2011
289NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
290NDA/MAL/HDP/0707HETERO LABS LTD AIVEEN (U) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
291NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
292NDA/MAL/HDP/0712GLAXOSMITHKLINE TRADING SERVICES LTD, IRELANDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSEINDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOEFRANCE ORAL LIQUID ORDINARY SUSPENSIONS 1.0X20.0 ML BOTTLE01/07/1997
293NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGALLPHAMED PHARMBIL ARZNEIMITTEL GMBH HILDERBRAND, STR 12-37081, GOTTINGEN GERMANY ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2015
294NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGALLPHAMED PHARMBIL ARZNEIMITTEL GMBHHILDERBRAND, STR 12-37081, GOTTINGEN GERMANY ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2015
295NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.DTRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER01/07/2014
296NDA/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 INDIAINDIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.4 ML PRE- FILLED SYRINGE01/07/2011
297NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIA ORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE01/07/2013
298NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIA OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2014
299NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE 50MG TROIKAA PHARMACEUTICALS LTD SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIA ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2014
300NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506INDIA ORAL LIQUID ORDINARY LIQUIDS 1.0X225.0 ML BOTTLE01/07/2013
301NDA/MAL/HDP/0728IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 25/67.5 ARTESUNATE+AMODIAQUINE25MG+67.5MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER01/07/2013
302NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER01/07/2013
303NDA/MAL/HDP/0732AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOLTAMED-100 DICLOFENAC100 MGMEDICO REMEDIES PVT LIMITED8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2015
304NDA/MAL/HDP/0734AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2015
305NDA/MAL/HDP/0736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUS ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
306NDA/MAL/HDP/0740MEDOCHEMIE LTDLABOREX UGANDA LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUS ORAL SOLID ORDINARY TABLETS 1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
307NDA/MAL/HDP/0741MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS CYPRUS ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
308NDA/MAL/HDP/0742MEDOCHEMIE LTDLABOREX UGANDA LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUS ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
309NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KIT TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYA ORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER 01/07/2013
310NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSENBAYER PHARMA AG 51368 LEVERKUSENGERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER01/07/2013
311NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADIINDIAPARENTERAL ORDINARY DRY VIALS 1X1 G VIAL01/07/2014
312NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSENBAYER PHARMA AG 51368 LEVERKUSENGERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER01/07/2013
313NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
314NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MG DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONINGGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2015
315NDA/MAL/HDP/0759MICRO LABS LTDLABOREX UGANDA LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD-NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2011
316NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT IIVILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2011
317NDA/MAL/HDP/0765SHANGHAI DAHUA PHARMACEUTICAL CO., LTD.UNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTDCHANG ZENG FARM, CHONGMING COUNTY, SHANGHAICHINA PARENTERAL RETARD IMPLANTS 1.0X10.0X2.0 ROD IMPLANT01/07/2010
318NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIA OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/1999
319NDA/MAL/HDP/0770BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-500AMPICILLIN500MGCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407CHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL01/07/2013
320NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
321NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTDPLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
322NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1999
323NDA/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.PINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER01/07/2013
324NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
325NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPHENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTDPLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP01/07/2010
326NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD18KM, MULTAN ROAD, LAHORE 53800, PAKISTANPAKISTAN OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE01/07/2014
327NDA/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)INDIA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
328NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AGSCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER01/07/2015
329NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
330NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2 GLIMEPIRIDE 2MG DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONINGGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
331NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3 GLIMEPIRIDE 3MG DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONINGGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
332NDA/MAL/HDP/0822ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL01/07/2014
333NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2013
334NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MG MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA AMN LIFE SCIENCE PVT LTD-67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT INDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2013
335NDA/MAL/HDP/0827GALPHA LABORATORIES LTDDAWASANA PHARMACEUTICALS LTDCLANOXY 1.2 AMOXICILLIN + CLAVUNATE POTASSIUM1000MG/200MGGALPHA LABORATORIES LTDAT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL + 1*20ML VIAL OF WFI01/07/2015
336NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER01/07/2015
337NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2013
338NDA/MAL/HDP/0832MERCK UNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER01/07/2015
339NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
340NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
341NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2012
342NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X2.0 TABLET BLISTER01/07/2013
343NDA/MAL/HDP/0843MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP01/07/2013
344NDA/MAL/HDP/0845VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER01/07/2013
345NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD-PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER01/07/2014
346NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD--PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2014
347NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED 10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2012
348NDA/MAL/HDP/0853 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDBRUSTAN GELIBUPROFEN + LEVOMENTHOL5% W/W+ 3%W/WSUN PHARMACEUTICAL IND. LTDPLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X50.0 G CONTAINER01/07/2012
349NDA/MAL/HDP/0855HETERO LABS LTD AIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
350NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTDPLOT NO E -37, 39 ,DINDIA VAGINAL TABLETS 1.0X6.0 PESSARY STRIP01/07/2000
351NDA/MAL/HDP/0858ASTRA ZENECA MACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA SWEDEN OPERATIONSASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJE ASTRAZENECA PHARMACEUTICAL CO LTD.NO. 2 HUANGSHAN ROAD, WUXI, 214028, JIANGSUCHINA SWEDEN ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2001
352NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTDPLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIA PARENTERAL ORDINARY AMPOULES 2.0X5.0X2.0 ML AMPOULE01/07/2013
353NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT VAPIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
354NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID LINEZOLID2MG/MLAMANTA HEALTHCARE LIMITEDPLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
355NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X2.0X6.0X2.0 ML VIAL01/07/2013
356NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITEDTHOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE01/07/2010
357NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTDBLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1X2X6X2 ML VIAL01/07/2013
358NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLSAKAR HEALTH CARE PVT LTD10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI CHINA INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE01/07/2009
359NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD -L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIA ORAL SOLID ORDINARY TABLETS 1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
360NDA/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 MAHARASHTRAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X170.0 ML BOTTLE01/07/2007
361NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2012
362NDA/MAL/HDP/0882MERCK UNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.SCENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCE ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
363NDA/MAL/HDP/0883MERCK UNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.SCENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCE ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
364NDA/MAL/HDP/0889ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDNSSODIUM CHLORIDE + GLUCOSE0.9%W/V + 5% W/VABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/2012
365NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTH SODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTDSURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE01/07/2015
366NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIA TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2015
367NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 10 ML VIAL WFI01/07/2013
368NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SR NIFEDIPINE20MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
369NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2015
370NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACE RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTDSURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE01/07/2015
371NDA/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 PRADESHINDIA PARENTERAL ORDINARY VIALS 1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN01/07/2015
372NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X5.0X4.0 ML VIAL01/07/2012
373NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP01/07/2004
374NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 AJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2013
375NDA/MAL/HDP/0929IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MG IPCA LABORATORIES LTDPLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIA ORAL SOLID ORDINARY TABLETS 10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER01/07/2012
376NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDHEALTHCARE LTD.ESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER01/07/2013
377NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDHEALTHCARE LTD.ESOMEGA 40MG ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER01/07/2013
378NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE01/07/2013
379NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5ML LORATADINE5MG/5MLCOSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYA ORAL LIQUID ORDINARY LIQUIDS 1.0X60.0 ML BOTTLE01/07/2013
380NDA/MAL/HDP/0951NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL ORDINARY S C AMPOULES 1.0X5.0X2.0 ML AMPOULE01/07/2013
381NDA/MAL/HDP/0952NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEFECTALCEFTRIAXONE1GNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL01/07/2013
382NDA/MAL/HDP/0953NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL01/07/2013
383NDA/MAL/HDP/0954NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL RETARD OTHER VIALS 1.0X20.0 ML VIAL01/07/2013
384NDA/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 LTDISAAPUR P.O DAPPAR 140056 INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2012
385NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 AJANTA PHARMA LIMITED PAITHANMANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER01/07/2013
386NDA/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, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2005
387NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESHBANGLADESH ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE01/07/2015
388NDA/MAL/HDP/0978SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROX 75 SR CAPSULEAMBROXOL75MGSQUARE PHARMACEUTICALS LIMITEDKALIAKOIR GAZIPUR – 1750, BANGLADESHBANGLADESH ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2012
389NDA/MAL/HDP/0981HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC SR TABLETS DICLOFENAC SODIUM100MGHOVID BERHAD (CHEMOR SITE)-LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIA ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2008
390NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPT ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
391NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
392NDA/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 EGYPT TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
393NDA/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 INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2014
394NDA/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 EGYPT ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
395NDA/MAL/HDP/0999EVA PHARMAUNITED HEALTHCARE DISTRIBUTORS LTDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2014
396NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITEDTHOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X5.0X2.5 ML AMPOULE01/07/2012
397NDA/MAL/HDP/1001EVA PHARMAUNITED HEALTHCARE DISTRIBUTORS LTDTHIOEVATHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
398NDA/MAL/HDP/1002SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPROKEN 750CIPROFLOXACIN750MGSQUARE PHARMACEUTICALS LIMITEDKALIAKOIR GAZIPUR – 1750, BANGLADESHBANGLADESH ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER01/07/2013
399NDA/MAL/HDP/10030SAKAR HEALTHCARE LIMITED -TATA UGANDA LIMITEDNISTANNYSTATIN100,000IUSAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARATINDIAORAL LIQUID ORDINARY SUSPENSIONS 1X30 ML BOTTLE17/05/2022
400NDA/MAL/HDP/10033MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDEMCARCARBAMAZEPINE200 MGMEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER14/07/2022
401NDA/MAL/HDP/10034AUROLABSWASTIK PHARMACEUTICAL LTDM-FLOXMOXIFLOXACIN HYDROCHLORIDE0.5 %W/VAUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI €“ 625 020 TAMIL NADU INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE14/07/2022
402NDA/MAL/HDP/10036MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDMEDOMOLPARACETAMOL500 MGMEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X1.0X10.0 TABLET BLISTER14/07/2022
403NDA/MAL/HDP/10037BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBORINI-KLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30 MG + 500 MG + 250 MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET STRIP14/07/2022
404NDA/MAL/HDP/10038MEDOPHARM PRIVATE LIMITEDVITACARE LIMITEDCLEDOMOX 312.5 MG/5 MLAMOXILLIN TRIHYDRATE + POTASSIUM CLAVULANATE312.5 MG/5 MLMEDOPHARM PVT LIMITEDNO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202INDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML CONTAINER14/07/2022
405NDA/MAL/HDP/10039LEGIT MEDEQ 2007 LIMITEDLEGIT MEDEQ 2007 LIMITEDZENMICTRANEXAMIC ACID500MG/5 MLZEN PHARMA PVT LTD75/1, GIDC. VAPI-396 195 GUJARAT,INDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0 ML AMPOULE, 1.0X1.0X10.0X5.0 ML AMPOULE14/07/2022
406NDA/MAL/HDP/10041PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDPUMPINOXESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGPHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDAN ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X14.0 TABLET CONTAINER06/07/2022
407NDA/MAL/HDP/10042GLOBELA PHARMA PVT. LTD.SHREEJI CARE LIMITEDBACIPROCIPROFLOXACIN HYDROCHLORIDE500 MGGLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER19/07/2022
408NDA/MAL/HDP/10043ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROYO-ADRENALINEADRENALINE ACID TARTRATE1 MG/MLSANJAR PHARMACEUTICALS LIMITEDSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1X1X10X1 ML AMPOULE,19/07/2022
409NDA/MAL/HDP/10044ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTERBI RO 250TERBINAFINEHYDROCHLORIDE250 MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER19/07/2022
410NDA/MAL/HDP/10045PHARMACTIV FZCOHEALTHCARE LTD.SURGITECCEFOTAXIME SODIUM1 G/VIALSURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTANPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*5ML, WFI IN A CLEAR GLASS AMPOULE19/07/2022
411NDA/MAL/HDP/10046ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDARTEMETHER INJECTION 80 MG/MLARTEMETHER80 MG/ MLSCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X6.0X1.0 ML AMPOULE19/07/2022
412NDA/MAL/HDP/10048JOSHPA AFRICA LTDAAFIYA (A) LIMITEDAAFISUNATE 60 MGARTESUNATE60 MG/VIALSANJAR PHARMACEUTICALS LIMITEDSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1X60 MG VIAL19/07/2022
413NDA/MAL/HDP/10049ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDERYTHROMYCIN ESTOLATE ORAL SUSPENSION USP 125 MG/5MLERYTHROMYCIN ESTOLATE125 MG/5MLSCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE19/07/2022
414NDA/MAL/HDP/10052UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDHI DEE 5000 IUCHOLECALCIFEROL5,000IUUNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDANORAL SOLID ORDINARY OTHER CAPSULES 1X1X30 CAPSULE CONTAINER19/07/2022
415NDA/MAL/HDP/10054LEGIT MEDEQ 2007 LIMITEDLEGIT MEDEQ 2007 LIMITEDHEMCROZIRON SUCROSE COMPLEX20 MG/MLZEN PHARMA PVT LTD75/1, GIDC. VAPI-396 195 GUJARAT,INDIAPARENTERAL ORDINARY I V AMPOULES 1.0X1.0X5.0X5.0 ML AMPOULE19/07/2022
416NDA/MAL/HDP/10055BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFIMABUTE-400CEFIXIME TRIHYDRATE400MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER19/07/2022
417NDA/MAL/HDP/10056MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDAVARINSIMETHICONE+ ALVERINE CITRATE300 MG + 60 MGMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILANDORAL SOLID ORDINARY OTHER CAPSULES 1X5X1X10 CAPSULE BLISTER19/07/2022
418NDA/MAL/HDP/10059SAGA LIFESCIENCES LTDABACUS PHARMA (AFRICA) LIMITEDFULCOVERITRACONAZOLE100 MGSAGA LABORATORIES .198/2 & 198/3, CHACHRAWADI, VASNA NO. CLARIS LIFE SCIENCE, TA SANAND, DIST. DIST: AHMEDABADINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X4.0 CAPSULE STRIP19/07/2022
419NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT 92 SIPCOT HOSUR 635 126 TAMIL NADUINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
420NDA/MAL/HDP/10061AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP PLUSCLOPIDOGREL + ASPIRIN75 MG + 75 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER 19/07/2022
421NDA/MAL/HDP/10062BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBRUCLOX-500CLOXACILLIN SODIUM500MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE STRIP19/07/2022
422NDA/MAL/HDP/10063BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDCARDIONE 25SPIRONOLACTONE25MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER19/07/2022
423NDA/MAL/HDP/10065LAURUS LABS LIMITED - BEYOND LOGISTICS LTDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/ 300 MG/ 300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600 MG + 300 MG + 300 MGLAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X90.0 TABLET BOTTLE,1.0X30.0 TABLET BOTTLE19/07/2022
424NDA/MAL/HDP/10066CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDFEMPROLETROZOLE2.5MGCIPLA LTDUNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X3X10 TABLET BLISTER19/07/2022
425NDA/MAL/HDP/10067TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRITINITINIDAZOLE500MGTRIVENI FORMULATIONS LTDPLOT NO. 52,53,54,63,62,64 ALEAP INDUSTRIUAL ESTATE SARAMPALLI VIJAYWADAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X25.0X4.0 TABLET BLISTER19/07/2022
426NDA/MAL/HDP/10068LEGIT MEDEQ 2007 LIMITEDLEGIT MEDEQ 2007 LIMITEDZ- ENOXENOXAPARIN SODIUM10 MG/0.1 MLZEN PHARMA PVT LTD75/1, GIDC. VAPI-396 195 GUJARAT,INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.6.0 ML PRE- FILLED SYRINGE, 1.0X0.4.0 ML PRE- FILLED SYRINGE14/07/2022
427NDA/MAL/HDP/10069MICRO LABS LIMITEDLABOREX UGANDA LIMITEDOPELAN ODT 5OLANZAPINE5 MGMICRO LABS LIMITED .,92, SIPCOT, HOSUR 635126INDIA ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X3.0X10.0 TABLET BLISTER14/07/2022
428NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYARANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
429NDA/MAL/HDP/10074TAURUS CHEMICALS (P) LTD. HEALTHCARE LTD.MAGACID SUSPENSIONALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE(215 MG + 80 MG + 25 MG)/5MLAL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN PAKISTAN ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X120.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE14/07/2022
430NDA/MAL/HDP/10075ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTELPER 80TELMISARTAN80 MGGLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER14/07/2022
431NDA/MAL/HDP/10076ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRO-CID INJOMEPRAZOLE SODIUM40MGSANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 MG VIAL + 10 ML WATER FOR INJECTION AMPOULE14/07/2022
432NDA/MAL/HDP/10080COMED CHEMICALS LTD.LEGIT MEDEQ 2007 LIMITEDLYSER-DDICLOFENAC SODIUM + SERRATIOPEPTIDASE50 MG + 10 MGCOMED CHEMICALS LTD (UNIT-III)VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP14/07/2022
433NDA/MAL/HDP/10081INDIANA OPHTHALMICS SWASTIK PHARMACEUTICAL LTDIO-NEPANEPAFENAC0.1%W/VINDIANA OPHTHALMICS (135, 136, 137, GIDC ESTATE, WADHWAN-363035)INDIAOPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML Bottle14/07/2022
434NDA/MAL/HDP/10083THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDMORCETESCITALOPRAM OXALATE20 MGSEARLE PAKISTAN LTD..F-319, S.I.T.E., OPP. KESC POWER STATION, KARACHIPAKISTAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER14/07/2022
435NDA/MAL/HDP/10084M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDSEDAFOLPROPOFOL10 MG/ MLASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X1.0X20.0 ML VIAL14/07/2022
436NDA/MAL/HDP/10087MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAZUNATEARTESUNATE60 MG/VIAL MACLEODS PHARMACEUTICALS LTD. ..UNIT I/UNIT II, PLOT 25-27, SR. NO. 366, PREMIER IND. ESTATE, KACHIGAM, DAMAN (U.T)INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X60.0 MG VIAL + 1* 1ML CLEAR GLASS AMPOULE OF 5%W/V SODIUM BICARBONATE + 1*5ML CLEAR GLASS AMPOULE OF 0.9%W/V SODIUM CHLORIDE14/07/2022
437NDA/MAL/HDP/10089NABIQASIM INDUSTRIES (PVT) LIMITEDHEALTHCARE LTD.CEFEXOL DS SUSPENSIONCEFIXIME TRIHYDRATE200 MG/5 MLNABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHIPAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1X1X30 ML BOTTLE14/07/2022
438NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL01/07/2012
439NDA/MAL/HDP/10090NABIQASIM INDUSTRIES (PVT) LIMITEDHEALTHCARE LTD.CEFEXOL SUSPENSIONCEFIXIME TRIHYDRATE100 MG/5 MLNABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHIPAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1X1X30 ML BOTTLE14/07/2022
440NDA/MAL/HDP/10091ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDPG-150PREGABALIN150 MGZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 1X3X10 CAPSULE BLISTER,14/07/2022
441NDA/MAL/HDP/10092ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROTHISTRONE 5NORETHISTERONE5 MGSYNOKEM PHARMACEUTICALS LTD-PLOT NO.- 35-36, SECTOR-6A, IIE (SIDCUL), RANIPUR (BHEL) INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER14/07/2022
442NDA/MAL/HDP/10093 CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDMUCOSIL BRSALBUTAMOL + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN + MENTHOL2.0 MG + 4.0 MG + 100 MG + 1.0 MGRAVIAN LIFE SCIENCE PVT LTDPLOT 34, SEC 8A, IIE, SIDCUL, HARIDWAR-269403 UTTARAKHAND INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1X1X100 ML BOTTLE18/07/2022
443NDA/MAL/HDP/10095COMED CHEMICALS LTD.LEGIT MEDEQ 2007 LIMITEDRAPCO -20RABEPRAZOLE SODIUM20 MGCOMED CHEMICALS LTD (UNIT-III)VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER18/07/2022
444NDA/MAL/HDP/10096COMED CHEMICALS LTD.LEGIT MEDEQ 2007 LIMITEDZACY- SRACECLOFENAC200 MGCOMED CHEMICALS LTD (UNIT-III)VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER18/07/2022
445NDA/MAL/HDP/10097ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDNULOC 20ESOMEPRAZOLE MAGNESIUM20 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1X3X10 TABLET BLISTER18/07/2022
446NDA/MAL/HDP/10098ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDNULOC 40ESOMEPRAZOLE MANESIUM40 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1X3X10 TABLET BLISTER18/07/2022
447NDA/MAL/HDP/10099DAFRA PHARMA GMBHMULTIPHAR UGANDA LIMITEDGLYFERON 1000METFORMIN HYDROCHLORIDE1000 MGBILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1X3X10 TABLET BLISTER18/07/2022
448NDA/MAL/HDP/10100HETERO LABS LTD AIVEEN (U) LIMITEDPANTINPANTOPRAZOLE SODIUM SESQUIHYDRATE40 MG/VIALASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL18/07/2022
449NDA/MAL/HDP/10101AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL 50VILDAGLIPTIN50 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER 18/07/2022
450NDA/MAL/HDP/10102AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDVILDARIL 100VILDAGLIPTIN100 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER18/07/2022
451NDA/MAL/HDP/10103PINNACLE LIFE SCIENCE PVT. LTDABACUS PHARMA (AFRICA) LIMITEDCOLDPILPARACETAMOL +PHENYLEPHRINE HYDROCHLORIDE + CHLORPEHNAMINE MALEATE650 MG + 5 MG + 2 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1X10X10 TABLET BLISTER18/07/2022
452NDA/MAL/HDP/10104IND-SWIFT LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT 40TELMISARTAN40 MGIND-SWIFT LIMITED /VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJABINDIA TABLETS (COATED1.0X3.0X10.0 TABLET BLISTER06/07/2022
453NDA/MAL/HDP/10105IND-SWIFT LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT 80TELMISARTAN80 MGIND-SWIFT LIMITED /VILL-JAWAHARPUR, OFF NH21, DERABASSI DIST: MOHALI, PUNJABINDIA ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER06/07/2022
454NDA/MAL/HDP/10106VEERAM HEALTHCARE (U) LIMITEDVEERAM HEALTHCARE (U) LIMITEDSERAFENDICLOFENAC POTASSIUM + SERRATIOPEPTIDASE50 MG + 10 MGKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER, 1.0X2.0X10.0 TABLET BLISTER14/07/2022
455NDA/MAL/HDP/10107VEERAM HEALTHCARE (U) LIMITEDVEERAM HEALTHCARE (U) LIMITEDEXPECTAMBROXOL HYDROCHLORIDE + TERBUTALINE SULPHATE + GUAIFENESIN(15 MG + 1.25 MG + 50 MG)/ 5 MLKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE, 1.0X1.0X30.0 ML BOTTLE14/07/2022
456NDA/MAL/HDP/10108ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPIRO 20PIROXICAM20 MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIAORAL SOLID ORDINARY CAPSULES 1X10X10 CAPSULE BLISTER14/07/2022
457NDA/MAL/HDP/10109ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRO MIFEN 500MEFENAMIC ACID500 MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER14/07/2022
458NDA/MAL/HDP/10110ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRO TAMIC 500TRANEXAMIC ACID500 MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X10X10 TABLET BLISTER14/07/2022
459NDA/MAL/HDP/10112KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDKESKETOKETOCONAZOLE2 % W/WKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE14/07/2022
460NDA/MAL/HDP/10113ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRO-PERICEMPIROXICAM20 MGSCOTT-EDIL PHARMACIA LTD (UNIT I)56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIAINDIAORAL SOLID ORDINARY CAPSULES 1X10X10 CAPSULE BLISTER14/07/2022
461NDA/MAL/HDP/10114CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300/300 MGLAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300 MG + 300 MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARKUGANDA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER06/07/2022
462NDA/MAL/HDP/10115ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDASPIRIN DELAYED RELEASE TABLETS USP 75MGASPIRIN75 MGSCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA INDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER14/07/2022
463NDA/MAL/HDP/10117FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVENOSMILHIDROSMIN200 MGFAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAINSPAIN ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER06/07/2022
464NDA/MAL/HDP/1012NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL ORDINARY OTHER VIALS 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL01/07/2013
465NDA/MAL/HDP/10129HETERO LABS LTD AIVEEN (U) LIMITEDDARUNAVIR AND RITONAVIR TABLETS 400 MG/50 MGDARUNAVIR ETHANOLATE + RITONAVIR400 MG + 50 MGHETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE,INDIA ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE18/07/2022
466NDA/MAL/HDP/1013NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTDPLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 ML VIAL01/07/2013
467NDA/MAL/HDP/10134MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDISONIAZID/ RIFAPENTINE COATED TABLETS 300 MG + 300 MGISONIAZID + RIFAPENTINE300MG +300MGOXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X12.0 TABLET STRIP18/07/2022
468NDA/MAL/HDP/10135RAPTAKOS, BRETT & CO. LTD.EUROPA HEALTHCARE (U) LTDZEVAC SYRUPZINC ACETATE (AS DIHYDRATE)20MG/5MLRAPTAKOS BRETT & CO.LTD1ST POKHRAN ROAD,THANE 400 606INDIAORAL LIQUID ORDINARY SYRUPS 1X1X60 ML BOTTLE18/07/2022
469NDA/MAL/HDP/10138NABIQASIM INDUSTRIES (PVT) LIMITEDHEALTHCARE LTD.CLARITHRO TABLETSCLARITHROMYCIN500MGNABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1X1X10 TABLET BLISTER18/07/2022
470NDA/MAL/HDP/1014ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDTIDAZOL TABLETSTINIDAZOLE500MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X4.0 TABLET BLISTER01/07/2015
471NDA/MAL/HDP/10140UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDALDROL 5DONEPEZIL HYDROCHLORIDE5MGUNICHEM LABORATORIES BADI-UNIT IIVILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/07/2022
472NDA/MAL/HDP/10141UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDALDROL 10DONEPEZIL HYDROCHLORIDE10MGUNICHEM LABORATORIES BADI-UNIT IIVILLAGE BHATAULI, BADDI HIMACHAL PRADESH, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/07/2022
473NDA/MAL/HDP/10144VIRCHOW BIOTECH PVT LTD, SURGIPHARM (U) LIMITEDCLASIPROBACILLUS CLAUSII SPORES2 X 10^9 SPORES/ 5 MLVIRCHOW BIOTECH PRIVATE LIMITEDSURVEY NO. 172 PART, GAGILLAPUR, QUTHBULLPUR, RR DISTRICT, TELANGANA-500043INDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X5.0 ML AMPOULE06/07/2022
474NDA/MAL/HDP/10145 CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDI-PILLLEVONORGESTREL1.5MGCIPLA LTD-UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X1.0 TABLET BLISTER12/13/2023
475NDA/MAL/HDP/10146ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDUMBILICA GELCHLORHEXIDINE GLUCONATE4%W/WATCO LABS LTD,B-18, S.I.T.E, KARACHIPAKISTANTOPICAL EXTERNAL GELS AND SOLS 1X10 G TUBE18/07/2022
476NDA/MAL/HDP/10148AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 60ETORICOXIB60MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER 18/07/2022
477NDA/MAL/HDP/10149AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 90ETORICOXIB90MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER 18/07/2022
478NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1X10X10 CAPSULE STRIP01/07/2013
479NDA/MAL/HDP/10150AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDRALEF 120ETORICOXIB120MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER 18/07/2022
480NDA/MAL/HDP/10151S KANT HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFUNGARINMICONAZOLE2%W/WS KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.INDIA ORAL TOPICAL GELS AND SOLS 1.0X1.0X30.0 G TUBE06/07/2022
481NDA/MAL/HDP/10152BIOFARMA PLASMA LIMITED LIABILITY COMPANYONCOPHARM (U) LTDALBUMIN-BIOPHARMAHUMAN ALBUMIN20G/100MLBIOPHARMA PLASMA LIMITED LIABILITY COMPANY37-V KYIVSKA ST., BILA TSERKVA, KYIV REGION, 09100 - UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1X1X100 ML VIAL18/07/2022
482NDA/MAL/HDP/10155MEDIPAK LIMITEDHEALTHCARE LTD.MEDISOL NSSODIUM CHLORIDE0.9%W/VMEDIPAK LTD132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHOREPAKISTAN PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE02/09/2022
483NDA/MAL/HDP/10156MEDIPAK LIMITEDHEALTHCARE LTD.MEDISOL 5%DEXTROSE 5%W/VMEDIPAK LTD132/2/ INDUSTRIAL ESTATE KOT LAKHPAT, LAHOREPAKISTAN PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE02/09/2022
484NDA/MAL/HDP/10164ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDASPIRIN TABLETSACETYLSALICYCLIC ACID300MGELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA KENYA ORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP,1.0X200.0 TABLET TIN,1.0X1000.0 TABLET TIN02/09/2022
485NDA/MAL/HDP/10168ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDLYFEORAL REHYDRATION SALTN/AELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA KENYA ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X14.0 G SACHET,1.0X28.0 G SACHET02/09/2022
486NDA/MAL/HDP/10169ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDORODARSULFADOXINE+PYRIMETHAMINE500MG+25MGELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA KENYA ORAL SOLID ORDINARY TABLETS 1.0X30.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER02/09/2022
487NDA/MAL/HDP/1017ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDELYCLOXAMPICILLIN/CLOXACILLIN125MG/125MGELYS CHEMICAL INDUSTRIES LIMITEDROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2015
488NDA/MAL/HDP/10170ELYS CHEMICAL INDUSTRIES LTDELYS CHEMICALS INDUSTRIES UGANDA LTDPREDNISOLONE TABLETSPREDNISOLONE5MGELYS CHEMICAL INDUSTRIES LIMITED,-OFF ENTERPRISE ROAD, OPP HILLLOCK-INN ROAD B, INDUSTRIAL AREA KENYA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER02/09/2022
489NDA/MAL/HDP/10172SURGE LABORATORIES (PVT.) LTD.HEALTHCARE LTD.SURGICOMB INJECTION 2G CEFOPRAZONE SODIUM + SULBACTUM SODIUM(1G + 1G)/VIALSURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTAN PARENTERAL ORDINARY DRY VIALS 1.0X1.0X2.0 G VIAL + 10ML WFI CLEAR GLASS AMPOULE09/09/2022
490NDA/MAL/HDP/10173APAROZA PHARMA LTDAPAROZA PHARMA LIMITEDESCAPELLELEVONORGESTREL1.5MGGEDEON RICHTER PLC (H-1103 BUDAPEST, GYOMROI UT 19-21 HUNGARY)HUNGARYORAL SOLID ORDINARY TABLETS 1.0X1.0X1.0 TABLET BLISTER29/09/2022
491NDA/MAL/HDP/10177ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMETOCLOPRAMIDE TABLETS BP 10 MGMETOCLOPRAMIDE HYDROCHLORIDE10 MGCIRON DRUGS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR – 401404, MAHARASHTRAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
492NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDA ORAL SOLID ORDINARY CAPSULES 100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER01/07/1997
493NDA/MAL/HDP/10183 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDTEXAKINDTRANEXAMIC ACID500MG/5MLMANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X4.0X5.0 ML AMPOULE09/09/2022
494NDA/MAL/HDP/10185MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTURBOVAS-10ROSUVASTATIN CALCIUM10MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0X10.0 TABLET BLISTER09/09/2022
495NDA/MAL/HDP/10186PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDAARLOFLOX OZOFLOXACIN + ORNIDAZOLE200 MG + 500 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X10.0 TABLET BLISTER09/09/2022
496NDA/MAL/HDP/10187PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDAARCET 5CETIRIZINE HYDROCHLORIDE5 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
497NDA/MAL/HDP/10188PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDAARLEFLOX 750LEVOFLOXACIN HEMIHYDRATE750 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER09/09/2022
498NDA/MAL/HDP/10189PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDETRICOX 120ETORICOXIB120 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
499NDA/MAL/HDP/10192INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINFUTAXIM 1 GMCEFOTAXIME SODIUM1 G/ VIALZEISS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.)INNOVA CAPTAB LIMITED 1281/1, HILLTOP INDUSTRIAL ESTATE, NEAR EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN [H.P] - INDIAINDIA PARENTERAL RETARD DRY VIALS 1.0X1.0X1.0 G VIAL09/09/2022
500NDA/MAL/HDP/10193UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVIVAZAC PLUSIRBESARTAN + HYDROCHLOROTHIAZIDE300 MG + 12.5 MGUNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
501NDA/MAL/HDP/10196CONCEPT PHARMACEUTICAL LTDJEET PHARMACEUTICALS LIMITEDPANTEC-DSRPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE40 MG + 30 MGCONCEPT PHARMACEUTICALS LIMITEDKISHANPUR JAMALPUR ROORKEE DIST HARIDWAR -247667 UTTARAKHAND, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER29/09/2022
502NDA/MAL/HDP/10197CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDLEVOZINELEVOCETIRIZINE DIHYDROCHLORIDE5 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
503NDA/MAL/HDP/10199MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGOFEN 200IBUPROFEN200 MGMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILAND ORAL SOLID ORDINARY OTHER CAPSULES 1.0X6.0X1.0X1.0X10.0 CAPSULE BLISTER09/09/2022
504NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIAINDIA ORAL SOLID RETARD LAYERED TABLETS 1.0X10.0X1.0X12.0 TABLET BLISTER01/07/2012
505NDA/MAL/HDP/10200UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDSENERGY PLUS 5/160/12.5 MGAMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE5 MG + 160 MG + 12.5 MGUNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER29/09/2022
506NDA/MAL/HDP/10201PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDETRICOX 60ETORICOXIB60 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
507NDA/MAL/HDP/10207INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDTACROTAS-1TACROLIMUS MONOHYDRARE1 MGINTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER09/09/2022
508NDA/MAL/HDP/10209FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRAMAPA FORT 75MG/650MGTRAMADOL HYDROCHLORIDE + PARACETAMOL75 MG + 650 MGFERRER INTERNATIONAL, S.AC/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES,SPAIN ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER09/09/2022
509NDA/MAL/HDP/10210FDC LTD AIVEEN (U) LIMITEDIOPROST EYE DROPSLATANOPROST0.005%W/VFDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABADINDIAOPHTHALMIC LIQUIDS 1.0X1.0X5.0 ML BOTTLE29/09/2022
510NDA/MAL/HDP/10211PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDSPAZNOLDICLOFENAC SODIUM + PARACETAMOL + CHLORZOXAZON50 MG + 325 MG + 250 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
511NDA/MAL/HDP/10212PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDSPASNIL PMEFENAMIC ACID + PARACETAMOL500 MG + 325 MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
512NDA/MAL/HDP/10213 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDPANTAKIND-40PANTOPRAZOLE SODIUM40 MGMANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X6.0X10.0 TABLET BLISTER09/09/2022
513NDA/MAL/HDP/10214MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDILAXTEN 20 MG TABLETSBILASTINE20MG A. MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL-VIA CAMPO DI PILE 67100 L'AQUILA (AQ) ITALYORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER09/09/2022
514NDA/MAL/HDP/10215ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPARACETAMOL INTRAVENOUS INFUSIONPARACETAMOL10 MG/ML ABARIS HEALTHCARE PVT. LTDSURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740INDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML CONTAINER09/09/2022
515NDA/MAL/HDP/10216KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDLULIZOL CREAMLULICONAZOLE1%W/WCURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE29/09/2022
516NDA/MAL/HDP/10218BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCOMIT-100SILDENAFIL CITRATE100 MGBLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER09/09/2022
517NDA/MAL/HDP/10219BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCOMIT-50SILDENAFIL CITRATE50 MGBLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER09/09/2022
518NDA/MAL/HDP/1022 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES - UNITED HEALTHCARE DISTRIBUTORS LTDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPT ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
519NDA/MAL/HDP/10225LUKAS LAB LTDPLUTO PHARMACEUTICALS LIMITEDLUSNAT 60ARTESUNATE60 MGBLISS INDAS LIFESCIENCE P. LTD..PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMANINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X60.0 MG VIAL + 1ML 0F 5.0%W/V SODIUM BICARBONATE VIAL + 5ML OF 0.9%W/V SODIUM CHLORIDE VIAL09/09/2022
520NDA/MAL/HDP/10226LUKAS LAB LTDPLUTO PHARMACEUTICALS LIMITEDLUSNAT 120ARTESUNATE120 MGBLISS INDAS LIFESCIENCE P. LTD..PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMANINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X120.0 MG VIAL + 2ML OF 5.0%W/V SODIUM BICARBONATE VIAL + 10ML OF 0.9%W/V SODIUM CHLORIDE VIAL09/09/2022
521NDA/MAL/HDP/10228BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDSEPTOPRIM 960TRIMETHOPRIM + SULFAMETHOXAZOLE160 MG + 800 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
522NDA/MAL/HDP/10229BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDSEPTOPRIM - STRIMETHOPRIM + SULFAMETHOXAZOLE(40 MG + 200 MG)/5 MLCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE09/09/2022
523NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED..PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 MYLAN LABORATORIES LIMITED.-PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER01/07/2013
524NDA/MAL/HDP/10230BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDMBENMEBENDAZOLE100 MG/5 MLCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X30.0 ML BOTTLE09/09/2022
525NDA/MAL/HDP/10231BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDMBEN 100MEBENDAZOLE100 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X20.0X6.0 TABLET BLISTER09/09/2022
526NDA/MAL/HDP/10232BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDTOPGYLMETRONIDAZOLE BENZOATE125 MG/5 MLCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE09/09/2022
527NDA/MAL/HDP/10233BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDPAINFORCE 400IBUPROFEN400 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
528NDA/MAL/HDP/10234 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDTERBINAFORCE 250TERBINAFINEHYDROCHLORIDE250 MGMANKIND PHARMA LIMITEDUNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
529NDA/MAL/HDP/10235BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDLOFNAC GELLINSEED OIL + DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + MENTHOL3.00%W/W + 1.16% W/W + 10.00%W/W + 5.00%W/WKREMOINT PHARMA PVT LTD PLANT IIB-8, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST) DIST. THANE 421506INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE09/09/2022
530NDA/MAL/HDP/10239 B&O PHARMTRIDEM PHARMA UGANDA LIMITEDZITMYCAZITHROMYCIN500MGCSPC OUYI PHARMACEUTICAL CO. LTD.WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINACHINA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER09/09/2022
531NDA/MAL/HDP/10240MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDOLMESAR 40OLMESARTAN MEDOXOMIL40MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
532NDA/MAL/HDP/10241S K AGE EXPORTSDAVIMED PHARMA LIMITEDLARIACT FORTEARTEMETHER + LUMEFANTRINE80 MG + 480 MGS KANT HEALTHCARE LIMITED1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER09/09/2022
533NDA/MAL/HDP/10242EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDINSTGRADOLUTEGRAVIR SODIUM50MGEMCURE PHARMACEUTICALS LIMITEDPLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE09/09/2022
534NDA/MAL/HDP/10246 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLENDESDESLORATADINE5MGGLENMARK PHARMACEUTICALS LIMITEDPLOT NO. S - 7, COLVALE, INDUSTRIAL ESTATE COLVALE, BARDEZ 403513, GOA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER19/09/2022
535NDA/MAL/HDP/10247 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 228.5AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE200MG/5ML + 28.5MG/5MLCOPMED PHARMACEUTICALS PVT LTD-UNIT II. ,PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIAINDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE09/09/2022
536NDA/MAL/HDP/10249FDC LTD AIVEEN (U) LIMITEDIOPROST – TLATANOPROST + TIMOLOL MALEATE(50 MCG + 5 MG)/MLFDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABADINDIA OPHTHALMIC DROPS 1.0X1.0X2.5 ML BOTTLE09/09/2022
537NDA/MAL/HDP/10250JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB SINUS PAIN EXTRA STRENGTHCODEINE PHOSPHATE +CHLORPHENIRAMINE MALEATE +PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL10 MG + 2 MG + 30 MG + 500 MGJOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWNSOUTH AFRICA ORAL SOLID ORDINARY TABLETS 1.0X1.0X12.0 TABLET BLISTER09/09/2022
538NDA/MAL/HDP/10251THE UNITED PHARMACEUTICALS MFG, CO. LTD,WIDE SPECTRUM ENTERPRISES (U) LIMITEDCITADONEBETAMETHASONE0.6 MG/5 MLUNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDAN ORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE09/09/2022
539NDA/MAL/HDP/10254CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDAZICEN 500AZITHROMYCIN500MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER09/09/2022
540NDA/MAL/HDP/10258THE UNITED PHARMACEUTICALS MFG, CO. LTD,WIDE SPECTRUM ENTERPRISES (U) LIMITEDSENERGY PLUS 5/160 25 MGAMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE5 MG + 160 MG + 25 MGUNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
541NDA/MAL/HDP/10259THE UNITED PHARMACEUTICALS MFG, CO. LTD,WIDE SPECTRUM ENTERPRISES (U) LIMITEDSENERGY PLUS 10/160 12.5 MGAMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE10 MG + 160 MG + 12.5 MGUNITED PHARMACEUTICALS MANUFACTURING LTD COAL- RAGEEM, SAHAB, P.O BOX 69, AMMAN 11591, JORDANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
542NDA/MAL/HDP/10261BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDNTCLOT-C75CLOPIDOGREL BILSULFATE75 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER09/09/2022
543NDA/MAL/HDP/10262AUROLABSWASTIK PHARMACEUTICAL LTDAUROFLOXOFLOXACIN0.3%W/VAUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI €“ 625 020 TAMIL NADU INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE19/09/2022
544NDA/MAL/HDP/10263BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDWORMAID ORAL SUSPENSIONALBENDAZOLE200 MG/5MLCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0 ML BOTTLE09/09/2022
545NDA/MAL/HDP/10267SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDPROTOZOX-500NITAZOXANIDE500MGSAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
546NDA/MAL/HDP/10268BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDWORMAID TABLETALBENDAZOLE400 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA BIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X1.0 TABLET BLISTER09/09/2022
547NDA/MAL/HDP/10269NATIONAL PHARMACEUTICAL INDUSTRIES CO.MEDVIN PHARMA LIMITEDDIOCLAV 625 MGAMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMANP.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMANOMAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET STRIP09/09/2022
548NDA/MAL/HDP/10280INDCHEMIE HEALTH SPECIALITIES PVT. LTD.NUMED STORES SMC LIMITEDZENOXIM 500CEFUROXIME AXETIL500 MGINDCHEMIE HEALTH SPECIALITIES PVT. LTDVILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
549NDA/MAL/HDP/10281PLANET PHARMACEUTICALS UGANDA LTDPLANET PHARMACEUTICALS UGANDA LTDH- CURE ESESOMEPRAZOLE MAGNESIUM + CLARITHROMYCIN + TINIDAZOLE40MG + 500MG + 500MGFREDUN PHARMACEUTICALS LIMITED,14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANEINDIA ORAL SOLID ORDINARY TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER09/09/2022
550NDA/MAL/HDP/10282 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMUPIWAYSMUPIROCIN2.0 W/WNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE09/09/2022
551NDA/MAL/HDP/10283DAWA LIMITED-SUPER MEDIC LTDDAZOLECLOTRIMAZOLE100MGDAWA LIMITEDPLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYAKENYA VAGINAL TABLETS 1.0X1.0X6.0 PESSARY BLISTER09/09/2022
552NDA/MAL/HDP/10284NATIONAL PHARMACEUTICAL INDUSTRIES CO.MEDVIN PHARMA LIMITEDMACROMAX 500AZITHROMYCIN500MGNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY OMANP.O.BOX 120, RUSAYL, POSTAL CODE-124, SULTANATE OF OMANOMAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER09/09/2022
553NDA/MAL/HDP/10285MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDDOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION (DISPERSIBLE TABLETS) 10MGDOLUTEGRAVIR SODIUM10 MGMACLEODS PHARMACEUTICALS LTD ,.PHASE I & II, PLOT NO. 25-27 SURVEY NO. 366, PREMIERE INDUSTRIAL ESTATE, KACHIGAN, DAMAN-396210INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X90.0 TABLET CONTAINER09/09/2022
554NDA/MAL/HDP/10286ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPERLEX 250CEFALEXIN MONOHYDRATE250 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER09/09/2022
555NDA/MAL/HDP/10287DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDVILDA DENK 50 MGVILDAGLIPTIN50 MGDENK PHARMA GMBH & CO. KGGOLLSTR. 1, 84529, TITTMONINGGERMANY ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER09/09/2022
556NDA/MAL/HDP/10292SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDSPASMOTRITDICYCLOMINE HYDROCHLORIDE + PARACETAMOL20MG + 500MGSAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
557NDA/MAL/HDP/10294ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)ALTCIPCIPROFLOXACIN200MGALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIAINDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE09/09/2022
558NDA/MAL/HDP/10296LUPIN LIMITED-AIVEEN (U) LIMITEDRIFAMPIN, ISONIAZID, PYRAZINAMIDE, ETHAMBUTOL HYDROCHLORIDE TABLETS USP150/75/400/275MGRIFAMPIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE150MG + 75MG + 400MG + 275MGLUPIN LTDA-28/1, M.I.D.C., CHIKALTHANA, AURANGABAD-431210, MAHARASHTRA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X14.0 TABLET BLISTER09/09/2022
559NDA/MAL/HDP/10297BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACECLAV 1000AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE875 MG + 125 MGMEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
560NDA/MAL/HDP/10298ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDCOXZOTA 90ETORICOXIB90 MGZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
561NDA/MAL/HDP/10299BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACECLAV 625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500 MG + 125 MGMEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER09/09/2022
562NDA/MAL/HDP/1030LABORATORIOS SALVAT SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMALACURDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGCIRON DRUGS PHARMACEUTICALS PRIVATE LTD,35-37, 43-45, CFC-B DEWAN UDYOG NAGAR, ALIYALI, DIST - PALGHAR 401 404, MAHARASHTRAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER01/07/2014
563NDA/MAL/HDP/10300BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACECLAV 375AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE250 MG + 125 MGMEDICEF PHARMA-NO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP) INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER09/09/2022
564NDA/MAL/HDP/10303MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDAPZIN-5DAPAGLIFLOZIN5 MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
565NDA/MAL/HDP/10304MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDAPZIN-10DAPAGLIFLOZIN10 MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
566NDA/MAL/HDP/10305SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDSPASCOLICDICYCLOMINE HYDROCHLORIDE + MEFENAMIC ACID10 MG + 250 MGSAGA LIFESCIENCES LIMITEDSURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TA-SANAND, DIST. AHMEDABAD - 382210, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER09/09/2022
567NDA/MAL/HDP/10307ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDDESLOZED-5DESLORATADINE5 MGZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
568NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPT ORAL SOLID ORDINARY TABLETS 1.0X1.0X5.0 TABLET BLISTER01/07/2013
569NDA/MAL/HDP/10310ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDZINRO INFUSIONORNIDAZOLE500MG/100MLABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGAUGANDA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE09/09/2022
570NDA/MAL/HDP/10311LAURUS LABS LIMITED - BEYOND LOGISTICS LTDLOPINAVIR AND RITONAVIR TABLETS USPLOPINAVIR + RITONAVIR200MG + 50MGLAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET BOTTLE09/09/2022
571NDA/MAL/HDP/10313LAURUS LABS LIMITED - BEYOND LOGISTICS LTDLOPINAVIR AND RITONAVIR TABLETS USPLOPINAVIR + RITONAVIR100MG + 25MGLAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE09/09/2022
572NDA/MAL/HDP/10315ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDINDOMETHACININDOMETHACIN25MGM/S SCOTT-EDIL PHARMACIA LIMITED-56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE TIN,1.0X500.0 CAPSULE TIN,1.0X10.0X10.0 CAPSULE BLISTER01/07/2008
573NDA/MAL/HDP/10317Y.S.P. INDUSTRIES (M) SDN. BHD.ROYAL PHARMA 2011 LIMITEDVOREN SUPPOSITORY 100 MGDICLOFENAC SODIUM100MGY.S.P INDUSTRIES (M) SDN BHN.LOT 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN PENDUSTRIAN BANDAR BARU BANGI, 43000, KAJANG, SELANGOR, MALAYSIAMALAYSIA RECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP09/09/2022
574NDA/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 EGYPT ORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
575NDA/MAL/HDP/10320ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMETROSCOT 125MG/5MLMETRONIDAZOLE BENZOATE125MG/5MLM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE09/09/2022
576NDA/MAL/HDP/10323AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDXELTINTOFACITINIB CITRATE5MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
577NDA/MAL/HDP/10324APEX LABORATORIES PRIVATE LIMITED NORVIK ENTERPRISES LIMITEDZINCOVIT TABLETSVITAMIN A (AS ACETATE) + VITAMIN D3 (CHOLECALCIFEROL) + VITAMIN E (AS DL-TOCOPHERYL ACETATE) + THIAMINE NITRATE + RIBOFLAVIN + PYRIDOXINE HYDROCHLORIDE + CYANOCOBALAMIN + NICOTINAMIDE + CALCIUM PANTOTHENATE + ASCORBIC ACID + MAGNESIUM OXIDE + MANGANESE SU5000IU + 400IU + 15MG +10MG + 10MG + 2MG + 7.5MCG + 50MG + 10MG + 75 MG + 30MG + 2.8MG + 2MG + 63MG +70MCGAPEX LABORATORIES PRIVATE LIMITED- PLANT 1-B-23, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, KANCHEEPURAM DISTRICT 603 110 INDIA ORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER09/09/2022
578NDA/MAL/HDP/10325MEDLEY PHARMACEUTICALS LTDEUROPA HEALTHCARE (U) LTDONCETCETIRIZINE DIHYDROCHLORIDE5MG/5MLMEDLEY PHARMACEUTICALS LTDPLOT 18 & 19 SURVEY NO. 378/7&8, 379/2&3 ZARI CAUSEWAY ROAD, KACHIGAM DAMAN-396210, INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE09/09/2022
579NDA/MAL/HDP/10326SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDRISEOL 50TRAMADOL HYDROCHLORIDE50MGSUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER19/09/2022
580NDA/MAL/HDP/1033FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAIN ORAL LIQUID ORDINARY LIQUIDS 1.0X20.0X10.0 ML SACHET01/07/2015
581NDA/MAL/HDP/10332MIDDLE EAST PHARMACEUTICAL INDUSTRIES CO. LTD. (AVALON PHARMA)GAMA PHARMACEUTICALS (U) LIMITEDAVOCOMMOMETASONE FUROATE0.05%W/WMIDDLE EAST PHARMACEUTICAL INDUSTRIES COMPANY LIMITED (AVALON PHARMA)P.O. BOX 4180, RIYADH 11491, 2ND INDUSTRIAL CITY, RIYADH, SAUDI ARABIASAUDI ARABIANASAL TOPICAL PRESSURISED AEROSOLS 1.0X1.0X120.0 METERED DOSE BOTTLE19/09/2022
582NDA/MAL/HDP/10335GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDPRIDOCAINELIDOCAINE + PRILOCAINE2.5% W/W + 2.5%W/WGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY EGYPT TOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE09/09/2022
583NDA/MAL/HDP/10338NEOMI PHARMACEUTICALS PVT LTD -ROYAL PHARMA 2011 LIMITEDROART 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X24.0 TABLET BLISTER09/09/2022
584NDA/MAL/HDP/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX AMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUSCYPRUS ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE01/07/2007
585NDA/MAL/HDP/10340GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDKERELLABETAMETHASONE DIPROPIONATE + SALICYLIC ACID(0.5 MG+ 220 MG)/GGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY EGYPT TOPICAL EXTERNAL LOTIONS 1.0X1.0X30.0 ML BOTTLE09/09/2022
586NDA/MAL/HDP/10343DAWA LIMITED-SUPER MEDIC LTDKENAZOLEKETOCONAZOLE2%W/WDAWA LIMITEDPLOT NO. 7879/8 BABADOGO ROAD, RUARAKA P. O. BOX 16633-00620 NAIROBI, KENYAKENYA TOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE09/09/2022
587NDA/MAL/HDP/10346EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDLACTORIVLACTULOSE10 G/15 MLEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X120.0 ML BOTTLE09/09/2022
588NDA/MAL/HDP/10349SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDGLUMACARTEMETHER + LUMEFANTRINE80MG + 480MGGUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004CHINA ORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER,30.0X6.0 TABLET BLISTER09/09/2022
589NDA/MAL/HDP/10353BIOMATRIX HEALTHCARE PVT LTD.-MEDIWORLD PHARMA AFRICA LTDPAINAIDPARACETAMOL + IBUPROFEN + CAFFEINE400 MG + 325 MG + 40 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD – 382 220, GUJARAT INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER09/09/2022
590NDA/MAL/HDP/10355INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRIVATAS 15RIVAROXABAN15 MGINTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
591NDA/MAL/HDP/10356INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRIVATAS 20RIVAROXABAN20MGINTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X0.01 TABLET BLISTER09/09/2022
592NDA/MAL/HDP/10358PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDVOLDIC - KDICLOFENAC POTASSIUM50MGPHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER09/09/2022
593NDA/MAL/HDP/10361AFRICURE PHARMACEUTICALS (INDIA) PVT. LTDAFRICURE PHARMACEUTICALS U LIMITEDAFRICALCALCIUM LACTATE300 MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA.INDIAORAL SOLID ORDINARY TABLETS 1X10X10 TABLET BLISTER19/09/2022
594NDA/MAL/HDP/10363ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRO - AMIKACINAMIKACIN SULFATE500 MG/2 MLSANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL19/09/2022
595NDA/MAL/HDP/10365MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDMYLTEGA DTDOLUTEGRAVIR SODIUM10MGMYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X90.0 TABLET BOTTLE09/09/2022
596NDA/MAL/HDP/10369AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDSITAPRIL 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
597NDA/MAL/HDP/10370AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDSITAPRIL 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
598NDA/MAL/HDP/10371ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROLEXIN 250CEFALEXIN MONOHYDRATE250MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER19/09/2022
599NDA/MAL/HDP/10376SURGE LABORATORIES (PVT.) LTD.HEALTHCARE LTD.SURGICOMB 1G INJECTIONCEFOPRAZONE SODIUM + SULBACTUM SODIUM0.5G + 0.5GSURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTAN PARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL + 1*5ML AMPOULE OF WFI09/09/2022
600NDA/MAL/HDP/10378CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDESOMIZAPESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
601NDA/MAL/HDP/10379ACINO PHARMA (PTY) LTDLABOREX UGANDA LIMITEDORATANE® 10 MGISOTRETINOIN10MGDOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND SWISS CAPS AG HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X4.0X15.0 CAPSULE BLISTER19/09/2022
602NDA/MAL/HDP/1038SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME TRIHYDRATE 200MGSQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESHBANGLADESH ORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER01/07/2014
603NDA/MAL/HDP/10380ACINO PHARMA (PTY) LTDLABOREX UGANDA LIMITEDORATANE® 20 MGISOTRETINOIN20MGDOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND SWISS CAPS AG HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLANDNEW ZEALAND SWITZERLANDORAL SOLID ORDINARY OTHER CAPSULES 1X4X15 CAPSULE BLISTER19/09/2022
604NDA/MAL/HDP/10381ACINO PHARMA (PTY) LTDLABOREX UGANDA LIMITEDORATANE® 40 MGISOTRETINOIN40MGDOUGLAS MANUFACTURING LIMITEDCORNER TE PAI PLACE AND CENTRAL PARK DRIVE, LINCOLN, AUCKLAND 0610 - NEW ZEALAND SWISS CAPS AG HUSENSTRASSE 35, CH-9533 KIRCHBERG (SG) - SWITZERLANDNEW ZEALANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X15.0 CAPSULE BLISTER19/09/2022
605NDA/MAL/HDP/10382PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDPINN-TRYPTILLINAMITRIPTYLINE HYDROCHLORIDE25MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER09/09/2022
606NDA/MAL/HDP/10385XL LABORATORIES PRIVATE LIMITED-ROYAL PHARMA 2011 LIMITEDSOFKOFDEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE10MG + 5MG + 2MGXL LABORATORIES PRIVATE LIMITEDA-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER19/09/2022
607NDA/MAL/HDP/10386MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDOLMAC 5OLANZAPINE5MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
608NDA/MAL/HDP/10387MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDOLMAC 10OLANZAPINE10MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER09/09/2022
609NDA/MAL/HDP/10389EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDVIREXIM INJECTIONCEFTRIAXONE SODIUM1GEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*10ML AMPOULE OF WFI09/09/2022
610NDA/MAL/HDP/10390AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DT 40/240ARTEMETHER + LUMEFANTRINE40MG + 240MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X6.0 TABLET BLISTER09/09/2022
611NDA/MAL/HDP/10391SANDOZ GMBH .SURGIPHARM (U) LIMITEDHYDROXYUREA 100MGHYDROXYCARBAMIDE100MGHAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG GERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET BOTTLE,1.0X1.0X90.0 TABLET BOTTLE,1.0X1.0X120.0 TABLET BOTTLE,1.0X200.0 TABLET BOTTLE09/09/2022
612NDA/MAL/HDP/10392SANDOZ GMBH .SURGIPHARM (U) LIMITEDHYDROXYUREA 1000MGHYDROXYCARBAMIDE1000MGHAUPT PHARMA AMAREG GMBH-DONAUSTAUFER STRASSE 378, 93055 REGENSBURG GERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE09/09/2022
613NDA/MAL/HDP/1040SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3 DSCEFIXIME TRIHYDRATE 400MGSQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESHBANGLADESH ORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE BLISTER01/07/2014
614NDA/MAL/HDP/10418AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA CT 100SILDENAFIL CITRATE100 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X4.0 TABLET BLISTER08/02/2023
615NDA/MAL/HDP/10419AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSITAPRIL M 50/1000SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
616NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5 TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO PHARMACEUTICALS PVT. LIMITEDPLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP01/07/2013
617NDA/MAL/HDP/10420AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSITAPRIL M 50/500SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 500 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
618NDA/MAL/HDP/10421MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDMIOPOLOL ER 50METOPROLOL SUCCINATE50MGINVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANEINDIA ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
619NDA/MAL/HDP/10422MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDMIOPOLOL ER 25METOPROLOL SUCCINATE25MGINVENTIA HEALTHCARE PVT LTD F1-F1/1 ADDITIONAL MIDC AMBERNATH (E) DIST. THANEINDIA ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
620NDA/MAL/HDP/10427AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCELMAC 400CELECOXIB40 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
621NDA/MAL/HDP/10428DENK PHARMA GMBH & COBENLE CONSULT LIMITEDAMOXI-DENK 1000AMOXICILLIN TRIHYDRATE1000 MGPENCEF PHARMA GMBHBREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
622NDA/MAL/HDP/10429DENK PHARMA GMBH & COBENLE CONSULT LIMITEDAMOXI-DENK 500AMOXICILLIN TRIHYDRATE500 MGPENCEF PHARMA GMBHBREITENBACHSTRABE 13-14, 13509 BERLIN - GERMANYGERMANY ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER08/02/2023
623NDA/MAL/HDP/10430CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUADRIMUNEABACAVIR + LAMIVUDINE + LOPINAVIR + RITONAVIR30 MG + 15 MG + 40 MG +10 MGCIPLA LIMITED, GOA (UNIT X)PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147, L-147/1 TO L-147/3, L-138 AND L-147/A, VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE, GOA. PIN: 403722INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X120.0 CAPSULE CONTAINER08/02/2023
624NDA/MAL/HDP/10433BIOLOGICAL E. LIMITEDGITTOES PHARMACEUTICALS LIMITEDTETANUS ANTITOXIN 1500 IU/ML BPTETANUS ANTITOXIN1500 IU/MLBIOLOGICAL E. LIMITED18/1 & 3, AZAMABAD, HYDERABAD, TELANGANAINDIAPARENTERAL ORDINARY VIALS1.0X1.0X20.0 ML VIAL08/02/2023
625NDA/MAL/HDP/10435PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)AFEBRIL 5 MG/2.5MLDIAZEPAM5MG/2.5MLPROFARMA SH.AMYSLYM KETA,TIRANAALBANIA RECTAL SYSTEMIC OTHER SUPPOSITORIES 1.0X5.0X1.0 ML AMPOULE,1.0X2.5 ML AMPOULE,1.0X5.0X1.0X2.5 ML VIAL08/02/2023
626NDA/MAL/HDP/10436YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.KAIYUANTANG (U) LIMITEDPETHIDINE HYDROCHLORIDE INJECTIONPETHIDINE HYDROCHLORIDE50 MG/MLYICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED (NO. 19, DALIAN ROAD, YICHANG DEVELOPING ZONE, YICHANG, HUBEI, CHINA)CHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE10/02/2023
627NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
628NDA/MAL/HDP/10441BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDPREDNOVA 5PREDNISOLONE5MGBIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
629NDA/MAL/HDP/10447PT SANBE FARMAMEDVIN PHARMA LIMITEDTRADOSIKTRAMADOL HYDROCHLORIDE50 MG/MLPT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3)JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIAINDONESIA PARENTERAL ORDINARY AMPOULES 1.0X2.0X1.0X5.0X2.0 ML AMPOULE08/02/2023
630NDA/MAL/HDP/10448PT SANBE FARMAMEDVIN PHARMA LIMITEDDOLONESLIDOCAINE + PRILOCAINE(25 MG + 25 MG)/GPT CAPRIFARMINDO LABORATORIES ,JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIAINDONESIA TOPICAL EXTERNAL CREAMS 1.0X1.0X5.0 G TUBE08/02/2023
631NDA/MAL/HDP/1045SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIMAX 500 AZITHROMYCIN500MGSQUARE CEPHALOSPORINS LTDKALIAKOIR, GAZIPUR – 1750, BANGLADESHBANGLADESH ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER01/07/2013
632NDA/MAL/HDP/10450PT SANBE FARMAMEDVIN PHARMA LIMITEDMEFINAL 500MEFENAMIC ACID500 MGPT CAPRIFARMINDO LABORATORIES ,JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIAINDONESIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP08/02/2023
633NDA/MAL/HDP/10451GUANGZHOU WONDFO BIOTECH CO. LTDMETRO PHARMACEUTICALS LIMITEDWAXFREESODIUM BICARBONATE5%W/VLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA NASAL TOPICAL LIQUIDS 1.0X1.0X10.0 ML BOTTLE08/02/2023
634NDA/MAL/HDP/10452JAMJOOM PHARMACEUTICALS COMPANYMU PHARMA CO -SMC LIMITEDOPTIPREDPREDNISOLONE ACETATE1.0% W/V JAMJOOM PHARMACEUTICALS COMPANY - PLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIASAUDI ARABIA OPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE08/02/2023
635NDA/MAL/HDP/10453SANJAR PHARMA LLP.NILKANTH PHARMACY LIMITEDARTICURE 60MGARTESUNATE60MGSANJAR PHARMA LLP (SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA)INDIAPARENTERAL ORDINARY DRY VIALS 1.0x60.0 MG Vial + 10ML OF 0.9% SODIUM CHLORIDE SOLUTION, LDPE AMPOULE + 1ML OF 5.0% SODIUM BICARBONATE SOLUTION, GLASS AMOULE10/02/2023
636NDA/MAL/HDP/10455UNIMED LABORATORIESOMAB UGANDA LIMITEDENOXAMED 2000 IU ANTI-XA /0.2 MLENOXAPARIN SODIUM2000 IU ANTI-XA /0.2 ML (EQUIVALENT TO 20 MG PER 0.2 ML)UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.2 ML PRE- FILLED SYRINGE08/02/2023
637NDA/MAL/HDP/10456UNIMED LABORATORIESOMAB UGANDA LIMITEDENOXAMED 4000 IU ANTI-XA /0.4 MLENOXAPARIN SODIUM4000 IU ANTI-XA /0.4 ML (EQUIVALENT TO 40 MG PER 0.4 ML)UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE08/02/2023
638NDA/MAL/HDP/10457UNIMED LABORATORIESOMAB UGANDA LIMITEDENOXAMED 6000 IU ANTI-XA /0.6 MLENOXAPARIN SODIUM6000 IU ANTI-XA /0.6 ML (EQUIVALENT TO 60 MG PER 0.6 ML)UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE08/02/2023
639NDA/MAL/HDP/10458UNIMED LABORATORIESOMAB UGANDA LIMITEDENOXAMED 8000 IU ANTI-XA /0.8 MLENOXAPARIN SODIUM8000 IU ANTI-XA /0.8 ML (EQUIVALENT TO 80 MG PER 0.8 ML)UNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X2.0X0.4 ML PRE- FILLED SYRINGE08/02/2023
640NDA/MAL/HDP/10459UNIMED LABORATORIESOMAB UGANDA LIMITEDPARAMEDPARACETAMOL1G/100MLUNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIA PARENTERAL ORDINARY INFUSION BAGS 1.0X6.0X1.0X100.0 ML BAG08/02/2023
641NDA/MAL/HDP/10460PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDAERIALLERG 5MGDESLORATIDINE5 MGPHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
642NDA/MAL/HDP/10461PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDAERIALLERG 0.5MG/MLDESLORATIDINE0.5MG/MLPHARMA INTERNATIONAL CO. LTD AL QASTAL AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA 11941, AMAANJORDAN ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X125.0 ML BOTTLE08/02/2023
643NDA/MAL/HDP/10462AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOR - LOOP 10ANHYDROUS TORSEMIDE10 MGAUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE)INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
644NDA/MAL/HDP/10463FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISFORMETHOCARBAMOL500 MGFAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAINSPAIN ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
645NDA/MAL/HDP/10464JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN 4 FLU TABLETSDIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE12.5MG + 500MG + 22.5MGSPECGX LLC100 LOUIS LATZER DRIVE, GREENVILLE, ILLINOIS, 62246 - UNITED STATES OF AMERICA JOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWNUNITED STATES SOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER08/02/2023
646NDA/MAL/HDP/10466ARCELIA LIFE SCIENCES LTD.NOVOMED HEALTHCARE LIMITEDARCELIA CEFIXIMECEFIXIME TRIHYDRATE400 MGASSOCIATED BIOTECH-VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
647NDA/MAL/HDP/10467ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRABIRIV-DSRRABEPRAZOLE SODIUM + DOMPERIDONE20 MG + 30 MGEAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER10/02/2023
648NDA/MAL/HDP/10468ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCORTIRIV-100HYDROCORTISONE SODIUM SUCCINATE100 MG/VIALEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL, 1.0X50.0X100.0 MG VIAL08/02/2023
649NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 180MGFEXOFENADINE 180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER01/07/2013
650NDA/MAL/HDP/10472ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTRAMADOL HYDROCHLORIDE INJECTION 100 MG/2MLTRAMADOL HYDROCHLORIDE100 MG/2 MLM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X2.0 ML AMPOULE08/02/2023
651NDA/MAL/HDP/10473ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPOLYMOL SUSPENSION 125MG/5ML.PARACETAMOL125MG/5ML.M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE, 1.0X60.0ML BOTTLE08/02/2023
652NDA/MAL/HDP/10474ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPOLYMOL EXTRAPARACETAMOL + CAFFEINE500 MG + 30 MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
653NDA/MAL/HDP/10477CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDPENACAMPIROXICAM20 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER08/02/2023
654NDA/MAL/HDP/10483NVS KENYA LTD SURGIPHARM (U) LIMITEDPATIZRARANIBIZUMAB10 MG/MLNOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONSNOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLANDSWITZERLAND PARENTERAL ORDINARY VIALS 1.0X1.0X0.23 ML VIAL08/02/2023
655NDA/MAL/HDP/10484INDIANA OPHTHALMICS SWASTIK PHARMACEUTICAL LTDTETROPTETRACYCLINE HYDROCHLORIDE1%W/W INDIANA OPHTHALMICS135, 136, 137, GIDC ESTATE, WADHWAN-363035INDIA OPHTHALMIC OINTMENTS 1.0X1.0X5.0 G TUBE08/02/2023
656NDA/MAL/HDP/10485ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDRIVAROX 15RIVAROXABAN15 MGESKAYEF BANGLADESH LTD-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH
BANGLADESH ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
657NDA/MAL/HDP/10486ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDRIVAROX 20RIVAROXABAN20 MGESKAYEF BANGLADESH LTD-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH
BANGLADESH ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER08/02/2023
658NDA/MAL/HDP/10488ESKAYEF PHARMACEUTICALS LTD.SWASTIK PHARMACEUTICAL LTDGTN 2.6 SRDILUTED NITROGLYCERIN2.6 MGESKAYEF BANGLADESH LTD-400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH
BANGLADESH ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER08/02/2023
659NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2013
660NDA/MAL/HDP/10492MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDDOLUTEGRAVIR SODIUM TABLETS 50 MGDOLUTEGRAVIR SODIUM50 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT IIPLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN - 396210 (UT) - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BLISTER08/02/2023
661NDA/MAL/HDP/10493CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDROUNOXTRAMADOL HYDROCHLORIDE50 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER08/02/2023
662NDA/MAL/HDP/10496UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDIRIS SYRUPDESLORATADINE0.5 MG/MLUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYAL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDANJORDAN ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE08/02/2023
663NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE 10MG INTAS PHARMACEUTICALS LTDPLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)
INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER01/07/2013
664NDA/MAL/HDP/10502MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVORIOLE 200VORICONAZOLE200MGMSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION (PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, )INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER10/02/2023
665NDA/MAL/HDP/10503AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDHI-ALFA SR 10ALFUZOSIN HYDROCHLORIDE10MGAUROBINDO PHARMA LIMITED UNIT 3PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
666NDA/MAL/HDP/10505ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOPTOR EYE DROPSKETOROLAC TROMETHAMINE0.5%W/VABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGAUGANDA OPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE08/02/2023
667NDA/MAL/HDP/10506PHARMATHEN S.AGOODMAN INTERNATIONAL LTDA-CNOTREN® 10MGISOTRETINOIN10MGGAP S.A. (46 AGISSILAOU STR. 17341 AGIOS DIMITRIOS) PHARMATHEN INTERNATIONAL S.A (INDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECE) PHARMATHEN S.A (6, DERVENAKION STR. 15351 PALLINI ATHENS)GREECEORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER10/02/2023
668NDA/MAL/HDP/10507AUROLABSWASTIK PHARMACEUTICAL LTDTOB - DEXTOBRAMYCIN SULFATE + DEXAMETHASONE SODIUM PHOSPHATE0.3%W/V + 0.1%W/VAUROLAB .NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020INDIA OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE08/02/2023
669NDA/MAL/HDP/10508BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFIMABUTE-100CEFIXIME TRIHYDRATE100MG/5MLBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE08/02/2023
670NDA/MAL/HDP/10511VRUSHIK INVESTMENT (U) LTD.SHREEJI PHARMACEUTICALS LIMITEDMETOMETOCLOPRAMIDE HYDROCHLORIDE10MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
671NDA/MAL/HDP/10519PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID500MGPT SANBE FARMA UNIT 1JALAN INDUSTRI I NO. 9 RT. 01 RW.08, KELURAHAN UTAMA, KECAMATAN CIMAHI SELATAN, KOTA CIMAHI 40553 - INDONESIAINDONESIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP08/02/2023
672NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGEN MICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/WAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
673NDA/MAL/HDP/10523 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDSYNRIAM DTARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE37.5 MG + 187.5 MGSUN PHARMACEUTICAL IND. LTDPLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X3.0 TABLET BLISTER08/02/2023
674NDA/MAL/HDP/1053GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-125 DT AMOXICILLIN125MGMILAN LABORATORIES (INDIA) PVT LTD .PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
675NDA/MAL/HDP/10530ZOTA HEALTHCARE LTDHARLEYS UGANDA LIMITEDCOXZOTA 120ETORICOXIB120MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
676NDA/MAL/HDP/10531GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDENO CALCIUM ANTACID TABLETSCALCIUM CARBONATE500MGGLAXOSMITHKLINE LIMITEDLIKONI ROAD, INDUSTRIAL AREA, P.O. BOX 78392-00507, VIWANDANI, NAIROBI GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC320 SOUTH BROADWAY ST. LOUIS, MISSOURI, 63102 - UNITED STATES OF AMERICAKENYA UNITED STATES ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER08/02/2023
677NDA/MAL/HDP/10532ALKEM LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME TRIHYDRATE400MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0 CAPSULE BLISTER08/02/2023
678NDA/MAL/HDP/10535FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGINOVAGDEQUALINIUM CHLORIDE + TYROTHRICIN + ? -GLYCYRRHETINIC ACID (ENOXOLONE) + HYDROCORTISONE ACETATE + LIDOCAINE HYDROCHLORIDE(100MG + 400MG + 60MG + 60MG+100MG) PER 100 MLFERRER INTERNATIONAL, S.AC/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES,SPAIN ORAL TOPICAL SPRAYS WITHOUT GAS 1.0X1.0X10.0 ML BOTTLE08/02/2023
679NDA/MAL/HDP/10536KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDMUPISOFT OINTMENTMUPIROCIN2.0% W/WCURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X5.0 G TUBE, 1.0X1.0X15.0 G TUBE08/02/2023
680NDA/MAL/HDP/10537KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNIOSOL OINTMENTCLOBETASOL PROPIONATE0.05%W/WCURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X30.0 G TUBE08/02/2023
681NDA/MAL/HDP/10538KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDSUDIF CREAMFUSIDIC ACID2.0 %W/WCURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205INDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE08/02/2023
682NDA/MAL/HDP/10539ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZOTAMET-850METFORMIN HYDROCHLORIDE850MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER08/02/2023
683NDA/MAL/HDP/1054GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE BLISTER01/07/2011
684NDA/MAL/HDP/10540 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDATAZANAVIR AND RITONAVIR TABLETSATAZANAVIR SULFATE + RITONAVIR300MG + 100MGSUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE08/02/2023
685NDA/MAL/HDP/10544AUROLABSWASTIK PHARMACEUTICAL LTDATROPATROPINE SULFATE1%W/VAUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIABRAZIL OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE08/02/2023
686NDA/MAL/HDP/10545BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDBRAMOLPARACETAMOL10MG/MLBROOKES PHARMA (PRIVATE) LIMITED58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTAN PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML VIAL08/02/2023
687NDA/MAL/HDP/10547PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)HALOPERIDOL SOLUTION FOR INJECTION 5MG/MLHALOPERIDOL5MG/MLPROFARMA SH.AMYSLYM KETA,TIRANAALBANIA PARENTERAL ORDINARY VIALS 1.0X2.0X5.0X1.0 ML VIAL08/02/2023
688NDA/MAL/HDP/10551SANJAR PHARMA LLP.MOTI PHARMA (UGANDA) LIMITEDADRENLINADRENALINE ACID TARTRATE1MGSANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 MG AMPOULE08/02/2023
689NDA/MAL/HDP/10552MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDZOPIMAC 2ESZOPICLONE2MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X100.0 TABLET CONTAINER08/02/2023
690NDA/MAL/HDP/10553ACINO AG.LABOREX UGANDA LIMITEDTITANAFIL 5TADALAFIL5MGPHARMACTIVE ILAC SAN. VE TIC. A.S.CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH. FATIH BULV. NO: 32 KAPAKLI/TEKIRDAG - 2820133250 - TURKEYTURKEY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER08/02/2023
691NDA/MAL/HDP/10554ACINO AGLABOREX UGANDA LIMITEDTITANAFIL 20TADALAFIL20MGPHARMACTIVE ILAC SAN. VE TIC. A.S.CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH. FATIH BULV. NO: 32 KAPAKLI/TEKIRDAG - 2820133250 - TURKEYTURKEY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER08/02/2023
692NDA/MAL/HDP/10557BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDLOFNAC-50DICLOFENAC SODIUM50MGBLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
693NDA/MAL/HDP/10558KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNEOCLEAN GELCLINDAMYCIN PHOSPHATE + NICOTINAMIDE1.0 %W/W + 4.0%W/WCURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X10.0 G TUBE08/02/2023
694NDA/MAL/HDP/10559KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNIOSALIC OINTMENTCLOBETASOL PROPIONATE + SALICYLIC ACID0.05%W/W + 3.00W/WCURETECH SKINCAREPLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X30.0 G TUBE, 1.0X1.0X20.0 G TUBE08/02/2023
695NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENT BETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE01/07/2013
696NDA/MAL/HDP/10561ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDWORIVALBENDAZOLE400MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER08/02/2023
697NDA/MAL/HDP/10562EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDACESON-PACECLOFENAC + PARACETAMOL100MG + 500MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER08/02/2023
698NDA/MAL/HDP/10563ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDENARIV-10ENALAPRIL MALEATE10MGEAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER10/02/2023
699NDA/MAL/HDP/10565AUROLABSWASTIK PHARMACEUTICAL LTDPILOPILOCARPINE NITRATE2%W/VAUROLAB .NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020INDIA OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE08/02/2023
700NDA/MAL/HDP/10566AUROLABSWASTIK PHARMACEUTICAL LTDAUROCARPINEPILOCARPINE NITRATE0.5%W/VAUROLAB .NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020INDIA OPHTHALMIC DROPS 1.0X5.0X1.0 ML VIAL08/02/2023
701NDA/MAL/HDP/10567AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDCELMAC 200CELECOXIB200MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
702NDA/MAL/HDP/10568AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 5/4AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE5 MG + 4 MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
703NDA/MAL/HDP/10569AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 5/8AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE5MG + 8MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
704NDA/MAL/HDP/1057NECTAR LIFESCIENCES LTDSUPER MEDIC LTD FIXINECT-200MGCEFIXIME 200MGNECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA
INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2013
705NDA/MAL/HDP/10570AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 10/4AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE10 MG + 4 MGNALAGARH, DISTT. SOLAN, H.P.-173205 INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
706NDA/MAL/HDP/10571AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAMADAY PL 10/8AMLODIPINE BESILATE + PERINDOPRIL ERBUMINE10MG + 8MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER08/02/2023
707NDA/MAL/HDP/10572MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDNAT-B FORTETHIAMINE MONONITRATE (VITAMIN B1) + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) + METHYLCOBALAMIN (VITAMIN B12) + FOLIC ACID + D-ALPHA-TOCOPHEROL ACETATE + VITAMIN A + VITAMIN D3 + COPPER SULPHATE ANHYDROUS + CHROMIUM PICOLINATE + ZINC AMINO ACID CHELATE100 MG + 200 MG + 500 MCG + 200 MCG + 200 IU + 5000 IU + 400 IU + 1.0 MG + 0.20 MG + 15.0 MGMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILAND ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER08/02/2023
708NDA/MAL/HDP/10578BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDOCORTINHYDROCORTISONE1%W/WKREMOINT PHARMA PVT LTD. B-8, ADDITIONAL AMBERNATH M.I.D.C, OPP. ANAND NAGIAR POLICE CHECK POST, AMBERNATH (E), DIST. THANE.INDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE08/02/2023
709NDA/MAL/HDP/10579 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDBENZYL BENZOATE APPLICATION BPBENZYL BENZOATE25%W/VRENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDA TOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE08/02/2023
710NDA/MAL/HDP/10593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMOMRIVMOMETASONE FUROATE0.1%W/WEAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE06/03/2023
711NDA/MAL/HDP/10597MEDISEL(K) LTDSUPER MEDIC LTDGABANERVEGABAPENTIN + METHYLCOBALAMIN300MG + 500MCGCORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
712NDA/MAL/HDP/10598DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDMIXIFCEFIXIME TRIHYDRATE400MGDAR AL DAWA (NA'UR PRINCE HASHEM BIN AL-HUSSEIN STREET P.O. BOX 9364 AMMAN 11191 JORDAN)JORDANORAL SOLID ORDINARY OTHER CAPSULES 1.0X5.0 CAPSULE BLISTER21/03/2023
713NDA/MAL/HDP/10600MEDISEL(K) LTDAIVEEN (U) LIMITEDOSTEOCERINGLUCOSAMINE SULPHATE POTASSIUM CHLORIDE + METHL SULPHONYL METHANE (MSM) + DIACEREIN750MG + 250MG + 50MGCORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
714NDA/MAL/HDP/10602WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.GOODMAN INTERNATIONAL LTDZIROMIN 200 MG/5 ML AZITHROMYCIN DIHYDRATE200 MG/5 MLWORLD MEDICINE ILAC SAN VE TIC A.S. (15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEY)TURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X30.0ML BOTTLE06/06/2023
715NDA/MAL/HDP/10604ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDPIPERATAZ 4.5PIPERACILLIN + TAZOBACTAM4 G + 0.5 GUNI MEDICOLABSUNI MEDICOLABS, PLOT NO. 21-22, PHARMACITY, SELAQUI, DEHRADUN - 248011INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X4.5 G VIAL15/02/2023
716NDA/MAL/HDP/10606MEDISEL(K) LTDAIVEEN (U) LIMITEDEMADON SYRUPONDANSETRON HYDROCHLORIDE2MG/5MLCORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIA ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X30.0 ML BOTTLE15/02/2023
717NDA/MAL/HDP/10607CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.DOLACKETOROLAC TROMETHAMINE10 MGCADILA PHARMACEUTICALS LTD1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDABAD, GUJARAT STATE, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP15/02/2023
718NDA/MAL/HDP/10609FDC LIMITED -AIVEEN (U) LIMITEDOCUDORDORZOLAMIDE HYDROCHLORIDE2%W/VFDC LIMITED-WALUJ.PLOT B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 (DIST AURANGABAD)INDIA OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
719NDA/MAL/HDP/1061SHOSAAN ASIC PACIFICRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2010
720NDA/MAL/HDP/10615LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLEVOZIN 5LEVOCETIRIZINE DIHYDROCHLORIDE5MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
721NDA/MAL/HDP/10616COSMOS LTD.ASTRA PHARMA (U) LIMITEDGLYSIT 5DAPAGLIFLOZIN5MGCOSMOS LTD..RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
722NDA/MAL/HDP/10617COSMOS LTD.ASTRA PHARMA (U) LIMITEDGLYSIT 10DAPAGLIFLOZIN10MGCOSMOS LTD..RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER15/02/2023
723NDA/MAL/HDP/10618BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDFOLIGRAF 150 I.URECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH)150 I.U/1ML BHARAT SERUM AND VACCINES LIMITEDPLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIA PARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X1.0 ML PRE- FILLED SYRINGE15/02/2023
724NDA/MAL/HDP/10619?LKO ?LAÇ SANAYI VE TICARET A. ?. CORE ACCESS LIMITEDDEXIRENDEXKETOPROFEN TROMETAMOL50MG/2MLIDOL LLAC DOLUM A.SDAVUTPASA CADDESI. CEBE ALI BEY SOK. NO. 20 34010/ DAVUTPASA - TOPKAPI / ISTANBULTURKEY PARENTERAL ORDINARY AMPOULES 1.0X1.0X6.0X2.0 ML AMPOULE15/02/2023
725NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITEDUNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA
INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON01/07/2013
726NDA/MAL/HDP/10621RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPENIRENPHENOXYMETHYLPENICILLIN POTASSIUM250MGRENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
727NDA/MAL/HDP/10622CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDPANTOPRAM 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40 MGCENTURION LABORATORIES PVT LTDPLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIAINDIA ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
728NDA/MAL/HDP/10623RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSTERIRENCHLORHEXIDINE GLUCONATE5% W/VRENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDA TOPICAL EXTERNAL LIQUIDS 1.0X5.0 L CONTAINER15/02/2023
729NDA/MAL/HDP/10624MSN LABORATORIES PRIVATE LIMITED,ABACUS PHARMA (AFRICA) LIMITEDMIBZOBORTEZOMIB3.5 MG/VIALMSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION (PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, )INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X3.5 MG VIAL21/03/2023
730NDA/MAL/HDP/10625LA RENON HEALTHCARE PRIVATE LIMITEDAIVEEN (U) LIMITEDESOGRESS 40ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40 MGSTANFORD LABORATORIES PRIVATE LIMITED (A SUBSIDIARY COMPANY OF LA RENON HEALTHCARE PRIVATE LIMITED)8, INDUSTRIAL AREA, MEHATPUR - 174315, HIMACHAL PRADESH - INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
731NDA/MAL/HDP/10631GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDRYALTRISOLOPATADINE HYDROCHLORIDE + MOMETASONE FUROATE665 MCG/25 MCGGLENMARK PHARMACEUTICALS LIMITED-UNIT IIIVILLAGE KISHANPURA, BADDI-NALAGARH ROAD TEHSIL BADDI, DIST. SOLAN, BADDI 173205 INDIAINDIA NASAL SYSTEMIC DROPS 1.0X1.0X240.0 METERED DOSE BOTTLE15/02/2023
732NDA/MAL/HDP/10634ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROFLU-CAREPARACETAMOL + CAFFEINE + CHLORPHENIRAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE500MG + 30MG + 2MG + 10MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER, 1.0X50.0X4.0 TABLET BLISTER,15/02/2023
733NDA/MAL/HDP/10637ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSETRIZINCETIRIZINE10MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
734NDA/MAL/HDP/10640FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISTEMMETHOCARBAMOL + PARACETAMOL380 MG + 300 MGFAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA – SPAINSPAIN ORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER15/02/2023
735NDA/MAL/HDP/10649PINNACLE LIFE SCIENCE PVT. LTDABACUS PHARMA (AFRICA) LIMITEDESOCID 40ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGPINNACLE LIFE SCIENCE PVT LTDKHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
736NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIA RECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER01/07/2007
737NDA/MAL/HDP/10652ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZ-OFLOX 200OFLOXACIN200MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER15/02/2023
738NDA/MAL/HDP/10653ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDCOXZOTA-60ETORICOXIB60MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
739NDA/MAL/HDP/10654ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)COMPOUND SODIUM LACTATE INTRAVENOUS INFUSIONSODIUM LACTATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE0.320%W/V + 0.600%W/V + 0.040%W/V + 0.027%W/VALTHEA PHARMA PRIVATE LIMITEDWORKS: PLOT NO. 374, SHED NO. 'E', ALPHA INDL. PARK, ATHIAWAD, DABHEL, NANI DAMAN - 396210 (U.T.), INDIAINDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE15/02/2023
740NDA/MAL/HDP/10660ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDAZITOZ-250AZITHROMYCIN DIHYDRATE250MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
741NDA/MAL/HDP/10661ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLIVOTA-750LEVOFLOXACIN HEMIHYDRATE750MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER15/02/2023
742NDA/MAL/HDP/10662ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDTOMOZAMOSAPRIDE CITRATE DIHYDRATE5MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
743NDA/MAL/HDP/10663FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRAMAPA 37.5 MG/325 MGTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5 MG/325 MGFERRER INTERNATIONAL, S.AC/ JOAN BUSCALLA, 1-9 08173 SANT CUGAT DEL VALLES,SPAIN ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER15/02/2023
744NDA/MAL/HDP/10664FDC LTD AIVEEN (U) LIMITEDOCUDORT-TDORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE(20 MG + 5 MG)/MLFDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABADINDIA OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
745NDA/MAL/HDP/10668LUPIN LIMITEDAIVEEN (U) LIMITEDDOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMERATE 50MG/300MG/300MGDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50 MG + 300 MG + 300 MGLUPIN LIMITED NAGPURPLOT NO. 6A, SECTOR 17, SPECIAL ECONOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET CONTAINER15/02/2023
746NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTDISSAPUR P.O DAPPAR 140506INDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2010
747NDA/MAL/HDP/10673EAST AFRICAN (INDIA) OVERSEASROYAL PHARMA 2011 LIMITEDCETARIVCETIRIZINE HYDROCHLORIDE5MG/5MLEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE15/02/2023
748NDA/MAL/HDP/10678KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDARTELUMARTEMETHER + LUMEFANTRINE20 MG + 120 MGKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X24.0 TABLET BLISTER15/02/2023
749NDA/MAL/HDP/10679ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDPG-75PREGABALIN75 MGZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER15/02/2023
750NDA/MAL/HDP/10681BIODEAL LABORATORIES LTD PLOT NO.123ABACUS PHARMA (AFRICA) LIMITEDPODOSAL OINTMENTPODOPYLLUM RESIN + SALICYLIC ACID20%W/W + 25%W/WBIODEAL LABOARATORIES LTD (123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBI)INDIATOPICAL EXTERNAL OINTMENTS 1.0X3.0X10.0 G TUBE07/05/2024
751NDA/MAL/HDP/10688MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDUROKADUTASTERIDE0.5 MGMEGA LIFESCIENCES PUBLIC CO. LTDPLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILANDTHAILAND ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
752NDA/MAL/HDP/10689ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLOSARZED-100LOSARTAN POTASSIUM100 MGZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
753NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTDN-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X1.0 ML AMPOULE01/07/2014
754NDA/MAL/HDP/10690SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDPROTAC-40PANTOPRAZOLE SODIUM40 MGSUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIAINDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
755NDA/MAL/HDP/10691GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROGLOPENTIN 400 MGGABAPENTIN400MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY EGYPT ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
756NDA/MAL/HDP/10692GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROGLOPENTIN 300 MGGABAPENTIN300MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY EGYPT ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
757NDA/MAL/HDP/10696MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCELEBIB CAPSULES 200MGCELECOXIB200MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
758NDA/MAL/HDP/10697BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDASPORELIXCETRORELIX ACETATE0.25MGBHARAT SERUM AND VACCINES LIMITEDPLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIA PARENTERAL ORDINARY I V VIALS 1.0X0.25 MG VIAL + 1*1ML GLASS AMPOULE OF WFI15/02/2023
759NDA/MAL/HDP/10706BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDNTSUGA 500METFORMIN HYDROCHLORIDE500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
760NDA/MAL/HDP/10707MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDZOPIMAC 3ESZOPICLONE3MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X100.0 TABLET CONTAINER15/02/2023
761NDA/MAL/HDP/10708BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDCAFENOLACETYLSALICYLIC ACID + CAFFEINE375MG + 25MGBETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554, MOGADISHU ROAD INDUSTRIAL AREA, NAIROBI KENYAKENYA ORAL SOLID ORDINARY TABLETS 1.0X8.0X20.0 TABLET BLISTER15/02/2023
762NDA/MAL/HDP/10709CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDVINGLYN M 50/850VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 850 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
763NDA/MAL/HDP/10710CADILA HEALTHCARE LIMITED;ABACUS PHARMA (AFRICA) LIMITEDOXALGIN GELDICLOFENAC DIETHYLAMINE+ METHYL SALICYLATE + VIRGIN LINSEED OIL + CAPSAICIN + RACEMENTHOL1.0%W/W + 10.0%W/W + 3.0%W/W + 0.05%W/W + 5.0%W/WEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE15/02/2023
764NDA/MAL/HDP/10715AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/500VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 500MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
765NDA/MAL/HDP/10716AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/850VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 850 MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
766NDA/MAL/HDP/10717AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDVILDARIL M 50/1000VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 1000 MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
767NDA/MAL/HDP/10719HETERO LABS LTD AIVEEN (U) LIMITEDGOAB 5SOLIFENACIN SUCCINATE5 MGM/S. ANNORA PHARMA PRIVATE LIMITEDSY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
768NDA/MAL/HDP/1072UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 80/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE 80MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDANJORDAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2013
769NDA/MAL/HDP/10720HETERO LABS LTD AIVEEN (U) LIMITEDGOAB 10SOLIFENACIN SUCCINATE10MGM/S. ANNORA PHARMA PRIVATE LIMITEDSY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE – 502313, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
770NDA/MAL/HDP/10721MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDFLEXABENZ GELDICLOFENAC DIETHYLMAINE + LINSEED OIL + METHYL SALICYLATE + MENTHOL + CYCLOBENZAPRINE HYDROCHLORIDE1.0%W/W + 3.0%W/W + 10.0%W/W + 5.0%W/W + 2.0%W/WOXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIAINDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE15/02/2023
771NDA/MAL/HDP/10723SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDINSULIN H MIXRECOMBINANT HUMAN INSULIN + RECOMBINANT PROTAMINE -HUMAN INSULIN(30IU + 70IU)/MLSOUTH EGYPT DRUG INDUSTRIES COMPANY (SEDICO)-FIRST INDUSTRIAL ZONE, 6TH OF OCTOBER CITY - EGYPT EGYPT PARENTERAL ORDINARY S C VIALS 1.0X1.0X10.0 ML VIAL15/02/2023
772NDA/MAL/HDP/10724MERIDIAN ENTERPRISES PRIVATE LIMITED.VIDA AFRICA LTDMONIZOL 3MICONAZOLE NITARATE400MGMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIAINDIAVAGINAL SUPPOSITORIES 1X1X3 PESSARY SACHET20/09/2023
773NDA/MAL/HDP/10725AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 2.5BISOPROLOL FUMARATE2.5MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
774NDA/MAL/HDP/10726AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 5BISOPROLOL FUMARATE5MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
775NDA/MAL/HDP/10727AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBESICOR 10BISOPROLOL FUMARATE10MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
776NDA/MAL/HDP/10728LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRAPI-COOLCHOLINE SALICYLATE + LIDOCAINE HYDROCHLORIDE8.70% W/W + 2.00% W/WLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA ORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE15/02/2023
777NDA/MAL/HDP/10729LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBRISCORILSALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN(1MG + 2MG + 50MG ) PER 5MLLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE15/02/2023
778NDA/MAL/HDP/10730UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNICHLOR 25CHLORTHALIDONE25MGUNICHEM LABORATORIES LIMITED (C-31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. )INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023
779NDA/MAL/HDP/10731UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNICHLOR 50CHLORTHALIDONE50 MGUNICHEM LABORATORIES LIMITED (C-31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. )INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER06/03/2023
780NDA/MAL/HDP/1074NECTAR LIFESCIENCES LTDSUPER MEDIC LTDCEFUAXITCEFUROXIME 500MGNECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA
INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2013
781NDA/MAL/HDP/10742CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDVINGLYNVILDAGLIPTIN50 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
782NDA/MAL/HDP/10743CADILA HEALTHCARE LIMITED “ZYDUS TOWER” - ABACUS PHARMA (AFRICA) LIMITEDVINGLYN M 50/500VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 500 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
783NDA/MAL/HDP/10748KESAR PHARMAVEERAM HEALTHCARE (U) LIMITEDLULI CREAMLULICONAZOLE1% W/WKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE15/02/2023
784NDA/MAL/HDP/10750LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCIN PLUSPARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE + CHORPHENIRAMINE MALEATE500 MG + 15 MG + 10 MG + 2 MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER15/02/2023
785NDA/MAL/HDP/10753LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDHISTALIN 8BETAHISTINE DIHYDROCHLORIDE8 MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
786NDA/MAL/HDP/10754LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDHISTALIN 16BETAHISTINE DIHYDROCHLORIDE16 MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
787NDA/MAL/HDP/10755NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDZADYCINE-250AZITHROMYCIN DIHYDRATE250 MGNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
788NDA/MAL/HDP/10756NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIGRA 100SILDENAFIL CITRATE100 MGNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X1.0 TABLET BLISTER15/02/2023
789NDA/MAL/HDP/10757NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDZADYCINE-500AZITHROMYCIN DIHYDRATE500 MGNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER15/02/2023
790NDA/MAL/HDP/10758NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIZOLEALBENDAZOLE400 MGNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER15/02/2023
791NDA/MAL/HDP/1076UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST 4MGMONTELUKAST SODIUM4MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDP.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDAN ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2013
792NDA/MAL/HDP/10760TORQUE PHQRCEAUTICALS PVT LTDSHURIK LTDSKINNCARECLOBETASOL PROPIONATE + SALICYLIC ACID0.05% W/W+ 3.00%W/WTORQUE PHARMACEUTICALS PVT. LTD. UNIT-1, VILLAGE- ISSAPUR, DAPPAR, POST- DAPPAR, PUNJAB- 140506INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X20.0 G TUBE15/02/2023
793NDA/MAL/HDP/10761WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.GOODMAN INTERNATIONAL LTDZIROMINAZITHROMYCIN DIHYDRATE500MGWORLD MEDICINE ILAC SAN VE TIC A.S. (15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEY)TURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER21/03/2023
794NDA/MAL/HDP/10763AUROLABSWASTIK PHARMACEUTICAL LTDAUROCORTTRIAMCINOLONE ACETONIDE40 MG/MLAUROLAB LIMITEDNO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X5.0X1.0 ML VIAL15/02/2023
795NDA/MAL/HDP/10764 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOPIVIDCLOPIDOGREL HYDROGEN SULPHATE75MGHOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAKMALAYSIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
796NDA/MAL/HDP/10765GLOBAL NAPI FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDHEXGABALIN 75PREGABALIN75MGGLOBAL NAPI PHARMACEUTICALS-2ND INDUSTRIAL ZONE, ST 18, 6TH OCTOBER CITY EGYPT ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER15/02/2023
797NDA/MAL/HDP/10766CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAMA-50TRAMADOL HYDROCHLORIDE50MGCACHET PHARMACEUTICAL PVT LTD.VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205INDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER15/02/2023
798NDA/MAL/HDP/10768AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEBUNTA 5NEBIVOLOL HYDROCHLORIDE5 MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER15/02/2023
799NDA/MAL/HDP/10769RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIREN-500AMOXICILLIN TRIHYDRATE500MGRENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER15/02/2023
800NDA/MAL/HDP/10776CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDLEEFLOXLEVOFLOXACIN HEMIHYDRATE0.5%W/VCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1)PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 INDIA OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE15/02/2023
801NDA/MAL/HDP/1078MICRO LABS LTD LABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTDSP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE01/07/2013
802NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2000
803NDA/MAL/HDP/10792MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDNEBIMAC 5NEBIVOLOL HYDROCHLORIDE5 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER03/05/2023
804NDA/MAL/HDP/10795PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)DIAZEPAM 10MG/2MLDIAZEPAM 10MG/2MLPROFARMA SH.AMYSLYM KETA,TIRANAALBANIA PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE03/05/2023
805NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2009
806NDA/MAL/HDP/10806ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDLOSARZED-50LOSARTAN POTASSIUM50MGZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
807NDA/MAL/HDP/10807LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCIN PLUSPARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE(250MG + 10MG + 2MG + 5MG) PER 5MLLINCOLN PHARMACEUTICALS LTD .,.10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARATINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE03/05/2023
808NDA/MAL/HDP/10808ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDROSUNA-10ROSUVASTATIN CALCIUMROSUNA-10ZOTA HEALTHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER03/05/2023
809NDA/MAL/HDP/10816LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDAMITRYP-25AMITRIPTYLINE HYDROCHLORINE25 MGLINCOLN PHARMACEUTICALS LTD .,.10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER03/05/2023
810NDA/MAL/HDP/10818LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLINFLOXOFLOXACIN0.3 % W/VLINCOLN PHARMACEUTICALS LTD .,.10,12,13, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ-382721 TA: KALOL, DIST. GHANDINAGAR, GUJARATINDIA OPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE03/05/2023
811NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
812NDA/MAL/HDP/10821PROFARMA SH.AJOINT MEDICAL STORE (UPMB - UCMB)ADRENALINE 1 MG/1MLADRENALINE HYDROGENTARTRATE1 MG/1MLPROFARMA SH.AMYSLYM KETA,TIRANAALBANIA PARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE03/05/2023
813NDA/MAL/HDP/10822BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACECLAV 228.5AMOXICILLIN TRIHYDRATE + CLAVULANIC ACID(200MG + 28.5 MG) PER 5MLMEDICEF PHARMANO. 28, PHASE 1, EPIP, JHARRMAJRI, BADDI, DIST SOLAN (HP)INDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE03/05/2023
814NDA/MAL/HDP/10823AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVACODIL 12.5CARVEDILOL12.5MGAUROBINDO PHARMA LIMITED UNIT 3PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/06/2023
815NDA/MAL/HDP/10824AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM OD 5OLANZAPINE5MGAUROBINDO PHARMA LTD, UNIT VIISY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X4.0X7.0 TABLET BLISTER06/06/2023
816NDA/MAL/HDP/10825NOVARTIS OVERSEAS INVESTMENT SURGIPHARM (U) LIMITEDUPERIO 50MGSACUBITRIL + VALSARTAN24.3MG + 25.7MGNOVARTIS FARMA S.P.A.-NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER06/06/2023
817NDA/MAL/HDP/10826NOVARTIS OVERSEAS INVESTMENT SURGIPHARM (U) LIMITEDUPERIO 100MGSACUBITRIL + VALSARTAN48.6MG +51.4MGNOVARTIS FARMA S.P.A.-NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER06/06/2023
818NDA/MAL/HDP/10827NOVARTIS OVERSEAS INVESTMENT SURGIPHARM (U) LIMITEDUPERIO 200MGSACUBITRIL + VALSARTAN97.2MG + 102.8MGNOVARTIS FARMA S.P.A.-NOVARTIS FARMA S.P.A. VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER06/06/2023
819NDA/MAL/HDP/10828TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FENOTOR 200FENOFIBRATE200MGTORRENT PHARMACEUTICALS LIMITEDPLOT NO. Z104-106, DAHEJ SEZ PART II, TALUKA: VAGRA, DIST.: BHARUCH-392130, GUJARAT- INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER06/06/2023
820NDA/MAL/HDP/10829TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FENOTOR 67FENOFIBRATE67 MGTORRENT PHARMACEUTICALS LIMITEDPLOT NO. Z104-106, DAHEJ SEZ PART II, TALUKA: VAGRA, DIST.: BHARUCH-392130, GUJARAT- INDIAINDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER06/06/2023
821NDA/MAL/HDP/1083GALPHA LABORATORIES LTDDAWASANA PHARMACEUTICALS LTDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITEDVILLAGE €“ THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/07/2013
822NDA/MAL/HDP/10830DAFRA PHARMA GMBH MULTIPHAR UGANDA LIMITEDMUSCURELTHIOCOLCHICOSIDE8 MGBILIM ILAC SAN.VE TIC.A.SGEBZE ORGANIZE SANAYI BOLGESI (GOSB), 1900 SOKAK NO 1904, KOCAELI, TURKEYTURKEY ORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER06/06/2023
823NDA/MAL/HDP/10831AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDLASTAVIN 80VALSARTAN80 MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER19/06/2023
824NDA/MAL/HDP/10832AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLASTAVIN 160VALSARTAN160MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER06/06/2023
825NDA/MAL/HDP/10833AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMOLNAFLUMOLNUPIRAVIR200MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 AUROBINDO PHARMA LIMITED UNIT 3PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 INDIA ORAL SOLID ORDINARY CAPSULES 1.0X1.0X40.0 CAPSULE BOTTLE06/06/2023
826NDA/MAL/HDP/10834MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 100SITAGLIPTIN HYDROCHLORIDE100MGSAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023
827NDA/MAL/HDP/10835MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 50SITAGLIPTIN HYDROCHLORIDE50MGSAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X18.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023
828NDA/MAL/HDP/10836MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANSIPTIN 25SITAGLIPTIN HYDROCHLORIDE25MGSAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X16.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER06/06/2023
829NDA/MAL/HDP/10838SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTDTATA UGANDA LIMITEDDOLUTEGRAVIR TABLETS 50MGDOLUTEGRAVIR SODIUM50MGSHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD1479, ZHANGHENG ROAD, CHINA (SHANGHAI) PILOT FREE TRADE ZONE, SHANGHAI 201203 - CHINACHINA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER06/06/2023
830NDA/MAL/HDP/10839 STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDZEEDERMZINC OXIDE15%W/WSTEDMAN PHARMACEUTICALS PVT. LTD.C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE06/06/2023
831NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTDBABA DOGO ROAD RUARAKA KENYA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
832NDA/MAL/HDP/10840 STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZ THROAT SPRAYPOVIDONE IODINE0.45%W/VSTEDMAN PHARMACEUTICALS PVT. LTD. (C-4, SIDCO PHARMACEUTICALS COMPLEX, ALATHUR, THIRUPORUR- 603 110, TAMIL NADU INDIA)INDIAORAL TOPICAL SPRAYS WITHOUT GAS 1.0X1.0X50.0ML CONTAINER06/06/2023
833NDA/MAL/HDP/10841AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUTABIT PLUS 0.5/0.4DUTASTERIDE + TAMSULOSIN HYDROCHLORIDE0.5 MG + 0.4 MGAUROBINDO PHARMA LTD, UNIT VIISY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER06/06/2023
834NDA/MAL/HDP/10842WOCKHARDT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEMROKLEVONADIFLOXACIN800 MG / 100MLWOCKHARDT LIMITED BIOTECH PARK, H-14/2, M.I.D.C, WALUJ, AURANGABAD - 431136, INDIAINDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML VIAL06/06/2023
835NDA/MAL/HDP/10851DEVA HOLDING A.S-SHREEJI PHARMACEUTICALS LIMITEDLOSAPRES PLUS 50 MG / 12.5 MGLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50 MG + 12.5 MGDEVA HOLDING A.S (CERKEZKOY PRODUCTION SITE)CERKEZKOY ORGANIZE SANAYI BOLGESI. KARAAGAC MAH. ATATURK CAD. NO: 32 59510 KAPAKLI/TEKIRDAG/TURKEYTURKEY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER03/05/2023
836NDA/MAL/HDP/10852INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINTRAMTRAMADOL HYDROCHLORIDE50MGFREDUN PHARMACEUTICALS LIMITED,14,15,16 - ZORABIAN INDUSTRIAL COMPLEX, VEOOR, PALGHAR (E), THANEINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER03/05/2023
837NDA/MAL/HDP/10854CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDGLIMITAB 2 TABLETSGLIMEPIRIDE2MGCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 1) (PLOT 3,5B, 2C TIVIM INDUSTRIAL ESTATE, KARASVADA, MAPUSA, GOA 403526 )INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER25/05/2023
838NDA/MAL/HDP/1086SHOSAAN ASIC PACIFICRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE 50MG +250MG + 750MGNEM LABORATORIES LIMITED133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
839NDA/MAL/HDP/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA TOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE01/07/2013
840NDA/MAL/HDP/10873MARCYRL PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTORSAMOLEX 10MGTORSEMIDE10 MGMARCYRL PHARMACEUTICAL INDUSTRIES WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITYEGYPT ORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
841NDA/MAL/HDP/10874: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDPAN IVPANTOPRAZOLE SODIUM40MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X40.0 MG VIAL (+ 10 ML OF 0.9%W/V SODIUM CHLORIDE INJECTION, LDPE AMPOULE)17/08/2023
842NDA/MAL/HDP/10878LUPIN LIMITED-AIVEEN (U) LIMITEDLINEZOID 600 MG TABLETSLINEZOLID600MGLUPIN LTD198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
843NDA/MAL/HDP/10879LUPIN LIMITED-AIVEEN (U) LIMITEDISONIAZID TABLETS 300MGISONIAZID300MGLUPIN LIMITED A-28/1 MIDC CHIKALTHANA AURANGABADINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
844NDA/MAL/HDP/10880TABROS PHARMAHEALTHCARE LTD.HEMSAMIC CAPSULETRANEXAMIC ACID500MGTABROS PHARMAL-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTANINDIA ORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER24/07/2023
845NDA/MAL/HDP/10881MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR PR-750METFORMIN HYDROCHLORIDE750MGINVENTIA HEALTHCARE LIMITEDF-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIAINDIA ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
846NDA/MAL/HDP/10882BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDFOLIGRAF 1200 IURECOMBINANT - HUMAN FOLLICLE STIMULATING HORMONE (R-HFSH)1200IU/VIAL (MULTIDOSE)BHARAT SERUM AND VACCINES LIMITEDPLOT NO. K-27 ADDITIONAL M.I.D.C INDIAINDIA PARENTERAL ORDINARY DRY AMPOULES 1.0X1.0 VIAL 1 PREFILLED SYRINGE OF DILUENT + 15 DISPOSABLE SYRINGES]17/08/2023
847NDA/MAL/HDP/10883 CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDDAPAGLIFLOZIN TABLETS 10 MGDAPAGLIFLOZIN PROPANEDIOL10MGCIPLA LIMITEDPLOT NOS. L-139, S-103 & M-62 VERNA INDUSTRIAL ESTATE, VERNA SALCETTE GOA, 403 722 - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER17/08/2023
848NDA/MAL/HDP/10884ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMALOTEM 80/480MGARTEMETHER + LUMEFANTRINE80 MG + 480 MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER17/08/2023
849NDA/MAL/HDP/10885MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDNEBIMAC 10NEBIVOLOL HYDROCHLORIDE10MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)BLOCK N1, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X7.0 TABLET BLISTER17/08/2023
850NDA/MAL/HDP/10886LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCLOTRILIN-VCLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD (10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA)INDIAVAGINAL CREAMS 1.0X1.0X15.0 G TUBE28/08/2023
851NDA/MAL/HDP/10888M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDCOVIFORREMDESIVIR100MG/VIALASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL17/08/2023
852NDA/MAL/HDP/10889WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.GOODMAN INTERNATIONAL LTDPIRETIKOL PLUSPARACETAMOL + CHLORPHENIRAMINE MALEATE + PHENYLEPHRINE HYDROCHLORIDE(160 MG + 1 MG + 2.5 MG)/5 MLWORLD MEDICINE ILAC SAN VE TIC A.S.15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEYTURKEYORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE16/04/2024
853NDA/MAL/HDP/10890M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDZIQUANTAPRAZIQUANTEL600MGHETERO LABS LIMITED (UNIT V)SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER17/08/2023
854NDA/MAL/HDP/10891LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDBINAFINTERBINAFINE HYDROCHLORIDE1%W/WLINCOLN PHARMACEUTICALS LTD (10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA)INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE28/08/2023
855NDA/MAL/HDP/10894REYOUNG PHARMACEUTICAL CO LTDBIOGEN PHARMA LIMITEDFRUSOGENFUROSEMIDE20MG/2MLREYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINA PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE17/08/2023
856NDA/MAL/HDP/10896REYOUNG PHARMACEUTICAL CO LTDBIOGEN PHARMA LIMITEDAMPIGENAMPICILLIN SODIUM + CLOXACILLIN SODIUM(250MG + 250MG)VIALREYOUNG PHARMACEUTICAL CO. LIMITEDNO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINACHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X0.5 G VIAL17/08/2023
857NDA/MAL/HDP/10897HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDDAPADAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE5MGHILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER17/08/2023
858NDA/MAL/HDP/10898HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDROLIP EZE TABLETSROSUVASTATIN CALCIUM + EZETIMIBE20MG +10MGHILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
859NDA/MAL/HDP/10900DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDTRAMADOL DENKTRAMADOL HYDROCHLORIDE100MG/2 MLSOLUPHARM GMBH INDUSTRIESTRASSE 3, 34212 MELSUNGENGERMANY PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE17/08/2023
860NDA/MAL/HDP/10903MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDBIDSIPTINVILDAGLIPTIN50MGSAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAIN ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
861NDA/MAL/HDP/10904MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDUROKA PLUSDUTASTERIDE + TAMSULOSIN HYDROCHLORIDE0.5MG + 0.4MGSAG MANUFACTURING S.LCARRETERA NACIONAL 1 KM 36, SAN AGUSTIN DEL GUADALIX, 28750, SPAINSPAIN ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER17/08/2023
862NDA/MAL/HDP/10905BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDVERQUVO 2.5 MG TABLETVERICIGUAT2.5MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER, 1.0X28.0 TABLET CONTAINER28/08/2023
863NDA/MAL/HDP/10906BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDVERQUVO 5MG TABLETVERICIGUAT5MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER, 1.0X28.0 TABLET CONTAINER28/08/2023
864NDA/MAL/HDP/10907BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDVERQUVO 10 MG TABLETVERICIGUAT10MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER, 1.0X28.0 TABLET CONTAINER28/08/2023
865NDA/MAL/HDP/10908BDR PHARMACEUTICALS INTERNATIONAL PVT LTDONCOPHARM (U) LTDLIVONIBESORAFENIB TOSYLATE20 MGBDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITEDR.S. NO. 578, NR, EFFLUENT CHANNEL ROAD,; VILLAGE - LUNA, TAL-PADRA; DIST - VADODARA - 391440; GUJARAT - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET CONTAINER17/08/2023
866NDA/MAL/HDP/10909NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDCADZOLECLOTRIMAZOLE1% W/WNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE17/08/2023
867NDA/MAL/HDP/10910NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVI-IBUIBUPROFEN200MGNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
868NDA/MAL/HDP/10911NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIZOLEALBENDAZOLE200MG/5MLNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL LIQUID ORDINARY EMULSIONS 1.0X1.0X10.0 ML BOTTLE17/08/2023
869NDA/MAL/HDP/10912NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDFLUZINECETIRIZINE DIHYDROCHLORIDE10MGNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
870NDA/MAL/HDP/10914DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDHI CEF 250CEFALEXIN MONOHYDRATE250 MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER17/08/2023
871NDA/MAL/HDP/10915DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDDAVICEF 1 GCEFTRIAXONE SODIUM1G/VIALINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X10.0 ML VIAL17/08/2023
872NDA/MAL/HDP/10916DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDCEFOTECCEFOTAXIME SODIUM1G/VIALINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIA PARENTERAL RETARD DRY VIALS 1.0X1.0X1.0 G VIAL17/08/2023
873NDA/MAL/HDP/10917DAVIMED PHARMA LIMITEDDAVIMED PHARMA LIMITEDCEFTRIAXONECEFTRIAXONE SODIUM1G/VIALINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIA PARENTERAL ORDINARY DRY VIALS 1.0X25.0X1.0X1.0 G VIAL17/08/2023
874NDA/MAL/HDP/10918BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDESUPRONEESOMEPRAZOLE SODIUM40 MG/VIALBLISS INDASI LIFESCIENCE PRIVATE LIMITEDPLOT NO. 73 TO 76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN- 396 210INDIA PARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL + 1*10 ML, SODIUM CHLORIDE IN LDPE PACK17/08/2023
875NDA/MAL/HDP/10919BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSANFIXIME 400CEFIXIME TRIHYDRATE400MGEAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER05/09/2023
876NDA/MAL/HDP/10920ACINO AG.LABOREX UGANDA LIMITEDPARACONICA™ PLUS 500 MG/150 MGPARACETAMOL + IBUPROFEN500 MG + 150 MGSIGMA LABORATORIES PRIVATE LIMITED6, 7, 8 TIVIM INDUSTRIAL ESTATE, TIVIM, MAPUSA 403526, GOAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
877NDA/MAL/HDP/10921AVACARE GLOBALGOODMAN INTERNATIONAL LTDAVAFLOX 500LEVOFLOXACIN HEMIHYDRATE500 MGWORLD MEDICINE ILAC SAN VE TIC A.S.15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEYTURKEY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER17/08/2023
878NDA/MAL/HDP/10922LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABCLAV 1G TABLETSAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE875MG + 125MGLABORATORY & ALLIED LTD PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYAKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER17/08/2023
879NDA/MAL/HDP/10923BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDROSUSTAR 10MGROSUVASTATIN CALCIUM10MGBAROQUE PHARMACEUTICALS PVT. LTD (PLOT 192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER05/09/2023
880NDA/MAL/HDP/10924BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDMETOPRIX 10METOCLOPRAMIDE10 MGBIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
881NDA/MAL/HDP/10925BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDHERPIRAX 200ACICLOVIR200 MGBIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARATINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
882NDA/MAL/HDP/10926BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACELEVO 500LEVOFLOXACIN HEMIHYDRATE500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
883NDA/MAL/HDP/10927BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACELEVO 750LEVOFLOXACIN HEMIHYDRATE750MGBIOMATRIX HEALTHCARE PRIVATE LIMITEDSURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
884NDA/MAL/HDP/10928FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDFIX-ACEFIXIME TRIHYDRATE100MG/5MLTHE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESH ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X75.0 ML BOTTLE17/08/2023
885NDA/MAL/HDP/10931UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIDROL 10ALFUZOSIN HYDROCHLORIDE10 MGUNICHEM LABORATORIES LTDUNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205INDIA ORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
886NDA/MAL/HDP/10932SHREEJI CARE LIMITEDSHREEJI CARE LIMITEDCALCIGLO-LCALCIUM LACTATE300MGGLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER17/08/2023
887NDA/MAL/HDP/10933BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE20 MG + 160 MGBLISS GVS PHARMA LIMITED10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIAINDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X3.0 TABLET BLISTER,1.0X2.0X3.0 TABLET BLISTER17/08/2023
888NDA/MAL/HDP/10934FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDALERCONOLOPATADINE HYDROCHLORIDE1 MG/MLTHE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESH OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE17/08/2023
889NDA/MAL/HDP/10935FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDSUPERPIME 1G IM/IV INJECTIONCEFEPIME HYDROCHLORIDE1 G/VIALTHE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESH PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL17/08/2023
890NDA/MAL/HDP/10936LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDTEARLIN-0.5 %CARMELLOSE SODIUM0.5% W/VLINCOLN PHARMACEUTICALS LTD (10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA)INDIAOPHTHALMIC DROPS 1.0X1.0X10.0ML BOTTLE05/09/2023
891NDA/MAL/HDP/10937LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDTEARLIN-1 %CARMELLOSE SODIUM1.0% W/VLINCOLN PHARMACEUTICALS LTD (10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA)INDIAOPHTHALMIC DROPS 1.0X1.0X10.0ML BOTTLE05/09/2023
892NDA/MAL/HDP/10938AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATORKEY 80ATORVASTATIN CALCIUM TRIHYDRATE80 MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
893NDA/MAL/HDP/10939WOCKHARDT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEMROK OALALEVONADIFLOXACIN500 MGWOCKHARDT LIMITED -BIOTECH PARK, H-14/2, M.I.D.C, WALUJ, AURANGABAD - 431136, INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER17/08/2023
894NDA/MAL/HDP/1094MICRO LABS LTD LABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME 100MG/5MLMICRO LABS LTD-NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE01/07/2013
895NDA/MAL/HDP/10940BRAWN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDMASTIC-LCMONTELUKAST SODIUM + LEVOCETIRIZINE DIHYDROCHLORIDE10MG + 5MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
896NDA/MAL/HDP/10944TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TORLEVA 500MGLEVETIRACETAM500MGTORRENT PHARMACEUTICALS LTD .,INDRAD - 382721, TAL: KADI, CITY - INDRAD, DIST. MEHSANA, GUJARAT STATE - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
897NDA/MAL/HDP/10945ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDXYLOPIL-2%LIDOCAINE HYDROCHLORIDE20MG/MLPSYCHOTROPICS INDIA LTDPLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIAINDIA PARENTERAL ORDINARY VIALS 1.0X1.0X30.0 ML VIAL (CLEAR GLASS VIAL)17/08/2023
898NDA/MAL/HDP/10946MACLEODS PHARMACEUTICALS LTDAIVEEN (U) LIMITEDMONTEMAC-10MONTELUKAST SODIUM10MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
899NDA/MAL/HDP/10947MACLEODS PHARMACEUTICALS LTDAIVEEN (U) LIMITEDOLMESAR HOLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE20 MG + 12.5 MGMACLEODS PHARMACEUTICALS LIMITED, UNIT VIVILLAGE THEDA, KHARUNI LODHI MAJRA RD, TEHSIL BADDI N2, DISTRICT SOLAN, HIMACHAL PRADESH–174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
900NDA/MAL/HDP/10948WALLACE PHARMACEUTICALS PVT. LTDSTAR PHARMACEUTICALS LTDFLUCOLDPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENAMINE MALEATE500 MG + 10 MG + 2 MGWALLACE PHARMACEUTICALS PVT LTDBHATIAN, NALAGARH, DIST. SOLAN HP 174101INDIA ORAL SOLID ORDINARY TABLETS 1.0X5.0X5.0X10.0 TABLET BLISTER17/08/2023
901NDA/MAL/HDP/10949BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDCLAMOXIN-375 TABLETSAMOXICILLIN SODIUM + POTASSIUM CLAVULANATE250MG + 125 MGMEDOPHARM PVT LIMITEDNO. 50 KAYARAMBEDU VILLAGE, GUDUVANCHERY-603202INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER17/08/2023
902NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER01/07/2012
903NDA/MAL/HDP/10950 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDDICORATE ER 500DIVALPROEX SODIUM500 MGSUN PHARMA LABORATORIES LIMITED6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIAINDIA ORAL SOLID RETARD COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER17/08/2023
904NDA/MAL/HDP/10951THE UNITED PHARMACEUTICALS MFG, CO. LTD,WIDE SPECTRUM ENTERPRISES (U) LIMITEDVIVAZAC PLUSIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 25MGUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANY (AL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDAN)JORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER29/08/2023
905NDA/MAL/HDP/10952MINAPHARM PHARMACEUTICAL & CHEMICAL INDUSTRIESSWASTIK PHARMACEUTICAL LTDHYDROQUINEHYDROXYCHLOROQUINE SULPHATE200 MGMINAPHARM COMPANY FOR PHARMACEUTICALS AND CHEMICAL INDUSTRIESPARTS NO. 15/4; 16/4, INDUSTRIAL ZONE A2 - 10TH OF RAMADHAN CITY - EGYPTEGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
906NDA/MAL/HDP/10953KOPRAN LIMITEDTATA UGANDA LIMITEDLOKIT HPCLARITHROMYCIN + TINIDAZOLE + OMEPRAZOLE250 MG + 500 MG + 20 MGKOPRAN LIMITEDVILLAGE - SAVROLI (KHOPOLI), TALUKA - KHALAPUR, DIST. RAIGAD 410202, MAHARASHTRA INDIAINDIA ORAL SOLID ORDINARY COMBINATION PACK COATED TABLETS 1.0X7.0X1.0X1.0X6.0 TABLET STRIP (EACH STRIP CONTAINS 2 TABLETS OF CLARITHROMYCIN + 2 TABLETS OF TINIDAZOLE + 2 CAPSULES OF OMEPRAZOLE)17/08/2023
907NDA/MAL/HDP/10954RENATA LIMITEDUHAI PHARMACYFUROCEF®CEFUROXIME AXETIL500MGRAJENDRAPUR POTENT PRODUCT FACILITY (RPPF), RENATA LIMITEDNOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR 1700 - BANGLADESHBANGLADESH ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X6.0 TABLET BLISTER17/08/2023
908NDA/MAL/HDP/10956RENATA LIMITEDUHAI PHARMACYZITHRINAZITHROMYCIN500MGRENATA LIMITED
RAJENDRAPUR GENERAL FACILITY, NOYAPARA BHAWAL MIRZAPUR RAJENDRAPUR GAZIPUR, 1700 BANGLADESH
BANGLADESH ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X5.0 TABLET BLISTER17/08/2023
909NDA/MAL/HDP/10957ORCHIDIA PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-AVAZIRTOBRAMYCIN + DEXAMETHASONE(3 MG + 1 MG)/MLORCHIDIA PHARMACEUTICAL INDUSTRIESAL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPTEGYPT OPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE17/08/2023
910NDA/MAL/HDP/10958ORCHIDIA PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDALPHANOVABRIMONIDINE TARTRATE0.15%W/VORCHIDIA PHARMACEUTICAL INDUSTRIESAL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPTEGYPT OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE17/08/2023
911NDA/MAL/HDP/10959MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDVALMACA 160/10AMLODIPINE BESYLATE + VALSARTAN10 MG + 160 MGMACLEODS PHARMACEUTICALS LIMITED. .BLOCK N1, N2 & N3, VILLAGE THEDA P.O MANPURA, TEHSIL NALAGARH, DIST SOLAN, HIMACHAL PRADESH 174101INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER17/08/2023
912NDA/MAL/HDP/1096ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDARTEMETHERARTEMETHER80MG/MLSANJAR PHARMA LLP HIMATNAGAR-VIJOPUR HIGHWAY, DEDHROTA HIMATNAGAR 383 220, GUJARAT INDIAINDIA PARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE,1.0X1.0X8.0X1.0 ML AMPOULE01/07/2014
913NDA/MAL/HDP/10960AXA PARENTERALS LTDVITACARE LIMITEDAXADEX D5GLUCOSE ANHYDROUS5% W/VAXA PARENTERALS LTDPLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHANDINDIA PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X100.0 ML BOTTLE17/08/2023
914NDA/MAL/HDP/10961ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDLEPTROGINE 25MGLAMOTRIGINE25 MGADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPTEGYPT ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
915NDA/MAL/HDP/10962MYLAN LABORATORIES LIMITED-KIMSY MEDS LTDDARUNAVIR/RITONAVIR TABLETS 400 MG/50 MGDARUNAVIR ETHANOLATE + RITONAVIR400 MG + 50 MGMYLAN LABORATORIES LTD .F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET CONTAINER17/08/2023
916NDA/MAL/HDP/10963PHARMATHEN S.AGOODMAN INTERNATIONAL LTDMEPERYAMEROPENEM TRIHYDRATE1GDEMO SA (21ST KM NATIONAL ROAD, ATHENS, LAMIA 14568 KRYONERI, ATHENS) GREECEPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL14/08/2023
917NDA/MAL/HDP/10964RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAZIRENAZITHROMYCIN DIHYDRATE500MGRENE INDUSTRIES LTDPLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER17/08/2023
918NDA/MAL/HDP/10965INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMPHETAS-500MYCOPHENOLATE MOFETIL500MGINTAS PHARMACEUTICALS LTD ..PLOT NO. 457-458 VILL MATODA BAVLA ROAD TA SANAND DIST AHMEDABAD PIN-382 210 GUJARART STATEINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER17/08/2023
919NDA/MAL/HDP/10966EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSKYTINIB 12.5SUNITINIB MALATE12.5 MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIA ORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER17/08/2023
920NDA/MAL/HDP/10967EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSKYTINIB 25SUNITINIB MALATE25 MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIA ORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER17/08/2023
921NDA/MAL/HDP/10968HALEWOOD LABORATORIES PVT. LTD.AIVEEN (U) LIMITEDELECTRORUSH POWDER ORS BPSODIUM CHLORIDE + POTASSIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + DEXTROSE ANHYDROUS2.60 G + 1.50 G + 2.90 G + 13.50 GHALEWOOD LABORATORIES PVT. LIMITED319, PHASE - II, GIDC, VATVA, AHMEDABAD - 382445, GUJARATINDIA ORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X20.5 G SACHET17/08/2023
922NDA/MAL/HDP/10969FDC LTD AIVEEN (U) LIMITEDVITCOFOLFERROUS FUMARATE + FOLIC ACID + CYANOCOBALAMIN(100MG + 0.5MG + 5MCG)/5MLFDC LIMITED, WALUJ .PLOT NO. B-8, MIDC, INDUSTRIAL AREA, WALUJ 431136 DIST AURANGABADINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE17/08/2023
923NDA/MAL/HDP/10970UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDOLMETAN-H20/12.5 MGOLMESARTAN MEDOXOMIL + HYDROCHLOROTHIAZIDE20 MG + 12.5 MGUMEDICA LABORATORIES PVT. LTD (PLOT 221-GIDC, 2ND PHASE, VAPI 396195 GUJARAT )INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER29/08/2023
924NDA/MAL/HDP/10971AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIRATAM 1000MGLEVETIRACETAM1000MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZAEGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
925NDA/MAL/HDP/10972AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM OD 15OLANZAPINE15MGAUROBINDO PHARMA LTD, UNIT VIISY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,INDIA ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X4.0X7.0 TABLET BLISTER17/08/2023
926NDA/MAL/HDP/10973SWISS PARENTERALS LTD.SHREEJI PHARMACEUTICALS LIMITEDADRENALINE INJECTION BP 1MG/ML 1MLADRENALINE ACID TARTRATE1MG/MLSWISS PARENTERALS LIMITED (UNIT-1)808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIAINDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 ML AMPOULE17/08/2023
927NDA/MAL/HDP/10974EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSKYTINIB 50SUNITINIB MALATE50 MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIA ORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER17/08/2023
928NDA/MAL/HDP/10975VERVE HUMAN CARE LABORATORIESABACUS PHARMA (AFRICA) LIMITEDBUPIVER-HBUPIVACAINE HYDROCHLORIDE5MG/MLVERVE HUMAN CARE LABORATORIESPLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA.INDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X4.0 ML AMPOULE17/08/2023
929NDA/MAL/HDP/10976SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDPARAGESICDICLOFENAC SODIUM + PARACETAMOL + CHLORZOXAZONE50 MG + 325 MG + 250 MGSAGA LABORATORIES .198/2 & 198/3, CHACHRAWADI, VASNA NO. CLARIS LIFE SCIENCE, TA SANAND, DIST. DIST: AHMEDABADINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER17/08/2023
930NDA/MAL/HDP/10977BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDFIRIALTA®FINERENONE10MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER28/08/2023
931NDA/MAL/HDP/10978AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDANDORIVABANRIVAROXABAN10MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESPART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZAEGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
932NDA/MAL/HDP/10979BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDFIRIALTA®FINERENONE20MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER28/08/2023
933NDA/MAL/HDP/10980 CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEFENEC PLUSMEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE250 MG + 20 MGRAVIAN LIFE SCIENCE PVT. LIMITEDPLOT NO. 34, SECTOR: 8A, SIDCUL, IIE, HARIDWAR - 249403, UTTARAKHANDINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
934NDA/MAL/HDP/10982COMED CHEMICALS LTD.LEGIT MEDEQ 2007 LIMITEDRAPCO-DSRRABEPRAZOLE SODIUM + DOMPERIDONE20 MG + 30 MGCOMED CHEMICALS LTD (UNIT-III)VILL: DASSOMATRA BADDI, NALAGARGH ROAD DISTRICT: SOLAN, PIN.173205 HIMACHAL PRADESH INDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER17/08/2023
935NDA/MAL/HDP/10983AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDENALAPRIL-AGIO TABLETENALAPRIL MALEATE5MGAGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
936NDA/MAL/HDP/10984AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDENALAPRIL-AGIO TABLETENALAPRIL MALEATE10MGAGIO PHARMACEUTICALS LIMITED.T- 81, 82, MIDC, BHOSARI, PUNE - 411 026 INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
937NDA/MAL/HDP/10985APEX LABORATORIES PRIVATE LIMITED NORVIK ENTERPRISES LIMITEDZINCOVIT DROPSVITAMIN A (AS PALMITATE) + RRR -ALPHA-TOCOPHERYL ACETATE + COLECALCIFEROL + THIAMINE HYDROCHLORIDE + RIBOFLAVIN SODIUM PHOSPHATE + PYRIDOXINE HYDROCHLORIDE + ASCORBIC ACID + DEXPANTHENOL + NICOTINAMIDE + ZINC SULFATE HEPTAHYDRATE + LYSINE HYDROCHLORIDE(2500.00 IU + 2.50 MG + 200.00 IU + 1.00 MG + 1.00 MG + 0.50 MG + 40.00 MG + 1.00 MG + 10.00 MG + 13.30 MG + 10.00 MG)MLAPEX LABORATORIES PRIVATE LIMITED (PLANT III)510 KUNNAM VILLAGE AND POST, THENNERI (VIA) SRIPERUMBUDUR TK KANCHEEPRURAM DISTRICT, PIN CODE: 631 604, TAMIL NADUINDIA ORAL LIQUID ORDINARY DROPS 1.0X1.0X5.0 ML BOTTLE (AMBER GLASS BOTTLE)17/08/2023
938NDA/MAL/HDP/10986THE SEARLE COMPANY LIMITEDSURGIPHARM (U) LIMITEDJENTIN METSITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGSEARLE PAKISTAN LTD..F-319, S.I.T.E., OPP. KESC POWER STATION, KARACHIPAKISTAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER17/08/2023
939NDA/MAL/HDP/10987LUPIN LIMITED-AIVEEN (U) LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG AND 300 MGLAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300 MG + 300 MGLUPIN LTDPLOT NO. 6A, SECTOR 17, SPECIAL ECOOMIC ZONE, MIHAN, NAGPUR 441108, MAHARASHSTRAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER17/08/2023
940NDA/MAL/HDP/10988Y.S.P. INDUSTRIES (M) SDN. BHD.ROYAL PHARMA 2011 LIMITEDLACTULLACTULOSE670MG/MLY.S.P INDUSTRIES (M) SDN BHN.LOT 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN PENDUSTRIAN BANDAR BARU BANGI, 43000, KAJANG, SELANGOR, MALAYSIAMALAYSIA ORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE (AMBER PET BOTTLE)17/08/2023
941NDA/MAL/HDP/10989M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDBINFIN 5FINASTERIDE5MGHETERO LABS LIMITED (UNIT III)...22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER17/08/2023
942NDA/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 PRADESHINDIA TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE01/07/2012
943NDA/MAL/HDP/10990AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBISODAC-HF 10BISOPROLOL FUMARATE10MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER17/08/2023
944NDA/MAL/HDP/10991BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDIXAROLA 10 FILM-COATED TABLETSRIVAROXABAN10MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER, 1.0X2.0X14.0 TABLET BLISTER28/08/2023
945NDA/MAL/HDP/10992BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDIXAROLA 20 FILM-COATED TABLETSRIVAROXABAN20MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER, 1.0X2.0X14.0 TABLET BLISTER28/08/2023
946NDA/MAL/HDP/10993BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDIXAROLA 15 FILM-COATED TABLETSRIVAROXABAN15MGBAYER PHARMA AG ( 51368 LEVERKUSEN,)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER, 1.0X2.0X14.0 TABLET BLISTER28/08/2023
947NDA/MAL/HDP/10994DINLAS PHARMA EPZ LIMITEDAFRICURE PHARMACEUTICALS U LIMITEDPARADOLPARACETAMOL500MGDINLAS PHARMA EPZ LIMITEDPLOT NO. LR 7149/121, MOMBASA ROAD, SYOKIMAUKENYA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
948NDA/MAL/HDP/10998ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDMOCINMOXIFLOXACIN HYDROCHLORIDE400MG/100MLABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGAUGANDA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE17/08/2023
949NDA/MAL/HDP/10999MARCYRL PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDURICODROPFEBUXOSTAT80MGMARCYRL PHARMACEUTICAL INDUSTRIES WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITYEGYPT ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER17/08/2023
950NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X5.0 G TUBE01/07/2013
951NDA/MAL/HDP/11000JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB SINUS PAIN NON-DROWSYPARACETAMOL + PSEUDOEPHEDRINE HYDROCHLORIDE500 + 30 MGJOHNSON & JOHNSON (PTY) LTD241 MAIN ROAD, RETREAT, 7945, CAPE TOWNSOUTH AFRICA ORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER17/08/2023
952NDA/MAL/HDP/11001UNISON PHARMACEUTICALS PVT. LTD.HARLEYS UGANDA LIMITEDAKILOS-CRACECLOFENAC200MGUNISON PHARMACEUTICALS PRIVATE LIMITED – UNIT 1UNIT I, C/6, STEEL TOWN, OPP. NOVA PETRO, MORAIYA, TA. SANAND, DIST.: AHMEDABAD - 382213, GUJARATINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER17/08/2023
953NDA/MAL/HDP/11002CENTAUR PHARMACEUTICALS PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDMICONA VAGINAL CREAMMICONAZOLE NITRATE2%W/WCENTAUR PHARMACEUTICALS PVT. LTD (PLANT 2) (PLOT NO 39-41TIVIM INDUSTRIAL ESTATE, KARASWADA - MAPUSA, GOA-403526)INDIAVAGINAL CREAMS 1.0X1.0X40.0 G TUBE29/08/2023
954NDA/MAL/HDP/11003MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDBAROLERABEPRAZOLE20MGNAPROD LIFE SCIENCES PVT. LTDG-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRAINDIA PARENTERAL ORDINARY DRY VIALS 1.0X20.0 MG VIAL17/08/2023
955NDA/MAL/HDP/11004FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDFAST 125PARACETAMOL125MGTHE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESH RECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP17/08/2023
956NDA/MAL/HDP/11012COSMOS LTD.ASTRA PHARMA (U) LIMITEDCEMET 400CIMETIDINE 400MGCOSMOS LTD..RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBIKENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1997
957NDA/MAL/HDP/11015ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDHYDROCORTISONE CREAM BPHYDROCORTISONE ACETATE1% W/WCIRON DRUGS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR €“ 401404, MAHARASHTRAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE12/13/2023
958NDA/MAL/HDP/11016AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 15LENALIDOMIDE15MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER12/13/2023
959NDA/MAL/HDP/11017AUROBINDOPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 25LENALIDOMIDE25MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER12/13/2023
960NDA/MAL/HDP/11018AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEDWINMEDROXYPROGESTERONE150MG/MLEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X1.0 ML PRE- FILLED SYRINGE12/13/2023
961NDA/MAL/HDP/11019AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 5LENALIDOMIDE 5MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER12/13/2023
962NDA/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 EHSANMALAYSIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2011
963NDA/MAL/HDP/11020ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDIBUPLUSIBUPROFEN + PARACETAMOL100MG/125MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X60.0 ML BOTTLE12/13/2023
964NDA/MAL/HDP/11021ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDINTAFERONIRON SUCROSE 100MG/5ML.M/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X5.0 ML AMPOULE12/13/2023
965NDA/MAL/HDP/11022ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCEFIXIME QUIX DISPERSIBLE TABLETS 200MGCEFIXIME TRIHYDRATE200MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
966NDA/MAL/HDP/11023ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMOXVIDAMOXICILLIN TRIHYDRATE125 MG/5 MLM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML CONTAINER12/13/2023
967NDA/MAL/HDP/11024LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LTD CLONAPIN-2CLONAZEPAM2MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
968NDA/MAL/HDP/11025LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LTD DYGYLMETRONIDAZOLE BENZOATE125MG/5MLLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE12/13/2023
969NDA/MAL/HDP/11026LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LTD TELMISINTELMISARTAN40 MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
970NDA/MAL/HDP/11027ABACUS (A) PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCEFIMCZ-400CEFIXIME400 MGZEISS PHARMA LIMITEDIGC,SIDCO, PHASE II, SAMBA, JAMMU - 184121,(J&K)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER12/13/2023
971NDA/MAL/HDP/11028AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDAPLENE 50PREGABALIN50MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER12/13/2023
972NDA/MAL/HDP/11029AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDAPLENE 75PREGABALIN75MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER12/13/2023
973NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2014
974NDA/MAL/HDP/11030AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDAPLENE 150PREGABALIN150MGAJANTA PHARMA LIMITEDAJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER12/13/2023
975NDA/MAL/HDP/11031M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDNIZACARD 500RANOLAZINE500MGHETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE,INDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
976NDA/MAL/HDP/11032M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDNIZACARD 1000RANOLAZINE1000MGHETERO LABS PRIVATE LIMITED UNIT IIISURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATEINDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
977NDA/MAL/HDP/11033KESAR PHARMAJEET PHARMACEUTICALS LIMITEDFLUPLEXPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE ANHYDROUS500MG + 10MG + 2MG + 30MGKESAR PHARMA PVT LTDPLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET STRIP12/13/2023
978NDA/MAL/HDP/11034ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDARCELIA® ESOMEPRAZOLE TABLETS 40 MGESOMEPRAZOLE MAGNESIUM DIHYDRATE40 MGASSOCIATED BIOTECHVILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
979NDA/MAL/HDP/11035ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDARCELIA® ESOMEPRAZOLE TABLETS 20 MGESOMEPRAZOLE MAGNESIUM DIHYDRATE20 MGASSOCIATED BIOTECHVILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
980NDA/MAL/HDP/11036ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDDROCELIADROTAVERINE HYDROCHLORIDE40 MG/2 MLSANJAR PHARMA LLPSURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1X1X5X2X0 ML AMPOULE12/13/2023
981NDA/MAL/HDP/11037FERRER INTERNATIONAL, S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDISLEP 25LEVOSULPIRIDE25MGDOPPEL FARMACEUTICI SRL,VIA VOLTURNO 48-20089 QUINTO DE STAMPI, ROZZANO (MI)ITALYORAL SOLID ORDINARY TABLETS 1.0X1.0X20.0 TABLET BLISTER12/13/2023
982NDA/MAL/HDP/11038AUROBINDOPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDELOHIST 5DESLORATADINE5MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
983NDA/MAL/HDP/11039ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDLIGNOCAINLIDOCAINE20 MG/MLM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X30.0 ML VIAL12/13/2023
984NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BERHAD,LOT 56442, 7 1/2 MILES JALAN IPOH/CHEMOR 31200, CHEMOR PERAKMALAYSIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0 TABLET BLISTER01/07/2014
985NDA/MAL/HDP/11041NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN DIHYDRATE500MGNABIQASIM INDUSTRIES (PVT) LTD .17/24 KORANGI INDUSTRIAL AREA KORANGI KARACHIPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X3.0 TABLET BLISTER12/13/2023
986NDA/MAL/HDP/11042M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDMOVFORMOLNUPIRAVIR200MGHETERO LABS LIMITED (UNIT V)SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIAINDIAORAL SOLID RETARD OTHER CAPSULES 1.0X40.0 CAPSULE CONTAINER, 1.0X4.0X10.0 CAPSULE BLISTER12/13/2023
987NDA/MAL/HDP/11043AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDDIAZAC 5DAPAGLIFLOZIN5MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
988NDA/MAL/HDP/11044AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDDIAZAC 10DAPAGLIFLOZIN10MGAJANTA PHARMA LIMITEDPLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
989NDA/MAL/HDP/11047MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMURAXAL -10ALFUZOSIN HYDROCHLORIDE10MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID RETARD TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
990NDA/MAL/HDP/11048GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAPRETUDE 600 MGCABOTEGRAVIR200MG/MLGLAXO OPERATIONS UK LIMITEDHARMIRE ROAD, BARNARD CASTLE, DURHAM, DL 12 8DT - UNITED KINGDOMUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X25.0X3.0 ML VIAL, 1.0X5.0X3.0 ML VIAL12/13/2023
991NDA/MAL/HDP/11049NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDXYM-KIDSIMETHICONE + DILL OIL + FENNEL OIL40MG + 0.005ML + 0.0007MLNEXT WAVERAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P)INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE12/13/2023
992NDA/MAL/HDP/11050SURGE LABORATORIES (PVT) LTD,JEET PHARMACEUTICALS LIMITEDSERGIFEX 1GCEFTRIAXONE SODIUM1 G/VIALSURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTANPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL12/13/2023
993NDA/MAL/HDP/11051SURGE LABORATORIES (PVT) LTD,JEET PHARMACEUTICALS LIMITEDSERGIFEX 2GCEFTRIAXONE SODIUM2 G/VIALSURGE LABORATORIES (PVT) LTD.,,10TH KM, FAISALABAD ROAD, BIKHI, DISTRICT SHEIKHUPURA- PAKISTAN.PAKISTANPARENTERAL ORDINARY DRY VIALS 1.0X2.0 G VIAL12/13/2023
994NDA/MAL/HDP/11052ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAKO-PASACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE100 MG + 325 MG + 15 MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
995NDA/MAL/HDP/11053ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOLODINEOLOPATADINE HYDROCHLORIDE0.1% W/VABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER12/13/2023
996NDA/MAL/HDP/11054ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDTORATOBRAMYCIN SULPHATE0.3% W/VABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER12/13/2023
997NDA/MAL/HDP/11055ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDTORA-DTOBRAMYCIN SULPHATE + DEXAMETHASONE SODIUM PHOSPHATE0.3%W/V + 0.1%W/VABACUS PARENTERAL DRUGS LIMITEDPLOT 114, BLOCK 191, KINGAUGANDAOPHTHALMIC DROPS 1.0X1.0X5.0 ML CONTAINER12/13/2023
998NDA/MAL/HDP/11056PHARMA INTERNATIONAL COMPANY OMAB UGANDA LIMITEDVOLDIC ® 1% EMULGELDICLOFENAC DIETHYLAMINE1%W/WPHARMA INTERNATIONAL COMPANY ,.AL-QASTAL AREA, AIRPORT ROAD, P.O. BOX 334 AL JUBAIHA, 11941, AMMAN - JORDANJORDANTOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE12/13/2023
999NDA/MAL/HDP/11057BETA HEALTHCARE INTERNATIONAL LIMITEDBETA HEALTHCARE UGANDA LIMITEDSHELTRIZINECETIRIZINE HYDROCHLORIDE10MGBETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554, MOGADISHU ROAD INDUSTRIAL AREA, NAIROBI KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
1000NDA/MAL/HDP/11058ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDEXYT-200ALBENDAZOLE200MG/5MLM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0 ML BOTTLE12/13/2023
1001NDA/MAL/HDP/11059AURA LIFECARE PVT. LTD.REDDYS PHARMA LIMITEDAURADERM-0.05CLOBETASOL0.05%W/WAURA LIFECARE PRIVATE LIMITEDSURVEY NO. 254/14/1, JAROD-SAVLI ROAD, P.O. KARACHIYA, 391 520, TAL. SAVLI, DIST. VADODARA - INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE, 1.0X1.0X15.0 G TUBE12/13/2023
1002NDA/MAL/HDP/1106EVA PHARMAUNITED HEALTHCARE DISTRIBUTORS LTDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPT ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER01/07/2013
1003NDA/MAL/HDP/11060WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.GOODMAN INTERNATIONAL LTDROXIPIMECEFEPIME HYDROCHLORIDE1G/VIALPHARMAVISION SAN. VE TIC. A.S.DAVUTPASA CAD. NO: 145 ZEYTINBURNU / ISTANBUL - TURKEYTURKEYPARENTERAL RETARD DRY VIALS 1.0X1.0X1.0 G VIAL12/13/2023
1004NDA/MAL/HDP/11061MIDASCARE PHARMACEUTICALS PRIVATE LIMITED, ABACUS PHARMA (AFRICA) LIMITEDMISTDRESSLIDOCAINE + CETRIMIDE1%W/W + 0.10%W/WMIDAS CARE PHARMACEUTICALS PVT LTD.B-16 MIDC, WALUJ AURANGABAD 431136, MAHARASHTRA, INDIAINDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X100.0 ML CANNISTER12/13/2023
1005NDA/MAL/HDP/11062ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDGAVISILALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE250MG + 250MG + 50MGM/S SCOTT-EDIL PHARMACIA LTD 56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X200.0 ML BOTTLE12/13/2023
1006NDA/MAL/HDP/11063PHARMA BAVARIA INTERNACIONAL(PBI) PORTUGUALGOODMAN INTERNATIONAL LTDCOMBOFUSIVPARACETAMOL + IBUPROFEN10MG/ML + 3MG/MLS.M. FARMACEUTICI S.R.LZONA INDUSTRIALE, 85050 TITO (PZ)ITALYPARENTERAL ORDINARY VIALS 1.0X10.0X100.0 ML VIAL12/13/2023
1007NDA/MAL/HDP/11064MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDISONIAZID DISPERSIBLE TABLETS 100 MGISONIAZID100 MGOXALIS LABS LIMITEDVILLAGE THEDA, P.O LODHIMAJRA, TEHSIL BADDI DIST: SOLAN (H.P.) PIN CODE: 174101 - INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET STRIP12/13/2023
1008NDA/MAL/HDP/11065JAMJOOM PHARMACEUTICALS COMPANYMU PHARMA CO -SMC LIMITEDAROXMOXIFLOXACIN HYDROCHLORIDE0.5% W/VJAMJOOM PHARMACEUTICALS COMPANYPLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIASAUDI ARABIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE12/13/2023
1009NDA/MAL/HDP/11066MACARTHYS LABORATORIES LTDLABOREX UGANDA LIMITEDCOLISTIMETHATE SODIUM 1 MIUCOLISTIMETHATE SODIUM1MU/VIALALTAN PHARMACEUTICALS S.A.AVDA. DE LA CONSTITUCION 198 - 199, POLIGONO INDUSTRIAL MONTE BOYAL, CASARRUBIOS DE MONTE, 45950 TOLEDO - SPAINSPAINPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.0 MU VIAL12/13/2023
1010NDA/MAL/HDP/11067AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVAUR 250LEVETIRACETAM250MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1011NDA/MAL/HDP/11068AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVAUR 500LEVETIRACETAM500MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1012NDA/MAL/HDP/11069AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVAUR 1000LEVETIRACETAM1000MGAUROBINDO PHARMA LIMITED, UNIT - XVPLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1013NDA/MAL/HDP/11070MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJITRIT-5TOFACINIB 5MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X15.0 TABLET BLISTER12/13/2023
1014NDA/MAL/HDP/11071MYLAN PHARMACEUTICALS PRIVATE LIMITED, INDIAKIMSY MEDS LTDOGIVRI„¢ 440 MGTRASTUZUMAB440MG/VIALBIOCON BIOLOGICS LIMITEDSPECIAL ECONOMIC ZONE, PLOT NO. 2, 3, 4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMASANDRA POST, BENGALURU - 560099, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X440.0 MG VIAL12/13/2023
1015NDA/MAL/HDP/11072MEDOPHARMNUGEN PHARMACEUTICALS UGANDA LIMITEDNUNINEQUININE SULFATE300MGMEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
1016NDA/MAL/HDP/11073DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDPARACO-DENK 500/30PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE500 MG + 30 MGBENE-ARZNEIMITTEL GMBHPRODUCTION AND WAREHOUSING- HERTERICHSTR. 1-3 D-81479 MUNICH GERMANY. QUALITY CONTROL LABORATORY - BAYERWALDSTR. 7-9 D-82538 GERETSRIED, GERMANY. HIGH-RACK WAREHOUSING €“ GEWERBERING 11 D-82140 OLCHING, GERMANY GERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER12/13/2023
1017NDA/MAL/HDP/11074MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDFAMYTECMISOPROSTOL200MCGMYLAN LABORATORIES LIMITEDPLOT NO. 20 & 21, PHARMEZ, SARKHEJ - BAVLA, NATIONAL HIGHWAY NO. 8 - A, NEAR VILLAGE - MATODA, TAL - SANAND, DIST., AHMEDABAD - 382213INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER12/13/2023
1018NDA/MAL/HDP/11075HEALTH LINK PHARMACY LTDHEALTH LINK PHARMACY LIMITEDROLXIN ODDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE120 MG + 960 MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER12/13/2023
1019NDA/MAL/HDP/11076SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDG-COSPE®SULFADOXINE + PYRIMETHAMINE500MG + 25MGGUILIN PHARMACEUTICAL CO LTD .NO. 43, QULIDIAN ROAD, GUILIN 541004CHINAORAL SOLID ORDINARY TABLETS 1.0X100.0X3.0 TABLET BLISTER12/13/2023
1020NDA/MAL/HDP/11078BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDB-LACTLACTULOSE3.35GM/5MLFRESENIUS KABI AUSTRIA GMBHESTERMANNSTRASSE 17, A-4020 LINZAUSTRIAORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE02/02/2024
1021NDA/MAL/HDP/11079MEDOPHARMPLANET PHARMACEUTICALS UGANDA LTDMIRAFOLICFOLIC ACID5MGMEDOPHARMNO. 34B, INDUSTRIAL AREA, MALUR-563160, KARNATAKAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER, 1.0X100.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER, 1.0X50.0X10.0 TABLET BLISTER02/02/2024
1022NDA/MAL/HDP/11080MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-AMHOLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE20MG + 5MG + 12.5MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1023NDA/MAL/HDP/11081INFUGEN PHARMA PVT. LTD.GITTOES PHARMACEUTICALS LIMITEDINFUROXIMCEFUROXIME SODIUM750MGZEISS PHARMACEUTICALS PRIVATE LIMITEDPLOT NO. 72 EPIP-PHASE-1 JHARMAJRI BADDI DISTRICT SOLAN (H.P.)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X750.0 MG VIAL02/02/2024
1024NDA/MAL/HDP/11082UNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVIVAZAC PLUSIRBESARTAN + HYDROCHLOROTHIAZIDE150 MG + 12.5 MGUNITED PHARMACEUTICALS MANUFACTURING LIMITED COMPANYAL-RAGEEM, SAHAB, P.O. BOX 60, AMMAN 11591 - JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1025NDA/MAL/HDP/11083ASPIRO PHARMA LIMITED.AIVEEN (U) LIMITEDCANDIVOR 200 MG/VIALVORICONAZOLE200MGASPIRO PHARMA LIMITEDSY. NO. 321, BIOTECH PARK, PHASE-III, KARKAPATLA, MARKOOK MANDAL, SIDDIPET DISTRICT-502 281, TELANGANA, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X200.0 MG VIAL02/02/2024
1026NDA/MAL/HDP/11084MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDINVEL FORTE LMETRONIDAZOLE + MICONAZOLE NITRATE + LIDOCAINE750 MG + 200 MG + 100 MGBLISS GVS PHARMA LTDPLOT NO. 11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI, PALGHAR, MAHARASHTRA 401404, INDIAINDIAVAGINAL SUPPOSITORIES 1.0X1.0X7.0 SUPPOSITORY STRIP, 1.0X2.0X7.0 SUPPOSITORY STRIP02/02/2024
1027NDA/MAL/HDP/11085CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEMITINO INJECTIONONDANSETRON HYDROCHLORIDE4MG/2MLSAKAR HEALTHCARE PVT LTDBLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X2.0 ML AMPOULE02/02/2024
1028NDA/MAL/HDP/11086BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDERYBRU 500ERYTHROMYCIN STEARATE500MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER02/02/2024
1029NDA/MAL/HDP/11088LAURUS LABS LIMITED - BEYOND LOGISTICS LTDDARUNAVIR 400 MGDARUNAVIR400MGLAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X60.0 TABLET BOTTLE02/02/2024
1030NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE 2MG/5MLDAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKAKENYA ORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE01/07/2014
1031NDA/MAL/HDP/11090LES LABORATOIRES SERVIERHARLEYS UGANDA LIMITEDDIAMICRON MR 60 MGGLICLAZIDE60MGLES LABORATOIRES SERVIER INDUSTRIE (LSI)905 ROUTE DE SARAN 45520 GIDY - FRANCEFRANCEORAL SOLID RETARD TABLETS 1.0X2.0X15.0 TABLET BLISTER02/02/2024
1032NDA/MAL/HDP/11094BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFETNAL 500CEFUROXIME AXETIL500MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER02/02/2024
1033NDA/MAL/HDP/11098VERVE HUMAN CARE LABORATORIESABACUS PHARMA (AFRICA) LIMITEDADEVERADRENALINE ACID TARTRATE1MG/MLVERVE HUMAN CARE LABORATORIESPLOT NO. 15A PHARMACITY, SELAQUI, DEHRADUN, UTTARAKHAND, 248011, INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE02/02/2024
1034NDA/MAL/HDP/11101SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDCLARITHROMYCIN 500 MGCLARITHROMYCIN500MGSANDOZ S.R.LSTR. LIVEZENI NR. 7A 540472 TARGU-MURES ROMANIAROMANIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER02/02/2024
1035NDA/MAL/HDP/11102ENCORE HEALTHCARE PVT. LTD.REDDYS PHARMA LIMITEDONTADEX 50MGTRAMADOL HYDROCHLORIDE50MGENCORE HEALTHCARE PVT LTDD-5, MIDC AREA, PAITHAN- 431148, DIST. AURANGABAD, MAHARASHTRA - INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER02/02/2024
1036NDA/MAL/HDP/11103CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDLOXIBS 50LOSARTAN POTASSIUM50MGCACHET PHARMACEUTICAL PVT LTD.VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1037NDA/MAL/HDP/11104CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDROSUCACH 10ROSUVASTATIN CALCIUM10MGCACHET PHARMACEUTICAL PVT LTD.VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH-173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1038NDA/MAL/HDP/11105AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD. HEALTHCARE LTD.TELOSINTAMSULOSIN HYDROCHLORIDE0.4MGAL FAZAL PHARMA INDUSTRIES (PVT) LTDPLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER02/02/2024
1039NDA/MAL/HDP/11106SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., ROYAL PHARMA 2011 LIMITEDSCOTXONE-1GCEFTRIAXONE SODIUM1GM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL02/02/2024
1040NDA/MAL/HDP/11107 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDAZITO 500AZITHROMYCIN DIHYDRATE500MGZIM LABORATORIES LIMITEDB-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER02/02/2024
1041NDA/MAL/HDP/11109LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDBETALEB-N CREAMBETAMETHASONE VALERATE + NEOMYCIN SULPHATE0.1%W/W + 0.5%W/WLEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE02/02/2024
1042NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GEL DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITEDPLOT 7879, BABA DOGO ROAD RUARAKAKENYA TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE01/07/2013
1043NDA/MAL/HDP/11110SAGA LABORATORIES ABACUS PHARMA (AFRICA) LIMITEDGLIBEMET 500/2.5METFORMIN HYDROCHLORIDE + GLIBENCLAMIDE500 MG + 2.5 MGSAGA LABORATORIES .198/2 & 198/3, CHACHRAWADI, VASNA NO. CLARIS LIFE SCIENCE, TA SANAND, DIST. DIST: AHMEDABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER02/02/2024
1044NDA/MAL/HDP/11111RUSAN PHARMA LTD.NORVIK ENTERPRISES LIMITEDADDNOKBUPRENORPHINE HYDROCHLORIDE8MGRUSAN PHARMA LTDKHASRA NO. 122MI, CENTRAL HOPE TOWN, BEHIND PHARMA CITY, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIARUSAN PHARMA LIMITEDPLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL ECONOMIC ZONE, GANDHIDHAM KUTCH 370 230 GUJARATINDIAORAL SOLID ORDINARY SUBLINGUAL TABLETS 1.0X1.0X7.0 TABLET BLISTER, 1.0X4.0X7.0 TABLET BLISTER02/02/2024
1045NDA/MAL/HDP/11112HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDBETASONEBETAMETHASONE VALERATE0.1%W/WHOVID BERHAD (IPOH SITE)121, JALAN TUNKU ABDUL RAHMAN 30010 IPOH PERAKMALAYSIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE02/02/2024
1046NDA/MAL/HDP/11113ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDATRONA-20ATORVASTATIN CALCIUM20MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1047NDA/MAL/HDP/11114FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDAPTIN M 50/500 F/C TABLETVILDAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 500MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED (7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400)BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER20/05/2024
1048NDA/MAL/HDP/11115FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDSITOMET 50/500SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 500 MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED (7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400)BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER10/01/2024
1049NDA/MAL/HDP/11116FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDSITOMET 50/1000SITAGLIPTIN PHOSPHATE MONOHYDRATE + METFORMIN HYDROCHLORIDE50 MG + 1000 MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED (7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400)BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER10/01/2024
1050NDA/MAL/HDP/11117FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDFAST 250 SUPPOSITORYPARACETAMOL250MGTHE ACME LABORATORIES LIMITEDDHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESHBANGLADESHRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP02/02/2024
1051NDA/MAL/HDP/11118LUPIN LIMITED-AIVEEN (U) LIMITEDMOXIFLOXACINMOXIFLOXACIN HYDROCHLORIDE400 MGLUPIN LIMITEDUNIT-2, PLOT NO. M-2 & M-2-A, SPECIAL ECONOMIC ZONE, PHASE II, MISC. ZONE, APPAREL PARK, DIST. DHAR - M.P. PITHAMPUR, 454775, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER02/02/2024
1052NDA/MAL/HDP/11119AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDETIMICOL 10EZETIMIBE10MGAUROBINDO PHARMA LTD, UNIT VIISY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1053NDA/MAL/HDP/11120AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVALABIN 500VALACICLOVIR HYDROCHLORIDE500MGAUROBINDO PHARMA LIMITED, UNIT IIISURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X7.0 TABLET BLISTER02/02/2024
1054NDA/MAL/HDP/11128ATCO LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDBETAMET-NBETAMETHASONE AS VALERATE + NEOMYCIN SULPHATE0.1% W/W + 0.5% W/WATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 PAKISTAN TOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE12/13/2023
1055NDA/MAL/HDP/11129EAST AFRICAN (INDIA) OVERSEASABACUS PHARMA (AFRICA) LIMITEDPARARIV-IIBUPROFEN + PARACETAMOL100 MG + 162.5 MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE12/13/2023
1056NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTDISAAPUR P.O DAPPAR 140056 INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/1997
1057NDA/MAL/HDP/11130CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVINGLYN M 50/1000VILDAGLIPTIN + METFORMIN HYDROCHLORIDE50 MG + 1000 MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1058NDA/MAL/HDP/11135MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR PR-500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE LIMITED-F-1 - F-1/1 - F75/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH EAST 421506, DIST. THANE, MAHARASHTRA - INDIA INDIA ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
1059NDA/MAL/HDP/11136KESAR PHARMAABACUS PHARMA (AFRICA) LIMITEDALZOLALBENDAZOLE400 MGKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIA ORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER12/13/2023
1060NDA/MAL/HDP/11137M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDDARUNIVIR AND RITONIVIR TABLETSDARUNAVIR ETHANOLATE + RITONAVIR800 MG + 100 MGHETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE, INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER12/13/2023
1061NDA/MAL/HDP/11138CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCABALIN 150PREGABALIN150 MGCACHET PHARMACEUTICALS PVT LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205 INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X12.0 CAPSULE BLISTER12/13/2023
1062NDA/MAL/HDP/11139LAURUS LABS LIMITED - BEYOND LOGISTICS LTDEMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETSEMTRICITABINE + TENOFOVIR ALAFENAMIDE200 MG + 25 MGLAURUS LABS LTD (UNIT 2)-PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH, INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE12/13/2023
1063NDA/MAL/HDP/1114SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER01/07/2012
1064NDA/MAL/HDP/11140SINOVAC BIOTECH CO LTDBHL HEALTHCARE LIMITEDHEALIVE (JUNIOR USE)INACTIVATED HEPATITIS A VIRUS ANTIGEN, TZ84 STRAIN PRODUCED IN HUMAN DIPLOID (2BS) CELLS ADSORBED ON ALUMINIUM HYDROXIDE250 IU/1.0 MLSINOVAC BIOTECH COMPANY LIMITED - CHANGPING SITE-NO. 15, ZHITONG ROAD, CHANGPING DISTRICT, BEIJING, 102200 - CHINA CHINA PARENTERAL ORDINARY VIALS 1.0X1.0X0.5 ML VIAL,1.0X1.0X0.5 ML PRE- FILLED SYRINGE12/13/2023
1065NDA/MAL/HDP/11141SINOVAC BIOTECH CO LTDBHL HEALTHCARE LIMITEDHEALIVE (ADULT USE)INACTIVATED HEPATITIS A VIRUS ANTIGEN, TZ84 STRAIN PRODUCED IN HUMAN DIPLOID (2BS) CELLS ADSORBED ON ALUMINIUM HYDROXIDE250 IU/1.0 MLSINOVAC BIOTECH COMPANY LIMITED - CHANGPING SITE-NO. 15, ZHITONG ROAD, CHANGPING DISTRICT, BEIJING, 102200 - CHINA CHINA PARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL,1.0X1.0X1.0 ML PRE- FILLED SYRINGE12/13/2023
1066NDA/MAL/HDP/11142PSYCHOTROPICS INDIA LTD-BIOGEN PHARMA LIMITEDCEFTRIONE-1CEFTRIAXONE SODIUM1G/VIALPSYCHOTROPICS INDIA LTD-PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL12/13/2023
1067NDA/MAL/HDP/11143HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDROLIP EZEROSUVASTATIN CALCIUM + EZETIMIBE5MG +10MGHILTON PHARMACEUTICALS (PVT) LIMITED-PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTAN ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
1068NDA/MAL/HDP/11144CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETSEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400MG + 300MG + 300 MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK UGANDA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET BOTTLE12/13/2023
1069NDA/MAL/HDP/11145NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDCADZOLE-VCLOTRIMAZOLE100 MGNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) INDIA VAGINAL TABLETS 1.0X1.0X6.0 TABLET STRIP12/13/2023
1070NDA/MAL/HDP/11147UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDMEMTIN 10MEMANTINE HYDROCHLORIDE10 MGUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1071NDA/MAL/HDP/11148ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDCONAZ CREAMKETOCONAZOLE2% W/WATCO LABORATORIES LIMITED-B-18, S.I.T.E, KARACHI - 74700 PAKISTAN TOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE12/13/2023
1072NDA/MAL/HDP/11149JAMJOOM PHARMACEUTICALS COMPANYMU PHARMA CO -SMC LIMITEDLICANLULICONAZOLE1% W/WJAMJOOM PHARMACEUTICALS COMPANY - PLOT NO: ME1:3, PHASE V, INDUSTRIAL CITY, P.O. BOX 6267 - KINGDOM OF SAUDI ARABIASAUDI ARABIA TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE12/13/2023
1073NDA/MAL/HDP/11150LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABCLAV 625MG TABLETSAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500 MG + 125 MGLABORATORY & ALLIED LTD -PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, NEXT TO LIBRA HOUSE, MOMBASA ROAD- NAIROBI - KENYA KENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X2.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER12/13/2023
1074NDA/MAL/HDP/11151BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDNUROQ 75PREGABALIN75 MGBAROQUE PHARMACEUTICAL PVT LTD-192/2 & 3, SOKHADA, 388620, TA: KHAMHAT DIST. ANANT (GUJARAT) INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER12/13/2023
1075NDA/MAL/HDP/11152BAROQUE PHARMACEUTICALS PVT LTDJEET PHARMACEUTICALS LIMITEDCOCELCELECOXIB200 MGBAROQUE PHARMACEUTICAL PVT LTD-192/2 & 3, SOKHADA, 388620, TA: KHAMHAT DIST. ANANT (GUJARAT) INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER12/13/2023
1076NDA/MAL/HDP/11153MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAFARIV 15RIVAROXABAN15 MGMYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
1077NDA/MAL/HDP/11154MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAFARIV 20RIVAROXABAN20 MGMYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
1078NDA/MAL/HDP/11155IDA FOUNDATYIONKIMSY MEDS LTDBENZATHINE BENZYLPENICILLIN 1.2MIUBENZATHINE BENZYLPENICILLIN1.2 MIUREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
1079NDA/MAL/HDP/11156IDA FOUNDATIONKIMSY MEDS LTDBENZATHINE BENZYLPENICILLIN 2.4MIUBENZATHINE BENZYLPENICILLIN2.4 MIUREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
1080NDA/MAL/HDP/11157GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDDOVATO 50MG/300MGDOLUTEGRAVIR + LAMIVUDINE50 MG + 300 MGGLAXOSMITHKLINE, LLC1011 NORTH ARENDELL AVENUE ZEBULON, NORTH CAROLINA 27597UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE02/02/2024
1081NDA/MAL/HDP/11158MARCYRL PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDTORSAMOLEX 20MGTORSEMIDE20MGMARCYRL PHARMACEUTICAL INDUSTRIES WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITYEGYPTORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER02/02/2024
1082NDA/MAL/HDP/11159AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDTIBAN 20TENEGLIPTIN HYDROBROMIDE HYDRATE20MGAJANTA PHARMA LIMITEDB-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD MAHARASHTRA STATE INDIA 431 128INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1083NDA/MAL/HDP/11160ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDROSUNA-5ROSUVASTATIN CALCIUM5MGZOTA HEATHCARE LIMITEDPLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, CITY: SURAT, DIST: SURAT, GUJARAT STATE - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1084NDA/MAL/HDP/11161CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEMITINO-8 INJECTIONONDANSETRON HYDROCHLORIDE8MG/4MLEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X4.0 ML AMPOULE02/02/2024
1085NDA/MAL/HDP/11162UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDRABZOLRABEPRAZOLE SODIUM20MGNAPROD LIFE SCIENCES PVT. LTDG-17/1, MIDC TARAPUR IND. AREA, BOISAR, 401506 MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 MG VIAL, 1.0X1.0X20.0 G VIAL02/02/2024
1086NDA/MAL/HDP/11163UNIMED LABORATORIES.OMAB UGANDA LIMITEDCIPROJECTCIPROFLOXACIN200MGUNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIAPARENTERAL ORDINARY INFUSION BAGS 1.0X100.0 ML BAG02/02/2024
1087NDA/MAL/HDP/11164IDA FOUNDATYIONKIMSY MEDS LTDBENZATHINE BENZYLPENICILLIN 5MIUBENZATHINE BENZYLPENICILLIN5 MIUREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
1088NDA/MAL/HDP/11165IDA FOUNDATYIONKIMSY MEDS LTDBENZATHINE BENZYLPENICILLIN 1MIUBENZATHINE BENZYLPENICILLIN1MIUREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY DRY VIALS 1.0X50.0X15.0 ML VIAL12/13/2023
1089NDA/MAL/HDP/11166GLOBELA PHARMA PVT. LTD.ROYAL PHARMA 2011 LIMITEDPYLOGLOB KITCLARITHROMYCIN + OMEPRAZOLE + TINIDAZOLE250 MG + 20 MG + 500 MGGLOBELA PHARMA PVT.LTD.357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIAINDIAORAL SOLID ORDINARY COMBINATION PACK COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER21/02/2024
1090NDA/MAL/HDP/11167MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAGULANT 2.5APIXABAN2.5 MGMYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
1091NDA/MAL/HDP/11168MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDXAGULANT 5APIXABAN5 MGMYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
1092NDA/MAL/HDP/11169IDA FOUNDATYIONKIMSY MEDS LTDDICLOFENAC SODIUMDICLOFENAC SODIUM75MG/3MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE12/13/2023
1093NDA/MAL/HDP/1117SHOSAAN ASIC PACIFICRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIA OPHTHALMIC OINTMENTS 1.0X20.0X3.5 G TUBE01/07/2013
1094NDA/MAL/HDP/11170JEVIANA HEALTH CARE LLP, MARVIN PHARMA LIMITEDMARIPRAZOLEOMEPRAZOLE SODIUM40 MG/VIALSANJAR PHARMACEUTICALS LIMITED-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA INDIA PARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL + 1*10 ML, WATER FOR INJECTION IN LDPE AMPOULE12/13/2023
1095NDA/MAL/HDP/11171BIOMATRIX HEALTHCARE PVT LTD.-MEDIWORLD PHARMA AFRICA LTDPRIMECIPCIPROFLOXACIN HYDROCHLORIDE500 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
1096NDA/MAL/HDP/11172ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDGLANTRIMDORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE2%W/V + 0.5%W/VATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700PAKISTANOPHTHALMIC LIQUIDS 1.0X1.0X5.0 ML BOTTLE02/02/2024
1097NDA/MAL/HDP/11173ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDWINOLAP 0.1OLOPATADINE HYDROCHLORIDE0.1%W/VATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700PAKISTANOPHTHALMIC LIQUIDS 1.0X1.0X5.0 ML BOTTLE02/02/2024
1098NDA/MAL/HDP/11174ATCO LABORATORIES LIMITEDHARLEYS UGANDA LIMITEDWINOLAP 0.2%OLOPATADINE HYDROCHLORIDE0.2%W/VATCO LABORATORIES LIMITEDB-18, S.I.T.E, KARACHI - 74700PAKISTANOPHTHALMIC LIQUIDS 1.0X1.0X2.5 ML BOTTLE02/02/2024
1099NDA/MAL/HDP/11175ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDURIPAN XROXYBUTYNIN HYDROCHLORIDE10MGADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1100NDA/MAL/HDP/11176AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBORTEBINBORTEZOMIB3.5MGEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X3.5 MG VIAL02/02/2024
1101NDA/MAL/HDP/11177ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDLEPTROGINE 200 MGLAMOTRIGINE200MGADWIA S.A.E.1ST INDUSTRIAL ZONE A1, 10TH OF RAMADAN CITY, EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER02/02/2024
1102NDA/MAL/HDP/11178UNIMED LABORATORIES.OMAB UGANDA LIMITEDSYNERGIC 500IMIPENEM + CILASTATIN500 MG + 500 MGUNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 ML VIAL02/02/2024
1103NDA/MAL/HDP/11179UNIMED LABORATORIES.OMAB UGANDA LIMITEDTAZOBACT 4G/500 MGPIPERACILLIN SODIUM + TAZOBACTAM SODIUM4G + 500MGUNIMED LABORATORIESP.O. BOX 38 - I.Z. KALAA KEBIRA - 4060 KALAA KEBIRA - TUNISIATUNISIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X4.5 G VIAL02/02/2024
1104NDA/MAL/HDP/1118EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 52.5TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR), (TNK-T-PA)52.5GENNOVA BIOPHARMACEUTICALS LIMITEDBLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057INDIA PARENTERAL ORDINARY I V VIALS 1.0X52.5 MG VIAL + (1*10ML AMPOULE WFI)01/07/2013
1105NDA/MAL/HDP/11182INDIANA OPHTHALMICS SWASTIK PHARMACEUTICAL LTDAYZEECONAZITHROMYCIN DIHYDRATE1%W/WINDIANA OPHTHALMICS135, 136, 137, GIDC ESTATE, WADHWAN-363035INDIAOPHTHALMIC OINTMENTS 1.0X1.0X5.0 G TUBE02/02/2024
1106NDA/MAL/HDP/11189BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDCLEOBACT 150CLINDAMYCIN HYDROCHLORIDE150 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER12/13/2023
1107NDA/MAL/HDP/11190BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDACNEXCLINDAMYCIN PHOSPHATE1% W/WNANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA INDIA TOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE12/13/2023
1108NDA/MAL/HDP/11191BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDFUNGIDERMCLOTRIMAZOLE + ZINC OXIDE + DIMETHICONE1% W/W + 1.75% W/W + 2.50% W/WNANZ MED SCIENCE PHARMA PVT. LTD-RAMPUR GHAT, PAONTA SAHIB, DISTRICT SIRMOUR-173025, HIMACHAL PRADESH, INDIA INDIA TOPICAL EXTERNAL DUSTING POWDERS 1.0X50.0 G BOTTLE12/13/2023
1109NDA/MAL/HDP/11192BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDERINOCIN 250ERYTHROMYCIN STEARATE250 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
1110NDA/MAL/HDP/11193UNOSOURCE PHARMA LTD.MEDVIN PHARMA LIMITEDWELGRA 100SILDENAFIL CITRATE100 MGAKUMS DRUGS AND PHARMACEUTICALS-19,20,21, SEC.6-A, IIE, SIDCUL, RANIPUR,HARIDWAR-249403, UTTARAKHAND, INDIAINDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER12/13/2023
1111NDA/MAL/HDP/11194UNOSOURCE PHARMA LTD.MEDVIN PHARMA LIMITEDUNOKETROKETOROLAC TROMETHAMINE30 MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD ,-2,3,4,5, SECTOR 6B, SIDCUL, I.I.E, RANIPUR, HARIDWAR-249403, INDIA INDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 ML AMPOULE12/13/2023
1112NDA/MAL/HDP/11195FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDWINOP 60KETOROLAC TROMETHAMINE60MG/2MLTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH INDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X2.0 ML AMPOULE12/13/2023
1113NDA/MAL/HDP/11196FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDPERMINPERMETHRIN5%W/WTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH BANGLADESH TOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE12/13/2023
1114NDA/MAL/HDP/11197LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDMYCOFILMYCOPHENOLATE MOFETIL500 MGLINCOLN PHARMACEUTICALS LTD-10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER12/13/2023
1115NDA/MAL/HDP/11198ARCELIA LIFE SCIENCES LTD.NOVOMED HEALTHCARE LIMITEDGENTAMICIN SULPHATEGENTAMICIN SULPHATE80MG/2MLSANJAR PHARMA LLP-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA INDIA PARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL12/13/2023
1116NDA/MAL/HDP/11199PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYMET-500METFORMIN HYDROCHLORIDE500 MGBAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1117NDA/MAL/HDP/11200PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDHYTAN – 80TELMISARTAN80MGBAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1118NDA/MAL/HDP/11201PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDHYTAN – 40TELMISARTAN40MGBAFNA PHARMACEUTICALS LIMITED UNIT II-NO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER12/13/2023
1119NDA/MAL/HDP/11202AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDIRNIZET 40IRINOTECAN HYDROCHLORIDE TRIHYDRATE20MG/MLEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 INDIA PARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X2.0 ML VIAL12/13/2023
1120NDA/MAL/HDP/11203AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 40CEFPODOXIME PROXETIL40MG PER 5MLAUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI- R7-AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI SY.NO.329/39 & 329/47 CHITKUL(V) PATANCHERU MANDAL, SANGA REDDY DISTTELANGANA502307 INDIA ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE12/13/2023
1121NDA/MAL/HDP/11204KLM LABORATORIES PVT. LTD.REDDYS PHARMA LIMITEDNIOFINE CREAMTERBINAFINE HYDROCHLORIDE1.0% W/WCURETECH SKINCARE-PLOT NO. 33 & 34, PHASE IV, BHATOLI KALAN, BADDI DISTT. SOLAN (HP) 173205 INDIA TOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE12/13/2023
1122NDA/MAL/HDP/11205OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED20MMANNITOL20% W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED-SURVEY NO. 199 TO 201 & 208 TO 210, MF01 AND MF02 VILLAGE- VASNA CHACHARWADI, TAL. SANAND DISTRICT. AHMEDABAD-382 213 INDIA PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X500.0 ML BOTTLE12/13/2023
1123NDA/MAL/HDP/11206XL LABORATORIES PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDFLAMO 400IBUPROFEN400 MGXL LABORATORIES PRIVATE LIMITED-A-141, EPIP INDUSTRIAL AREA, NEEMRANA, DIST. ALWAR, RAJASTHAN - 301705 (INDIA) INDIA ORAL SOLID ORDINARY OTHER CAPSULES 1.0X6.0X1.0X10.0 CAPSULE BLISTER12/13/2023
1124NDA/MAL/HDP/11208ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROZMET - 500METFORMIN500 MGEAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER12/13/2023
1125NDA/MAL/HDP/11209ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDRO-VIT-K 10PHYTOMENADIONE10MG/ML SANJAR PHARMACEUTICALS LIMITED-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA INDIA PARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X1.0 ML AMPOULE12/13/2023
1126NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITEDBLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDA OTIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
1127NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPAR PARACETAMOL500 MGAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2012
1128NDA/MAL/HDP/11232AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPLERISTEMPLERIXAFOR24MG/1.2MLEUGIA PHARMA SPECIALITIES LIMITEDSURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X1.2.0 ML VIAL22/03/2024
1129NDA/MAL/HDP/11233UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDAMCARDIA-10AMLODIPINE BESYLATE10 MGUNIQUE PHARMACEUTICAL LABS LIMITED. .PLOT NO. 215-219 AND 304-308, GIDC INDUSTRIAL ESTATE, PANOLI - 394 116, DIST: BHARUCH - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1130NDA/MAL/HDP/11234LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDMOXILEB 250 DTAMOXICILLIN TRIHYDRATE250MGLEBEN LABORATORIES PVT LTD .L-14 PHASE III MIDC AKOLA 444 104INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER22/03/2024
1131NDA/MAL/HDP/11235CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDQUALITY CHEMICALS LTDZENTAIR 1.0MGENTECAVIR1.0MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARKUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER22/03/2024
1132NDA/MAL/HDP/11236REDDYS PHARMA LIMITEDREDDYS PHARMA LIMITEDAURATRIM-GBBETAMETHASONE DIPROPIONATE + CLOTRIMAZOLE + GENTAMICIN SULFATE0.05% W/W + 1.0% W/W + 0.1% W/WAURA LIFECARE PRIVATE LIMITEDSURVEY NO. 254/14/1, JAROD-SAVLI ROAD, P.O. KARACHIYA, 391 520, TAL. SAVLI, DIST. VADODARA - INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE, 1.0X30.0 G TUBE22/03/2024
1133NDA/MAL/HDP/11237LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPERILINMETOCLOPRAMIDE HYDROCHLORIDE 10MG/2MLLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE22/03/2024
1134NDA/MAL/HDP/11238LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDESLORA-5DESLORATADINE5MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER22/03/2024
1135NDA/MAL/HDP/11239NEM LABORATORIES (PVT) LTDRENE PHARMACY LTDTIGBODERM -G CREAMCLOTRIMAZOLE + GENTAMICIN SULFATE + BETAMETHASONE DIPROPIONATE1% W/W + 0.1% W/W + 0.05% W/WNEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE, 1.0X30.0 G TUBE22/03/2024
1136NDA/MAL/HDP/1124GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA TOPICAL EXTERNAL LIQUIDS 1.0X1.0X500.0 ML BOTTLE01/07/2013
1137NDA/MAL/HDP/11241ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDTERBINAFINE TABLETS USP, 250 MGTERBINAFINE HYDROCHLORIDE250MGEAST AFRICAN (INDIA) OVERSEASPLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1138NDA/MAL/HDP/11242FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDSITAP 50SITAGLIPTIN PHOSPHATE MONOHYDRATE50MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1139NDA/MAL/HDP/11243SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDZETIRISEALBENDAZOLE200MG/5MLSUNRISE INTERNATIONAL LABS LTDPLOT NO. 100, LANE-5, SECTOR-II, PHASE-II, IDA, CHERLAPALLY INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0 ML BOTTLE22/03/2024
1140NDA/MAL/HDP/11244LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDESOPRALINESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1141NDA/MAL/HDP/11245LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVALPIN-200SODIUM VALPROATE200MGLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP22/03/2024
1142NDA/MAL/HDP/11246SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD., ROYAL PHARMA 2011 LIMITEDSCOFIX 400CEFIXIME TRIHYDRATE400MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITEDHILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER22/03/2024
1143NDA/MAL/HDP/11248 SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDVIDAGLINVILDAGLIPTIN50 MGSUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1144NDA/MAL/HDP/11249LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH-LARTEMETHER + LUMEFANTRINE(180 MG + 1080 MG)/ 60MLLINCOLN PHARMACEUTICALS LTD10, 12, 13, TRIMUL ESTATE, AFTER VADSAR VILLAGE, NEAR KHATRAJ CHOWKADI, KHATRAJ-382721, GHANDINAGAR, GUJARAT, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE22/03/2024
1145NDA/MAL/HDP/1125AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXONE 1000CEFTRIAXONE1000MGAUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI- R7AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI SY.NO.329/39 & 329/47 CHITKUL(V) PATANCHERU MANDAL, SANGA REDDY DISTTELANGANA502307 INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL01/07/2009
1146NDA/MAL/HDP/11250AUROCHEM LABORATORIES(I) PVT LTDSUPER MEDIC LTDDOBESIL HCALCIUM DOBESILATE MONOHYDRATE + LIDOCAINE HYDROCHLORIDE + HYDROCORTISONE ACETATE + ZINC OXIDE0.5 % W/W + 3.0 %W/W + 0.25 % W/W + 5.0 % W/WAUROCHEM LABORATORIES (I) PVT LTD8, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401404INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE22/03/2024
1147NDA/MAL/HDP/11252AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDTELMICLAR HTZ 40/12.5TELMISARTAN + HYDROCHLOROTHIAZIDE40 MG + 12.5 MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER16/03/2024
1148NDA/MAL/HDP/11253FRESENIUS KABI MANUFACTUING S.A. (PTY) LTD SURGIPHARM (U) LIMITEDCLINDAMYCIN FRESENIUS 600MG/4MLCLINDAMYCIN PHOSPHATE600MG/4MLFRESENIUS KABI MANUFACTURING SA (PTY) LIMITED6 GIBAUD ROAD, KORSTEN, 6020, PORT ELIZABETH, SOUTH AFRICALABESFAL LABORATORIOS ALMIRO, S.A ZONA INDUSTRIAL DO LAGEDO, 3465-157 SANTIAGO DE BESTEIROS PORTUGALSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X4.0 ML AMPOULE22/03/2024
1149NDA/MAL/HDP/11254AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDORIXO 400OFLOXACIN400MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER16/03/2024
1150NDA/MAL/HDP/11255MANKIND PHARM LTDTATA UGANDA LIMITEDMAHACEF-200CEFIXIME TRIHYDRATE200 MGCOPMED PHARMACEUTICALS PVT LTD-UNIT II. ,PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER22/03/2024
1151NDA/MAL/HDP/11256BRAWN LABORATORIES LTDTATA UGANDA LIMITEDMOXIBRUMOXIFLOXACIN0.5% W/VBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X10.0 ML BOTTLE22/03/2024
1152NDA/MAL/HDP/11257BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRUCOXIA-90ETORICOXIB90MGBRAWN LABORATORIES LIMITED13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1153NDA/MAL/HDP/11258AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDADERAN HTZ 16/12.5CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE16 MG + 12.5 MGAJANTA PHARMA LIMITEDMIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER16/03/2024
1154NDA/MAL/HDP/11259UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDMAGNILEKGADOPENTETATE DIMEGLUMINE469MG/MLUNIQUE PHARMACEUTICAL LABORATORIESPLOT NO.4, PHASE IV, GIDC, INDUSTRIAL AREA, PANOLI- 394 116, DIST: BHARUCH, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL, 1.0X10.0 ML VIAL, 1.0X15.0 ML VIAL22/03/2024
1155NDA/MAL/HDP/11260MANKIND PHARM LTDTATA UGANDA LIMITEDMAHACEF-100CEFIXIME TRIHYDRATE100 MGCOPMED PHARMACEUTICALS PVT LTD-UNIT II. ,PLOT 50, GONDPUR INDUSTRIAL AREA, PAONTA, SAHIB, SIRMOUR, HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER22/03/2024
1156NDA/MAL/HDP/11261LA RENON HEALTHCARE PRIVATE LIMITEDAIVEEN (U) LIMITEDCOLIHENZCITICOLINE SODIUM500MGSTANFORD LABORATORIES PRIVATE LIMITED (A SUBSIDIARY COMPANY OF LA RENON HEALTHCARE PRIVATE LIMITED)8, INDUSTRIAL AREA, MEHATPUR - 174315, HIMACHAL PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER16/03/2024
1157NDA/MAL/HDP/11262AMN LIFE SCIENCE PVT LTDVITACARE LIMITEDMOXITAM 125AMOXICILLIN TRIHYDRATE125MG PER 5MLAMN LIFE SCIENCE PVT LTD67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARATINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE22/03/2024
1158NDA/MAL/HDP/11263ORCHIDIA PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNORMOPROSTLATANOPROST50MCG/MLORCHIDIA PHARMACEUTICAL INDUSTRIESAL OBOUR CITY INDUSTRIAL ZONE, AREA 14, 15 - PLOT NO. 12011 - CAIRO - EGYPTEGYPTOPHTHALMIC DROPS 1.0X1.0X3.0 ML BOTTLE22/03/2024
1159NDA/MAL/HDP/11264M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDFLAIROFROFLUMILAST250MCGHETERO LABS LIMITED (UNIT III)...22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X15.0 TABLET BLISTER16/03/2024
1160NDA/MAL/HDP/11265INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDNEUTASRECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR300MCG/0.5MLINTAS PHARMACEUTICALS LTD (BIOPHARMA DIVISION)PLOT NO. 423/P/A, SARKHEJ-BAVLA HIGHWAY, MORAIYA, TALUKA SANAND, AHMEDABAD- 382213, GUJARATINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE22/03/2024
1161NDA/MAL/HDP/11266I-CARE PHARMA LTDAIVEEN (U) LIMITEDIZ 500AZITHROMYCIN DIHYDRATE500MGCORONA REMEDIES PVT. LTDVILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER16/03/2024
1162NDA/MAL/HDP/11267CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCACHMAX-200CEFIXIME TRIHYDRATE200 MGINNOVA CAPTAB PVT. LTD1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER16/03/2024
1163NDA/MAL/HDP/11268DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDPARACO-DENK 1000/60PARACETAMOL + CODEINE PHOSPHATE HEMIHYDRATE1000 MG + 60 MGBENE-ARZNEIMITTEL GMBHHERTERTICHSTR. 1-3, 81479 MUNCHEN - GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP16/03/2024
1164NDA/MAL/HDP/11269INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDDOXORUBICIN INJECTIONDOXORUBICIN2MG/MLINTAS PHARMACEUTICALS LTD.PLOT NO. 457, 458, & 191/218P,VILLAGE: MATODA, TAL. SANAND, AHMEDABAD, GUJARAT, 382210 INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X25.0 ML VIAL22/03/2024
1165NDA/MAL/HDP/11270RUSAN PHARMA LTD.NORVIK ENTERPRISES LIMITEDADDNOK-N 2/0.5BUPRENORPHINE HYDROCHLORIDE + NALOXONE HYDROCHLORIDE2 MG + 0.5 MGRUSAN PHARMA LTDKHASRA NO. 122MI, CENTRAL HOPE TOWN, BEHIND PHARMA CITY, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY SUBLINGUAL TABLETS 1.0X3.0X10.0 TABLET BLISTER, 1.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER22/03/2024
1166NDA/MAL/HDP/11271LAURUS LABS LIMITED - BEYOND LOGISTICS LTDDOLUTEGRAVIR SODIUM 50 MG, EMTRICITABINE 200 MG AND TENOFOVIRAL AFENAMIDE 25 MGDOLUTEGRAVIR SODIUM + EMTRICITABINE + TENOFOVIR ALAFENAMIDE50 MG + 200 MG + 25 MGLAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE16/03/2024
1167NDA/MAL/HDP/11273LAURUS LABS LIMITED - BEYOND LOGISTICS LTDABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE TABLETSABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE600 MG + 50 MG + 300 MGLAURUS LABS LTD (UNIT 2)PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE, 1.0X180.0 TABLET BOTTLE, 1.0X90.0 TABLET BOTTLE16/03/2024
1168NDA/MAL/HDP/11274HILTON PHARMA (PVT) LTDBOOTS PHARMACEUTICALS LIMITEDDAPA 10MGDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE10 MGHILTON PHARMACEUTICALS (PVT) LIMITEDPLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER16/03/2024
1169NDA/MAL/HDP/11275INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSPIRONOLACTONESPIRONOLACTONE25MGINTAS PHARMACEUTICALS LIMITED CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1170NDA/MAL/HDP/11276CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 400/300/300 MG TABLETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400MG + 300MG + 300MGCIPLA LIMITEDPLOT NO. A-33, A-2 & A-37/2/2 (UNIT-I), A-42(UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRACIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARKUGANDAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER, 1.0X90.0 TABLET CONTAINER16/03/2024
1171NDA/MAL/HDP/11277SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDANGILOCK 50LOSARTAN POTASSIUM50 MGSQUARE PHARMACEUTICALS LIMITED - DHAKA UNITKALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER16/03/2024
1172NDA/MAL/HDP/11278 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-500AMOXICILLIN TRIHYDRATE500MGMILAN LABORATORIES (INDIA) PVT LTD,63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAIINDIAORAL SOLID ORDINARY CAPSULES 1.0X5.0X1.0X20.0 CAPSULE BLISTER16/03/2024
1173NDA/MAL/HDP/11279MSN LABORATORIES PRIVATE LIMITED,GOOD DAY PHARMACY LIMITEDSILOTRIF 8SILODOSIN8MG MSN LABORATORIES LTD. PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, ZIP CODE - 502 325, ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER16/03/2024
1174NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.DTRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIA ORAL SOLID ORDINARY COMBINATION PACK TABLETS 1.0X4.0 TABLET BLISTER01/07/2013
1175NDA/MAL/HDP/11280BRAWN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBRUGENTA EYE/EAR DROPSGENTAMICIN SULFATE0.3%W/VBRAWN LABORATORIES LTD .13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE16/03/2024
1176NDA/MAL/HDP/11281WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.GOODMAN INTERNATIONAL LTDSERTOFENDEXKETOPROFEN TROMETAMOL25MGWORLD MEDICINE ILAC SAN VE TIC A.S.15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER16/03/2024
1177NDA/MAL/HDP/11282WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ŏ.GOODMAN INTERNATIONAL LTDCULENTO 4MGMONTELUKAST SODIUM4MGWORLD MEDICINE ILAC SAN VE TIC A.S.15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEYTURKEYORAL SOLID ORDINARY GRANULES 1.0X28.0 SACHET CARTON16/03/2024
1178NDA/MAL/HDP/11283THE SEARLE COMPANY LIMITEDHEALTHCARE LTD.VAPTOR 10MGROSUVASTATIN CALCIUM10MGSEARLE PAKISTAN LIMITED,F-319, SITE KARACHIPAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER16/03/2024
1179NDA/MAL/HDP/11284MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDMYDEKLA 60DACLATASVIR DIHYDROCHLORIDE60MGMYLAN LABORATORIES LTD .F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X28.0 TABLET CONTAINER16/03/2024
1180NDA/MAL/HDP/11285JSC BIOCAD, SAINT PETERSBURGONCOPHARM (U) LTDBEVALASTBEVACIZUMAB25 MG/MLJSC BIOCAD NEUDORF, FACILITY 2BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515RUSSIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X16.0 ML VIAL, 1.0X1.0X4.0 ML VIAL, 1.0X1.0X100.0 MG VIAL, 1.0X1.0X400.0 MG VIAL22/03/2024
1181NDA/MAL/HDP/11286JSC BIOCADONCOPHARM (U) LTDACELLBIARITUXIMAB10 MG/MLJSC BIOCAD NEUDORF, FACILITY 2BLD. 38, CONSTRUCTION 1, SVYAZI ST., STRELNA, SAINT-PETERSBURG, RUSSIA, 198515RUSSIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X1.0X50.0 ML VIAL, 1.0X1.0X500.0 MG VIAL22/03/2024
1182NDA/MAL/HDP/11287LABORATÓRIOS BASIONCOPHARM (U) LTDMIDAZOLAM BASIMIDAZOLAM15 MG/3 MLLABORATORIOS BASI - INDUSTRIA FARMACEUTICAPARQUE INDUSTRIAL MANUEL LOURENCO FERREIRA, LOTES 8, 15 E 16, 3450-232 MORTAGUA - PORTUGALPORTUGALPARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE22/03/2024
1183NDA/MAL/HDP/11288MICRO LABS LIMITEDPHARMA VILLE LIMITEDPARACETAMOL BP 500MG TABLETPARACETAMOL 500MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/03/2024
1184NDA/MAL/HDP/11289MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDADCCLENA 5LENALIDOMIDE5MGMYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X14.0 CAPSULE BLISTER16/03/2024
1185NDA/MAL/HDP/11290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDADCCLENA 10LENALIDOMIDE10MGMYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X14.0 CAPSULE BLISTER16/03/2024
1186NDA/MAL/HDP/11291MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDADCCLENA 15LENALIDOMIDE15MGMYLAN LABORATORIES LTDPLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X14.0 CAPSULE BLISTER16/03/2024
1187NDA/MAL/HDP/11293PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOFECON 500MYCOPHENOLATE MOFETIL500MGCONCORD BIOTECH LIMITED297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X10.0 TABLET BLISTER22/03/2024
1188NDA/MAL/HDP/11294PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOFECON C-250MYCOPHENOLATE MOFETIL250 MGCONCORD BIOTECH LIMITED297-298/2P, AT. VALTHERA, TAL - DHOLKA, DIST - AHMEDABAD - 382225, GUJARAT - INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER22/03/2024
1189NDA/MAL/HDP/11295PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYGLI €“ 100SITAGLIPTIN100MGBAFNA PHARMACEUTICALS LIMITED UNIT IINO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1190NDA/MAL/HDP/11296PRISMA PHARMA FZEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYGLI-50SITAGLIPTIN50MGBAFNA PHARMACEUTICALS LIMITED UNIT IINO. 147, MADHAVARAM RED HILLS ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI, TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1191NDA/MAL/HDP/11297MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-AMOLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE40MG + 5MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1192NDA/MAL/HDP/11298MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-AMOLMESARTAN MEDOXOMIL + AMLODIPINE BESILATE20MG + 5MGMICRO LABS LIMITED, HOSURNO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/03/2024
1193NDA/MAL/HDP/11299LABORATÓRIOS VITÓRIA, S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRAUSANCITICOLINE SODIUM100MG/MLFAES FARMA SAMAXIMO AGUIRRE 14. 48940 LEIOA €“ SPAINSPAINORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X50.0 ML BOTTLE22/03/2024
1194NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS 500MGLINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2012
1195NDA/MAL/HDP/11309LABORATORIOS BASI INDUSTRIA FARMACEUTICA S.AHEAVENCENT THERAPEUTICS LIMITEDAZITHROMYCINAZITHROMYCIN500MGGUFIC BIOSCIENCES LIMITED (UNIT 2)SURVEY NO. 171, NATIONAL HIGHWAY NO. 8, NEAR GRID, AT & PO: KABILPORE, NAVSARI - 396424, GUJARAT - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL28/03/2024
1196NDA/MAL/HDP/1131FEROZSONS LABORATORIES LTDHEALTHCARE LTD.XAVOR 50LOSARTAN50MGFEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2014
1197NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITEDNO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP01/07/2012
1198NDA/MAL/HDP/11329AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDGLIMERON 4GLIMEPIRIDE 4MGAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER22/05/2024
1199NDA/MAL/HDP/11330MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDPREGASAFE M 75PREGABALIN + METHYLCOBALAMIN75 MG + 750 MCGMSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION-PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, INDIA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER24/05/2024
1200NDA/MAL/HDP/11331MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDALMOTAN 12.5ALMOTRIPTAN MALATE12.5 MGMSN LABORATORIES (PVT) LTD-FORMULATIONS DIVISION-PLOT NO. 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANAGAREDDY DISTRICT- 502-325-TELENGANA, INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X1.0 TABLET BLISTER22/05/2024
1201NDA/MAL/HDP/11332WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?.GOODMAN INTERNATIONAL LTDPIRETIKOLPARACETAMOL250MG/5MLWORLD MEDICINE ILAC SAN VE TIC A.S.-15 TEMMUZ MAHALLESI, CAMI YOLU CADDESI, NO: 50 K:4 WM PLAZA, GUNESIL-BAGCILAR/INSTANBUL, TURKEY TURKEY ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE24/05/2024
1202NDA/MAL/HDP/11333MERIDIAN ENTERPRISES PRIVATE LIMITED.VIDA AFRICA LTDNASO-FLOSODIUM CHLORIDE0.9%W/VMERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA INDIA NASAL SYSTEMIC DROPS 1.0X1.0X20.0 ML BOTTLE22/05/2024
1203NDA/MAL/HDP/11334MERIDIAN ENTERPRISES PRIVATE LIMITED.VIDA AFRICA LTDZORIN ADULTXYLOMETAZOLINE HYDROCHLORIDE0.1% W/VMERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA INDIA NASAL SYSTEMIC DROPS 1.0X1.0X10.0 ML BOTTLE24/05/2024
1204NDA/MAL/HDP/11335MERIDIAN ENTERPRISES PRIVATE LIMITED.VIDA AFRICA LTDZORIN PAEDIATRICXYLOMETAZOLINE HYDROCHLORIDE0.05% W/VMERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA INDIA NASAL SYSTEMIC DROPS 1.0X1.0X10.0 ML BOTTLE22/05/2024
1205NDA/MAL/HDP/11336MICRO LABS LIMITEDLABOREX UGANDA LIMITEDTOLSIN 0.4TAMSULOSIN HYDROCHLORIDE0.4 MGMICRO LABS LIMITED, HOSUR-NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA INDIA ORAL SOLID RETARD FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER22/05/2024
1206NDA/MAL/HDP/11337ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDROCIDMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE (250 MG + 250 MG)/5 MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA INDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE24/05/2024
1207NDA/MAL/HDP/11338MIDASCARE PHARMACEUTICALS PRIVATE LIMITED, ABACUS PHARMA (AFRICA) LIMITEDRELISPRAY DRDICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LEVOMENTHOL01.16 % W/W + 10.00 % W/W + 5% W/WMIDAS CARE PHARMACEUTICALS PVT LTD.-B-16 MIDC, WALUJ AURANGABAD 431136, MAHARASHTRA, INDIA INDIA TOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X55.0 G CANNISTER24/05/2024
1208NDA/MAL/HDP/11339ZUVENTUS HEALTHCARE LIMITEDNORVIK ENTERPRISES LIMITEDCORTIMAX 6 MGDEFLAZACORT6 MGM/S ZUVENTUS HEALTHCARE LIMITED (KAMEREY BHASMEY, ELAKA PAKYONG, RANGPO, EAST SIKKIM, 737132 - INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER11/06/2024
1209NDA/MAL/HDP/1134FEROZSONS LABORATORIES LTDHEALTHCARE LTD.XAVOR DIULOSARTAN AND HYDROCHLORTHIAZIDE50/12.5MGFEROZSONS LABORATORIES LTDAMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/07/2013
1210NDA/MAL/HDP/11340ZUVENTUS HEALTHCARE LIMITEDNORVIK ENTERPRISES LIMITEDCORTIMAX 12MGDEFLAZACORT12 MGM/S ZUVENTUS HEALTHCARE LIMITED (KAMEREY BHASMEY, ELAKA PAKYONG, RANGPO, EAST SIKKIM, 737132 - INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER11/06/2024
1211NDA/MAL/HDP/11341PUNISKA HEALTHCARE PRIVATE LIMITEDNORVIK ENTERPRISES LIMITEDAEPISETEMLEVETIRACETAM100 MG/MLPUNISKA HEALTHCARE PRIVATE LIMITED (SURVEY NO. 168/1/1, PIPAN, SANAND, DISTRICT - AHMEDABAD 380053, GUJARAT - INDIA)INDIAPARENTERAL ORDINARY VIALS 1.0X2.0X5.0 ML VIAL11/06/2024
1212NDA/MAL/HDP/11342SHREEJI CARE LIMITEDSHREEJI CARE LIMITEDDICLOFENACDICLOFENAC SODIUM 50MGGLOBELA PHARMA PVT.LTD.-357, 358, ROAD NO. 3, SACHIN G.I.D.C., SACHIN, SURAT - 394230, GUJARAT INDIA INDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1213NDA/MAL/HDP/11343SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDANGILOCK 25LOSARTAN POTASSIUM25MGSQUARE PHARMACEUTICALS LIMITED - DHAKA UNIT (KALIAKOIR GAZIPUR)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1214NDA/MAL/HDP/11344WOCKHARDT LTDSTAR PHARMACEUTICALS LTDZEDEX COLDACETAMINOPHEN + DEXTROMETHORPHAN HYDROBROMIDE + PHENYLEPHRINE HYDROCHLORIDE325 MG + 10 MG + 5 MGSOFTGEL HEALTHCARE PRIVATE LIMITED (20/1, VANDALUR - KELAMBAKKAM ROAD, PUDUPAKKAM VILLAGE, KANCHEEPURAM DISTRICT, TAMIL NADU - 603 103 - INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1215NDA/MAL/HDP/11345WOCKHARDT LTDSTAR PHARMACEUTICALS LTDZEDEX DACETAMINOPHEN + DEXTROMETHORPHAN HYDROBROMIDE + DOXYLAMINE SUCCINATE325 MG + 10 MG + 6.25 MGSOFTGEL HEALTHCARE PRIVATE LIMITED (20/1, VANDALUR - KELAMBAKKAM ROAD, PUDUPAKKAM VILLAGE, KANCHEEPURAM DISTRICT, TAMIL NADU - 603 103 - INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X25.0X4.0 CAPSULE BLISTER01/06/2024
1216NDA/MAL/HDP/11346MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTORSINEX-10TORSEMIDE10MGMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1217NDA/MAL/HDP/11347REDDYS PHARMA LIMITEDREDDYS PHARMA LIMITEDREDCEPHIN SLCEFTRIAXONE SODIUM + SULBACTAM SODIUM1000 MG + 500 MGINJECT CARE PARENTERALS PVT LTD (PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.5G VIAL01/06/2024
1218NDA/MAL/HDP/11348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDOTRINALXYLOMETAZOLINE HYDROCHLORIDE0.1%W/VABACUS PARENTERAL DRUGS LIMITED (PLOT 114, BLOCK 191, KINGA)UGANDANASAL TOPICAL DROPS 1.0X1.0X10.0 ML VIAL01/06/2024
1219NDA/MAL/HDP/11349VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDZINAVIR 750 MGCEFUROXIME SODIUM750MGINJECT CARE PARENTERALS PVT LTD (PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X750MG VIAL + 1.0X1.0X10.0ML WFI IN LDPE BOTTLE01/06/2024
1220NDA/MAL/HDP/11350BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDKLOVINALMETRONIDAZOLE + CLOTRIMAZOLE + LACTOBACILLUS SPORES500 MG + 100 MG + 150 MILLIONSBLISS GVS PHARMA LIMITED (10,11 & 12,DEWAN UDYOG NAGAR,ALIYALI,PALGHAR,MAHARASHTRA 401404,INDIA)INDIAVAGINAL TABLETS 1.0X1.0X6.0 PESSARY STRIP01/06/2024
1221NDA/MAL/HDP/11351AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDLOTELLOTEPREDNOL ETABONATE0.5%W/WAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) INDIA OPHTHALMIC GELS/SOLS 1.0X1.0X5.0 ML BOTTLE22/05/2024
1222NDA/MAL/HDP/11352AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDBRINZOXBRINZOLAMIDE1.0% W/VAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) INDIA OPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML BOTTLE22/05/2024
1223NDA/MAL/HDP/11353AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDBETOACTBEPOTASTINE BESILATE1.5% W/VAJANTA PHARMA LIMITED-MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM) INDIA OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE22/05/2024
1224NDA/MAL/HDP/11354ARCELIA LIFE SCIENCES LTD.NOVOMED HEALTHCARE LIMITEDTRANEXAMIC ACID TABLETS BP 500 MGTRANEXAMIC ACID500MGASSOCIATED BIOTECH-VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1225NDA/MAL/HDP/11355EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDMOLENA-200MOLNUPIRAVIR200MGEMCURE PHARMACEUTICALS LIMITED-PLOT NO. P-2. ITBT PARK, PHASE II, MIDC, HINJWADI PUNE 411057, MHARASHTRA STATE INDIA INDIA ORAL SOLID ORDINARY CAPSULES 1.0X1.0X40.0 CAPSULE CONTAINER22/05/2024
1226NDA/MAL/HDP/11357MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDDOVPRELAPRETOMANID200MGMYLAN LABORATORIES LIMITED-NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD - 431 136, MAHARASHTRA, INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X26.0 TABLET CONTAINER24/05/2024
1227NDA/MAL/HDP/11358BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDEVAFACTDIENOGEST2MGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER24/05/2024
1228NDA/MAL/HDP/11359ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDHALOSCOT 5HALOPERIDOL5MGM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1229NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA TOPICAL EXTERNAL EMULSIONS 1.0X1.0X100.0 ML BOTTLE01/07/2013
1230NDA/MAL/HDP/11360ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDHALOSCOT 10HALOPERIDOL10MGM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1231NDA/MAL/HDP/11361ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDETORIB 90ETORICOXIB90MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER24/05/2024
1232NDA/MAL/HDP/11362ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDETORIB 120ETORICOXIB120MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER24/05/2024
1233NDA/MAL/HDP/11363ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDETORIB 60ETORICOXIB60MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER24/05/2024
1234NDA/MAL/HDP/11364ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDDESLOSCOT-5DESLORATADINE5MGM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER24/05/2024
1235NDA/MAL/HDP/11365 CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 400/300/300 MG TABLETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400MG + 300MG + 300MGCIPLA LIMITED-PLOT NO. A-42 (UNIT-II), MIDC, PATALGANGA - 410220, DISTRICT: RAIGAD, MAHARASHTRA - INDIA INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER,1.0X90.0 TABLET CONTAINER24/05/2024
1236NDA/MAL/HDP/11366ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSCOZINC-20 DTZINC SULPHATE MONOHYDRATE20MGM/S SCOTT-EDIL PHARMACIA LTD -56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER24/05/2024
1237NDA/MAL/HDP/11367AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDACLOHERP 200ACICLOVIR200 MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0 TABLET BLISTER22/05/2024
1238NDA/MAL/HDP/11368AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDACLOHERP 400ACICLOVIR400MGAUROBINDO PHARMA LIMITED, UNIT - XV-PLOT NO. 17A, E BONANGI (V), PARAWADA (M), VISAKHAPATNAM DISTRICT, ANDHRA PRADESH. PIN: 531021 INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0 TABLET BLISTER22/05/2024
1239NDA/MAL/HDP/11369EUGIA PHARMA SPECIALITIES LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAMFONY 20TAMOXIFEN CITRATE20MGEUGIA PHARMA SPECIALITIES LIMITED-SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101 INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER22/05/2024
1240NDA/MAL/HDP/11370GAMA PHARMACEUTICALS (U) LIMITEDGAMA PHARMACEUTICALS (U) LIMITEDGYNO-DAKTAZOL OVULESMICONAZOLE NITRATE400MGJERUSALEM PHARMACEUTICALS CO. LTD-AL-BIREH RAMALLAH INDUSTRIAL ZONE, AL-BIREH NABLUS ROAD, P.O. BOX: 3570 PALESTINE PALESTINE VAGINAL SUPPOSITORIES 1.0X1.0X3.0 OVULE BLISTER22/05/2024
1241NDA/MAL/HDP/11371NVS KENYA LTD SURGIPHARM (U) LIMITEDPAGENAX 120 MG/MLBROLUCIZUMAB120 MG/MLNOVARTIS PHARMA STEIN AG STERILE OPERATIONS SOLID OPERATIONS-NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 STEIN - SWITZERLAND NOVARTIS PHARMA AG-LICHTSTRASSE 35 - 4056 BASEL, SWITZERLAND SWITZERLAND PARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL + 1*1 FILTER NEEDLE22/05/2024
1242NDA/MAL/HDP/11372BIOSIMILARS NEWCO LIMITEDKIMSY MEDS LTDOGIVRITRASTUZUMAB150MG/VIALBIOCON BIOLOGICS LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO. 2, 3, 4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMASANDRA POST, BENGALURU - 560099, INDIA INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X15.0 ML VIAL22/05/2024
1243NDA/MAL/HDP/11373HEALTH LINK PHARMACY LTDHEALTH LINK PHARMACY LIMITEDROYOMOL 500PARACETAMOL500 MGINNOVA CAPTAB PVT. LTD-1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.) INDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER22/05/2024
1244NDA/MAL/HDP/11376UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIFEN 10BACLOFEN10 MGUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER24/05/2024
1245NDA/MAL/HDP/11377CENTURION LABORATORIES PVT. LTD. SHREEJI PHARMACEUTICALS LIMITEDFERROUS SULFATE TABLETS BP 200 MGFERROUS SULFATE200MGCENTURION LABORATORIES PVT LTD (PLOT NO 2, BIO-TECH PARK, MANJUSAR, TAL-SAVLI VADODARA, GUJARAT INDIA)INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1246NDA/MAL/HDP/11378UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDUNIFEN 20BACLOFEN20MGUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER24/05/2024
1247NDA/MAL/HDP/11379LAURUS LABS LIMITED - BEYOND LOGISTICS LTDDARUNAVIR TABLETS 600 MGDARUNAVIR600MGLAURUS LABS LTD (UNIT 2) (PLOT NO. 19, 20 & 21 WESTERN SECTOR, APSEZ, ATCHUTAPURAM, 531011, VISAKHAPTNAM, ANDRA PRADESH,)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0.10.0 TABLET BLISTER01/06/2024
1248NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA TOPICAL EXTERNAL LOTIONS 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2013
1249NDA/MAL/HDP/11381LES LABORATOIRES SERVIERHARLEYS UGANDA LIMITEDDAFLON 500MGDIOSMIN 90% + HESPERIDIN 10%500MGSERVIER EGYPT INDUSTRIES LIMITED (SEI) (PLOT NO. 37 1ST INDUSTRIAL ZONE. PLOT NO. 184 - 8 2ND INDUSTRIAL ZONE €“ 6TH OCTOBER CITY GIZA - EGYPT)EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER01/06/2024
1250NDA/MAL/HDP/11382AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDGLIMERON 1GLIMEPIRIDE1MGAJANTA PHARMA LIMITED (MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM))INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1251NDA/MAL/HDP/11383MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMETAPIR 100TOPIRAMATE100MGMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1252NDA/MAL/HDP/11385BETA DRUGS LTDPHARMACINE UGANDA LIMITEDADCARB 450MG/45MLCARBOPLATIN10 MG/MLBETA DRUGS LIMITED-KHURUNI-LOHIMAJRA ROAD THE: BADDI, DISTT: SOLAN (H.P) - INDIA INDIA PARENTERAL ORDINARY VIALS 1.0X1.0X45.0 ML VIAL22/05/2024
1253NDA/MAL/HDP/11386MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMETAPIR - 50TOPIRAMATE50MGMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1254NDA/MAL/HDP/11389OMNICALS PHARMA PVT. LTDGITTOES PHARMACEUTICALS LIMITEDOMIZINC 20ZINC SULFATE MONOHYDRATE20MGTHE ACME LABORATORIES LIMITED-DHULIVITA, DHAMRAI, DHAKA - 1350, BANGLADESH INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER22/05/2024
1255NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE0.1%W/WAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2012
1256NDA/MAL/HDP/11390BHARAT SERUMS & VACCINES LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPHONEXAMPHOTERICIN B50MGBHARAT SERUM AND VACCINES LIMITED (PLOT NO. K-27 ADDITIONAL M.I.D.C INDIA)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X50.0 MG VIAL01/06/2024
1257NDA/MAL/HDP/11392AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTELMICLAR 80TELMISARTAN80MGAJANTA PHARMA LIMITED (MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM))INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1258NDA/MAL/HDP/11393AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDGLIMERON 3GLIMEPIRIDE3MGAJANTA PHARMA LIMITED (MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM))INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1259NDA/MAL/HDP/11395AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDGLIMERON 2GLIMEPIRIDE2MGAJANTA PHARMA LIMITED (MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM))INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1260NDA/MAL/HDP/11396AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDESMOLOC 40ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGAJANTA PHARMA LIMITED (PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130)INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1261NDA/MAL/HDP/11398AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDROSUCHOL -10ROSUVASTATIN10MGAJANTA PHARMA LIMITED (AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1262NDA/MAL/HDP/11399DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDOLOGAN DENKPARACETAMOL + IBUPROFEN + CAFFEINE250 MG + 200 MG + 50 MGARTESAN PHARMA GMBH & CO. KG-WENDLANDSTR.1, 29439, LUCHOW GERMANY ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER24/05/2024
1263NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2013
1264NDA/MAL/HDP/11400 ZIM LABORATORIES LTDREDDYS PHARMA LIMITEDCLARZIM 500CLARITHROMYCIN500MGZIM LABORATORIES LIMITED (B-21/22 MIDC AREA KALMESHWAR 441501, DIST NAGPUR, MAHARASHTRA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1265NDA/MAL/HDP/11401MICRO LABS LIMITEDLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE BILAYER TABLETS 50MG/135MGMICRO LABS LTD,-PLOT S-155 TO S-159, VERNA IND. ESTATE, PHASE III, VERNA-GOA-403722 INDIA ORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER22/05/2024
1266NDA/MAL/HDP/11402MICRO LABS LIMITEDLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE BILAYER TABLETS 25MG/67.25MGARTESUNATE + AMODIAQUINE HYDROCHLORIDE25MG/67.25MGMICRO LABS LTD,-PLOT S-155 TO S-159, VERNA IND. ESTATE, PHASE III, VERNA-GOA-403722 INDIA ORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER22/05/2024
1267NDA/MAL/HDP/11404AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDLASTAVIN AM 5/160AMLODIPINE + VALSARTAN5 MG + 160 MGAJANTA PHARMA LIMITED (AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1268NDA/MAL/HDP/11405MICRO LABS LIMITEDLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE BILAYER TABLETS 100MG/270MGARTESUNATE + AMODIAQUINE HYDROCHLORIDE100MG + 270MGMICRO LABS LTD,-PLOT S-155 TO S-159, VERNA IND. ESTATE, PHASE III, VERNA-GOA-403722 INDIA ORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER22/05/2024
1269NDA/MAL/HDP/11406MEDICAL UNION PHARMACEUTICALS.KARURI PHARMACEUTICALS LTD.INSULINAGYPT 70/30 100 IU/ML INJECTION 10 MLINSULIN HUMAN (RECOMBINANT DNA ORIGIN)100 IU/ML (70% ISOPHANE INSULINE + 30% REGUILAR INSULIN)MEDICAL UNION PHARMACEUTICALS, 6TH OCTOBER SITE (2ND INDUSTRIAL ZONE, PLOT NO. 1, STREET NO. 22, GIZA GOVERNORATE - EGYPT)EGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X10.0ML VIAL 21/06/2024
1270NDA/MAL/HDP/11407PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDITRAPINNITRACONALE100 MGPINNACLE LIFE SCIENCE PVT LTD (KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP))INDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X4.0 CAPSULE BLISTER01/06/2024
1271NDA/MAL/HDP/11408MEDOCHEMIE LTD.LABOREX UGANDA LIMITEDCELMANTIN 20ROSUVASTATIN CALCIUM20MGMEDOCHEMIE (FACTORY AZ). (2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL)CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1272NDA/MAL/HDP/11409ZOTA HEALTHCARE LTD.REDDYS PHARMA LIMITEDATRONA-10ATORVASTATIN CALCIUM10MGZOTA HEALTHCARE LIMITED (PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.X3.0X10.0 TABLET BLISTER01/06/2024
1273NDA/MAL/HDP/11410EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDSEVCAR 400SEVELAMER CARBONATE400MGEMCURE PHARMACEUTICALS LIMITED, (LANE NO.3, PHASE II SIDCO INDUSTRIAL COMPLEX BARI, BRAHMANA JAMMU (J&K) 181133 - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET Blister01/06/2024
1274NDA/MAL/HDP/11411EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDSEVCAR 800SEVELAMER CARBONATE800MGEMCURE PHARMACEUTICALS LIMITED, (LANE NO.3, PHASE II SIDCO INDUSTRIAL COMPLEX BARI, BRAHMANA JAMMU (J&K) 181133 - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1275NDA/MAL/HDP/11412LG CHEM, LTD. MM PARTNERS LOGISTICS LIMITEDEUPOLIOINACTIVATED POLIOVIRUS TYPE 1 (SABIN STRAIN) + INACTIVATED POLIOVIRUS TYPE 2 (SABIN STRAIN) + INACTIVATED POLIOVIRUS TYPE 3 (SABIN STRAIN)5 D-ANTIGEN UNITS + 8 D-ANTIGEN UNITS + 16 D-ANTIGEN UNITSLG CHEM LIMITED, OSONG PLANT- 151, OSONGSAENGMYEONG-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, HUNGCHEONGBUK-DO (POSTAL CODE: 28162) - REPUBLIC OF KOREANORTH KOREA PARENTERAL ORDINARY VIALS 1.0X10.0X2.5 ML VIAL,1.0X10.0X0.5 ML VIAL24/05/2024
1276NDA/MAL/HDP/11413BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXIN DISPERSIBLE 40/320DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40 MG + 320 MGBLISS GVS PHARMA LTD,-PLOT 10, SURVEY NO. 38/1, DEWAN UDYONG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE - INDIA INDIA ORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X3.0 TABLET BLISTER24/05/2024
1277NDA/MAL/HDP/11414AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBSTYLE 5NEBIVOLOL HYDROCHLORIDE5MGAUROBINDO PHARMA LIMITED UNIT 3-PLOT NO. 313, 314, BACHUPALLY, RR DIST. 500090 INDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER24/05/2024
1278NDA/MAL/HDP/11415NEXT WAVE (INDIA)REVITAL HEALTH CARE LTDMUPORIGMUPIROCIN2% W/WNEXT WAVE-RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P) INDIA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE22/05/2024
1279NDA/MAL/HDP/11416BIODEAL LABORATORIES LTD PLOT NO.123ABACUS PHARMA (AFRICA) LIMITEDPODOSAL PAINTPODOPHYLLUM RESIN20%W/VBIODEAL LABOARATORIES LTD (123, LUNGA LUNGA ROAD, INDUSTRIAL AREA, NAIROBI)KENYATOPICAL EXTERNAL LIQUIDS 1.0X1.0X10.0 ML Vial12/06/2024
1280NDA/MAL/HDP/11417 CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYTEL 80TELMISARTAN80MGEAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1281NDA/MAL/HDP/11418FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDACORATICAGRELOR90 MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED (7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400)BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0TABLET BLISTER21/05/2024
1282NDA/MAL/HDP/11419FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDAPTINVILDAGLIPTIN50MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED (7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400)BANGLADESHORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER21/05/2024
1283NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOL CLOTRIMAZOLE 1%W/WAGOG PHARMA LTDPLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIA TOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE01/07/2013
1284NDA/MAL/HDP/11420AJANTA PHARMA LIMTEDABACUS PHARMA (AFRICA) LIMITEDADERAN HTZ 8/12.5CANDESARTAN CILEXETIL + HYDROCHLOROTHIAZIDE8 MG + 12.5 MGAJANTA PHARMA LIMITED (MIRZA-PALASHBARI ROAD, VILLAGE-KOKJHAR, PALASHBARI 781128 KAMRUP(R.ASSAM))INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1285NDA/MAL/HDP/11421INFUGEN PHARMA PVT. LTD.TATA UGANDA LIMITEDINFUSUNATEARTESUNATE60 MG /VIALSANJAR PHARMACEUTICALS LIMITED-SURVEY NO. 622/2/1/4, DEDHROTA, TA- HIMATNAGAR, DIST SABARKANTHA, GUJARAT, INDIA INDIA PARENTERAL ORDINARY DRY VIALS 1.0X1.0X60.0 MG VIAL + 5ML CLEAR GLASS AMPOULE OF 0.9%W/V SODIUM CHLORIDE INJECTION BP + 1ML CLEAR GLASS AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION 22/05/2024
1286NDA/MAL/HDP/11422BIOMATRIX HEALTHCARE PVT LTD.-MEDIWORLD PHARMA AFRICA LTDCLEOBACT 300CLINDAMYCIN HYDROCHLORIDE300 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED-SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT INDIA ORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER22/05/2024
1287NDA/MAL/HDP/11423S KANT HEALTHCARE LTD -ABACUS PHARMA (AFRICA) LIMITEDSKLOBETACLOBETASOL PROPIONATE0.05% W/WS KANT HEALTHCARE LIMITED (1802 -1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA.)INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 TUBE01/06/2024
1288NDA/MAL/HDP/11424SERUM INSTITUTE OF INDIA PVT LTDNORVIK ENTERPRISES LIMITEDROTASIL - LIQUIDLIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT STRATIN [G1, G2, G3, G4 AND G9] ? 10^5.6 FFU /SEROTYPE PER DOSE (2.0 ML)SERUM INSTITUTE OF INDIA LTD .-PLOT NO. 212/2 HADAPSAR, OFF SOLI POONAWALLA ROAD, PUNE 411028 - INDIA INDIA ORAL LIQUID ORDINARY DROPS 1.0X50.0X4.0 ML VIAL22/05/2024
1289NDA/MAL/HDP/11425M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDSACUVAN 24/26SACUBITRIL + VALSARTAN24 MG + 26 MGHETERO LABS LIMITED (UNIT III)... (22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1290NDA/MAL/HDP/11426GLAXOSMITHKLINE BIOLOGICALS S.A. UNITED HEALTHCARE DISTRIBUTORS LTDMOSQUIRIXRTS,S (PLASMODIUM FALCIPARUM AND HEPATITIS B ANTIGEN )GLAXOSMITHKLINE BIOLOGICALS S.A-PARC DE LA NOIRE EPINE, AVENUE FLEMING 20-1300 WAVRE - BELGIUM GLAXOSMITHKLINE BIOLOGICALS-637 RUE DES AULMOIS, 59230 SAINT-AMAND-LES-EAUX BELGIUM PARENTERAL ORDINARY DRY VIALS 1.0X50.0X2.0 DOSE VIAL + 1*50*1ML GLASS VIAL OF DILUENT 24/05/2024
1291NDA/MAL/HDP/11427M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE TABLETS 600MG/50MG/300MGABACAVIR SULFATE + DOLUTEGRAVIR SODIUM + LAMIVUDINE600MG + 50MG + 300MGHETERO LABS LIMITED (UNIT V) (SY. NO. 439, 440, 441 & 458, POLEPALLY VILLAGE, JADCHERLA MANDAL MAHABOOBNAGAR DISTRICT, PIN-509 301, TELANGANA, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER01/06/2024
1292NDA/MAL/HDP/11428M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDSACUVAN 49/51SACUBITRIL + VALSARTAN49 MG + 51 MGHETERO LABS LIMITED (UNIT III)... (22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1293NDA/MAL/HDP/11429M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDGLINSIP 25SITAGLIPTIN PHOSPHATE25MGM/S. ANNORA PHARMA PRIVATE LIMITED (SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE €“ 502313, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER01/06/2024
1294NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITEDTRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT - INDIAINDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2012
1295NDA/MAL/HDP/11430M/S HETERO LABS LIMITEDAIVEEN (U) LIMITEDGLINSIP 50SITAGLIPTIN PHOSPHATE50 MGM/S. ANNORA PHARMA PRIVATE LIMITED (SY. NO. 261, ANNARAM VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELENGANA STATE €“ 502313, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER01/06/2024
1296NDA/MAL/HDP/11432CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCACHMONT-LC TABLETLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM5 MG + 10 MGCACHET PHARMACEUTICALS PVT LTD . (VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET Blister01/06/2024
1297NDA/MAL/HDP/11434CACHET PHARMACEUTICALS PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCACHMONT-LC SYRUPLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM(2.5 MG + 4 MG )/5 MLCACHET PHARMACEUTICALS PVT LTD . (VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205)INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60 ML BOTTLE01/06/2024
1298NDA/MAL/HDP/11436SYNOKEM PHARMACEUTICALS LIMITEDBIOGEN PHARMA LIMITEDLEVOCETRILEVOCETIRIZINE DIHYDROCHLORIDE5 MGSYNOKEM PHARMACEUTICALS LIMITED (SYNOKEM PHARMACEUTICALS LIMITED, PLOT NO. 35-36, SECTOR-6A, IIE, (SIDCUL), RANIPUR (BHEL), HARIDWAR, 249403, (UTTARAKHAND) - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 01/06/2024
1299NDA/MAL/HDP/11437NEXT WAVE (INDIA)DAVIMED PHARMA LIMITEDDAVIGRA-50SILDENAFIL CITRATE50 MGNEXT WAVE (RAMPUR GHAT ROAD, POANTA SAHIB, DISTRICT SIRMOUR 173025 (H.P))INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER01/06/2024
1300NDA/MAL/HDP/11438MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOFLAMETOFENAMATE10% W/WMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X50.0 G TUBE01/06/2024
1301NDA/MAL/HDP/11439ZOTA HEALTHCARE LTDREDDYS PHARMA LIMITEDZOTAMET 500METFORMIN HYDROCHLORIDE500MGZOTA HEALTHCARE LIMITED (PLOT NO. 169, SURAT SPECIAL ECONOMIC ZONE, NR. SACHIN RAILWAY SATTION, SACHIN - 394230, SURAT, GUJARAT)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.X10.0X10.0 TABLET BLISTER01/06/2024
1302NDA/MAL/HDP/11440MICRO LABS LIMITEDLABOREX UGANDA LIMITEDURYDOS-4SILODOSIN4 MGMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1303NDA/MAL/HDP/11441MICRO LABS LIMITEDLABOREX UGANDA LIMITEDURYDOS-8SILODOSIN8 MGMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1.0.X10.0 TABLET BLISTER01/06/2024
1304NDA/MAL/HDP/11442HILTON PHARMA (PVT) LTDLIFEWAY PHARMACEUTICALS LTDSITAGLU 50 MGSITAGLIPTIN PHOSPHATE50 MGHILTON PHARMACEUTICALS (PVT) LIMITED (PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900)PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER01/06/2024
1305NDA/MAL/HDP/11443AL ANDALOUS FOR PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDCARDIOTIMIDE 5 MGTORSEMIDE5MGAL ANDALOUS FOR PHARMACEUTICAL INDUSTRIES (PART NO. 7/6 - 6TH INDUSTRIAL AREA - 6TH OCTOBER CITY - GIZA)EGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER01/06/2024
1306NDA/MAL/HDP/11444HILTON PHARMA (PVT) LTDLIFEWAY PHARMACEUTICALS LTDSITAGLU 100 MGSITAGLIPTIN PHOSPHATE100 MGHILTON PHARMACEUTICALS (PVT) LIMITED (PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI-74900)PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER01/06/2024
1307NDA/MAL/HDP/11445BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDDICLOTRIXDICLOFENAC SODIUM50 MGBIOMATRIX HEALTHCARE PRIVATE LIMITED (SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT)INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1308NDA/MAL/HDP/11446INJECTCARE PARENTERALS PVT. LTDREDDYS PHARMA LIMITEDFORCILBENZYL PENICILLIN SODIUM1,000,000 UNITS (600MG) PER VIALINJECT CARE PARENTERALS PVT LTD (PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X60.0ML CONTAINER01/06/2024
1309NDA/MAL/HDP/11447FAROMED LIFESCIENCES LLPMETRO PHARMACEUTICALS LIMITEDSITAP 100SITAGLIPTIN PHOSPHATE MONOHYDRATE100MGADVANCED CHEMICAL INDUSTRIES (ACI) LIMITED (7, HAJEEGONJ ROAD, GOODNYL, NARAYANGONJ - 1400)BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET Blister21/05/2024
1310NDA/MAL/HDP/11448SYNOKEM PHARMACEUTICALS LIMITEDROYAL PHARMA 2011 LIMITEDIBURO-200IBUPROFEN200MGSYNOKEM PHARMACEUTICALS LIMITED (SYNOKEM PHARMACEUTICALS LIMITED, PLOT NO. 35-36, SECTOR-6A, IIE, (SIDCUL), RANIPUR (BHEL), HARIDWAR, 249403, (UTTARAKHAND) - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1311NDA/MAL/HDP/11449PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPISELPANTOPRAZOLE SODIUM40 MG/VIALPT SANBE FARMA UNIT 3. (JL INDUSTRI CIMAREME NO.8 PADALARANG 40533 BANDUNG)INDONESIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL01/06/2024
1312NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTDPLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTAN ORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE01/07/2005
1313NDA/MAL/HDP/11450 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDDICORATE ER 250DIVALPROEX SODIUM250MGSUN PHARMA LABORATORIES LIMITED (6-9, EPIP, KARTHOLI, BARI BRAHMANA, JAMMU - 181133 (JAMMU AND KASHMIR) - INDIA)INDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1314NDA/MAL/HDP/11454COSMOS LTD.ASTRA PHARMA (U) LIMITEDHARTEZE 10RIVAROXABAN10MGCOSMOS LTD..-RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI KENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER31/05/2024
1315NDA/MAL/HDP/11455COSMOS LTD.ASTRA PHARMA (U) LIMITEDHARTEZE 15RIVAROXABAN15MGCOSMOS LTD..-RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI KENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER31/05/2024
1316NDA/MAL/HDP/11456COSMOS LTD.ASTRA PHARMA (U) LIMITEDHARTEZE 20RIVAROXABAN20MGCOSMOS LTD..-RANGWE ROAD OFF, LUNA LUNGA ROAD, INDUSTRIAL AREA - NAIROBI KENYA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER31/05/2024
1317NDA/MAL/HDP/11457PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDROXPINN 20RIVAROXABAN20 MGPINNACLE LIFE SCIENCE PVT LTD (KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1318NDA/MAL/HDP/11458PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDPIXAB 5APIXABAN5 MGPINNACLE LIFE SCIENCE PVT LTD (KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1319NDA/MAL/HDP/11459LINCOLN PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDLIDOCAINE & ADRENALINE INJECTION BPLIDOCAINE HYDROCHLORIDE + ADRENALINE ACID TARTRATE(21.33 MG + 0.0125 MG)/MLLINCOLN PARENTERAL LTD . (11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT)INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X30.0ML, 1.0X1.0X50.0ML VIAL01/06/2024
1320NDA/MAL/HDP/11460AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANASOMA 1ANASTROZOLE1MGEUGIA PHARMA SPECIALITIES LIMITED (SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1321NDA/MAL/HDP/11461BIOMATRIX HEALTHCARE PVT LTD.-MEDIWORLD PHARMA AFRICA LTDLOPAGYLLOPERAMIDE HYDROCHLORIDE2MGBIOMATRIX HEALTHCARE PRIVATE LIMITED (SURVEY NO. 624, SARKHEJ - BAVLA HIGHWAY, VILLAGE: RAJODA, TAL. - BAVLA, DIST. - AHMEDABAD - 382 220, GUJARAT)INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0CAPSULE BLISTER01/06/2024
1322NDA/MAL/HDP/11462LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDLINEZODLINEZOLID600 MGLINCOLN PARENTERAL LTD . (11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1323NDA/MAL/HDP/11463LINCOLN PHARMACEUTICALS LTD.METRO PHARMACEUTICALS LIMITEDMAJEROLCARBAMAZEPINE200 MGLINCOLN PARENTERAL LTD . (11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/06/2024
1324NDA/MAL/HDP/11464CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCACHMAX- DSCEFIXIME TRIHYDRATE100MG/5MLINNOVA CAPTAB PVT. LTD (1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.))INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0ML BOTTLE, 1.0X1.0X100.0ML BOTTLE01/06/2024
1325NDA/MAL/HDP/11465PINNACLE LIFE SCIENCE PVT. LTDMETRO PHARMACEUTICALS LIMITEDROXPINN 10RIVAROXABAN10 MGPINNACLE LIFE SCIENCE PVT LTD (KHASRA NO. 1328 - 1330, VILLAGE MANPURA. TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH, 174101 - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1326NDA/MAL/HDP/11466CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDLYSOFLAMPARACETAMOL + DICLOFENAC POTASSIUM + SERRATIOPEPTIDASE500 MG + 50 MG + 15 MGCACHET PHARMACEUTICALS PVT LTD . (VILLAGE THANA, BADDI, TEHSIL-NALAGARH DIST. SOLAN, HIMACHAL PRADESH-173205)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1327NDA/MAL/HDP/11467ZUVENTUS HEALTHCARE LIMITEDNORVIK ENTERPRISES LIMITEDGUTCLEAR SYRUPLACTITOL MONOHYDRATE10 G/15 MLPINNACLE LIFE SCIENCE PVT LTD (KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP))INDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE01/06/2024
1328NDA/MAL/HDP/11468MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDNAT D 5000 IUCHOLECALCIFEROL5000 IUMEGA LIFESCIENCES PUBLIC CO. LTD (PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND)THAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X30 CAPSULE CONTAINER, 1.0X60.0 CAPSULE CONTAINER01/06/2024
1329NDA/MAL/HDP/11470AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 7.5LENALIDOMIDE7.5 MGEUGIA PHARMA SPECIALITIES LIMITED (SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101)INDIAORAL SOLID RETARD OTHER CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER01/06/2024
1330NDA/MAL/HDP/11471AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEDOBOOK 20LENALIDOMIDE20 MGEUGIA PHARMA SPECIALITIES LIMITED (SURVEY NO. 550, 551&552, KOLTHUR VILLAGE, SHAMEERPET MANDAL, MEDCHAL- MALKAJGIRI DISTRICT, TELANGANA, INDIA, 500101)INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X7.0 CAPSULE BLISTER01/06/2024
1331NDA/MAL/HDP/11473MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOROLORTICAGRELOR90 MGMICRO LABS LIMITED ., (92, SIPCOT, HOSUR 635126)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1332NDA/MAL/HDP/11475EMCURE PHARMACEUTICALS LTD -HARLEYS UGANDA LIMITEDJUSTEEZ 50VILDAGLIPTIN50MGEMCURE PHARMACEUTICALS LIMITED, (LANE NO.3, PHASE II SIDCO INDUSTRIAL COMPLEX BARI, BRAHMANA JAMMU (J&K) 181133 - INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER01/06/2024
1333NDA/MAL/HDP/11476AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTELFOCUS -H-80/12.5TELMISARTAN + HYDROCHLOROTHIAZIDE80 MG + 12.5 MGAUROBINDO PHARMA LTD, UNIT VII (SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,)INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1334NDA/MAL/HDP/11477BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBUCLAPOXIME 200CEFPODOXIME PROXETIL200MGBRAWN LABORATORIES LIMITED (13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1335NDA/MAL/HDP/11478AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTELFOCUS -H-40/12.5TELMISARTAN + HYDROCHLOROTHIAZIDE40 MG + 12.5 MGAUROBINDO PHARMA LTD, UNIT VII (SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,)INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1336NDA/MAL/HDP/11479AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTELFOCUS -H-80/25TELMISARTAN + HYDROCHLOROTHIAZIDE80 MG + 25 MGAUROBINDO PHARMA LTD, UNIT VII (SY. NO. 411/P, 425/P, 434/P, 435/P & 458/P, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (SEZ), TSIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHRLA MANDAL, MAHABOOB NAGA DISTRICT, PIN CODE: 509302,)INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1337NDA/MAL/HDP/11480MICRO LABS LIMITEDLABOREX UGANDA LIMITEDMOMESONEMOMETASONE FUROATE0.1% W/WMICRO LABS LIMITED, HOSUR (NO. 92, SIPCOT INDUSTRIAL COMPLEX, HOSUR 635126 TAMIL NADU - INDIA)INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE01/06/2024
1338NDA/MAL/HDP/11481INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRISPITAS 1RISPERIDONE1MGINTAS PHARMACEUTICALS LIMITED (CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND))INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER01/06/2024
1339NDA/MAL/HDP/11482ARCELIA LIFE SCIENCES LTD.PLUTO PHARMACEUTICALS LIMITEDARCELIA® CEFIXIMECEFIXIME200 MGASSOCIATED BIOTECH (VILLAGE: KISHANPURA, GUGUMAJRA ROAD, BADDI THE: NALAGARH HIMACHAL PRADESH 174101 - INDIA)INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0x1.0x10.0 TABLET Blister01/06/2024
1340NDA/MAL/HDP/11483ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDZINAXIME 750CEFUROXIME SODIUM750 MGINNOVA CAPTAB PVT. LTD (1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.))INDIAPARENTERAL ORDINARY DRY VIALS 1.0X750 MG VIAL (10.0ML CLEAR GLASS VIAL)01/06/2024
1341NDA/MAL/HDP/11484ACINO AGLABOREX UGANDA LIMITEDVICORDIA 5 MGIVABRADINE HYDROCHLORIDE5MGPHARMATHEN INTERNATIONAL S.A (INDUSTRIAL PARK SAPES, RODOPI PREFECTURE, BLOCK NO. 5, RODOPI 69300 - GREECE)GREECEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER01/06/2024
1342NDA/MAL/HDP/11485ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMAGMEN 625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500 MG + 125 MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED (HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER01/06/2024
1343NDA/MAL/HDP/11486ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDMAGMEN-312.5AMOXICILLIN + CLAVULANATE POTASSIUM250 MG + 62.5 MGM/S SCOTT-EDIL ADVANCE RESEARCH LABORATORIES AND EDUCATION LIMITED (HILL-TOP, INDUSTRIAL AREA, BHATOLI KALAN, BADDI, DISTT. SOLAN (HP) - 173205, INDIA)INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE01/06/2024
1344NDA/MAL/HDP/11488ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDZINAXIME DSCEFUROXIME AXETIL125MG/5MLINNOVA CAPTAB PVT. LTD (1281/1, HILTOP INDUSTRIAL ESTATE, NEAR EPIP PHASE-I, JHARMAJRI, BADDI-173205 (H.P.))INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0ML CONTAINER01/06/2024
1345NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..PLOT 13777 CLUB ROAD, PAST KIKUYUKENYA ORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER01/07/2015
1346NDA/MAL/HDP/11490ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFINRIVFINASTERIDE5 MGEAST AFRICAN (INDIA) OVERSEAS (PLOT NO.1, PHARMACITY SELAQUI DEHRADUN €“ 248011 (U.K), INDIA)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X10 G Tube01/06/2024
1347NDA/MAL/HDP/11491ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDOMESCOTOMEPRAZOLE SODIUM40 MG/VIALM/S SCOTT-EDIL PHARMACIA LTD (56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL (10.0ML AMBER GLASS) + 1.0X10.0ML AMPOULE, WFI IN LDPE BOTTLE01/06/2024
1348NDA/MAL/HDP/11492ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDCOCINEAMIKACIN SULFATE500MG/2MLM/S SCOTT-EDIL PHARMACIA LTD (56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA)CHINAPARENTERAL ORDINARY VIALS 1.0X1.0X2.0ML VIAL01/06/2024
1349NDA/MAL/HDP/11494ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDHYOSCINE BUTYLBROMIDE 20 MG/MLHYOSCINE BUTYLBROMIDE20 MG/MLM/S SCOTT-EDIL PHARMACIA LTD (56 EPIP, PHASE-I, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) INDIA)INDIAPARENTERAL ORDINARY AMPOULES 1X15 ML Bottle, 1X50 ML Bottle01/06/2024
1350NDA/MAL/HDP/11496SWISS PARENTERALS LTDSHREEJI CARE LIMITEDPHYLLINEAMINOPHYLLINE250MG/10MLSWISS PARENTERALS LIMITED (UNIT-1) (808, 809, 810, KERALA INDUSTRIAL ESTATE, GIDC, NR. BAVLA, AHMEDABAD - 382220, GUJARAT - INDIA)INDIAPARENTERAL ORDINARY AMPOULES 1.0X4.0X7.0 TABLET Blister22/05/2024
1351NDA/MAL/HDP/11497 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDDOLOKIND PLUSACECLOFENAC + PARACETAMOL100 MG + 325 MGMANKIND PHARMA LIMITED (UNIT - II, VILLAGE KISHANPURA, P.O. JAMNIWALA, TEHSIL PAONTA SAHIB, DISTRICT SIRMOUR - 173025, HIMACHAL PRADESH - INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/06/2024
1352NDA/MAL/HDP/11498AMN LIFE SCIENCE PVT LTDVITACARE LIMITEDAVAM 156AMOXICILIN TRIHYDRATE + POTASSIUM CLAVULANATE(125 MG + 31.25 MG)/5 MLAMN LIFE SCIENCE PVT LTD (67/P-1, MALAV, AREA-BHILAD, VALSAD-396105, GUJARAT)INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0x1.0x60.0 ML Container, 1.0x1.0x100.0 ML Container01/06/2024
1353NDA/MAL/HDP/11499BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDARMENATE-60ARTESUNATE60MG/VIALINDASI LIFESCIENCE PRIVATE LIMITED (PLOT NO. 73 TO 77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN - 396210, INDIA)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL OF 5.0ML VIAL OF 5.0% SODIUM CARBOTE + 2.5ML OF 0.9%W/V SODIUM CHLORIDE05/06/2024
1354NDA/MAL/HDP/1154 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITEDINDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

INDIA PARENTERAL ORDINARY DRY VIALS 1.0X30.0 ML VIAL01/07/2012
1355NDA/MAL/HDP/1158TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRAMADOL TRAMADOL50MGTRIVENI FORMULATIONS LTD .PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2012
1356NDA/MAL/HDP/1160DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS-CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEY ORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0 TABLET BLISTER01/07/2011
1357NDA/MAL/HDP/1163SHOSAAN ASIC PACIFICRENE PHARMACY LTDFRUSEMIDE FUROSEMIDE40MGNEM LABORATORIES PVT LTDPLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATEINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
1358NDA/MAL/HDP/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIA ORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
1359NDA/MAL/HDP/1166PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC PHARMA LIMITEDMALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2013
1360NDA/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.INDIA PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE01/07/2010
1361NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYAKENYA TOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE01/07/2009
1362NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE 5MGARISTO PHARMACEUTCALS PVT LTDPLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER01/07/2013
1363NDA/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.INDIA PARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL,1.0X30.0 ML VIAL01/07/2010
1364NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIA ORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER01/07/2013
1365NDA/MAL/HDP/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY MERCK SERONO SA-1170 AUBONNE(SWITZERLAND) ITALY, SWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON01/07/2015
1366NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
1367NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
1368NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANT DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYA ORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE01/07/2013
1369NDA/MAL/HDP/1188ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDGMYCIN-80GENTAMYCIN SULPHATE80MG/2MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE01/07/2013
1370NDA/MAL/HDP/1189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75 DICLOFENAC SODIUM75MG/ML REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINA PARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE01/07/2013
1371NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..PLOT 13777 CLUB ROAD, PAST KIKUYUKENYA TOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE01/07/2012
1372NDA/MAL/HDP/1198THEMIS MEDICARE LTD.STAR PHARMACEUTICALS LTDMALITHER INJECTIONARTEMETHER80MG/MLTHEMIS MEDICARE LTD SECTOR 6A ,PLOT NO. 16,17 & 18 IIE,BHEL SIDCUL,HARIDWAR UTTARAKHAND 249403INDIA PARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE01/07/2013
1373NDA/MAL/HDP/1199THEMIS MEDICARE LTDSTAR PHARMACEUTICALS LTDTHEMISET 75PALONOSETRON HYDROCHLORIDE0.075MG/1.5ML THEMIS MEDICARE LIMITEDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIA PARENTERAL ORDINARY VIALS 1.0X1.5 ML VIAL01/07/2013
1374NDA/MAL/HDP/1201THEMIS MEDICARE LTDSTAR PHARMACEUTICALS LTDTHEMISETPALONOSETRON HYDROCHLORIDE0.25MG/5ML THEMIS MEDICARE LIMITEDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIA PARENTERAL ORDINARY VIALS 1.0X1.5 ML VIAL01/07/2013
1375NDA/MAL/HDP/1204THEMIS MEDICARE LTDSTAR PHARMACEUTICALS LTDDEXEM INJECTIONDEXMEDETOMIDINE HYDROCHLORIDE 100THEMIS MEDICARE LTDSECTOR 6A, PLOT NO. 16 TO18, IIE, BHEL HARIDWA, UTTARAKHANDINDIA PARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE01/07/2013
1376NDA/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 KINGDOM TOPICAL EXTERNAL OTHER GELS/SOLS 1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER01/07/2013
1377NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTDPLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2011
1378NDA/MAL/HDP/1209MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2011
1379NDA/MAL/HDP/1211ASTRA ZENECA MACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA ABSE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDEN ORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER01/07/2011
1380NDA/MAL/HDP/1214FERRER INTERNACIONAL S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.AJOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAIN ORAL SOLID ORDINARY CAPSULES 1.0X2.0X15.0 CAPSULE BLISTER01/07/2013
1381NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIA VAGINAL SUPPOSITORIES 1.0X10.0 TABLET BLISTER01/07/2013
1382NDA/MAL/HDP/1219DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MG DENK PHARMA GMBH & CO. KG GOLLSTR. 1 84529 TITTMONINGGERMANY ORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER01/07/2014
1383NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART ARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITEDNO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIA ORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BLISTER01/07/2008
1384NDA/MAL/HDP/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTDBABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYA TOPICAL EXTERNAL OINTMENTS 1.0X1.0X25.0 G TUBE01/07/1997
1385NDA/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.INDIA ORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2005
1386NDA/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.
INDIA ORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP01/07/2007
1387NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTDPLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
1388NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICALS LTD .VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205INDIA ORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
1389NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK PHARMACEUTICALS LTD .VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205INDIA ORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/2014
1390NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER01/07/2012
1391NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTDVILL ISSAPUR P.O DAPPAR INDIAINDIA ORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER01/07/2013
1392NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED-RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYA ORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER01/07/1998
1393NDA/MAL/HDP/1255CIPLA LTD.ABACUS PHARMA (AFRICA) LIMITEDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTDMIDC PATALGANGA 410 220 DIST. RAIGADINDIA ORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER01/07/1997
1394NDA/MAL/HDP/1259IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ- 6.25CARVEDILOL6.25MG IPCA LABORATORIES LTDPLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2013
1395NDA/MAL/HDP/1261IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ-12.5CARVEDILOL12.5MG IPCA LABORATORIES LTDPLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIA ORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER01/07/2013
1396NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITED